chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Balance disorder, Dizziness, Fatigue, Herpes zoster
Clinical narrative: This spontaneous report was received from a 71 year old female consumer, reporting on herself, with allergy to FLAGYL, allergy to codeine and allergy to sulfa. On 11-JUN-2008, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as 1 DF) (route, lot number and expiration date were not reported) in the left arm. Patient was not on concomitant therapies at the time of the report. The patient reported that after receiving ZOSTAVAX vaccine, on 14-JUN-2008, she experienced 3 days later pain in left arm, pains in the stomach, injection site was red and painful and also a headache. Also has experienced some shingles blistering on her right side of her vagina, in the crease by the leg, with little pain also some tiredness, lightheaded, off balance and stomach pain as well. At the time of the report the outcome was reported as not recovered. Patient received was prescribed a ointment for treatment of the shingles. No lab diagnostics studies were performed. Patient sought medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Vaginal mucosal blistering, Vulvovaginal pain
Clinical narrative: This spontaneous report was received from a 71 year old female consumer, reporting on herself, with allergy to FLAGYL, allergy to codeine and allergy to sulfa. On 11-JUN-2008, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as 1 DF) (route, lot number and expiration date were not reported) in the left arm. Patient was not on concomitant therapies at the time of the report. The patient reported that after receiving ZOSTAVAX vaccine, on 14-JUN-2008, she experienced 3 days later pain in left arm, pains in the stomach, injection site was red and painful and also a headache. Also has experienced some shingles blistering on her right side of her vagina, in the crease by the leg, with little pain also some tiredness, lightheaded, off balance and stomach pain as well. At the time of the report the outcome was reported as not recovered. Patient received was prescribed a ointment for treatment of the shingles. No lab diagnostics studies were performed. Patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Altered state of consciousness, Crying, Dyspnoea
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N) concerning a 14 year old female patient with thalassemia trait, history of eczema and no drug allergies/drug reactions. It was reported that on 24-JUN-2014 the patient was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # reported as K004546), intramuscularly into the right arm. Concomitant therapies included FLUARIX which was given into the left arm prior to receiving GARDASIL. On 29-SEP-2014, the patient received the second 0.5 mL dose of GARDASIL (Lot # reported as K004546). The nurse reported that on 29-SEP-2014 the patient experienced being oblivious and then experienced crying, shortness of breath and extreme abdominal pain after receiving GARDASIL. Nurse reported that abdominal pain improved after five to seven minutes. It was reported that the patient was observed for 25 minutes and went home with only mild abdominal pain. Patients vital signs were normal. Shortness of breath resolved completely in 2014. There were no laboratory diagnostic tests performed. The patient informed nurse that the second dose of GARDASIL hurt more than the first dose. Nurse reported that a 25 gauge, one inch needle was used for GARDASIL injection. There was no treatment given for the adverse events. The outcome for being oblivious, crying, extreme abdominal pain was reported as recovering. The outcome of the pain for the first dose was recovered in 2014 and for the pain with the second dose was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 13-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that improperly stored VARIVAX (Merck) (about 8 doses) were administered to patients (on an unknown date). No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Muscular weakness, Neuralgia
Clinical narrative: 1 month post vaccine administration, pt states her arm is weak, there is radiating nerve pain, she is experiencing limited mobility, pt is wearing a sling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache
Clinical narrative: This spontaneous report as received from a 67 year old female patient with arthritis. The patient cannot take morphine and codeine. The patient reported that she had received the ZOSTAVAX (lot#, dose, frequency, route, indication not reported) vaccination from her physician approximately three and half weeks ago (approximately on an unknown date in beginning of September). Concomitant therapy included ibuprofen (also reported as no concomitant medications used). Approximately three and half weeks ago, on an unknown date in beginning of September after receiving the vaccination she had a headache and joint pains in her body. The patient did not seek medical attention. There was no product quality complaint. No treatment was given for the event. No lab diagnostics studies were performed. The events improved and the outcome was reported as recovered. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly, on 22-JUL-2014, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 22-SEP-2014, the patient received the third 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: On 10/9/14 patient stated she noticed a rash on left side of her neck 30 minutes after receiving the Hep B vaccination; Rash also noticed on right side of her neck 45 minutes after the Hep B vaccination was given. Patient stated the rash was accompanied by itching. Itching has since resolved. Patient reported adverse event 20 days after receiving vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (lot # not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site bruising, Injection site swelling, Injection site warmth, Papule
Clinical narrative: Swollen, bruised and warm to touch at injection site. Small red papules on arm, sides and back. Tx w/MEDRIL dose pak, 4 mg tablets.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling at injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with VAQTA (dose, lot number, expiration date and route not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unkonwn date, the patients were administered with PROQUAD (Merck) (dose, Lot number, expiration date and route were not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hep A given. Hep B was ordered.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unkonwn date improperly stored doses of RECOMBIVAX HB (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified nurse-midwife refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2008 the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 28-MAR-2014 the second dose of GARDASIL was administered (dose, route, anatomical location, lot number and expiration date were unspecified) and the third dose of GARDASIL was administered on 20-may-2014 (dose, route, anatomical location, lot number and expiration date were unspecified). No adverse effect was reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with VARIVAX (Merck) (dose, lot number, expiration date and route not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching and pain at site of injection (L) arm treating Kw/ KEFLEX, prednisone, BENADRYL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with RECOMBIVAX HB (dose, lot number, expiration date and route were not reported), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 79 year old patient of unknown gender. Pertinent medical history, drug reaction or allergies were not reported. On 17-JAN-2014 and 18-AUG-2014, the patient was vaccinated with ZOSTAVAX, (dose, dose number, route, anatomical location, lot number and expiration date were not reported) (also reported as patient received 2 doses of ZOSTAVAX). No adverse symptoms reported. Concomitant therapies were not reported. The outcome the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of M-M-R II (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was receive from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly store doses of VAQTA (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. Pertinent medical history, drug reactions or allergies were not reported. On 26-SEP-2014 the patient was vaccinated with expired ZOSTAVAX lot # J001693, expiration date 08-MAY-2014, 0.65 ml, subcutaneous in the right arm (dose number was not reported). No adverse effects reported at the time of this report. No concomitant therapies were reported. The outcome of the events was unknown. Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of ROTATEQ oral, (strength, dosage, lot number and expiration date were not reported) oral, were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of PNEUMOVAX 23 (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Gene mutation identification test positive, Grand mal convulsion
Clinical narrative: I discovered patient in her crib having a seizure. At this time we rushed her to the emergency room. The following is copied from the neurologist's note: generalized status epilepticus requiring intubation and multiple anticonvulsants.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Bacterial test, CSF test, Computerised tomogram, Convulsion, Cytogenetic analysis
Clinical narrative: I discovered patient in her crib having a seizure. At this time we rushed her to the emergency room. The following is copied from the neurologist's note: generalized status epilepticus requiring intubation and multiple anticonvulsants.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram, Endotracheal intubation, Metabolic function test, Nuclear magnetic resonance imaging, Status epilepticus
Clinical narrative: I discovered patient in her crib having a seizure. At this time we rushed her to the emergency room. The following is copied from the neurologist's note: generalized status epilepticus requiring intubation and multiple anticonvulsants.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Eye burns, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a 37 year old female pharmacist refers to herself. Patient's current condition included simple partial seizures. No relevant medical history has been reported. Her past drug history was unknown. On 10-SEP-2014, the patient was drawing up ZOSTAVAX lot # K003596 expiration date: 12-MAR-2015 (unknown dose, units or frequency) for an unknown indication (also reported as accidentally, route left eye). Concomitant therapies included KEPPRA. On 10-SEP-2014, patient accidentally squirted in her left eye as she was drawing up ZOSTAVAX and it had a retractable needle. On 10-SEP-2014, she also reported that her eye burned a little but then she flushed it briefly and after flushing, her eye was red. It was unknown if there was any relevant laboratory data. It was reported that as of 10-SEP-2014 it was unknown if she will accidentally get ZOSTAVAX in her eye again. The outcome of the event her eye burned a little was reported as resolved. The outcome of the event after flushing her eye was red was reported as not recovered/not resolved (also reported as her eye continues to be red) and the outcome of the event accidentally squirted in her left eye was not reported. Causality between ZOSTAVAX and the events were not reported. Follow up information was received and it was reported that the faulty retractable needle retracted when drawing up ZOSTAVAX and shot 1 at the left eye. The Lot number was reported as K008884 for ZOSTAVAX. It was reported that the patient required emergency room visit. The outcome of the events were reported as recovered on 10-OCT-2014. The patient did not sign any informed consent form. The vaccine administrator and the facility details were updated. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irrigation, Eye irritation, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a 37 year old female pharmacist refers to herself. Patient's current condition included simple partial seizures. No relevant medical history has been reported. Her past drug history was unknown. On 10-SEP-2014, the patient was drawing up ZOSTAVAX lot # K003596 expiration date: 12-MAR-2015 (unknown dose, units or frequency) for an unknown indication (also reported as accidentally, route left eye). Concomitant therapies included KEPPRA. On 10-SEP-2014, patient accidentally squirted in her left eye as she was drawing up ZOSTAVAX and it had a retractable needle. On 10-SEP-2014, she also reported that her eye burned a little but then she flushed it briefly and after flushing, her eye was red. It was unknown if there was any relevant laboratory data. It was reported that as of 10-SEP-2014 it was unknown if she will accidentally get ZOSTAVAX in her eye again. The outcome of the event her eye burned a little was reported as resolved. The outcome of the event after flushing her eye was red was reported as not recovered/not resolved (also reported as her eye continues to be red) and the outcome of the event accidentally squirted in her left eye was not reported. Causality between ZOSTAVAX and the events were not reported. Follow up information was received and it was reported that the faulty retractable needle retracted when drawing up ZOSTAVAX and shot 1 at the left eye. The Lot number was reported as K008884 for ZOSTAVAX. It was reported that the patient required emergency room visit. The outcome of the events were reported as recovered on 10-OCT-2014. The patient did not sign any informed consent form. The vaccine administrator and the facility details were updated. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left shoulder where injection was had "itching and pain".  Following day had "hardness and more swelling".
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Rash
Clinical narrative: Was diagnosed with shingles 4 days later.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Painful warm erythema swollen circle, increasing in size, about 4 cm wide.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood bilirubin increased, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: Copious mucus in back of throat. Headache. Nausea. Stomach ache. Weakness in arms and legs. Numbness in fingers and face. Severe pain in calf muscles, both legs, resulting in difficulty walking and using stairs both up and down. Most symptoms subsided after 2-3 days. Leg pain continued for one week.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Muscular weakness, Nausea, Pain in extremity, Urine analysis abnormal
Clinical narrative: Copious mucus in back of throat. Headache. Nausea. Stomach ache. Weakness in arms and legs. Numbness in fingers and face. Severe pain in calf muscles, both legs, resulting in difficulty walking and using stairs both up and down. Most symptoms subsided after 2-3 days. Leg pain continued for one week.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Copious mucus in back of throat. Headache. Nausea. Stomach ache. Weakness in arms and legs. Numbness in fingers and face. Severe pain in calf muscles, both legs, resulting in difficulty walking and using stairs both up and down. Most symptoms subsided after 2-3 days. Leg pain continued for one week.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, induration at the sight of injection of 4 cm.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Crying, Cyanosis, Dyskinesia, Eye movement disorder
Clinical narrative: Recvd Prevnar 13 #3 and Pediarix #3 at 6 month physical 10/7/2014.  Per parent report was fine the rest of the day. rash noted in office had resolved. Had given Tylenol 'just in case' when they got home.   Slept well.  At 3.40am woke up with 'desperate' crying - when picked her up felt hot. Gave her 1.25ml of Tylenol. And ~10 minutes later head rolled back, eyes rolled back. Arms became stiff with jerking movements as well as right leg. Was moaning. Breathing became a concerned and her face turned blue for 5 minutes.  took "20 minutes" for jerking movements to resolve. Call 911 - EMS temp axillary and otic was "around 100F". She was sleepy afterwards.  Movements had resolved prior to EMS per dad - Checked temp 100.4F axillary afterwards - no Tylenol given.  Were told it was a febile seizure.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Febrile convulsion, Moaning, Musculoskeletal stiffness, Posture abnormal, Rash
Clinical narrative: Recvd Prevnar 13 #3 and Pediarix #3 at 6 month physical 10/7/2014.  Per parent report was fine the rest of the day. rash noted in office had resolved. Had given Tylenol 'just in case' when they got home.   Slept well.  At 3.40am woke up with 'desperate' crying - when picked her up felt hot. Gave her 1.25ml of Tylenol. And ~10 minutes later head rolled back, eyes rolled back. Arms became stiff with jerking movements as well as right leg. Was moaning. Breathing became a concerned and her face turned blue for 5 minutes.  took "20 minutes" for jerking movements to resolve. Call 911 - EMS temp axillary and otic was "around 100F". She was sleepy afterwards.  Movements had resolved prior to EMS per dad - Checked temp 100.4F axillary afterwards - no Tylenol given.  Were told it was a febile seizure.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Skin warm, Somnolence
Clinical narrative: Recvd Prevnar 13 #3 and Pediarix #3 at 6 month physical 10/7/2014.  Per parent report was fine the rest of the day. rash noted in office had resolved. Had given Tylenol 'just in case' when they got home.   Slept well.  At 3.40am woke up with 'desperate' crying - when picked her up felt hot. Gave her 1.25ml of Tylenol. And ~10 minutes later head rolled back, eyes rolled back. Arms became stiff with jerking movements as well as right leg. Was moaning. Breathing became a concerned and her face turned blue for 5 minutes.  took "20 minutes" for jerking movements to resolve. Call 911 - EMS temp axillary and otic was "around 100F". She was sleepy afterwards.  Movements had resolved prior to EMS per dad - Checked temp 100.4F axillary afterwards - no Tylenol given.  Were told it was a febile seizure.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Malaise, headache, fatigue.
Age: 40.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Arthralgia, Arthritis, Gait disturbance, Joint swelling, Mobility decreased
Clinical narrative: Swelling of joints (fingers, wrists, toes, ankles) combined with painful joints within 2 weeks after Hep A/B vaccine. Following second vaccine joint pain/inflammation worsened, resulting in partial loss of use of hands and difficulty walking due to foot pain.
Age: 40.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Pain in extremity
Clinical narrative: Swelling of joints (fingers, wrists, toes, ankles) combined with painful joints within 2 weeks after Hep A/B vaccine. Following second vaccine joint pain/inflammation worsened, resulting in partial loss of use of hands and difficulty walking due to foot pain.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Pain beginning at the deltoid for 1 week, and then radiating down the arm for 2 additional weeks.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: She developed a red rash at the site of administration.  It is hot and painful.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Lacrimation increased, Throat irritation, Vomiting
Clinical narrative: Received vaccination about 2:30. About 7:30 PM started having scratchy throat and watery eyes. Woke up at 2:30 AM with violent diarrhea and vomiting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Lethargy, Local reaction
Clinical narrative: Large about 2.5 inch erythematous and pruritic localized reaction around injection sight. No notice of bruising. Has lasted 3 days and is now getting better. patient reported being lethargic but no other reaction or side effects were noted by patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Rash
Clinical narrative: Erythema, rash, soreness, limited range of motion.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Erythema, rash, soreness, limited range of motion.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Tinnitus
Clinical narrative: Severe dizziness and severe ringing in ears.  Unable to walking without holding on to something.  Still ongoing after 15 hours.  Taking meclizine for dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vertigo
Clinical narrative: When I woke up and sat up in bed the room was spinning.  I sat there for about 5 minutes before attempting to get out of bed.  The vertigo finally stopped.  I have never experienced vertigo before.  The evening on the day I received the shot, my left upper arm was sore, red and swollen.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large pruritic erythematous reaction around injection site. She has never had any reaction for the last 42 years to flu vaccine she said.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Severe hives.
Age: 0.77
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Clostridium test positive, Culture stool, Dehydration, Diarrhoea haemorrhagic, Parasite stool test
Clinical narrative: Bloody diarrhea, fever, dehydration.
Age: 0.77
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Ultrasound abdomen
Clinical narrative: Bloody diarrhea, fever, dehydration.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Severe aching at joints or arms and legs, severe chills, 104.3 fever.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: Patient described extreme muscle soreness, tingling in fingers, 1/2 grip strength, cannot lift arm or move across her body.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Atrioventricular block first degree, Chest pain, Electrocardiogram abnormal, Neck pain, Pain in jaw
Clinical narrative: Chest pain that radiated to right side of neck and jaw, EKG done. No treatment needed.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus bradycardia
Clinical narrative: Chest pain that radiated to right side of neck and jaw, EKG done. No treatment needed.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Chills, Cough, Dysphagia
Clinical narrative: Coughing, chest pain, back pain, chills, headache, eye pain, difficulty swallowing, feeling as if throat was closing up.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Headache, Throat tightness
Clinical narrative: Coughing, chest pain, back pain, chills, headache, eye pain, difficulty swallowing, feeling as if throat was closing up.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy muscle, Blood test, Dyspnoea, Electromyogram, Headache
Clinical narrative: Hives, headache, muscle pain. 5 days later, Face and neck swelling. Followed by shortness of breath and muscle weakness. Continuing still 21 months later.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Muscular weakness, Myalgia, Pulmonary function test, Swelling face
Clinical narrative: Hives, headache, muscle pain. 5 days later, Face and neck swelling. Followed by shortness of breath and muscle weakness. Continuing still 21 months later.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives, headache, muscle pain. 5 days later, Face and neck swelling. Followed by shortness of breath and muscle weakness. Continuing still 21 months later.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Body temperature increased, Myalgia
Clinical narrative: Severe muscle pain, severe joint pain in ankles, knees and hips, joint pain in fingers back and shoulders. Temperature up 4.5 degrees F.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Dizziness, Dyspnoea, Fasciitis, Injection site erythema, Injection site swelling
Clinical narrative: Shortness of breath, dizziness, fever, redness, swelling, warmth at injection site, fasciitis over left deltoid muscle, early myositis
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site warmth, Myositis, Pyrexia
Clinical narrative: Shortness of breath, dizziness, fever, redness, swelling, warmth at injection site, fasciitis over left deltoid muscle, early myositis
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Muscular weakness
Clinical narrative: Shortness of breath, dizziness, fever, redness, swelling, warmth at injection site, fasciitis over left deltoid muscle, early myositis
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Ear pain, Headache
Clinical narrative: DIZZINESS, CHILLS, FEVER?, EXCRUCIATING EAR PAIN, NAUSEA, PAIN BILATERAL ANTERIOR LATERAL NECK, HUGE HEADACHE, WEAKNESS. SYMPTOMS STARTED 3-4 HOURS AFTER  FLU-SHOT AND LASTED TILL EVENING OF 10/09/2014. 10/10/2014 WOKE UP WITH NO SYMPTOMS OF ANY KIND!!!!
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Neck pain
Clinical narrative: DIZZINESS, CHILLS, FEVER?, EXCRUCIATING EAR PAIN, NAUSEA, PAIN BILATERAL ANTERIOR LATERAL NECK, HUGE HEADACHE, WEAKNESS. SYMPTOMS STARTED 3-4 HOURS AFTER  FLU-SHOT AND LASTED TILL EVENING OF 10/09/2014. 10/10/2014 WOKE UP WITH NO SYMPTOMS OF ANY KIND!!!!
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Chills, Condition aggravated, Convulsion, Dizziness
Clinical narrative: Pt reports feeling nausea and dizziness after vaccination, exercised with trainer at gym for a short time, unable to complete workout as she felt nauseated & dizzy. Started having cold chills, husband took pt to ER, had convulsions (?seizures), tachycardia, fever of 101. Treated in ER and released same day.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Tachycardia
Clinical narrative: Pt reports feeling nausea and dizziness after vaccination, exercised with trainer at gym for a short time, unable to complete workout as she felt nauseated & dizzy. Started having cold chills, husband took pt to ER, had convulsions (?seizures), tachycardia, fever of 101. Treated in ER and released same day.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT CAME IN ON 10/7 & STATED SHE WENT TO DR FOR SHINGLES. DR. ORDERED ACYCLOVIR 800MG TID.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Woke up with a red spot where vaccine was given, felt warm and itchy. Thursday spot got bigger and by Friday it spread out a little.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Injection site rash, Injection site swelling, Nausea
Clinical narrative: Rash and swelling at injection site. Injection site pain. Nausea. Coughing. Sneezing. All over body aches/pains.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Sneezing
Clinical narrative: Rash and swelling at injection site. Injection site pain. Nausea. Coughing. Sneezing. All over body aches/pains.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: PATIENT REPORTED ON 10/10/2014 TO PHARMACIST OF PAIN STILL AT INJECTION SITE.  STATED NO SWELLING OR REDNESS AT SITE.  NO FEVER WAS NOTED AS WELL.    RECOMMENDED TO SPEAK TO PHYSICIAN CONCERNING PAIN.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Pharyngeal oedema
Clinical narrative: Swelling of throat/gland on left side, only.  Gargled warm salt water, used hot/wet compress, and took naproxen for swelling.
Age: 0.05
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of drug administration, Irritability, Lumbar puncture normal, Pyrexia, Viral infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 days old female patient. The patient did not have pertinent medical history and drug reactions or allergies. On the day of birth, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength 2.5microgram/0.5ml, dose, lot#, expiration date and route were unknown). There were no concomitant therapies. On 02-OCT-2014 the patient was inadvertently administered a second dose of RECOMBIVAX HB (strength 2.5microgram/0.5ml, dose, lot#, expiration date and route were unknown). The nurse stated that later that day on 02-OCT-2014 (also reported as 03-OCT-2014), the patient had a fever and was "fussy". The patient was admitted to hospital to rule out sepsis on 02-OCT-2014. A "Septic Workup" with a spinal tap was performed. She stated that the "septic workup" was negative and it was determined that the patient had a viral illness. No treatment was given, only "supportive measures". She stated that the patient was discharged from the hospital on 05-OCT-2014. The nurse stated that the patient was "still running a low fever" but was no longer "fussy". The outcome of the event was not recovered. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Muscle twitching, Pain in extremity
Clinical narrative: Redness and soreness at injection site on right arm.  Next day 7:00 AM right arm feels heavy, pain continues and there is muscle twitching activity.  Later that day there is muscle twitching in and pain in left arm also.  There is also numbness in both feet. These symptoms continue through 10/10/2014.  Doctor advises to rub arm and take over the counter pain relievers.  Did not have any of these symptoms prior to receiving vaccine.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Sensation of heaviness
Clinical narrative: Redness and soreness at injection site on right arm.  Next day 7:00 AM right arm feels heavy, pain continues and there is muscle twitching activity.  Later that day there is muscle twitching in and pain in left arm also.  There is also numbness in both feet. These symptoms continue through 10/10/2014.  Doctor advises to rub arm and take over the counter pain relievers.  Did not have any of these symptoms prior to receiving vaccine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Insomnia, Neck pain, Pain
Clinical narrative: My neck progressively hurts worse and worse. I am in extreme pain if I try to straighten or move my neck. My arm where the shot was given is knotted but not too sore. My pain kept me from sleeping. I tried heat, Tylenol, and Ibuprofen. I am setting a doctors appointment now. Pharmacy has instructed that do so.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Malaise, Pain in extremity
Clinical narrative: Pain in arm, headache, malaise, abdominal discomfort.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, MMR
Symptoms: Blood culture negative, Culture urine negative, Febrile convulsion
Clinical narrative: MMR, Hib, Flu vaccine received 9/26/14. Admitted on 10/4/14 after having 2 febrile seizures. Had a 3rd brief seizure after admission. Discharged home on 10/6/14.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Thrombotic thrombocytopenic purpura
Clinical narrative: After my daughter received GARDASIL shots she began to have auto immune disorders. Two of them! The first was TTP or chronic hives. It was uncontrollable with any treatment attempted. It eventually after a year of agony for her at age 12-13 years old had hives all over her face. On prednisone. It was very difficult emotionally for her. Then after that went away she got ITP which is an auto immune disorder where her own anti body's were attacking her BLOOD PLATELETS faster than she could produce. This can cause spontaneous internal bleeding and her platelet would be monitored n go so low as to unreadable on blood work. She was hospitalized about every 3 weeks. She had to go thru intravenous immune globulin treatments and would remain in there two to three days at a time. In the home times she suffered from side effects of treatments n had to get blood work frequently. After about 8 months to a year it disappeared. She's now 17 and still suffers low platelet levels and it's side effects. All from the immunization GARDASIL. I advise you beware in advising this product please.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: After my daughter received GARDASIL shots she began to have auto immune disorders. Two of them! The first was TTP or chronic hives. It was uncontrollable with any treatment attempted. It eventually after a year of agony for her at age 12-13 years old had hives all over her face. On prednisone. It was very difficult emotionally for her. Then after that went away she got ITP which is an auto immune disorder where her own anti body's were attacking her BLOOD PLATELETS faster than she could produce. This can cause spontaneous internal bleeding and her platelet would be monitored n go so low as to unreadable on blood work. She was hospitalized about every 3 weeks. She had to go thru intravenous immune globulin treatments and would remain in there two to three days at a time. In the home times she suffered from side effects of treatments n had to get blood work frequently. After about 8 months to a year it disappeared. She's now 17 and still suffers low platelet levels and it's side effects. All from the immunization GARDASIL. I advise you beware in advising this product please.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Shot well tolerated, no discomfort. After 30-60 minutes noticed her arm becoming sore at site and radiating down to elbow. Described as severe. Hx similar pain with fibromyalgia years ago, but has had flu shots since then without incident. By next day pain is resolving without treatment. Level 4 or 5 on scale of 10.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Chills, Feeling cold, Hyperhidrosis, Pallor
Clinical narrative: Tolerated first every flu shot well, no problems after 15-20 min.  After 2 hours returns, violently shivering, c/o feeling cold, breathing regularly but states his breathing felt "wrong." Extremely anxious, fingers of both hands extremely blanched, but hands above knuckles normal. Warm and diaphoretic on hands and arms. Went to nurses office where (I was told later) his BP was fine, O2 sat was in 80's until he breathed deeply and it "shot up to 95". Color returned to proximal fingers and seemed calmer when wife arrived, went to ED via 911 call by nurse.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Respiration abnormal, Skin warm
Clinical narrative: Tolerated first every flu shot well, no problems after 15-20 min.  After 2 hours returns, violently shivering, c/o feeling cold, breathing regularly but states his breathing felt "wrong." Extremely anxious, fingers of both hands extremely blanched, but hands above knuckles normal. Warm and diaphoretic on hands and arms. Went to nurses office where (I was told later) his BP was fine, O2 sat was in 80's until he breathed deeply and it "shot up to 95". Color returned to proximal fingers and seemed calmer when wife arrived, went to ED via 911 call by nurse.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Numbness in left side of face, paralysis feeling, left side of face, severe dull headaches.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Rash macular
Clinical narrative: Macular rash along same arm as injection, spreading over arm for next 48 hours.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: PATIENT EXPERIENCED INTENSE PAIN AT THE INJECTION SITE AT THE TIME OF INJECTION.  PAIN HAS NOT BEEN RELIEVED BY COLD THERAPY (ICE), IBUPROFEN, TIME, OR ACUPUNCTURE.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Patient said that her arm was red warm and that there was pain at the injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Heart rate increased, Injection site pain, Pain in extremity
Clinical narrative: Rapid heartbeat-between 20-24 beats faster than normal for me-lasted until after I feel asleep.  In AM, rate was back to normal.  Arm sore from injection, which I considered not to be important. I have had the high dose flu vaccine -Fluzone- before and never had any problems. I felt quite uncomfortable, but had no chest pain and did not need to go to the ER.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing
Clinical narrative: Pt flushed and had trouble breathing. Paramedics administered oxygen and pt took albuterol inhaler she had for COPD.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain and reduced range of motion in the arm where shot was given.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Swelling (8 cm diameter), inflammation, and tenderness at injection site.  Body aches, back and hip pain, general malaise and lethargy.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: Swelling (8 cm diameter), inflammation, and tenderness at injection site.  Body aches, back and hip pain, general malaise and lethargy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Nervousness, Pharyngeal oedema
Clinical narrative: Patient received Influenza vaccine at 0740, waited in clinic for 15 minutes, then left. 5 minutes later, patient returned and stated that she had begun to experience some swelling of the throat, and numbness to tongue, and felt "shaky".  Patient was taken immediately to treatment room and laid down, and pulse oximetry was established, with initial presentation of 99-100%, and HR of low 100's.  Epi-pen was prepared for usage, and the provider, FNP-C came to evaluate patient.  FNP-C noted clear lung sounds on auscultation, and while speaking to patient also observed that patient did not have any difficulty speaking.  Patient was monitored for approximately 30 minutes, with a gradual decrease from the mild throat swelling to none, and numbness of the tongue to numbness of the back half of the tongue.  On initial screening for the vaccine, patient answered yes to an MSG allergy, and yes to attempting to become pregnant.  The Novartis Fluvirin vaccine was advised by the screening RN.  Clinic staff called to inform patient's supervisor that she would not be returning to work that day.  Patient stated her commute is approximately 15 minutes by driving from this area, so clinic staff administered diphendramine 25 mg PO just before discharge, to time for onset of relief after patient arrived at home.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Blood electrolytes, Fatigue, Gait disturbance
Clinical narrative: Became fatigued and achy soon after at the grocery store. Went home. Slept in Lazy Boy Chair for 3 hours. Whole right side of my body ached from neck to feet, including arm and fingers. Started limping when I stood up. Took two Aspirin. Body continued to ache through Sunday, Monday and was sleep disturbed. By Thursday only leg ached and I continued to limp. Woke Friday morning in a lot of pain (cleaned house the day before), had trouble sleeping in the night. Applied sports cream at midnight. Continued to take aspirin. Went to urgent care to make sure nothing more serious was going on. Dr. electrolyte scan and checked for a muscle enzyme. He said the tests were normal (October 10).Leg is still hurting including knee. Hard to carry on normal movement and hard to drive a car.