chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Flu symptoms on a mini scale; body aches, headache, feverish, tired & run down within the first week of injection. Symptoms mostly disappeared by Dec 1. By December 3 I had a shingles attack, in spite of having a shingles vaccine 3 years ago. Attack was minor and confined to stomach/side on my left side only. Consists of 5-6 small blisters that look exactly as in on line article, and the attendant pain.   (Thought I had rolled in glass when I woke up on 12/3/17). Pain is there when area touched but not now especially troublesome after getting dressed. Then, on 12/4/17 morning, began diarrhea in liquid form, still experiencing at 6 PM 12/4. In addition, I thought my moderate Crohn's had flared the week after the flu shot, after being well controlled for a year and a half, but  the current succession of flu symptoms make that suspect.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Eczema
Clinical narrative: Eczema all over his back and butt which has been there since the vaccine and he is almost one now. It is becoming worse and more prominent.
Age: 0.92
Sex: M
Vaccine: HIBV, MMR, PNC13, YF
Symptoms: Urticaria
Clinical narrative: Mother reported hives for 2.5 weeks after yellow fever vaccine. Reported to this RN on 10/16/2017 during a follow-up visit for other vaccines. No action from health department clinic since child was no longer having reaction. Unknown what the treatment was.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented with redness and soreness at the injection site. Patient was told to apply cold compresses and take ibuprofen or TYLENOL for the pain. Talked with patient on Monday and the injection site reaction had improved.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Choking, Cough, Dysuria, Fatigue
Clinical narrative: Day following immunization, coughing to point of choking (spasm), stomach hurt, urination, fatigue, runny nose, red eyes. Felt poorly and missed work 11/30, and went to ER 12/1 and missed work..At work 12/4/2017.29.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Impaired work ability, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Day following immunization, coughing to point of choking (spasm), stomach hurt, urination, fatigue, runny nose, red eyes. Felt poorly and missed work 11/30, and went to ER 12/1 and missed work..At work 12/4/2017.29.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Day following immunization, coughing to point of choking (spasm), stomach hurt, urination, fatigue, runny nose, red eyes. Felt poorly and missed work 11/30, and went to ER 12/1 and missed work..At work 12/4/2017.29.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus
Clinical narrative: Patient complains of major "itchiness" as well as severe body pain 4 hours after receiving the vaccination on 11/29. On 12/4, Patient called the pharmacy and complained of those symptoms. Advised patient to take BENADRYL to help with body itchiness as well as TYLENOL to help patient with the pain. Advised patient to contact their PCP if symptoms don't improve.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Both injections were given in the same arm, an inch a part. Patient reported arm was sore the following day, two days later patient came into our store reporting arm was red, swollen and painful. With advice, she went to the urgent care clinic. Cellulitis was the diagnosis. She was given an antibiotic and a steroid. On follow up, she is responding to the medications and arm was no longer red and swollen.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Pain
Clinical narrative: Fever, generalized body aches, headache, nausea,diarrhea, malaise.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, generalized body aches, headache, nausea,diarrhea, malaise.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Insomnia, Rash erythematous
Clinical narrative: I HAD A BLACK SPOT WHERE THE SHOT WAS GIVEN, HAD PAIN IN MY RIGHT SHOULDER AND UNABLE TO SLEEP, RED RASH ON RIGHT SHOULDER.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: Generally mild and not unexpected, but worse than previous years. More soreness at site than usual. Malaise/Fatigue. Mild diaphoresis. Body temperature 100.0F.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Diagnosed as Bell's Palsy.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Exposure during pregnancy
Clinical narrative: Gave pt flu vaccine, after a few mins pt states having heart fluttering and chest burning and constriction. Observed pt. Pt was able to continue to take deep breaths and was alert and responsive the entire time.  Continued to have heart flutting and due to pregnancy and heart symptoms, contacted 911. Pt was taken by ems to hospital for observation.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Patient developed severe arm pain. I believe within a few hours of the vaccination. Her husband took her to the emergency room where they examined her and took x-rays. They could find no structural issue. She was sent home with a pain prescription and instructions to ice for 3 days and then alternate ice with warm. Patient saw her family physician, I believe the next day. He referred her to orthopedic for exam. He scheduled patient for an MRI this coming Saturday, 12/09/2017. I talked to patient today...she is getting better, but, still experiencing pain.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Asthenia, Blood 25-hydroxycholecalciferol, Blood cortisol
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Blood testosterone, Blood thyroid stimulating hormone, Blood uric acid, Borrelia test
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein, Chest X-ray, Culture, Differential white blood cell count, Electrocardiogram
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Epstein-Barr virus test, Full blood count, Hepatitis C antibody, Lipids, Metabolic function test
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Microscopy, Mobility decreased, Pain, Periarthritis, Prostatic specific antigen
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Thyroxine free, Tri-iodothyronine free, Urine analysis
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Vitamin B12
Clinical narrative: Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body -- hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site rash, Injection site swelling, Swelling, Swelling face
Clinical narrative: Pt given KINRIX and PROQUD approx 1:45 on the afternoon of 12/1. By the next day, mo noticed a couple "bumps" on her left thigh that progressed to a swollen area about the size of a fist. Then about 5 pm she developed redness and swelling to the rt side of her face, swelling progressed down neck, chest and behind ear. Tonsils also looked red and swollen. No labored breathing or wheezing. Mom administered oral Benadryl and started to take her to the ER. On their way to ER her sx started to improve and they returned home. Mom gave another dose of Bendaryl on 12/3 and today 12/4 is applying topical hct to swollen area on thigh which is not half the size is was.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Tonsillar erythema, Tonsillar hypertrophy
Clinical narrative: Pt given KINRIX and PROQUD approx 1:45 on the afternoon of 12/1. By the next day, mo noticed a couple "bumps" on her left thigh that progressed to a swollen area about the size of a fist. Then about 5 pm she developed redness and swelling to the rt side of her face, swelling progressed down neck, chest and behind ear. Tonsils also looked red and swollen. No labored breathing or wheezing. Mom administered oral Benadryl and started to take her to the ER. On their way to ER her sx started to improve and they returned home. Mom gave another dose of Bendaryl on 12/3 and today 12/4 is applying topical hct to swollen area on thigh which is not half the size is was.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient says about 1 week after injection her arm started to hurt and is still persisting 1 month later. Patient's arm is tender to touch, she denies fever, swelling, redness or any nodules. Pharmacist referred patient to physician for evaluation.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient stated that he had a fainting incident after receiving a flu-shot about 7 years ago. After carefully reviewing his current condition, both parties agreed to receive an MMR vaccine for his school purpose. Immediately after giving MMR vaccine, patient appeared to be slightly pale. Patient was advised to drink some water and remain seated next 10 minutes. About 10 minutes after receiving the vaccine, patient's face turned pale, and he lost consciousness for 2 seconds in sitting up position, holding up his both arms close to his chest. Patient gained his consciousness quickly after the incidence and laid on the bench with his legs elevated. After 10 minutes of lying down, his blood pressure was measured at 116/65 and pulse was 56. His face color returned to normal, and patient was able to make conversation. No sign of shortness of breath or allergic reaction. Second blood pressure was measured 10 minutes after, and it came back 121/70 with pulse 56. Patient and mother agreed to leave. Follow-up phone call was made at 6:30pm on the same day. Mother stated "He is fine and back to normal himself".
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: Syncope. Pt fainted.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm where PREVNAR B injection was administered was red, bumpy, hot, painful right away after shot. 4 days later started getting worse, 1 week later seen at urgent care and diagnosed with cellulitis, got Abx, swollen jaw on left side, seen by dentist given mouthwash. May lose tooth due to infection. Has headache due to infection.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site warmth, Swelling face, Tooth infection
Clinical narrative: Left arm where PREVNAR B injection was administered was red, bumpy, hot, painful right away after shot. 4 days later started getting worse, 1 week later seen at urgent care and diagnosed with cellulitis, got Abx, swollen jaw on left side, seen by dentist given mouthwash. May lose tooth due to infection. Has headache due to infection.
Age: 5.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling, erythema, itching at site of vaccination.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Eye infection, Nausea, Sensation of foreign body
Clinical narrative: Patient stated that the day after flu shot given, she experienced severe coughing that led to nausea/vomiting, she lost her voice, developed an eye infection and felt a lump in her throat.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient stated that the day after flu shot given, she experienced severe coughing that led to nausea/vomiting, she lost her voice, developed an eye infection and felt a lump in her throat.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Generalised erythema, Injection site discolouration, Injection site swelling, Pyrexia
Clinical narrative: Patient returned to pharmacy on 11/20/17 S/P PREVNAR 13 immunization c/o swelling at sight of injection and fever. Pharmacist described the upper aspect of left arms as silver dollar sized dark area and generalized redness about 4 inches in length. Patient was advised to ice arm and to seek attention at urgent care. Follow up T/C with patient on 11/24/17; Mostly resolved - pt did not seek medical attn. Again advised to MD if condition returned.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin reaction
Clinical narrative: Patient returned to pharmacy on 11/20/17 S/P PREVNAR 13 immunization c/o swelling at sight of injection and fever. Pharmacist described the upper aspect of left arms as silver dollar sized dark area and generalized redness about 4 inches in length. Patient was advised to ice arm and to seek attention at urgent care. Follow up T/C with patient on 11/24/17; Mostly resolved - pt did not seek medical attn. Again advised to MD if condition returned.
Sex: M
Vaccine: YF
Symptoms: Blister, Erythema, Injection site vesicles, Pruritus, Swelling
Clinical narrative: Initial unsolicited report received from the literature, on 23-Oct-2017. This case is linked with linked with 2017SA207244, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280, 2017SA207282, 2017SA205665 (Same reporter). The following is the abstract from the article: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves 23 years old male patient who was vaccinated with second dose of YF-VAX (batch number: UE631AA, expiry date, route and site of administration were not reported) on 21 May 2006. The patient's medical history was not reported and concomitant medication were reported as none. On 21 May 2006 same day evening patient reports slight amount of swelling that progressed the following day to include advance of the redness and swelling from triceps area to just below his elbow with blister formation along the outer aspect of his arm and also had 3 blisters along inner aspect of the arm with redness extending upward to at 4 inches below left axilla. On 23 May 2006, two days post vaccination, patient had multiple vesicles at inoculation site, large area of redness with blisters, swelling and itchy of upper arm. Patient required emergency visit. Patient denies fever, SOB, chest or joint pains, headache, nausea or vomiting. Laboratory investigation were reported as none. Patient was treated with Prednisone 40mg 1 tab orally seven days. ALLEGRA 180mg tab orally daily and BENADRYL 50mg 1 tab orally HS. RTC in 1 week for evaluation. On an unspecified date, patient was recovered from events. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Blood potassium, Blood test, Computerised tomogram, Facial paralysis, Fatigue
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Glycosylated haemoglobin, Headache, Hypoaesthesia oral, Laboratory test, Lipids
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Activated partial thromboplastin time, Blood magnesium, Blood potassium, Computerised tomogram head, Facial paralysis
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Full blood count, Glycosylated haemoglobin, International normalised ratio, Lipids, Metabolic function test
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Nuclear magnetic resonance imaging brain
Clinical narrative: Bell's palsy started 2 days later, was admitted to hospital and had stroke workup, saw neurology. Treated with antivirals and steroids. Symptoms improved slowly over next few months, still mild symptoms remain.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Erythema, Loss of consciousness, Oedema peripheral, Peripheral swelling
Clinical narrative: The patient Is an 81-year-old female with a history of diabetes and CVD received PREVNAR 13 and seasonal IIV on Thursday 26 October 2017 to her left deltoid and experienced a significant local reaction to her upper extremity and weakness. She reports she experienced significant pain during the injection process, both vaccines administered very deeply. The Vaccinator 'hit the bone'.  She also had expressed concerns about receiving both vaccine simultaneously in the same arm. The left arm was avoided due to history of right mastectomy. She states next day the left arm was on fire, 'had fever in it ', was bright red, pruritic, edematous and painful from her shoulder to her elbow. She has discomfort in the axilla. She maintained ROM. She treated it with Benadryl, Tylenol, and ice. She reports it is still erythematous and has a fluid collection at the elbow but is overall much improved and most of the pruritus has resolved. She states she also experienced a systemic reaction characterized by severe weakness. She had an episode of near syncope while showering. She was too weak to get up. She receives assistance from family member and recovered. On Monday (day 4) she went to urgent care and was instructed to continue her current treatment of Benadryl, Tylenol and ice packs. She has stopped medications in the past two days. She experienced no immediate reaction after vaccine receipt such as urticaria, pruritus, oral/facae or throat swelling. She denies systemic reaction of fever, chills, headache, nausea, cough or generalized dermatitis.. She reports previous vaccine reaction of severe edema, erythema and pain from shoulder to below the elbow, with decreased range of motion to shingles vaccine in 2009 (She was unsure if shingles or pneumococcal, but shingles is documented).  She confirms receipt was at clinic. She denies any previous issues with influenza vaccine.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Skin warm
Clinical narrative: The patient Is an 81-year-old female with a history of diabetes and CVD received PREVNAR 13 and seasonal IIV on Thursday 26 October 2017 to her left deltoid and experienced a significant local reaction to her upper extremity and weakness. She reports she experienced significant pain during the injection process, both vaccines administered very deeply. The Vaccinator 'hit the bone'.  She also had expressed concerns about receiving both vaccine simultaneously in the same arm. The left arm was avoided due to history of right mastectomy. She states next day the left arm was on fire, 'had fever in it ', was bright red, pruritic, edematous and painful from her shoulder to her elbow. She has discomfort in the axilla. She maintained ROM. She treated it with Benadryl, Tylenol, and ice. She reports it is still erythematous and has a fluid collection at the elbow but is overall much improved and most of the pruritus has resolved. She states she also experienced a systemic reaction characterized by severe weakness. She had an episode of near syncope while showering. She was too weak to get up. She receives assistance from family member and recovered. On Monday (day 4) she went to urgent care and was instructed to continue her current treatment of Benadryl, Tylenol and ice packs. She has stopped medications in the past two days. She experienced no immediate reaction after vaccine receipt such as urticaria, pruritus, oral/facae or throat swelling. She denies systemic reaction of fever, chills, headache, nausea, cough or generalized dermatitis.. She reports previous vaccine reaction of severe edema, erythema and pain from shoulder to below the elbow, with decreased range of motion to shingles vaccine in 2009 (She was unsure if shingles or pneumococcal, but shingles is documented).  She confirms receipt was at clinic. She denies any previous issues with influenza vaccine.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Axillary pain, C-reactive protein increased, Injection site erythema, Injection site oedema
Clinical narrative: The patient Is an 81-year-old female with a history of diabetes and CVD received PREVNAR 13 and seasonal IIV on Thursday 26 October 2017 to her left deltoid and experienced a significant local reaction to her upper extremity and weakness. She reports she experienced significant pain during the injection process, both vaccines administered very deeply. The Vaccinator 'hit the bone'.  She also had expressed concerns about receiving both vaccine simultaneously in the same arm. The left arm was avoided due to history of right mastectomy. She states next day the left arm was on fire, 'had fever in it ', was bright red, pruritic, edematous and painful from her shoulder to her elbow. She has discomfort in the axilla. She maintained ROM. She treated it with Benadryl, Tylenol, and ice. She reports it is still erythematous and has a fluid collection at the elbow but is overall much improved and most of the pruritus has resolved. She states she also experienced a systemic reaction characterized by severe weakness. She had an episode of near syncope while showering. She was too weak to get up. She receives assistance from family member and recovered. On Monday (day 4) she went to urgent care and was instructed to continue her current treatment of Benadryl, Tylenol and ice packs. She has stopped medications in the past two days. She experienced no immediate reaction after vaccine receipt such as urticaria, pruritus, oral/facae or throat swelling. She denies systemic reaction of fever, chills, headache, nausea, cough or generalized dermatitis.. She reports previous vaccine reaction of severe edema, erythema and pain from shoulder to below the elbow, with decreased range of motion to shingles vaccine in 2009 (She was unsure if shingles or pneumococcal, but shingles is documented).  She confirms receipt was at clinic. She denies any previous issues with influenza vaccine.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Local reaction, Presyncope
Clinical narrative: The patient Is an 81-year-old female with a history of diabetes and CVD received PREVNAR 13 and seasonal IIV on Thursday 26 October 2017 to her left deltoid and experienced a significant local reaction to her upper extremity and weakness. She reports she experienced significant pain during the injection process, both vaccines administered very deeply. The Vaccinator 'hit the bone'.  She also had expressed concerns about receiving both vaccine simultaneously in the same arm. The left arm was avoided due to history of right mastectomy. She states next day the left arm was on fire, 'had fever in it ', was bright red, pruritic, edematous and painful from her shoulder to her elbow. She has discomfort in the axilla. She maintained ROM. She treated it with Benadryl, Tylenol, and ice. She reports it is still erythematous and has a fluid collection at the elbow but is overall much improved and most of the pruritus has resolved. She states she also experienced a systemic reaction characterized by severe weakness. She had an episode of near syncope while showering. She was too weak to get up. She receives assistance from family member and recovered. On Monday (day 4) she went to urgent care and was instructed to continue her current treatment of Benadryl, Tylenol and ice packs. She has stopped medications in the past two days. She experienced no immediate reaction after vaccine receipt such as urticaria, pruritus, oral/facae or throat swelling. She denies systemic reaction of fever, chills, headache, nausea, cough or generalized dermatitis.. She reports previous vaccine reaction of severe edema, erythema and pain from shoulder to below the elbow, with decreased range of motion to shingles vaccine in 2009 (She was unsure if shingles or pneumococcal, but shingles is documented).  She confirms receipt was at clinic. She denies any previous issues with influenza vaccine.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Red blood cell sedimentation rate increased, Skeletal injury, Streptococcus test negative
Clinical narrative: The patient Is an 81-year-old female with a history of diabetes and CVD received PREVNAR 13 and seasonal IIV on Thursday 26 October 2017 to her left deltoid and experienced a significant local reaction to her upper extremity and weakness. She reports she experienced significant pain during the injection process, both vaccines administered very deeply. The Vaccinator 'hit the bone'.  She also had expressed concerns about receiving both vaccine simultaneously in the same arm. The left arm was avoided due to history of right mastectomy. She states next day the left arm was on fire, 'had fever in it ', was bright red, pruritic, edematous and painful from her shoulder to her elbow. She has discomfort in the axilla. She maintained ROM. She treated it with Benadryl, Tylenol, and ice. She reports it is still erythematous and has a fluid collection at the elbow but is overall much improved and most of the pruritus has resolved. She states she also experienced a systemic reaction characterized by severe weakness. She had an episode of near syncope while showering. She was too weak to get up. She receives assistance from family member and recovered. On Monday (day 4) she went to urgent care and was instructed to continue her current treatment of Benadryl, Tylenol and ice packs. She has stopped medications in the past two days. She experienced no immediate reaction after vaccine receipt such as urticaria, pruritus, oral/facae or throat swelling. She denies systemic reaction of fever, chills, headache, nausea, cough or generalized dermatitis.. She reports previous vaccine reaction of severe edema, erythema and pain from shoulder to below the elbow, with decreased range of motion to shingles vaccine in 2009 (She was unsure if shingles or pneumococcal, but shingles is documented).  She confirms receipt was at clinic. She denies any previous issues with influenza vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. The patient's pertinent medical history included diabetes, high cholesterol and high blood pressure. The patient had no drug reactions or allergies. On 11-APR-2017 at 10.00 AM, the patient was vaccinated with PNEUMOVAX 23 intramuscular in left arm (lot # N022703, expiration date: 27-FEB-2019, dose and schedule were not reported) for prophylaxis. On the same day, at 12.00 PM the patient received an unknown flu shot in the left arm. On an unknown date in 2017, the patient experienced swelling of the left arm, redness and pain between the shoulder and elbow of the arm. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided by the reporter.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. The patient's pertinent medical history included diabetes, high cholesterol and high blood pressure. The patient had no drug reactions or allergies. On 11-APR-2017 at 10.00 AM, the patient was vaccinated with PNEUMOVAX 23 intramuscular in left arm (lot # N022703, expiration date: 27-FEB-2019, dose and schedule were not reported) for prophylaxis. On the same day, at 12.00 PM the patient received an unknown flu shot in the left arm. On an unknown date in 2017, the patient experienced swelling of the left arm, redness and pain between the shoulder and elbow of the arm. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided by the reporter.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a pharmacist who refers to an 89 year old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 04-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N022703, expiration date:27-FEB-2019, dose, and route of administration were not provided) as preventive care. On 04-NOV-2017, the patient experienced feeling very shaky and felt like she had a fever but did not have a fever and has been feeling this way ever since received PNEUMOVAX 23. The patient went to see a physician and received unspecified treatment for the event. The outcome of the events and the relatedness between the events and suspected vaccine were not reported.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Feeling abnormal, Nervousness
Clinical narrative: This spontaneous report was received from a pharmacist who refers to an 89 year old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 04-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N022703, expiration date:27-FEB-2019, dose, and route of administration were not provided) as preventive care. On 04-NOV-2017, the patient experienced feeling very shaky and felt like she had a fever but did not have a fever and has been feeling this way ever since received PNEUMOVAX 23. The patient went to see a physician and received unspecified treatment for the event. The outcome of the events and the relatedness between the events and suspected vaccine were not reported.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no pertinent medical history nor concomitant medications. On 15-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N004564, intramuscular for prophylaxis (dose, site of administration and expiration date were not reported). On 16-NOV-2017, the patient began to experience pain, swelling and redness 1 inch around the injection site, fever and chills. The patient went to an unspecified emergency room for treatment and was hospitalized in approximately November 2017. She received unspecified prescriptions of prednisone (manufacturer unknown) and KEFLEX. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no pertinent medical history nor concomitant medications. On 15-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N004564, intramuscular for prophylaxis (dose, site of administration and expiration date were not reported). On 16-NOV-2017, the patient began to experience pain, swelling and redness 1 inch around the injection site, fever and chills. The patient went to an unspecified emergency room for treatment and was hospitalized in approximately November 2017. She received unspecified prescriptions of prednisone (manufacturer unknown) and KEFLEX. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Intermittent hives, treatment with antihistamines and Zantac. Hives started 11/12/17 to 12/4/2017.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient reported back to pharmacy on 12/04/17 showing pronounced redness on arm around injection site.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Per patient-atypical vaccine reaction. Shortly after administration developed sharp pain down upper arm esp with movement/raising arm. Complaints of achiness down middle of arm/elbow, throbs at times. Unable to sleep on left side. Restricted movement and tender/sore to touch. Patient stated that she thought the vaccine was administered too high on her left arm. She was sent to an Occupational Health Provider and was diagnosed with symptoms of subacromial bursitis. The medical provider was not conovinced the symptoms were related to the injection. She recieved a steroid injection with some relief initially but symptoms have worsened.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Per patient-atypical vaccine reaction. Shortly after administration developed sharp pain down upper arm esp with movement/raising arm. Complaints of achiness down middle of arm/elbow, throbs at times. Unable to sleep on left side. Restricted movement and tender/sore to touch. Patient stated that she thought the vaccine was administered too high on her left arm. She was sent to an Occupational Health Provider and was diagnosed with symptoms of subacromial bursitis. The medical provider was not conovinced the symptoms were related to the injection. She recieved a steroid injection with some relief initially but symptoms have worsened.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain for 3 weeks after injections in left arm.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling abnormal, Peripheral coldness
Clinical narrative: Patient experiencing very cold hands and very dizzy and feeling out of it.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Cool compresses 20 minutes every hour or two while awake, elevate Lt arm.
Age: 69.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Extreme pain in arm (where shot given) painful rash entire length of arm, Fever and chills, Headache, achey all over. I rested and took Ibuprofen for 3 days. Feel fine now.
Age: 69.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Rash
Clinical narrative: Extreme pain in arm (where shot given) painful rash entire length of arm, Fever and chills, Headache, achey all over. I rested and took Ibuprofen for 3 days. Feel fine now.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: Patient came to the pharmacy expecting to received the PREVNAR 13 vaccine. Miscommunication occurred and the patient received the FLUAD vaccine on 12/4/17 at approximately 11:45am. By 12:15pm the patient arrived home and noticed his patient receipt was for the FLUAD vaccine. The  patient came into the pharmacy on 12/5/17 at approximately 9:50am reporting arm pain.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site erythema
Clinical narrative: Red area on right thigh that expanded to 11cm by 5cm.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Swelling
Clinical narrative: Pain, swelling.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient says her arm has been sore since receiving the flu shot.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Pain, swelling, redness, and itchiness on right arm. Patient went to see her primary physician regarding the rash and was prescribed steroids by topical and oral route.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Lethargy, Pyrexia, Urticaria, White blood cell count normal
Clinical narrative: Following day, mother describes fever to 104F, hives - welts size of mosquito bites over anterior thighs, legs, and upper arms, along with lethargy.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood glucose increased, Blood ketone body present, Erythema, Nausea
Clinical narrative: Within 30 minutes of leaving doctor's office and receiving vaccine patient start to feel weak and nausea. By the next day she was vomiting, had a fever of 102 and a very sore arm. 2 days after receiving the vaccine she went to student health clinic and they told her what she had was probably viral but upon looking at her arm, she had redness and puffiness. They marked the red circle with a pen so the patient could monitor for worsening conditions. By the next day, she continued to have a fever and nausea and the redness on area was worse so she reported to her local ED. At this time she received fluids and insulin due to high blood sugars and ketones from Type 1 Diabetes and received antibiotics for worsening redness, swelling and pain the her left arm.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Viral infection, Vomiting
Clinical narrative: Within 30 minutes of leaving doctor's office and receiving vaccine patient start to feel weak and nausea. By the next day she was vomiting, had a fever of 102 and a very sore arm. 2 days after receiving the vaccine she went to student health clinic and they told her what she had was probably viral but upon looking at her arm, she had redness and puffiness. They marked the red circle with a pen so the patient could monitor for worsening conditions. By the next day, she continued to have a fever and nausea and the redness on area was worse so she reported to her local ED. At this time she received fluids and insulin due to high blood sugars and ketones from Type 1 Diabetes and received antibiotics for worsening redness, swelling and pain the her left arm.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient developed a 6 cm area of erythema/hives surrounding injection site for MMR and varicella on right thigh within 5 minutes of receiving vaccine. The patient was monitored in our office but no additional treatments were given. No other symptoms developed and the rash almost completely resolved within 20 minutes.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Decreased appetite, Fluid intake reduced, Opisthotonus, Screaming
Clinical narrative: Hysterical ear-piercing screaming and crying fits throughout the day. Hysterical ear-piercing screaming crying fits during the night accompanied by clenching of fists, arching back, and shaking of arms like in extreme pain. Fits lasting up to 1 hour or more in length each time. Black and blue circles under eyes, loss of appetite, and loss of drinking appetite. He will put hand up to head as if having pain in his head and will let out a scream and cry.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Skin discolouration, Tremor
Clinical narrative: Hysterical ear-piercing screaming and crying fits throughout the day. Hysterical ear-piercing screaming crying fits during the night accompanied by clenching of fists, arching back, and shaking of arms like in extreme pain. Fits lasting up to 1 hour or more in length each time. Black and blue circles under eyes, loss of appetite, and loss of drinking appetite. He will put hand up to head as if having pain in his head and will let out a scream and cry.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: About 45 minutes after receiving vaccine the patient was at home and while reaching into the refrigerator he got dizzy and passed out. Patients wife said he lost consciousness for a few seconds.  Patient said he felt dizzy and tired for several minutes afterward and did not feel completely normal for 2 days afterwards.
Sex: U
Vaccine: PPV
Symptoms: Injection site pruritus, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 09-NOV-2017, the patient was inadvertently vaccinated with an expired and improperly stored dose of PNEUMOVAX 23 for prophylaxis (dose and route were unknown; lot # L034335, expiry date: 18-MAY-2017). The vaccine underwent a temperature of 22C for a timeframe of 5 and 1/2 months (from end of May 2017 until 08-NOV-2017). There was not previous temperature excursion and data logger was not involved. In November 2017, the patient experienced itching at the site of injection (Injection site pruritus). The outcome of injection site pruritus, was unknown.  The causality assessment between PNEUMOVAX 23 and injection site pruritus was not reported.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 82-year-old female patient. The patient's concomitant therapies included some unspecified medications. The patient did not have any pertinent medical history, drug reactions or allergies. On 07-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in right arm, lot# N020502 and expiration date 08-FEB-2019 (dose was not reported) as pneumonia prevention. On approximately 08-NOV-2017 (reported as "about a day later"), the patient started having redness, stiffness and swelling on her right arm. It was reported that the swelling was about the size of a grapefruit. No treatment was given for the events and no lab diagnostics were performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Injury associated with device, Laboratory test
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age who was also a nurse. The patient's relevant medical history, concomitant medications and past drug history were unknown. On 11-NOV-2017, the patient was administrating RECOMBIVAX HB (lot# N006321, expiration date 08-NOV-2019; dose, strength, route unknown) to a newborn baby. The patient accidentally got a finger stick and stuck herself after giving the baby the injection (occupational exposure to product, accidental exposure to product and injury associated with device). In November 2017, the patient had testing done after the finger stick but didn't have the result back yet. As of 12-NOV-2017, the patient would no longer got RECOMBIVAX HB because of it was accidental, and the outcome of the finger stick was unknown. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1711USA005222:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-JAN-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M005286, expiration date 08-OCT-2017, (strength and route of administration were not provided) for prophylaxis. The reporter stated that on 09-AUG-2017, the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23, lot# N010106, expiration date 15-NOV-2018 (strength and route of administration were not provided) for prophylaxis.  No adverse events were reported.