chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 360 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 384 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Information has been received from a pharmacist referring to a 57 years old female patient with penicillin allergy. There was no medical history. Concomitant therapies included gemfibrozil, lisinopril (manufacturer unknown), atorvastatin, omeprazole (manufacturer unknown), warfarin. On 12-OCT-2016, the patient received a dose of BOOSTRIX (manufacturer unspecified) in the right arm and a dose of PNEUMOVAX 23 (lot number was reported as M036161 with expiration date 06-MAY-2018) 0.5 ml once, intramuscularly in the left arm. The patient was a smoker so she was indicated for PNEUMOVAX 23. An unspecified time after receiving PNEUMOVAX 23, the patient developed "swelling in left arm that was red, warm and painful and extended from her shoulder to her elbow". The patient went to an unspecified Urgent Care facility (unspecified date) in regards to the reaction and was told to go to the emergency room. The patient went to the emergency room on an unspecified date and was admitted to the hospital due to the reaction. While in the hospital the patient was diagnosed with cellulitis in her left arm and given unspecified antibiotics and morphine as treatment. The patient was discharged from the hospital on 16-OCT-2016. At the time of the reporting, the patient was still in a little bit of pain but her arm looked much better. The causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 57 years old female patient with penicillin allergy. There was no medical history. Concomitant therapies included gemfibrozil, lisinopril (manufacturer unknown), atorvastatin, omeprazole (manufacturer unknown), warfarin. On 12-OCT-2016, the patient received a dose of BOOSTRIX (manufacturer unspecified) in the right arm and a dose of PNEUMOVAX 23 (lot number was reported as M036161 with expiration date 06-MAY-2018) 0.5 ml once, intramuscularly in the left arm. The patient was a smoker so she was indicated for PNEUMOVAX 23. An unspecified time after receiving PNEUMOVAX 23, the patient developed "swelling in left arm that was red, warm and painful and extended from her shoulder to her elbow". The patient went to an unspecified Urgent Care facility (unspecified date) in regards to the reaction and was told to go to the emergency room. The patient went to the emergency room on an unspecified date and was admitted to the hospital due to the reaction. While in the hospital the patient was diagnosed with cellulitis in her left arm and given unspecified antibiotics and morphine as treatment. The patient was discharged from the hospital on 16-OCT-2016. At the time of the reporting, the patient was still in a little bit of pain but her arm looked much better. The causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Cough, Erythema, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Patient began coughing and wheezing shortly after receiving the seasonal flu shot. Her arm (injection site) swelled significantly.
Age: 0.25
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Tenderness
Clinical narrative: Patient began coughing and wheezing shortly after receiving the seasonal flu shot. Her arm (injection site) swelled significantly.
Age: 0.25
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Cough, Injection site swelling, Wheezing
Clinical narrative: Patient began coughing and wheezing shortly after receiving the seasonal flu shot. Her arm (injection site) swelled significantly.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Lacrimation increased, Palpitations, Pruritus, Rhinorrhoea
Clinical narrative: Whole body hives, runny nose and watery eyes, throat constricted, flushed face, racing heart rate, itchiness.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Urticaria
Clinical narrative: Whole body hives, runny nose and watery eyes, throat constricted, flushed face, racing heart rate, itchiness.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV9, MNQ, TDAP
Symptoms: Facial asymmetry
Clinical narrative: Right sided facial asymmetry.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site paraesthesia, Nausea
Clinical narrative: Lightheaded, nausea, HA, tingling on the injected area.
Age: 37.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Skin warm
Clinical narrative: Red, hot palm of hand. Hurts up shoulder and under part of arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Pain at injection site in arm, pain that lasted for months. Range of motion limited, moving arm is painful. Pain & weakness in arm that received injection.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose increased, Continuous positive airway pressure, Diabetes mellitus, Hyperglycaemia, Pollakiuria
Clinical narrative: A spontaneous report has been received. The report concerns a 41 year old male patient (ethnic origin: Other), with weight: 260.0 pounds and height as 5 feet 10 and one half inches. Patient's relevant history and concurrent diseases were not reported. Concomitant medications included canaglifozin for diabetes. Patient took nasal FLUMIST Quadrivalent (influenza virus vaccine live, intranasal) vaccine 0.2 ml for flu vaccination from either 2008 or 2009. Patient reported that the vaccine was administered to him yearly. Patient was being diagnosed with sleep apnea in approximately 2008 or 2009. Patient used a CPAP for the sleep apnea, approximately in 2008. Patient was diagnosed with diabetes/hyperglycemia approximately two years ago but could not remember if it was 2014 or 2015. Patient stated that before diagnosis his blood sugar went up to 423, he was taken to a hospital and treated for diabetic shock. Because of his hyperglycemia patient had frequent urination. The outcome of the events of diabetes/hyperglycemia, diabetic shock and sleep apnea/use of CPAP with sleep apnea were unknown. The reporter considered the events diabetes/hyperglycemia to be serious due to seriousness criteria of hospitalization. The company physician considered the event diabetic shock to be serious due to seriousness criteria of important medical event and event sleep apnea/use of CPAP with sleep apnea was considered as non-serious. Sender's Comments: Shock hypoglycaemic and diabetes mellitus are not listed in the company core data sheet for FLUMIST. Patient's underlying diabetes mellitus could be contributory to shock hypoglycaemic. However, there is limited information on details of diabetes (type 1 or 2), exact administration of suspect, dietary history, event start date, diagnostic work up like glycosylated haemoglobin level, complete blood sugar level, risk factors like stress, obesity which makes individual causal assessment difficult.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Shock hypoglycaemic, Sleep apnoea syndrome
Clinical narrative: A spontaneous report has been received. The report concerns a 41 year old male patient (ethnic origin: Other), with weight: 260.0 pounds and height as 5 feet 10 and one half inches. Patient's relevant history and concurrent diseases were not reported. Concomitant medications included canaglifozin for diabetes. Patient took nasal FLUMIST Quadrivalent (influenza virus vaccine live, intranasal) vaccine 0.2 ml for flu vaccination from either 2008 or 2009. Patient reported that the vaccine was administered to him yearly. Patient was being diagnosed with sleep apnea in approximately 2008 or 2009. Patient used a CPAP for the sleep apnea, approximately in 2008. Patient was diagnosed with diabetes/hyperglycemia approximately two years ago but could not remember if it was 2014 or 2015. Patient stated that before diagnosis his blood sugar went up to 423, he was taken to a hospital and treated for diabetic shock. Because of his hyperglycemia patient had frequent urination. The outcome of the events of diabetes/hyperglycemia, diabetic shock and sleep apnea/use of CPAP with sleep apnea were unknown. The reporter considered the events diabetes/hyperglycemia to be serious due to seriousness criteria of hospitalization. The company physician considered the event diabetic shock to be serious due to seriousness criteria of important medical event and event sleep apnea/use of CPAP with sleep apnea was considered as non-serious. Sender's Comments: Shock hypoglycaemic and diabetes mellitus are not listed in the company core data sheet for FLUMIST. Patient's underlying diabetes mellitus could be contributory to shock hypoglycaemic. However, there is limited information on details of diabetes (type 1 or 2), exact administration of suspect, dietary history, event start date, diagnostic work up like glycosylated haemoglobin level, complete blood sugar level, risk factors like stress, obesity which makes individual causal assessment difficult.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This spontaneous case, initially received on 12-Oct-2016, was reported by a non health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided. Past medical history included sensitivities to some meds. The patient has no known allergies. Drug history includes the flu shot (reaction: shivering, feeling like she was going to pass out). Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 10-OCT-2016 to 10-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56707. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2016, the patient experienced a rapid pulse (120 pounding out of her chest for 5-10 minutes and then went down), 3 or 4 episode of dizziness, numb lips and chin, shakiness and shivering uncontrollably. The patient went to the ER (Emergency Room) on 10-Oct-2016 and was given antihistamine. The patient states she does not have hives or anything. Symptoms resolved after receiving IV (intravenous) diphenhydramine, took 40 minutes after treatment to resolve. All events: medically significant, outcome: recovered / resolved, stop date: 10-Oct-2016). Sender's Comments: Company comments: Listedness: Assessment according to the agency for CSL's Inactivated Influenza Virus Vaccine, rapid heart rate and all other events are unlisted. Chills is listed. Causality: Related. Time to event onset is same day following vaccination. Events suggest an autonomic reaction to vaccine. Causality is considered related to Influenza vaccination due to temporal association and no other triggers reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Tremor
Clinical narrative: This spontaneous case, initially received on 12-Oct-2016, was reported by a non health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided. Past medical history included sensitivities to some meds. The patient has no known allergies. Drug history includes the flu shot (reaction: shivering, feeling like she was going to pass out). Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 10-OCT-2016 to 10-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56707. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2016, the patient experienced a rapid pulse (120 pounding out of her chest for 5-10 minutes and then went down), 3 or 4 episode of dizziness, numb lips and chin, shakiness and shivering uncontrollably. The patient went to the ER (Emergency Room) on 10-Oct-2016 and was given antihistamine. The patient states she does not have hives or anything. Symptoms resolved after receiving IV (intravenous) diphenhydramine, took 40 minutes after treatment to resolve. All events: medically significant, outcome: recovered / resolved, stop date: 10-Oct-2016). Sender's Comments: Company comments: Listedness: Assessment according to the agency for CSL's Inactivated Influenza Virus Vaccine, rapid heart rate and all other events are unlisted. Chills is listed. Causality: Related. Time to event onset is same day following vaccination. Events suggest an autonomic reaction to vaccine. Causality is considered related to Influenza vaccination due to temporal association and no other triggers reported.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Headache, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non health care professional on 07 Oct 2016. This case involves a 62-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and site was not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications was not reported. On an unspecified date, within two hours post vaccination, the patients had experienced headache (reported as continue to today 07 Oct 2016). On an unspecified date following the vaccination, the patient had extremely painful arm and also had bruise. Lab data and corrective treatment was not reported. Patient's event outcome was reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 10 Oct 2016. This case involves a 66 year old female patient who was vaccinated with a dose of Fluzone HD (Batch number: UI634AB expiration date: 22 Mar 2017 and a dose of Pneumovax (Manufacture: Merck, Batch number: L047185, expiration date and route not reported) on 04 Oct 2016. Patient had cough and chest congestion illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions included Hyperlipidemia, PAD, and Emphysema. Concomitant medications were not reported. On 05 Oct 2016, 1 day following the vaccination, the patient had cellulitis to arm, arm began with erythema in morning. On 06 Oct 2016 was worse with warmth and pain. No fever noted. Patient required ER/doctor visit. Cellulitis diagnosed only by physical exam. Relevant diagnostic tests, laboratory data were not reported. The patient was treated with doxycycline. The outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical events Cellulitis to arm/with warmth and pain. List of documents held by sender: none. Sender's Comments: Patient had suspected cellulitis following FLUZONE HD vaccine. Time to onset is compatible, but additional information regarding patient medical history, allergic history, aseptic precaution taken for injection, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed as two vaccine is administered.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited misuse case received from a nurse on 10 Oct 2016. This case involves a 57 year old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI684AA Expiry date: 30 Jun 2017) subcutaneously in left deltoid on 06 Oct 2016. The patient had a medical history of recent Upper respiratory infection and illness at the time of vaccination was reported as unknown and any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications were not reported. On 07 Oct 2016, one day after vaccination the patient had Redness swelling entire upper arm (Extensive swelling of vaccinated limb, Erythema and Vaccination site reaction). It was a case of incorrect route of drug administration (FLUZONE QIV given poss SC L deltoid). The patient was seen in the emergency room(ER). The patient lab tests were not reported. The patient had corrective treatment with antibiotics. The outcome of the events were reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 11 Oct 2016. Manufacturer Report Number: 2016454215. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID ADSORBED/TETANUS VACCINES and TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had allergy to vaccine tetanus toxoid, absorbed, tetanus vaccines and toxoid. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same source, same vaccine). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of Flu Shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The medical history and concomitant medications were not reported. On an unknown date, 2 weeks following the vaccination, the patient was just about died with the flu. The laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851(Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had flu. It was reported that every year patient received flu shot and had flu. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient felt worse. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient got sick in bed for 2 weeks. Further the reporter thought "I was going to die". The patient's laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure systolic increased, Bronchospasm, Chest discomfort, Choking, Eyelid oedema
Clinical narrative: Felt Heavy in the chest and Felt choking feeling or closing throat? Bronchial spasm. Felt shaky after 2-3 minutes. SBP went up Over 40 than usual. Lasted about 2 to 3 minutes and subsided. Eyes were red and puffy and felt heaviness on the head.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Nervousness, Ocular hyperaemia, Throat tightness
Clinical narrative: Felt Heavy in the chest and Felt choking feeling or closing throat? Bronchial spasm. Felt shaky after 2-3 minutes. SBP went up Over 40 than usual. Lasted about 2 to 3 minutes and subsided. Eyes were red and puffy and felt heaviness on the head.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient experiencing pain at injection site, fever chills, nausea and vomiting.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic, Swelling
Clinical narrative: Raised and itchy rash on left leg, above and the interior side of knee. Area of rash was approximately 4 x 3 inches. Visited with primary care doctor on 09/27/2016; she advised over the counter antihistamine and topical cortisone cream. Said to outline rash area with a pen/marker and watch for growth or more adverse reactions. If any, return to doctor for more follow-up. Rash lessened over next week.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Patient had 4 episodes of diarrhea on Wednesday and nausea, still continuing with diarrhea today 10/20/2016, patient normally is constipated so this is very abnormal for her, just concerned.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Swelling and hives on left arm/shoulder.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Cellulitis, Hypersensitivity, Monocyte count increased, Neutrophil count increased, Platelet count decreased
Clinical narrative: Cellulitis - vs allergic reaction after PNEUMOVAX and influenza vaccine. Start KEFLEX tomorrow. BENADRYL PO (warned of sedation and urinary retention). Return tomorrow for recheck, sooner if worsening.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: Cellulitis - vs allergic reaction after PNEUMOVAX and influenza vaccine. Start KEFLEX tomorrow. BENADRYL PO (warned of sedation and urinary retention). Return tomorrow for recheck, sooner if worsening.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Blood calcium, Laboratory test abnormal, Pain in extremity, White blood cell count increased
Clinical narrative: Cellulitis - vs allergic reaction after PNEUMOVAX and influenza vaccine. Start KEFLEX tomorrow. BENADRYL PO (warned of sedation and urinary retention). Return tomorrow for recheck, sooner if worsening.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Human chorionic gonadotropin abnormal
Clinical narrative: Miscarriage. I am now a GTAP 2-1-1-1. I had no reaction other than this pregnancy loss.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Eye swelling, Headache, Hypersensitivity, Pyrexia, Swelling face
Clinical narrative: This is a spontaneous report obtained from a contactable nurse manager. A 16-year-old female patient received, on 06Oct2016, TRUMENBA, (Lot. N16808, Expiration date: Jul2017) at 03:09 PM, intramuscular, in the right deltoid, at 0.5 ml, single dose; MENACTRA, (Manufacturer: Sanofi, Lot. U1693AB) intramuscular, at1 DF, single dose; and FLUZONE, (Manufacturer: Sanofi, Lot. U1693AB) intramuscular, at 1 DF, single dose; all for immunization. Relevant medical history and concomitant medications were none. On 06Oct2016, the patient experienced horrendously swollen left eye, allergic reaction, headache, fever (low grade fever of 100 to 101 Fahrenheit) and her left side of the face was swollen. Doctor visit was required for eye swollen and fever on 08Oct2016; then returned with a headaches so the patient had two visits. Treatment received were the following: Tylenol, probably two 325 mg tablets (she was not sure of it) (from 06Oct2016 and ongoing) and hydroxyzine 25 mg, tablet, one tablet every 8 hours as needed (from 08Oct2016, she was not taking it right now). The patient did not recover from the event, headache; while clinical outcome of the other events was recovering.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A 20 years old female patient of unspecified age, race and gender received the first single dose of TRUMENBA (Lot N77282, Expiry Date 30Jun2017) on 08Jul2016 for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever after first dose of vaccine on an unspecified date in 2016 with unknown outcome.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient reported that she felt sick with 'every flu shot I have ever had'. The patient's concomitant medications were not reported. On an unknown date, following the vaccination, the patient got sick. The patient's laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a customer via social media on 10 October 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. This case involves a patient (unknown age and gender) who was vaccinated with INFLUENZA VACCINE (Flu shot) (batch number, expiry date of product, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date and unspecified duration following the vaccination, the patient experienced flu. Lab data included and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient got sick. The patient's laboratory data and corrective treatment was not reported. On unspecified date, patient recovered from the event. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Contusion, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Progressive redness, swelling, itching at the injection site: @24hrs 4x3.5in @ 36hrs size doubled @ 48hrs. Redness & swelling had consumed arm from shoulder to elbow. Dizziness/lightheaded, nausea, very weak and feeling of exhaustion (slept 14hrs). Seen PCP at 36hrs Rx Cephalexin 500mg and steroid injection. Symptoms began to subside after 48hrs and returned to normal (except for itching and 'bruising' affect) after 72hrs.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Progressive redness, swelling, itching at the injection site: @24hrs 4x3.5in @ 36hrs size doubled @ 48hrs. Redness & swelling had consumed arm from shoulder to elbow. Dizziness/lightheaded, nausea, very weak and feeling of exhaustion (slept 14hrs). Seen PCP at 36hrs Rx Cephalexin 500mg and steroid injection. Symptoms began to subside after 48hrs and returned to normal (except for itching and 'bruising' affect) after 72hrs.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Severe nausea, body aches, injection site pain.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Red, inflamed, itchy area about the size of a hand below the upper arm vaccination site, above the elbow.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Cerebrovascular accident, Communication disorder, Facial paralysis
Clinical narrative: Patient came back to pharmacy about 20 minutes after receiving the vaccine with her son. He stated that she was not communicating and would not eat and not acting like self. As we were waiting to talk to her doctor she showed signs of a stroke such as drooping lip on one side of face. I instead called 911.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Immediate post-injection reaction, Injection site discomfort, Injection site pain, Neck pain
Clinical narrative: Injection given high on the deltoid. Employee immediately had pain which was localized in the right shoulder and radiated up her right neck and occipital area.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: Localized Reaction.  On 10-19-2016 2020, it was and is 5 cm (or 2 inches) wide, red, and indurated. It was accidentally touched early in the day that set it off to itching. I am fighting the urge to rub it like when I had the chicken pox when I was in 6th grade.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Headache, Skin warm
Clinical narrative: Shivering uncontrollably, feeling cold, could not get warm, headache.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Decreased appetite, Headache, Heart rate increased
Clinical narrative: Shaking chills, fever, pounding headache, pounding heartbeat, muscle aches, vomiting, loss of appetite, inability to sleep, minor injection site soreness. So bad the first 24 hrs. that I thought I'd have to go to ER, but didn't. After 48 hours symptoms improved. After that time came down with mild sore throat and cough which lasted a week. Still have worse muscle aches than before injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Shaking chills, fever, pounding headache, pounding heartbeat, muscle aches, vomiting, loss of appetite, inability to sleep, minor injection site soreness. So bad the first 24 hrs. that I thought I'd have to go to ER, but didn't. After 48 hours symptoms improved. After that time came down with mild sore throat and cough which lasted a week. Still have worse muscle aches than before injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vomiting
Clinical narrative: Shaking chills, fever, pounding headache, pounding heartbeat, muscle aches, vomiting, loss of appetite, inability to sleep, minor injection site soreness. So bad the first 24 hrs. that I thought I'd have to go to ER, but didn't. After 48 hours symptoms improved. After that time came down with mild sore throat and cough which lasted a week. Still have worse muscle aches than before injection.
Age: 65.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Rash erythematous, Swelling
Clinical narrative: Developed red raised area of skin on back of neck and top of head.
Age: 65.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Developed red raised area of skin on back of neck and top of head.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dermatitis, Skin infection
Clinical narrative: Skin inflammation and a minor skin infection.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Hypersensitivity, Hypoaesthesia, Neuralgia, Pain in extremity
Clinical narrative: 1 hour after receiving flu vaccine patient developed L facial numbness/nerve pain radiating to bridge of nose with extreme sensitivity.  Following morning, patient stated numbness/pain radiating to L arm/L leg.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, and redness at site of vaccination. No treatment. Patient reports that it feels a little better today.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Local swelling, Skin warm
Clinical narrative: Red, raised and hot. Size of softball on my left arm.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Received vaccination on Tuesday afternoon and felt fine until Tuesday evening around 8:00-8:30 PM when client reports that he first developed a scratchy throat and a cough which he describes and deep and hacking. He had chills off and on until about 9:00 PM when the intermittent chills developed into a constant chills/shaking and sweating. It was at this point that client reports he took an ALKA-SELTZER Cold and Flu OTC medicine and proceeded to fall asleep. He awoke at midnight and the chills were gone but he had body aches. The next morning he felt tired and worn out and had a lingering cough which proceeded to last throughout the day on Wednesday, 10/19/2016. He reports that his symptoms have completely resolved today.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Throat irritation
Clinical narrative: Received vaccination on Tuesday afternoon and felt fine until Tuesday evening around 8:00-8:30 PM when client reports that he first developed a scratchy throat and a cough which he describes and deep and hacking. He had chills off and on until about 9:00 PM when the intermittent chills developed into a constant chills/shaking and sweating. It was at this point that client reports he took an ALKA-SELTZER Cold and Flu OTC medicine and proceeded to fall asleep. He awoke at midnight and the chills were gone but he had body aches. The next morning he felt tired and worn out and had a lingering cough which proceeded to last throughout the day on Wednesday, 10/19/2016. He reports that his symptoms have completely resolved today.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Cognitive disorder, Dizziness, Educational problem, Fatigue, Feeling abnormal
Clinical narrative: He has had a series of 3 shots. Second dose 07/17/2012, last one given: 01/09/13. He began to experience light headedness and dizziness after the first shot. It was happening off an on. By the third shot, he had been continuously sick with fatigue, headaches, blurry vision off an on. After many weeks of tests due to his symptoms, they found strep bacteria in his blood. Gave him a round of antibiotics. We saw an infectious disease doctor to rule out rheumatic fever which we did. He began to get stretch marks all over his body that look like the bartonella rash on his lower back, sides and shoulders. He still has them and is 16. He still experiences numbness and tingling sensations. Has stated numerous times that he has a feeling of fogginess in his head after receiving the vaccines. I requested doxycycline for him for acne. I later learned that this is an antibiotic that is sometimes used to help with bartonella. I am thinking this is why his symptoms may have stabilized instead of progressed. I am not certain that the health issues are due to the HPV vaccine, but since these symptoms began after the first shot, looking back on the situation, I feel the vaccine may have played a part in it. His grades in school changed at that time, and his memory and cognitive function changed. I feel it is worth mentioning because it is coincidental.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Headache, Hypoaesthesia, Memory impairment, Paraesthesia, Rash
Clinical narrative: He has had a series of 3 shots. Second dose 07/17/2012, last one given: 01/09/13. He began to experience light headedness and dizziness after the first shot. It was happening off an on. By the third shot, he had been continuously sick with fatigue, headaches, blurry vision off an on. After many weeks of tests due to his symptoms, they found strep bacteria in his blood. Gave him a round of antibiotics. We saw an infectious disease doctor to rule out rheumatic fever which we did. He began to get stretch marks all over his body that look like the bartonella rash on his lower back, sides and shoulders. He still has them and is 16. He still experiences numbness and tingling sensations. Has stated numerous times that he has a feeling of fogginess in his head after receiving the vaccines. I requested doxycycline for him for acne. I later learned that this is an antibiotic that is sometimes used to help with bartonella. I am thinking this is why his symptoms may have stabilized instead of progressed. I am not certain that the health issues are due to the HPV vaccine, but since these symptoms began after the first shot, looking back on the situation, I feel the vaccine may have played a part in it. His grades in school changed at that time, and his memory and cognitive function changed. I feel it is worth mentioning because it is coincidental.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Skin striae, Streptococcus test positive, Vision blurred
Clinical narrative: He has had a series of 3 shots. Second dose 07/17/2012, last one given: 01/09/13. He began to experience light headedness and dizziness after the first shot. It was happening off an on. By the third shot, he had been continuously sick with fatigue, headaches, blurry vision off an on. After many weeks of tests due to his symptoms, they found strep bacteria in his blood. Gave him a round of antibiotics. We saw an infectious disease doctor to rule out rheumatic fever which we did. He began to get stretch marks all over his body that look like the bartonella rash on his lower back, sides and shoulders. He still has them and is 16. He still experiences numbness and tingling sensations. Has stated numerous times that he has a feeling of fogginess in his head after receiving the vaccines. I requested doxycycline for him for acne. I later learned that this is an antibiotic that is sometimes used to help with bartonella. I am thinking this is why his symptoms may have stabilized instead of progressed. I am not certain that the health issues are due to the HPV vaccine, but since these symptoms began after the first shot, looking back on the situation, I feel the vaccine may have played a part in it. His grades in school changed at that time, and his memory and cognitive function changed. I feel it is worth mentioning because it is coincidental.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle strain, Pain
Clinical narrative: Patient could not move arm on 10/08/2016. She had soreness the day before. Dr. on 10/08 diagnosed it as a shoulder strain. Dr on 10/11/2016 diagnosed the problem as a reaction to the flu shot.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Injection site swollen, red and hot. Injection was in the deltoid, swelling went down to forearm.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Angioedema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swollen, Sore, and Warm extremity where both immunizations were given.  PNEUMOVAX and Influenza. Soreness continue migrating distally, along with angioedema.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Hyporesponsive to stimuli, Pallor
Clinical narrative: Became pale after injection- initially cried, but then became pale and less responsive, but would open eyes with gentle stimulation- ?decreased respirations, but by the time I got my stethoscope on the chest- which seemed to stimulate him he recovered- pulse and respirations were strong and color pink throughout my observation. Mother states he had a similar response after Hepatitis vaccine at 1 month- both just after vaccine and on and off brief pale episodes during the next 24 hours. Sibling has a history of breath-holding.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS
Age: 20.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Dizziness, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Area of shot red hot itchy and swollen.  Pt c/o discomfort at sight, feeling lightheaded and feverish.
Age: 20.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Area of shot red hot itchy and swollen.  Pt c/o discomfort at sight, feeling lightheaded and feverish.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Cough, Erythema, Feeling hot, Lung disorder
Clinical narrative: After receiving both injections, I left  pharmacy area of store and walked to bathroom. Began feeling tickle in lungs and began coughing. Increased as I was using the bathroom facility. Face felt very hot. Looked in mirror and face was extremely red. Returned to pharmacy. Sat down. Felt pressure in chest, loud ringing in ears, heart racing. Began to have very severe back spasms, beginning at lumbar and radiating  into thoracic area. Had approximately 6-10 spasms. Then all symptoms slowly ended, although my hands were shaking uncontrollably for several more minutes. Entire event lasted approx. 10-15 minutes.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle spasms, Palpitations, Tinnitus, Tremor
Clinical narrative: After receiving both injections, I left  pharmacy area of store and walked to bathroom. Began feeling tickle in lungs and began coughing. Increased as I was using the bathroom facility. Face felt very hot. Looked in mirror and face was extremely red. Returned to pharmacy. Sat down. Felt pressure in chest, loud ringing in ears, heart racing. Began to have very severe back spasms, beginning at lumbar and radiating  into thoracic area. Had approximately 6-10 spasms. Then all symptoms slowly ended, although my hands were shaking uncontrollably for several more minutes. Entire event lasted approx. 10-15 minutes.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Increased swelling, redness and warmth to skin size of palm below injection site--Topical ice--no other treatment given.