chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patients were vaccinated with M-M-R II (dosing details, lot#, expiry date were not reported) for prophylaxis. On an unknown date, the patients had negative titers for one or more of the components of M-M-R II. The outcome of events was unknown. The reporter did not provide the causality between the events and M-M-R II. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Sleep disorder
Clinical narrative: Pt had pain at injection site on L arm that lasted > 4 months that limited her range of motion and interfered w/ her sleep.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: 1st day after vaccines administered had itching and swelling at site of varicella vaccine. 2nd day after vaccine administered had pain in her arm. 3rd day after vaccine administered her body felt tingly all over.
Age: 16.0
Sex: F
Vaccine: FLU4, IPV, MENB, MNQ
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, redness, hot to the touch, pain at vaccine sites on bilateral deltoid area; bruising appearance.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Dysphagia, Lactose intolerance, Rash, Urticaria
Clinical narrative: Mom stated almost 2 weeks after patient received vaccination for Flu, MCV4(MENACTRA) and Men B (TRUMENBA) she developed some rash/hives that started in her hands, forearm and knees. She aslo had some swallowing problems and had lactose intolerant. She doesn't know if its from the dairy or from the vaccine.  She doesn't know if patient was coming with something at that time too. They had seen the doctor and was prescribed Benadryl, Steroid and Zantac and has been taking it since then. they were also referred to an immunologist.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 18 year old male patient who had had unspecified difficulties with vaccines in the past. The patient's current conditions included hyperthyroidism and hypersensitivity to AUGMENTIN. Concomitant therapies included levothyroxine sodium (manufacturer unknown). On 06-FEB-2017, the patient was vaccinated with the first dose of hpv GARDASIL 9 (lot # M024261, expiration date: 30-JUL-2018) subcutaneously, for prevention of human papilloma virus (hpv). It was stated that, at the time of vaccination, he had a cold and was already not feeling well. On 06-FEB-2017, immediately after receiving the dose, the patient experienced convulsions. After that, he was monitored and his stats were good, so he was sent home on the same day (reported as "soon after"). 07-FEB-2017, reported as "on the next day", the medical assistant called the patient's mother, who stated that he was tired and not feeling right. On 08-FEB-2017, the patient was recovered from the events (reported as "now back to normal"). Causality relationship between the events and GARDASIL 9 vaccination was not reported. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to unspecified number of patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX, 1 dose, (dosing details not provided) for prevention of shingles. Subsequently, on an unknown date (s), the patients developed shingles. The patients sought medical attention. Outcome of the event and causality were not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Dysphagia, Hypoaesthesia, Influenza like illness, Paralysis
Clinical narrative: Initial unsolicited report received from a consumer on 13-FEB-2017. This case involves a 20-year-old female patient who was vaccinated intramuscularly with a third dose of IMOVAX (Lot number, expiry date, dose were unknown) in an unknown side (reported as right) on 20-JAN-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as denies. Any other vaccinations within four weeks of vaccinations were also reported as denies. Concomitant medications were reported unknown. On an unknown date following initial vaccination, the patient experienced severe flu like symptoms, arthralgia, fever (highest recorded temp 102), then with second vaccine she experienced numbness and tingling in throat and following third vaccine on 20 January 2017; she experienced "paralysis" of throat lasting 5-6 hours by which the patient was unable to swallow. The patient had received intramuscularly two previous doses of IMOVAX on an unknown date. The emergency visit to a doctor was not reported. laboratory investigation was reported as body temperature of 102 degree Fahrenheit and corrective treatment was not reported. The outcome of the event was reported as recovered. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Pharyngeal paraesthesia, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 13-FEB-2017. This case involves a 20-year-old female patient who was vaccinated intramuscularly with a third dose of IMOVAX (Lot number, expiry date, dose were unknown) in an unknown side (reported as right) on 20-JAN-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as denies. Any other vaccinations within four weeks of vaccinations were also reported as denies. Concomitant medications were reported unknown. On an unknown date following initial vaccination, the patient experienced severe flu like symptoms, arthralgia, fever (highest recorded temp 102), then with second vaccine she experienced numbness and tingling in throat and following third vaccine on 20 January 2017; she experienced "paralysis" of throat lasting 5-6 hours by which the patient was unable to swallow. The patient had received intramuscularly two previous doses of IMOVAX on an unknown date. The emergency visit to a doctor was not reported. laboratory investigation was reported as body temperature of 102 degree Fahrenheit and corrective treatment was not reported. The outcome of the event was reported as recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016248113) on 13-Feb-2017. This case involves a female patient (age not reported), who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, route and site of administration: not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, after the vaccination patient had allergy to the vaccine. Laboratory investigations and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Chills, low-grade fever, swelling and redness at site.  Aching feeling all-over body.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-02-19.
Age: 76.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: On 8/11/2016 patient received the FLUZONE high dose on Right arm and HAVRIX on left. The next day her right arm hurt and is still painful today. Some days it's more painful than others. She describes it as a muscular or nerve pain. It sometimes wakes her at night.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest X-ray abnormal, Computerised tomogram, Cough, Feeling cold
Clinical narrative: Redness around shot. Got pneumonia - was in the hospital 5 days. On 12/17/2016 I got a flu shot at pharmacy, they said I should get a pneumonia shot so I went back on 12/23/2016 for the pneumonia shot, my arm got a little red. By Thursday 12/29/2016 at about 4:30 in the afternoon I started feeling achy and cold chilled. On Friday I went to urgent care at about 4:30 and they checked me for the flu. I did not have the flu so they said if I did not feel better to come back. The next day I went back with a fever and a bad cough. They put me on a Z-PAK, a inhaler and cough medicine. I wasn't getting any better and couldn't get my temp below 103 so I went to the emergency room. They took an x-ray of my lungs and said I had pneumonia and since I was not getting better with the Z-PAK they admitted me to the hospital. I was given 3 antibiotics at a time through IV. Had to have another x-ray and a CT scan. I was in the hospital 5 days. I have been seeing a lung specialist and just had a follow up CT scan on 2/17/2017 and need to go back to Dr. on March 3rd. I haven't got my strength back to normal and still have a little cough. So I would say I had a reaction to the shot I got.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza virus test negative, Injection site erythema, Pain, Pneumonia, Pyrexia
Clinical narrative: Redness around shot. Got pneumonia - was in the hospital 5 days. On 12/17/2016 I got a flu shot at pharmacy, they said I should get a pneumonia shot so I went back on 12/23/2016 for the pneumonia shot, my arm got a little red. By Thursday 12/29/2016 at about 4:30 in the afternoon I started feeling achy and cold chilled. On Friday I went to urgent care at about 4:30 and they checked me for the flu. I did not have the flu so they said if I did not feel better to come back. The next day I went back with a fever and a bad cough. They put me on a Z-PAK, a inhaler and cough medicine. I wasn't getting any better and couldn't get my temp below 103 so I went to the emergency room. They took an x-ray of my lungs and said I had pneumonia and since I was not getting better with the Z-PAK they admitted me to the hospital. I was given 3 antibiotics at a time through IV. Had to have another x-ray and a CT scan. I was in the hospital 5 days. I have been seeing a lung specialist and just had a follow up CT scan on 2/17/2017 and need to go back to Dr. on March 3rd. I haven't got my strength back to normal and still have a little cough. So I would say I had a reaction to the shot I got.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash pruritic, Rash pustular
Clinical narrative: Patient was taking a shower when his spouse noticed that he had a rash on his chest and left arm.  Next morning patient woke up with rash on chest, both arms, back, neck, and upper legs.  Rash is itchy with pustules.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 19-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-AUG-2016, the patient received his first dose of GARDASIL injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 16-OCT-2016, the patient received in error a dose of MENACTRA injection (dose, route of administration, anatomical location, lot # and expiration date were not reported), instead of GARDASIL. The pharmacist did not know why this medication error occurred. On 01-FEB-2017 (reported as "today"), the patient returned to the pharmacy to receive his third dose of GARDASIL and during that vaccination session the error was discovered. On 01-FEB-2017, the patient received his second dose of GARDASIL injection (lot # L026034 with expiration date at 23-JUL-2017) (dose, route of administration and anatomical location were not reported) for prophylaxis. The patient did not experience an adverse effect. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a currently 11 year old female patient. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not provided. On 29-JUN-2006, the patient was vaccinated with the first dose of VARIVAX, (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis, then on 02-AUG-2016 was vaccinated with a second dose of VARIVAX (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report has been received from a physician assistant via  company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, (strength, route of administration, frequency, lot#, dose and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced injection site reaction after the vaccination. Product quality complaint was not involved. At the time of reporting the outcome of injection site reaction was unknown.  The relatedness between the injection site reaction and ZOSTAVAX, was not provided. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses of M-M-R II, lot number L036851, expiration date 23-SEP-2017 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes, due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007055: US-009507513-1702USA001638:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a physician via company representative and refers to a teenage male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient administered unidentified Merck HPV vaccine (name and lot number not provided) (formulation, strength, dose, and route of administration were not reported). On an unknown date, after receiving the injection, the patient fainted on two different occasions. The physician stated that an ambulance was called to transport the patient to the hospital, but upon arrival the consumer felt better and did not go with the ambulance to the hospital. No product quality complaint was involved. The outcome of fainted on two different occasions was reported as unknown. The relatedness between the event and unidentified Merck HPV vaccine was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report has been received from a office manager and refers to a 58 year old male patient. The concurrent conditions included high cholesterol and concomitant therapies included atorvastatin calcium (LIPITOR). The patient did not have any known drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque-Forming Units (PFU), 0.65 ml, subcutaneously, lot # M001745 expiration date 07-APR-2017. On unknown date in February 2017, the patient experienced a large welt in the injection site. No treatment was given for the adverse event. There were no lab diagnostic studies performed. The patient sought medical attention by calling to the office. No product quality complaint was involved. The outcome of a large welt in the injection site was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with dose of improperly stored VAQTA injection (strength, dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. The vaccine experienced a temperature excursions between 32 Fahrenheit degrees (F) and 36 (F) for 3 hours and 30 minutes and below 32 (F) (31 (F)) for 1 hour and 30 minutes, which were detected by a digital data logger. There was no previous temperature excursion. No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a nurse prescriber via a company representative refers to a 19 year old female patient. The patient's pertinent medical history included sprained ankle. No historical medications nor drug reactions/allergies were reported. On 21-FEB-2017, the patient was vaccinated with GARDASIL 9 injection, 0,5 ml, first of 3 doses (schedule: 0,2,6 months), intramuscularly (lot # M034195, expiration date unknown) for prophylaxis. Concomitant therapies included IBUPROFEN. On 21-FEB-2017, after receiving her first dose of vaccine, the patient experienced rash and hives on her face and neck and her rash/hives were itchy. The nurse prescriber gave the patient an injection of an unspecified dose of BENADRYL for these effects. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review the events of itchy rash and hives on face and neck treated with injection of BENADRYL were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacy intern concerning a female patient who was over 60 years old.  Medcial history and concomitant medications were unknown by the reporter.  On 21-FEB-2017, the patient received ZOSTAVAX (route and ot number not provided) for prevention of shingles due to her age.  She then experienced erythema, redness and itchiness at the injection site.  The patient visited the pharmacy for the events but did not receive treatment.  Patient present status was not recovered.  The reporter stated, "I just want to know where the liability lies".   Additional information is not expected as the reporter did not provide consent to follow up.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 71-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on 25Jan2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a reaction of arm swelling at the injection site on an unspecified date in 2017 with outcome of unknown.  Patient states she was given 10 days of antibiotics.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 3rd of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the injection hurt a lot on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 Same reporter/product, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 5th of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the injection hurt a lot on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 Same reporter/product, different patient.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: DOS 12/18 Mild tenderness, mild redness and warmth skin condition, arm pain Rx Methylprednisolone, Ranitidine.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Influenza, Influenza A virus test positive, Laryngitis, Oropharyngeal pain
Clinical narrative: Case number PHEH2017US005319, is an initial spontaneous report received from a consumer on 18 Feb 2017. This report refers to a 56 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Nov 2016. On 13 Feb 2017, the patient experienced sore throat, laryngitis, body aches and difficulty breathing. On 18 Feb 2017, the patient was diagnosed with influenza type A. The patient received treatment with liquid lidocaine for sore throat. The patient visited emergency room (urgent care). The outcome of influenza type A was not reported and rest of all events was reported as condition improving. The seriousness of the event influenza type A was not reported and rest of all events was reported as non serious. The causality of the events was not reported. The seriousness assessment of influenza, vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Vaccination failure
Clinical narrative: Case number PHEH2017US005319, is an initial spontaneous report received from a consumer on 18 Feb 2017. This report refers to a 56 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Nov 2016. On 13 Feb 2017, the patient experienced sore throat, laryngitis, body aches and difficulty breathing. On 18 Feb 2017, the patient was diagnosed with influenza type A. The patient received treatment with liquid lidocaine for sore throat. The patient visited emergency room (urgent care). The outcome of influenza type A was not reported and rest of all events was reported as condition improving. The seriousness of the event influenza type A was not reported and rest of all events was reported as non serious. The causality of the events was not reported. The seriousness assessment of influenza, vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 45.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye pain, Injection site pain, Nausea, Tachycardia
Clinical narrative: INJECTION SITE SORENESS, NAUSEA, EYEBALLS HURT, TACHYCARDIA.
Age: 45.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye pain, Injection site pain, Nausea
Clinical narrative: INJECTION SITE SORENESS, NAUSEA, EYEBALLS HURT, TACHYCARDIA.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: F rom elbow to shoulder of my right arm, I can not raise my arm to the back of my head or try to reach something to my right without pain.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood test, CSF test, Chest X-ray, Computerised tomogram
Clinical narrative: Initial Back Pain, Partial Paralysis, Hospitalized from 9/18/2015 through 9/26/2015. Diagnosed with Acute Transverse Myelitis. Given Intravenous Steroids for days. Had rehab therapy for about 3 months. Still have numbness and back pain.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Initial Back Pain, Partial Paralysis, Hospitalized from 9/18/2015 through 9/26/2015. Diagnosed with Acute Transverse Myelitis. Given Intravenous Steroids for days. Had rehab therapy for about 3 months. Still have numbness and back pain.
Age: 11.0
Sex: F
Vaccine: DTP, HPVX, MMRV
Symptoms: Abdominal pain upper, Arthralgia, Decreased activity, Disturbance in attention, Dizziness
Clinical narrative: Headaches, Stomach pain, decrease in activity, dizzy spells, poor concentration, blurry vision, joint pain (mainly in the knees)  Symptoms have came on gradually over the last 8 months since vaccination.
Age: 11.0
Sex: F
Vaccine: DTP, HPVX, MMRV
Symptoms: Electrocardiogram, Headache, Imaging procedure, Laboratory test, Vision blurred
Clinical narrative: Headaches, Stomach pain, decrease in activity, dizzy spells, poor concentration, blurry vision, joint pain (mainly in the knees)  Symptoms have came on gradually over the last 8 months since vaccination.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Patient felt nauseate, tired and had a headache. Patient woke up with a fever and body aches.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site abscess, Injection site cellulitis
Clinical narrative: Cellulitis, abscess formation at site of varicella injection on left thigh; patient admitted 12 days after receiving vaccinations for PENTACEL, PREVNAR, MMR, Varicella on b/l thighs.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL, HPV9, MENB, MNQ, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt was administered a varicella vaccine that they did not need.  They had already been fully vaccinated against this vaccine preventable disease previously.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: After 24 hours, patient experienced low grade fever, vaccine site pain and arm pain.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve injury, Pain
Clinical narrative: Patient states nerve damage, pain, and weakness of left arm.  immunization was injected correctly and in right area.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever. Dizziness. Chills. Emesis.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm to touch, itchy, redness at injection site , spreading down arm. Pt went to dr office and received Keflex 500 three times daily and Prednisone 10 mg taper.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant therapies were not reported. On 08-FEB-2017, the patient was vaccinated in error with an expired dose of PNEUMOVAX23 lot # L024132 with expiration date 21-JAN-2017, intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On 16-FEB-2017, the patient received an improperly stored dose of ROTATEQ lot # M025568, expiration date 07-NOV-2017, (dosage and therapy route were not provided) for prophylaxis. Information regarding concomitant therapies was not reported. The dose of ROTATEQ was exposed to a temperature >32°F but <31°F and was out of range for 52 hours. A data logger was used to track the temperature and there were no prior temperature excursions. No adverse experiences had been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Wheezing
Clinical narrative: This is a spontaneous report from a contactable Registered medical assistant calling on behalf of a CRNP. A 67-year-old male patient received PREVNAR 13 lot R12276 Expiry Date 28Feb2018, intramuscular in Feb2017 at 0.5 ml, single for immunisation (health maintenance).  Medical history included ongoing hypertension, hyperlipidaemia, gastrooesophageal reflux disease.  Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN), atorvastatin calcium (ATORVASTATIN CALCIUM), ranitidine (RANITIDINE).  On 21Feb2017 within 4 hours after vaccination he started having fever, headache, shortness of breath, wheezing, and aching with outcome of unknown.  The patient underwent lab tests and procedures which included physical examination of unknown results.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 2nd of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the injection hurt a lot on an unspecified date with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 8th of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the injection hurt a lot on an unspecified date with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Gait disturbance, Injected limb mobility decreased, Syncope
Clinical narrative: Body collapsed. Bedridden, left arm went up half way-needed a sling arm still the same. arm drops down when put up in air. When walking my body veered off to the side.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cough, Headache, Influenza, Influenza A virus test positive
Clinical narrative: Case number PHEH2017US005441, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 15 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 04 Feb 2017, the patient experienced flu, fever, cough, headache, weakness. On 07 Feb 2016 the patient was diagnosed with flu type A. It was reported that cough lingered and the symptoms resolved. The outcome of events pyrexia and headache was reported as complete recovery on 09 Feb 2017 and for the event asthenia was reported as complete recovery on 10 Feb 2017. The outcome of the event cough was reported as condition improving and event influenza was reported as complete recovery on an unknown date. The seriousness and causality of the event influenza was not reported. The seriousness assessment of the events influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: Case number PHEH2017US005441, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 15 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 04 Feb 2017, the patient experienced flu, fever, cough, headache, weakness. On 07 Feb 2016 the patient was diagnosed with flu type A. It was reported that cough lingered and the symptoms resolved. The outcome of events pyrexia and headache was reported as complete recovery on 09 Feb 2017 and for the event asthenia was reported as complete recovery on 10 Feb 2017. The outcome of the event cough was reported as condition improving and event influenza was reported as complete recovery on an unknown date. The seriousness and causality of the event influenza was not reported. The seriousness assessment of the events influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Arm immediately swelled, turned red, egg size, burning, tingling/itching.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pruritus, X-ray
Clinical narrative: Arm immediately swelled, turned red, egg size, burning, tingling/itching.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Significant pain in entire upper extremity with progression to weakness, numbness, and tingling over the next few days.  Two weeks out, pain improved but with worsening of weakness, tingling and numbness.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, and body aches. Did use acetominaphen rest and fluids. symptoms are gradually subsiding.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: PT REPORTED REDNESS, ITCHING, PAIN, AND IRRITATION AT INJECTION SITE ON ARM.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised
Clinical narrative: Pt experienced itching all over.  No shortness of breath or breathing problems were reported.  Just itching.  Pt took benadryl by mouth and got better.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Arrhythmia, Confusional state, Dizziness, Electrocardiogram abnormal, Fall
Clinical narrative: Patient was administered Tdap and TWINRIX vaccinations  at Pharmacy. After the second vaccination patient complained of feeling dizzy and lightheaded and was instructed to stay seated. Patient then started to fall out of her seat and was caught from hitting her head on the ground. Patient was unconcious for ~5 seconds and awoke in slight confusion. Patient had her blood pressure read with a reading of 95/45 and EMT was eventually called after after 5 minutes. EMT arrived and assessed the patient with similar blood pressure readings and did an EKG with findings of dysarrythmias and low blood pressure. She was recommended to go to the hospital to be further evaluated, but the patient declined. Patient was released from EMT care and from the pharmacy.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Patient was administered Tdap and TWINRIX vaccinations  at Pharmacy. After the second vaccination patient complained of feeling dizzy and lightheaded and was instructed to stay seated. Patient then started to fall out of her seat and was caught from hitting her head on the ground. Patient was unconcious for ~5 seconds and awoke in slight confusion. Patient had her blood pressure read with a reading of 95/45 and EMT was eventually called after after 5 minutes. EMT arrived and assessed the patient with similar blood pressure readings and did an EKG with findings of dysarrythmias and low blood pressure. She was recommended to go to the hospital to be further evaluated, but the patient declined. Patient was released from EMT care and from the pharmacy.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site swelling, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: EVENING OF 2/24 VACCINATED ARM (LEFT) DEVELOPED SWELLING FROM SHOULDER TO THE WRIST, 2/25 EXPERIENCED MUSCLE AND JOINTS ACHES ALL OVER AND LOW GRADE FEVER.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history included cold sores. The patient's concurrent conditions included diabetes mellitus. Concomitant medications were not reported and the patient had not drug reactions or allergies. On 18-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency, route and anatomical location were not reported) (lot # M035147 and expiration date 25-OCT-2017) for prophylaxis. On an unknown date in 2017, the patient experienced cold sores (oral herpes) and was treated with valacyclovir. It was unknown if laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered from the event cold sores. The causality between cold sores and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses of PNEUMOVAX 23, lot number M029680, expiration date 17-JAN-2018 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007056: US-009507513-1702USA001638:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN)other health professional refers to a patient of unknown age. The nurse reported that the patient received their thrd dose of GARDASIL 9 earlier than the recommended interval. On 23-NOV-2016,the patient was vaccinated with GARDASIL 9 and on 17-FEB-2017 was  vaccinated with third dose of GARDASIL 9. No adverse effects were reported and no further information was provided. The outcome of inappropriate schedule of drug administration and no adverse event is unknown.    Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # M020071 with expiration date 18-JUL-2017 (dose, frequency and route of administration were unspecified) for prophylaxis. No adverse effects were reported. It was stated that the vaccines were exposure to a temperature greater than 14 but lower than 46 Fahrenheit degrees for a time frame of 2 hours and 30 minutes. It was also reported that there was a previous exposure to the same temperature for a time frame of 12 hours. The report was due to a data logger. This is one of two reports from the same reporter 1702USA010221. Additional information is not expected since the reported refused to be contacted.; Sender's Comments: US-009507513-1702USA010221:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses VARIVAX, lot # M02338 with expiration date 11-MAY-2018 (dose, frequency and route of administration were unspecified) for prophylaxis. No adverse effects were reported. It was stated that the vaccines were exposure to a temperature greater than 14 but lower than 46 Fahrenheit degrees for a time frame of 2 hours and 30 minutes. It was also reported that there was a previous exposure to the same temperature for a time frame of 12 hours. The report was due to a data logger. This is one of two reports from the same reporter 1702USA009210. Additional information is not expected since the reported refused to be contacted.; Sender's Comments: US-009507513-1702USA009210:
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: This spontaneous report was received from a Pharm. D, referring to a 41 year old female patient with no drug reactions/allergies. The patient's medical history and concomitant medications were unknown. On 18-FEB-2017, the patient was vaccinated with a dose of VAQTA (lot # M039055; expiration date 22-JUL-2018) at the pharmacy (Route and anatomical location were not provided). On 18-FEB-2017, 5 minutes after vaccination with VAQTA, the patient complained of paresthesia oral reported as " tongue feeling funny", oropharyngeal pain described as "sore throat" and pharyngeal oedema reported as "felt like throat was swelling". The pharmacist reported that she brought the patient to a physician "down the hall" who injected the patient with BENADRYL(injection) and then epinephrine (injection). Then, the patient was released by the physician. It was unknown if some lab diagnostic studies were performed. The pharmacist reported that she spoke with the patient on 22-FEB-2017 and she was recovering from the events. The pharmacist considered paraesthesia oral, oropharyngeal pain and  pharyngeal oedema as life threatening and medical significant events. There was no product quality complaint involved. The primary reporter did not assess the causality between the events and VAQTA. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Herpes zoster, Musculoskeletal pain
Clinical narrative: Pain in left shoulder and under arm, was told by minor emergency center it was shingles.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Mother called to report that arm is very swollen from top of arm to elbow.  Area is itchy but no other symptoms.  TC to NP for advice for parent - Children's tylenol q 6 hours for 3 days, children's Benadryl  q 6hrs for 24 hours.  Cold compress to area 10 minutes every hour while awake.  Keep arm up on arm of chair/couch or on pillows.  Seek medical care if worsens today or does not begin to resolve by tomorrow.  TC to mother to relay information and let her know I would be making a Vaers report and that someone from their office may contact her. I will call her tomorrow to check on status.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Patient had an allergic reaction a few hours after the administration of the vaccine. She had to go to the emergency room, she was having difficulty breathing.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Chills, Ear pain, Headache, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, swollen left testicle, testicular pain fever, sore joints, headache, sore ears, sore jaw, chills.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Pain in jaw, Pyrexia, Testicular pain, Testicular swelling
Clinical narrative: Swollen lymph nodes, swollen left testicle, testicular pain fever, sore joints, headache, sore ears, sore jaw, chills.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red Rash, with one raised bump and itching at injection site.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: C/o pain and swelling, no redness notes no swelling noted, patient stated at 7 days out arm still sore. doctor gave steroid shot.
Age: 23.0
Sex: F
Vaccine: DPP, MEN
Symptoms: Injected limb mobility decreased, Injection site erythema
Clinical narrative: My left arm where i got the shot is red and I can't move my arm.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Ataxia, Muscular weakness
Clinical narrative: Acute onset of bilateral upper extremity weakness and ataxia.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: I was giving the baby her immunizations.  I accidentally gave the Rotovirus vaccine as injectable instead of oral.  I spoke to the provider and my supervisor right away.  The provider went and spoke to the parents and I was not aware of any reaction at the time.  Patient will be coming back to get the oral rotavirus.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Sore for two-three days but she thought it was better until she rolled over onto her shoulder while in bed. Sore since and it hurts to lift her arm shoulder height or reach across her trunk.  No redness or swelling at the injection site noted.
Age: 32.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Injection site pain
Clinical narrative: Erythema, sensitivity to touch L triceps.