chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Feeling abnormal, Lymphadenopathy, Malaise
Clinical narrative: Received Flu vaccine on 10/17. Began feeling "funny" neck lymph node  swelling on right side, woke up on 10/19, not feeling well, neck was painful, difficulty breathing, cough, sore throat, progressively worsening thru out the day. Went to ED for evaluation. Patient was seen/treated by Dr.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: Received Flu vaccine on 10/17. Began feeling "funny" neck lymph node  swelling on right side, woke up on 10/19, not feeling well, neck was painful, difficulty breathing, cough, sore throat, progressively worsening thru out the day. Went to ED for evaluation. Patient was seen/treated by Dr.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Myalgia, Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Patient called stating that she received the pneumococcal vaccine on 8/24/2018 and her left arm became very sore, swollen, red, and she could barely stand the pain that she had to take a pain pill; stated she also iced it several times. Myalgia and erythema multiform.
Sex: U
Vaccine: PNC13
Symptoms: Middle insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient woke up out of the sleep and can't move it (arm), and described that it hurts like it's broken or some on an unspecified date. Outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced patient experienced achiness for 1-2 days at the injection site after vaccination on an unspecified date. The outcome of the event was recovered. Information on the batch number has been requested
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Vaccination site reaction
Clinical narrative: Local large reaction on (L) arm at site of vaccine - no systemic symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient is experiencing a sharp pain in the arm he received the injection in when lifting or rotating his arm. He states he first noticed the pain the evening he received the vaccine and it has worsened with time. He is not in constant pain and is able to find positions that are comfortable. He will be notifying his physician as well to see what he should do moving forward.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Feeling cold, Peripheral swelling, Skin reaction
Clinical narrative: Patient experienced tiredness, chills and felt cold. Her arm swelled up on the inside of her arm. Her arm also became red. Patient received vaccine on Wednesday and on that night and into Thursday experienced symptoms. Went to MD and got prescribed LEVAQUIN and prednisone.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: At site of injection, 4 inch raised, red welt. Warm to touch and itchy. Using hydrocortisone and cool compress for symptoms. Shot on 10/20/2018 with reaction occurring same day. Site 2 days later is 4 inches in diameter.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient received flu vaccine 10/15 father noted that eve small amt redness; afebrile. Called on call 10/16 increased redness swelling at site, went to ER Dx with cellulitis on KEFLEX. 10/22 Spoke with parent area all improved.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain
Clinical narrative: Patient reports severe left shoulder pain 7/10 x 2 weeks after receiving the flu vaccine. Also, she experienced a 50 cent piece bruise that occurred the next morning. She was encouraged to use ice and heat to her left shoulder. She reports the heat was helpful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red, sore, and itchy at injections site. There is a white bullseye area where vaccine was injected.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: ARM STARTED TO SWELL AND GOT RED WITHIN A COUPLE HOURS OF VACCINATION, IT WAS ALSO WARM TO TOUCH. REDNESS SPREAD OVER NEXT 2 DAYS AND PATIENT WENT TO EMERGENCY ROOM ON 10/14 AND WAS GIVEN A CEFAZOLIN INJECTION AND A PRESCRIPTION FOR CEPHALEXIN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Neck pain
Clinical narrative: Chills, fever, headache, joint ache, neck ache, body ache, very tired. Lasted 36 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever, headache, joint ache, neck ache, body ache, very tired. Lasted 36 hours.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT PRESENTED WITH INJECTION SITE REACTION. PATIENT COMPLAINED OF SORENESS, SWELLING, SENTISITVITY, AND HEAT IN THE AREA. SHE MENTIONED PAIN IN THE AREA ASWELL.   PATIENT CAME BACK TO THE PHARMACY 2 DAYS POST INJECTION AND THE INVOLVED AREA WAS STILL SWELLED  AND RED AND A LOT OF HEAT FROM THE SITE. PATIENT HAS HAD THE FLU VACCINE IN THE PAST WITHOUT ANY PROBLEMS.
Age: 70.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: Abdominal pain upper, Cold sweat, Diarrhoea, Fatigue, Injected limb mobility decreased
Clinical narrative: Pain started a few hours after the injection. Prior to that, there was no pain or discomfort at the actual time of the injection or for a few hours afterwards. Symptoms started in the late afternoon with Extreme deep pain in upper right arm, inability to move arm without pain, nausea, fever, cold sweat, stomach ache, diarrhea, ill feeling, fatigue. All but the stomach upset lasted at least one week. The extreme pain in arm lasted 2 weeks before beginning to reside. At this date, the pain is still apparent with certain arm movements, but is not extreme. I called my doctor on 9/21/18 (2 weeks after injection and spoke with the nurse describing my symptoms. The nurse talked with the doctor and returned my call on 9/24/18. The instructions were to take 200 mg. Ibuprofen 2 x a day for a week. However, I have continued that treatment.
Age: 70.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: Injection site pain, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Pain started a few hours after the injection. Prior to that, there was no pain or discomfort at the actual time of the injection or for a few hours afterwards. Symptoms started in the late afternoon with Extreme deep pain in upper right arm, inability to move arm without pain, nausea, fever, cold sweat, stomach ache, diarrhea, ill feeling, fatigue. All but the stomach upset lasted at least one week. The extreme pain in arm lasted 2 weeks before beginning to reside. At this date, the pain is still apparent with certain arm movements, but is not extreme. I called my doctor on 9/21/18 (2 weeks after injection and spoke with the nurse describing my symptoms. The nurse talked with the doctor and returned my call on 9/24/18. The instructions were to take 200 mg. Ibuprofen 2 x a day for a week. However, I have continued that treatment.
Age: 70.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: X-ray limb normal
Clinical narrative: Pain started a few hours after the injection. Prior to that, there was no pain or discomfort at the actual time of the injection or for a few hours afterwards. Symptoms started in the late afternoon with Extreme deep pain in upper right arm, inability to move arm without pain, nausea, fever, cold sweat, stomach ache, diarrhea, ill feeling, fatigue. All but the stomach upset lasted at least one week. The extreme pain in arm lasted 2 weeks before beginning to reside. At this date, the pain is still apparent with certain arm movements, but is not extreme. I called my doctor on 9/21/18 (2 weeks after injection and spoke with the nurse describing my symptoms. The nurse talked with the doctor and returned my call on 9/24/18. The instructions were to take 200 mg. Ibuprofen 2 x a day for a week. However, I have continued that treatment.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema
Clinical narrative: Approximately 20 minutes after receiving the influenza vaccine, patient began feeling swelling in her throat. She received a dose of an EPIPEN and was instructed to go to the ER. She waited and received a 2nd dose of the EPIPEN then went to the ED for further evaluation.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site movement impairment, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Excessive swelling in left thigh. Edema noted from left groin to left calf. Erythema and redness extends from injection site circumferentially around thigh. Severe pain noted in left thigh, child refuses to bear weight on affected extremity or bend leg at the knee.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Weight bearing difficulty
Clinical narrative: Excessive swelling in left thigh. Edema noted from left groin to left calf. Erythema and redness extends from injection site circumferentially around thigh. Severe pain noted in left thigh, child refuses to bear weight on affected extremity or bend leg at the knee.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cellulitis, Erythema, Hyperhidrosis, Nausea
Clinical narrative: I had the flu shot on Friday afternoon. I woke up Saturday sweating and in pain. Arm was very swollen. Fever of 100.2 before ibuprofen. IB helped with the pain and fever but the second it wore off it was back. I was nauseous and weak feeling all day and all throughout Sunday and today. Sunday the fever hit 101.6 and the swelling was the WORST (I have pictures). The whole area is hot to the touch. I finally went back to the doctors today and they determined it is cellulitis and they prescribed amoxicillin. How I got a bacterial infection from a vaccine is beyond me. As of today I am still weak feeling, and most of my upper body hurts as if I have been working out, and parts of my arm periodically feel tingly like my arm is asleep.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paraesthesia, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: I had the flu shot on Friday afternoon. I woke up Saturday sweating and in pain. Arm was very swollen. Fever of 100.2 before ibuprofen. IB helped with the pain and fever but the second it wore off it was back. I was nauseous and weak feeling all day and all throughout Sunday and today. Sunday the fever hit 101.6 and the swelling was the WORST (I have pictures). The whole area is hot to the touch. I finally went back to the doctors today and they determined it is cellulitis and they prescribed amoxicillin. How I got a bacterial infection from a vaccine is beyond me. As of today I am still weak feeling, and most of my upper body hurts as if I have been working out, and parts of my arm periodically feel tingly like my arm is asleep.
Age: 73.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Arthropathy, Injection site discolouration, Musculoskeletal pain
Clinical narrative: After a day, I had very dark circle at the site of injection, about the size of a nickel. A few days later I had severe shoulder pain that lasted until today (at this point it's very nearly gone). I also had some joint-issues that have also resolved in the last few days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Fever of 101 degrees Fahrenheit, chills, and sweating for 24 hours beginning 10-12 hours after receiving the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Has localized rash and redness to site of injection. States is itchy and bumpy. Has been putting Benadryl cream on it to help decrease the itch.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Eye swelling, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: None was given, no action taken.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site warmth, Pain
Clinical narrative: None was given, no action taken.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Nasal congestion, Rhinorrhoea, Sinus headache
Clinical narrative: Increased post-nasal congestion, runny nose, sinus headache, reduced lung capacity.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Chest X-ray normal, Chills, Dyspnoea, Electrocardiogram normal
Clinical narrative: 10/17/18 0930 AM: Developed right hand numbness, 1330: shortness of breath, chills, pain radiating from neck to tailbone along the spine and rapid heart rate. Evaluated at ED 10/17/2018 1635 and later admitted to Hospital. At that time experiencing intermintent  numbness and tingling, all 4 distal extremities.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic normal
Clinical narrative: 10/17/18 0930 AM: Developed right hand numbness, 1330: shortness of breath, chills, pain radiating from neck to tailbone along the spine and rapid heart rate. Evaluated at ED 10/17/2018 1635 and later admitted to Hospital. At that time experiencing intermintent  numbness and tingling, all 4 distal extremities.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Spinal pain
Clinical narrative: 10/17/18 0930 AM: Developed right hand numbness, 1330: shortness of breath, chills, pain radiating from neck to tailbone along the spine and rapid heart rate. Evaluated at ED 10/17/2018 1635 and later admitted to Hospital. At that time experiencing intermintent  numbness and tingling, all 4 distal extremities.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Pain in Right ear radiated into neck, could not move head without pain and swollen lymph node in right neck.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Dysgeusia, Injection site pain
Clinical narrative: I received the flu vaccine for employment purposes. I am not sure which flu vaccine it was. Metallic taste in mouth. Soreness at the injection site
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Laboratory test, Pyrexia
Clinical narrative: Father reports that one hour after vaccine administered, patient has chills and teeth were chattering and later developed a fever. Father took patient to ER and they diagnosed him with fever, but father feels it was an adverse reaction. All symptoms have resolved.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Brain oedema, Central nervous system lesion, Computerised tomogram, Dependence on oxygen therapy, Diaphragmatic paralysis
Clinical narrative: Pt presented with respiratory failure, mechanical ventilator, oxygen dependent, left torticollis, dysphagia, right diaphragm paralysis, right sided hemiparesis, swelling at right hemi cord - medulla oblongata through C6. NG tubes, feeding tube dependent. Pt was diagnosed with transverse myelitis. Pt treated with IVIG, steriods and antibiotics
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dysphagia, Feeding tube user, Gastrointestinal tube insertion, Hemiparesis, Immunoglobulin therapy
Clinical narrative: Pt presented with respiratory failure, mechanical ventilator, oxygen dependent, left torticollis, dysphagia, right diaphragm paralysis, right sided hemiparesis, swelling at right hemi cord - medulla oblongata through C6. NG tubes, feeding tube dependent. Pt was diagnosed with transverse myelitis. Pt treated with IVIG, steriods and antibiotics
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Mechanical ventilation, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Respiratory failure
Clinical narrative: Pt presented with respiratory failure, mechanical ventilator, oxygen dependent, left torticollis, dysphagia, right diaphragm paralysis, right sided hemiparesis, swelling at right hemi cord - medulla oblongata through C6. NG tubes, feeding tube dependent. Pt was diagnosed with transverse myelitis. Pt treated with IVIG, steriods and antibiotics
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Torticollis, X-ray
Clinical narrative: Pt presented with respiratory failure, mechanical ventilator, oxygen dependent, left torticollis, dysphagia, right diaphragm paralysis, right sided hemiparesis, swelling at right hemi cord - medulla oblongata through C6. NG tubes, feeding tube dependent. Pt was diagnosed with transverse myelitis. Pt treated with IVIG, steriods and antibiotics
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Pt presented on 10/21/18 with erythema approximately 2 inch diameter surrounding the injection site. Pt proceeded to see an MD later in the day who determined this is a local site reaction. Pt iced the reaction and on 10/22 the reaction has decreased. No other symptoms were reported.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Injection site pain, Night sweats, Pulse abnormal
Clinical narrative: Second dose of SHINGRIX administered by Pharmacy Saturday 10-20-2018 @ 2:00PM. Sunday 7:00AM 10-21-2018 woke with fatigue and a fever of 100.9. The injection site was extremely painful. I went to the CDC website for adverse reactions to SHINGRIX, and read the data, etc. As suggested by the website I took two 325mg Tylenol and by 11:00am 10-21-2018 my temperature was 99.7. I took two more doses of Tylenol during the day Sunday 10-21-2018 and by 5:00pm Sunday my temperature returned to normal. My pulse rate also returned to normal, which had been at 94. Sunday night and early Monday morning 10-22-2018 I had light night sweats. Feeling better today @ 1:00pm 10-22-2018.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Second dose of SHINGRIX administered by Pharmacy Saturday 10-20-2018 @ 2:00PM. Sunday 7:00AM 10-21-2018 woke with fatigue and a fever of 100.9. The injection site was extremely painful. I went to the CDC website for adverse reactions to SHINGRIX, and read the data, etc. As suggested by the website I took two 325mg Tylenol and by 11:00am 10-21-2018 my temperature was 99.7. I took two more doses of Tylenol during the day Sunday 10-21-2018 and by 5:00pm Sunday my temperature returned to normal. My pulse rate also returned to normal, which had been at 94. Sunday night and early Monday morning 10-22-2018 I had light night sweats. Feeling better today @ 1:00pm 10-22-2018.
Age: 1.25
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Pyrexia
Clinical narrative: He ran a slight fever of 101 later that evening when the TYLENOL wore off. The next day at daycare, he ran a high fever of 102.3. He showed no other signs of illness other than the high fever. I gave him Ibuprofen and alternated with TYLENOL for about 12 hours to keep his fever down since he's had a febrile seizure before.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Pain
Clinical narrative: The patient reported having symptoms the morning after injection, 9 a.m. on 9/26/2018. The patient reported having flu like symptoms, achy, tired and dizziness. The patient reported feeling better after 3 days, however she had had episodes of dizziness for the last 3.5 weeks.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia oral, Pain, Paraesthesia oral
Clinical narrative: Following flu shot complained of body aches and numbness and tingling of the lips. Got better after 30 min.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient's daughter came in and informed us that her Mother had her flu shot on 10/20/18 and has since developed a hard lump that is below and off to the side of the injection site. It is not painful to patient. It is warm and red in appearance. Told pt daughter to apply compresses to area and see how it does in the next few days. If it doesn't get better or worse told them to contact their PCP.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pruritus generalised
Clinical narrative: Itching in the palms and the bottom of the feet on and off itching throughout the body ever since she got the shot.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature decreased, Diarrhoea, Gastroenteritis viral, Insomnia, Irritability
Clinical narrative: MOP presents with 12 month of female with diffuse rash to body, fever, N/V/D since Friday. MOP advised her dtr received routing 1 yo vaccine (PROQUAD, Hib, PCV13) on 10/11/2018. The next day she was cranky and fussy and began experiencing diarrhea (watery). On Saturday, she had a fever and mom was treating with TYLENOL. Mom advised infant taken to ER Sunday am 0745 for fever 103, n/v/d, fussiness and not sleeping x2 days. Mom advised child vomited x 2 but can keep small amounts of formula down. ER diagnosed with viral gastroenteritis and released home. Mom advised on Monday, day 4 post vaccines, she noted a red rash begin on infants chest that progressed to her back,  forehead, arms and legs. Mom has been using MOTRIN as instructed, and child's temp today w/pediatrician was 96.8 F. Mom advised child still has episodes of watery diarrhea today but no further n/v. Mom states rash has not spread, but appears more pronounced today. 10/22/2018 rash almost resolved, afebrile and acting normally.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Nausea, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: MOP presents with 12 month of female with diffuse rash to body, fever, N/V/D since Friday. MOP advised her dtr received routing 1 yo vaccine (PROQUAD, Hib, PCV13) on 10/11/2018. The next day she was cranky and fussy and began experiencing diarrhea (watery). On Saturday, she had a fever and mom was treating with TYLENOL. Mom advised infant taken to ER Sunday am 0745 for fever 103, n/v/d, fussiness and not sleeping x2 days. Mom advised child vomited x 2 but can keep small amounts of formula down. ER diagnosed with viral gastroenteritis and released home. Mom advised on Monday, day 4 post vaccines, she noted a red rash begin on infants chest that progressed to her back,  forehead, arms and legs. Mom has been using MOTRIN as instructed, and child's temp today w/pediatrician was 96.8 F. Mom advised child still has episodes of watery diarrhea today but no further n/v. Mom states rash has not spread, but appears more pronounced today. 10/22/2018 rash almost resolved, afebrile and acting normally.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Vomiting
Clinical narrative: MOP presents with 12 month of female with diffuse rash to body, fever, N/V/D since Friday. MOP advised her dtr received routing 1 yo vaccine (PROQUAD, Hib, PCV13) on 10/11/2018. The next day she was cranky and fussy and began experiencing diarrhea (watery). On Saturday, she had a fever and mom was treating with TYLENOL. Mom advised infant taken to ER Sunday am 0745 for fever 103, n/v/d, fussiness and not sleeping x2 days. Mom advised child vomited x 2 but can keep small amounts of formula down. ER diagnosed with viral gastroenteritis and released home. Mom advised on Monday, day 4 post vaccines, she noted a red rash begin on infants chest that progressed to her back,  forehead, arms and legs. Mom has been using MOTRIN as instructed, and child's temp today w/pediatrician was 96.8 F. Mom advised child still has episodes of watery diarrhea today but no further n/v. Mom states rash has not spread, but appears more pronounced today. 10/22/2018 rash almost resolved, afebrile and acting normally.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm became very sore and throbbed keeping the patient awake thru the night. Patient self treated with heat and TYLENOL and arm was still sore at 4 days post injection. Referred to doctor who prescribed steroid dose pak and antibiotic. It is notable that patient had cellulitis from injection in July as well.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Neurological examination, Pruritus generalised, Rash, Rash maculo-papular
Clinical narrative: Generalized pruritis, maculopapular rash beginning at injection site spreading to both upper arms, forearms, thighs, calves, and chest 995.3, 905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter 708.9 L50.9 Uticaria, unspecified Treated with corticosteroid injection, 20mg prednisone 2x daily, Atarax  25 mg every 8 hrs as needed.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Generalized pruritis, maculopapular rash beginning at injection site spreading to both upper arms, forearms, thighs, calves, and chest 995.3, 905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter 708.9 L50.9 Uticaria, unspecified Treated with corticosteroid injection, 20mg prednisone 2x daily, Atarax  25 mg every 8 hrs as needed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain, Pain in extremity, Pyrexia
Clinical narrative: Within  20 hours aches all over, arm red and sore. Within 24 hours fever of 101. Took advil, went to bed, fever broke during the night and achy-ness began to resolve.  Even 72 hours later arm red, sore and knot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Fatigue, Oedema peripheral, Pain, Throat tightness
Clinical narrative: General ache and tiredness, some tightness in throat by lymph glands, progressed to left underarm pain and swelling in afternoon and evening. Pain persisted in underarm area, some relief with TYLENOL and rest.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: Client presented on 10/18/2018 for Hepatitis B dose#2. The 1st Hepatitis B dose given was HEPLISAV B on 9/13/2018. This nurse reviewed NCIR and the trade name was not listed, therefore, an ENGERIX B was given for the 2nd dose instead of the HEPLISAV B. When the client was informed the date of the next vaccine he said it was a 2 shot series. It was then that I realized I had given a different brand of hepatitis B vaccine. Dynavax company was called for recommendation. Information given was that there is limited Data on the safety & immunogenicity effects when HepB-CpG is interchanged with Hep B vaccines from other manufacturers. When feasible, the same manufacturer's vaccines should be used to complete the series. It is suggested to adhere to a 3 dose scheduling, waiting a minimum of 16 weeks in between dose 1 & 3. The client was called & informed of above & informed of the next dose date.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Electroencephalogram abnormal, Petit mal epilepsy, Seizure like phenomena, Syncope
Clinical narrative: Per patient's mother: 6 days post vaccination with MENVEO vaccine patient had an episode of  syncope with seizure like movements while at school EMS was called and patient was transported to Hospital. 10/2/18 patient had two more episodes with same symptoms of syncope and seizure like movements while at school. 10/4/18 while in school patient began to have repeat of above symptoms of seizure like activity. Patient went to Clinic for further evaluation. Pt was hospitalized with 3 day EEG monitoring showed absence epilepsy. Patient was started on LAMICTAL and has not had further seizures.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Drooling, Hypoaesthesia oral, Oral pain
Clinical narrative: After brushing my teeth the left side of my mouth (same side as vaccine) started pulsating and I was drooling. I called the nurse through my insurance company and she said this is a normal reaction for the PREVNAR vaccine. I was awake for 90 minutes until I got sleepy and slept the rest of the night. I did not have the pulsating again in the past 3 days. I have had numbness in my mouth on the left side.  However, Dr. and another primary care doctor said this is not a normal reaction. I saw a different doctor this morning and she could not find my response to this drug wherever she was looking.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Injection site swelling, Pruritus, Rash, Rash pustular
Clinical narrative: Skin breakout and extreme itching on face and torso. Two large pustules on face. Bump at injection sight (still there). Itching eased after several days and pustules on face are fading but still red after 20 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Ear pain, Headache, Injection site erythema, Injection site induration
Clinical narrative: Injection site became warm, red firm and swollen. Approximately 3x 5 inches. Ran fever 100.1, headache, ear pain, slight neck stiffness all on the right side with generalized malaise and felt weak.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Injection site became warm, red firm and swollen. Approximately 3x 5 inches. Ran fever 100.1, headache, ear pain, slight neck stiffness all on the right side with generalized malaise and felt weak.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising, Vaccination site swelling
Clinical narrative: Patient had local swelling and bruising at the site of the vaccination. It was approximately 10 minutes after the shot when checking on the patient that it was noticed. Swelling was about the size of a 50 cent piece.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: 36 hours of aches, chills, nausea, low fever.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: GAVE CLIENT THE 2 VACCINES AND SHE TOERATED THEM WELL. CLIENT AND HER MOTHER WENT TO  THE FRONT ADMISSION DESK AND MAKE FOLLOWUP APPT FOR SECOND HPV. CLIENT STARTED TO GET LIGHT HEADED, VERY PALE AND DIZZY. BP WAS 120/60. PUT COOL WATER COMPRESSES ON HER FOREHEAD AND BACK OF NECK. GAVE WATER TO DRINK. SHE DIDN'T EAT MUCH FOR BREAKFAST. SHE STARTED TO FEEL BETTER AND WENT HOME WITH MOHTER. TOLD CLIENT WHEN SHE GETS SHOTS TO EAT MORE FOR BREAKFAXT.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. Between 01-FEB-2018 and 20-APR-2018, the patients were inadvertently vaccinated with improperly stored VARIVAX, 0.5 ml subcutaneously, lot # N029631, N022983 and N031001 (anatomical location and expiration dates not provided) and PROQUAD, lot # 022954, N001490, N025923, N035172 and lot # reported as N031294 (route of administration, anatomical location and expiration dates were not provided). Both vaccines were administered for prophylaxis and reconstituted with properly stored sterile diluent (MERCK). The administered doses of the vaccines experienced an unknown temperature excursion during an unknown time frame, and was recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Lot Number N031294 is an invalid lot for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is a non-valid report due to lack of patient identifiers.
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates in 2018, patients were vaccinated with an improperly stored dose of ROTATEQ (lot # N024295 exp 24-MAR-2019) and an improperly stored dose of GARDASIL 9 (lot #N020353 exp 28-APR-2020 and lot #N017686 exp 02-FEB-2020, for prophylaxis (dosage schedule not provided). The administered doses of the vaccines experienced a temperature excursion of 47 degrees F to 77 degrees F (49.1 degrees F) for 1 hour, from 21-MAR-2018 to 17-MAY-2018, as recorded by a data logger. The vaccines had had previous temperature excursion of 47 degrees F to 77 degrees F for 30 minutes, on an unspecified date.  There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative, reporting for the daughter. A female patient of an unspecified age received the 3rd dose of TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very sore arm and significant redness at injection site on an unspecified date. She described it as looking like a "bull eye". The outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender started received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness, swollen and feels warm at the injection site on an unspecified date after pneumococcal 13-val conjugate vaccine (dipht crm197 protein) administration. The events were non serious and the outcome was recovered. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018424203 same reporter, event, drug for different patients. US-PFIZER INC-2018424204 same reporter, event, drug for different patients.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager). This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289666, 2018SA289688, 2018SA289640, 2018SA289651, 2018SA289702, 2018SA289731 and 2018SA290377, same reporter. This case involves a 6 years old male patient who received IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPV (VERO) lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289731, 2018SA289688 and 2018SA289702. This case involves a 15 years old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager). This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289666, 2018SA289688, 2018SA289640, 2018SA289611, 2018SA289702, 2018SA289731 and 2018SA290377, same reporter. This case involves a 9 years old female patient who received vaccine IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPV (VERO) lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289731, 2018SA289688 and 2018SA289702. This case involves a 4 years old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289731, 2018SA289666 and 2018SA289702. This case involves an eight-year-old female patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289666, 2018SA289702 and 2018SA289688 (same reporter). This case involves twelve-year-old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a four patients who had reactions, while he/she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. The patient experienced a non-serious reactions (adverse event) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was had reactions. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old female patient who received two doses of FLUZONE HIGH DOSE, which included one wrong FLUZONE HD dose instead of Pneumococcal Vaccine. The patient's past medical history was not provided. No concomitant medications received. On 16-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, lot UJ022AB (expiry date: 18-Apr-2019) via unknown route in the right deltoid and on an unknown date, patient received another dose of FLUZONE HIGH DOSE instead of Pneumonia vaccine. It was a case of actual medication error due to extra dose administered and Wrong vaccine administered. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA288342 (same reporter). This case involves 2 patient of a 4 years old (gender was unknown) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT instead of 0.5 ml in the right arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccine were used. On 13-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259KA via intramuscular route in the right arm. It was case of actual medication error due to Vaccine under dose. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.