chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Monocyte count, Neutrophil count, Platelet count, Protein total, Prothrombin time
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell count, Red cell distribution width, Troponin I, White blood cell count
Clinical narrative: 10 days after receiving vaccine, I developed chest pains and shortness of breath. All the symptoms of a heart attack. Felt like a 200 pound of pressure on my chest. After 10 days I felt fine with no lingering pressure or pain.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Streptococcal infection, Streptococcus test positive
Clinical narrative: Patient reports lip swelling in the evening of flu vaccine, resolved 3 days later. She did not call the clinic or go to ER, she came in on 12.07.18 and was positive for strep infection antibiotic was given.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient gave birth following birth advised to have MMR booster as patient's titers were low. Patient given MMR vaccine following MMR vaccination by 3 days proximally on the 17th patient began to have a rash starting about the high thigh across the body and back but not extending to the arms. Described as mildly pruritic. Patient came into the facility concerned because she is a breast-feeding new mother.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site indentation, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swollen, very red from shoulder to elbow, extreme pain in whole arm, swelling caused an indent at injection site but no open area. This started on the following morning after the injection. These symptoms lasted through Tuesday, December 18th, then it began to resolve with less swelling and redness. Pain decreased then, but arm is still sore to touch in the area of the injection.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Exercise tolerance decreased, Fatigue, Feeling abnormal
Clinical narrative: I'm in a facility and on the month of October I was called to get the flu vaccine. Within a couple of hours I started to feel bad. The next day I woke up with fever, body aches, a headache, it was hard to breathe, my feet had a lot of red spots and they hurt when I walked, sweating and tiredness. After 2 days of the symptoms I couldn't not stand it anymore and filled out a form to be seen at the clinic. After 3 days of sending the request, the nurse asked whether I had received the flu vaccine. I told her yes and she asked me when; I told her 1 week ago. She asked me when the symptoms started and I told her that they started on the same day as the vaccine. She started to examine me and noted that I had high fever and a lot of red spots on my feet and that I could barely walk. She sent me to the doctor who he saw that I was not well so they sent me as an emergency to the hospital. I stayed there for 1 week and on 10/30/18 I was discharged. When I returned to the facility the doctor prescribed antibiotics because I still could not walk well and the red spots on my feet had not disappeared. Today I can walk but only a little. I can't walk too much because my feet hurt and I can't do any sports or exercise because my body aches.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Malaise, Pain
Clinical narrative: I'm in a facility and on the month of October I was called to get the flu vaccine. Within a couple of hours I started to feel bad. The next day I woke up with fever, body aches, a headache, it was hard to breathe, my feet had a lot of red spots and they hurt when I walked, sweating and tiredness. After 2 days of the symptoms I couldn't not stand it anymore and filled out a form to be seen at the clinic. After 3 days of sending the request, the nurse asked whether I had received the flu vaccine. I told her yes and she asked me when; I told her 1 week ago. She asked me when the symptoms started and I told her that they started on the same day as the vaccine. She started to examine me and noted that I had high fever and a lot of red spots on my feet and that I could barely walk. She sent me to the doctor who he saw that I was not well so they sent me as an emergency to the hospital. I stayed there for 1 week and on 10/30/18 I was discharged. When I returned to the facility the doctor prescribed antibiotics because I still could not walk well and the red spots on my feet had not disappeared. Today I can walk but only a little. I can't walk too much because my feet hurt and I can't do any sports or exercise because my body aches.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I'm in a facility and on the month of October I was called to get the flu vaccine. Within a couple of hours I started to feel bad. The next day I woke up with fever, body aches, a headache, it was hard to breathe, my feet had a lot of red spots and they hurt when I walked, sweating and tiredness. After 2 days of the symptoms I couldn't not stand it anymore and filled out a form to be seen at the clinic. After 3 days of sending the request, the nurse asked whether I had received the flu vaccine. I told her yes and she asked me when; I told her 1 week ago. She asked me when the symptoms started and I told her that they started on the same day as the vaccine. She started to examine me and noted that I had high fever and a lot of red spots on my feet and that I could barely walk. She sent me to the doctor who he saw that I was not well so they sent me as an emergency to the hospital. I stayed there for 1 week and on 10/30/18 I was discharged. When I returned to the facility the doctor prescribed antibiotics because I still could not walk well and the red spots on my feet had not disappeared. Today I can walk but only a little. I can't walk too much because my feet hurt and I can't do any sports or exercise because my body aches.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Rash on left leg at a possible site of injection there seems to be an enlarged redness area and bump that is a little hard it was not there at time of vaccine injection it appeared when rash appeared. Rash all over the body. Did have a low grade fever 4 days prior to rash appearing, no other Sx noted. Appeared 12/25 morning. Provider suggested to try hydrocortisone cream 1%. As mother had already tried BENADRYL and BENADRYL cream with no relief.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash on left leg at a possible site of injection there seems to be an enlarged redness area and bump that is a little hard it was not there at time of vaccine injection it appeared when rash appeared. Rash all over the body. Did have a low grade fever 4 days prior to rash appearing, no other Sx noted. Appeared 12/25 morning. Provider suggested to try hydrocortisone cream 1%. As mother had already tried BENADRYL and BENADRYL cream with no relief.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Musculoskeletal stiffness, Skull X-ray, Syncope
Clinical narrative: Pt had episode of syncope directly after administration of vaccine. Pt fell off exam table and bumped his head on the floor by his right eyebrow. Pt body stiffened up for approximately 20 seconds.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Erythema, Skin warm
Clinical narrative: The large red patch began and spread with finger like things coming from it and it was hot. The doctor said I had a bacteria infection and prescribed an antibiotic. Patients should be made aware that the vaccine is mixed on site i.e the powder and the liquid. There must have been some slip between the cup and the lip.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Fatigue, Neuralgia, Pain
Clinical narrative: Next morning I hurt all over. Drank tea. Very tired next week. Following Tuesday my left thigh nerves were on fire. Hurt to put on slacks, sit, etc. called doc after taking ALEVE Back and Muscle. Given steroid taper, helped w/pain. When pills ran out, pain in thigh and knee returned. They wanted to inject hip w/steroid. Pain subsided and I said no to injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray limb abnormal, X-ray of pelvis and hip abnormal
Clinical narrative: Next morning I hurt all over. Drank tea. Very tired next week. Following Tuesday my left thigh nerves were on fire. Hurt to put on slacks, sit, etc. called doc after taking ALEVE Back and Muscle. Given steroid taper, helped w/pain. When pills ran out, pain in thigh and knee returned. They wanted to inject hip w/steroid. Pain subsided and I said no to injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Asthenopia, Balance disorder, Chills, Condition aggravated
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Concurrent medical conditions included nonspecific reaction (the patient had some symptoms before vaccination). On 11th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and unsteadiness. In December 2018, the patient experienced pain in arm (serious criteria other: serious as per reporter), chills, increased urinary frequency, painful respiration, burning in throat and erythema of extremities. On an unknown date, the patient experienced condition aggravated. The patient was treated with BENADRYL. On an unknown date, the outcome of the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and erythema of extremities were recovered/resolved and the outcome of the unsteadiness and condition aggravated were unknown. It was unknown if the reporter considered the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head, erythema of extremities, unsteadiness and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Less than a day, after receiving SHINGRIX, at same night she experienced pain in the same arm (left) in which she received the injection. The pain lasted for a few days. Less than a day, after receiving SHINGRIX, at the same night she also experienced an increase in urinary frequency, going to the bathroom 4 times during the night and also stated that her breathing felt uncomfortable. Less than week after receiving SHINGRIX, her throat felt like it was burning and her left arm was a little red as well. She also experienced chills. When she woke up the next day, she felt wobbly and weak, her neck was tight, ears were stuffy and her eyes felt weighted. She also felt like there was 20 lbs of weight on her head. The patient took a BENADRYL and that it helped a little bit, but did not help much. She felt like she had some of these symptoms prior to receiving the vaccine, however, she felt like these symptoms were intensified after receiving the vaccine. The reporter did not consent to follow-up. The reported stated that my issue was not resolved, I still had to see a doctor. Your representative could not give me answers to everything having to do with side effects, serious side effects. So, I would see my doctor as soon as possible.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Erythema, Head discomfort, Muscle tightness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Concurrent medical conditions included nonspecific reaction (the patient had some symptoms before vaccination). On 11th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and unsteadiness. In December 2018, the patient experienced pain in arm (serious criteria other: serious as per reporter), chills, increased urinary frequency, painful respiration, burning in throat and erythema of extremities. On an unknown date, the patient experienced condition aggravated. The patient was treated with BENADRYL. On an unknown date, the outcome of the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and erythema of extremities were recovered/resolved and the outcome of the unsteadiness and condition aggravated were unknown. It was unknown if the reporter considered the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head, erythema of extremities, unsteadiness and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Less than a day, after receiving SHINGRIX, at same night she experienced pain in the same arm (left) in which she received the injection. The pain lasted for a few days. Less than a day, after receiving SHINGRIX, at the same night she also experienced an increase in urinary frequency, going to the bathroom 4 times during the night and also stated that her breathing felt uncomfortable. Less than week after receiving SHINGRIX, her throat felt like it was burning and her left arm was a little red as well. She also experienced chills. When she woke up the next day, she felt wobbly and weak, her neck was tight, ears were stuffy and her eyes felt weighted. She also felt like there was 20 lbs of weight on her head. The patient took a BENADRYL and that it helped a little bit, but did not help much. She felt like she had some of these symptoms prior to receiving the vaccine, however, she felt like these symptoms were intensified after receiving the vaccine. The reporter did not consent to follow-up. The reported stated that my issue was not resolved, I still had to see a doctor. Your representative could not give me answers to everything having to do with side effects, serious side effects. So, I would see my doctor as soon as possible.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Pollakiuria, Throat irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Concurrent medical conditions included nonspecific reaction (the patient had some symptoms before vaccination). On 11th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and unsteadiness. In December 2018, the patient experienced pain in arm (serious criteria other: serious as per reporter), chills, increased urinary frequency, painful respiration, burning in throat and erythema of extremities. On an unknown date, the patient experienced condition aggravated. The patient was treated with BENADRYL. On an unknown date, the outcome of the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and erythema of extremities were recovered/resolved and the outcome of the unsteadiness and condition aggravated were unknown. It was unknown if the reporter considered the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head, erythema of extremities, unsteadiness and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Less than a day, after receiving SHINGRIX, at same night she experienced pain in the same arm (left) in which she received the injection. The pain lasted for a few days. Less than a day, after receiving SHINGRIX, at the same night she also experienced an increase in urinary frequency, going to the bathroom 4 times during the night and also stated that her breathing felt uncomfortable. Less than week after receiving SHINGRIX, her throat felt like it was burning and her left arm was a little red as well. She also experienced chills. When she woke up the next day, she felt wobbly and weak, her neck was tight, ears were stuffy and her eyes felt weighted. She also felt like there was 20 lbs of weight on her head. The patient took a BENADRYL and that it helped a little bit, but did not help much. She felt like she had some of these symptoms prior to receiving the vaccine, however, she felt like these symptoms were intensified after receiving the vaccine. The reporter did not consent to follow-up. The reported stated that my issue was not resolved, I still had to see a doctor. Your representative could not give me answers to everything having to do with side effects, serious side effects. So, I would see my doctor as soon as possible.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chills, nausea and injected limb mobility decreased. On an unknown date, the outcome of the chills, nausea and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, nausea and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The patient received a dose of SHINGRIX on right arm. The reporter stated that for a while, the patient could not lift her right arm above her head. The patient did not have any additional information. The patient did not consent to follow up.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (Lot No. R013570, expiration date 18-MAR-2021) and ROTATEQ (Lot no. R007988, exp. data 16-OCT-2019) following a temperature excursion. Call made because of "data logger". No adverse event was reported. Temperature: 48F. Time frame: 1 hour 3 minutes. Previous temperature excursion: No.
Age: 75.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP
Symptoms: Expired product administered, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 75-year-old male patient who received BOOSTRIX (batch number 393D9, expiry date 28th May 2018) for prophylaxis. Concomitant products included FLUAD and PREVNAR 13. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient received BOOSTRIX which was already expired on 28th May 2018. Follow up information was pharmacist on 26th November 2018: The reporter details were updated. The patient's demographic details was updated. On 7th October 2018, the patient received BOOSTRIX intramuscularly in left deltoid. On 7th October 2018 (Sunday), the patient came morning for a flu shot. The reporting pharmacist checked the immunization registry and found that the patient was due for PREVENAR 13 and Tdap as well. The reporter discussed with the patient and the patient said that he wanted all three vaccinations, so that he would be up to date, understood that his options were to get them all that day or get two vaccines on the same day and come back for one vaccine if he didn't wanted to receive 2 shots in one arm. They went over adverse risks for the vaccines. The reporter told to the patient that he wanted to make sure that all the vaccine should be in stock and went to the refrigerator to pull products and check expiry plates. The pharmacist misread 2018 as 2019 and told to the patient that it will took 15 min to process the vaccine. They were busy and reporter were processed the labels and drew up the Tdap and vaccinated the patient giving the flu shot and pneumonia in right deltoid and the Tdap in left deltoid. The pharmacist discovered after the patient left and was finishing with the paperwork that the expiry date was actually 28th May 2018. The reporter contacted CDC on 8th October 2018 (Monday), they recommended to contact manufacturer. Then the pharmacist contacted manufacturer and they defer to the CDC recommendation on revaccinate because expired dose invalid. The reporter contacted the patient and planned to come on 7th October 2018 for revaccination but forgot. The patient said that less than a year after receiving BOOSTRIX his arm were swollen for a couple of days. On 4th November 2018, the patient was revaccinated with BOOSTRIX. The reporter called to remind the patient that he need to had Tdap repeated due to invalid on 7th October 2018. The primary care physician was also agreed on revaccination. The VAERS details were updated. This was medication error with harm.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Positron emission tomogram normal
Clinical narrative: This case was reported by a consumer and described the occurrence of shivering in a patient who received SHINGRIX for prophylaxis. The patient's past medical history included lung cancer. On 10th December 2018, the patient received the 1st dose of SHINGRIX. On 14th December 2018, 4 days after receiving SHINGRIX, the patient experienced shivering and tiredness. On an unknown date, the outcome of the shivering was unknown and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On 14th December 2018, list evening the patient woke up in the middle of night with uncontrollable shivering. The patient was not running a fever, but very tired which had continued till the day of reporting. Just curious if this could be a reaction 4 day after the fact. No other problems with the shot of possible note. The patient also had lung cancer. Diagnosed in 2013, 2 years of chemo then 1 year of Opdivo, finally last August 2017, 2 sessions of high dose radiation. No treatments since then and last PET (positron emission tomography) 1 month before the date of reporting showed no increase in size (6mm) of remaining tumors.
Sex: F
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a child female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient received Flu shot for the first time and she suffered a seizure behind it. These lies started way back before date of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Product supply issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction and product supply issue. On an unknown date, the outcome of the adverse reaction was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient mentioned in passing that he received his 1st dose of SHINGRIX vaccine and he experienced a significant reaction with the intramuscular injection as he would expect with an intramuscular injection. The patient was upset about SHINGRIXhingrix availability and it was a difficult call. This was all the information collected regarding the adverse event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Back disorder, C-reactive protein increased, Gait disturbance, Limb discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired. On an unknown date, the outcome of the pain, hip discomfort and walking difficulty were not recovered/not resolved and the outcome of the leg discomfort and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The nurse practitioner stated that she developed terrible pain and had problems in her back, hips, and legs a few days after receiving the SHINGRIX. The adverse events were continuing to get worse and the nurse now is dependent on a cane to help her walk. She was having issues performing her daily activities. In follow up the reporter refered to rheumatology for symptoms  On unknown date, lab tests C-reactive protein rate, Red blood cell sedimentation rate test were elevated and raising, Antinuclear antibody test and Rheumatoid factors were normal. Lab Comments: On unknown date, lab tests CRP rate, SED rate, ANA test and Rheumatoid factors were performed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal discomfort, Pain, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired. On an unknown date, the outcome of the pain, hip discomfort and walking difficulty were not recovered/not resolved and the outcome of the leg discomfort and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The nurse practitioner stated that she developed terrible pain and had problems in her back, hips, and legs a few days after receiving the SHINGRIX. The adverse events were continuing to get worse and the nurse now is dependent on a cane to help her walk. She was having issues performing her daily activities. In follow up the reporter refered to rheumatology for symptoms  On unknown date, lab tests C-reactive protein rate, Red blood cell sedimentation rate test were elevated and raising, Antinuclear antibody test and Rheumatoid factors were normal. Lab Comments: On unknown date, lab tests CRP rate, SED rate, ANA test and Rheumatoid factors were performed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired. On an unknown date, the outcome of the pain, hip discomfort and walking difficulty were not recovered/not resolved and the outcome of the leg discomfort and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain, hip discomfort, walking difficulty, leg discomfort and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The nurse practitioner stated that she developed terrible pain and had problems in her back, hips, and legs a few days after receiving the SHINGRIX. The adverse events were continuing to get worse and the nurse now is dependent on a cane to help her walk. She was having issues performing her daily activities. In follow up the reporter refered to rheumatology for symptoms  On unknown date, lab tests C-reactive protein rate, Red blood cell sedimentation rate test were elevated and raising, Antinuclear antibody test and Rheumatoid factors were normal. Lab Comments: On unknown date, lab tests CRP rate, SED rate, ANA test and Rheumatoid factors were performed.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Increased upper airway secretion, Malaise, Productive cough, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced sickness and runny nose. On an unknown date, the outcome of the sickness and runny nose were recovered/resolved. It was unknown if the reporter considered the sickness and runny nose to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient unknown flu vaccine several years ago before the date of reporting on unknown arm. After receiving the vaccine, he was sick almost the whole winter. He continuously had a runny nose. The patient received whooping cough vaccine on right arm in August 2018. Approximately a week after receiving the vaccine, he started coughing continuously since. He felt like he had congestion in his throat. Within the last day before the date of reporting, he has noted that the cough has lessened and he feels the congestion was breaking up. At the time of reporting he was coughing up the phlegm. He also remembers getting an unknown flu vaccine several years ago. The reporter indicated that both vaccines were administered in the physician's office. The reporter gave consented to follow up. The reporter gave permission for his physician to be contacted.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Type I hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of type i hypersensitivity in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, an unknown time after receiving SHINGRIX, the patient experienced type i hypersensitivity (serious criteria GSK medically significant). On an unknown date, the outcome of the type i hypersensitivity was unknown. It was unknown if the reporter considered the type i hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the age group was captured adult as per vaccine indication. The healthcare professional (HCP) reported that, the patient might have experienced a type 1 hypersensitivity reaction after receiving a dose of SHINGRIX. No further details were provided. The HCP did not give consent to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Rash
Clinical narrative: Chills, sore arm, rash on arm, mild nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmological examination abnormal, Papilloedema, Sudden visual loss, Visual impairment
Clinical narrative: Had sudden loss of vision, finger count vision, diffuse optic nerve swelling in left eye starting or noticed on December 9, 2018. Last dose was November 15, 2018.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness
Clinical narrative: Patient states that 24 hours after receiving vaccine she started experiencing muscle weakness.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Pt developed a fever of 101 and red papules on trunk and extremities.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia, Pain
Clinical narrative: Swelling, redness at site of injection, including muscle aches and entire body fatigue and pain.
Age: 11.0
Sex: F
Vaccine: FLUC4, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Posture abnormal, Seizure
Clinical narrative: Patient tolerated vaccination administration well. She moved into the chair while her sister received her vaccination. I noticed patient face started to turn white and starting sweating. I went to check on patient and her head slumped down as I made it to her and she began convulsing. This episode lasted less than 15 seconds and patient setup and asked what had happen. PA was grabbed by the father while I attended to the patient. He immediately moved her to the table and elevated her feet.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hardening in Rt deltoid; warm to touch 4 days following administration of vaccination. Prescribed ZYRTEC 10mg PO daily x7days, Ibuprofen 400mg PO TID x7days. Monitored daily. Symptoms resolved by completed of medication cycle.
Age: 50.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Injection site joint movement impairment, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: There is pain in the right shoulder that begins the day after the tetanus shot. There is also reduced range of motion in the shoulder to approximately 120 degrees, with pain beginning at about 60 degrees, but I can work through the pain to about 120 degrees. I have difficulty pulling my shirt over my head with the right arm, shoulder pain with lifting a coffee mug in the right arm, weakness in the right arm,  and pain that wakes me from sleep.
Age: 50.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Musculoskeletal pain, Pain, Poor quality sleep
Clinical narrative: There is pain in the right shoulder that begins the day after the tetanus shot. There is also reduced range of motion in the shoulder to approximately 120 degrees, with pain beginning at about 60 degrees, but I can work through the pain to about 120 degrees. I have difficulty pulling my shirt over my head with the right arm, shoulder pain with lifting a coffee mug in the right arm, weakness in the right arm,  and pain that wakes me from sleep.
Age: 1.08
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chest X-ray normal, Cough, Injection site erythema, Pharyngitis, Pyrexia
Clinical narrative: He received the vaccinations on 12/7. On 12/8 he had an erythematous area on his left thigh which was non tender. On 12/12 he developed fever to 103 and was seen in the office. He had pharyngitis and a cough. Rapid strep testing and viral PCR were negative. The fever to 103 persisted until 12/15. On 12/14 he went to the Emergency Department where he had a chest xray that was normal. On 12/15 the fever resolved and he developed a maculopapular rash on his face and trunk. The rash resolved on 12/17 and on 12/18 he was seen back in the office and he was back to his baseline.
Age: 1.08
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash maculo-papular, Streptococcus test negative, Viral test
Clinical narrative: He received the vaccinations on 12/7. On 12/8 he had an erythematous area on his left thigh which was non tender. On 12/12 he developed fever to 103 and was seen in the office. He had pharyngitis and a cough. Rapid strep testing and viral PCR were negative. The fever to 103 persisted until 12/15. On 12/14 he went to the Emergency Department where he had a chest xray that was normal. On 12/15 the fever resolved and he developed a maculopapular rash on his face and trunk. The rash resolved on 12/17 and on 12/18 he was seen back in the office and he was back to his baseline.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Myalgia
Clinical narrative: Arm soreness, in my upper arm muscle, that was expected at first but continues to now.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site swelling
Clinical narrative: I administered the BOOSTRIX injection into the left deltoid muscle and immediatly after removing the needle from the site, blood projectile squirted out from the injection site and then a red raised circle formed around the perimeter of the injection site. The patient also reported that there was itchiness present around the injection site but nowhere else.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date ,the patient was vaccinated with a dose of M-M-R II by intramuscular route instead subcutaneous route (indication, strength, dose, frequency, lot number and expiration date were not provided) for prophylaxis, which was administered with a sterile diluent.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from the patient's father, referring to his daughter as a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown, date the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis (strength, route, anatomical location, lot/batch # and expiration date were not provided). The reporter stated that on unspecified dates, the patient received her second and third doses of GARDASIL 9 late (inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-NOV-2016, a healthcare provider administered the ZOSTAVAX (lot# and route not provided) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 04-JUN-2018, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given MMR vaccine on 12/20/18 but it was discovered to be expired on 12/16/18. CDC was contacted and they stated the vaccine was invalid and pt would need to be re-vaccinated 4 weeks after dose given on 12/20/18. Pt's parents were notified today, 12/26/18, about the error. Pt did not have side effects from this expired vaccine.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Joint range of motion decreased, Skin warm, Swelling
Clinical narrative: Erythematous warm swelling below the injection site noted the day following the injection, some limited ROM of arm, started on abx and has not returned to office with further complaints.
Age: 55.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, PPV
Symptoms: Erythema, Hypersensitivity, Injection site swelling
Clinical narrative: Patient received 4 vaccines in total: 2 on LA and 2 on RA. Hep B on upper LA and PNEUMOVAX on lower LA. Patient developed swelling at the injection sites and left shoulder. Patient also had red rash on her upper body. Patient went to urgent care where MD diagnosed her with allergic reaction to vaccines.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash, inner legs (most), fold of knees, armpit area, fold of arms and lighter upper arms.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: PATIENT CALLED PHARMACY ON 11/30 COMPLAINING OF PAIN AT INJECTION SITE AND KNOT SIZE OF A SILVER DOLLAR. RECALLED PATIENT ON 12/3/18 AND SHE STATED WAS THE SIZE OF A 50 CENT PIECE AND SHAPE OF AN UPSIDE DOWN PEAR. IT WAS NO LONGER PAINFUL, BUT STILL WARM TO THE TOUCH. AT THIS TIME, THE SITE HAS RETURNED TO NORMAL.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage, Loss of consciousness, Skin abrasion
Clinical narrative: After getting the Tdap, patient slightly bleed, then passed out while sitting on the exam table. Patient fell on me, I called for Dr. she immediate came in the room and saw her. Patient was Observed for 30 minutes. She has an abrasion on her left shin. Patient left and was ok vitals were stabled.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Joint swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Had arm/shoulder  pain/swelling/redness for 7 days; At day 5 left hand was painful in joints and swollen and reddened. Right hand became painful and reddened after 3 more days. She saw her primary physician and received a course of Cephalexin 500 TID x7 days starting 12/19/18. Hands were still somewhat swollen and pink (not red) after 7 day course completed. Pain is reduced after Abx course.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Had arm/shoulder  pain/swelling/redness for 7 days; At day 5 left hand was painful in joints and swollen and reddened. Right hand became painful and reddened after 3 more days. She saw her primary physician and received a course of Cephalexin 500 TID x7 days starting 12/19/18. Hands were still somewhat swollen and pink (not red) after 7 day course completed. Pain is reduced after Abx course.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: She states that she got a cold sore 7 days after she received the immunization - this happened with both shots in the series.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Irritability, Pyrexia
Clinical narrative: Mid grade fever presented 8 days post vaccine and did not subside for 9 days. After 9 days of consistent fever, he was two days free of fever. Since this, the mid grade fever has presented intermittently. Additional symptoms include non-productive cough and extreme irritability.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Dysaesthesia, Fatigue, Myalgia, Otitis media
Clinical narrative: Myalgias and lassitude starting day 2, 12h after vaccine but resolving in hours; day 3 - asymptomatic; after day 4: symptoms of bronchitis with dry or minimally productive sputum, rales on inspiration and pronounced wheezing, myalgias, dysestheshias (cuteness, scalp), fatigue. After the first 2 days of these symptoms rhinorrhea, signs of otitis media.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Productive cough, Rales, Rhinorrhoea, Wheezing
Clinical narrative: Myalgias and lassitude starting day 2, 12h after vaccine but resolving in hours; day 3 - asymptomatic; after day 4: symptoms of bronchitis with dry or minimally productive sputum, rales on inspiration and pronounced wheezing, myalgias, dysestheshias (cuteness, scalp), fatigue. After the first 2 days of these symptoms rhinorrhea, signs of otitis media.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scab
Clinical narrative: Pt contracted shingles disease; reported pain and scabs on Rt side of torso. Saw Primary doctor and receieved. RXs for Valacyclovir, and Gabapentin. Six weeks later she is still experiencing pain (though less than at first)and is on Acyclovir daily.