chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a 18 year old female patient. Medical history and concomitant medications were not reported. On an unknown date 2 months ago in July 2016, the patient was vaccinated with dose 1 of GARDASIL 9 (Lot# and expiry were not reported). The physician noted that the following date after this dose in July 2016, the patient experienced a rash and hives which was treated with BENADRYL. The outcome and causality for rash and urticaria was unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Medical history and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # L004466, expiry date:02-AUG-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant regarding unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (digital logger) (lot # M004508, expiry: 29-JUN-2017). The vaccines were exposed On 10-AUG-2016 at 28.9F for 3.8 hours, on 11-AUG-2016 at 31.8F for 1.7 hours and on 26-AUG-2016 at 31.1F for 3.75 hours. There was no previous temperature excursion. No adverse effects were reported. This is 1 of 3 reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complaint of pain on shoulder and arm. Patient also complaint of lack of mobility and movement of arm. Patient was prescribed Tramadol for pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On an unspecified date, the patient received with a dose of improperly stored ROTATEQ (lot # M019708, expiration date 25-Oct-2017; 2 ml once), orally. The vaccine was exposed to temperature excursion of 33.3 degrees Fahrenheit for 3 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Redness, swelling at injection site, nausea, achiness, low energy level, can't sleep.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Redness, swelling at injection site, nausea, achiness, low energy level, can't sleep.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a nurse concerning a female patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date and dose were unknown), intramuscularly (rather than the recommended subcutaneous route). No apparent adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Weakness persisting in her left arm continuing 12 days post administration. Initial pain greater than usual upon administration.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 19-SEP-2016, the patient was vaccinated with VARIVAX (dose, route and lot number were not reported) who was actually indicated for a dose of ZOSTAVAX (dose, route and lot number were not reported). There was no adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Higher fever developed 48 hours after administration, ceased. Extreme arm pain developed approximately 12 hours after administration radiates down to fingers. Could barely lift arm. Got better but still painful and throbbing.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Joint swelling, Nervousness, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. The patient's pertinent medical history was not reported. She was allergic to cats and dogs. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose, route and lot number were not reported). No concomitant medications were reported. On 18-SEP-2016, the patient felt shaky (nervousness) and had joint swelling. She sought medical attention. No treatment was given for the events and there were no lab tests performed. There was no intervention to prevent serious criteria. On 21-SEP-2016 (reported as "today"), the patient returned to the office still feeling shaky however ankle swelling was resolved. The physician stated that she was his partners patient and he did not know her much. The outcome of nervousness was reported as not recovered/not resolved. The outcome of joint swelling was reported as recovered/resolved. The causal relationship between the drug and the events was not reported. There was no product complaint involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient said she experience at injection site swollen, hard, hot, tender, painful, bruises. Sun-> Wed-> Red Rash and hives, itchy on face.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Patient said she experience at injection site swollen, hard, hot, tender, painful, bruises. Sun-> Wed-> Red Rash and hives, itchy on face.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient approached consultation counter about reaction. Pharmacist took patient into consultation room where patient demonstrated reaction. (L) arm approximately 2-3" below injection site. 2" x 4" red, raised area, warm and painful to touch. Also had reaction to pneumonia vaccine last year urgent care visit, resolved 2-3 days later.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route were unknown; lot # M001814 with expiration date 15-OCT-2018 and lot # M006709 with expiration date 06-DEC-2018). The vaccines were exposed under temperature of 46.9 degrees Fahrenheit for 10 minutes. The previous temperature excursions were 47.2 degrees Fahrenheit for 10 minutes, 47.3 degrees Fahrenheit for 10 minutes and 46.9 degrees Fahrenheit for 10 minutes. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of improperly store MMR II (dose and route were not reported), lot# M002419 and expiry date: 12-JAN-2018. The storage detail for the vaccine was a temperature excursion to 22.6 C for 48 hours 30 minutes. No adverse effects were reported. There was not product quality complaint involved. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses(3 doses) of VAQTA (2 doses of batch# M001815 with an expiry date 20-SEP-2017 and 1 dose of batch# M030598 with an expiry date 13-OCT-2017) (dosing details not known). The administered doses experienced a temperature excursion of 0.5 degree Celsius for 1 hour and 32 minutes. The vaccine underwent previous temperature excursions of 1 degree Celsius for 7 hours and 34 minutes. The call was because of a "data logger". No adverse effects were reported. This is one of two reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 20-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (dose was not reported) lot # K007742 and expiry date: 28-MAY-2016. It was reported that the vaccine was properly stored. There were no adverse events reported. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in 2015, the patient was vaccinated with ZOSTAVAX (dosing details not known) by subcutaneous route. On an unknown date in 2016, the patient was diagnosed with shingles (herpes zoster). The patient contacted physician assistant and sought medical attention. The patient received treatment for the event. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Pruritus, Skin warm
Clinical narrative: Pt woke up in middle of night and with lt arm itching. Pt scratched it sore and hot (3 inches long, 1 inch wide area). Rt side on back of arm. Called doctor listed to notify of incident. Cold compress, Hydrocortisone cream, BENADRYL or ZYRTEC recommended for pt. Authorized 9-22-16 3:52 pm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Severe rash from knee to top of head. Itching
Sex: U
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Itching swollen eyes recommended ocular lubricant and ketotifen, told patient to contact your office ASAP.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Injection site swelling, Limb discomfort, Rash macular
Clinical narrative: Unusual feeling in arm after vaccination. the next morning she reports red blotches with swelling around the injection site and around bicep towards antecubital area. She reported to me in the morning on 9/24/16 and the swelling was decreased but the red blotches remain. 2 blotches about 4 square inches per blotch.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # M011660 with expiration date 08-SEP-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 40 degrees Fahrenheit for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 5 days old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient, a 5 days old newborn, was vaccinated with a dose of VAQTA (strength was unknown, reports as 25/0.5, dose and route unknown, lot # M009377, 17-JUN-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M023383 with expiration date 11-MAY-2018; dose and route were unknown). The vaccines were exposed to temperature excursion of 40 degrees Fahrenheit for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Intermittent vomiting, diarrhea, low grade temperatures.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Report received from a health professional, RN (registered nurse), on 15-Sep-2009. A 48 year-old female received AFLURIA 0.5 cc IM once in left deltoid (lot number 01549211A; exp. date 08-Jun-2010) for flu immunity on 09-Sep-2009. The patient has a history of hypertension (controlled). No concomitant medications were reported. On 09-Sep-2009, the same day as the AFLURIA administration, the patient developed a hard, red, hot area around injection site (left deltoid). The patient received no treatment. The adverse reactions resolved by 13-Sep-2009. The reporter did not report any causality in reference to the patient receiving AFLURIA. Automated Data Corrections (01-JUN-2016 14:31:13): Set drug reaction causality to the worst of drug reaction and vaccine(s) reaction assessments (significant change). Change state names entered to standardized codes. Set missing seriousness on the event and drug reaction levels (significant change). Set "Medically significant" for cases with serious events but without seriousness criteria (significant change). Create history record and set the last received date for corrected cases. Sender's Comments: ASSESSMENT: This case was reported as non serious. The company considered the events as probable.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Bedridden, Laboratory test, Pain
Clinical narrative: Joint pain and within one week. Whole body pain. Bed restricted. No meds help the pain.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Bedridden, Blood test, Computerised tomogram, Lumbar puncture
Clinical narrative: Joint pain and within one week. Whole body pain. Bed restricted. No meds help the pain.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Nuclear magnetic resonance imaging, Pain, Single photon emission computerised tomogram
Clinical narrative: Joint pain and within one week. Whole body pain. Bed restricted. No meds help the pain.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a nurse referring to a 23 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-AUG-2016, the patient was given VARIVAX (lot# and expiration date were unknown) 0.5 ml, subcutaneously while she was pregnant (exposure during pregnancy). The patient's last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. Subsequently on an unknown date in 2016, the patient had a miscarriage and was hospitalized. Treatment given for the adverse event was unknown. Labs performed were unknown. The pregnancy outcome was spontaneous abortion. The causality assessment between the miscarriage and VARIVAX was not reported. Upon internal review, miscarriage was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activities of daily living impaired, Dyspnoea, Dysstasia, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: Motor tics - facial/sneezing, arms and legs contracting, loss of awareness to actions.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle twitching, Pain in extremity, Respiratory arrest, Screaming, Seizure like phenomena
Clinical narrative: Motor tics - facial/sneezing, arms and legs contracting, loss of awareness to actions.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Sneezing
Clinical narrative: Motor tics - facial/sneezing, arms and legs contracting, loss of awareness to actions.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Altered state of consciousness, Extremity contracture, Sneezing, Tic
Clinical narrative: Motor tics - facial/sneezing, arms and legs contracting, loss of awareness to actions.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Biopsy bone marrow, Blood test, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Diplegia, Lumbar puncture, Lymphadenectomy, Muscular weakness, Nuclear magnetic resonance imaging spinal
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Pathology test, Scan with contrast
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abasia, Asthenia, Back pain, Biopsy bone marrow, Biopsy lymph gland
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, Demyelinating polyneuropathy, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Insomnia, Lumbar puncture, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging spinal, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Fatigue, Malaise, Nasal congestion
Clinical narrative: Chills, achy all over body, tired, sore throat, feeling "sick" lasting until late night on 9/24/2016.  Next morning (9/24/2016) started cough, runny nose, sore throat. Today is 9/25/2016, still have coughing and severe running nose, nasal-congestion, tired and sore throat.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Chills, achy all over body, tired, sore throat, feeling "sick" lasting until late night on 9/24/2016.  Next morning (9/24/2016) started cough, runny nose, sore throat. Today is 9/25/2016, still have coughing and severe running nose, nasal-congestion, tired and sore throat.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Rash, Skin warm
Clinical narrative: Pt came by pharmacy on 9/19 and showed arm to pharmacist on duty. She said arm was red with raised rash, warm to touch and she was having difficulty moving her arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of ROTATEQ lot # L033694 with expiration date 16-JUN-2017 and lot # L035510 with expiration date 13-MAY-2017, orally (dose not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial unsolicited report received from a non-health care professional (Patient's husband) on 15 September 2016. This case involves an 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose not reported) on 14 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported and illness at time of vaccination was reported as none. Concomitant medications were not provided. On 14 Sep 2016, same day following the vaccination, the patient experienced hives on face. On 15 Sep 2016, one day following the vaccination, the patient experienced itchy hives. It was also reported that, the patient did not had a previous reaction to flu vaccines. Lab data was not reported. Corrective treatment includes Allegra. Patient event outcome was reported as unknown. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blister, Feeling hot, Nodule, Pain, Swelling
Clinical narrative: Initially soreness, then warmth and swelling, then continued warmth, by Thursday PM a blister occured with continued warmth, tenderness, and a knot beneath skin.  By Saturday, multiple blisters and decreased warmth and swelling.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Initially soreness, then warmth and swelling, then continued warmth, by Thursday PM a blister occured with continued warmth, tenderness, and a knot beneath skin.  By Saturday, multiple blisters and decreased warmth and swelling.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Pain at injection site right deltoid. No visible swelling or erythema. Ecchymotic area below area of vaccination. Advised to ice area and use NSAID over the counter.
Age: 34.0
Sex: M
Vaccine: FLUN4
Symptoms: Electromyogram, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Generalized pain in left shoulder and left tricep.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dehydration, Injection site pain, Syncope
Clinical narrative: Chills, soreness at injection site, dehydrated and collapsed next AM 9-16-16 and went to ER.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Axillary pain, Headache, Hyperhidrosis
Clinical narrative: Started having deltoid pain about 1100am, then about 2200 that night was having right armpit pain and deltoid pain, took Ibuprofen 600 mg pO and glass of wine, and then didn't sleep well, states the armpit was swollen and and the whole upper arm was swollen elbow to shoulder, achy joints and generalized weakness, armpit pain and sweating.  Took multiple times during the day, Ibuprofen 800mg three times that day and didn't touch the pain at all.  Put ice to arm and then put heat to right arm. Then on 9/24 didn't sleep well that night.  Then on 9/25, the muscle pain to right deltoid was better, the armpit pain was the same, weakness, sweaty.  As day progressed felt better.  States today 9/25 has headache and achy joints in wrists, elbows, and knees, no fever today.  Took Ibuprofen all day Sunday and this morning. Has some swelling to right arm and pain to armpit today, rates 5/10. Given Tylenol 1000 mg po today for discomfort. States did not sleep well last night.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Peripheral swelling, Poor quality sleep
Clinical narrative: Started having deltoid pain about 1100am, then about 2200 that night was having right armpit pain and deltoid pain, took Ibuprofen 600 mg pO and glass of wine, and then didn't sleep well, states the armpit was swollen and and the whole upper arm was swollen elbow to shoulder, achy joints and generalized weakness, armpit pain and sweating.  Took multiple times during the day, Ibuprofen 800mg three times that day and didn't touch the pain at all.  Put ice to arm and then put heat to right arm. Then on 9/24 didn't sleep well that night.  Then on 9/25, the muscle pain to right deltoid was better, the armpit pain was the same, weakness, sweaty.  As day progressed felt better.  States today 9/25 has headache and achy joints in wrists, elbows, and knees, no fever today.  Took Ibuprofen all day Sunday and this morning. Has some swelling to right arm and pain to armpit today, rates 5/10. Given Tylenol 1000 mg po today for discomfort. States did not sleep well last night.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site induration, Injection site macule, Injection site vesicles, Rash macular, Tenderness
Clinical narrative: Superior border of macule 3 cm superior of injection site. Large dusky red macular, with amorphous inferior border 12 cm by 6 cm. Secondary light brown secondary coloring covering majority of macule. Patient had palpable induration 6 cm - 5 at site of vaccination. Patient has 2X3 cm of small dense blistering centered at injection site. Overall normal amount of post Tdap tenderness.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site macule, Injection site pain, Injection site rash
Clinical narrative: Superior border of macule 3 cm superior of injection site. Large dusky red macular, with amorphous inferior border 12 cm by 6 cm. Secondary light brown secondary coloring covering majority of macule. Patient had palpable induration 6 cm - 5 at site of vaccination. Patient has 2X3 cm of small dense blistering centered at injection site. Overall normal amount of post Tdap tenderness.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site reaction, Injection site vesicles, Musculoskeletal stiffness, Vaccination site induration
Clinical narrative: Superior border of macule 3 cm superior of injection site. Large dusky red macular, with amorphous inferior border 12 cm by 6 cm. Secondary light brown secondary coloring covering majority of macule. Patient had palpable induration 6 cm - 5 at site of vaccination. Patient has 2X3 cm of small dense blistering centered at injection site. Overall normal amount of post Tdap tenderness.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Developed generalized rash anterior and posterior thorax, denies SOB, wheezing.  Self treated with Benadryl with relief.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Soreness, stiffness, limited mobility in arm and shoulder. Feels like joint and muscle pain. It got a little better after a week and is now getting worse. I have tried anti pain and anti inflammatory meds, ice, hot and cold compress.  Nothing helps.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Sleep disorder
Clinical narrative: Left arm became sore. As the day went on my arm hurt more and hurt quite a bit when lifted. Was not able to sleep on it. On Sun. 9/27/2016 I noticed some redness on my arm and it was warm. Went to pharmacy to have pharmacist check it.  Said it was a reaction to shot.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Vaccination complication
Clinical narrative: Left arm became sore. As the day went on my arm hurt more and hurt quite a bit when lifted. Was not able to sleep on it. On Sun. 9/27/2016 I noticed some redness on my arm and it was warm. Went to pharmacy to have pharmacist check it.  Said it was a reaction to shot.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Cold sweat, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Redness, induration, and soreness at least 6x8 cm around site.  Feelings of fatigue, stomach upset, sore throat, and clamminess.  Symptoms improved next day, with local reaction improving as well.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Local reaction, Oropharyngeal pain
Clinical narrative: Redness, induration, and soreness at least 6x8 cm around site.  Feelings of fatigue, stomach upset, sore throat, and clamminess.  Symptoms improved next day, with local reaction improving as well.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Swelling face
Clinical narrative: RASH/FACIAL SWELLING.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received FLUARIX QUADRIVALENT. On 31st August 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: 2 to 3 days after receiving (on an unknown deltoid) the patient experienced injection site pain and cannot lift arm due to the pain. The patient required an emergency room visit due to the events and no overnight hospitalization was required.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Decreased appetite, Diarrhoea, Fatigue, Mental impairment
Clinical narrative: Tired, loss of appetite, vomiting, diarrhea, enlarged abdomen, difficulty thinking, continued until 9-12-16.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Tired, loss of appetite, vomiting, diarrhea, enlarged abdomen, difficulty thinking, continued until 9-12-16.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NO ADVERSE EVENTS KNOWN AT THIS TIME.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: NONE KNOWN OF.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Site reaction at injection site - redness, feverish, and irritated.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Electroencephalogram, Foaming at mouth, Postictal state, Retching
Clinical narrative: Mom heard child heaving over her baby monitor. Entered room to find child having a seizure noted foam in mouth, witnessed for approx. 1 minute then child was post tictal. Mom called 911 and went to ER.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Mom heard child heaving over her baby monitor. Entered room to find child having a seizure noted foam in mouth, witnessed for approx. 1 minute then child was post tictal. Mom called 911 and went to ER.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Loss of consciousness, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Information has been received from a physician via a field employee referring to a 76 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 20-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (unspecified strength, dosage, frequency, route, lot number and expiration date) and also received another vaccine concurrently described as: a "high dose flu shot in the same arm due to the patient refusing to have vaccines in two separate arms". The patient experienced a reaction afterwards that same day described as: a "red, hot, swollen arm and a low grade fever". The patient's arm was still "red hot and swollen this morning on 21-SEP-2016 and the patient passed out and went to the hospital" (hospital was unspecified). The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased, Cough, Dysphonia, Feeling hot, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself and from a contactable physician. A 76-year-old male patient received PREVNAR 13, (NDC 0005-1971-01) via intramuscular route on the left arm at 0.5 ml single on 15Jul2016 at 15:00, for immunization. On the same date and time the patient also received pneumococcal vaccine (PNU IMUNE 23, manufactured by Merck) intramuscular on the left arm for immunization. Medical history included ongoing hypertension, diagnosed for over 20 years. Concomitant medications included COZAAR, tablet 100 mg daily orally and ASPIRIN at 81 mg daily, both for hypertension. On unknown date in 2016 the patient experienced dry cough, pain, vaccination site warmth, muscle soreness, sensation of warmth on all his shoulder, his deltoids, shoulder pain, blood pressure jumped a little bit, discomfort in his hand, he was sick and hoarseness. The outcome of the events was reported as unknown except for dry cough from which the patient was not recovered. Follow-up (12Sep2016): New information reported from a contactable physician includes: suspect vaccine details (dose and NDC number of pneumococcal 13-val conj vac (dipht crm197 protein)), concomitant medication acetylsalicylic acid was added.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Myalgia, Pain, Pain in extremity, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself and from a contactable physician. A 76-year-old male patient received PREVNAR 13, (NDC 0005-1971-01) via intramuscular route on the left arm at 0.5 ml single on 15Jul2016 at 15:00, for immunization. On the same date and time the patient also received pneumococcal vaccine (PNU IMUNE 23, manufactured by Merck) intramuscular on the left arm for immunization. Medical history included ongoing hypertension, diagnosed for over 20 years. Concomitant medications included COZAAR, tablet 100 mg daily orally and ASPIRIN at 81 mg daily, both for hypertension. On unknown date in 2016 the patient experienced dry cough, pain, vaccination site warmth, muscle soreness, sensation of warmth on all his shoulder, his deltoids, shoulder pain, blood pressure jumped a little bit, discomfort in his hand, he was sick and hoarseness. The outcome of the events was reported as unknown except for dry cough from which the patient was not recovered. Follow-up (12Sep2016): New information reported from a contactable physician includes: suspect vaccine details (dose and NDC number of pneumococcal 13-val conj vac (dipht crm197 protein)), concomitant medication acetylsalicylic acid was added.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (mother) reported for her son. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain at the injection site and down to his elbow, he had pain in his arm/with moving his arm, pain that was radiated down his arm to his elbow and the pain was also in his shoulder, he was also very tired. The outcome of the events was unknown. Reporter mentioned that she wanted to know if Tylenol could be taken with TRUMENBA because her son had a lot of pain in the arm.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia
Clinical narrative: This is spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age and ethnicity received a single dose of PREVNAR 13, (Lot N16561, expiry date Sep2017) via an unspecified route of administration on an unspecified date in Sep2016 for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2016 the patient experienced muscle aches in neck and she developed a large red area from the injection site and arm from injection site to the elbow was red, hot and itchy. Outcome of muscle aches in neck was unknown, the patient was not recovered from the other reported events.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This is spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age and ethnicity received a single dose of PREVNAR 13, (Lot N16561, expiry date Sep2017) via an unspecified route of administration on an unspecified date in Sep2016 for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2016 the patient experienced muscle aches in neck and she developed a large red area from the injection site and arm from injection site to the elbow was red, hot and itchy. Outcome of muscle aches in neck was unknown, the patient was not recovered from the other reported events.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia
Clinical narrative: Patient's arm was red, warm and painful from deltoid to elbow.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient's arm was red, warm and painful from deltoid to elbow.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This is a spontaneous report from a contactable Family Medicine PA via Pfizer sales representative. This Family Medicine PA reported similar events for two patients. This is the second of two reports. A 15-year-old female patient of an unspecified ethnicity received TRUMENBA, intramuscular on 15Aug2016 at 0.5 ml, single for immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced arm was warm and arm was a little achy/ arm was painful on 15Aug2016. It was not known if any treatment was given. The patient recovered from both events on unknown date.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Dizziness, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a contactable physician assistant communicated to a Pfizer sales representative, that reported similar events for two patients. This is the first of two cases. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, intramuscular on 17Aug2016 at 0.5 ml, single for immunisation. The patient medical history was not reported and concomitant medications were none. The patient experienced felt achy, lightheaded, felt like she had the flu and temperature of 101.8 on 17Aug2016, 1.5 to 2 hours after immunization. Patient was given Zyrtec and Tylenol. Patient completely recovered from all the events on 18Aug2016.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Flu-like symptoms (sneezing, coughing, aches) the evening of vaccine then gone next morning. Injection site warm and swollen x 3 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Flu-like symptoms (sneezing, coughing, aches) the evening of vaccine then gone next morning. Injection site warm and swollen x 3 days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Headache, Nausea, Vaccination complication
Clinical narrative: Shortly after receiving the vaccination, the patient complained of headache, dizziness, nausea. She was flushed and vomited. She was taken to the ER by flu staff at Hospital, where the flu clinic was held for employees. The patient reports that no medications were given in the ER. She was told that she had reacted to the vaccine and was advised not to receive further flu vaccines. She remained in bed at home the following day and has fully recovered without residual symptoms.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Shortly after receiving the vaccination, the patient complained of headache, dizziness, nausea. She was flushed and vomited. She was taken to the ER by flu staff at Hospital, where the flu clinic was held for employees. The patient reports that no medications were given in the ER. She was told that she had reacted to the vaccine and was advised not to receive further flu vaccines. She remained in bed at home the following day and has fully recovered without residual symptoms.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: SWELLING, REDNESS, A LITTLE WARMTH. PT WENT TO URGENT CARE THE FOLLOWING DAY, WAS GIVING CEPHALEXIN AND SWELLING STARTED GOING DOWN IN TWO DAYS.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Headache, Vaccination complication
Clinical narrative: Within an hour after receiving the flu vaccination, the patient complained of headache, said "I see the lights."  Also complained of chest pain and shortness of breath. Employee flu clinic was being held at Urgent Care.  Patient was seen by the staff.  EKG was done, B/P-106/68, HR-97, SPO2 98%, temp 97.7.  Aspirin po was given and she was transferred to the ER.  Patient was reached by phone on 9/22.  She was given a nebulizer treatment in the ER which alleviated her SOB.  She reports a history of asthma.  She was told by the staff that she was having a reaction to the flu vaccine.  She was fully recovered on 9/22 without residual symptoms.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza, Influenza A virus test positive, Influenza virus test negative, Pain
Clinical narrative: Fever (101 -  102 deg), aches, headache, - flu symptoms. Visited Urgent Care clinic and tested positive for flu.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever (101 -  102 deg), aches, headache, - flu symptoms. Visited Urgent Care clinic and tested positive for flu.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: A few hours after first capsule of oral typhoid vaccine client describes nausea and stomach pain. After second dose client has Nausea, Vomiting and Diarrhea, stomach cramps.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer refers to a 54 year old male patient. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, approximately in 2013 (reported as "3 years ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiry date were not reported). On an unknown date, the patient experienced pneumonia and it was reported that he gets it a lot. His last episode was in March 2016. It was enquired if he should be given PREVNAR 13. The outcome of pneumonia was unknown. The reporter did not provide the relatedness for the event with PNEUMOVAX 23. Upon internal review, "pneumonia" was determined to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Flushing
Clinical narrative: Within the hour of the patient's First flu vaccination, patient complained of feeling flushed, shortness of breath and cough. The clinic was being held at an Urgent Care, so the patient was seen by the staff.  She was given 50mg po Benadryl.  B/P-141/71, P-91, SPO2-98%. She was also administered a albuterol nebulizer treatment and Solumedrol 125mg, IM.  Patient returned to work in the afternoon.  I have not been able to reach her by phone or email for follow up.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red circle around injection site that is hot to touch- assumed infection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction, Pain, Swelling
Clinical narrative: Mild local reaction lasting >24 hours.  Mild swelling and soreness.  Redness surrounding the injection site with radius of about 0.75 inches.  The patient was advised to apply a cold compress to the affected area for 15 minutes, take an antihistamine for swelling, and take acetaminophen for soreness. She was advised to report any worsening of symptoms.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: Significant bruising starting 2 inches underneath the vaccination site & ending right above the elbow.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Malaise, Nausea
Clinical narrative: 12 minutes after administering FLUARIX 2016/17 flu shot the patient stated that he was feeling nauseous and ill. Patient looked flush.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Nausea, Tremor
Clinical narrative: Uncontrolled shaking; Nausea, unable to get warm, using furniture to make it to bed.