chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Paraesthesia, Pyrexia, Rash macular
Clinical narrative: Fever, low back pain, tingling of arms & legs- starting 12 hours after injection, mildly responsive to OTC pain meds for 24 hours. Decreasing affects for additional 48 hours. Red splotches started appearing at sore injection site at 48 hrs & continuing to expand through present size of  4-1? splotches at current time of 90 hours after injection. Current pain level at injection site of 20% of pain at hour 12.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Large area of redness and swelling; very itchy as well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: Woke up with  beet red, hot face, no temperature. Back to normal by next morning.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Influenza, Influenza virus test negative, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sudden onset dizziness, lightheadedness, fever, body aches, rhinorrhea, nasal congestion, sinus pain and pressure, and sore throat. Symptoms only lasted a day and a half and then resolved on their own. (No harm was done and I recovered with no problems. I am a healthcare provider and thought that it was important to send). I thought that I had the flu because of the sudden onset and the symptoms so I returned to Clinic for a flu test that was negative.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Paranasal sinus discomfort, Pyrexia, Rhinorrhoea, Sinus pain
Clinical narrative: Sudden onset dizziness, lightheadedness, fever, body aches, rhinorrhea, nasal congestion, sinus pain and pressure, and sore throat. Symptoms only lasted a day and a half and then resolved on their own. (No harm was done and I recovered with no problems. I am a healthcare provider and thought that it was important to send). I thought that I had the flu because of the sudden onset and the symptoms so I returned to Clinic for a flu test that was negative.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain in arm that started a day and a half after vaccine administration (2/9/18). Pain has continued and on 4/10/18 pain increased and is limiting mobility. The patient states the pain is spreading to upper arm, shoulder and into the neck almost to spine. She is able to move arm but states it feels "heavy." She states it is a sharp pain and described it as an ache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, N-terminal prohormone brain natriuretic peptide increased, Neuralgia, Pyrexia, Tremor
Clinical narrative: Hi temperature, shaking, extreme nerve pain nausia muscle aches.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives on abdomen under breasts, arms, back.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood sodium decreased
Clinical narrative: Per patient, he had to go to hospital emergency room and was given iv fluids because there was sodium lost. He also stated that he was there for about 3 days.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Asthenia, Blood sodium decreased, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: Per patient, he had to go to hospital emergency room and was given iv fluids because there was sodium lost. He also stated that he was there for about 3 days.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Fall, Feeling cold, Slow response to stimuli, Somnolence
Clinical narrative: Per patient, he had to go to hospital emergency room and was given iv fluids because there was sodium lost. He also stated that he was there for about 3 days.
Age: 40.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Injection site rash, Joint stiffness, Lymphadenopathy
Clinical narrative: Patient developed a rash at injection site, that spread into armpit. The rash was painful, and the patient's axillary lymph nodes were swollen. Patient also developed arthralgia in the elbow below the injection site (left arm). He was treated with a course of azithromycin for possible infection. The rash resolved within days, but arthralgia in the elbow persists to present. Patient complains of soreness and stiffness in the joint, especially when trying to grip or lift with his left hand.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Petechiae, Pyrexia, Rash
Clinical narrative: "Shortly after" getting the second shot (absolutely no reaction to the first one) the arm broke out BELOW the injection site - nothing at the actual injection site. The patient describes the area to have looked as having looked like she had been stung by a LOT of bees or been punched in the arm repeatedly, very red to the point of looking bruised and with petechia. She states that she treated it with some over the counter hydrocortisone cream, which seemed to help. She presented to the pharmacy on 4/13 and showed me her arm and there was still some mild redness in a fairly large area below where the patient described the injection site to be; the patient says it is vastly improved over what it had been. The area was about the same size/general dimensions as an adult hand. She said she did run a low grade fever for a couple of days, but she had expected that.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: On the morning after receiving the shot, the patient called and reported a red, raised welt in the area the shot was given. Patient advised to watch for spread of welt or fever. On the second day after receiving the shot, the welt had spread to 2 inches below injection site and about 3 inches above and not quite halfway around the arm and she developed a fever of 99.8 degrees F. Shot was given subcutaneously rather than intramuscularly as indicated.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site reaction, Mobility decreased, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: Patient reports that her arm started feeling "stiff" and difficult to raise several hours after the shot. Claims it has become difficult to raise her arm above shoulder level. Reports flat, pink rash/discolored patch about 4" in diameter around injection site developed at some point during the night of injection. Rash does not itch, burn, or hurt. Presented to pharmacy on 3/13 and wanted us to be aware/document and suggest if she should follow up with provider. At that time pharmacist on duty noted rash as described above, but color was more faded than original day, according to patient. Verified rash was local to injection site, patient had no systemic symptoms, and advised patient to follow up with provider if mobility continued to be an issue or symptoms worsened/did not resolve.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Arthralgia, Erythema, Peripheral swelling
Clinical narrative: The patient stated her arm started swelling and turning red the evening of her immunization. Then the reaction progressed to aching and hurting joints all over the body. Her hands also began to swell. She went to an ER 2 days after the immunization. They prescribed her Naprosyn and Amoxicillin each for 5 days. She reported her adverse reaction to me on 4/14/18. I told her to take BENADRYL as well.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: PT HAD A BREAKOUT OF COLD SORE ON LIP AND RASH AROUND NECK AND CHEST 2 DAYS AFTER RECEIVING VACCINE, THEN A WEEK AFTER A SMALL RASH COMING ON RIGHT EYE BELOW EYEBROW.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Oral herpes, Rash
Clinical narrative: PT HAD A BREAKOUT OF COLD SORE ON LIP AND RASH AROUND NECK AND CHEST 2 DAYS AFTER RECEIVING VACCINE, THEN A WEEK AFTER A SMALL RASH COMING ON RIGHT EYE BELOW EYEBROW.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: I'm unsure of which brand of Dtap was used. My symptoms are severe pain in the injection arm (left), every joint in my body hurts almost as though I had been in an accident. I feel very weak and run down. I don't have a fever or any other symptoms. It is 04/14 now and I am still experiencing these symptoms. I've gotten a tetanus shot before and never had any of the issues I'm currently experiencing.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Malaise, Pain in extremity
Clinical narrative: Patient feeling severe pain the arm that started immediately after the vaccine. Also having difficulty breathing and is feeling really sick. The arm is very sore and red.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Body temperature, Pain, Skin warm, Swelling
Clinical narrative: Patient feeling severe pain the arm that started immediately after the vaccine. Also having difficulty breathing and is feeling really sick. The arm is very sore and red.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash pruritic, Swelling
Clinical narrative: After expected days of a sore arm, I now have an itchy rash with some local swelling 5 days after shot. No open sore. It's like a huge mosquito  bite. It just started so I will have to update with more information on the resolution. I took a photo if you want it.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, red raised pattern of skin where injection was given.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Within 24 hours of MENVEO administration, pt developed urticarial rash over L deltoid measuring 9 x 6 cm that was persisting at the time of revisit, approximately 48 hours after administration. Also reported mild tenderness at site. No edema observed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu like symptoms, soreness, redness, swelling at injection site for the last 4 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: Swollen, enlarged, hard, red and hot area on right arm from shoulder to elbow. Red, bloated, swollen and inflamed face. Severe headache. Arm did not fully recover until 3 weeks. Face subsided in symptoms in 2 weeks. Headache required ADVIL 2x day for a week.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Swelling face
Clinical narrative: Swollen, enlarged, hard, red and hot area on right arm from shoulder to elbow. Red, bloated, swollen and inflamed face. Severe headache. Arm did not fully recover until 3 weeks. Face subsided in symptoms in 2 weeks. Headache required ADVIL 2x day for a week.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Soreness in arm, injection site pain and general redness in the left arm.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood culture negative, Blood lactic acid normal, Cellulitis, Chest X-ray normal, Chills
Clinical narrative: On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cough, Fatigue, Headache, Hyperhidrosis, Influenza A virus test negative
Clinical narrative: On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Influenza B virus test, Influenza virus test negative, Nausea, Oropharyngeal pain, Pain
Clinical narrative: On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pharyngitis, Pyrexia, Streptococcus test, Streptococcus test negative, Systemic inflammatory response syndrome
Clinical narrative: On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Toxic skin eruption, Troponin I normal, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Bundle branch block, Chest pain, Chills, Electrocardiogram normal, Myocardial necrosis marker normal
Clinical narrative: Patient sought evaluation of chest pain with onset about 9 days post receipt of smallpox vaccination. Had experienced some chills, and body aches starting around 9 Apr, but on 13 Apr, sharp, shooting pains were noted on left side of chest. No changes with deep breaths or position changes. No dyspnea or palpitations. No /n/v or diaphoresis. SPV vaccine site progressing normally. In emergency room patient was evaluated for chest pain. She was afebrile and had negative ECG and normal troponin levels. ER physician thought pain was probably musculoskeletal and prescribed NSAIDs.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pain, Troponin normal
Clinical narrative: Patient sought evaluation of chest pain with onset about 9 days post receipt of smallpox vaccination. Had experienced some chills, and body aches starting around 9 Apr, but on 13 Apr, sharp, shooting pains were noted on left side of chest. No changes with deep breaths or position changes. No dyspnea or palpitations. No /n/v or diaphoresis. SPV vaccine site progressing normally. In emergency room patient was evaluated for chest pain. She was afebrile and had negative ECG and normal troponin levels. ER physician thought pain was probably musculoskeletal and prescribed NSAIDs.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest pain, Electroencephalogram normal, Pain in extremity
Clinical narrative: Patient sought evaluation of chest pain with onset about 9 days post receipt of smallpox vaccination. Had experienced some chills, and body aches starting around 9 Apr, but on 13 Apr, sharp, shooting pains were noted on left side of chest. No changes with deep breaths or position changes. No dyspnea or palpitations. No /n/v or diaphoresis. SPV vaccine site progressing normally. In emergency room patient was evaluated for chest pain. She was afebrile and had negative ECG and normal troponin levels. ER physician thought pain was probably musculoskeletal and prescribed NSAIDs.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: About 2 to 3 hours after received the vaccine the patient says her left arm starting to swell up and become red. It became worse throughout the evening but was improving by the next morning but was still swollen and red. When she went to the pharmacy the next day the pharmacist recommended taking BENADRYL.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Biopsy skin abnormal, Fibrous histiocytoma, Injection site nodule, Injection site scar, Injection site swelling
Clinical narrative: Developed skin bump at site of HPV injection on right lower deltoid a couple weeks after vaccination. Lesion grow over time. On 5/31/17 there was a 1.5 cm x 2 cm dermal nodule on right upper arm. Lesion excised 9/27/17. Path showed cellular benign fibrous histiocytoma. Now has wide scar and possible recurrence of the benign tumor of this site.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin lesion, Skin lesion removal
Clinical narrative: Developed skin bump at site of HPV injection on right lower deltoid a couple weeks after vaccination. Lesion grow over time. On 5/31/17 there was a 1.5 cm x 2 cm dermal nodule on right upper arm. Lesion excised 9/27/17. Path showed cellular benign fibrous histiocytoma. Now has wide scar and possible recurrence of the benign tumor of this site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Pruritus, Rash generalised, Urticaria
Clinical narrative: Headache, full body rash, hives, itchy after 1 hr post shot. Limited difficulty in swallowing. Relieved by BENADRYL.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 10 x 8 centimeter erythema around injection site.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, RVX
Symptoms: Grunting, Somnolence
Clinical narrative: She Fell into a very deep sleep, we were unable to wake or stimulate to wake her for up to 8 hours. She was grunting and trying to wake but would never open her eyes. Kept falling back into deep sleep. This went on for hours. She could not drink from bottle during this time. During the first 6 hours after her vaccines. We thought she was just sleeping longer than usual but once we realized she was having trouble waking the Situation went on for the remainder of the night. Unsure of brand of vaccine so I listed unknown- but she was given Hep B, DTaP, polio, rotavirus, and HIB - ALL AT ONCE.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported immediate redness, pain, and significant swelling around the entire circumference of her left arm from the shoulder down to the elbow within one hour of the vaccination. After initial consultation with a pharmacist that same day, she applied ice and took ibuprofen and diphenhydramine throughout the day. The next morning, she reported that the swelling improved a bit, but the arm was still red and painful and felt like "dead weight." Additionally, she reported a painful  lump in the crease of her inner elbow, about the size of a quarter raised to a height of 1/4 inch. She plans to go to Urgent Care for additional relief of the pain and swelling.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mass
Clinical narrative: Patient reported immediate redness, pain, and significant swelling around the entire circumference of her left arm from the shoulder down to the elbow within one hour of the vaccination. After initial consultation with a pharmacist that same day, she applied ice and took ibuprofen and diphenhydramine throughout the day. The next morning, she reported that the swelling improved a bit, but the arm was still red and painful and felt like "dead weight." Additionally, she reported a painful  lump in the crease of her inner elbow, about the size of a quarter raised to a height of 1/4 inch. She plans to go to Urgent Care for additional relief of the pain and swelling.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: Fever, weakness, muscle pain not relieved by Ibuprofen.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Nausea, Pruritus
Clinical narrative: The shot was given Wednesday around 1 PM and on Thursday around 4 PM I started having chills and nausea. Saturday morning I noticed a blister on my back Saturday night more blisters on my legs but very few and not in a row like a nerve track. Sunday morning a few more blisters appear. Basting an itch a little bit nothing severe at this time.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Back pain, Condition aggravated, Coordination abnormal
Clinical narrative: INCREASED BACK PAIN, LOSS OF COORDINATION.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Shoulder pain at injection site and joint area.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dehydration, Discomfort
Clinical narrative: Entire body is sensitive to movement in a negative way. Like extreme dehydration. Yet I drank over 1 gallon of water yesterday. No energy, not able to get comfortable in any position. Tylenol helps a little.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelids pruritus, Flushing, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The next morning, I woke up with a fever 98.8 and was nauseated. That afternoon, I started having sharp, stabbing pains in my thigh. I could not get an ultrasound (was concerned about blood clots) at our doctor's office, so I went to the Emergency Room of the local hospital. They did not find a blood clot, so they gave me some Tylenol and sent me home. The next day, the pain was gone, and I felt better, However, a week later, there was a rash on my face, and my eyelids were "itchy", so, for two nights, I took Benadryl (the morning after I had the shot, my face was flushed).  Monday morning, I called my doctor and reportd my reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Ultrasound scan normal
Clinical narrative: The next morning, I woke up with a fever 98.8 and was nauseated. That afternoon, I started having sharp, stabbing pains in my thigh. I could not get an ultrasound (was concerned about blood clots) at our doctor's office, so I went to the Emergency Room of the local hospital. They did not find a blood clot, so they gave me some Tylenol and sent me home. The next day, the pain was gone, and I felt better, However, a week later, there was a rash on my face, and my eyelids were "itchy", so, for two nights, I took Benadryl (the morning after I had the shot, my face was flushed).  Monday morning, I called my doctor and reportd my reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Eyelids pruritus, Fatigue, Gait disturbance, Hypersensitivity
Clinical narrative: The next morning, I woke up with a fever 98.8 and was nauseated. That afternoon, I started having sharp, stabbing pains in my thigh. I could not get an ultrasound (was concerned about blood clots) at our doctor's office, so I went to the Emergency Room of the local hospital. They did not find a blood clot, so they gave me some Tylenol and sent me home. The next day, the pain was gone, and I felt better, However, a week later, there was a rash on my face, and my eyelids were "itchy", so, for two nights, I took Benadryl (the morning after I had the shot, my face was flushed).  Monday morning, I called my doctor and reportd my reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash, Ultrasound scan normal
Clinical narrative: The next morning, I woke up with a fever 98.8 and was nauseated. That afternoon, I started having sharp, stabbing pains in my thigh. I could not get an ultrasound (was concerned about blood clots) at our doctor's office, so I went to the Emergency Room of the local hospital. They did not find a blood clot, so they gave me some Tylenol and sent me home. The next day, the pain was gone, and I felt better, However, a week later, there was a rash on my face, and my eyelids were "itchy", so, for two nights, I took Benadryl (the morning after I had the shot, my face was flushed).  Monday morning, I called my doctor and reportd my reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pyrexia, Swelling
Clinical narrative: Redness and swelling which began 24 hours after injection and progressed over the next 72 hours.  Associated initially with fever of 101. That lasted 12 hours. Generalize malaise.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient said she had chills and lots of shaking and says felt like she probably had a fever although she did not confirm by taking temperature.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site urticaria, Myalgia
Clinical narrative: I developed a very large raised welt at the injection site which has been slow to resolve. Also headache, muscle soreness particularly around my upper back and neck, as well as fatigue.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Shivering w/slight fever, joint aches, fatigue all began approx. 12 hours after injection and lasted approx. 30 hours. Pain at injection site began 12 hours after injection and is still present but diminishing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial vaccination in right arm was extremely painful, like no other vaccine ever received. By same evening, right arm hurt badly as if I was punched in the arm badly. Sore upper arm lasted for the next week. Later same evening began to feel achy and a little feverish. By following morning, could not go to work because I had chills, fever, aches, and developed what appeared to be a hive on my left 5th finger. The hive lasted at least a week before reducing but it now comes and goes. Other than the hive, I mostly recovered by day 2 and was OK to go back to normal activities by 3rd day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Initial vaccination in right arm was extremely painful, like no other vaccine ever received. By same evening, right arm hurt badly as if I was punched in the arm badly. Sore upper arm lasted for the next week. Later same evening began to feel achy and a little feverish. By following morning, could not go to work because I had chills, fever, aches, and developed what appeared to be a hive on my left 5th finger. The hive lasted at least a week before reducing but it now comes and goes. Other than the hive, I mostly recovered by day 2 and was OK to go back to normal activities by 3rd day.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient stated that she had red, swollen and painful area near to injection site. On april 13th, patient went to the doctor office and seek medical attention, dr believed that she had infection at the site of infection so she was given antibiotic (keflex).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash (hives) all over body. Legs, arms, back, face.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Pain and moderate swelling in armpit. Pain and swelling at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms, low grade fever, soreness, fatigue, general malaise, redness, swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Flu like symptoms, low grade fever, soreness, fatigue, general malaise, redness, swelling.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Diarrhoea, Fatigue
Clinical narrative: Flu-like symptoms, temperature of 102.1, headache, fatigue, nausea, weakness when standing, stomach cramps, diarrhea, frequent urination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pollakiuria
Clinical narrative: Flu-like symptoms, temperature of 102.1, headache, fatigue, nausea, weakness when standing, stomach cramps, diarrhea, frequent urination.
Age: 0.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 24 HOURS POST INJECTION: ERYTHEMA SURROUNDING INJECTION SITE, HOT TO TOUCH. 48 HOURS POST INJECTION: ERYTHEMA INCREASED 4X TIMES ORIGINAL SIZE SURROUNDING INJECTION SITE, HOT TO TOUCH.
Age: 34.0
Sex: F
Vaccine: ANTH, MMR, TYP
Symptoms: Dysgeusia, Dysphagia, Dysphonia, Energy increased, Injection site pain
Clinical narrative: Within minutes of vaccine receipt, patient suddenly felt very energetic/amped up but cannot specifically recall heart racing or palpitations. Then noted a strong metallic taste in her throat. Walked from immunizations to flight med for PHA and about 5 min later developed raspy voice and frequent throat clearing with lump in throat sensation and trouble swallowing. Her clinic recommended ER evaluation after checking her vitals which were reported as normal. She was taken to local ER where throat symptoms were documented without hives or flushing. Normal BP 123/93 and HR= 64 bpm. Was treated with solumedrol, benadryl and famotidine. Released when symptoms had resolved and went home where she slept for 4 hours. No further symptoms reported. Neither shoulder swelled or was immediately red or painful but the site where she received her anthrax injection was achy about 1 week later.
Age: 34.0
Sex: F
Vaccine: ANTH, MMR, TYP
Symptoms: Sensation of foreign body, Skin test, Throat irritation
Clinical narrative: Within minutes of vaccine receipt, patient suddenly felt very energetic/amped up but cannot specifically recall heart racing or palpitations. Then noted a strong metallic taste in her throat. Walked from immunizations to flight med for PHA and about 5 min later developed raspy voice and frequent throat clearing with lump in throat sensation and trouble swallowing. Her clinic recommended ER evaluation after checking her vitals which were reported as normal. She was taken to local ER where throat symptoms were documented without hives or flushing. Normal BP 123/93 and HR= 64 bpm. Was treated with solumedrol, benadryl and famotidine. Released when symptoms had resolved and went home where she slept for 4 hours. No further symptoms reported. Neither shoulder swelled or was immediately red or painful but the site where she received her anthrax injection was achy about 1 week later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, warm and painful the evening of the injection. The following morning the redness and swelling had increased in color and size. That evening the patient measured the length and width of the red, swollen area and it was 3 inches by 2 inches. The area was warm to the touch and still painful. The morning of the third day after the injection the area of redness and swelling had grown to 3 1/2 inches by 2 1/2 inches. The patient went to convenient care and was seen by a PA-C. Throughout this time period the site was treated with an ice pack and MOTRIN. The patient was told to continue the icing and MOTRIN and monitor the injection site for another 24 hours and report back to the PA-C as to any changes in size of redness and swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site rash, Lethargy, Mobility decreased
Clinical narrative: Normal pain at injection site, but realized she could not lift arm very high, but that went away. She felt lethargic and tired on Friday and Saturday night (4/13 and 4/14 respectively). Come the morning of Sunday 4/15, she took a shower and noticed 4 raised bumps on deltoid of the arm she received the injection. These are almost in a curved line from the injection site, though there is not a raised bump at the injection site. Patient is not upset or mad, just felt the need to tell a healthcare professional about the occurrence and will still get the 2nd dose in the SHINGRIX series.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Rash, Tenderness
Clinical narrative: 4/9/2018 left arm pain and redness, painful to the touch. On 4-12-18 rash on neck and right side of face appeared. Patient went to PCP who instructed her to take BENADRYL and go to eye doctor. Eye doctor said there was no eye involvement, that she was ok.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever, onset about 9 PM, lasting until about 5 AM; body aches; overall fatigue a couple hours prior to fever onset. No symptoms after fever besides muscle stiffness at injection site, which resolved in about 1 week.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Induration of Left arm; redness, heat, muscle hard to palpation.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: PATIENT REPORTED SWELLING AND REDNESS. LASTED APPROX 1 WEEK.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Dyskinesia, Pyrexia, Seizure like phenomena
Clinical narrative: Extreme chills that seemed like a seizure - no control over limbs, fever of 102, diarrhea.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Dyskinesia, Motor dysfunction, Pyrexia
Clinical narrative: Extreme chills that seemed like a seizure - no control over limbs, fever of 102, diarrhea.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Seizure
Clinical narrative: Extreme chills that seemed like a seizure - no control over limbs, fever of 102, diarrhea.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness radiating down patient's arm from injection site (half arm is red). Patient received prescriptions for BENADRYL, ZANTAC, ibuprofen. Just started on medications.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Same day: Acute stinging; red swelling; hot to the touch; quite sore. 1 day later: Asthma attack with asthma cough and wheezing; red swelling 3 in. diameter; hot feverish at site; quite sore. Queasy and mild nausea. Strong flu-like fatigue. Slept 15 hours. 2 days later: Sore and swollen. Feverish at site. Mild headache. Sleepy again. 3 days later: Swollen and feverish at site. Less sore. 4 days later: Swollen but receding, Warm at site. Less sore. 5 days later (today): Swelling gone, but still warm at site. Only slightly sore. NOTE: Patient had ZOSTAVAX shingles vaccine August 31, 2012 with no adverse effects.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain, Somnolence, Swelling
Clinical narrative: Same day: Acute stinging; red swelling; hot to the touch; quite sore. 1 day later: Asthma attack with asthma cough and wheezing; red swelling 3 in. diameter; hot feverish at site; quite sore. Queasy and mild nausea. Strong flu-like fatigue. Slept 15 hours. 2 days later: Sore and swollen. Feverish at site. Mild headache. Sleepy again. 3 days later: Swollen and feverish at site. Less sore. 4 days later: Swollen but receding, Warm at site. Less sore. 5 days later (today): Swelling gone, but still warm at site. Only slightly sore. NOTE: Patient had ZOSTAVAX shingles vaccine August 31, 2012 with no adverse effects.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Same day: Acute stinging; red swelling; hot to the touch; quite sore. 1 day later: Asthma attack with asthma cough and wheezing; red swelling 3 in. diameter; hot feverish at site; quite sore. Queasy and mild nausea. Strong flu-like fatigue. Slept 15 hours. 2 days later: Sore and swollen. Feverish at site. Mild headache. Sleepy again. 3 days later: Swollen and feverish at site. Less sore. 4 days later: Swollen but receding, Warm at site. Less sore. 5 days later (today): Swelling gone, but still warm at site. Only slightly sore. NOTE: Patient had ZOSTAVAX shingles vaccine August 31, 2012 with no adverse effects.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Initially had a bump that formed but has gone down. It spread then down front of arm about a 2 by 5 inch on bicep area a few inches from top of shoulder. It was itchy, warm and red for a few days but seems that it is going away now. After shot patient stated that her had felt like getting stiff but does not feel that way no longer.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: PATIENT REPORTS LINGERING ARM PAIN THAT INTERFERES WITH SOME DAILY ACTIVITIES.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Pt experienced redness at injection site and to the front of the arm with reduced range of motion. Arm was extremely sore to the touch and was still red three days later. Pt also experienced a low-grade fever on both sides of the head that did resolve with administration of ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (R) thigh red, swollen and warm.
Sex: M
Vaccine: FLUR3, PPV
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from the health authority (under reference number: 720141) in the United States on 03-Apr-2018. This case involves a 76-year-old male patient who received a dose of FLUBLOK TIV (batch number: QFAA1702, expiry date not reported) intramuscularly in the left arm on 04-Oct-2017 and also received a dose of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (PPV) (batch number, expiry date dose, dose in series, site and route of administration was not reported) on 04-Oct-2017. The patient's medical history was not reported. It was unknown if the subject received FLUBLOK in the past. Concomitant medications included an unspecified pneumococcal vaccine. On 04-Oct-2017, same day post vaccination, the patient experienced cellulitis. Laboratory investigation was not reported. It was unknown if any corrective treatment was provided. The outcome of event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event cellulitis. List of documents held by sender: none. Sender's Comments: This patient developed cellulitis following vaccination with FLUBLOK TIV. Time to onset was compatible. The company's assessment of the causal relationship between cellulitis and FLUBLOK is related. However, additional information including condition at the time of vaccination, medical history, previous vaccinations and tolerance, lab test ruling out other infectious etiology and concomitantly administered Pneumococcal vaccine relatedness is needed to confirm the causality.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a other health professional and described the occurrence of shingles in a 60-year-old male patient who received SHINGRIX. On 9th March 2018, the patient received SHINGRIX. On 13th March 2018, 4 days after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: On 15th March 2018, the patient was diagnosed with shingles.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laryngeal oedema, Laryngoscopy abnormal, Muscle spasms, Myositis, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of laryngeal edema in a 75-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced laryngeal edema (serious criteria GSK medically significant), myositis and muscle spasm. The patient was treated with Steroids. On an unknown date, the outcome of the laryngeal edema, myositis and muscle spasm were unknown. It was unknown if the reporter considered the laryngeal edema, myositis and muscle spasm to be related to SHINGRIX. Additional information was received as follows: The age at administration was not reported. The patient never had the reaction to anything. The patient reported that the patient had acute myositis in his quadricep  muscles 1 day after vaccination, spasm  of masseter muscles 2 days later vaccination and had severe edema of his posterior larynx (airway), later requiring a course of steroids. The patient was concerned about getting the follow up booster dose and asking for any suggestion.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laryngeal oedema, Muscle spasms, Myositis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of laryngeal edema in a 75-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced laryngeal edema (serious criteria GSK medically significant), myositis and muscle spasm. The patient was treated with Steroids. On an unknown date, the outcome of the laryngeal edema, myositis and muscle spasm were unknown. It was unknown if the reporter considered the laryngeal edema, myositis and muscle spasm to be related to SHINGRIX. Additional information was received as follows: The age at administration was not reported. The patient never had the reaction to anything. The patient reported that the patient had acute myositis in his quadricep  muscles 1 day after vaccination, spasm  of masseter muscles 2 days later vaccination and had severe edema of his posterior larynx (airway), later requiring a course of steroids. The patient was concerned about getting the follow up booster dose and asking for any suggestion.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT GOT SHINGLES 2 WEEKS AFTER THE VACCINE WAS GIVEN. PATIENT NOTICED RASH ON 3/29/18.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PATIENT GOT SHINGLES 2 WEEKS AFTER THE VACCINE WAS GIVEN. PATIENT NOTICED RASH ON 3/29/18.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Malaise, Pain in extremity
Clinical narrative: Swelling, hot upon touch, Pt claims temperature and Pain.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Body temperature, Pain, Skin warm, Swelling
Clinical narrative: Swelling, hot upon touch, Pt claims temperature and Pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Induration, Pyrexia
Clinical narrative: Large induration 3-4inches, high fever, chills, headache.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 26 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. In 2016, the patient received 1st dose in GARDASIL 9 series (dose, route, lot# and expiration date were not reported) for prophylaxis. On 28-MAR-2018, the patient received 2nd dose in GARDASIL 9 series (lot# N013276, expiration date 21-JAN-2020; dose and route were not reported) (Inappropriate schedule of vaccine administered). No adverse effects were reported. No product quality complaints was filed.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse regarding a male patient of unknown age. Pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. On 04-APR-2018 the patient was vaccinated with PNEUMOVAX 23 lot # N030986 with expiry date of 11-MAY-2019 for vaccination (prophylaxis). On 05-APR-2018, the patient was seen at a healthcare center due to complaint of injection site pain at unspecified location (vaccination site pain). The patient had a bright red, warm to touch area over the injection site and streaking on shoulder and axilla along with mild swelling (Adverse event). No laboratory tests were done. Patient received treatment with non-steroidal anti-inflammatory drugs 3 times a day and ice the injection site area. Outcome and causality of the events were not reported. No product quality complaint was involved.