chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Received shot at about 9.30 am. Within a half hour experienced a more than moderate pain on inside of arm from elbow to wrist. Happened 3 times for a duration of about 10 seconds. I have never had that pain before and it happened only those three times. By 5pm tired, some muscle pain and injection site quite sore. The next day was the worst, with muscle aches, headache, moving the arm was somewhat painful, swelling and redness of injection site and body was cold...not shivering but close to it. Extremely tired.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Received shot at about 9.30 am. Within a half hour experienced a more than moderate pain on inside of arm from elbow to wrist. Happened 3 times for a duration of about 10 seconds. I have never had that pain before and it happened only those three times. By 5pm tired, some muscle pain and injection site quite sore. The next day was the worst, with muscle aches, headache, moving the arm was somewhat painful, swelling and redness of injection site and body was cold...not shivering but close to it. Extremely tired.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Burning sensation, Computerised tomogram thorax normal, Eyelid ptosis, Fundoscopy abnormal
Clinical narrative: Three days after receiving the vaccine, the patient developed a burning, painful macular rash with overlying vesicles in her lower back and left leg. She initially presented to her dermatologist who diagnosed her with disseminated zoster and began valacyclovir 1 gram three times a day as well as gabapentin 300 mg three times a day for pain. About a week later, the patient presented to her ophthalmologist who found right-sided ptosis with a miotic pupil. This anisocoria was greatest in darkness and reversed with apraclonidine, consistent with Horner's syndrome. Fundoscopic exam of the right eye revealed two small subretinal hemorrhages along the superior arcade. The patient underwent computed tomography (CT) of the chest and magnetic resonance angiography (MRA) of the head and neck, both of which were unremarkable. Over the following two months, the rash and the subretinal hemorrhages resolved and the ptosis and anisocoria improved.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster disseminated, Horner's syndrome, Miosis, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Three days after receiving the vaccine, the patient developed a burning, painful macular rash with overlying vesicles in her lower back and left leg. She initially presented to her dermatologist who diagnosed her with disseminated zoster and began valacyclovir 1 gram three times a day as well as gabapentin 300 mg three times a day for pain. About a week later, the patient presented to her ophthalmologist who found right-sided ptosis with a miotic pupil. This anisocoria was greatest in darkness and reversed with apraclonidine, consistent with Horner's syndrome. Fundoscopic exam of the right eye revealed two small subretinal hemorrhages along the superior arcade. The patient underwent computed tomography (CT) of the chest and magnetic resonance angiography (MRA) of the head and neck, both of which were unremarkable. Over the following two months, the rash and the subretinal hemorrhages resolved and the ptosis and anisocoria improved.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Pupils unequal, Rash macular, Retinal haemorrhage
Clinical narrative: Three days after receiving the vaccine, the patient developed a burning, painful macular rash with overlying vesicles in her lower back and left leg. She initially presented to her dermatologist who diagnosed her with disseminated zoster and began valacyclovir 1 gram three times a day as well as gabapentin 300 mg three times a day for pain. About a week later, the patient presented to her ophthalmologist who found right-sided ptosis with a miotic pupil. This anisocoria was greatest in darkness and reversed with apraclonidine, consistent with Horner's syndrome. Fundoscopic exam of the right eye revealed two small subretinal hemorrhages along the superior arcade. The patient underwent computed tomography (CT) of the chest and magnetic resonance angiography (MRA) of the head and neck, both of which were unremarkable. Over the following two months, the rash and the subretinal hemorrhages resolved and the ptosis and anisocoria improved.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Rash all over body, small raised bumps with pink/red splotches around them.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, redness. Some nausea is also attributed to the shot and occurs with the swelling.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Blood in stools two times several days after the vaccine, mucousy stools 3-5 days after vaccine, diarrhea beginning 5 days after vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Called to complain experiencing increased heart rate sweating nausea and extreme headache at time of call I advised patient to go to ER or urgent care. She went to urgent care.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Reported to pharmacy several days after immunization with a large area of her arm swollen, red and painful. Her concern was that it was continuing to intensify over time.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Immobile, Pain, Paraesthesia
Clinical narrative: The patient describes that the evening following the vaccines she felt pain from "head to toe" and "chills". She lied down on the bed and put some sheets over. She then felt immobile and she describes a feeling as an "electric shock". She tried to move to call her husband on the phone (he was in the house but in another room) but she could not reach for the phone. She spent the night awake and felt better in the morning, when she could then move.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood magnesium increased, CSF white blood cell count negative, Computerised tomogram head normal, Electroencephalogram abnormal, Enterovirus test negative
Clinical narrative: Right leg shaking when awakened, occurred 3 times at home. Also had episode of right leg flexed and extended right arm, eyes staring straight ahead. Lasted a few seconds. Examined in the office - seemed OK. No fever, no URI symptoms, no vomiting or diarrhea. The next day seen in ER after right arm twitching, legs twitching and  head turned to left. This episode lasted about 15 seconds.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Gram stain negative, Herpes simplex test negative, Influenza virus test negative, Metabolic function test normal
Clinical narrative: Right leg shaking when awakened, occurred 3 times at home. Also had episode of right leg flexed and extended right arm, eyes staring straight ahead. Lasted a few seconds. Examined in the office - seemed OK. No fever, no URI symptoms, no vomiting or diarrhea. The next day seen in ER after right arm twitching, legs twitching and  head turned to left. This episode lasted about 15 seconds.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscle contractions involuntary, Muscle twitching, Nuclear magnetic resonance imaging brain abnormal, Partial seizures, Posture abnormal
Clinical narrative: Right leg shaking when awakened, occurred 3 times at home. Also had episode of right leg flexed and extended right arm, eyes staring straight ahead. Lasted a few seconds. Examined in the office - seemed OK. No fever, no URI symptoms, no vomiting or diarrhea. The next day seen in ER after right arm twitching, legs twitching and  head turned to left. This episode lasted about 15 seconds.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Staring, Tremor
Clinical narrative: Right leg shaking when awakened, occurred 3 times at home. Also had episode of right leg flexed and extended right arm, eyes staring straight ahead. Lasted a few seconds. Examined in the office - seemed OK. No fever, no URI symptoms, no vomiting or diarrhea. The next day seen in ER after right arm twitching, legs twitching and  head turned to left. This episode lasted about 15 seconds.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Dysphagia, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Swelling and severe pain, redness and itching where the vaccine was given. Headache, hard to swallow and joint pain.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and severe pain, redness and itching where the vaccine was given. Headache, hard to swallow and joint pain.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Abnormal faeces, Dermatitis diaper, Diarrhoea
Clinical narrative: Child has had acidic and very watery stools since the evening of the immunization, which is unusual for him. No changes in diet prior or after immunization. Treating subsequent diaper rash with otc DESITIN cream.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Shot was given around 4:50 on 2/3/18 in left arm. Tingling, numbness feeling began in the middle, ring, and little finger about 1-2 hours after the shot was given. Shortness of breath, chest heaviness occurred soon after. Took Benadryl around 7:00pm. Called on call Doctor around 8:45pm and reported symptoms; doctor advised to seek medical help next day if symptoms worsened. Headache and nausea occurred. Tingling feeling moved into palm in the left hand. Throughout night chest tightness increased. Trouble sleeping. Woke around 12:00am when tingling, numbness, burning and constricted feeling then began in left foot around the toes and sole of foot and then progressed up leg into calf area, knee and some in the thigh area. Left hand began improving by morning, however, left leg still affected. Sought medical assistance at Healthcare walk-in care.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Muscle tightness, Nausea, Paraesthesia
Clinical narrative: Shot was given around 4:50 on 2/3/18 in left arm. Tingling, numbness feeling began in the middle, ring, and little finger about 1-2 hours after the shot was given. Shortness of breath, chest heaviness occurred soon after. Took Benadryl around 7:00pm. Called on call Doctor around 8:45pm and reported symptoms; doctor advised to seek medical help next day if symptoms worsened. Headache and nausea occurred. Tingling feeling moved into palm in the left hand. Throughout night chest tightness increased. Trouble sleeping. Woke around 12:00am when tingling, numbness, burning and constricted feeling then began in left foot around the toes and sole of foot and then progressed up leg into calf area, knee and some in the thigh area. Left hand began improving by morning, however, left leg still affected. Sought medical assistance at Healthcare walk-in care.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Drooling, Electroencephalogram abnormal, Gaze palsy, Lethargy, Muscle twitching
Clinical narrative: Eating dinner, then sudden onset seizure with head turning to left, eyes fixed, drooling, became stiff and twitching noted. Lethargic afterward and vomited once. Temperature 99.4-101. Taken by EMS to hospital. Became more alert after 30 minutes- vomited again.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain normal, Posture abnormal, Pyrexia, Seizure
Clinical narrative: Eating dinner, then sudden onset seizure with head turning to left, eyes fixed, drooling, became stiff and twitching noted. Lethargic afterward and vomited once. Temperature 99.4-101. Taken by EMS to hospital. Became more alert after 30 minutes- vomited again.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Vomiting
Clinical narrative: Eating dinner, then sudden onset seizure with head turning to left, eyes fixed, drooling, became stiff and twitching noted. Lethargic afterward and vomited once. Temperature 99.4-101. Taken by EMS to hospital. Became more alert after 30 minutes- vomited again.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Given in the left arm. Very sore upper arm and shoulder. Swollen, hot, red. Lasted for 4 days. On the 4th day left arm started to ache felt like a tightness around upper arm. Arm constantly hurts. Nothing I take relieved the ache.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Pt says she had rash below the shot site after 3 hrs of vaccination and it was itiching and burning sensation. Came to pharmacy on 02/3/2018 2 days later to show to rph. Told to take benadryl and suggested to opt dr care so she went urgent care and was given steroid shot and prednisone tabs and per pt md didnot say it is from pneumovax shot. Pt came to pick rx on 02/04/2018 and went to ER again as it was spreading to face and neck. So Er told her to continue the prednisone tabs and pt says she thinks this is from vaccine.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Dyspnoea, Dyspnoea exertional, Eye swelling
Clinical narrative: Rash on chest, headaches, swelling -mainly above left eye, feverish, weakness, some dizziness, difficulty breathing during exercise  (3 days after the flu shot).
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash on chest, headaches, swelling -mainly above left eye, feverish, weakness, some dizziness, difficulty breathing during exercise  (3 days after the flu shot).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Pruritus, Rash
Clinical narrative: Rash on chin and arms and itching, stomach cramps,diarrhea. Patient took benadryl and the reaction lessened.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt contacted pharmacy on 1/31 and stated that his arm has been sore since date of vaccination. RPh on duty suggested that patient contact MD to discuss and have evaluated.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Sore muscles in left arm and shoulder starting day after injection, continuing as of date of report. Difficulty raising arm. No injection site topical reaction. Treated with ibuprofen.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient reported moderate-severe pain in shoulder after receiving immunization. He reported to the pharmacy on 1/31/2018 that he was still experiencing pain at the injection site and is unable to lift his arm above his shoulder. He had an appointment with Dr. in January and said it was likely due to the vaccine being administered too high. He suspected blood was pooling in the patient's shoulder and recommended an MRI.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Somnolence, Syncope
Clinical narrative: Patient was very nervous to take the intramuscular vaccine. After I applied the vaccine, she waited in the room, her brother and sister were taking  the vaccines as well.  After all had their vaccines, she was standing and preparing to leave when she mention to her mother she was  drowse in a joke way. I start talking to her, asking if she was serious or joking, because I would recommend her to wait  if she was drowse. As I talked to her, she started to faint and fall. Me and her mother hold her to avoid the fall. I put her lay down on the floor. She recovered in few seconds. I kept observing her signs and breathing. She was fine after that.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dysstasia, Emotional distress, Fall, Fatigue
Clinical narrative: My daughter received her 3rd HPV injection/vaccination. Within two months, she experienced several months of unexpected, sporadic, leg weakness, falling down, leg giving out on her, tired, weak, knee gave out, fall over, cant stand up for too long, general weakness and fatigue. Missed school, peers laughed and ridiculed her at school during episodes, teachers viewed her and reported her as a distraction. Emotional distress with trying to fit into the new school while trying to control adverse events from occurring in front of complete strangers. Adverse reactions occurred at home but mostly in school when walking, changing classes all day.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of control of legs, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: My daughter received her 3rd HPV injection/vaccination. Within two months, she experienced several months of unexpected, sporadic, leg weakness, falling down, leg giving out on her, tired, weak, knee gave out, fall over, cant stand up for too long, general weakness and fatigue. Missed school, peers laughed and ridiculed her at school during episodes, teachers viewed her and reported her as a distraction. Emotional distress with trying to fit into the new school while trying to control adverse events from occurring in front of complete strangers. Adverse reactions occurred at home but mostly in school when walking, changing classes all day.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal transplant, Discomfort, Eye disorder, Eye pain, Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about May 2008, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX (exact date unknown), the patient was diagnosed with shingles on her forehead and was referred to an eye-doctor for further evaluation of severe eye pain and diminished vision. Thereafter, the patient was diagnosed with shingles in her left eye. The patient continued to suffer from eye pain, discomfort, pain and diminished vision. The patient underwent a left-eye cornea transplant on 11-FEB-2015, and continued to suffer from eye complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe eye pain and diminished vision/shingles in her left eye with left eye cornea transplant was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Visual impairment
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about May 2008, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX (exact date unknown), the patient was diagnosed with shingles on her forehead and was referred to an eye-doctor for further evaluation of severe eye pain and diminished vision. Thereafter, the patient was diagnosed with shingles in her left eye. The patient continued to suffer from eye pain, discomfort, pain and diminished vision. The patient underwent a left-eye cornea transplant on 11-FEB-2015, and continued to suffer from eye complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe eye pain and diminished vision/shingles in her left eye with left eye cornea transplant was determined to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Inflammation, Joint range of motion decreased, Muscle disorder, Muscular weakness
Clinical narrative: Nerve Inflammation. Pain immediately felt after injection. them experienced pinching in muscle, tingling down arm, weakness in muscles, and loss of range of motion.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia
Clinical narrative: Nerve Inflammation. Pain immediately felt after injection. them experienced pinching in muscle, tingling down arm, weakness in muscles, and loss of range of motion.
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: This is a spontaneous report from a contactable consumer. A 15-month-old patient of an unspecified race/ethnicity and gender started to receive PREVNAR 13, at single dose and Hepatitis A, both via an unspecified route of administration on 22Jan2018 for immunisation. Medical history included febrile convulsion. Concomitant medications were not reported. On 22Jan2018, the patient experienced fever at 102°F and a febrile seizure that required hospitalization with outcome of unknown. The patient also developed tonsillitis on an unspecified date with outcome of unknown. The events were described as follows: This patient was immunized with the Hepatitis A and PREVNAR 13 vaccines on the morning of 22Jan2018. Later that evening, the patient's parent brought the patient to the emergency department of a hospital for the presentation of a 102 degree fever and a febrile seizure. The patient was admitted to the hospital for treatment. The parent of the patient then notified the paediatrician who administered the vaccine and whose office is currently reporting the adverse event of the hospitalization. The reporter of the adverse event stated in the report that the patient had been treated in the past for febrile seizures, before being immunized with the Hepatitis A and PREVNAR 13. The patient went for a follow up appointment on 25Jan2018 with physician in which he presented with tonsillitis. The information on the lot number has been requested.
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA, PNC13
Symptoms: Febrile convulsion, Pyrexia, Tonsillitis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 15-month-old patient of an unspecified race/ethnicity and gender started to receive PREVNAR 13, at single dose and Hepatitis A, both via an unspecified route of administration on 22Jan2018 for immunisation. Medical history included febrile convulsion. Concomitant medications were not reported. On 22Jan2018, the patient experienced fever at 102°F and a febrile seizure that required hospitalization with outcome of unknown. The patient also developed tonsillitis on an unspecified date with outcome of unknown. The events were described as follows: This patient was immunized with the Hepatitis A and PREVNAR 13 vaccines on the morning of 22Jan2018. Later that evening, the patient's parent brought the patient to the emergency department of a hospital for the presentation of a 102 degree fever and a febrile seizure. The patient was admitted to the hospital for treatment. The parent of the patient then notified the paediatrician who administered the vaccine and whose office is currently reporting the adverse event of the hospitalization. The reporter of the adverse event stated in the report that the patient had been treated in the past for febrile seizures, before being immunized with the Hepatitis A and PREVNAR 13. The patient went for a follow up appointment on 25Jan2018 with physician in which he presented with tonsillitis. The information on the lot number has been requested.
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Culture negative, Incisional drainage, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient with repeated infections and primary immunodeficiency. On 27-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 in the left deltoid (route, dose, dose number not reported), lot number reported as PN012127, expiration date: 20-JAN-2019, for prophylaxis (indication also reported as primary immunodeficiency). Concomitant therapies included MIDRON and fluoxetine (manufacturer unknown). On 08-JAN-2018, 13 days after onset of therapy the patient experienced fever of 99.8 F and the injection site became painful, red, swollen and hot to touch. The patient sought medical attention and was diagnosed with cellulitis. That same day the patient was admitted to a medical center and had a surgical drainage at the left arm. During the procedure, it was drained yielded pus with negative cultures. It was noted that the patient was not able to move her arm. As treatment the patient received a prescription for a ten days course of clindamycin (manufacturer unknown). The nurse mentioned that on 11-JAN-2018, the patient's fever, pain and swelling had improved but not resolved yet. The outcome of "not able to move her arm" was unknown. The reporter considered the event "the patient was not able to mover her arm" to be disabling. The relationship between therapy with PNEUMOVAX 23 and injection site cellulitis was unknown. Lot number PN012127 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Purulent discharge, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient with repeated infections and primary immunodeficiency. On 27-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 in the left deltoid (route, dose, dose number not reported), lot number reported as PN012127, expiration date: 20-JAN-2019, for prophylaxis (indication also reported as primary immunodeficiency). Concomitant therapies included MIDRON and fluoxetine (manufacturer unknown). On 08-JAN-2018, 13 days after onset of therapy the patient experienced fever of 99.8 F and the injection site became painful, red, swollen and hot to touch. The patient sought medical attention and was diagnosed with cellulitis. That same day the patient was admitted to a medical center and had a surgical drainage at the left arm. During the procedure, it was drained yielded pus with negative cultures. It was noted that the patient was not able to move her arm. As treatment the patient received a prescription for a ten days course of clindamycin (manufacturer unknown). The nurse mentioned that on 11-JAN-2018, the patient's fever, pain and swelling had improved but not resolved yet. The outcome of "not able to move her arm" was unknown. The reporter considered the event "the patient was not able to mover her arm" to be disabling. The relationship between therapy with PNEUMOVAX 23 and injection site cellulitis was unknown. Lot number PN012127 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
Age: 52.0
Sex: F
Vaccine: HIBV, MENB
Symptoms: Joint range of motion decreased, Pain in extremity, Periarthritis, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Pain began in both arms within hours of injection. Sleep disruption due to pain began 1/26/18 in both arms. Right arm still painful but full range of motion by 2-1-2018. Left arm continued to be painful with around a 90 degree range of motion max w/ impingement. Visit to convenient care facility 2-1-2018 for pain management and evaluation of left arm. 2-4-2018 diagnosis of adhesive capsulitis w impingement of left arm. Tx: anti-inflammatories, warm compress, exercise, cold compress. PT to begin next.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. It was reported that on 05-JAN-2018, the patient was vaccinated with a properly stored but expired dose of PROQUAD with lot number M031566 and expiration date on 24-DEC-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referrin to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allegies, concurrent conditions and concomitant medications were not reported. In 2015, the patient was vaccinated with the first and second dose of GARDASIL 9 for prophylaxis (route of administration, lot # and expiration date were nott reported). It was reported that the patient did not receive the third dose. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Neuralgia, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in December 2017, the patient was vaccinated with PNEUMOVAX23 (dosing details were not reported) for prophylaxis. On an unknown date in December 2017 (a week after injection) the patient experienced nerve pain (neuropathy). The outcome of neuropathy peripheral was reported as recovered/resolved completely. The pharmacist (the reporter) believed that this reaction was to something else (captured as not related), but the patient felt it was from the vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-SEP-2011, the patient was vaccinated with the first dose of  GARDASIL for prophylaxis (lot number and expiration date were not provided). On 04-JAN-2018, the patient was vaccinated with GARDASIL 9 as second dose, for prophylaxis (lot number and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to an unknown age patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2018, the patient was inadvertently vaccinated with one expired dose of VARIVAX (Lot # M002064 with expiration date 12-JAN-2018) for prophylaxis (dose number and route of administration were not reported). No adverse effects reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 57 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2018, the patient was vaccinated with a dose of GARDASIL 9 (dosing details were not reported) (lot # N022584, expiry date: 15-JUN-2020) for prophylaxis instead a dose PNEUMOVAX 23. On 31-JAN-2018, 1 day after onset of therapy the patient experienced wrong drug administered. The reporter confirmed that there was no confusion between the two products, and the provider who erroneously administered the GARDASIL 9 had simply selected the wrong vaccine from their supply. No adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: HPVX
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a physician refers to a 15 or 16 years old female patient. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date approximately in January 2016 (also reported as one and one half to two years ago), the patient was vaccinated with an unspecified dose of GARDASIL (dosing details were not reported), intramuscularly for prophylaxis or GARDASIL 9 (dosing details were not reported) intramuscularly for prophylaxis (unidentified Merck hpv vaccine administered). It could not be confirmed if the patient had been administered GARDASIL or GARDASIL 9. The patient experienced a headache for one month after being administered the GARDASIL or GARDASIL 9 vaccine. The patient did seek medical attention, but the route by which the patient sought medical attention could not be confirmed. The outcome of headache was unknown. Causality assessment was not reported. No product quality complaint involved.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative regarding a 19 year old female patient. The patient's pertinent medical conditions, drug areactions and concomitant medications were unknown. On unknown dates in 1998, 1999 and 2003, the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) (also reported as possibly manufactured by the company) (dosing details and lot # were not reported) for prophylaxis. On an unknown date, the patient underwent unspecified laboratory tests and the results were hepatitis B was not reactive (hepatitis b antibody negative). Outcome of the event was not reported. Causality of the event was not reported. No product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2014, a few weeks after being vaccinated, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 17-APR-2014, the patient received subsequent treatment for new and ongoing symptoms of shingles and pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage caused secondary to zoster infections. On or about 11-FEB-2016, the patient was treated for continued and worsening pain, which was identified as neuralgia that was not able to be adequately controlled by treatment. The patient has been prescribed gabapentin, tea, LIPODERM and LORTAB for management of her persistent symptoms and chronic pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JUN-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2012 (date discrepancy), the patient was treated by a physician for the onset of a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her persistent painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, generalized joint and muscle pain. Treated with TYLENOL and PEPTO BISMOL. Fever, nausea, vomiting, and generalized pain absent 36 hours after initial presentation. Diarrhea and headache reduced, but still present after 50+  hours.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, generalized joint and muscle pain. Treated with TYLENOL and PEPTO BISMOL. Fever, nausea, vomiting, and generalized pain absent 36 hours after initial presentation. Diarrhea and headache reduced, but still present after 50+  hours.
Age: 19.0
Sex: M
Vaccine: HEP, HPV9, MENB
Symptoms: Fall, Head injury
Clinical narrative: PT RECEIVED VACCINATIONS, WHILE PUTTING ON BLOUSE PT FELL TO FLOOR AND HIT HEAD. CODE BLUE IMMEDIATELY CALLED. ASSESSED AND DISPOSITIONED BY PROVIDER AND NURSE. PT WAS DISCHARGED BY NURSE.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching: lasted about 3 1/2 days. Morning after the shot woke feeling chills, aches: lasted approximately one day.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Back pain, Chest pain, Eye irritation, Fatigue, Headache
Clinical narrative: RUNNING A LOW GRADE FEVER, 97.5. TO 97.8, A BURNING, ACHING PAIN IN ARM THAT HAS SPREAD TO BACK BETWEEN SHOULDER BLADES, LEFT UPPER ARM AND ACROSS CHEST. PAIN SOMETIMES IS UNBEARABLE. FATIGUE, BURNING EYES, HEADACHE. HAVE BEEN SLEEPING IN CHAIR BECAUSE THE PAIN CAUSES ME TO NOT BE ABLE TO LIE DOWN. HARD TO EXPLAIN THE PAIN, IT BURNS BUT ALSO HURTS, ACHES.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: RUNNING A LOW GRADE FEVER, 97.5. TO 97.8, A BURNING, ACHING PAIN IN ARM THAT HAS SPREAD TO BACK BETWEEN SHOULDER BLADES, LEFT UPPER ARM AND ACROSS CHEST. PAIN SOMETIMES IS UNBEARABLE. FATIGUE, BURNING EYES, HEADACHE. HAVE BEEN SLEEPING IN CHAIR BECAUSE THE PAIN CAUSES ME TO NOT BE ABLE TO LIE DOWN. HARD TO EXPLAIN THE PAIN, IT BURNS BUT ALSO HURTS, ACHES.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Eye irritation, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: RUNNING A LOW GRADE FEVER, 97.5. TO 97.8, A BURNING, ACHING PAIN IN ARM THAT HAS SPREAD TO BACK BETWEEN SHOULDER BLADES, LEFT UPPER ARM AND ACROSS CHEST. PAIN SOMETIMES IS UNBEARABLE. FATIGUE, BURNING EYES, HEADACHE. HAVE BEEN SLEEPING IN CHAIR BECAUSE THE PAIN CAUSES ME TO NOT BE ABLE TO LIE DOWN. HARD TO EXPLAIN THE PAIN, IT BURNS BUT ALSO HURTS, ACHES.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient experienced a fever of 102.9-103 approximately 9 hours after receiving the Flu shot. Patient was not experiencing any illness symptoms prior to receiving the shot. Fever was controlled via alternating doses of childrens ibuprofen and Tylenol. Fever has not gone below 99 and is continuing to spike to 102 if dosage time is missed.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: The injection site and approx 2 inches around the injection site started swelling, turning pink, firm and warm to the touch and also had a very prominent border at 10am. By 1pm the size of the swelling was much larger and it became a lot more firm, red, and very hot to the touch. He was starting to pull and scratch at the area and became fussy during diaper changes. I administered TYLENOL suspension (6.5mL) by mouth and also BENADRYL (2.5mL) by mouth. I also applied a cold compress to the site for approx 10-15mins. By 7pm the redness spread and covered a large portion of the front of his thigh. The following morning at 6:30am his leg was the same so I took him to emergency room. They performed a sonogram of the area and diagnosed him with cellulitis and prescribed clindamycin 15mg/mL. I was unable to fill his prescription at the time so he never took it. This morning (the next day) the swelling and redness has subsided. It is still slightly warm to the touch and a hard knot at the injection site remained.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site swelling, Injection site warmth, Irritability, Ultrasound scan
Clinical narrative: The injection site and approx 2 inches around the injection site started swelling, turning pink, firm and warm to the touch and also had a very prominent border at 10am. By 1pm the size of the swelling was much larger and it became a lot more firm, red, and very hot to the touch. He was starting to pull and scratch at the area and became fussy during diaper changes. I administered TYLENOL suspension (6.5mL) by mouth and also BENADRYL (2.5mL) by mouth. I also applied a cold compress to the site for approx 10-15mins. By 7pm the redness spread and covered a large portion of the front of his thigh. The following morning at 6:30am his leg was the same so I took him to emergency room. They performed a sonogram of the area and diagnosed him with cellulitis and prescribed clindamycin 15mg/mL. I was unable to fill his prescription at the time so he never took it. This morning (the next day) the swelling and redness has subsided. It is still slightly warm to the touch and a hard knot at the injection site remained.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product colour issue
Clinical narrative: This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 12-JAN-2018 (reported as today), the patient was vaccinated with M-M-R II lot # N013296 and expiration date 28-APR-2019 for prophylaxis (dose, frequency and route were not provided). The reporter stated that the vaccine was clearer than it was yellow in appearance. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA001719.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous report as received from a Nurse refers to a patients of unknown demography. On an unknown date the patients were vaccinated a dose of GARDASIL 9 via an injection into the gluteal muscle (Incorrect route of drug administration). No known adverse effects.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # N020352 (expiry: 10-APR-2020), N004799 (expiry: 15-NOV-2019) and M044717 (expiry: 19-JUL-2019), improperly stored RECOMBIVAX HB lot # N006321 (expiry: 08-NOV-2019), M045546 (12-JUN-2018) and improperly stored ROTATEQ lot # N005626 (expiry: 26-NOV-2018), M041766 (08-MAY-2018) and M045546 (expiry: 12-JUN-2018). For GARDASIL 9, the temperature and time frame was reported as 47 F to 77 F (57.18F) 14 hours and 50 minutes and there was no temperature excursion. For ROTATEQ, the temperature and time frame was reported as 47 F to 77 F (50.05F) for 225 hours and 57 minutes with previous temperature excursion. For RECOMBIVAX HB, the temperature and time was reported as 47 F to 77 F (57.18F) for 240 hours and 47 minutes with previous temperature excursion. No adverse effects reported. No PQC involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product colour issue
Clinical narrative: This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 12-JAN-2018 (reported as today), the patient was vaccinated with M-M-R II lot # N013296 and expiration date 28-APR-2019 for prophylaxis (dose, frequency and route were not provided). The reporter stated that the vaccine was clearer than it was yellow in appearance. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA005333.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse events occurred. Expired vaccine was given as the expiration date on box and vial was confusing. Listed as 18OCT17 and thought to expire October 17, 2018 BUT actually expired October 18, 2017.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Heart rate increased, Peripheral swelling, Skin tightness
Clinical narrative: My pulse shot up as high  as 119, it eventually lowered to at or around 86 and now it's back in the 100's again. my arms feel like they're puffed up as tight as they can go. This fatigues.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Left Superior Arm, Left Armpit and Left Chest swelling.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site swelling, Oedema peripheral, Swelling
Clinical narrative: Left Superior Arm, Left Armpit and Left Chest swelling.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Product packaging confusion
Clinical narrative: NONE - Patient received an expired dose of HIB as packaging was confusing. The expiration was written as 18OCT17 and it was thought that the vaccine expired October 17, 2018 when it actually expired October 18, 2017. This was not found until the end of January 2018 when all of our vaccines were brought back to office after the 2 1/2 months of the vaccines being at the main hospital due to the vaccine refrigerator being broken.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: NONE - The expiration for HIB on the box and vials was written as 18OCT17 and it was thought that the vaccine expired October 17, 2018 when it actually expired October 18, 2017. This was not found until the end of January 2018 when all of our vaccines were brought back to office after the 2 1/2 months of the vaccines being at the main hospital due to the vaccine refrigerator being broken.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abnormal sensation in eye, Diarrhoea, Headache, Nausea
Clinical narrative: After first dose, slight abdominal cramps, and nausea. After second dose, severe nausea, slight vomiting, bad abdominal pain, diarrhea, headache, eyes feel different.