chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray limb
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by other non-health professional via health authority (VAERS ID: 685335) and concerns a 58-years-old adult female patient. The patient's historical condition included high blood pressure and high cholesterol. The concomitant medication included hydrochlorothiazide, citalopram, BELVIQ, valsartan and low dose aspirin. Administration of Company suspect drug: On 30-Dec-2016, the patient received influenza virus vaccine polyvalent, dose, batch number, expiry date and route of administration: not reported) at left arm. Adverse reactions/events and outcomes: On 31-Dec-2016, after administration of INN flu vaccine seasonal, the patient experienced pain at injection site, pain in shoulder, arm and pain radiates to down arm. The patient went to the doctor, the doctor did x-ray of her arm and could not find anything. The doctor stated that the patient did not know the problem. Relevant test: On an unspecified date: X-ray of limb was done and no findings was noted. Action taken with the INN flu vaccine seasonal was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN flu vaccine seasonal. This case was not serious. Significant case correction received on 17-May-2017: Listedness was corrected and as determined causality of the events musculoskeletal pain and pain in extremity was corrected from not related to related.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by other non-health professional via health authority (VAERS ID: 685335) and concerns a 58-years-old adult female patient. The patient's historical condition included high blood pressure and high cholesterol. The concomitant medication included hydrochlorothiazide, citalopram, BELVIQ, valsartan and low dose aspirin. Administration of Company suspect drug: On 30-Dec-2016, the patient received influenza virus vaccine polyvalent, dose, batch number, expiry date and route of administration: not reported) at left arm. Adverse reactions/events and outcomes: On 31-Dec-2016, after administration of INN flu vaccine seasonal, the patient experienced pain at injection site, pain in shoulder, arm and pain radiates to down arm. The patient went to the doctor, the doctor did x-ray of her arm and could not find anything. The doctor stated that the patient did not know the problem. Relevant test: On an unspecified date: X-ray of limb was done and no findings was noted. Action taken with the INN flu vaccine seasonal was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN flu vaccine seasonal. This case was not serious. Significant case correction received on 17-May-2017: Listedness was corrected and as determined causality of the events musculoskeletal pain and pain in extremity was corrected from not related to related.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Influenza, Pyrexia
Clinical narrative: This Spontaneous case, initially received via Health Authority (VAERS ID: 685381) on 05-May-2017 was reported by other non-healthcare professional and concerns a 57-years-old adult female patient. The patient's medical history included arthritis, surgery, gastritis (2015). It was also reported that diarrhea, fever and vomiting there in Dec 2015. In past, the patient had influenza vaccine. Administration of Company suspect drug: On an unspecified date, the patient was administered by INN Flu Vaccine Seasonal, (route of administration: injection NOS, dose, batch number, expiration date: not reported). Indication not reported. The patient also received LYRICA (dose, dose in series, batch number, expiry date, site, route of administration was not reported for both). Adverse events/reactions and outcomes: On 01-Oct-2016, after INN Flu Vaccine Seasonal, the patient experienced flu, fever 100 degrees, vomiting, diarrhea, the patient could not eat much, did not have an appetite, felt very tired and worn out. The action taken after INN Flu Vaccine Seasonal was not reported. The outcome of the events flu and vomiting was reported as recovered/resolved, the outcome of the events fever and diarrhea was reported as recovering/resolving. The outcome of the event felt very tired and worn was reported as not recovered/not resolved and for the event patient could not eat much, did not have an appetite was not reported. Reporter's Assessment: The reporter did not assess the causality between INN Flu Vaccine Seasonal and events was not reported. The event influenza was considered as serious (medically significant). This case report was serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: This Spontaneous case, initially received via Health Authority (VAERS ID: 685381) on 05-May-2017 was reported by other non-healthcare professional and concerns a 57-years-old adult female patient. The patient's medical history included arthritis, surgery, gastritis (2015). It was also reported that diarrhea, fever and vomiting there in Dec 2015. In past, the patient had influenza vaccine. Administration of Company suspect drug: On an unspecified date, the patient was administered by INN Flu Vaccine Seasonal, (route of administration: injection NOS, dose, batch number, expiration date: not reported). Indication not reported. The patient also received LYRICA (dose, dose in series, batch number, expiry date, site, route of administration was not reported for both). Adverse events/reactions and outcomes: On 01-Oct-2016, after INN Flu Vaccine Seasonal, the patient experienced flu, fever 100 degrees, vomiting, diarrhea, the patient could not eat much, did not have an appetite, felt very tired and worn out. The action taken after INN Flu Vaccine Seasonal was not reported. The outcome of the events flu and vomiting was reported as recovered/resolved, the outcome of the events fever and diarrhea was reported as recovering/resolving. The outcome of the event felt very tired and worn was reported as not recovered/not resolved and for the event patient could not eat much, did not have an appetite was not reported. Reporter's Assessment: The reporter did not assess the causality between INN Flu Vaccine Seasonal and events was not reported. The event influenza was considered as serious (medically significant). This case report was serious (medically significant).
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other-non health professional via regulatory authority (VAERS ID: 685589) and concerns a 55-years-old male patient. Patient had historical condition of blood pressure, cholesterol and glaucoma since an unspecified date. Concomitant medications include NORVASC, DIOVAN, simvastatin, latanoprost and multivitamins. Administration of company suspect drug: On 30-Sep-2016, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch no. and expiry date: not reported. Adverse reactions/events and outcomes: On 20-Oct-2016, patient woke up and it was painful to raise arm. It was reported that the pain was radiating from left shoulder. Patient was treated with ADVIL and TYLENOL as needed. On annual visit the physician recommended eight therapy sessions. Physical therapy was helpful but pain was still there, pain level was 7-8/10 when arm was raised. Pain was mild and patient noticed pain when he used to wake up at night. At the time of report shoulder pain still existed. Action taken with the INN flu vaccine seasonal was not reported. Outcome of the events were not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other-non health professional via regulatory authority (VAERS ID: 685589) and concerns a 55-years-old male patient. Patient had historical condition of blood pressure, cholesterol and glaucoma since an unspecified date. Concomitant medications include NORVASC, DIOVAN, simvastatin, latanoprost and multivitamins. Administration of company suspect drug: On 30-Sep-2016, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch no. and expiry date: not reported. Adverse reactions/events and outcomes: On 20-Oct-2016, patient woke up and it was painful to raise arm. It was reported that the pain was radiating from left shoulder. Patient was treated with ADVIL and TYLENOL as needed. On annual visit the physician recommended eight therapy sessions. Physical therapy was helpful but pain was still there, pain level was 7-8/10 when arm was raised. Pain was mild and patient noticed pain when he used to wake up at night. At the time of report shoulder pain still existed. Action taken with the INN flu vaccine seasonal was not reported. Outcome of the events were not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-healthcare professional via regulatory authority (vaccine adverse event reporting system: 685806) and concerns a 67-years-old elderly female patient. The patient's concomitant medication included Zolpidem. Administration of Company suspect drug: On 31-Jan-2017, the patient was administered with FLUAD (egg-derived, mf59, dose: 0.5 ml, batch number: 165703) via intramuscular route at left arm. Non-company suspect drug: On 13-Dec-2016, the patient was administered with PREVNAR 13 (batch number: N47827, dose: not reported) via intramuscular route at right arm. On 13-Dec-2016, the patient was administered with ZOSTAVAX (batch number: M035697, dose: not reported) via subcutaneous route at left arm. Adverse reactions/events and outcomes: On 11-Mar-2017, the patient had experienced swollen and painful arm and no other complaint was reported. Action taken with the influenza vaccine was not reported. Outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between the study vaccine and the events. This report was not serious.
Age: 29.0
Sex: M
Vaccine: FLUX, TYP, FLUX, TYP
Symptoms: Back injury, Fall, Fatigue, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 685841) and concerns a 29-years-old Male patient. The patient's medical history Included: Gilbert's syndrome. Administration of Company suspect drug: On 05-May-2007, the patient was administered with influenza virus vaccine polyvalent (dosage, route of administration, batch number, anatomical location: unknown). Non-company suspect drug: On 05-May-2007, patient was administered with Typhoid vaccine (dosage, route of administration, batch number, anatomical location: unknown). Adverse reactions/events and outcomes: On an unspecified date after administration of INN Flu Vaccine Seasonal and Typhoid vaccine, the patient developed fatigue, upper extremity and lower extremity weakness, paresthesias of arms. About a month after late 2008 or early 2009 immunisation (as reported), evaluation shows symptoms caused by back trauma from a fall, TMJ disorder (Temporomandibular joint syndrome). Action taken with the suspect product was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Age: 29.0
Sex: M
Vaccine: FLUX, TYP, FLUX, TYP
Symptoms: Temporomandibular joint syndrome
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 685841) and concerns a 29-years-old Male patient. The patient's medical history Included: Gilbert's syndrome. Administration of Company suspect drug: On 05-May-2007, the patient was administered with influenza virus vaccine polyvalent (dosage, route of administration, batch number, anatomical location: unknown). Non-company suspect drug: On 05-May-2007, patient was administered with Typhoid vaccine (dosage, route of administration, batch number, anatomical location: unknown). Adverse reactions/events and outcomes: On an unspecified date after administration of INN Flu Vaccine Seasonal and Typhoid vaccine, the patient developed fatigue, upper extremity and lower extremity weakness, paresthesias of arms. About a month after late 2008 or early 2009 immunisation (as reported), evaluation shows symptoms caused by back trauma from a fall, TMJ disorder (Temporomandibular joint syndrome). Action taken with the suspect product was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous case, initially received on 15-Mar-2017, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Past medical history includes egg allergy. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported. Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced severe nausea and vomiting after receiving an unspecified influenza vaccine. Reporter's comments: The pharmacist reported that the patient felt that this was due to the egg content of the unspecified influenza vaccine as the patient felt she had an egg allergy.
Sex: F
Vaccine: HIBV, FLUX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 via vaccine adverse event reaction system (VAERS - 699328) reported by an other non-health professional and concerns a female patient of unknown age. Administration of Company suspect drugs (s): On an unspecified date in 2013 the patient was administered with influenza virus vaccine polyvalent (dosage, frequency, duration, batch number: not reported, route of administration: unknown). Other company suspect drug: On an unspecified date the patient was administered with one other vaccine (dosage, frequency, duration: not reported, route of administration: unknown). Adverse reactions/events and outcomes: On an unspecified date in 2013 after administration of INN Flu Vaccine Seasonal, the patient experienced fever of 103F and vomiting. Action taken with INN Flu vaccine seasonal was not reported and outcome of the events fever, vomiting were recovered. Reporter's Assessment: The other non-healthcare professional had not provided the causality assessment between events fever, Vomiting and INN Flu vaccine seasonal. This report is non-serious.
Sex: F
Vaccine: HIBV, FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 via vaccine adverse event reaction system (VAERS - 699328) reported by an other non-health professional and concerns a female patient of unknown age. Administration of Company suspect drugs (s): On an unspecified date in 2013 the patient was administered with influenza virus vaccine polyvalent (dosage, frequency, duration, batch number: not reported, route of administration: unknown). Other company suspect drug: On an unspecified date the patient was administered with one other vaccine (dosage, frequency, duration: not reported, route of administration: unknown). Adverse reactions/events and outcomes: On an unspecified date in 2013 after administration of INN Flu Vaccine Seasonal, the patient experienced fever of 103F and vomiting. Action taken with INN Flu vaccine seasonal was not reported and outcome of the events fever, vomiting were recovered. Reporter's Assessment: The other non-healthcare professional had not provided the causality assessment between events fever, Vomiting and INN Flu vaccine seasonal. This report is non-serious.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PAIN, TENDERNESS, AND SWELLING AT THE INJECTION SITE AND 8 INCHES AROUND THE INJECTION SITE.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Insomnia, Rash
Clinical narrative: Difficulty breathing, sleeping, rash.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Given.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Hives on Arms and Legs. Not on Trunk. Vital signs WNL. Feet purple but quickly resolved.  No other symptoms.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm with Severe swelling, redness, tenderness, patient states it is "hot" to touch in deltoid region where Anthrax vaccine was administered. Pt has limited mobility in Right arm. Pain is radiating down right arm and shoulder.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of DTaP/IPV and MMR/V given.  Child was here for 4 yo WCC but clinic did not realize she had come in January for a nurse visit for the same vaccines.  No adverse symptoms noted at this time.  Mom informed once duplication error was noted (soon after admin).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception
Clinical narrative: Diagnosed with intussusception on 6/27/17.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received TRUMENBA on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness and arm swelling, both on an unspecified date after vaccination, with unknown outcome.
Sex: U
Vaccine: PNC13
Symptoms: Pathogen resistance, Pneumonia pneumococcal, Surgery
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported that a child of unspecified age, gender and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was up to date and still got invasive pneumococcal pneumonia and had emergency surgery. Head of infectious disease said that the bacteria had mutated and became antibiotic resistant because of the pneumococcal vaccine. No follow-up attempts possible. No further information expected.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Chills, Dyspnoea, Headache, Malaise
Clinical narrative: After 3rd dose in series, patient experienced fever, chills, headache, abdominal pain, shortness of breath and general malaise.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: After 3rd dose in series, patient experienced fever, chills, headache, abdominal pain, shortness of breath and general malaise.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Blood glucose increased, Condition aggravated, Headache, Nodule, Pain in extremity
Clinical narrative: I received a DTaP vaccine on 6/19/2017 and within 24 hours my arm had developed a golf ball sized know that is very painful and warm to the touch. I also have a severe headache and 100.9 fever. I am type 1 diabetic and the last 36 hours, my blood sugars have been above 350.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Skin warm, Type 1 diabetes mellitus
Clinical narrative: I received a DTaP vaccine on 6/19/2017 and within 24 hours my arm had developed a golf ball sized know that is very painful and warm to the touch. I also have a severe headache and 100.9 fever. I am type 1 diabetic and the last 36 hours, my blood sugars have been above 350.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Feeling hot, Flushing, Headache, Injection site erythema, Pain
Clinical narrative: Patient complained that the same night after she got the vaccine she ran a fever (did not take but stated she was very hot), had a headache, felt flushed, and actually stayed home from school the next day. One week later, the injection redness was gone, but patient still has soreness to her arm with movement or lifting.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient complained that the same night after she got the vaccine she ran a fever (did not take but stated she was very hot), had a headache, felt flushed, and actually stayed home from school the next day. One week later, the injection redness was gone, but patient still has soreness to her arm with movement or lifting.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Arthralgia, Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling in arm where shot was given, then pain and swelling continued in other joints all over her body, couldn't sleep, couldn't walk, couldn't dress herself - was told by doctor's office to take ADVIL and BENADRYL but this didn't help much. Went back to Doctor and made several calls to doctor. Pain and swelling continued. Was referred to a Rheumatologist and this doctor said vaccine could have brought this out in her. Diagnosed her with Rheumatoid Arthritis. Nodules formed on her lymph nodes and had to go through series of tests to see what it was. Also had to stay in the hospital overnight. Now is getting infusions every six months to help with the arthritis. Was never sick before having this vaccine, and now feels bad most of the time. Has never been the same since having this vaccine.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Joint swelling, Laboratory test, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: Pain, swelling in arm where shot was given, then pain and swelling continued in other joints all over her body, couldn't sleep, couldn't walk, couldn't dress herself - was told by doctor's office to take ADVIL and BENADRYL but this didn't help much. Went back to Doctor and made several calls to doctor. Pain and swelling continued. Was referred to a Rheumatologist and this doctor said vaccine could have brought this out in her. Diagnosed her with Rheumatoid Arthritis. Nodules formed on her lymph nodes and had to go through series of tests to see what it was. Also had to stay in the hospital overnight. Now is getting infusions every six months to help with the arthritis. Was never sick before having this vaccine, and now feels bad most of the time. Has never been the same since having this vaccine.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Rheumatoid arthritis
Clinical narrative: Pain, swelling in arm where shot was given, then pain and swelling continued in other joints all over her body, couldn't sleep, couldn't walk, couldn't dress herself - was told by doctor's office to take ADVIL and BENADRYL but this didn't help much. Went back to Doctor and made several calls to doctor. Pain and swelling continued. Was referred to a Rheumatologist and this doctor said vaccine could have brought this out in her. Diagnosed her with Rheumatoid Arthritis. Nodules formed on her lymph nodes and had to go through series of tests to see what it was. Also had to stay in the hospital overnight. Now is getting infusions every six months to help with the arthritis. Was never sick before having this vaccine, and now feels bad most of the time. Has never been the same since having this vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Local reaction of redness, slightly raised, warm to touch, roughly 3 inches in diameter. No pain or itching per patient.
Age: 22.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Fall
Clinical narrative: FELT LIGHTHEADED AND FELL BUT STATED WAS NOT SURE IF IT WAS FROM SHOTS OR BECAUSE HE HAD NOT EATEN YET TODAY.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.   The patient experienced vaccination hurts a lot more than other vaccinations on an unspecified date with outcome of unknown.
Sex: F
Vaccine: IPV
Symptoms: Multiple sclerosis
Clinical narrative: Initial unsolicited social media report received from a consumer (patient) via other company on 20-Jun-2017. This case involves a female patient (age not reported), who was vaccinated with IPV (VERO) (IPOL) (batch number, expiry date, dose, dose in series and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unspecified date, following the vaccination patient developed multiple sclerosis. Laboratory investigation and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: multiple sclerosis. List of the documents held by sender: none.; Sender's Comments: Multiple sclerosis was reported following IPOL vaccine however diagnosis was not confirmed. Exact time to onset is unknown. More details regarding patient's medical history, concurrent condition, exact time to onset, history of viral infection before vaccination, history of autoimmune disease and investigation reports would be helpful for the complete assessment of the case. Based on the available information no conclusion can be drawn.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Pain in extremity, Somnolence
Clinical narrative: 45 Minutes after shot=dizzy, drowsy, painful arm. Day after shot=no ADR. 1 week after shot=painful arm. Today=no ADR
Age: 4.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Muscle twitching, Urinary incontinence
Clinical narrative: Right shoulder began involuntarily twitching the day after she received the flu vaccine and has been continuous. Mother states that urinary incontinence has also worsened.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Bruxism, Immediate post-injection reaction, Pyrexia, Restlessness, Seizure
Clinical narrative: She received MMR, dTAP, Hep B, and HIb vaccine at the same time. Immediately following, she had a seizure that lasted 1.5 minutes. Since then, she has developed facial ticks, teeth grinding, and restlessness. She also had a fever of 102 degrees F 3 days after that lasted 3 days.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Tic
Clinical narrative: She received MMR, dTAP, Hep B, and HIb vaccine at the same time. Immediately following, she had a seizure that lasted 1.5 minutes. Since then, she has developed facial ticks, teeth grinding, and restlessness. She also had a fever of 102 degrees F 3 days after that lasted 3 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Migraine
Clinical narrative: Pt developed migraine headaches.
Age: 16.0
Sex: M
Vaccine: HEP, HPV4, IPV, MNQ, TD
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Patient arrived for vaccine visit. No concerns were voiced. Patient sat on bed and was administered 5 vaccines: Hep B, IPV, MENACTRA, Td and HPV. HPV was administered last. After the HPV vaccine was administered, the patient fainted. Patient was laid down on the bed and was unresponsive for 15-20 seconds. The nurse assessed the patient and vital signs were: BP 108/76, O299%, P67. Pt was oriented x3. No fall or injury was noted. patient felt better and ready for discharge. 30 minutes after HPV administration Patient reported to CMA that he was nervous and hadn't eaten.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood glucose normal, Cold sweat, Cyanosis, Unresponsive to stimuli
Clinical narrative: 6/23/17 - 10:00 AM Adm. vac. PREVNAR 13 and PENTACEL (DTAP-IPV-HIB). 10:05 - Mom states baby (R) leg with blue. Baby unresponsive and in cold sweat. Dr. exam baby - glucose 123 - HR 110-90 - Resp 16-24. Baby responding to stimuli. EMS called. Baby sent.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Patient informed nurse on 06/21/2017 that she experienced same tingling bilaterally in hands after receiving Rabies vaccine on 06/14/17. Stated tingling was first noted on 06/15/17.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscle contractions involuntary, Muscle spasms
Clinical narrative: This spontaneous case, initially received on 14-APR-2017, was reported by other health professional (physician) and concerns a 82-years-old female elderly patient. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date: not reported, batch number: 1515901, anatomical location: left arm and route of administration: intramuscular route). Non-company suspect drug: On 21-Dec-2015, the patient received PREVNAR (dose number: 1, dosage: 0.5 ml, batch number: M27767, expiry date: illegible, anatomical location: right arm and route of administration: intramuscular route). Adverse reactions/events and outcomes: On 21-Dec-2015, after administration of suspect vaccine, the patient still had a constant pain at the injection site, immobile right arm with associated symptoms, no used of her right arm, losing function in her arm, she could not use her right arm and could not move her arm past her head, spasms, swollen arm, muscle contraction. She did not have any feeling in her right arm and muscle was constantly hurting. Action taken with the vaccine was not reported. Outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. The reporter assessed the causality of the events considered to be related to the pneumococcal vaccine. This report was not serious.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 14-APR-2017, was reported by other health professional (physician) and concerns a 82-years-old female elderly patient. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date: not reported, batch number: 1515901, anatomical location: left arm and route of administration: intramuscular route). Non-company suspect drug: On 21-Dec-2015, the patient received PREVNAR (dose number: 1, dosage: 0.5 ml, batch number: M27767, expiry date: illegible, anatomical location: right arm and route of administration: intramuscular route). Adverse reactions/events and outcomes: On 21-Dec-2015, after administration of suspect vaccine, the patient still had a constant pain at the injection site, immobile right arm with associated symptoms, no used of her right arm, losing function in her arm, she could not use her right arm and could not move her arm past her head, spasms, swollen arm, muscle contraction. She did not have any feeling in her right arm and muscle was constantly hurting. Action taken with the vaccine was not reported. Outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. The reporter assessed the causality of the events considered to be related to the pneumococcal vaccine. This report was not serious.
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine, Memory impairment
Clinical narrative: This spontaneous case, initially received on 20-Apr-2017 was reported by a other non-health professional and concerns a male patient of unknown age. Administration of Company suspect drug (s): On an unspecified date the patient was administrated with INN Flu Vaccine Seasonal (dosage, batch number, route of administration not reported). Patient was administered with GILENYA (dosage: 0.5mg, oral route, daily) on an unspecified date in 2015 and noticed increase in forgetfulness. Patient had FLAGYL, permethrin, pneumococcal vaccine, PROZAC allergies. Patient concomitant medications include baclofen, CHANTIX, gabapentin, GILENYA, vitamin b12, ZOLOFT. Adverse reactions/events and outcomes: It was reported that the patient had allergy to vaccine. Reporter's Assessment: The other non-health professional did not provide any assessment between the event and suspect vaccine. Causality was not reported.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Swelling
Clinical narrative: Swelling, joint pain.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Patient informed nurse on 06/21/2017 that she experienced some tingling bilaterally in hands after receiving Rabies vaccine on 06/14/17. Stated tingling was first noted on 06/15/17.
Age: 1.67
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 103.1 taken rectally so far on and off for 3 days.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: My daughter got the live Chickenpox vaccine and two weeks later, woke up with many small red bumps on her legs (thighs), back, torso. Some were raised, others were not. The redness went away but ever since, she has small raised skin-colored bumps all over skin. She had NEVER had any bumps on her skin prior to this shot.
Age: 65.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Erythematous raised patch 3X5 inches with firmness and tenderness to palpation on left arm.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient developed rash on her body.
Sex: F
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: This spontaneous case, initially received on 17-APR-2017 (combined report) was reported by other-health professional and concerns a female patient of an unspecified age and gender. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). Non-company suspect drug: On an unspecified date, the patient received TRILEPTAL (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On unspecified date after administration of influenza vaccine and oxcarbazepine, the patient experienced a seizure. Action taken with the suspect vaccine was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality of the event in relation to the influenza vaccine. This case was non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHEH2017US008279, is an initial spontaneous report received from a consumer on 17 May 2017. This report refers to a years old male patient. Historical condition was not reported. Past medications included HUMIRA and ENBREL. Current condition included psoriasis. Concomitant medication was not reported. The patient received Influenza virus vaccine Seasonal INN (manufacture unknown, batch number not reported) on an unknown date, recently. After receiving flu shot the patient got sick for period of time. Outcome oft he event was unknown. Seriousness of the event and causality was not reported.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: WITHIN HOURS OF RECEIVING IMMUNIZATION, PATIENT BEGAN TO EXPERIENCE FEVER (102+), CHILLS, HEADACHES AND MALAISE. INJECTION SITE BECAME SWOLLEN AND SORE. SYMPTOMS PERSISTED THROUGH THE WEEKEND. ON 6/27/2017 SHE WAS EVALUATED AND TREATED WITH PREDNISONE. TO BE SEEN AGAIN 6/30/2017.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: WITHIN HOURS OF RECEIVING IMMUNIZATION, PATIENT BEGAN TO EXPERIENCE FEVER (102+), CHILLS, HEADACHES AND MALAISE. INJECTION SITE BECAME SWOLLEN AND SORE. SYMPTOMS PERSISTED THROUGH THE WEEKEND. ON 6/27/2017 SHE WAS EVALUATED AND TREATED WITH PREDNISONE. TO BE SEEN AGAIN 6/30/2017.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain upper, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Initially "not feeling well." Then became nauseated, stomach ache, headache, lightheaded, vomited once, and developed fever (102.4F tympanic in office the next day).
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initially "not feeling well." Then became nauseated, stomach ache, headache, lightheaded, vomited once, and developed fever (102.4F tympanic in office the next day).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site vesicles
Clinical narrative: Lt arm blister 8mm x 5mm.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Sitting in the chair about 15 min after vaccine was administered and he had a seizure.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Peripheral swelling, Rash, Vaccination site swelling
Clinical narrative: Woke up 6/23/17 with swollen hands and feet, especially fingers. "Looks like he gained 10 pounds." Denies any SOB/dyspnea. Sites where vaccines were administered were without redness or local swelling. Left arm (where 2 vaccines were administered) had increased swelling than the right. Doctor ordered BENADRYL, CLARITIN, and Ranitidine. Symptoms resolved and then 2 days later developed bumps on his face which resolved after swimming.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain lower, Abdominal pain upper, Pollakiuria
Clinical narrative: Came into the clinic 4/19/17 to get travel vaccines. Got Typhoid pills. Started taking them 5/1/17. Then on 5/3/17 called to c/o severe stomach pains that started 5/2/17 and continued to be bad. Lower right abd pain and c/o very frequent urination. Instructed to call her doctor to be seen to rule out other cause. Next day, mother called back and said the doctor did not see her, over the phone he said it was related to the typhoid pills and instructed her to continue them. She took the second dose on 5/3/17. Then on 5/8/17 called--stopped oral typhoid after dose #2 due to severe symptoms as listed above. Symptoms resolved 5/6/17 evening. No treatment for symptoms.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient has redness, swelling, heat and stiffness at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has slight swelling and tenderness at injection site it is also itchy 3 days later.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash generalised, Rhinorrhoea
Clinical narrative: Red raised rash all over body, runny nose, not feeling well. Spot around belly button was large and swollen. Went to the doctor and got antihistamine and was recommended oatmeal baths and lotion. On 6/28 some of the rash was better but it had spread and worsened on face and back. After nap in the PM child had over 104° fever. Gave ibuprofen and fever went down over a couple of hours.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Swelling
Clinical narrative: Red raised rash all over body, runny nose, not feeling well. Spot around belly button was large and swollen. Went to the doctor and got antihistamine and was recommended oatmeal baths and lotion. On 6/28 some of the rash was better but it had spread and worsened on face and back. After nap in the PM child had over 104° fever. Gave ibuprofen and fever went down over a couple of hours.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: She complained of sore and red arm, then it became so painful 4 hrs later that she went to the ER. She was given prednisone and cetirizine after the ER visit and felt better 2 days later.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2017US005958, is an initial spontaneous report received from a consumer via Merck on 24 Feb 2017. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza virus vaccine INN (unknown whether seasonal or pandemic) on an unspecified date. On an unknown date, the patient developed Guillain-Barre syndrome. The outcome of the event Guillain-Barre syndrome was unknown. The seriousness and causality of the event Guillain-Barre syndrome was not reported. The seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on the Novartis Important Medical Events list.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Condition aggravated, Foaming at mouth, Pyrexia, Seizure
Clinical narrative: Having seizures, incontinent of urine foaming at the mouth, fever with temp up to 103, and no memory of the 3 days of symptoms! (Husband stayed with her, gave her clear liquids and medications.)
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Urinary incontinence
Clinical narrative: Having seizures, incontinent of urine foaming at the mouth, fever with temp up to 103, and no memory of the 3 days of symptoms! (Husband stayed with her, gave her clear liquids and medications.)
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Redness, swelling with localized moderate inflammatory reaction - to left thigh.
Age: 55.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Burning sensation, Pain, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: About a week after the vaccines, I broke out with red spots. They were itchy, stinging, and burning. Then when they started to leave, a few were replace with itchy whelps. Especially on right arm.
Age: 55.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: About a week after the vaccines, I broke out with red spots. They were itchy, stinging, and burning. Then when they started to leave, a few were replace with itchy whelps. Especially on right arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient experienced bumpy, red rash around site of injection that lasted approximately one week.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Decreased appetite, Dizziness, Paraesthesia, Somnolence
Clinical narrative: Vaccine received: 6/24/17. Reactions began: 6/26/17. Drowsiness, faint-feeling, tingling, lightheadedness, loss of appetite - taken to ER on 6/26/17.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Faint.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Accidental extra vaccines given due to inaccurate vaccine records provided by mother. Mother stated child had not received 4yr old vaccines and records verified that. Day after vaccines given additional records received that indicated all vaccines were up to date and those given 6/26/17 were extra.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Accidental extra vaccines given due to inaccurate vaccine records provided by mother. Mother stated child had not received 4yr old vaccines and records verified that. Day after vaccines given additional records received that indicated all vaccines were up to date and those given 6/26/17 were extra.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patient received Hepatitis B - adult - Lot number BX2X3, GlaxoSmithKline, exp 7/13/19 IM (L) deltoid on 3/7/17. Pt. returned to clinic on 6/19/17 and reported her (L) arm swelled and had hives after injection on 3/7/17.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Left arm swollen a little at injection site, last for 3-4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Erythema, Headache, Induration, Peripheral swelling
Clinical narrative: Deltoid doubled in size hard, red, swelling, headache and temp.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Pt received routine vaccines 6/27/17 at 11yo physical in office. Following administration Pt. with multiple hives to upper (RT) arm distally. Area with positive warmth; no induration; no resp. S/S or N/V. Gave PO BENADRYL and monitored status x30 min. plus. Improved 6/28/17 per mom=all S/S have resolved.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Skin warm, Tremor
Clinical narrative: Chills, shaking - possible fever first symptoms that night. Next day examined at clinic red hot area over majority of upper arm. Continued to spread and have should joint pain area. Antibiotics and prednisone ordered.
Age: 0.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt had a mild fever of 100.4, Pt treated with TYLENOL.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased
Clinical narrative: 2 red lines around arm. Unable to move shoulder for 1-2 days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen arm (left) below injection site and around elbow. Icepacks, BENADRYL, ADVIL.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling on right deltoid (vaccination site), redness, sharp pain.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling on right deltoid (vaccination site), redness, sharp pain.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHEH2017US005869, is an initial spontaneous report received from a consumer on 23 Feb 2017. This report refers to a female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine unknown INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced flu. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. Consent to contact was not provided.