chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient experienced lower back pain, sharp pain in arms, hands, and thighs, plus nausea and vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Pt. felt dizzy but did not notify anyone then fell to the floor face down, fainting for a few seconds. Went to ER by ambulance.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Skin surrounding the injection site was red and warm to touch. Sold patient some generic BENADRYL tablets to take and CORTAID cream to put on area.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hypertensive crisis, Malaise, Pain
Clinical narrative: Pharyngitis with URI, malaise, body aches, fatigue, headache. Urgent hypertension.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngitis, Upper respiratory tract infection
Clinical narrative: Pharyngitis with URI, malaise, body aches, fatigue, headache. Urgent hypertension.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Secretion discharge, Soft tissue infection, Subcutaneous abscess
Clinical narrative: Soft tissue infection - skin abscess (R) arm mildly painful, increased in size, redness; KEFLEX rx'd. Spontaneously drained 10/22/13.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Soft tissue infection - skin abscess (R) arm mildly painful, increased in size, redness; KEFLEX rx'd. Spontaneously drained 10/22/13.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Visual impairment
Clinical narrative: Faint feeling, dizzy, black spots in sight in beginning.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site erythema
Clinical narrative: Eye itching 6 hours after administration lasting for 24 hours. Injection site reaction: Entire upper arm reddening lasting for 72 hours after admin. Dissipated by half by 4 days after.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient felt her chest tight and shortness of breath approximately 16 minutes after vaccinating her against the flu vaccine.  Oxygen was administered for 30 minutes.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Mass, Pain in extremity
Clinical narrative: Tender lump on left upper anterior chest. Sore left arm. Also, red, itchy, warm area at site of injection, resolving.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Tender lump on left upper anterior chest. Sore left arm. Also, red, itchy, warm area at site of injection, resolving.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: (R) deltoid swelling, tenderness/erythema extending to entire arm and fingers day after vaccinations given the 3rd day (day seen in clinic) swelling only in deltoid area.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Itchy red rash body, arms and legs. Treatment: ATARAX 25 mg 1 po
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Balance disorder
Clinical narrative: Loss of balance/equilibrium x2 days after immunization. Deep ache across back of waist line for 21 week after immunization.
Age: 1.23
Sex: F
Vaccine: DTAP, DTAPHEPBIP, FLU3, MMR, PNC13, VARCEL
Symptoms: Abdominal discomfort, Crying, Dry skin, Grunting, Lethargy
Clinical narrative: 5:30 pm. Screaming in pain, tense, tried a warm bath, laid on floor, lethargic crying, screaming , moaning, grunting stomach tight, palms of hands red and rough.
Age: 1.23
Sex: F
Vaccine: DTAP, DTAPHEPBIP, FLU3, MMR, PNC13, VARCEL
Symptoms: Moaning, Pain, Palmar erythema, Screaming, Tension
Clinical narrative: 5:30 pm. Screaming in pain, tense, tried a warm bath, laid on floor, lethargic crying, screaming , moaning, grunting stomach tight, palms of hands red and rough.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: She came in 2 days after the immunization with a large rash, dark red, irregular shaped around 4 cm x 4 1/2 cm, with a lighter flat rash around the smaller rash 6 1/2 cm x 7 1/2 cm. It itches and only hurts when something bumps it or she lays on it. She "noticed" rash morning after immunization. Her normal temp is 97.4 but 10/23/13 in evening it was around 99. She feels well otherwise. Rash was bigger per pt 10/24 than it was 10/23 PM. Dr office drew line around rash, around periphery at 2:00 PM 10/24. Pt came to show us at 4:00 PM. Rash has started receding.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Headache, Myalgia, Skin burning sensation
Clinical narrative: Approximately 4 hours after receiving flu vaccine injection, hives/erythema/burning skin developed over neck, chest and ears bilaterally. 24 hrs after vaccine developed severe headache, joint and muscle pain.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Approximately 4 hours after receiving flu vaccine injection, hives/erythema/burning skin developed over neck, chest and ears bilaterally. 24 hrs after vaccine developed severe headache, joint and muscle pain.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patients husband called about 4 hours after admin of vaccine; He said the patient's shoulder had a lump about the size of an egg and was painful. No redness, not hot to the touch (Left shoulder).
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Laboratory test normal, VIIth nerve paralysis, X-ray normal
Clinical narrative: Right side face drooping, seen in ED Dx Bells Palsy. Prednisone 20 mg PO BID vaccine given 10/2/13. Onset sxs 10/18/13.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient was administered vaccine. Afterwards approximately 2 minutes she was in line to check out and felt light headed and proceeded to faint. A staff member caught her and she woke right up. EMT was called and went to ER.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia, VIIth nerve paralysis
Clinical narrative: 24 hours after the flu shot-tingling/numbness (L) arm/leg/body 48 hours after the flu shot-facial numbness (L) side asymmetrical smile 75% loss strength (L) arm/leg, (L) facial partial paralysis.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: 9/5/13 Cellulitis rt upper extremity prescribed clindamycin 300 mg 4 times daily for 7 days.
Age: 21.0
Sex: M
Vaccine: FLUN4, SMALL, TYP
Symptoms: Blister, Ocular hyperaemia, Post vaccination autoinoculation, Rash
Clinical narrative: Pt received SPX on 02 Oct. 13 on 09 Oct 13 pt noted redness around left eye and rash on upper lid. Pt went to clinic on 11 Oct 13 with no pain or visual problems. Grouped blisters noted by provider on upper eye lid. Referred to another clinic and to ER. Was confirmed to be autoinoculation form SPX. She was given VIROPTIC drops and valcyclovir.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On 08-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously(reported as under the skin). On an unknown date in 2013, the patient was diagnosed with neuropathy. He stated that this started after he received ZOSTAVAX. He said that he felt a tingling sensation in his left shoulder down his wrist. Electromyography (EMG) was performed (results unknown). The patient stated it was slightly improving (recovering). Patient sought medical attention for the event. The reporter considered the event of neuropathy to be significant disability. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram, Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On 08-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously(reported as under the skin). On an unknown date in 2013, the patient was diagnosed with neuropathy. He stated that this started after he received ZOSTAVAX. He said that he felt a tingling sensation in his left shoulder down his wrist. Electromyography (EMG) was performed (results unknown). The patient stated it was slightly improving (recovering). Patient sought medical attention for the event. The reporter considered the event of neuropathy to be significant disability. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated that she had fever, chills, swollen arm and went to the ER. The MD did not say it was vaccine related.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Chills, Local swelling, Pyrexia
Clinical narrative: Pt stated that she had fever, chills, swollen arm and went to the ER. The MD did not say it was vaccine related.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy skin, Blood thyroid stimulating hormone, Full blood count, Glycosylated haemoglobin, Metabolic function test
Clinical narrative: Rash to axilla / groin lasting several month.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Rash to axilla / groin lasting several month.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy, Lymphocytic infiltration, Rash
Clinical narrative: Rash to axilla / groin lasting several month.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Balance disorder, Chest pain, Headache, Influenza like illness, Palpitations
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Rash
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Aphasia, Cerebrovascular accident, Chest X-ray, Chest pain, Confusional state
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Dizziness, Dyskinesia, Electrocardiogram, Headache, Influenza like illness
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Postural orthostatic tachycardia syndrome, Rash
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Tachycardia
Clinical narrative: First signs were rash on right arm and left leg, followed by flu like symptoms, followed by chest pain, tachycardia, shooting pain in right forearm, stroke-like symptoms including loss of control of leg, aphasia and confusion and a headache which persists to the present. Was taken to ER on 9/23 for stroke like event and followed by neurologist on 9/24 and had MRI on 9/25. also saw neurologist on 10/9 for persistent symptoms of headache, dizziness and orthostatic tachycardia.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MEN, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Abasia, Head injury, Hypotension, Opisthotonus, Syncope
Clinical narrative: Patient fainted and had "jerky movements" for about 15-20 seconds immediately after he was given the HPV vaccine. He also had a drop in BP. The patient felt very weak and fatigued after giving the shots.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MEN, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Asthenia, Blood pressure decreased, Dyskinesia, Fatigue, Immediate post-injection reaction
Clinical narrative: Patient fainted and had "jerky movements" for about 15-20 seconds immediately after he was given the HPV vaccine. He also had a drop in BP. The patient felt very weak and fatigued after giving the shots.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MEN, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted and had "jerky movements" for about 15-20 seconds immediately after he was given the HPV vaccine. He also had a drop in BP. The patient felt very weak and fatigued after giving the shots.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder, Dysstasia
Clinical narrative: Imbalance sensation per pt (need walker).
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder
Clinical narrative: Imbalance sensation per pt (need walker).
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder, Nuclear magnetic resonance imaging brain
Clinical narrative: Imbalance sensation per pt (need walker).
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea, fever which comes and goes between 100.00 degrees and 101.7 degrees. Usually around 101 degrees. Chills.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain-Barre Syndrome, causing weakness of the legs.
Age: 33.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain upper, Insomnia, Nausea, Pyrexia
Clinical narrative: Started running moderate fever, severe stomach cramps, nausea - just started.  Pain severe enough to prevent sleep.
Age: 33.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain upper
Clinical narrative: Started running moderate fever, severe stomach cramps, nausea - just started.  Pain severe enough to prevent sleep.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Epistaxis, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Severe leg pains, Severe, very red, extremely painful sore throat, intense headache and sinus congestion and pain, thick, colored, bloody mucus from nose and back of throat.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal erythema, Sinus congestion
Clinical narrative: Severe leg pains, Severe, very red, extremely painful sore throat, intense headache and sinus congestion and pain, thick, colored, bloody mucus from nose and back of throat.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age. On an unknown date a dose of expired ZOSTAVAX (lot # reported) (start date, dose and route not reported) was administered to a patient. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The nurse reported that the patient received her first dose of GARDASIL in July 2012, her second dose in January 2013 and her third dose in March 2013 (lot numbers, expiration dates and doses were not reported). No adverse event was reported. The patient's outcome was not reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to a 4 month old patient of unknown gender. On 08-AUG-2013 the patient was vaccinated with a first dose of ROTATEQ 2 ml, oral (lot number was not reported). On 09-OCT-2013 the patient was administered an expired second dose of ROTATEQ 2ml, oral (lot number reported as: 0302AE; exp date; 03-OCT-2013). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Neck pain
Clinical narrative: This spontaneous report as received from a female nurse of unknown age via company representative refers to herself. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, expiration, dose, route unspecified). On an unknown date the patient developed neck aches, swelling at the injection site and chills on the following day after receiving a dose of PNEUMOVAX23. The nurse also received a flu vaccine on the opposite arm on the same day. The patient had sought medical attention. Received 2 bags of IV fluid for treatment. The event outcome was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 21-OCT-2013 the patient was inadvertently administered with VARIVAX (lot number, indication and injection site were not reported) (0.5 ml, subcutaneous) and PROQUAD (Merck) (lot number indication and injection site were not reported) (0.5 ml, subcutaneous) on the same day. No adverse effects reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 73 year old male patient with no pertinent medical history. On 22-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 and a dose of influenza virus vaccine (manufacture unknown) in the same arm (dose number, dose, frequency, route and lot# not reported). On the same day, the patient received his allergy shots (manufacture unknown) in his other arm (dose number, dose, frequency, route and lot# not reported). After receiving PNEUMOVAX23 and influenza virus vaccine (manufacture unknown) in the same arm, on an unknown date in 2013 the patient experienced pain and swelling at the injection site. The patient also experienced some itching after receiving allergy shots (manufacture unknown). The patient did not receive any treatment and any lab diagnostic studies. The patient also did not seek any medical attention. On an unspecified date, the outcome of all events was reported as recovered on therapy. The patient was not reintroduced. The patient reported TYLENOL, OXYCONTIN and oxycodone did not work for him and he was allergic to them. The patient was also allergic to heparin. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare Worker refers to a patient of unknown age. On 18-OCT-2013 the patient received an expired dose of GARDASIL (lot#: 0837AA, expired on 11-OCT-2013) (intramuscular route; dose not reported). No known adverse effects. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 day old male Neonate. On 17-OCT-2013 (first day after birth while infant was still in hospital) the patient was vaccinated with first dose of RECOMBIVAX HB 5 mcg/0.5 ml, 5 Microgram, intramuscular in the left leg (lot # not reported). On 21-OCT-2013, a second dose of RECOMBIVAX HB was inadvertently administered. No adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no drug reactions/allergies. On 18-OCT-2013 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23, 23 injection (lot # J007786, expiration date 25-SEP-2014), intramuscularly in the left arm. Patient stated that she didn't sleep well on the night of 18-OCT-2013. Patient also stated that her left arm ached from her shoulder to her wrist, she "couldn't move her left arm" described as her left arm was  numb and she couldn't use it and she was "running a temperature". Temperature was unspecified. Patient sought medical attention at an unspecified emergency room on an unspecified date. Patient stated that she had a temperature in the emergency room of "99 something". It was unspecified if patient was admitted to the hospital. The event outcome was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Poor quality sleep
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no drug reactions/allergies. On 18-OCT-2013 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23, 23 injection (lot # J007786, expiration date 25-SEP-2014), intramuscularly in the left arm. Patient stated that she didn't sleep well on the night of 18-OCT-2013. Patient also stated that her left arm ached from her shoulder to her wrist, she "couldn't move her left arm" described as her left arm was  numb and she couldn't use it and she was "running a temperature". Temperature was unspecified. Patient sought medical attention at an unspecified emergency room on an unspecified date. Patient stated that she had a temperature in the emergency room of "99 something". It was unspecified if patient was admitted to the hospital. The event outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a female patient of unknown age. Medical assistant reported that a patient received Dose 1 of GARDASIL (lot# was not reported) sometime in August 2012 and then received Dose 2 sometime in July 2013. Patient had not received Dose 3 yet. No symptoms reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 15 month old male patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiry not reported). On an unknown date, the patient experienced rash that looked like german measles after receiving M-M-R II. The physician stated the patient developed the rash "20 days after" receiving M-M-R II. No medical attention was sought. After asking a few of the safety questions, the physician was not willing to answer any further questions. The outcome of rash was unknown. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with hypertension and hypothyroidism. The patient's medical history included morphine-derivatives: unknown reaction. On 21-OCT-2013 the patient was vaccinated SC with single dose of ZOSTAVAX (lot # J004600, Exp. 18-JUL-2014). Concomitant therapies included estrogens (unspecified) patch, thyroid supplement and ZIAC. On 22-OCT-2013, the patient developed redness and pain at the injection site. The patient called the pharmacy on 23-OCT-2013, to report the area of redness was the size of a softball and the pain was getting worse. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of redness and pain at the injection site was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a 61 year old female patient regarding herself. The patient's current condition included allergy to penicillin. Patient's medical history was none. On 01-OCT-2013, the patient was vaccinated with a single dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) injection. Concomitant medications were none. On 02-OCT-2013, about 24 hours after the injection, at the site of the shot, there was a long elliptical shaped redness that sort of was whiter in the middle and came to a point at the end with three small white pimples in the middle that itched mildly. Approximately on 03-OCT-2013 (also reproted as on Thursday and Friday), the area of redness and puffiness expanded until it was about 4 inches long and 1.5 inches wide at the widest part, and a couple of more small white pimples formed that were also itchy. A couple of those still existed. It stabilized at that point, and very slowly began to recede. This was day 6 after receiving the vaccine, and then it took another five days to totally dissipate, and even now the patient had a couple of the little pimples that were left, all the redness and swelling were going, no pain, just mild itching and puffiness and expansion. The patient sought medical attention (saw the doctor). No treatment was given. Lab Diagnostics Studies Performed was none. The outcome of all the reported events was recovering/resolving. Additional information is not expected.
Age: 1.3
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 15 month old patient of unknown gender. On 08-OCT-2013, the patient ws vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous in an arm. Other suspect therapies included a dose of PROQUAD (Merck), 0.5 ml in a separate arm. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to his son, a 11 year old male patient. There was no pertinent medical history, and no known drug reactions/allergies. On 04-OCT-2012 the patient was vaccinated with the first and only dose of GARDASIL 1 DF, intramuscular (dose strength not provided). There were no concomitant medications. On 04-OCT-2012 the patient experienced injection site pain after receiving the vaccination. The patient was treated with TYLENOL. No medical attention was sought. The outcome of injection site pain was reproted as recovered/resolved on approximately 08-OCT-2012 (4 days after vaccination). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a unknown number of patients of unknown gender and age. The healthcare worker reported that different facilities reported excursions for M-M-R II. from 26-JUN-2013 to 29-JUN-2013 for 72 hours and doses were administered. On 28-JUL-2013 for 12 hours at 9 degree Celsius and on 03-AUG-2013 for 12 hours at 9 degree Celsius excursions occurred. These were separate lots at separate facilities. She stated that does from each were administered to patients approximately on unknown dates in 2013. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Rash erythematous
Clinical narrative: This spontaneous report as received from a other health professional refers to a 61 year old female patient at the time of reporting. Medical history and concomitant medication was reported as none. On 02-OCT-2013 the patient was vaccinated with ZOSTAVAX lot # J004269 dose 1, 0.5 ml, subcutaneous. On an unknown date in October 2013 the patient experienced dermatitis on shoulder, trunk and buttocks. The patient sought medical attention on 10-OCT-2013 and stated that the reaction "looks like red spots". She first noticed the reaction earlier in the week and began treatment with Benadryl cream. The physician prescribed VALTREX "to be on the safe side". The outcome of dermatitis on shoulder, trunk and buttocks was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. Pharmacist reported that unspecified patients frequently experience a small rash at the injection site after vaccination with ZOSTAVAX. The rash only lasts about 48 hours before resolving. No specific patients were mentioned. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route, indication not reported). Concomitant therapy included valacyclovir hydrochloride. On an unknown date in 2013 ("subsequently") the patient developed a large red mark at the injection site. The patient sought medical attention via called the pharmacist. The outcome of the event was reported as not recovered. The pharmacist also noted she had seen other red marks at a ZOSTAVAX injection site, just not as large. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Needle issue, Syringe issue
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-JUN-2013 the patient was vaccinated with a partial first dose of GARDASIL (Lot#, dose and route not reported), due to syringe or needle leakage (the GARDASIL dose leaked where the needle and syringe connected). The GARDASIL dose was drawn into an unspecified administration syringe from a GARDASIL vial. Concomitant therapy was not reported. The patient received a second dose of GARDASIL on 12-SEP-2013. No adverse event reported. The follow up as received from a licensed practical nurse refers to 12 years old male. The patient did not think the patient received adequate first dose of GARDASIL due to leakage from syringe on 06-JUN-2013. Additional information is not expected.
Sex: U
Vaccine: HPV4, MMR, RV5, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that an unspecified number of patients may have received M-M-R II, GARDASIL, ROTATEQ, and VAQTA that were exposed to unknown temperatures for four hours and VARIVAX (Merck), measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), PROQUAD (Merck) and ZOSTAVAX exposed to unknown temperatures for five hours during interoffice transport. All vaccines were possibly administered to patients. No adverse symptoms reported. The nurse was unable to provide further temperature excursion details, dates of administration and lot number/expiration dates to inquire whether these patients need to be vaccinated. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on 28AUG2013 was vaccinated with PNEUMOVAX. The reported lot # for PNEUMOVAX was H015710 with an expiration date of 11JUN2014. The patient experienced an adverse reaction to PNEUMOVAX (not further specified). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Blood test, Diplopia, Dyspnoea, Electromyogram
Clinical narrative: This is a spontaneous report from a contactable physician reporting for a patient, through a Pfizer Sales Representative. This 77 year old female patient received PREVNAR 13 intramuscular on 23Sep2013 at 0.5 ml once. Relevant medical history and concomitant medication was unknown. It was reported that on 23Sep2013 the patient was administered PREVNAR 13 and unspecified flu vaccine after which since an unknown date in 2013 the patient was not feeling well, was not able to walk and had complications in breathing. It was further reported that on 10Oct2013 the patient was hospitalized, after which since 11 or 12Oct2013 while in the hospital the patient had severe weakness on the right side of the body and lower extremities, double vision problem, and was diagnosed with Guillain-Barre syndrome. It was mentioned that the patient was still in the hospital at the time of report. Relevant laboratory data included magnetic resonance imaging (MRI), electromyography (EMG) and blood work, all on an unknown date in Oct2013 for which the results were unknown. The patient had taken PREVNAR 13 only once on 23Sep2013. Therapeutic measure taken included gamma globulin injection since an unknown date in Oct2013 at an unknown dose and frequency. The clinical outcome was unknown at the time of report.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome, Hemiparesis, Immunoglobulin therapy, Malaise, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable physician reporting for a patient, through a Pfizer Sales Representative. This 77 year old female patient received PREVNAR 13 intramuscular on 23Sep2013 at 0.5 ml once. Relevant medical history and concomitant medication was unknown. It was reported that on 23Sep2013 the patient was administered PREVNAR 13 and unspecified flu vaccine after which since an unknown date in 2013 the patient was not feeling well, was not able to walk and had complications in breathing. It was further reported that on 10Oct2013 the patient was hospitalized, after which since 11 or 12Oct2013 while in the hospital the patient had severe weakness on the right side of the body and lower extremities, double vision problem, and was diagnosed with Guillain-Barre syndrome. It was mentioned that the patient was still in the hospital at the time of report. Relevant laboratory data included magnetic resonance imaging (MRI), electromyography (EMG) and blood work, all on an unknown date in Oct2013 for which the results were unknown. The patient had taken PREVNAR 13 only once on 23Sep2013. Therapeutic measure taken included gamma globulin injection since an unknown date in Oct2013 at an unknown dose and frequency. The clinical outcome was unknown at the time of report.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable physician reporting for a patient, through a Pfizer Sales Representative. This 77 year old female patient received PREVNAR 13 intramuscular on 23Sep2013 at 0.5 ml once. Relevant medical history and concomitant medication was unknown. It was reported that on 23Sep2013 the patient was administered PREVNAR 13 and unspecified flu vaccine after which since an unknown date in 2013 the patient was not feeling well, was not able to walk and had complications in breathing. It was further reported that on 10Oct2013 the patient was hospitalized, after which since 11 or 12Oct2013 while in the hospital the patient had severe weakness on the right side of the body and lower extremities, double vision problem, and was diagnosed with Guillain-Barre syndrome. It was mentioned that the patient was still in the hospital at the time of report. Relevant laboratory data included magnetic resonance imaging (MRI), electromyography (EMG) and blood work, all on an unknown date in Oct2013 for which the results were unknown. The patient had taken PREVNAR 13 only once on 23Sep2013. Therapeutic measure taken included gamma globulin injection since an unknown date in Oct2013 at an unknown dose and frequency. The clinical outcome was unknown at the time of report.
Age: 73.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Erythema, Fatigue, Injection site pain, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 73 year old female patient with sulfa allergy. There was no pertinent medical history. On 22-OCT-2013 the patient was vaccinated with ZOSTAVAX in the left arm (dose and route were not provided). There were no concomitant medications. On 22-OCT-2013, a few hours after vaccination, the patient experienced pain at the injection site. On the next day, 23-OCT-2013, the patient experienced redness, extreme tiredness and swelling. The patient received treatment with ADVIL (dose and manufacturer not specified). The patient did not seek medical attention. No lab diagnostics studies were performed. The outcome of redness, pain at the injection site, extreme tiredness and swelling was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 73 year old female patient with sulfa allergy. There was no pertinent medical history. On 22-OCT-2013 the patient was vaccinated with ZOSTAVAX in the left arm (dose and route were not provided). There were no concomitant medications. On 22-OCT-2013, a few hours after vaccination, the patient experienced pain at the injection site. On the next day, 23-OCT-2013, the patient experienced redness, extreme tiredness and swelling. The patient received treatment with ADVIL (dose and manufacturer not specified). The patient did not seek medical attention. No lab diagnostics studies were performed. The outcome of redness, pain at the injection site, extreme tiredness and swelling was reported as not recovered/not resolved. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist, via a EPBU/Publicis field representative, refers to a 63 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing information and route was not provided). The pharmacist reported that the patient experienced hives after receiving ZOSTAVAX. The outcome of hives is unknown. No reporter causality provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Fever, chills, headache, body aches, nausea, stomach cramps, sore throat, thick sputum.  Event came on very suddenly.  It lasted about 8 hours until approx. 1 AM and then all symptoms disappeared as suddenly as they came on.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Sputum abnormal
Clinical narrative: Fever, chills, headache, body aches, nausea, stomach cramps, sore throat, thick sputum.  Event came on very suddenly.  It lasted about 8 hours until approx. 1 AM and then all symptoms disappeared as suddenly as they came on.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red area at injection site, hot to the touch, hard, raised. Increased in size to diameter of approximately 2 1/2 inches by 2 inches. Remained hot, swollen and raised for 3 days.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Flushing, Heart rate increased, Influenza like illness, Insomnia
Clinical narrative: Began with flu like symptoms, but progressed to "shakes" and nervous "twitches", elevated heart rate (84 bpm) and blood pressure (157/87), flushed face, and skipped heartbeats. Lasted for several hours into sleep. Was only able to sleep with aid of sedative.  I was OK by morning.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle twitching, Tremor
Clinical narrative: Began with flu like symptoms, but progressed to "shakes" and nervous "twitches", elevated heart rate (84 bpm) and blood pressure (157/87), flushed face, and skipped heartbeats. Lasted for several hours into sleep. Was only able to sleep with aid of sedative.  I was OK by morning.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess drainage, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient developed general malaise, local redness, swelling and pain in the area of injection on the left upper arm. Patient was seen by the surgeon, who lanceted and drained the abscess.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Headache, Malaise, Musculoskeletal stiffness, Neck pain
Clinical narrative: On 10/10/2013 Pt c/o generally not feeling well. On 10/11/2013 Pt. states couln't get out of bed, c/o neck pain, can't turn neck, pain radiating from neck to head.  Pt. states she had to support neck and head by using hands for support.  Denies fever, cough.  Denies any synptoms at site of injection.  Pt. did see her private MD and was prescribed an antiinflamatory medication x4 days.  Pt. states she is feeling much better, symptoms have lessened, but have not gone away 100%.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Immediate post-injection reaction, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: Left arm was sore immediately following injection.  At about 2 a.m. the next morning, patient experienced a temp of 102 degrees, uncontrollable shaking, and cramps on the anterior aspect of both thighs, pulse >100.  Lasted about 2 hours.  Stayed in bed that day.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Left arm was sore immediately following injection.  At about 2 a.m. the next morning, patient experienced a temp of 102 degrees, uncontrollable shaking, and cramps on the anterior aspect of both thighs, pulse >100.  Lasted about 2 hours.  Stayed in bed that day.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache
Clinical narrative: SEVERE HIP PAIN & HEADACHE.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient reported experiencing tingling in fingers of hand of same arm of Fluzone immunization around 45 minutes after administered. Her fingers continued to tingle for the remainder of the day, but when she woke up the next morning she was fine.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Culture, Papule, Pruritus, Rash erythematous
Clinical narrative: Diffuse erythematous papules covering trunk and extremeties, no involvement of face.  Some papules were crusting and healing after a blister phase.  She had itching but did not feel ill nor other complaints.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Scab
Clinical narrative: Diffuse erythematous papules covering trunk and extremeties, no involvement of face.  Some papules were crusting and healing after a blister phase.  She had itching but did not feel ill nor other complaints.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Eye swelling, Oropharyngeal pain, Salivary gland enlargement
Clinical narrative: Cough, sore throat, swollen eyes, seepage from eyes, swollen salivary gland under tongue.  Symptoms were better after 12 hours and much better after 36 hours.  Took no action with symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness, swelling, and itching at vaccination site with Zostavax. Patient tried using hydrocortisone with no relief. Has been having these symptoms for approximately 5 days.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: Muscle spasms and neck stiffness, especially in trapezius muscles on shoulder. Naproxen (440mg) and icing the shoulder provided moderate relief (pain down from 8 to 4) after pain awoke me from sleep.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Eye swelling, Oedema mouth, Pain in extremity
Clinical narrative: Vaccine given 10/21/13 given approx 9AM. 10/22/13 pt noticed a red mark and very sore arm (right arm). On 10/23/13 red area red 10cm in size, 3cm center that is blistered. Swelling noted under right eye and R side of mouth.  *Pt also had a TDdap in the past with no reaction 2008.
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red indurated warm painful (R) deltoid. Doxycycline 2 x 1 day x 7 d. BENADRYL 25 mg 2 x day x 2 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye pruritus
Clinical narrative: Patient c/o dizziness. Patient sat for 5 min. felt like her eyes were itching. Gave pt orange juice. BP 143/94 P-95. 10 min later orthostatic BP-lying 156/90 sitting 147/88, P-79. Pt seemed stable and went home.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Movement disorder
Clinical narrative: Unable to breathe deeply - albuterol inhaler was not helpful. Started aching in joints and unable to move. I took 800mg MOTRIN and symptoms got better. This lasted 24-36 hrs.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Initial headache, followed by headache, fever and stiff neck. This was followed by 12 days of weakness and exhaustion. Some confusion.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial headache, followed by headache, fever and stiff neck. This was followed by 12 days of weakness and exhaustion. Some confusion.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Mild pain in both arms - only has shot in right arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia
Clinical narrative: Approx 10 hrs post injection, sudden onset shivering, teeth chattering, unable to control, lasted 3 hours. Approx 8 pm to 11 pm took showers, took 600 mg ibuprofen and 25 mg BENADRYL and went to bed under covers. Shivering noted - achy muscles all over for next 2 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: 30-45 minutes after flu vaccination pt c/o dizziness and feeling like she was passing out. No loss of consciousness. Taken to ER for evaluation.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Upper extremity mass
Clinical narrative: Right arm bruised with a lump.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Nausea, Tremor, Vomiting
Clinical narrative: Woke up with chills, shaking, nausea, one episode of vomiting and diarrhea 2-3 hours after the immunization.