chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Bacterial test negative, Blood calcium decreased, Blood creatinine normal, Blood glucose increased
Clinical narrative: Initial case received from a health care professional on 01 October 2014. A 38-year-old female patient had received an intramuscular dose of FLUZONE on 26 September 2014 at 10: 30AM (batch number UI189AA, site of administration not reported). She had a medical history of hypothyroidism, Von Willebrand's disease, endocrine disease; as well as food allergies (not specified) and "opioids (anaphylaxis)". No illness was reported at time of vaccination. She had received "many" previous doses of Flu vaccine. She had received no other vaccinations within the 4 weeks prior 26 September 2014. It was not reported whether she was taking concomitant medications. On 26 September 2014, at 12:00PM, i.e. 1.5 hours post vaccination, she experienced rash in the area of injection site. The patient discovered the rash while she was eating her lunch. While waiting to be evaluated at the ER, she also developed difficulty breathing. She was diagnosed with anaphylaxis and was admitted overnight to the ICU. As relevant diagnostic tests, the following was reported: "EKG, Chem, CDC, MRSA cultures for admission". No results were provided. It was unknown whether the patient had received corrective treatment. The patient's outcome was recovered. This case is linked to the case 2014SA137013 which was reported by the same reporter on the same day (01 October 2014). Follow-up information received on 27 October 2014 from a health care professional. FLUZONE was administered in the left deltoid. Lot number was corrected from U1189AA to UI189AA. Patient medical history was clarified: the patient had an history of drug allergy: opiates - anaphylaxis. It was precised that before she started to experience the symptoms, she had lunch: soft-shelled tacos with carne asada. It was also mentioned that, in fact, she had no food allergies. No allergy test was done on admission. Laboratory results were provided. On 26 September 2014, the patient was found with: calcium 8.0 mg/dl (L), glucose 154 mg/dl (H), creatinine 1.1 mg/dl (H), MCV 79.9 fl (L), MCH 26.3 pG (L), neutrophil percentage 93.0% (H), lymphocyte percentage 5.8% (L), monocyte percentage 1.0% (L). On 27 September 2014, she was had: potassium 3.5 mmol/L (L), calcium 8.3 mg/dl (L), glucose 139 mg/dl (H), white blood cells 11.3 10^3/ul (H), MCV 79.7 fl (L), MCH 26.1 pG (L), neutrophil percentage 87.3% (H), lymphocyte percentage 9.7% (L), monocyte percentage 2.8% (L). On 26 September 2014, culture VRE screen (rectal swab) showed no vancomycin resistant enterococcus isolated, and culture MSRA screen (nares) showed no methicillin resistant staphylococcus aureus until 03 October 2014; as well as BENADRYL (25mg PO, TID) on unspecified date. She was hospitalized from 26 September 2014 to 27 September 2014 (reported as 1 day). Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium normal, Culture negative, Dyspnoea, Electrocardiogram normal, Injection site rash
Clinical narrative: Initial case received from a health care professional on 01 October 2014. A 38-year-old female patient had received an intramuscular dose of FLUZONE on 26 September 2014 at 10: 30AM (batch number UI189AA, site of administration not reported). She had a medical history of hypothyroidism, Von Willebrand's disease, endocrine disease; as well as food allergies (not specified) and "opioids (anaphylaxis)". No illness was reported at time of vaccination. She had received "many" previous doses of Flu vaccine. She had received no other vaccinations within the 4 weeks prior 26 September 2014. It was not reported whether she was taking concomitant medications. On 26 September 2014, at 12:00PM, i.e. 1.5 hours post vaccination, she experienced rash in the area of injection site. The patient discovered the rash while she was eating her lunch. While waiting to be evaluated at the ER, she also developed difficulty breathing. She was diagnosed with anaphylaxis and was admitted overnight to the ICU. As relevant diagnostic tests, the following was reported: "EKG, Chem, CDC, MRSA cultures for admission". No results were provided. It was unknown whether the patient had received corrective treatment. The patient's outcome was recovered. This case is linked to the case 2014SA137013 which was reported by the same reporter on the same day (01 October 2014). Follow-up information received on 27 October 2014 from a health care professional. FLUZONE was administered in the left deltoid. Lot number was corrected from U1189AA to UI189AA. Patient medical history was clarified: the patient had an history of drug allergy: opiates - anaphylaxis. It was precised that before she started to experience the symptoms, she had lunch: soft-shelled tacos with carne asada. It was also mentioned that, in fact, she had no food allergies. No allergy test was done on admission. Laboratory results were provided. On 26 September 2014, the patient was found with: calcium 8.0 mg/dl (L), glucose 154 mg/dl (H), creatinine 1.1 mg/dl (H), MCV 79.9 fl (L), MCH 26.3 pG (L), neutrophil percentage 93.0% (H), lymphocyte percentage 5.8% (L), monocyte percentage 1.0% (L). On 27 September 2014, she was had: potassium 3.5 mmol/L (L), calcium 8.3 mg/dl (L), glucose 139 mg/dl (H), white blood cells 11.3 10^3/ul (H), MCV 79.7 fl (L), MCH 26.1 pG (L), neutrophil percentage 87.3% (H), lymphocyte percentage 9.7% (L), monocyte percentage 2.8% (L). On 26 September 2014, culture VRE screen (rectal swab) showed no vancomycin resistant enterococcus isolated, and culture MSRA screen (nares) showed no methicillin resistant staphylococcus aureus until 03 October 2014; as well as BENADRYL (25mg PO, TID) on unspecified date. She was hospitalized from 26 September 2014 to 27 September 2014 (reported as 1 day). Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Laboratory test, Lymphocyte percentage decreased, Mean cell haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Initial case received from a health care professional on 01 October 2014. A 38-year-old female patient had received an intramuscular dose of FLUZONE on 26 September 2014 at 10: 30AM (batch number UI189AA, site of administration not reported). She had a medical history of hypothyroidism, Von Willebrand's disease, endocrine disease; as well as food allergies (not specified) and "opioids (anaphylaxis)". No illness was reported at time of vaccination. She had received "many" previous doses of Flu vaccine. She had received no other vaccinations within the 4 weeks prior 26 September 2014. It was not reported whether she was taking concomitant medications. On 26 September 2014, at 12:00PM, i.e. 1.5 hours post vaccination, she experienced rash in the area of injection site. The patient discovered the rash while she was eating her lunch. While waiting to be evaluated at the ER, she also developed difficulty breathing. She was diagnosed with anaphylaxis and was admitted overnight to the ICU. As relevant diagnostic tests, the following was reported: "EKG, Chem, CDC, MRSA cultures for admission". No results were provided. It was unknown whether the patient had received corrective treatment. The patient's outcome was recovered. This case is linked to the case 2014SA137013 which was reported by the same reporter on the same day (01 October 2014). Follow-up information received on 27 October 2014 from a health care professional. FLUZONE was administered in the left deltoid. Lot number was corrected from U1189AA to UI189AA. Patient medical history was clarified: the patient had an history of drug allergy: opiates - anaphylaxis. It was precised that before she started to experience the symptoms, she had lunch: soft-shelled tacos with carne asada. It was also mentioned that, in fact, she had no food allergies. No allergy test was done on admission. Laboratory results were provided. On 26 September 2014, the patient was found with: calcium 8.0 mg/dl (L), glucose 154 mg/dl (H), creatinine 1.1 mg/dl (H), MCV 79.9 fl (L), MCH 26.3 pG (L), neutrophil percentage 93.0% (H), lymphocyte percentage 5.8% (L), monocyte percentage 1.0% (L). On 27 September 2014, she was had: potassium 3.5 mmol/L (L), calcium 8.3 mg/dl (L), glucose 139 mg/dl (H), white blood cells 11.3 10^3/ul (H), MCV 79.7 fl (L), MCH 26.1 pG (L), neutrophil percentage 87.3% (H), lymphocyte percentage 9.7% (L), monocyte percentage 2.8% (L). On 26 September 2014, culture VRE screen (rectal swab) showed no vancomycin resistant enterococcus isolated, and culture MSRA screen (nares) showed no methicillin resistant staphylococcus aureus until 03 October 2014; as well as BENADRYL (25mg PO, TID) on unspecified date. She was hospitalized from 26 September 2014 to 27 September 2014 (reported as 1 day). Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Monocyte percentage decreased, Neutrophil percentage increased, Staphylococcus test negative, White blood cell count increased
Clinical narrative: Initial case received from a health care professional on 01 October 2014. A 38-year-old female patient had received an intramuscular dose of FLUZONE on 26 September 2014 at 10: 30AM (batch number UI189AA, site of administration not reported). She had a medical history of hypothyroidism, Von Willebrand's disease, endocrine disease; as well as food allergies (not specified) and "opioids (anaphylaxis)". No illness was reported at time of vaccination. She had received "many" previous doses of Flu vaccine. She had received no other vaccinations within the 4 weeks prior 26 September 2014. It was not reported whether she was taking concomitant medications. On 26 September 2014, at 12:00PM, i.e. 1.5 hours post vaccination, she experienced rash in the area of injection site. The patient discovered the rash while she was eating her lunch. While waiting to be evaluated at the ER, she also developed difficulty breathing. She was diagnosed with anaphylaxis and was admitted overnight to the ICU. As relevant diagnostic tests, the following was reported: "EKG, Chem, CDC, MRSA cultures for admission". No results were provided. It was unknown whether the patient had received corrective treatment. The patient's outcome was recovered. This case is linked to the case 2014SA137013 which was reported by the same reporter on the same day (01 October 2014). Follow-up information received on 27 October 2014 from a health care professional. FLUZONE was administered in the left deltoid. Lot number was corrected from U1189AA to UI189AA. Patient medical history was clarified: the patient had an history of drug allergy: opiates - anaphylaxis. It was precised that before she started to experience the symptoms, she had lunch: soft-shelled tacos with carne asada. It was also mentioned that, in fact, she had no food allergies. No allergy test was done on admission. Laboratory results were provided. On 26 September 2014, the patient was found with: calcium 8.0 mg/dl (L), glucose 154 mg/dl (H), creatinine 1.1 mg/dl (H), MCV 79.9 fl (L), MCH 26.3 pG (L), neutrophil percentage 93.0% (H), lymphocyte percentage 5.8% (L), monocyte percentage 1.0% (L). On 27 September 2014, she was had: potassium 3.5 mmol/L (L), calcium 8.3 mg/dl (L), glucose 139 mg/dl (H), white blood cells 11.3 10^3/ul (H), MCV 79.7 fl (L), MCH 26.1 pG (L), neutrophil percentage 87.3% (H), lymphocyte percentage 9.7% (L), monocyte percentage 2.8% (L). On 26 September 2014, culture VRE screen (rectal swab) showed no vancomycin resistant enterococcus isolated, and culture MSRA screen (nares) showed no methicillin resistant staphylococcus aureus until 03 October 2014; as well as BENADRYL (25mg PO, TID) on unspecified date. She was hospitalized from 26 September 2014 to 27 September 2014 (reported as 1 day). Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test abnormal, Palpitations
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). In September 2015, the patient received FLUARIX QUADRIVALENT. In September 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was recovered/resolved. It was unknown if the reporter considered the palpitation to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The reporter stated that, the patient went to the hospital on 30th September 2015 with heart palpitations and below normal plasma levels (unspecified laboratory test). On 5th October 2015, the patient was doing fine. The reported expiry date 16th June 2106 with lot number 7994K was updated to 16th June 2016 according to the sales database.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Hyperhidrosis, Pain, Respiratory tract congestion
Clinical narrative: Aches, pains, cough - sweating, congestion - M.D tx with antibiotic PHENERGAN with codeine amoxicillin 500 mg BID. 5 days post injection symptoms began.
Age: 14.0
Sex: F
Vaccine: FLU3, HEP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Developed itching, swelling, redness on left forearm after receiving varicella and hepatitis B vaccine.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Received Influenza vaccine on 11/17/15. On 11/18/15 he woke up with pain in the left deltoid, at the area of vaccine placement, also he had all motion limited ROM of LUE secondary to pain.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to 7 unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. The reporter stated that on unspecified dates between 13-NOV-2015 and 17-NOV-2015, the patients were administered improperly stored doses of PEDVAXHIB injection (lot # L030864 with expiration date 07-JUN-2018; dose and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning unspecified number of patents of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The patient individually reported to the pharmacist that on an unknown date, they experienced "redness and swelling at the injection site". No product quality complaint (PQC) was involved. The outcome of injection site erythema and injection site swelling was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient (age, gender, medical history and concomitant medication use not specified). The physician reported that on 27-MAR-2015 the patient was vaccinated with PEDVAXHIB (lot # J000564, expiration date 02-NOV2015), .5 ml, intramuscularly, that had been improperly stored. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocation nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L021214 and expiration date 10-JUN-2017 as reported (dose, route of administration and anatomical location were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality issue was involved. This sis one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLU4
Symptoms: Neurological symptom
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of neurologic reaction in a adult male patient who received FLUARIX QUADRIVALENT. In October 2015, the patient received FLUARIX QUADRIVALENT. In 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced neurologic reaction. On an unknown date, the outcome of the neurologic reaction was unknown. It was unknown if the reporter considered the neurologic reaction to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: In 2015, on an unknown date, 1 day after vaccination, the patient experienced sciatic nerve reaction.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a 60 year old female patient with hypersensitivity to penicillin (MARRS # 1511USA010009) and some opioids. There was not medical history. On 04-NOV-2015 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, lot # L012476, expiration date 20-JUL-2016 (dosage and route were not reported). Also was reported that the same day, she received two additional vaccines; pneumococcal vaccine (manufacturer unknown) (strength, dose, route and lot number were not reported) and influenza virus vaccine (unspecified), reported as "unspecified "flu" vaccine and unspecified "pneumonia" vaccine". The pharmacist reported that on an unknown date in November 2015 the patent experienced injection site rash and injection site pain, reported as "the patient experienced a rash at the injection site which was a little bigger than quarter and which also the patient described as a flat, warm and little painful". The patent sought medical attention, returning to pharmacy, there was not laboratory diagnostic performed. The patient was taking an unspecified dose of BENADRYL to treat the symptoms. The outcome of injection site rash and injection site pain was reported as not recovered at the time of this report. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 51-year-old male patient who received ENGERIX B adult (batch number 4T4GJ, expiry date 4th NOVEMBER 2017). Concomitant products included Atorvastatin and enalapril. On 8th NOVEMBER 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 9th NOVEMBER 2015, 1 day after receiving ENGERIX B adult, the patient experienced hives. On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to ENGERIX B adult. Additional results provided were as follows.  On 8th NOVEMBER 2015, at 13:00 PM, the patient received his 1st dose of ENGERIX B adult in left deltoid. On 9th NOVEMBER 2015, 1 day after vaccination, the patient experienced hives on the right elbow and on the both hands near the knuckles.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Dysphemia, Fatigue, Feeling abnormal, Flushing
Clinical narrative: 11/13/15 - Unusually tired, started complaining about hands itching before bed. 11/14/15 - Still unusually tired, felt warm wouldn't eat, threw up violently in his sleep at night. Complained about hands itching 11/15/15 - No appetite, but didn't feel sick. Hands still itching. Woke up with a flushed dry rash on face and bottom. 11/16/15  No appetite, hands itching. Woke up stuttering which has never happened before.  11/17/15: Woke up at 4am screaming that his arms and hands hurt and felt "sparkly".  Lasted for over 2 hours and then was terrified to try and go back to sleep.  Still no appetite.  We made him eat dinner and he threw it up.  Still unusually tired, but not able to sleep well. Still stuttering and complain about how it is "hard to talk". Complaining about legs hurting and feeling weird. 11/18/15:  Very tired, but difficulty sleeping. still "hard to talk" and stuttering.  No appetite.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity, Poor quality sleep, Pruritus, Rash, Screaming
Clinical narrative: 11/13/15 - Unusually tired, started complaining about hands itching before bed. 11/14/15 - Still unusually tired, felt warm wouldn't eat, threw up violently in his sleep at night. Complained about hands itching 11/15/15 - No appetite, but didn't feel sick. Hands still itching. Woke up with a flushed dry rash on face and bottom. 11/16/15  No appetite, hands itching. Woke up stuttering which has never happened before.  11/17/15: Woke up at 4am screaming that his arms and hands hurt and felt "sparkly".  Lasted for over 2 hours and then was terrified to try and go back to sleep.  Still no appetite.  We made him eat dinner and he threw it up.  Still unusually tired, but not able to sleep well. Still stuttering and complain about how it is "hard to talk". Complaining about legs hurting and feeling weird. 11/18/15:  Very tired, but difficulty sleeping. still "hard to talk" and stuttering.  No appetite.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder, Vomiting
Clinical narrative: 11/13/15 - Unusually tired, started complaining about hands itching before bed. 11/14/15 - Still unusually tired, felt warm wouldn't eat, threw up violently in his sleep at night. Complained about hands itching 11/15/15 - No appetite, but didn't feel sick. Hands still itching. Woke up with a flushed dry rash on face and bottom. 11/16/15  No appetite, hands itching. Woke up stuttering which has never happened before.  11/17/15: Woke up at 4am screaming that his arms and hands hurt and felt "sparkly".  Lasted for over 2 hours and then was terrified to try and go back to sleep.  Still no appetite.  We made him eat dinner and he threw it up.  Still unusually tired, but not able to sleep well. Still stuttering and complain about how it is "hard to talk". Complaining about legs hurting and feeling weird. 11/18/15:  Very tired, but difficulty sleeping. still "hard to talk" and stuttering.  No appetite.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dizziness, Headache, Influenza A virus test positive
Clinical narrative: Started with headache and chills, leading to nausea dizziness, and cough.  Symptoms worsened the following day.  On 11/18 went back to doctor and received flu test. Tested positive for both A and B type flu viruses.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza B virus test positive, Nausea
Clinical narrative: Started with headache and chills, leading to nausea dizziness, and cough.  Symptoms worsened the following day.  On 11/18 went back to doctor and received flu test. Tested positive for both A and B type flu viruses.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash
Clinical narrative: Rash around point where injection was applied.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: LARGE AREA OF REDNESS AND ITCHING AROUND INJECTIONS SITE.  ONE FLUID FILLED LARGE BLISTER IN THE CENTER OF THE REDNESS.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: 4:38 pm rx note: PATIENT HAS SOME SWELLING IN THE ARM FOLLOWING PNEUMOVAX SHOT; CALLED IN TO ASK IF SHE COULD USE ICE PACK.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain, swelling and itch at redness of site. Diameter is about 2 inches.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Pyrexia, Vomiting
Clinical narrative: PATIENT REPORTEDLY HAD 102 FEVER. NAUSEA/ VOMITING. DIFFICULTY BREATHING. SPENT 2 DAYS IN HOSPITAL.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on chest and arms that is thought to be from Shingles Vaccine, Zostavax Injection, Single Dose Vial 10PK.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash on chest and arms that is thought to be from Shingles Vaccine, Zostavax Injection, Single Dose Vial 10PK.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a red ring around her arm below the injection site (above the elbow) and it is slightly swollen and warm.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dizziness, Pruritus generalised, Throat irritation
Clinical narrative: Anaphylaxis- full-body itching, lightheadedness, scratchy throat.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Lip swelling
Clinical narrative: Parent of patient called about 1 hour after vaccine given to state the child felt like her lips were swollen and throat/mouth area swollen. Parent/patient encouraged to seek medical attention immediately at ER or doctors office.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Condition aggravated, Cough, Wheezing
Clinical narrative: Increased wheezing and cough during the night, no fever. This was after child saw doctor for well check in the am when he had no wheezing.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Cough, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Fever cough as pneumonia would chills tired fuzzy dizzy.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Fever cough as pneumonia would chills tired fuzzy dizzy.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to Right deltoid area.  Rocephin antibiotic given.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Symtoms occurred on day Day 5 after being immunized. The left arm at injection site presented reddness, swelling and itching. Patient self treatment was Tylenol Tablets and topical application of Cortisone cream.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient does not report to the pharmacy until Nov 12,2015. Patient stated that she has pain on the arms and the pain is very painful like she had never had before.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Tenderness
Clinical narrative: Day after vaccination had soreness in shoulder area as if she was "knuckle-punched". Area tender like a bruise As of Nov 16 still soreness in shoulder area. Was taking Tylenol will switch to Motrin. Also using warm compresses.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: Dizziness and Headache within 10 minutes of immunization. Leg weakness within one hour. Tightness in chest and fatigue overnight.  Ringing in ears today.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Dizziness and Headache within 10 minutes of immunization. Leg weakness within one hour. Tightness in chest and fatigue overnight.  Ringing in ears today.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Pain
Clinical narrative: Started as dull ache and has continued to increase to a more intense ache... taking Advil to be able to sleep.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Left upper arm swelling; no other sx reported.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: DEVELOPED FLU LIKE SYMPTOMS NEXT DAY AFTER GETTING VACCINATION, ON 11-2 GOT A ZPAK AND COUGH SYRUP, ON 11-18 GOT NAUSEA TABLETS.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains that her arm hurted for 2 weeks and after that she had trouble moving her arm.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hot flush, Nausea, Pruritus
Clinical narrative: Flush, hot. Nauseated, light headed, itching. Symptoms subsided about 20 minutes later. Pt took 50mg Benadryl on her own.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Per daughter, the day following the injection her arm was sore, but there were no visible defects on her arm.  She denied any weakness or tingling.  She says the pain has persisted for more than 3 weeks and her mother is still complaining about it.  She says Celebrex helps the pain during the day, but the pain interferes with sleep at night.  She has not sought medical attention yet but plans to call her PCP soon for advice.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Bone pain, Dyspnoea, Heart rate decreased
Clinical narrative: Approximately 6 hours after vaccine, began to have stomach upset and then later that evening began to have muscle and bone pain. Later that evening felt that heart rate was "low" and that "I couldn't get air", meaning was having some SOB. Also began to have rib cage pain and felt weak.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Myalgia
Clinical narrative: Approximately 6 hours after vaccine, began to have stomach upset and then later that evening began to have muscle and bone pain. Later that evening felt that heart rate was "low" and that "I couldn't get air", meaning was having some SOB. Also began to have rib cage pain and felt weak.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia, Vertigo
Clinical narrative: Fever and vertigo. Pruritic and swollen area at injection site.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: FEVER, COUGH, SORE THROAT, RUNNY NOSE, HEADACHE FOR 3 DAYS.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on arm/sholder that the immunization was given. Appeared 2 days after immunization was given.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Diagnostic procedure, Mobility decreased, Musculoskeletal pain, Pain, Rotator cuff syndrome
Clinical narrative: Sre shoulder that got worse every day, significant pain on third day, acute shoulder tendonitis, impingement diagnosed Nov 16 2015.  Extreme pain and lack of mobility.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Tendonitis
Clinical narrative: Sre shoulder that got worse every day, significant pain on third day, acute shoulder tendonitis, impingement diagnosed Nov 16 2015.  Extreme pain and lack of mobility.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient called on 11/17/15 stating they have a developing rash on their back, only on the back, but that it is all throughout, and it is beginning to itch. She is unsure if it is from the vaccine, as are we, but she was advised to see an md as it is progressing.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram thorax, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Severe left shoulder pain radiating into left neck/supraclavicular; associated swelling; eval by Dr. on 11/18/2015 and steroids initiated.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood immunoglobulin E, Irritability, Rash, Urticaria
Clinical narrative: Rash which progressed to fussiness and hives.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: There was severe swelling in the left upper/lower arm where the shot was administered. That area was painful to the touch, hot, and the arm was restricted movement on the arm as well.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Insomnia, Pyrexia, Tremor
Clinical narrative: Shaking, chills, rigor, high fever, couldn't sleep, no appetite.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Arm became sore and is still sore with any motion - range of motion is decreased - still sore almost 5 weeks later - pt thinks the injection went in bursa sac.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Local cellulitis treated with clindamycin. Patient with cellulitis last year after FLUZONE UI71AC given.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle soreness/stiffness to the point where he couldn't lift his arm. Went away for about 1 week then came back and still cannot raise left arm. Flu shot was administered about 1 month ago.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: The patient reported that she had chills, a fever of 101.3 deg F and she required more puffs of her inhaler in order to get sufficient air in her lungs.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient received PREVNAR-13 and FLUZONE HD. Patient claims a large rash appeared at injection site of PREVNAR-13, 5 days after injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscle tightness, Muscle twitching, Pain in extremity, Tension
Clinical narrative: (R) thumb with twitching 24 hrs post vaccination symptom x 4 days but waning in intensity. Also felt tired/achy sensation in (R) arm for a day. 5 days post vaccination - whole body feels tense and feels like muscle contracting "like I had 10 cups of coffee".
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Respiratory tract congestion
Clinical narrative: Flu-like s/s.. Fatigue, nausea, congestion, body aches.
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Patient felt light headed; fainted; 911 called paramedics checked BP and Blood sugars and everything was normal.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Trouble lifting arm (left). Could not lift arm over head. Pain in shoulder and middle arm. Seems to be resolving. Leave to high with shot pt felt.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Malaise, Pyrexia
Clinical narrative: The patient said that 4 to 5 hours after receiving the vaccine for the first time this year, she felt a burning sensation in her sinuses, a low grade fever of 99.9 degree F and a headache and general malaise. Symptoms lasted for 24 hours.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site infection
Clinical narrative: Case number PHEH2015US022723, is an initial spontaneous report received from a pharmacist on 04 Nov 2015. This report refers to a 58-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) prefilled syringe (PFS) intramuscularly on an unknown date. On 22 Oct 2015, the patient developed infection at the injection site. It was reported that the vaccine was administered while the patient was an in-patient at the hospital and the patient was discharged from the hospital on 22 Oct 2015. Final outcome of the event was unknown. Causality was not reported.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cardio-respiratory arrest, Respiratory symptom, Resuscitation
Clinical narrative: Mom reports slight respiratory symptoms before bed on 11/14/15. Mom went to get him out of bed on 11/15/15 and he was in cardiopulmonary arrest. CPR was attempted with no improvement.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Mouth swelling, Pain in extremity, Rash, Swelling face
Clinical narrative: Case number PHEH2015US022730, is an initial spontaneous report received from a consumer on 05 Nov 2015. This report refers to a 44 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date in Sep 2014. The patient experienced rash 2 days after the vaccination followed by swelling in mouth and face area, hand pain and foot pain (Sep 2014). The patient went to the hospital and she was admitted to reduce swelling. The patient was admitted with the events. The physician prescribed loratadine (manufacturer unknown), ranitidine (manufacturer unknown) and allergy medicine twice daily once symptoms started which the patient was taking for over one year. It was reported that when the patient tried to stop 3 medicines symptoms returned. Multiple tests were performed and results were reported as negative. Outcome of the events was reported as not recovered. Causality of the events were not reported.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient experiencing arm pain near injection site. Dull ache all the time exacerbated by movement. Started immediately after the vaccine. Patient has made an appointment to see his MD.
Age: 0.04
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: Pt was given vaccines (DTap-IPV-HBV (PEDIARIX), HIB, PCV13, ROTARIX) that was meant for another patient. No treatment Dr did address the incident with the parent. Not expecting any symptoms.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12 hours after injection noticed injection site reaction - incrased pain, redness, swelling at injectin site 2 days after receiving influenza vaccine (L thigh).
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Obvious zoster outbreak (R) TS.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient received FLUZONE HIGH DOSE to the left arm on 10/21/15 and returned to pharmacy today 11/1815 and said his arm is still hurting.
Age: 77.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: FLUZONE HD was given on 10/21/15 and patient returned to pharmacy 11/18/15 and complained that arm still hurts.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt called and stated he developed fever > 101 degrees post immunization with FLUZONE HD. Pt complained of feeling like he was going to "die". Took Ibuprofen and TYLENOL - was better the morning (11/18/15).
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Livedo reticularis, Ocular hyperaemia, Tachycardia
Clinical narrative: Patient came to the pharmacy today, 11/18/15 to notify us that 2 hours after receiving immunizations at our store, she started to have SOB, tachycardia, respiratory rate 32, marble skin (blue/whitish), redness of the eyes according to her husband, who is a physician. Patient in good condition now. Patient symptoms improved about 5 hours after vaccine administration. No ER visit needed. Patient took BENADRYL.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Injected limb mobility decreased, Malaise, Skin warm, Vomiting
Clinical narrative: Throwing up; hot area on arm; couldn't move left arm; very anxious; very sick feeling.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This case is linked to case number 2015SA007140 (same reporter and same patient). A 56-year-old female patient had received a dose of influenza vaccine (manufacturer unknown, batch number, dose number, 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 unspecified date, after vaccination, the patient had low grade fever and sore throat. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Influenza virus test negative
Clinical narrative: Initial pregnancy unsolicited literature report received on 03 Feb 2015. This case is linked to 2015SA016408 (same reported). One hundred and twelve pregnant female patients (age not reported) whose medical history and concomitant medication were not reported, had received a dose of INFLUENZA VACCINE (batch number, route and site of vaccination was not reported) on an unspecified date. Conclusion: Influenza had a greater negative impact on pregnant women than non-influenza ARIs, as indicated by symptom severity and greater likelihood of elevated temperature. These results highlight the importance of preventing and treating influenza illnesses in pregnant women. The case concerns with one hundred and twelve female patients who were identified to be influenza negative on an unspecified date. Corrective treatment and laboratory investigations were not reported. Documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Initial unsolicited report received from a healthcare professional on 05 February 2015. A 41-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, cycle in the series, route of administration, site of administration were not reported) on 30 January 2015. On 30 January 2015 after later that evening after vaccination patient felt like fever, and next day on 31 January 2015 patient developed swelling in her hand and feet as well as hives on her face. Laboratory investigations were not provided and patient was treated with MOTRIN. On an unknown date patient had recovered from the all events. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 18 March 2015. A 58-year-old female patient had received first dose of FLUZONE ID (batch number unknown) intradermally in left deltoid, on 10 February 2015. The patient had no illness at the time of vaccination and had a history of allergies to nuts and seafood. The patient's concomitant medications were not reported. On 12 February 2015, two days after vaccination, the patient had in the clavicle area a "soft" area that was swollen. There was no soreness or pain in that area. On 17 March 2015, the area was still soft and swollen with no problem at the injection site and there were no limited ROM at arm, shoulder or neck. The patient was sent to emergency room for doctor visit. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the event. List of documents held by sender: none. Follow up information received from a physician on 20 April 2015. The patient had received FLUZONE ID (batch number was not provided) on 10 February 2015. It was reported that patient was send to occupational health for physician visit and previously it was reported that the patient was sent to emergency room for physician visit. On an unspecified date two weeks later the patient had recovered from the event. It was reported the patient did not receive any treatment by employee health or PCP. Documents held by sender: none. Follow up information received from a nurse on 06 July 2015. It was reported that, FLUZONE ID was administered on 10 March 2015 (in initial report it was 10 February 2015). On 12 March 2015 (in initial report it was 12 February 2015), i.e. two days after administration patient had experienced "soft" area that was swollen in the clavicle area. No new additional information reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Bone contusion, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional (Pharmacy Account Specialist) on 09 February 2015. A female patient (age unknown) had received a dose of FLUZONE (batch number, dose number, route and site of administration were not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. It was reported that the patient might have been administered vaccine into bursa resulting in incorrect route of drug administration. On an unspecified date, the patient had bone bruising. MRI was done and showed bone bruising and corrective treatments were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: None.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, X-ray limb
Clinical narrative: Initial unsolicited report received from a consumer on 12 March 2015. A 81-year-old male patient had received first dose of FLUZONE HD (batch number was unknown and expiry date, dose and site of administration were not reported) via intramuscular route on 15-October-2014. The patient had no other vaccinations within 4 weeks of vaccination. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included Iodine and Cardiac stents. On 16-October-2014 (morning) one day after vaccination, the patient experienced arthritis and all over joint pain. The patient reported that the joint pain has persisted since then he has seem many doctors including an Orthopedic surgeon who can't find anything wrong. The patient required ER/doctor visit. Laboratory investigation included bila shoulder x-ray. Corrective treatment includes TYLENOL. At the time of report, the outcome of event was not recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from a Nurse on 12-Mar-2015. A female patient (age not provided), who had no medical history and no concomitant medications were taken, had received a dose of FLUZONE vaccine via intradermal route (dose details, batch number, expiry date and site of administration not provided) on 10-Jul-2013 and 0.5 ml first dose of PNEUMOVAX 23 via subcutaneous route (batch number: K019386, expiry date: 09-Jun-2016, site of administration was not provided) on 18-Jan-2015 around 13:00 hours. On an unspecified date, the patient developed redness at the injection site due to eggs being in the FLUZONE vaccine. On 18-Jan-2015 at 16:00 hours after vaccination, the patient developed swelling and redness at the injection site which extended to a 6 inch area. It was reported that "by the end of yesterday" the patient developed fever and chills. The fever was as high as 100.2 degree Fahrenheit. The swelling and redness at the injection site extended "yesterday" to a 6 inch area. Laboratory investigations were not performed and the patient received corrective treatment which was not specified. At the time of this report, the patient had recovered from the event: redness at the injection site, after administration of FLUZONE vaccine on an unspecified date. The patient had not recovered from the events: fever, chills, swelling and redness at the injection site which extended to a 6 inch area. It was reported that the patient sought medical attention. Documents held by sender: none. Follow up information received from a healthcare professional on 13 April 2015: No new information received, however events details were changed as per previous version source document.