chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain down arm, pain in elbow, deep purple bruise (lasted for 9 days) large lump at injection site, neck pain on side of injection, spasms in deltoid muscle down arm radiating to the hand, pain during night-causing me to wake, easily bruised, deep purple bruises-causes unknown.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Cough, Dysphagia
Clinical narrative: Coughing, airway felt tight, hard to swallow.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Dizziness, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Felt very tired, flu like symptoms, dizzy.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Nuclear magnetic resonance imaging
Clinical narrative: Felt very tired, flu like symptoms, dizzy.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site swelling, Rash generalised, Rash macular, Skin warm
Clinical narrative: Terrible pounding/ throbbing headache at 4:30 PM lasting approx. 5 hrs/ awoke at 0230, skin very hot to touch, red blotchy rash covering entire torso, neck, arms, and buttocks- still present now at 0420/ also of note, approx. 1.5- 2hrs after injection, injection site very swollen, felt like there was a tennis ball in my arm, swelling now going down.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Blood sodium decreased, Erythema, Fatigue, Local swelling, Loss of consciousness
Clinical narrative: After vaccine, patients arm got very swollen, red and hot. She felt very tired and achy. Later that evening she blacked out and no pulse could be found. Ambulance was called and patient was monitored at hospital overnight.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pulse absent, Skin warm
Clinical narrative: After vaccine, patients arm got very swollen, red and hot. She felt very tired and achy. Later that evening she blacked out and no pulse could be found. Ambulance was called and patient was monitored at hospital overnight.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Skin reaction, Skin warm
Clinical narrative: Redness of skin, hot to touch, fever on right arm on 9/27/13 (2 days after vaccine administration). Dx = cellulitis, given Rx for SEPTRA.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Disturbance in attention, Dizziness, Dysphagia, Eating disorder
Clinical narrative: This spontaneous report was received from a 78 year old female patient regarding herself. Patient's current condition included High blood pressure, high cholesterol and thyroid condition. The patient stated that sulfa (unspecified manufacturer) made her experienced an anaphylaxis reaction and she was admitted to an unspecified hospital for unspecified duration. On 19-SEP-2013, the patient was vaccinated with one dose of ZOSTAVAX (invalid lot # JC04268, expiry: 12-JUL-2014) for prevention of shingles. Concomitant therapies included LEVOTHYROID, METFORMIN and NEXIUM. On 21-SEP-2013, the patient experienced injection site reaction which included soreness, felt tender to touch, felt like it was swollen and her arm itched around the injection site. The patient also stated that after receiving the ZOSTAVAX she developed fever, woke up with dizziness and then could not focus, she felt like her bowels were "growling", could not go to the bathroom, had difficulty eating and swallowing, had an odd feeling in the back of her throat and mouth, broke out into a sweat, felt very light headed, and developed a headache. Patient sought medical attention contacted the pharmacist by phone. Patient took aspirin (unspecified manufacturer) as treatment. Bloodwork and lipid testing were performed (results not reported). The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal sounds abnormal, Headache, Hyperhidrosis, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 78 year old female patient regarding herself. Patient's current condition included High blood pressure, high cholesterol and thyroid condition. The patient stated that sulfa (unspecified manufacturer) made her experienced an anaphylaxis reaction and she was admitted to an unspecified hospital for unspecified duration. On 19-SEP-2013, the patient was vaccinated with one dose of ZOSTAVAX (invalid lot # JC04268, expiry: 12-JUL-2014) for prevention of shingles. Concomitant therapies included LEVOTHYROID, METFORMIN and NEXIUM. On 21-SEP-2013, the patient experienced injection site reaction which included soreness, felt tender to touch, felt like it was swollen and her arm itched around the injection site. The patient also stated that after receiving the ZOSTAVAX she developed fever, woke up with dizziness and then could not focus, she felt like her bowels were "growling", could not go to the bathroom, had difficulty eating and swallowing, had an odd feeling in the back of her throat and mouth, broke out into a sweat, felt very light headed, and developed a headache. Patient sought medical attention contacted the pharmacist by phone. Patient took aspirin (unspecified manufacturer) as treatment. Bloodwork and lipid testing were performed (results not reported). The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Lipids, Oral disorder, Pharyngeal disorder
Clinical narrative: This spontaneous report was received from a 78 year old female patient regarding herself. Patient's current condition included High blood pressure, high cholesterol and thyroid condition. The patient stated that sulfa (unspecified manufacturer) made her experienced an anaphylaxis reaction and she was admitted to an unspecified hospital for unspecified duration. On 19-SEP-2013, the patient was vaccinated with one dose of ZOSTAVAX (invalid lot # JC04268, expiry: 12-JUL-2014) for prevention of shingles. Concomitant therapies included LEVOTHYROID, METFORMIN and NEXIUM. On 21-SEP-2013, the patient experienced injection site reaction which included soreness, felt tender to touch, felt like it was swollen and her arm itched around the injection site. The patient also stated that after receiving the ZOSTAVAX she developed fever, woke up with dizziness and then could not focus, she felt like her bowels were "growling", could not go to the bathroom, had difficulty eating and swallowing, had an odd feeling in the back of her throat and mouth, broke out into a sweat, felt very light headed, and developed a headache. Patient sought medical attention contacted the pharmacist by phone. Patient took aspirin (unspecified manufacturer) as treatment. Bloodwork and lipid testing were performed (results not reported). The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a 78 year old female patient regarding herself. Patient's current condition included High blood pressure, high cholesterol and thyroid condition. The patient stated that sulfa (unspecified manufacturer) made her experienced an anaphylaxis reaction and she was admitted to an unspecified hospital for unspecified duration. On 19-SEP-2013, the patient was vaccinated with one dose of ZOSTAVAX (invalid lot # JC04268, expiry: 12-JUL-2014) for prevention of shingles. Concomitant therapies included LEVOTHYROID, METFORMIN and NEXIUM. On 21-SEP-2013, the patient experienced injection site reaction which included soreness, felt tender to touch, felt like it was swollen and her arm itched around the injection site. The patient also stated that after receiving the ZOSTAVAX she developed fever, woke up with dizziness and then could not focus, she felt like her bowels were "growling", could not go to the bathroom, had difficulty eating and swallowing, had an odd feeling in the back of her throat and mouth, broke out into a sweat, felt very light headed, and developed a headache. Patient sought medical attention contacted the pharmacist by phone. Patient took aspirin (unspecified manufacturer) as treatment. Bloodwork and lipid testing were performed (results not reported). The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Breast tenderness, Exposure during pregnancy, Menstruation irregular, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a approximately 24 years old female patient with no drug allergies. The patient's medical history included high risk HPV with colposcopy. On 26-SEP-2013 the patient was vaccinated with 0.5 ml  GARDASIL lot # J006236, exp 25-FEB-2013, dose 2, intramuscular and shortly after reported breast tenderness and irregular periods and asked for a pregnancy test. Nurse reported that the patient's urine pregnancy test was positive, confirming a pregnancy, but nurse noted that patient was suppose to be taking MICROGESTIN. Nurse noted that patients weight was 160 pounds and height was 67 inches. Nurse reported that patient received her first dose of 0.5 ml GARDASIL on 11-APR-2013. Pregnant gestation or LMP was reported as approximately 5 to 6 weeks (approximately 14-AUG-2013), EDD was approximately 22-MAY-2014. The patient had sought medical attention by seen at physician's office. The pregnancy outcome was pending. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a 71 year old female patient refers to herself. In fall 2011 the patient was vaccinated with ZOSTAVAX injection (dose unknown) for prevention for shingles. Concomitant therapies included baby aspirin and amlodipine besylate, CADUET. In early July 2013, patient began experiencing intense pain that prompted a Physician visit. The cause of pain was undetermined initially until the Shingles rash presented about one week later. This rash was concentrated on the left side torso area and extended onto abdomen and back. The patient was treated with sulfamethoxazole, BACTRIM, pain pills including PERCOCET and TYLENOL with codeine. At time of call the patient reported that her condition had improved and only residual tiredness remained (the patient was recovering). Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old  patient (gender unknown). On 13-SEP-2013 the patient was vaccinated with an expired dose of ROTATEQ lot # 0050AE, expiry date 30-AUG-2013, oral. Dose was reported as 0.5 ml (considered underdose). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 4-5 patients of unknown age. It was reported that the patients were of age to receive the vaccine as directed. On an unknown date the patients were vaccinated with ZOSTAVAX (standard dosing (not specified)), subcutaneous for prevention of shingles during a flu clinic held at the office. Lot number: J004310, expiry date not provided. On an unknown date the patients experienced injection site redness and swelling. Some of the patients sought medical attention by contacting the office and informing them of their symptoms, and some of the affected patients came in for an office visit and showed the reporting nurse what the reaction looked like. The outcome of injection site redness and swelling was not provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. Medical history and drug allergies/reactions were denied. In September 2013, the patient was vaccinated with PNEUMOVAX 23 lot J005011 exp 04-DEC-2014, 0.5 ml, intramuscular in the right deltoid. Concomitant medication was denied. In September 2013, within 24 to 72 hours after administration, the patient experienced a fever and redness with swelling at right deltoid administration site. Treatment was recommended over the phone was ice and TYLENOL. No lab diagnostics were performed. On an unspecified date, the outcome of fever and redness with swelling at right deltoid administration site was reported as recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with latex allergy. The patient's medical history included chickenpox. On 23-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J003806, expiry date 03-JUL-2014, dose reported as 0.7 ml, subcutaneously in the left back of upper arm. On 24-AUG-2013, the patient experienced spotty red rash on legs and burning sensation in legs at site of rash. The rash did not occur at the site of injection post-vaccination. The patient was not recently exposed to chickenpox and shingles. The outcome of adverse events was unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 19-SEP-2013 the patient was inadvertently administered RECOMBIVAX HB (dose, indication unknown) instead of VAQTA as prescribed. Other suspect therapies included VAQTA. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 12-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). An unspecified physician reported to the pharmacist that on an unknown date the patient developed polymyalgia rheumatic after receiving ZOSTAVAX. The action taken was not provided. The outcome of polymyalgia rheumatica was unknown. It was unspecified if the patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Eye pain, Injection site erythema, Injection site pruritus, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no reported medical history. On 09-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # J002777 dose 1, 0.65 ml, subcutaneous. No other suspect therapy or concomitant medication was reported. On 09-SEP-2013, 1 day after onset of therapy the patient experienced itching and redness covering approximately 2 inches at the injection site along with a broken blood vessel in left eye causing redness and pain. The pharmacist stated that "no rash has occurred". The patient used a cold compress to treat the redness and itching at the injection site. The patient went to an unspecified eye specialist who prescribed LOTEMAX (manufacturer unknown). The patient is currently having the prescription filled at the pharmacy and has not begun using LOTEMAX (manufacturer unknown) yet. The patient reported that the unspecified eye specialist stated that she is the second person that he's seen who developed a broken blood vessel in the eye after receiving ZOSTAVAX. The outcome of itching and redness covering approximately 2 inches at the injection site and broken blood vessel in left eye causing redness and pain was reported as not recovered/not resolved. The reporters relatedness of itching and redness covering approximately 2 inches at the injection site and broken blood vessel in left eye causing redness and pain to ZOSTAVAX is unknown. Same reporter link: 1310USA000897. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 19-SEP-2013 the patient was vaccinated with a only dose of M-M-R II (dose not reproted, lot # 1449AA, expired date: 13-SEP-2013) intramuscularly. No adverse effect reported. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to 9 months (at the time of third vaccination) and currently 18 years old male patient. On 06-APR-1995 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 08-MAY-1995 and the third dose was administered on 22-JAN-1996. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. No treatment was given for adverse events. This is one of 10 reports from the same source. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect storage of drug, Irritability, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a health care professional referring to a 13 month old white female patient with none preexisting allergies, birth defects, medical conditions and illness at the time of vaccination and none adverse events following prior vaccination. On 29-AUG-2013 at 11:00 AM, the patient was vaccinated with M-M-R II, lot #H018947, expiration date 18-OCT-2014, dose 1 in the right vastus lateralis (RVL) and VARIVAX lot # J003541, expiration date 25-MAR-2015, dose 1 in the left vastus lateralis (LVL), indication, dose and route for both vaccines were not reported. The vaccines were stored at an unknown temperature for an unknown period of time. Concomitant therapies included PREVNAR lot #G43220, dose 4 in the RVL on 29-AUG-2013 at 11:00 AM, and HAVRIS jot #JR737 dose 1 in the LVL on the same day at 11:02 AM. Indication, dose and route for both vaccines were not reported. On 29-AUG-2013, patient was seen for her well child exam. On 03-SEP-2013, patient returned to the clinic with a mild rash. On 16-SEP-2013, patient returned again covered head to toe with a raised non-papular rash, fussy, mildly febrile and runny nose. The patient was diagnosed with varicella as a result of an unspecified diagnostic test. Patient received treatment with BENADRYL liquid, TYLENOL for fever and cool tepid baths. The outcome of the events was reporting as recovering. This is one of several reports from same source. Additional information is not expected.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a health care professional referring to a 13 month old white female patient with none preexisting allergies, birth defects, medical conditions and illness at the time of vaccination and none adverse events following prior vaccination. On 29-AUG-2013 at 11:00 AM, the patient was vaccinated with M-M-R II, lot #H018947, expiration date 18-OCT-2014, dose 1 in the right vastus lateralis (RVL) and VARIVAX lot # J003541, expiration date 25-MAR-2015, dose 1 in the left vastus lateralis (LVL), indication, dose and route for both vaccines were not reported. The vaccines were stored at an unknown temperature for an unknown period of time. Concomitant therapies included PREVNAR lot #G43220, dose 4 in the RVL on 29-AUG-2013 at 11:00 AM, and HAVRIS jot #JR737 dose 1 in the LVL on the same day at 11:02 AM. Indication, dose and route for both vaccines were not reported. On 29-AUG-2013, patient was seen for her well child exam. On 03-SEP-2013, patient returned to the clinic with a mild rash. On 16-SEP-2013, patient returned again covered head to toe with a raised non-papular rash, fussy, mildly febrile and runny nose. The patient was diagnosed with varicella as a result of an unspecified diagnostic test. Patient received treatment with BENADRYL liquid, TYLENOL for fever and cool tepid baths. The outcome of the events was reporting as recovering. This is one of several reports from same source. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pyrexia, Spinal pain
Clinical narrative: S and S = severe spinal/joint pain. Tx = chiropractor therapy. Tx = cortisone injection. Received injection in AM. In pain by PM x 1 1/2 wks with low grade fever.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever 2 x 3 days TYLENOL/MOTRIN.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Arthrogram, Computerised tomogram, Electromyogram, Immediate post-injection reaction
Clinical narrative: Both vaccinations were inadvertently given very high up, at the top of my arms. This was excruciatingly painful and resulted in immediate, severe nerve pain which radiated down both arms into my hands, as well as marked localized shoulder pain. The left side was worse than the right side. I was unable to open the car door in the parking lot of the clinic following the vaccinations (or perform any other manual tasks). The severe shoulder/arm/hand pain and dysfunction persisted to such an extent that I was unable to perform any manual tasks and required assistance for carrying out activities of daily living, etc. Severe loss of mobility of both shoulders occurred as well. I notified clinic on several occasions about the severity of my signs and sought treatment at 2 emergency clinics because I was out of state immediately following the vaccinations. Preliminary therapy with oral prednisone did not improve the situation, so Dr. performed an intrabursal corticosteroid injection on the left side (which was the most severely affected). Within 6-8 weeks post vaccination, profound muscle atrophy of the shoulders, arms, chest and upper back occurred. Physical therapy has been on-going. Because of the presence of an implanted medical device, it is not feasible to have an MRI. A bilateral shoulder arthrogram-CT scan was done instead. Currently, 10 months later, the localized shoulder pain persists, along with continued radiating arm/hand pain weakness and dysfunction. Results of EMG testing are pending.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Muscle atrophy, Muscular weakness, Musculoskeletal pain
Clinical narrative: Both vaccinations were inadvertently given very high up, at the top of my arms. This was excruciatingly painful and resulted in immediate, severe nerve pain which radiated down both arms into my hands, as well as marked localized shoulder pain. The left side was worse than the right side. I was unable to open the car door in the parking lot of the clinic following the vaccinations (or perform any other manual tasks). The severe shoulder/arm/hand pain and dysfunction persisted to such an extent that I was unable to perform any manual tasks and required assistance for carrying out activities of daily living, etc. Severe loss of mobility of both shoulders occurred as well. I notified clinic on several occasions about the severity of my signs and sought treatment at 2 emergency clinics because I was out of state immediately following the vaccinations. Preliminary therapy with oral prednisone did not improve the situation, so Dr. performed an intrabursal corticosteroid injection on the left side (which was the most severely affected). Within 6-8 weeks post vaccination, profound muscle atrophy of the shoulders, arms, chest and upper back occurred. Physical therapy has been on-going. Because of the presence of an implanted medical device, it is not feasible to have an MRI. A bilateral shoulder arthrogram-CT scan was done instead. Currently, 10 months later, the localized shoulder pain persists, along with continued radiating arm/hand pain weakness and dysfunction. Results of EMG testing are pending.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Both vaccinations were inadvertently given very high up, at the top of my arms. This was excruciatingly painful and resulted in immediate, severe nerve pain which radiated down both arms into my hands, as well as marked localized shoulder pain. The left side was worse than the right side. I was unable to open the car door in the parking lot of the clinic following the vaccinations (or perform any other manual tasks). The severe shoulder/arm/hand pain and dysfunction persisted to such an extent that I was unable to perform any manual tasks and required assistance for carrying out activities of daily living, etc. Severe loss of mobility of both shoulders occurred as well. I notified clinic on several occasions about the severity of my signs and sought treatment at 2 emergency clinics because I was out of state immediately following the vaccinations. Preliminary therapy with oral prednisone did not improve the situation, so Dr. performed an intrabursal corticosteroid injection on the left side (which was the most severely affected). Within 6-8 weeks post vaccination, profound muscle atrophy of the shoulders, arms, chest and upper back occurred. Physical therapy has been on-going. Because of the presence of an implanted medical device, it is not feasible to have an MRI. A bilateral shoulder arthrogram-CT scan was done instead. Currently, 10 months later, the localized shoulder pain persists, along with continued radiating arm/hand pain weakness and dysfunction. Results of EMG testing are pending.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anaphylactic reaction, Dysphagia, Feeling cold, Hypersensitivity, Local swelling
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Poor peripheral circulation, Rash
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood pressure decreased, Consciousness fluctuating, Dysphagia, Electrocardiogram, Extensive swelling of vaccinated limb
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Feeling cold, Hallucination, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Poor peripheral circulation, Speech disorder, Throat tightness
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Ultrasound scan
Clinical narrative: Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse, female of unknown age who reporting on herself. On an unknown date in July 2013, reported as about one and half months ago, after she injected diluent into a vial of ZOSTAVAX (lot number not reported) and removed the needle from the vial, all of the contents of the vial sprayed into her face. The nurse did not reported experiencing any adverse reactions from having the ZOSTAVAX come into contact with her skin. PQC involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complaining of arm/shoulder pain after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 62 year old female patient with lupus. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient experienced varicella-like rash on her legs after receiving ZOSTAVAX. No pain was associated with the rash. No treatment was given. Laboratory diagnostics studies performed were none. No medical attention sought. The outcome of varicella-like rash on her legs was reported as recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Vomiting, nauseous and a migraine headache lasted for 24 hours then symptoms stop.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site inflammation
Clinical narrative: Area where shot administered became inflammed and bruised to the touch.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Crying, Diet refusal, Dyskinesia, Screaming
Clinical narrative: Inconsolable crying, shrieking, thrashing for over 3 hours. Refused nursing for 3 hours.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphagia, Feeling hot, Hypersensitivity, Pruritus
Clinical narrative: Fever, difficulty swallowing, general allergy symptoms: itching, sneezing, cough.  Heat feeling from site up into neck, and down upper arm X24 hours  All of these occurred even after taking antihistamine and ibuprofen every 4 hours after injection.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sneezing
Clinical narrative: Fever, difficulty swallowing, general allergy symptoms: itching, sneezing, cough.  Heat feeling from site up into neck, and down upper arm X24 hours  All of these occurred even after taking antihistamine and ibuprofen every 4 hours after injection.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Ear pain, Oropharyngeal pain, Pain
Clinical narrative: Aches, Sore Throat/Ears, Slight Difficulty Breathing, Lung Congestion, Mild Fever, Hoarseness, together, for 4 days - Took Aspirin.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Pulmonary congestion, Pyrexia
Clinical narrative: Aches, Sore Throat/Ears, Slight Difficulty Breathing, Lung Congestion, Mild Fever, Hoarseness, together, for 4 days - Took Aspirin.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Erythema, Flushing, Pruritus, Urticaria
Clinical narrative: Patient was flushed and red within the first 5- 10 minutes with a metallic like taste in her mouth, returned to nurse. When patient returned to nurse she was itchy and had hives on her chest and going up her neck onto her face. No breathing difficulty or throat tightening at that time noted. Patient took Benadryl and reported to feel better in 15 minutes.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Localized rash, erythema, warm to the touch.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swollen at site, hot, itchy, painful to touch. Took 2 Benadryl and ibuprofen.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: After receiving a flu shot, which was given unusually high in my arm, I woke the next morning unable to move my arm. I had a tremendous amount of pain. Before receiving the shot, I had no issues with this. After a few weeks of pain, I went to my doctor to report the issue. I saw the Physician's Assistant who sent me for an x-ray. After reading the x-ray, the doctor's office did nothing. I then when to an orthopedist, who read the x-ray and stated I had "bursitis". He gave me a cortisone shot which gave me relief. During the course of the year, my shoulder began to hurt again. I returned to my orthopedist in 2012 and he gave me another cortisone shot. This provided some, but not total relief. Now, in 2013, my shoulder has again begun hurting to the point where I am about to go back yet again to the orthopedist to see if anything can be done. I am totally convinced my shoulder pain is related to the flu shot I received in 2011, as symptoms came on immediately after receiving the shot.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, X-ray abnormal
Clinical narrative: After receiving a flu shot, which was given unusually high in my arm, I woke the next morning unable to move my arm. I had a tremendous amount of pain. Before receiving the shot, I had no issues with this. After a few weeks of pain, I went to my doctor to report the issue. I saw the Physician's Assistant who sent me for an x-ray. After reading the x-ray, the doctor's office did nothing. I then when to an orthopedist, who read the x-ray and stated I had "bursitis". He gave me a cortisone shot which gave me relief. During the course of the year, my shoulder began to hurt again. I returned to my orthopedist in 2012 and he gave me another cortisone shot. This provided some, but not total relief. Now, in 2013, my shoulder has again begun hurting to the point where I am about to go back yet again to the orthopedist to see if anything can be done. I am totally convinced my shoulder pain is related to the flu shot I received in 2011, as symptoms came on immediately after receiving the shot.
Age: 0.36
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Blood test normal, Convulsion, Foaming at mouth, Gaze palsy, Muscle twitching
Clinical narrative: Seizure. His body was stretched out, arms along his side, eyes rolled back, whole body was twitching, foam from mouth, gurgling noise from his mouth, breathing through his nose, and he was not responsive. Called 911. By the time they arrived his seizure had stopped and he was coming back. Took him to the ER just in case and bloodwork levels were ok.
Age: 0.36
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Unresponsive to stimuli
Clinical narrative: Seizure. His body was stretched out, arms along his side, eyes rolled back, whole body was twitching, foam from mouth, gurgling noise from his mouth, breathing through his nose, and he was not responsive. Called 911. By the time they arrived his seizure had stopped and he was coming back. Took him to the ER just in case and bloodwork levels were ok.
Age: 0.76
Sex: M
Vaccine: FLUX
Symptoms: Allergy test negative, Injection site urticaria, Urticaria
Clinical narrative: Hives at injection site, moved to other limbs, antihistamine administered orally at 12:30 PM.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Headache, Myalgia, Nausea
Clinical narrative: Nauseous, tight throat, red swollen eyes, fever, coughing, runny nose, spinning head, muscle aches, head ache.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Pyrexia, Rhinorrhoea, Throat tightness, Vertigo
Clinical narrative: Nauseous, tight throat, red swollen eyes, fever, coughing, runny nose, spinning head, muscle aches, head ache.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives down neck, torso, arms and legs and face. Treated with Benadryl and prednisone.
Age: 0.34
Sex: M
Vaccine: DTAP, RVX
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Dime size hard, swollen, red lump at the injection site (thigh).  Today's date is 10/2/2013 and patient's leg still has a hard lump but it is smaller and no longer red.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dysphonia, Eye discharge, Fatigue, Headache
Clinical narrative: Hoarseness, sore throat, watering eyes, blurry vision, mucus in eyes, vomiting, nausea, fever of 100.4, muscle ache, headache, achy joints, tiredness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Lacrimation increased, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Hoarseness, sore throat, watering eyes, blurry vision, mucus in eyes, vomiting, nausea, fever of 100.4, muscle ache, headache, achy joints, tiredness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Vision blurred, Vomiting
Clinical narrative: Hoarseness, sore throat, watering eyes, blurry vision, mucus in eyes, vomiting, nausea, fever of 100.4, muscle ache, headache, achy joints, tiredness.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Chest X-ray, Cough, Eye swelling, Gait disturbance
Clinical narrative: Developed hives from head to toe, with a more circular rash on my back(red circles with white rings around them), severe headache, swollen, watery eyes, and joint pain initially after my TDAP shot that day. By Wednesday 9/25/2013 developed sore throat, cough, severe joint pain that moved from place to place in my body. The joint pain is still present limiting my range of motion and ability to walk normally. I have also been diagnosed with Pneumonia at this time.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Joint range of motion decreased, Lacrimation increased, Oropharyngeal pain, Pneumonia
Clinical narrative: Developed hives from head to toe, with a more circular rash on my back(red circles with white rings around them), severe headache, swollen, watery eyes, and joint pain initially after my TDAP shot that day. By Wednesday 9/25/2013 developed sore throat, cough, severe joint pain that moved from place to place in my body. The joint pain is still present limiting my range of motion and ability to walk normally. I have also been diagnosed with Pneumonia at this time.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Developed hives from head to toe, with a more circular rash on my back(red circles with white rings around them), severe headache, swollen, watery eyes, and joint pain initially after my TDAP shot that day. By Wednesday 9/25/2013 developed sore throat, cough, severe joint pain that moved from place to place in my body. The joint pain is still present limiting my range of motion and ability to walk normally. I have also been diagnosed with Pneumonia at this time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Joint range of motion decreased, Limb discomfort
Clinical narrative: Minimal injection pain.  Approximately 2:00 PM pain, pressure and upper arm muscle weakness limited range of motion.  Upon examination noticed egg size lump directly under injection site. Lump had white center with red ring similar to reverse bullseye ring. Pain increased and increasing arm paralysis from enlargement of swelling.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Monoplegia, Muscular weakness, Pain in extremity
Clinical narrative: Minimal injection pain.  Approximately 2:00 PM pain, pressure and upper arm muscle weakness limited range of motion.  Upon examination noticed egg size lump directly under injection site. Lump had white center with red ring similar to reverse bullseye ring. Pain increased and increasing arm paralysis from enlargement of swelling.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: None reported at time of original report.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, warm to tough circular area at injection site about 3 inches in diameter. Patient provider placed patient on antibiotics for cellulitis.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 23.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever, chills, diarrhea, fatigue, stomach discomfort.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Patient developed full body aches, headahce, nausea, lightheadedness, chills, and fatigue about 10-14 hours after getting the vaccine.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient developed full body aches, headahce, nausea, lightheadedness, chills, and fatigue about 10-14 hours after getting the vaccine.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain of left upper arm.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Local swelling, Swelling face
Clinical narrative: Heat surge, face and neck became cherry red, face and neck swelling.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt on 18-Sep-2013) concerns a female patient who had a history of egg allergy. On an unspecified date "many years ago", the patient received an unspecified flu vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced an unspecified reaction to the vaccine. The patient's physician determined that the patient had a reaction to it because she had an egg allergy. The patient required medical attention and therefore she went to the hospital. The outcome was reported as recovered.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Condition aggravated, Granulomatosis with polyangiitis, Lung disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 67 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date 12 days after receiving the influenza vaccine, the patient developed a relapse of AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was c/PR3 (cytoplasmic proteinase 3). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was not reported (The patient achieved disease remission).
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Renal disorder
Clinical narrative: This literature report (initial receipt 17-Sep-2013) concerns a 67 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date 12 days after receiving the influenza vaccine, the patient developed a relapse of AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was c/PR3 (cytoplasmic proteinase 3). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was not reported (The patient achieved disease remission).
Sex: U
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Eye pain, Injection site erythema, Injection site pruritus, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (date, lot number, dose and frequency unknown). No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced a broken blood vessel in left eye causing redness and pain. A patient of the pharmacist reported that the unspecified eye specialist stated that she is the second person that the eye specialist has seen who developed a broken blood vessel in the eye after receiving ZOSTAVAX. The outcome of broken blood vessel in left eye causing redness and pain was reported as unknown. The reporters relatedness and itching and redness covering approximately 2 inches at the injection site and broken blood vessel in left eye causing redness and pain to ZOSTAVAX is unknown. Same reporter link: 1309JUSA005073. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Injection site induration, Injection site reaction, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age with no reproted medical history. On an unspecified date late in August in an unspecified year the patient was vaccinated with ZOSTAVAX dose 1 (lot number, route, dose and frequency unknown). No other suspect therapy or concomitant medication was reported. On an unspecified date "about a week later" the patient experienced one itchy bump developed above and below his elbow, including under his arm. A total of six, itchy, hard bumps have emerged on the same arm in which ZOSTAVAX was administered. The callers has not sought medical attention for the event and reports no pain. The bumps have remained for over one week. The caller notes that he received the vaccine along with his wife, at the same date, time and location. His wife experienced no adverse symptoms. No treatment information was reported. The outcome of six, itchy, hard bump arm above and below his elbow, including under his arm was reported as not recovered not resolved. The reporters relatedness of six, itchy, hard bump arm above and below his elbow, including under his arm to ZOSTAVAX is unknown. Additional information has been requested.