chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Injection site reaction, Skin lesion
Clinical narrative: On 2/17/17 Patient received MENACTRA vaccine and TRUMENBA vaccine, R and L arms respectively. Developed discomfort, lesions (R) (L) at injection sites. Patient seen for this by me 2/26/17. Recommended ice, BENADRYL, followup PRN.
Age: 49.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chills, Influenza, Influenza A virus test positive, Injection site inflammation, Injection site pain
Clinical narrative: 2/12/17: Fever, chills, rash and swelling. 2/13/17 Fever, chills, rash and swelling. Diagnosed with influenza, treated with Tamilflu 75mg twice daily. 2/15/17 Localized tenderness, rash, inflammation right arm extending 2/3 down from shoulder to elbow and right axillary area. Recommended cold packs and ibuprofen 800 mg every 8 hours. Symptoms resolved 2/17/17 per patient report.
Age: 49.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site rash, Pyrexia, Rash, Swelling
Clinical narrative: 2/12/17: Fever, chills, rash and swelling. 2/13/17 Fever, chills, rash and swelling. Diagnosed with influenza, treated with Tamilflu 75mg twice daily. 2/15/17 Localized tenderness, rash, inflammation right arm extending 2/3 down from shoulder to elbow and right axillary area. Recommended cold packs and ibuprofen 800 mg every 8 hours. Symptoms resolved 2/17/17 per patient report.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: 2.5-3 in welt at injection site. Redness and swelling.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: After 48 hours, patient noticed swelling at injection site and it was hot to touch and red in color. She developed a rash then. At this point it has started bruising 2 days later.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash, Skin infection
Clinical narrative: After 48 hours, patient noticed swelling at injection site and it was hot to touch and red in color. She developed a rash then. At this point it has started bruising 2 days later.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month-old (age reported also as 2 years), female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 18-NOV-2015 at 14:15 (reported also as 2:15 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004106: US-009507513-1702USA004107: US-009507513-1702USA004108: US-009507513-1702USA004109: US-009507513-1702USA004110: US-009507513-1702USA004103: US-009507513-1702USA004102: US-009507513-1611USA008278: US-009507513-1702USA004105.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 month old (reported also as 2 year-old), female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 09-OCT-2015 at 13:00 (reported as 1: 00 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). No adverse event was reported. The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1611USA008278.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 year old female patient. The patient's historical drugs included Lisinopril (manufacturer unknown) 10 mg, omeprazole 20 mg capsules and pravastatin 20 mg. The patient had no concomitant medications or drug reactions or allergies. Concurrent conditions were not reported. On 07-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot # M035693, expiration date: 07-NOV-2017) (dose, frequency and route of administration were unspecified) for prophylaxis. On 08-FEB-2017, the patient called the pharmacist  to report that she experienced an injection site reaction, about 2 inches by 1 inch oval slightly elevated, reddened and bruised. The pharmacist reported that otherwise the patient was fine, that she sought for medical attention and received unspecified treatment for these adverse events. At the time of the report, the outcome of injection site inflammation, vaccination site bruising and vaccination site erythema was reported as recovering. No causality relatedness was specified. 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 medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers: L039613, expiration date 08-OCT-2017; M000768, expiration date 05-JAN-2018; M011667, expiration date 08-MAR-2018; M014902, expiration date 18-MAR-2018 and lot number reported as M025185, expiration date 18-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of M-M-R II were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA010876: US-009507513-1702USA010877.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 17-FEB-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent. The pharmacist stated that, PNEUMOVAX 23 had been inadvertently mixed with sterile water and administered to the patient (product preparation error). Furthermore no adverse event was reported and no product quality issue was involved. Additional information is not expected as consent to contact the reporter was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. The reporter stated, that the patient received the dose of GARDASIL 9 a few weeks to early and they would give the correct dose soon (inappropriate schedule of drug administration). At the time of the report, the patient had not been re vaccinated. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates in 2017 (reported as "unspecified dates since 24-JAN-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ, orally, with lot # M018958 and expiration date 03-MAR-2018, for prophylaxis (dose number was unknown). The temperature excursion reported was - 0.9 Celsius degrees (C) for 8.5 hours (colder than 2 C), and higher than 8 C but lower than 25 C for 4.5 hours. A digital data logger was involved. No previous temperature excursions nor adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot numbers: M036294, expiration date 24-JAN-2018 and M038860, expiration date 13-MAR-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of PROQUAD were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA005585: US-009507513-1702USA010877.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot numbers: L034368, expiration date 08-SEP-2017; M033904, expiration date 20-JUN-2018 and M035142, expiration date 30-AUG-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of VARIVAX were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA005585: US-009507513-1702USA010876.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer Company representative. This pharmacist reported the same event for three patients. This is the third of three reports. An elderly female patient (65 or older) of an unspecified age and race received PREVNAR 13 at 0.5ml single dose as protection against Pneumococcal Pneumonia via unspecified route on unknown date. Medical history and concomitant medication were not reported. On unknown  date the patient experienced hard swollen arm and redness around the injection site. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081252 same reporter/drug/event, different patients; US-PFIZER INC-2017081535 same reporter/drug/event, different patients.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported the same event for three patients. This is the 2nd of three reports. An elderly female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5ml single, for immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced hard swollen arm and redness around the injection site. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081303 Same reporter/product/event, different patient.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: 24 hours following administration, pt developed extreme pain that radiated down left arm. She also experienced numbness in ring and pinky fingers - left hand. Visit to MD on 2/23/17.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Injection site reaction, Skin exfoliation, Skin mass
Clinical narrative: Patient developed large subcutaneous nodule with overlying scaling on skin at site of injection. Chart review revealed it was site of Hib vaccine. He has an old, smaller subQ nodule at site of 2 month Hib vaccine. Patient is otherwise doing well.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Pain, edema, erythema, cellulitis requiring antibiotics 02/15/2017.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash from FLUZONE vaccine.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: I received the PNEUMOVAX 23 inj 25mcg/0.5ml pf syr in left arm at 4:30pm. Around 8:00 pm I started to develop pain in my left arm. By 10:00 pm I was in extreme pain and could no move it. After 24 hours the pain started to lessen but still very painful. It has now been nearly 48 hours and 48 hours, and I cannot lift my arm higher than my chest.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: The patient reports he received the vaccine (AFLURIA Lot# WT58908) on 15 DEC 2016. He states about one hour later he developed increased thirst. About two hours he developed fever, up to 101.4, myalgias, arthralgias, headache, and severe fatigue and malaise, diarrhea. He denied cough, mucous drainage, SOB. The symptoms last 48 hours and then resolved. He missed work on Monday due to policy requiring afebrile status for 24 hours. He reports he had no immediate symptoms such as oral facial throat tongue swelling, urticaria, pruritus flushing etc. He denies any previous similar adverse event after vaccine and has received annual influenza vaccine for many years. No other household or work contacts were ill.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Thirst
Clinical narrative: The patient reports he received the vaccine (AFLURIA Lot# WT58908) on 15 DEC 2016. He states about one hour later he developed increased thirst. About two hours he developed fever, up to 101.4, myalgias, arthralgias, headache, and severe fatigue and malaise, diarrhea. He denied cough, mucous drainage, SOB. The symptoms last 48 hours and then resolved. He missed work on Monday due to policy requiring afebrile status for 24 hours. He reports he had no immediate symptoms such as oral facial throat tongue swelling, urticaria, pruritus flushing etc. He denies any previous similar adverse event after vaccine and has received annual influenza vaccine for many years. No other household or work contacts were ill.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Myoclonic epilepsy
Clinical narrative: My daughter experienced a tonic clonic seizure. She was diagnosed with epilepsy. After consulting with the doctor we established she was likely having absence and myoclonic seizures since around 2014. She had her last GARDASIL shot on 11-27-2013. There is no familial history of seizures and she does not follow the typical JME seizure pattern.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Petit mal epilepsy
Clinical narrative: My daughter experienced a tonic clonic seizure. She was diagnosed with epilepsy. After consulting with the doctor we established she was likely having absence and myoclonic seizures since around 2014. She had her last GARDASIL shot on 11-27-2013. There is no familial history of seizures and she does not follow the typical JME seizure pattern.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: MA gave vaccines ordered by provider. Grandma noticed hives on face, chest, shoulder immediately. RN and provider responded. Pt denied SOB, swelling of lips/tongue/throat. Pulse 92, SPO2 98%. A dose of BENADRYL given in clinic. Hives/redness disappeared w/in 1 hr.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received second flu vaccine in same season (first was in August according to patient and second was administered on 2/15/17).
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness at injection site (difficult to move arm) and low grade temp (101F) Pharmacist recommended Tylenol for aches and fever.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, itching at the injection site on right upper arm. Father reports fever but did not report temperature. Symptoms began the evening of 2/15/2017.  He presented to the clinic today 2/24/2017 with redness around the injection site, approximately 1-2 inches in diameter along with firm swelling.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: REDNESS AT SITE OF INJECTION. FOLLOWED BY BUMPS AT SITE OF INJECTION. FOLLOWED BY BUMPS ON TORSO AND LEGS.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection for prophylaxis (strength, dose, route, lot # and expiration date were not provided). Subsequently, the patient received the second and third doses of GARDASIL 9 injection, also for prophylaxis (strength, dose, route, lot # and expiration date were not provided) on 19-AUG-2016 and 25-JAN-2017. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to two unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as M038225 with expiry date of 07-SEP-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of >14 degrees Fahrenheit but < 46 degrees Fahrenheit for 120 hours. Data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a physician assistant referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 06-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (route, lot # and expiration date were not reported). On an unknown date, the patient experienced cellulitis at the injection site. It was stated that the patient was send to the emergency room and was treated with unspecified antibiotics per intravenous route. At the time of reporting the outcome of injection site cellulitis was unknown. A product quality complaint was not involved. The causality assessment between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot# and expiration date were not provided), for prevention of shingles. On an unknown date, a short time after receiving the vaccine, the patient developed shingles. The patient sought medical attention. She had the doctor's office appointment. On an unknown date, the patient recovered from the adverse event. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On 13-FEB-2017, the patient inadvertently received an expired dose of ZOSTAVAX (dosage, anatomical location and route of administration were not reported), lot # L044528, expiration date: 09-FEB-2017, for prophylaxis. No information about concomitant therapies was provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX injection, lot# M023384, expiration date: 11-MAY-2018 (dose and route of administration were not reported). The temperature excursion was ranged between 5 and 14 degrees Fahrenheit for 1 hour. No adverse effects were reported. There was no previous temperature excursion, digital data logger was used and product quality complaint was not involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: HPVX
Symptoms: Asthenia, Decreased appetite, Developmental delay, Hypotonia, Insomnia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed "a fever for 5 days, weakness, pale skin, loss of muscle tone, decreased sleep, decreased appetite, missed milestones and no weight gain". The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: HPVX
Symptoms: Pallor, Pyrexia, Weight gain poor, Wrong drug administered
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed "a fever for 5 days, weakness, pale skin, loss of muscle tone, decreased sleep, decreased appetite, missed milestones and no weight gain". The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date (reported as "a few years ago"), the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, for prevention of shingles (dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. Then, on an unknown date (reported as "the next day"), the patient developed shingles (herpes zoster). At the time of reporting, the outcome of the herpes zoster was unknown. The causality assessment between the herpes zoster and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness and vomited about 15 min after administration.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Full blood count, Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Patient reports that she developed pain left shoulder after receiving vaccine and has not been able to lift arm due to severe pain since.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Ear infection, Injection site erythema, Injection site mass, Injection site rash, Pyrexia
Clinical narrative: Mother reports she noticed a rash on patient's right thigh this AM. She had immunizations about 1 1/2 weeks ago and 3 days ago mother noticed a "nickel sized lump" on right thigh which is reddened. Was diagnosed with ear infection 1 week ago and started on AUGMENTIN. Did have a fever last week but none since 02/12. Normal appetite and fluid intake.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Patient reported blisters around site of ZOSTAVAX injection. Patient was instructed to keep the blisters covered and contact her doctor or pharmacy if reaction worsens.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Pain
Clinical narrative: Gradual onset of muscle tightness in the lumbar part of the back. Became intense and painful (per patient). Has been slowly improving over the last 7 days
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Arm hurt from shoulder to elbow - had chills, next day had welts on arm and hives and itchy.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site redness and soreness. Original injection site was fine after vaccine was administered but became red and sore a few weeks ago.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Day after visit for vaccine receipt started with rash and seen in clinic by me following day (2/23/17) and diagnosed with erythema multiforme.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Induration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3' x 4" red, warm swollen area where injection given. Urticaria and 2/10 pain. Applied ice intermittently, took Advil. Macular rash with slight bruising to center mass began today, center is harder to touch. Continued care is ongoing.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash macular, Urticaria
Clinical narrative: 3' x 4" red, warm swollen area where injection given. Urticaria and 2/10 pain. Applied ice intermittently, took Advil. Macular rash with slight bruising to center mass began today, center is harder to touch. Continued care is ongoing.
Age: 1.25
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Biopsy site unspecified abnormal, Dysstasia, Erythema, Joint irrigation, Lymphadenopathy
Clinical narrative: Initially it was a low grade fever, followed by a rash.  Went to pediatrician on the 11th, had red swollen glands and pus in neck, but negative for strep.  The fever lasted one week, then when he woke up on the 22nd, he couldn't stand.  Went to pediatrician and ER, and ultimately diagnosed with transient synovitis of the hip, but because biopsy showed pus, had to have a full hip irrigation.
Age: 1.25
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Purulent discharge, Pyrexia, Rash, Streptococcus test negative, Synovitis
Clinical narrative: Initially it was a low grade fever, followed by a rash.  Went to pediatrician on the 11th, had red swollen glands and pus in neck, but negative for strep.  The fever lasted one week, then when he woke up on the 22nd, he couldn't stand.  Went to pediatrician and ER, and ultimately diagnosed with transient synovitis of the hip, but because biopsy showed pus, had to have a full hip irrigation.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Anxiety, Asocial behaviour, Eyelid oedema, Fatigue
Clinical narrative: First symptoms experienced began  a few days later in the morning with skin sensitivity, it then turned into fatigue and a fever minutes later, I basically felt like I had the flu but was not not vomiting and had no diarrhea. I experienced one rather large and aggressive BM  and then that was over with.  I stayed home from work for 2 days and was exhausted. After those symptoms passed I began to feel strange as the weeks of February passed. I had thought as a full time student and full time employee that the lack of sunlight and socialization was causing some sort of seasonal depression. I noticed the severity of this around the weekend. I had become sensitive to loud noises and I did not really desire to be around ANYONE. During the last 14 day some new symptoms surfaced, I began to see rashes on my chest, nose, and scattered goosebumps that had no reason to be there. Ive been experiencing  some really difficult levels of anxiety- and I've had nothing to be anxious about- at least nothing thats out of the ordinary. It has effected my ability to sleep and I felt myself panicking  some days- I have had to go on Xynax daily to get through this. My skin has been itching me especially my head and calf areas. My eyes have been puffy and swollen some days and my hands have been quite cold during my evening classes where its difficult to complete my assignments on the computer. Ive also felt uncomfortably hot throughout the day and really thought there was something wrong so I schedule an appointment with my Hematologist. It was brought to my attention when I spoke with a friend that all of these symptoms were because of this vaccine. I HAD NO IDEA! Treatment will be through the use of various supplements
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Feeling hot, Hyperacusis, Hyperaesthesia, Impaired work ability
Clinical narrative: First symptoms experienced began  a few days later in the morning with skin sensitivity, it then turned into fatigue and a fever minutes later, I basically felt like I had the flu but was not not vomiting and had no diarrhea. I experienced one rather large and aggressive BM  and then that was over with.  I stayed home from work for 2 days and was exhausted. After those symptoms passed I began to feel strange as the weeks of February passed. I had thought as a full time student and full time employee that the lack of sunlight and socialization was causing some sort of seasonal depression. I noticed the severity of this around the weekend. I had become sensitive to loud noises and I did not really desire to be around ANYONE. During the last 14 day some new symptoms surfaced, I began to see rashes on my chest, nose, and scattered goosebumps that had no reason to be there. Ive been experiencing  some really difficult levels of anxiety- and I've had nothing to be anxious about- at least nothing thats out of the ordinary. It has effected my ability to sleep and I felt myself panicking  some days- I have had to go on Xynax daily to get through this. My skin has been itching me especially my head and calf areas. My eyes have been puffy and swollen some days and my hands have been quite cold during my evening classes where its difficult to complete my assignments on the computer. Ive also felt uncomfortably hot throughout the day and really thought there was something wrong so I schedule an appointment with my Hematologist. It was brought to my attention when I spoke with a friend that all of these symptoms were because of this vaccine. I HAD NO IDEA! Treatment will be through the use of various supplements
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness, Insomnia, Panic reaction, Peripheral coldness, Piloerection
Clinical narrative: First symptoms experienced began  a few days later in the morning with skin sensitivity, it then turned into fatigue and a fever minutes later, I basically felt like I had the flu but was not not vomiting and had no diarrhea. I experienced one rather large and aggressive BM  and then that was over with.  I stayed home from work for 2 days and was exhausted. After those symptoms passed I began to feel strange as the weeks of February passed. I had thought as a full time student and full time employee that the lack of sunlight and socialization was causing some sort of seasonal depression. I noticed the severity of this around the weekend. I had become sensitive to loud noises and I did not really desire to be around ANYONE. During the last 14 day some new symptoms surfaced, I began to see rashes on my chest, nose, and scattered goosebumps that had no reason to be there. Ive been experiencing  some really difficult levels of anxiety- and I've had nothing to be anxious about- at least nothing thats out of the ordinary. It has effected my ability to sleep and I felt myself panicking  some days- I have had to go on Xynax daily to get through this. My skin has been itching me especially my head and calf areas. My eyes have been puffy and swollen some days and my hands have been quite cold during my evening classes where its difficult to complete my assignments on the computer. Ive also felt uncomfortably hot throughout the day and really thought there was something wrong so I schedule an appointment with my Hematologist. It was brought to my attention when I spoke with a friend that all of these symptoms were because of this vaccine. I HAD NO IDEA! Treatment will be through the use of various supplements
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: First symptoms experienced began  a few days later in the morning with skin sensitivity, it then turned into fatigue and a fever minutes later, I basically felt like I had the flu but was not not vomiting and had no diarrhea. I experienced one rather large and aggressive BM  and then that was over with.  I stayed home from work for 2 days and was exhausted. After those symptoms passed I began to feel strange as the weeks of February passed. I had thought as a full time student and full time employee that the lack of sunlight and socialization was causing some sort of seasonal depression. I noticed the severity of this around the weekend. I had become sensitive to loud noises and I did not really desire to be around ANYONE. During the last 14 day some new symptoms surfaced, I began to see rashes on my chest, nose, and scattered goosebumps that had no reason to be there. Ive been experiencing  some really difficult levels of anxiety- and I've had nothing to be anxious about- at least nothing thats out of the ordinary. It has effected my ability to sleep and I felt myself panicking  some days- I have had to go on Xynax daily to get through this. My skin has been itching me especially my head and calf areas. My eyes have been puffy and swollen some days and my hands have been quite cold during my evening classes where its difficult to complete my assignments on the computer. Ive also felt uncomfortably hot throughout the day and really thought there was something wrong so I schedule an appointment with my Hematologist. It was brought to my attention when I spoke with a friend that all of these symptoms were because of this vaccine. I HAD NO IDEA! Treatment will be through the use of various supplements
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 12-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous injection, lot # M030138, expiration date 15-JUN-2018 (dose was not reported). The vaccine was stored improperly for 47.5 hours in the temperature between 14 and 46 degrees Fahrenheit. The temperature excursion was registered by the digital data logger. No adverse events were reported. This is one of the several cases reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014165.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneous injection, lot # M030138, expiration date 15-JUN-2018 (dose was not reported). The vaccine was stored improperly for 47,5 hours  in the temperature between 14 and 46 degrees Fahrenheit.. The temperature excursion was registered by the digital data logger. No adverse events were reported. This is one of the several reports received from by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014145:
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 51 year old female patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 01-FEB-2017, the patient was vaccinated with ZOSTAVAX in the left arm (route, strength, dosage schedule, lot # and expiration date were not reported) as prophylaxis. On an unspecified time (In February 2017), after receiving vaccination with ZOSTAVAX, the patient developed a "blistering rash along the backside of the left arm" (rash vesicular).  It was reported that on 04-FEB-2017, the patient was seen by physician assistant for the "blistering rash" and was prescribed a medrol pak and acyclovir as treatment. At the reporting time, the outcome of rash vesicular was unknown. The reporter did not assess causality between the rash vesicular and the vaccination with ZOSTAVAX. There was no product quality complain (PQC) involved.  This is one of two reports from the same reporter. Additional information is not expected as there was no consent to contact.; Sender's Comments: US-009507513-1702USA002822:
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: This spontaneous report was received from the patient's mother concerning a female patient who was 22 years old at the time of the report. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date (reported as when she was teenager), the patient was vaccinated with GARDASIL (lot# and expiration were unknown) 0.5 ml one time for prophylaxis, and the patient started shaking (tremor) and fainted (syncope). At the reporting time, the outcome of the events of tremor and syncope was unknown. The causality between GARDASIL and the events of tremor and syncope was not assessed. Additional information is not expected as no contactable information was provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an adult patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the adult patient was vaccinated with RECOMBIVAX HB 5/0.5 mcrg/ml (anatomical route of vaccination not reported) with a reported lot # M037348 with expiration date on 21-FEB-2019 for prophylaxis (drug administered to patient of inappropriate age). Furthermore, no adverse events were reported and no product quality issue was involved. Additional information is not expected as consent to follow up was not provided.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Diplopia, Ophthalmological examination normal
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old male patient of unspecified race/ethnicity received TRUMENBA (Lot# N11904, Exp date 31Jul2017), via an unspecified route of administration, on 24Oct2016, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced double vision for approximately one week on an unspecified date with outcome of recovered. Patient went to ophthalmologist and the ophthalmologist had no findings.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient report facial swelling the day after receiving influenza high dose.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Influenza, Injection site erythema, Injection site inflammation, Injection site scab
Clinical narrative: Pt. arm became very warm and red, a large area (approx. the size of a large spread out hand)She later developed a scab/hole at the injection site with no signs of infection.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pharyngitis streptococcal, Pneumonia, Skin warm
Clinical narrative: Pt. arm became very warm and red, a large area (approx. the size of a large spread out hand)She later developed a scab/hole at the injection site with no signs of infection.
Age: 25.0
Sex: F
Vaccine: ANTH, HEPAB
Symptoms: CSF test, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: Diagnosed with MS (was directed to report, potential connection?).
Age: 23.0
Sex: F
Vaccine: MEA, TDAP
Symptoms: Haemolytic anaemia
Clinical narrative: Hemolytic anemia.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Incomplete course of vaccination, Injection site pain
Clinical narrative: I received the 2nd dose of my Hep A/B shot. The first time didn't hurt. the second time hurt so much when the needle went in that I yelled. 2 years later my arm still aches at the site. It doesn't hurt all of the time or keep me from doing normal things. It's just a reminder of the shot every time it aches. I didn't complete the 3rd dose because of the previous issue. I've had shots and vaccines before without issue.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swelling and soreness on arm. Flu like symptoms. Pt presented in pharmacy on 2/24/2017 with red arm up from the elbow to shoulder. Patient says it is sore to touch and itchy.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Swelling and soreness on arm. Flu like symptoms. Pt presented in pharmacy on 2/24/2017 with red arm up from the elbow to shoulder. Patient says it is sore to touch and itchy.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Pt presented in clinic,02/23/17 at 4:15pm with complaints of having diarrhea, feeling tired, vomiting and swelling & redness at injection sites, which had resolved by visit on 02/23.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 52 year old female patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 30-JAN-2017, the patient was vaccinated with a dose of RECOMBIVAX HB 5 Microgram (0,5 ml) injection lot # M003658, expiration date 02-JUN-2018 (route was not reported). The patient was mistakenly vaccinated with a pediatric dose of RECOMBIVAX HB as a result of confusion. The reporter stated that the error occurred because "the doses of RECOMBIVAX HB looked similar. No adverse events were reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: This spontaneous report was received from a 77 year old female patient, reporting on herself. The patient did not have pertinent medical history. The patient's drug reactions or allergies included aspirin and oxycodone (PERCODAN), Aspirin, penicillin, and an unspecified medication that used to be used as anesthesia. On 16-DEC-2016, the patient was vaccinated in the physician office with PNEUMOVAX23 (which had the lot # M013156, expiration date unknown) route "injection", to prevent pneumococcal disease (dosage information was not provided). Concomitant medication was reported as "other unspecified". The patient experienced shooting pain around the injection site "quickly, right after the shot". Additionally, her "range of motion" began to decrease about "two days after the shot" and got "progressively worse" (mobility decreased). The patient also said that when she was sleeping, the pain "woke  her up and bothered her". The patient had not seen her physician for treatment, but she was self medicating with unspecified acetaminophen (TYLENOL) and pain cream reported as "methyl salicylate (BENGAY) kind of stuff". It was also reported that laboratory tests were not performed. The patient did not seek medical attention. And there was no product quality complaint. At the time of reporting, the outcome of mobility decreased, vaccination site pain and sleep disorder was not recovered. The causality assessment between the reported events and therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Dyspnoea, Influenza virus test negative, Injection site pain
Clinical narrative: Ssoreness at site, labored breathing, 101.5 temp, cough. Went back to doc today with same. They checked for flu(negative) Said it was reaction to shot. Watch over weekend.