chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient still complaining of dull pain in left arm, cannot pinpoint exact place, says it internal and generally all over. More painful after sleeping on it over night.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling in the injection site the following day after the vaccination. He had no pain or fever and did not take any medication to alleviate the symptoms. He came back to the pharmacy 4 days after the vaccination 11/29/17 but the redness and swelling has already significantly subsided and was advised to see his doctor if the situation get worse or does not improve.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test normal, Burning sensation, Chest X-ray normal, Chest discomfort
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Diplopia, Dizziness, Dyspnoea, Echocardiogram normal
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Fatigue, Gait inability, Headache, Hypoaesthesia
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Paraesthesia
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Quality of life decreased, Seizure like phenomena, Tremor, Urine analysis normal, Vision blurred
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Walking aid user
Clinical narrative: My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Eye swelling, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient complains of swelling/pain to left arm at injection site. Also having generalized body aches, swelling to his face and eyes. Symptoms started day of vaccination, one hour after administration. Patient waited at home to see if symptoms would improve, presented to ER 1 day later. Patient took no over the counter medications at home. Received IM TORADOL 30 mg and IM BENADRYL 50 mg. After administration of medications, patient reported relief of angioedema and pain.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: Patient complains of swelling/pain to left arm at injection site. Also having generalized body aches, swelling to his face and eyes. Symptoms started day of vaccination, one hour after administration. Patient waited at home to see if symptoms would improve, presented to ER 1 day later. Patient took no over the counter medications at home. Received IM TORADOL 30 mg and IM BENADRYL 50 mg. After administration of medications, patient reported relief of angioedema and pain.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site reaction, Muscular weakness
Clinical narrative: Weakness in left bicep and forearm -- has not improved since onset. Slight numbness.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and a registered nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 30-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 for prophylaxis, lot # M027552, expiry date: 04-FEB-2018 (dose and route were unknown). No adverse effects were reported. The temperature and time frame were as follows: 0°C to 1°C (1.4°C) for 17 hours and 21 minutes.  A previous temperature excursion was reported from 0°C to 1°C for 1 hour and 12 minutes. The call was because "data logger": Yes. On 07-NOV-2017, the registered nurse reported she had notified the manufactory about the temperature variation and they deemed that the vaccine was still viable.
Age: 11.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an 11 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-NOV-2017, the patient might have received a dose of PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # N014946 and expiration date 01-FEB-2019, instead of the prescribed dose of GARDASIL 9 (route, dose, frequency, and anatomical location were unknown) with lot # M041212 and expiration date 21-JUN-2019 for prophylaxis. The patient, was scheduled to receive the second dose of GARDASIL 9 in the 2 dose vaccination series. The nurse reported that GARDASIL 9 and the PNEUMOVAX 23 were not incorrectly administered due to product confusion, but that the vaccines may have been inadvertently administered to the wrong patient. No adverse effects reported. The is one of two cases from the same reporter. Sender's Comments: US-009507513-1711USA010364.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. 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 improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6F 14F for 76 minutes and in between 15F to 46F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. 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 improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6F 14F for 76 minutes and in between 15F to 46F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as "about 10 years ago" and before 65 years of age), the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). It could not be confirmed if the vaccine was Merck product. On 15-NOV-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # N011305 (dose and route of administration were not reported) for prophylaxis. The pharmacist was not aware of the administration of the previous dose. No adverse reaction was reported.
Age: 54.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an 54 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-NOV-2017, the patient might have received a dose of GARDASIL 9 (route, dose, frequency, and anatomical location were unknown) with lot # M041212 and expiration date 21-JUN-2019 instead of the prescribed dose of PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # N014946 and expiration date 01-FEB-2019 for prophylaxis. The nurse reported that GARDASIL 9 and the PNEUMOVAX 23 were not incorrectly administered due to product confusion, but that the vaccines might have been inadvertently administered to the wrong patient. No adverse effects reported. The is one of two cases from the same reporter. Sender's Comments: US-009507513-1711USA001333.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Narcolepsy, Quality of life decreased
Clinical narrative: Based on information received on 15 Nov 2017, the product code has been amended from 448 (MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE) to 449 (MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE). SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 15 Nov 2017. This case involves patient (age and gender were not reported) who was vaccinated with a dose of MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE (batch number, expiry date, route and site of administration were not reported) on an unspecified date in 2009. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination, patient got developed narcolepsy which ruined patient's life. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: Narcolepsy. List of documents held by sender: none. Addendum: 29 Nov 2017. The product code has been amended from 448 (MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE) to 449 (MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE). Sender's Comments: Patient experienced Narcolepsy after vaccination. Time to onset is not known. However, further information including patient's medical history, time to onset, details of the progression of narcolepsy, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching and hives to chest, back and face, redness to face and scalp. No wheezing or airway compromise. BENADRYL was given.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Blood test, Injection site reaction, Periarthritis, X-ray
Clinical narrative: Frozen shoulder in right shoulder - site of flu shot.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Arthralgia, Nausea, Urticaria
Clinical narrative: Nausea began approx. 3 hours after the vaccine was given. Later that night around 10 hours post-vaccine the joints in my hands began to ache severely (like arthritis). The next day the nausea became extremely severe, and approx. 36 hours after vaccination I developed hives on my eyelids.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Arthralgia, Erythema, Nausea, Oedema, Periorbital oedema
Clinical narrative: Nausea began approx. 3 hours after the vaccine was given. Later that night around 10 hours post-vaccine the joints in my hands began to ache severely (like arthritis). The next day the nausea became extremely severe, and approx. 36 hours after vaccination I developed hives on my eyelids.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Pruritus
Clinical narrative: Nausea began approx. 3 hours after the vaccine was given. Later that night around 10 hours post-vaccine the joints in my hands began to ache severely (like arthritis). The next day the nausea became extremely severe, and approx. 36 hours after vaccination I developed hives on my eyelids.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Arthralgia, Nausea, Urticaria
Clinical narrative: 2 days after vaccination, employee developed: sensation of body itching with few areas of erythema/edema on back and chest, and bilateral periorbital skin around the eyes- mild erythema and edema, and painful arthritis type pain sensation in all fingers and both hands joints, and nausea.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Arthralgia, Erythema, Nausea, Oedema, Periorbital oedema
Clinical narrative: 2 days after vaccination, employee developed: sensation of body itching with few areas of erythema/edema on back and chest, and bilateral periorbital skin around the eyes- mild erythema and edema, and painful arthritis type pain sensation in all fingers and both hands joints, and nausea.
Age: 29.0
Sex: F
Vaccine: FLUR3, FLUR4
Symptoms: Pruritus
Clinical narrative: 2 days after vaccination, employee developed: sensation of body itching with few areas of erythema/edema on back and chest, and bilateral periorbital skin around the eyes- mild erythema and edema, and painful arthritis type pain sensation in all fingers and both hands joints, and nausea.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Blood pressure increased, Blood urine present, Fatigue, Feeling jittery
Clinical narrative: Within 4 hours of receiving flu vaccine, patient experienced "jitteriness and shaking", also had increased blood pressure and heart rate per school nurse. Unable to obtain complete blood pressure reading at our office due to shaking, systolic = 104, unable to hear diastolic. Heart rate not recorded. Given MOTRIN and BENADRYL in office, in the evening given a dose of hydroxyzine.  Slept most of the afternoon and most of the evening, tired on the morning of 10/11/17, but no longer having tremors.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Full blood count normal, Heart rate increased, Tremor, Urine analysis abnormal
Clinical narrative: Within 4 hours of receiving flu vaccine, patient experienced "jitteriness and shaking", also had increased blood pressure and heart rate per school nurse. Unable to obtain complete blood pressure reading at our office due to shaking, systolic = 104, unable to hear diastolic. Heart rate not recorded. Given MOTRIN and BENADRYL in office, in the evening given a dose of hydroxyzine.  Slept most of the afternoon and most of the evening, tired on the morning of 10/11/17, but no longer having tremors.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyskinesia, Pain in extremity
Clinical narrative: Patient reported some odd body jerking that night when she laid down to go to bed. Also some arm soreness which I told her was normal.
Age: 40.0
Sex: M
Vaccine: ANTH, FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt states site of injection became warm and red with slight swelling. Pt states pain was worse than normal pain from anthrax vaccine and that prompted him to look at the site. Pt states no noted rash/hives, fever or chills. Pt states he used a hot compress on the site to reduce swelling and pain and this did help. Pt states the redness has gone away and swelling has gone down since using warm compress on the site.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a 53-year-old female patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018). Previously administered products included flu vaccine. Concomitant products included Hydrochlorothiazide, Lisinopril, SYNTHROID and vitamin C + D. On 21st November 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 21st November 2017, 15 min after receiving FLUARIX QUADRIVALENT, the patient experienced lip swelling (serious criteria other: as per reporter) and facial swelling (serious criteria other: as per reporter). The patient was treated with BENADRYL, MEDROL and PEPCID. In November 2017, the outcome of the lip swelling and facial swelling were recovered/resolved. The reporter considered the lip swelling and facial swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no allergy to medicines. The patient was on her concomitant medicines for years and took her regular medicine earlier on the day of vaccination. On the same day, 15 minutes after receiving FLUARIX QUADRIVALENT, the patient's lips began to swell and her face began to swell about an hour after the vaccination. The patient took BENADRYL 25 mg immediately and the next morning she also took a MEDROL dose pack. The patient continued to take her BENADRYL as well as PEPCID. The patient's condition improved after the 3rd day. The patient required emergency room visit. The patient normally takes a flu vaccine, but this might have been the first time that she took FLUARIX.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Local reaction, Rash
Clinical narrative: Patient received PNEUMOVAX in his left deltoid at primary care visit on 10/2/17. Patient had scheduled dermatology appointment 2 days later (10/4/17), where it was observed that he had a local injection site reaction to the vaccine. The reporter states the patient had erythema and tenderness at injection site.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was reporting on himself. The patient did not provide any information regarding concomitant medications, pertinent medical history, drug reactions or allergies. On 30-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not provided) for prevention of pneumonia. On 31-OCT-2017, the patient experienced severe pain in the arm near the injection site. The patient did not seek medical attention. No treatment was given for the adverse event. The patient did not have a fever and reported that there was no swelling at the injection site. The outcome of adverse event was reported as not recovered. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. No product quality complaint was reported.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Contusion, Injection site bruising, Injection site pain, Pruritus, Tenderness
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A 71-year-old female patient received, on 31Oct2017 (between 11:15 am and 11:30 am), the first dose of PREVNAR 13, (Lot. S58702, Expiration date: Aug2019, NDC number: 00005197102) intramuscularly, in the left deltoid, at single dose for immunization. Relevant medical history included high blood pressure, high cholesterol, chronic obstructive pulmonary disease (COPD), and arthritis. The patient experienced rashes in the past from bandages and tape. She was not sure if it was a latex allergy. The patient previously received, without any problems, FLUZONE on an unspecified date, in Nov2016, for immunization. Concomitant medications included oral alprazolam (tablet) 0.25 mg three times daily as needed from an unspecified date and ongoing; oral enalapril (tablet) 20 mg from 14Mar2014 and ongoing; oral atorvastatin (tablet) 40 mg, once daily from 14Mar2014 and ongoing; oral SYNTHROID, tablet 125 ug, once daily, from 29Apr2015 and ongoing; oral metoprolol tartrate (tablet) 100 mg, twice daily, from 02Dec2015 (dose was increased from 50 mg, one tablet twice a day, to 50 mg, two tablets twice a day. The pharmacist did not know the reason the dose was increased); and FLUZONE, (manufacturer: Sanofi Pasteur, Lot. UI877AA, Expiration date: 17May2018, NDC: 4928140188), received intramuscularly, in the left deltoid, at single dose, on 31Oct2017, for immunization. On 01Nov2017, the patient experienced severe bruising, tenderness, and itching. No treatment was received. The patient recovered from the adverse events on an unspecified date, in Nov2017. The events severe bruising and tenderness were assessed as serious (Medically Significant), while itching as non-serious. Sender's Comments: Current information is limited for fully medical assessment regarding the serious events of severe bruising and tenderness, especially lack of clinical course on the locations and the accompanying symptoms and the alternative etiology such as fall/trauma. Considering the close time association, bruising and pain at the vaccination site are the expected adverse events following the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the 1st of 2 reports. A female patient in their 70s received PREVNAR 13, intramuscular, on an unspecified date, at 0.5 ml single, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain and achiness in arm and severe cellulitis both on an unspecified date. The patient went to the doctor who prescribed Bactrim. Outcome of the events was unknown. The reporter assessed the events as medically significant and related to pneumococcal 13-val conj vac (dipht crm197 protein). The lot# has been requested.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of cellulitis and pain in arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate., Linked Report(s) : US-PFIZER INC-2017512485 Same reporter/drug/event, different patient.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Burning sensation, Chills, Dizziness, Feeling abnormal
Clinical narrative: Patient reports less than 24 hours after injection she developed a fever, chills, dizziness, arm pain and rash at the site. Father states her temp was 101 at the highest and never went below 100.2. That evening at bedtime she seemed to be having hallucinations, saying she was in an Indian tribe. Patient states when she went to cheer practice on Wed 11/29 she felt out-of-it and almost passed out. The left arm rash has worsened and spread from the injection site and today 11/30 now covers almost the whole upper arm. Pain is reported as 9/10 and described verbatim as 'it feels like my muscles are moving, and every time I try to lift my arm, it feels like balls of tissue rolling in the arm, and a burning sensation in the shoulder'. Patient also has limited mobility of left arm with mild weakness on left side.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hallucination, Hemiparesis, Injected limb mobility decreased, Injection site rash, Pain in extremity
Clinical narrative: Patient reports less than 24 hours after injection she developed a fever, chills, dizziness, arm pain and rash at the site. Father states her temp was 101 at the highest and never went below 100.2. That evening at bedtime she seemed to be having hallucinations, saying she was in an Indian tribe. Patient states when she went to cheer practice on Wed 11/29 she felt out-of-it and almost passed out. The left arm rash has worsened and spread from the injection site and today 11/30 now covers almost the whole upper arm. Pain is reported as 9/10 and described verbatim as 'it feels like my muscles are moving, and every time I try to lift my arm, it feels like balls of tissue rolling in the arm, and a burning sensation in the shoulder'. Patient also has limited mobility of left arm with mild weakness on left side.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Patient reports less than 24 hours after injection she developed a fever, chills, dizziness, arm pain and rash at the site. Father states her temp was 101 at the highest and never went below 100.2. That evening at bedtime she seemed to be having hallucinations, saying she was in an Indian tribe. Patient states when she went to cheer practice on Wed 11/29 she felt out-of-it and almost passed out. The left arm rash has worsened and spread from the injection site and today 11/30 now covers almost the whole upper arm. Pain is reported as 9/10 and described verbatim as 'it feels like my muscles are moving, and every time I try to lift my arm, it feels like balls of tissue rolling in the arm, and a burning sensation in the shoulder'. Patient also has limited mobility of left arm with mild weakness on left side.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: C-reactive protein, Full blood count, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Suspected SIRVA -Patient presented to me November 29, 2017 complaining of inability to move her left shoulder in full range of motion as well as severe shoulder pain since the vaccine October 17, 2017. She reports she thought it was just the "normal soreness" she would get after a vaccine but the pain only worsened and the limitation in range of motion became more apparent. She began taking 800 mg ibuprofen which did not help. She reports the pain felt like something was tearing inside her shoulder any time she moved her shoulder. She has had difficulty sleeping due to the pain. On exam yesterday her left shoulder had a normal appearance without erythema, warmth or swelling. Her active range of motion of teh left shoulder was greatly decreased with minimal ability to internally rotate, moderately decreased external rotation, abduction to 90°, and forward flexion to approximately 100°  and all with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. Her left shoulder was tender to palpation shoulder anteriorly and laterally. Her right shoulder was normal with full range of motion and no tenderness to palpation. Range of motion of her cervical spine was intact as well. There was no muscle atrophy noted. Abduction strength was decreased due to pain but otherwise motor strength was intact in both upper extremities. Her arms were neurovascularly intact. No rashes were noted. I sent her for an x-ray and started her on a Medrol Dosepak. I advised her to stop the ibuprofen while on the Medrol Dosepak and provided her with tramadol to help with the pain. I asked her to call me if the tramadol was not  enough to control her pain and advised her I would start on her on hydrocodone if needed. I also provided her with a referral for physical therapy.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Insomnia, Limb injury, Metabolic function test, Muscular weakness, Pain
Clinical narrative: Suspected SIRVA -Patient presented to me November 29, 2017 complaining of inability to move her left shoulder in full range of motion as well as severe shoulder pain since the vaccine October 17, 2017. She reports she thought it was just the "normal soreness" she would get after a vaccine but the pain only worsened and the limitation in range of motion became more apparent. She began taking 800 mg ibuprofen which did not help. She reports the pain felt like something was tearing inside her shoulder any time she moved her shoulder. She has had difficulty sleeping due to the pain. On exam yesterday her left shoulder had a normal appearance without erythema, warmth or swelling. Her active range of motion of teh left shoulder was greatly decreased with minimal ability to internally rotate, moderately decreased external rotation, abduction to 90°, and forward flexion to approximately 100°  and all with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. Her left shoulder was tender to palpation shoulder anteriorly and laterally. Her right shoulder was normal with full range of motion and no tenderness to palpation. Range of motion of her cervical spine was intact as well. There was no muscle atrophy noted. Abduction strength was decreased due to pain but otherwise motor strength was intact in both upper extremities. Her arms were neurovascularly intact. No rashes were noted. I sent her for an x-ray and started her on a Medrol Dosepak. I advised her to stop the ibuprofen while on the Medrol Dosepak and provided her with tramadol to help with the pain. I asked her to call me if the tramadol was not  enough to control her pain and advised her I would start on her on hydrocodone if needed. I also provided her with a referral for physical therapy.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Red blood cell sedimentation rate, X-ray limb normal
Clinical narrative: Suspected SIRVA -Patient presented to me November 29, 2017 complaining of inability to move her left shoulder in full range of motion as well as severe shoulder pain since the vaccine October 17, 2017. She reports she thought it was just the "normal soreness" she would get after a vaccine but the pain only worsened and the limitation in range of motion became more apparent. She began taking 800 mg ibuprofen which did not help. She reports the pain felt like something was tearing inside her shoulder any time she moved her shoulder. She has had difficulty sleeping due to the pain. On exam yesterday her left shoulder had a normal appearance without erythema, warmth or swelling. Her active range of motion of teh left shoulder was greatly decreased with minimal ability to internally rotate, moderately decreased external rotation, abduction to 90°, and forward flexion to approximately 100°  and all with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. Her left shoulder was tender to palpation shoulder anteriorly and laterally. Her right shoulder was normal with full range of motion and no tenderness to palpation. Range of motion of her cervical spine was intact as well. There was no muscle atrophy noted. Abduction strength was decreased due to pain but otherwise motor strength was intact in both upper extremities. Her arms were neurovascularly intact. No rashes were noted. I sent her for an x-ray and started her on a Medrol Dosepak. I advised her to stop the ibuprofen while on the Medrol Dosepak and provided her with tramadol to help with the pain. I asked her to call me if the tramadol was not  enough to control her pain and advised her I would start on her on hydrocodone if needed. I also provided her with a referral for physical therapy.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Oropharyngeal pain, Skin warm, Swelling
Clinical narrative: IMMEDIATE ITCHING, SORE THROAT, SWELLING - APPROXIMATELY 3"X3" - RED, HOT--- ONGOING, CURRENT SYMPTOMS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Cellulitic reaction at injection site, 24 hr after administration. 4x2 centimeter redness, warmth at site, hardness at injection site. Headache/fatigue but no fever. Worsened at 48 hrs post injection but now starting  to improve 96 hrs post injection (still with 4x2 area redness/warmth but less hardness at injection site). Patient called pharmacy 11/28/17 to describe symptoms, was told that redness at injection site normal, but symptoms worsened. Treated with ibuprofen. No medical treatment sought, symptoms currently improving.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Cellulitic reaction at injection site, 24 hr after administration. 4x2 centimeter redness, warmth at site, hardness at injection site. Headache/fatigue but no fever. Worsened at 48 hrs post injection but now starting  to improve 96 hrs post injection (still with 4x2 area redness/warmth but less hardness at injection site). Patient called pharmacy 11/28/17 to describe symptoms, was told that redness at injection site normal, but symptoms worsened. Treated with ibuprofen. No medical treatment sought, symptoms currently improving.
Age: 39.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Pt had tetanus injection last week in employee health, today the area is warm, swollen with a hard center. Area of redness is the size of a hand, Denies chills.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Localised infection, Pain in extremity
Clinical narrative: Red, painful area on (L) arm. Mostly anterior. Went to doctor. Diagnosed as infection. Given KEFLEX treatment.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 23-year-old female patient who received RABAVERT. The patient's past medical history included animal bite (she was bitten on her back by a bat). On 13th November 2017, the patient received the 1st dose of RABAVERT. In November 2017, less than a week after receiving RABAVERT, the patient experienced diarrhea and vomiting. On an unknown date, the outcome of the diarrhea and vomiting were unknown. It was unknown if the reporter considered the diarrhea and vomiting to be related to RABAVERT. Additional details were reported as follows: The reporter was the patient's mother. The reporter was an employee of the facility where the vaccine was given to her daughter and because the mother was questioning the process and how the vaccine was given. The reporter had been told by hospital administrator's she was causing trouble. The reporter noted the bat was not caught and was trying to just be an advocate for her daughter. She stated she was told by site manager of facility that the manufacturer had been contacted and everything was fine. This was 1 of 3 cases, reported by same reporter for same patient.
Sex: U
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient received ROTARIX and vomit afterwards. No additional information was provided.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Insomnia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Immediately felt as if shot was placed into my elbow, immediate pain up and down arm. Almost 1 month later, I cannot use my arm to even half function d/t pain. Pain getting worse or staying same, hard to sleep and get comfortable at night, impeding lifestyle.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Quality of life decreased
Clinical narrative: Immediately felt as if shot was placed into my elbow, immediate pain up and down arm. Almost 1 month later, I cannot use my arm to even half function d/t pain. Pain getting worse or staying same, hard to sleep and get comfortable at night, impeding lifestyle.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Abdominal distension, Chest X-ray abnormal, Chest discomfort, Chills
Clinical narrative: Morning after: chills, nausea, aches, chest pressure, cough. That cleared after two days, but cough/pressure remained. Got worse, thought it was post-nasal drip, went to ENT, who prescribed CLARITIN and ASMANEX and FLONASE. After two weeks, worse, plus a feeling of inflammation throughout body (throat, chest, pressure on top of abdomen, bloating lower abdomen, hemorrhoids). Referred to pulmonologist, put on antibiotics (2 courses of azithromycin); still bad, put on prednisone; as soon as I went off prednisone (twice), had bad episodes where I felt a ton pressure weighing down on chest and as though airway closing up. Back on prednisone, also put on nebulizer and now weaning off prednisone while nebulizing albuterol and budesonide. Still have days where pressure and inflammation rises, but have had a couple decent days where it felt like something had cleared.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram abnormal, Cough, Haemorrhoids, Inflammation, Nausea
Clinical narrative: Morning after: chills, nausea, aches, chest pressure, cough. That cleared after two days, but cough/pressure remained. Got worse, thought it was post-nasal drip, went to ENT, who prescribed CLARITIN and ASMANEX and FLONASE. After two weeks, worse, plus a feeling of inflammation throughout body (throat, chest, pressure on top of abdomen, bloating lower abdomen, hemorrhoids). Referred to pulmonologist, put on antibiotics (2 courses of azithromycin); still bad, put on prednisone; as soon as I went off prednisone (twice), had bad episodes where I felt a ton pressure weighing down on chest and as though airway closing up. Back on prednisone, also put on nebulizer and now weaning off prednisone while nebulizing albuterol and budesonide. Still have days where pressure and inflammation rises, but have had a couple decent days where it felt like something had cleared.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pulmonary function test, Throat tightness
Clinical narrative: Morning after: chills, nausea, aches, chest pressure, cough. That cleared after two days, but cough/pressure remained. Got worse, thought it was post-nasal drip, went to ENT, who prescribed CLARITIN and ASMANEX and FLONASE. After two weeks, worse, plus a feeling of inflammation throughout body (throat, chest, pressure on top of abdomen, bloating lower abdomen, hemorrhoids). Referred to pulmonologist, put on antibiotics (2 courses of azithromycin); still bad, put on prednisone; as soon as I went off prednisone (twice), had bad episodes where I felt a ton pressure weighing down on chest and as though airway closing up. Back on prednisone, also put on nebulizer and now weaning off prednisone while nebulizing albuterol and budesonide. Still have days where pressure and inflammation rises, but have had a couple decent days where it felt like something had cleared.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Fatigue, fever, site tenderness, muscle pain, body aches.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local reaction
Clinical narrative: Local reaction- 5 cm area of erythema around 24 hours of vaccination. Was seen in clinic without induration or signs of cellulitis.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid tender to touch with redness and swelling, slightly warm to touch, can feel hard lump in area of injection.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Left deltoid tender to touch with redness and swelling, slightly warm to touch, can feel hard lump in area of injection.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Irritability, Joint range of motion decreased, Mobility decreased
Clinical narrative: Immediate pain after receiving the shot, burning sensation and irritability. Pain eventually reduced, but not entirely. Noticed soreness and pain in shoulder and arm. Pain increased as time when on and is now the worst it has been. Pain starts in shoulder and radiates down arm. My range of motion is decreased, I cannot raise my arm, put pressure on my elbow and daily movements are painful, including putting a coat or sweater on. Pain has been constant since I received the shot, it has been over a month and overall pain has increased as well an immobility.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Immediate pain after receiving the shot, burning sensation and irritability. Pain eventually reduced, but not entirely. Noticed soreness and pain in shoulder and arm. Pain increased as time when on and is now the worst it has been. Pain starts in shoulder and radiates down arm. My range of motion is decreased, I cannot raise my arm, put pressure on my elbow and daily movements are painful, including putting a coat or sweater on. Pain has been constant since I received the shot, it has been over a month and overall pain has increased as well an immobility.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and redness from about 4" above the elbow down to about 4" above the wrist. Associated with pain and elevated blood pressure.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-NOV-2017, the patient was vaccinated with GARDASIL 9 (dose, site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 01-NOV-2017, reported as the same day, the patient experienced pain, erythema, and swelling at site of injection. The patient sought medical attention. The reporter stated that the patient treated herself with an unspecified pain medication, ice and BENADRYL. The outcome of the events was reported as not recovered. The relatedness between GARDASIL and the events was unknown.