chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assisstant and refers to a 6 month old male patient. The patient's medical history or concurrent conditions were not reported. The patient has 3 siblings. Concomitant therapies included PENTACEL, ENGERIX-B, and PREVNAR 13. On 11-JAN-2018, the patient received her third dose of ROTATEQ (lot number M017558, expiration date 27-FEB-2018) for prophylaxis, which was administered by the reporting medical assisstant. According to the reporter, the dose of ROTATEQ was improperly stored as it underwent the following temperature excursions: 47 fahrenheit (F) to 77 F (46.5 F) for 35 minutes; previous temperature excursion was 47 F to 77 F for 49 minutes. The patient was vaccinated in a private doctor's hospital/office and the suspect vaccine was purchased with public funds. No treatment for the reported experience was prescribed. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown. A digital data logger was involved.
Age: 31.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 31-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-AUG-2011, the patient was vaccinated with the first dose of VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). On 07-JUL-2017, reported also as "6 years later, the patient was vaccinated with the second dose of VARIVAX (dose, frequency and route of administration were not reported) lot # N014368 and expiration date: 09-MAY-2019. Both two vaccines were reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No causality assessment was provided by the reporter.
Age: 93.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Deafness unilateral
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 93 year-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 00005-1971-02) at single dose and FLUZONE QUADRIVALENT VACCINE (lot 02517-18IN, NDC number 492810417-50)  at 1 dosage form, both on 19Jan2018 for vaccination. The patient medical history was none. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE 37.5 mg AND HYDROCHLOROTHIAZID 25 mg)  once a day to keep his feet from swelling. The patient lost the hearing out of one of his ears on 20Jan2018. No relevant tests were done.The patient was not recovered. He wanted to know if this could be a possible adverse event of pneumococcal 13-val conj vac (dipht crm197 protein). The information on the lot number has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and UrticariaPruritus.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left deltoid pain intermittently lasting for past 2-3 months. No redness, swelling, bleeding, discharge.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm, Tenderness
Clinical narrative: Pt called on 1/23, rash on arm 4 inches in diameter, tender warm to touch. Pink with slight swelling. Had not tried anything yet. Instructed patient to apply ice pack or cool rag. Take APAP or ibuprofen and BENADRYL. Draw a circle around rash to see if it gets bigger/smaller/spreads, etc. Pt stopped in on 1/25. Rash was going away.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Rash, Scab, Skin haemorrhage
Clinical narrative: Face broke out into rash night of shots, woke up to forehead bleeding rash, scabbed up next day, then left done the same.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site urticaria, Malaise, Nausea, Vomiting
Clinical narrative: Severe headache, nausea, vomiting (x2), hives on the Right inner upper arm/axilla, malaise.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: 4 month old needed DTAP and IPV. MA found combo (KINRIX) that did not explicitly say on box that it was for ages 4-6 years. She did not check expiration date. Gave vaccine to baby. Then she went to enter it into the EHR and noticed that the vaccine was for ages 4-6 years and was expired. It was immediately reported to supervisor/NP. No treatment was needed at the time. Parent/caregiver of child was notified of mistake and asked to return to clinic for correct and not-expired vaccine. Parent refused stating that she would be taking the baby to another clinic due to mistake.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood, bright red, and "a good amount of it" per mom. In stool x 2-3 days. No fussiness. Self-resolved. Never brought to our attention until today.
Age: 30.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Hot flush
Clinical narrative: Symptoms: Copious, voluminous watery diarrhea. Cramping, churning abdominal pain. Gastroparesis. Vomiting. Muscular soreness involving arms, legs, back, neck. Fatigue, malaise, chills, hot flashes (but no fever, temperature never went above 99.0 F). Treatment: 1 L PLASMA-LYTE, TYLENOL, Gatorade, ZOFRAN, IMODIUM, fluid rehydration and supportive care. Time Course: Symptoms began the afternoon of 1/24 with diarrhea, progressing into abdominal pain and vomiting. By midday 1/25, the diarrhea, vomiting, and abdominal pain had subsided but muscular soreness and fatigue were still present. Now on 1/26, I still feel exhausted but am able to eat and drink and no longer have pain or diarrhea.
Age: 30.0
Sex: M
Vaccine: YF
Symptoms: Impaired gastric emptying, Influenza virus test negative, Malaise, Myalgia, Vomiting
Clinical narrative: Symptoms: Copious, voluminous watery diarrhea. Cramping, churning abdominal pain. Gastroparesis. Vomiting. Muscular soreness involving arms, legs, back, neck. Fatigue, malaise, chills, hot flashes (but no fever, temperature never went above 99.0 F). Treatment: 1 L PLASMA-LYTE, TYLENOL, Gatorade, ZOFRAN, IMODIUM, fluid rehydration and supportive care. Time Course: Symptoms began the afternoon of 1/24 with diarrhea, progressing into abdominal pain and vomiting. By midday 1/25, the diarrhea, vomiting, and abdominal pain had subsided but muscular soreness and fatigue were still present. Now on 1/26, I still feel exhausted but am able to eat and drink and no longer have pain or diarrhea.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Immune thrombocytopenic purpura, Platelet count decreased, Rash
Clinical narrative: After the vaccine, my daughter platelet dropped. First we could not figure out what caused it. Then we looked into the symptoms of the vaccine. She started getting rash and bruises. She is now diagnosed with ITP.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular, Rash vesicular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX. Concomitant products included ADDERALL and spironolactone. On 15th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pustule. On an unknown date, the outcome of the rash and pustule were not recovered/not resolved. It was unknown if the reporter considered the rash and pustule to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in right arm and noticed a rash containing pustules on both legs, with the right leg being worse. Issue worsened last night on 16th January 2018 but had improved today on 17th January 2018. The patient thought the rash appeared to resemble a shingles type of rash.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Migraine
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a 54-year-old female patient who received TWINRIX (batch number 2BA47, expiry date 27th September  2018). On 8th December 2017, the patient received TWINRIX. On an unknown date, less than a year after receiving TWINRIX, the patient experienced migraine and dizziness. On an unknown date, the outcome of the migraine and dizziness were unknown. It was unknown if the reporter considered the migraine and dizziness to be related to TWINRIX. Additional details were provided as follows: The patient was not hospitalized. It started about a week ago from the date of reporting, after the vaccine being administered. The reporter recommended the patient to see her provider to check if it was caused by other conditions. The patient had not seen a physician till the time of reporting and it has been a month ago from the same. The caller has been informed that they have reported an experience with GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. The reporter has agreed to have GlaxoSmithKline's Safety team follow-up with them via postal mail.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old male patient who received SHINGRIX. The patient's past medical history included shingles (several years ago) and shingles (last year). Concurrent medical conditions included penicillin allergy and peanut allergy. Concomitant products included Baby Aspirin and Losartan. On 22nd January 2018 10:00, the patient received the 1st dose of SHINGRIX. On 22nd January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 22nd January 2018 12:00, the patient experienced shivering. On 22nd January 2018 23:00, the patient experienced tiredness, pain and headache. In January 2018, the outcome of the headache and shivering were recovered/resolved. On an unknown date, the outcome of the tiredness, pain and injection site pain were recovering/resolving. The reporter considered the tiredness, pain, injection site pain, headache and shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included Atorvastatin. The patient received SHINGRIX in the left deltoid. Two hours after vaccination, the patient experienced shivering. Thirteen hours after vaccination, the patient experienced tiredness, soreness on his upper body and headache.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Cough, Hyperhidrosis, Pain
Clinical narrative: This spontaneous report was received from a license practitioner nurse via a company representative concerning a 66 year old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 05-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot# and expiration date were unknown), subcutaneously for prophylaxis. Approximately on 06-DEC-2017 (reported as one or two days after received the vaccine), the patient experienced sweat, "all around achiness", chills, 100.3 F temperature and non-productive cough. It was reported that the patient called physician but no treatment was given for the reported adverse events. At the reporting time, the outcome of hyperhidrosis, chills, body temperature abnormal, pain and cough was reported as recovering. The causality between PNEUMOVAX 23 and the events of hyperhidrosis, chills, body temperature abnormal, pain and cough was not assessed. The reporter stated that the events were not life threatening.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Full blown flu symptoms - within 10 minutes of shot arm swelled twice size in area of injection, sinuses swelled, mass produced mucus, sneezing fits all day, pressure headaches. 2nd day itchy throat, mass mucus production, coughing fits, fatigue, arm still swollen and very tender. 3rd day body aches, chills, foggy headed, pressure headaches, coughing, sneezing, arm still swollen and painful. 4th day is today and I really thought I would be feeling better but I'm still very cloudy headed, overly sleepy, fatigued, my arm is starting to go back to normal and the mucus production has slowed, which is a blessing, but the aches and chills are worse and I'm wondering how long this is going to go on for, I thought it was just supposed to be a day or two.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Injection site swelling, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Full blown flu symptoms - within 10 minutes of shot arm swelled twice size in area of injection, sinuses swelled, mass produced mucus, sneezing fits all day, pressure headaches. 2nd day itchy throat, mass mucus production, coughing fits, fatigue, arm still swollen and very tender. 3rd day body aches, chills, foggy headed, pressure headaches, coughing, sneezing, arm still swollen and painful. 4th day is today and I really thought I would be feeling better but I'm still very cloudy headed, overly sleepy, fatigued, my arm is starting to go back to normal and the mucus production has slowed, which is a blessing, but the aches and chills are worse and I'm wondering how long this is going to go on for, I thought it was just supposed to be a day or two.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Sinus disorder, Sneezing, Somnolence, Tenderness, Throat irritation
Clinical narrative: Full blown flu symptoms - within 10 minutes of shot arm swelled twice size in area of injection, sinuses swelled, mass produced mucus, sneezing fits all day, pressure headaches. 2nd day itchy throat, mass mucus production, coughing fits, fatigue, arm still swollen and very tender. 3rd day body aches, chills, foggy headed, pressure headaches, coughing, sneezing, arm still swollen and painful. 4th day is today and I really thought I would be feeling better but I'm still very cloudy headed, overly sleepy, fatigued, my arm is starting to go back to normal and the mucus production has slowed, which is a blessing, but the aches and chills are worse and I'm wondering how long this is going to go on for, I thought it was just supposed to be a day or two.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever of 101.7, fatigue.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 7 cm circular area medial to the injection site of the right leg with 1 cm circular urticarial lesions going up the thigh. Similar lesions on the palms of hands and forearms. Advised parents to use BENADRYL and cold compresses.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Bronchitis, Chest X-ray normal, Chills, Cough, Dyspnoea
Clinical narrative: SOB, chills, runny nose achy and sore throat reported after PPSV 23 administered. This was reported the next day to the provider. ER visit 1 day later for persistent SOB/cough. Dx with acute bronchitis.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: SOB, chills, runny nose achy and sore throat reported after PPSV 23 administered. This was reported the next day to the provider. ER visit 1 day later for persistent SOB/cough. Dx with acute bronchitis.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-JAN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD (rHa), lot number: M032497 (expiration date: 02-JAN-2018), for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy on 1-26-18 with a swollen and red arm. He said the symptoms started on the evening of the 24th. He said the swelling has went down. He is going to put ice on it and then let us know if it gets worse.
Age: 49.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Patient complaining of pain with movement of right arm. Visualized redness and felt hot to the touch in the area where the varicella vaccine was administered. No swelling noted. Advised patient to put ice on site for 30m with 30m interval breaks to help alleviate the pain/heat/redness. Patient stated understanding.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Hypersomnia, Nausea
Clinical narrative: She states that on a regular basis she usually gets up at 0300 but this morning she got at 0630 and had nausea.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: First symptoms were 2 huge glands directly behind left ear and 1 behind right ear. A second one came up behind the right ear later. Skin had random extreme itching in patches especially the neck (this was treated with ingesting tumeric). Jaw looked more rounded however glands in neck were not swollen. Bits of fatigue set in periodically. Taste changed and required a lot of salt on food. 1 week into symptoms 3 spots occurred on pallet/back of throat that were extremely painful, tonsils swelled like golf balls and were covered in numerous streams of thick white pus. Neck glands were swollen. Watery stool. Gas. Bloating. Sore stomach. Increased water retention/weight gain. Extreme insomnia and irritability. No medication was taken. Only raw garlic, ginger tea and tumeric were used as well as an alkalinizer. Symptoms started to ease from Jan 16th and I felt back to normal around Jan 19th 2018.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Flatulence, Fluid retention, Insomnia, Irritability, Lymphadenopathy
Clinical narrative: First symptoms were 2 huge glands directly behind left ear and 1 behind right ear. A second one came up behind the right ear later. Skin had random extreme itching in patches especially the neck (this was treated with ingesting tumeric). Jaw looked more rounded however glands in neck were not swollen. Bits of fatigue set in periodically. Taste changed and required a lot of salt on food. 1 week into symptoms 3 spots occurred on pallet/back of throat that were extremely painful, tonsils swelled like golf balls and were covered in numerous streams of thick white pus. Neck glands were swollen. Watery stool. Gas. Bloating. Sore stomach. Increased water retention/weight gain. Extreme insomnia and irritability. No medication was taken. Only raw garlic, ginger tea and tumeric were used as well as an alkalinizer. Symptoms started to ease from Jan 16th and I felt back to normal around Jan 19th 2018.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oropharyngeal pain, Palatal disorder, Pruritus, Swelling face, Tonsillar hypertrophy
Clinical narrative: First symptoms were 2 huge glands directly behind left ear and 1 behind right ear. A second one came up behind the right ear later. Skin had random extreme itching in patches especially the neck (this was treated with ingesting tumeric). Jaw looked more rounded however glands in neck were not swollen. Bits of fatigue set in periodically. Taste changed and required a lot of salt on food. 1 week into symptoms 3 spots occurred on pallet/back of throat that were extremely painful, tonsils swelled like golf balls and were covered in numerous streams of thick white pus. Neck glands were swollen. Watery stool. Gas. Bloating. Sore stomach. Increased water retention/weight gain. Extreme insomnia and irritability. No medication was taken. Only raw garlic, ginger tea and tumeric were used as well as an alkalinizer. Symptoms started to ease from Jan 16th and I felt back to normal around Jan 19th 2018.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Tonsillitis, Weight increased
Clinical narrative: First symptoms were 2 huge glands directly behind left ear and 1 behind right ear. A second one came up behind the right ear later. Skin had random extreme itching in patches especially the neck (this was treated with ingesting tumeric). Jaw looked more rounded however glands in neck were not swollen. Bits of fatigue set in periodically. Taste changed and required a lot of salt on food. 1 week into symptoms 3 spots occurred on pallet/back of throat that were extremely painful, tonsils swelled like golf balls and were covered in numerous streams of thick white pus. Neck glands were swollen. Watery stool. Gas. Bloating. Sore stomach. Increased water retention/weight gain. Extreme insomnia and irritability. No medication was taken. Only raw garlic, ginger tea and tumeric were used as well as an alkalinizer. Symptoms started to ease from Jan 16th and I felt back to normal around Jan 19th 2018.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: I received the FLULAVAL QUADRIVALENT IM in my Right Deltoid thru my Tattoo on 1/5/2018. In the morning of 1/7/2018 about 6 am I awoke to a horrible Tendinitis type pain in my right arm. The pain started at the point of the injection down to just distal my Right elbow. I have never had Tendinitis or a pain like this in my arm before. I called the office of Dr. on 1/10/2018 to report the pain. I was instructed by the office to use ICE on my arm and to make a follow up appointment if the pain did not go away. As of 1/26/2018 the pain is no different.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Cardio-respiratory arrest, Death, Resuscitation
Clinical narrative: 18 yo woman with a history of asthma was seen at ER for asthma exacerbation on 1/14/18 at 10 AM. She was treated with DUONEB and steroids with improvement of symptoms and was discharged on a course of prednisone. On 1/24/18 patient was seen for well visit with Dr. during which no complaints or abnormal exam findings were documented. A flu vaccine was administered at 3 pm. On 1/26/18 the patient was brought into hospital at 8:21 in cardiorespiratory arrest. After 60 minutes of resuscitation efforts, the patient was pronounced dead.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram head normal, Dyskinesia, Eye movement disorder, Hyperhidrosis, Loss of consciousness
Clinical narrative: Mom states child had seizure approximately 10-15 minutes after vaccine administered. Went pale and eyes rolled back with repeated jerking movements within the whole body x 3-4 minutes. Became diaphoretic and returned to consciousness with no recollection of what happened.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Seizure
Clinical narrative: Mom states child had seizure approximately 10-15 minutes after vaccine administered. Went pale and eyes rolled back with repeated jerking movements within the whole body x 3-4 minutes. Became diaphoretic and returned to consciousness with no recollection of what happened.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fatigue, nausea, vomiting, diarrhea, fever, severe headache, body aches.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fatigue, nausea, vomiting, diarrhea, fever, severe headache, body aches.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: The patient had a sore arm about 3 hours after the injection on 1/24/18 then the next day on 1/25/18 she began to get severe headaches, chills, painful arm fever and whole-body muscle weakness. On 1/26/18 the patient states that her headache initially went away, came back and went away again with the help of analgesics. She also has residual weakness in her injection arm. The remainder of the symptoms have subsided.
Age: 1.92
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Asterixis, Dyskinesia, Fall, Toe walking
Clinical narrative: On January 1, 2018 I observed him falling flat on his face, six falls were observed. He's still toe walking, and now is having involuntary movements of his arms/torso and arm flapping. I was able to get the arm flapping on video. I called the health department and was told by the nurse these behaviors weren't caused by the vaccine.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Adverse -Redness, swelling, soreness, numbness tingling of the fingers and hands. Treatment - Antibiotics.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Oropharyngeal pain, Vomiting
Clinical narrative: Began with stomach cramps followed by one bout of loose stool/diarrhea. At approximately 2:00AM vomiting began with a sore throat. She vomited four times about one hour apart with the sore throat dissipating after the third or fourth time. Very mild diarrhea occurred during vomiting. After each bout of vomiting she said her stomach felt relieved. She also complained of fatigue. There has been no vomiting, sore throat or diarrhea since approximately 7:00AM 1/26/2018. She says she is feeling quite well, is eating a mild diet and drinking water with no adverse side effects.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This may not be considered a serious side effect but I thought I should report it. Within hours after receiving the vaccination my arm was very painful. I could not reach or lift it. It actually made any aches in the rest of my body seem worse. I took some TYLENOL which seemed to take the edge off. The next day I still had difficulty reaching and I had large red spots on my arm. I also experienced diarrhea, which I never have. The third day I could start moving my arm more normally but still had tenderness.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This may not be considered a serious side effect but I thought I should report it. Within hours after receiving the vaccination my arm was very painful. I could not reach or lift it. It actually made any aches in the rest of my body seem worse. I took some TYLENOL which seemed to take the edge off. The next day I still had difficulty reaching and I had large red spots on my arm. I also experienced diarrhea, which I never have. The third day I could start moving my arm more normally but still had tenderness.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Burning sensation, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Employee had varicella vaccination administered in her right upper arm on 1/23/18; on 1/24/18 her right medial bicep area started becoming red, warm to touch, itching, and a burning sensation over her NEXPLANON (implanted birth control). Her NEXPLANON is located on the right medial lateral side of the upper arm. The area of redness measured 55 x 70 mm; this area was marked with a pen in order to see if it starts spreading. Employee's temperature was 99.7 degrees Fahrenheit when she was here. Employee denies feeling feverish. Consulted provider; will be seen by provider to be evaluated.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Employee had varicella vaccination administered in her right upper arm on 1/23/18; on 1/24/18 her right medial bicep area started becoming red, warm to touch, itching, and a burning sensation over her NEXPLANON (implanted birth control). Her NEXPLANON is located on the right medial lateral side of the upper arm. The area of redness measured 55 x 70 mm; this area was marked with a pen in order to see if it starts spreading. Employee's temperature was 99.7 degrees Fahrenheit when she was here. Employee denies feeling feverish. Consulted provider; will be seen by provider to be evaluated.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Phobia
Clinical narrative: Anxiety which then cause a blood phobia.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient experienced redness, swelling, pain and heat away from the injection site lower on the bicep/tricep area. After increased discomfort for about 3 days sought medical attention and was diagnosed as cellulitis. Treated with antibiotics, however experienced some blistering and peeling at site of redness.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth, Skin exfoliation
Clinical narrative: Patient experienced redness, swelling, pain and heat away from the injection site lower on the bicep/tricep area. After increased discomfort for about 3 days sought medical attention and was diagnosed as cellulitis. Treated with antibiotics, however experienced some blistering and peeling at site of redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: LOCALIZED SWELLING, ERYTHEMA, PRURITIS AT SITE OF INJECTION LEFT DELTOID.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Full body rash. Appeared 5 days after injection. Rash still there 6 days after initial onset of rash (date of report) bright red and splotchy. No fever, no congestion appeared with the rash. Was brought to doctor to look at the day after initial onset and on the date of this report.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: Itchiness, redness on injection arm, shortness of breath within 10 minutes of injection.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Burning at site of injection, tingling and numbness along arm of injection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscular weakness, Pain, Pain in extremity, Rash generalised
Clinical narrative: Severe headache that lasted 4 days. Could not lift or really use my left arm for almost a month without pain and weakness. Full body rash that lasted 2 months.
Age: 60.0
Sex: F
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, X-ray limb normal
Clinical narrative: Loss of mobility in my left arm. Pain in my upper left arm. Loss of range of motion in my left arm. Loss of strength in my left arm. It has not recovered.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in the left shoulder that has lasted for 6 weeks after immunization, is improving at this point.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Rotator cuff syndrome
Clinical narrative: Thought it was a rotator cuff injury, trouble lifting arm over shoulders, pain is better than it was and is improving.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: STARTED WITH A DULL ACHE. A HOUR LATER, SHOOTING PAIN DOWN ARM FROM ELBOW. I PUT AN ICE PACK ON IT FOR THE REST OF THE NIGHT. SINCE THEN A CONSTANT ACHE. CAN NOT LIFT ARM ABOVE SHOULDER HEIGHT. NOW HAVE PAIN SHOOTING UP MY NECK ON LEFT SIDE.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site pain, Administration site warmth, Injection site erythema
Clinical narrative: Sore and red administration site, warm on touch.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Peripheral swelling
Clinical narrative: Patient reported pain on injection and then called to report that she had three days of reduced range of movement in the arm and a swollen right hand. Patient reports that both hand and arm have returned to normal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient came to the pharmacy on 1/20/2018 saying she still has an achy arm, that is sore to touch, with minimal movement from the fluzone HD shot she received on 11/06/2017.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Dry throat, Throat irritation
Clinical narrative: Patient said she had serious reaction back in '1988 and came to Employee Health to talk about receiving the Flu Vaccine so that she did not have to wear a surgical mask throughout the hospital (which is our policy). Because of the past HX in 1988 of serious reaction the staff determined that it is safer to administer the Vaccine in a monitored area, which is in the Urgent care of the hospital. FLUARIX PF was administered at 4:05 p.m. and I staid with her in the exam room during this time. Approx. 5 minutes after injection that she started feeling a dry mouth 'like cotton mouth' in her throat. She did end up getting some water and had no trouble swallowing it. She proceeded from a dry throat to a scratchy throat. At that time, she independently walked out to the nurses station herself to talk to a provider to inform her of how she was feeling. Returned to the room with the provider and the aide came in and checked her 02 saturations, which were stable. She continued to have a dry, rapsy throat. Staff registered her and a different male provider came to assess her. At that time, this writer left the exam room to report this to my supervisor.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On the day following vaccination, patient called the pharmacy complaining of a red, swollen, softball size area at site of injection.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Infection, Inflammation
Clinical narrative: Redness, warmth, inflammation. Went to doctor who said it was an infection and prescribed cephalexin three times daily for 7 days.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: DIZZINES AND SYNCOPE AFTER APPROX 10 MIN OD ADMINISTERING FLU SHOT. NO LOSS OF CONSCIOUSNESS. HELP HIM TO RECOVER, WHICH HAPPEN AFTER ABOUT 15 MIN.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Pain in extremity
Clinical narrative: PT REPORTED ON 1/26/2018 OF PAIN IN LEFT ARM RADIATING TO LEFT UPPER CHEST. SAYS IT GOES AWAY AND COMES BACK, NO PHYSICAL SIGNS OF BRUISING OR REDNESS. PT SAYS SHE WILL CONTINUE TO MONITOR AND SEE DOCTOR IF IT DOESN'T GO AWAY.
Age: 7.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient came in to the clinic today for vaccine administration. As we compared with the Yellow immunization card and records, child needed MMR and Varicella vaccine. Medical assistant administered PROQUAD instead of MMR vaccine without realizing that it is a combo vaccination and also administered varicella vaccine separately. Child received 2 varicella vaccine. Child does not have any adverse reaction so far and we informed the mother and requested her to come back to clinic if any concerns arise.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Dizziness, Gait disturbance, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 75-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On 19th January 2018, the patient experienced shivering. On 21st January 2018, the patient experienced balance disorder, dizziness and stumbling. On an unknown date, the outcome of balance disorder, dizziness and stumbling were not recovered/not resolved and the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were recovering/resolving and the outcome of the shivering was recovered/resolved. The reporter considered the balance disorder, injection site swelling, injection site itching, dizziness, injection site lump, stumbling, shivering and injection site erythema to be related to SHINGRIX. Additional details were provide as follows: This case was reported by the patient herself. On 18th January 2018 at 10:00, the patient received a dose of SHINGRIX vaccine. The site reactions began almost right away. The reporter described the lump as 4 inches wide and 2 inches thick. It was itchy and very red but these reactions were subsiding. On 19th January 2018, 1 day after receiving SHINGRIX, the patient experienced shivering (began on Friday and lasted about 24 hours). On 21st January 2018, 3 days after receiving SHINGRIX, the patient experienced balance disorder, dizziness and stumbling. The patient did not experience any shivering since then. Then on Sunday morning she woke and felt dizzy and off balance. On the day of reporting, in morning, when the patient woke up, the feeling of being off balance was worse and she was stumbling. The patient had consulted with her doctor. The patient did ask for product information.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 75-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On 19th January 2018, the patient experienced shivering. On 21st January 2018, the patient experienced balance disorder, dizziness and stumbling. On an unknown date, the outcome of balance disorder, dizziness and stumbling were not recovered/not resolved and the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were recovering/resolving and the outcome of the shivering was recovered/resolved. The reporter considered the balance disorder, injection site swelling, injection site itching, dizziness, injection site lump, stumbling, shivering and injection site erythema to be related to SHINGRIX. Additional details were provide as follows: This case was reported by the patient herself. On 18th January 2018 at 10:00, the patient received a dose of SHINGRIX vaccine. The site reactions began almost right away. The reporter described the lump as 4 inches wide and 2 inches thick. It was itchy and very red but these reactions were subsiding. On 19th January 2018, 1 day after receiving SHINGRIX, the patient experienced shivering (began on Friday and lasted about 24 hours). On 21st January 2018, 3 days after receiving SHINGRIX, the patient experienced balance disorder, dizziness and stumbling. The patient did not experience any shivering since then. Then on Sunday morning she woke and felt dizzy and off balance. On the day of reporting, in morning, when the patient woke up, the feeling of being off balance was worse and she was stumbling. The patient had consulted with her doctor. The patient did ask for product information.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Rash, Skin discolouration, Vasculitis
Clinical narrative: This case was reported by a consumer and described the occurrence of vasculitis in a female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 1st June 2016). Co-suspect products included FLULAVAL QUADRIVALENT (batch number A3AD2, expiry date 1st May 2017). On 16th October 2015, the patient received the 2nd dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2016, the patient received the 3rd dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In October 2015, 6 days after receiving FLULAVAL QUADRIVALENT and FLULAVAL QUADRIVALENT and not applicable after receiving FLULAVAL QUADRIVALENT, the patient experienced vasculitis, rash, skin discoloration and joint pain. In September 2016, the patient experienced vasculitis, rash, skin discoloration and joint pain. On an unknown date, the outcome of the vasculitis, rash, skin discoloration, joint pain, vasculitis, rash, skin discoloration and joint pain were unknown. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. On 16th October 2015 01:12, the patient received 2nd dose of FLULAVAL QUADRIVALENT and on 15th September 2016 10:12, the patient received 3rd dose of FLULAVAL QUADRIVALENT. In 2015, 2016, and 2017, the patient had the flu vaccine, 6 days after each dose, the patient experienced vasculitis. The patient experienced severe rash on legs and trunk which lasted about a month, with some residual discoloration on legs and also experienced joint pain.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLULAVAL QUADRIVALENT. Additional information was provided as follows: The age at vaccination was not reported. The pharmacist reported that the physician wanted her to split the 0.5 ml dose of FLULAVAL QUADRIVALENT into 2 separate doses and give 0.25 ml of FLULAVAL QUADRIVALENT at separate visits. The healthcare professional wanted to know would this effect the integrity or what the effect would be on the patient if they received 0.25ml of FLULAVAL QUADRIVALENT at separate visits. The healthcare professional stated that the patient had a reaction to the 0.5 ml dose however, healthcare professional did not have any information on what the reaction was nor any patient information nor if it was for sure FLULAVAL QUADRIVALENT 0.5 ml that the patient had a reaction to. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, fatigue, headache, shivering, fever and nausea. On an unknown date, the outcome of the injection site pain, general body pain, headache, shivering, fever and nausea were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, general body pain, fatigue, headache, shivering, fever and nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX on Friday. The patient had experienced sore injection site, in addition to that on Saturday, general body aches, fatigue, headache, shivers, fever, and slight nausea feeling was also experienced. On Sunday, the patient was better, but still tired. The reporter stated that she did not know if GSK wanted this to be reported or not. In 2 months the patient intended to get the 2nd dose of SHINGRIX. She asked if she should expect the same results. This case was linked to case US2018GSK010904 (husband's case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, fatigue, headache, shivering, fever and nausea. On an unknown date, the outcome of the injection site pain, general body pain, headache, shivering, fever and nausea were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, general body pain, fatigue, headache, shivering, fever and nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX on Friday. The patient had experienced sore injection site, in addition to that on Saturday, general body aches, fatigue, headache, shivers, fever, and slight nausea feeling was also experienced. On Sunday, the patient was better, but still tired. The reporter stated that she did not know if GSK wanted this to be reported or not. In 2 months the patient intended to get the 2nd dose of SHINGRIX. She asked if she should expect the same results. This case was linked to case US2018GSK010904 (husband's case), reported by the same reporter.
Age: 19.0
Sex: U
Vaccine: MENB
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Injection site pain, Injection site swelling, Pain
Clinical narrative: Reaction to meningitis B on the left arm (localized swelling, mild tenderness). Pt states of body aches and lower back pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Insomnia, Tongue movement disturbance, Tremor
Clinical narrative: Tremors cont's Tongue darting Drug Induced subacute dyskinesia. Propranolol 7/11/17-9/9/17 with increased doses 80mg-320mg. INGREZZA 40mg 9/18/17 increased to 80mg QD x 17wk's no effect either medication.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: New patient to me but established with other Dr. Here with Mom and Dad. Rash first noted this morning. Dad shows me cell phone pics from earlier as rash has faded now- Fever started yesterday; got two doses of acetaminophen-none since 6:30p. Nursing well; acting OK overnight but felt warm and went back to sleep after nursing OK. Not itchy, not rubbing, not fussy, feeding fine no runny nose; no change in dry/play cough no V/D. AQUAPHOR but nothing new-last around 7 or 8pm Baths: J and J Lavendar and BABY MAGIC-had bath last night. Let him try a little pear at 6pm last night - no issues. No prior issues with vaccines. Yesterday's WCC reviewed- no issues -  received PEDIARIX, HIB, PREVNAR and ROTARIX vaccines (set #2).
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus generalised
Clinical narrative: Had both FLUZONE High Dose and PNEUMOVAX 23 on 8/29/17. First time for the PNEUMOVAX and within 1 day I felt itching all over and still persists. Told pharmacy, primary Dr. and Allergist. No answers on remedies.