chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient had redness and swelling on arm that went all the way down her arm and almost to her wrist.  She informed me of her symptoms on 12/9 and I told her to go to urgent care. She went to the doctors and was diagnosed with cellulitis. Saw her on 12/13 and she said her arm has improved significantly since she went on antibiotics (keflex).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Bradyphrenia, Fatigue, Feeling drunk, Somnolence
Clinical narrative: Patient states that she woke up the next morning around 10:30, which is late for her, feeling extremely drowsy. Throughout the day she felt drained and almost impaired "drunk" feeling. It was hard for her to process thoughts and carry on conversations. States she did not drink any alcohol or take any medications she doesn't usually take.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Blood glucose normal, Confusional state, Electrocardiogram QT prolonged, Neurological examination normal, Tremor
Clinical narrative: 11:30 AM Given Hep A, HPV and Influenza vaccines. Within +/-10 seconds of receiving the influenza vaccine, patient experienced shaking of hands, 3-5 seconds of confusion, and fell back on exam table into Medical Assistant's arms. 1 minute after symptoms, patient was placed on her back with legs elevated. ARNP examined pt. and vital signs were done. Vitals were within normal limits. Neurological exam was unremarkable. Pupils were equal and reactive to light bilaterally. Due to patient's past medical history of seizures (last episode age 4 years), Pediatrician was called and instructions were received to send her to the Emergency Room for evaluation of vasovagal episode.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: The injection was administered very high on the right shoulder at a Pharmacy by a Registered Pharmacist. The injection was painful and pain continued after injection. Pain worsening over the next 72 hours and the pain continued for an additional week before starting to improve. I was seen by Dr in clinic on 12/12/17 and diagnosed with tendinitis of the rotator cuff. Currently I am icing my shoulder several times daily, taking Ibuprofen. Physical therapy was recommended.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain, Pruritus
Clinical narrative: The night of getting vaccine patient began to experience redness and swelling around the area of the shot. Through the next few days the swelling and redness began to expand in a circular pattern over her shoulder and farther down her upper arm. The patient became concerned about the rash and saw a doctor 6 days later on which she was prescribed Keflex for a possible skin infection to rule it out. The patient is experiencing pain and itchiness and has restricted motion of her arm. The rash appears to have an unaffected circle around the site of the shot about 2 in diameter before the rash starts.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: The night of getting vaccine patient began to experience redness and swelling around the area of the shot. Through the next few days the swelling and redness began to expand in a circular pattern over her shoulder and farther down her upper arm. The patient became concerned about the rash and saw a doctor 6 days later on which she was prescribed Keflex for a possible skin infection to rule it out. The patient is experiencing pain and itchiness and has restricted motion of her arm. The rash appears to have an unaffected circle around the site of the shot about 2 in diameter before the rash starts.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash at injection site. Itching and some swelling and redness.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: PATIENT REPORT THAT THEY EXPERIENCED EXTREME PAIN IN THE VACCINATED ARM RESULTING IN A DIAGNOSIS OF FROZEN SHOULDER.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient states that she still feels pain at the injection site. It has been 2 and a half months.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient should have gotten a PNEUMOVAX 23 vaccination but received PREVNAR 13 in error. Patient did not experience any adverse effect but will need to still receive a PNEUMOVAX 23 vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Hot to touch raised red rash on face and body for 3 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Left shoulder not able to rotate. Painful to lay on. Left arm progressively worse since flu shot. No shoulder joint swelling per MD (per pt). Pt was seen at urgent care 12-14-17. No report of falling or injury to shoulder per pt. Pt given hydrocodone/APAP and ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extensive swelling of vaccinated limb, Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received KINRIX (batch number 7559R, expiry date 14th October 2019). Concomitant products included ZYRTEC and PROQUAD. On 4th December 2017, the patient received KINRIX (intramuscular) .5 ml. On 6th December 2017, 2 days after receiving KINRIX and an unknown time after starting MOTRIN, the patient experienced injection site warmth (serious criteria other: as per reporter). On an unknown date, the patient experienced extensive swelling of vaccinated limb (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), injection site itching (serious criteria other: as per reporter), injection site cellulitis and papular rash. The patient was treated with MOTRIN. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site cellulitis and papular rash were unknown and the outcome of the injection site warmth was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site cellulitis and papular rash to be related to KINRIX. The reporter considered the injection site warmth to be probably related to KINRIX. Additional details were provided as follows: On 4th December 2017, the patient received PROQUAD in the left arm subcutaneously. At 13:00 hours, the patient received KINRIX in the right shoulder. The patient came back to the pediatrician's office 3 days after receiving the KINRIX vaccine due to a significant injection site reaction. The patient's family administered MOTRIN as an intervention. The nurse described the size of the reaction as  significant based on the size of the patient's arm (she compared it to the circumference of the bottom of a water bottle). They were most concerned about the warmness of it since they were concerned if it could be cellulitis or a reaction to the vaccine since warmness was not listed in the vaccine information statements (VIS). The reporter also mentioned that the patient had papules on the neck and forehead.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash papular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received KINRIX (batch number 7559R, expiry date 14th October 2019). Concomitant products included ZYRTEC and PROQUAD. On 4th December 2017, the patient received KINRIX (intramuscular) .5 ml. On 6th December 2017, 2 days after receiving KINRIX and an unknown time after starting MOTRIN, the patient experienced injection site warmth (serious criteria other: as per reporter). On an unknown date, the patient experienced extensive swelling of vaccinated limb (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), injection site itching (serious criteria other: as per reporter), injection site cellulitis and papular rash. The patient was treated with MOTRIN. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site cellulitis and papular rash were unknown and the outcome of the injection site warmth was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site cellulitis and papular rash to be related to KINRIX. The reporter considered the injection site warmth to be probably related to KINRIX. Additional details were provided as follows: On 4th December 2017, the patient received PROQUAD in the left arm subcutaneously. At 13:00 hours, the patient received KINRIX in the right shoulder. The patient came back to the pediatrician's office 3 days after receiving the KINRIX vaccine due to a significant injection site reaction. The patient's family administered MOTRIN as an intervention. The nurse described the size of the reaction as  significant based on the size of the patient's arm (she compared it to the circumference of the bottom of a water bottle). They were most concerned about the warmness of it since they were concerned if it could be cellulitis or a reaction to the vaccine since warmness was not listed in the vaccine information statements (VIS). The reporter also mentioned that the patient had papules on the neck and forehead.
Sex: F
Vaccine: DTAPIPV
Symptoms: Injury associated with device
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of needle injury in a adult female patient who received KINRIX (batch number 75F53, expiry date 9th December 2019). On an unknown date, the patient received KINRIX. On an unknown date, immediately after receiving KINRIX, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. Additional details were provided as follows: The representative with the vaccine service center reported an adverse event that occurred on the day of reporting and reported to him. The reporter stated that the nurse was preparing to administer the vaccine to the patient the patient jerked. This in turn caused the nurse to prick her finger with the needle. The vaccine was not administered to the patient.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Aphthous ulcer, Diarrhoea, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 20-year-old female patient who received lamotrigine tablet (batch number Unknown, expiry date unknown) for bipolar disorder. Co-suspect products included Flu Seasonal QIV Dresden. Concomitant products included ALLEGRA D. On 14th November 2017, the patient started lamotrigine (oral) 25 mg once daily. In October 2017, the patient received Flu Seasonal QIV Dresden. In November 2017, less than a mother after starting lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating. On 30th November 2017, the patient experienced diarrhea. On an unknown date, the patient experienced viral infection. Lamotrigine was continued with no change. On an unknown date, the outcome of the influenza-like symptoms and viral infection were unknown and the outcome of the fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved. The reporter considered the influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis, sweating, diarrhea and viral infection to be probably related to lamotrigine and Flu Seasonal QIV Dresden. Additional details were provided as follows: On 30th November 2017, 16 days after receiving Lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced diarrhea. The patient experienced canker sores in her mouth. The patient was taken to the Emergency room yesterday and a flu test came back negative. They were told it was a viral illness and she was sent home. The caller stated that the symptoms had been getting worse. The patient received a flu shot of unknown brand in October 2017.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Lymphadenopathy, Pain, Photophobia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 20-year-old female patient who received lamotrigine tablet (batch number Unknown, expiry date unknown) for bipolar disorder. Co-suspect products included Flu Seasonal QIV Dresden. Concomitant products included ALLEGRA D. On 14th November 2017, the patient started lamotrigine (oral) 25 mg once daily. In October 2017, the patient received Flu Seasonal QIV Dresden. In November 2017, less than a mother after starting lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating. On 30th November 2017, the patient experienced diarrhea. On an unknown date, the patient experienced viral infection. Lamotrigine was continued with no change. On an unknown date, the outcome of the influenza-like symptoms and viral infection were unknown and the outcome of the fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved. The reporter considered the influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis, sweating, diarrhea and viral infection to be probably related to lamotrigine and Flu Seasonal QIV Dresden. Additional details were provided as follows: On 30th November 2017, 16 days after receiving Lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced diarrhea. The patient experienced canker sores in her mouth. The patient was taken to the Emergency room yesterday and a flu test came back negative. They were told it was a viral illness and she was sent home. The caller stated that the symptoms had been getting worse. The patient received a flu shot of unknown brand in October 2017.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Viral infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 20-year-old female patient who received lamotrigine tablet (batch number Unknown, expiry date unknown) for bipolar disorder. Co-suspect products included Flu Seasonal QIV Dresden. Concomitant products included ALLEGRA D. On 14th November 2017, the patient started lamotrigine (oral) 25 mg once daily. In October 2017, the patient received Flu Seasonal QIV Dresden. In November 2017, less than a mother after starting lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating. On 30th November 2017, the patient experienced diarrhea. On an unknown date, the patient experienced viral infection. Lamotrigine was continued with no change. On an unknown date, the outcome of the influenza-like symptoms and viral infection were unknown and the outcome of the fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved. The reporter considered the influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis, sweating, diarrhea and viral infection to be probably related to lamotrigine and Flu Seasonal QIV Dresden. Additional details were provided as follows: On 30th November 2017, 16 days after receiving Lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced diarrhea. The patient experienced canker sores in her mouth. The patient was taken to the Emergency room yesterday and a flu test came back negative. They were told it was a viral illness and she was sent home. The caller stated that the symptoms had been getting worse. The patient received a flu shot of unknown brand in October 2017.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: The patient per Mom gets flu shot each year. This year also the flu shot was given, right after injection to upper per pt and mom. Next day per pt and Mom, sais some pain on left arm and then pain in right arm with tingling and after that pt became better with the arm and then started having pain discomfort on ankle/feet on both sides, event to Pediatrics and was told might have Guillain Barre syndrome. Mom brought child for follow up and said having pain in both feet. At that pint as precaution ASAP referred Pt to ER, pt stable at that time, vitals stable, referred to ER for further evaluation. No swelling at injection site.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Edema.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient reports shooting pain in right arm and limited range of motion x 4 days. And shooting pain.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: And Urticaria.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, C-reactive protein normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Right thigh petechiae seen at Urgent Care and emergency room. Rx: supportive care.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Platelet count increased, White blood cell count normal
Clinical narrative: Right thigh petechiae seen at Urgent Care and emergency room. Rx: supportive care.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient had localised erythema swelling and bruising at injection site. Treated with IM steroid and oral prednisone taper. Give sympathetic warm compress.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Events started approximately 5-6 hours after vaccination. Arm became swollen, red, firm, and very sore. Majority of the symptoms weren't at the site of injection, rather in tricep/elbow area of (L) arm.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: I'm not sure of the exact type of flu shot I got. I just know it was a flu shot. A little over a week after getting the shot I experience extreme headache in the morning. As the day went by I started feeling body ache and tiredness. At night the symptoms got severe and I also developed a high fever and chills. I took ADVIL and it improve the symptoms. The fever eventually went away but the headache did not. The night of the symptoms I could not sleep because of the headache.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: I'm not sure of the exact type of flu shot I got. I just know it was a flu shot. A little over a week after getting the shot I experience extreme headache in the morning. As the day went by I started feeling body ache and tiredness. At night the symptoms got severe and I also developed a high fever and chills. I took ADVIL and it improve the symptoms. The fever eventually went away but the headache did not. The night of the symptoms I could not sleep because of the headache.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Hyperhidrosis, Irritability, Oropharyngeal pain, Pain in extremity
Clinical narrative: Massive diaphoresis, fever 102.5 +, headache, photophobia, terrible demeanor, sore throat, sore arm, swollen tender arm but not red.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Peripheral swelling, Photophobia, Pyrexia, Tenderness
Clinical narrative: Massive diaphoresis, fever 102.5 +, headache, photophobia, terrible demeanor, sore throat, sore arm, swollen tender arm but not red.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Rash maculo-papular, Respiratory symptom
Clinical narrative: This literature marketed report as received from the author of a public article. It was reported that current literature on the effectiveness of measles post-exposure prophylaxis (PEP) was limited and variable. The authors examined the effectiveness of measles, mumps, and rubella vaccine (MMR) and immune globulin (IG) PEP among children exposed to measles during an outbreak in 2013. Contacts were identified by the Department of Health and Mental Hygiene between 13-MAR-2013 and 30-JUN-2013. Immunity to measles and receipt of PEP was determined for contacts. PEP effectiveness [(1- relative risk of developing measles) x 100] was calculated for MMR, IG, and any PEP (MMR or IG) for nonimmune contacts aged less than 19 years. Of the contacts included, 44 received MMR PEP and 77 received IG PEP. Effectiveness of MMR PEP was 83.4% (95% confidence interval [CI], 34.4%, 95.8%). No contact who received IG PEP developed measles; effectiveness of IG PEP was 100% (approximated 95% CI, 56.2%, 99.8%). Effectiveness of receiving any PEP (MMR or IG) was 92.9% (95% CI, 56.2%, 99.8%). The authors concluded that contacts who received PEP were less likely to develop disease. Their findings supported current recommendations for administration of PEP following exposure to measles. These results highlighted the importance of a rapid public health outbreak response to limit measles transmission following case identification. This case refers to an infant patient of unknown gender, aged 6 to less than 12 months. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. In approximately 2013, the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) (dose, route and lot # not reported) for measles PEP. After receiving MMR, on an unknown date, the patient developed measles. The patient had generalized maculopapular rash with respiratory symptoms, but virus genotyping was not performed, and vaccine-strain virus could not be ruled out as the cause of symptoms. Developing measles after MMR was considered as effectiveness issues by the author. The outcome of the events was unknown. Upon internal review, measles after MMR was considered to be medically significant. This is one of two reports received from the same article (related case ID: 1712USA007366).; Sender's Comments: US-009507513-1712USA007366:
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive
Clinical narrative: This literature marketed report as received from the author of a public article. It was reported that current literature on the effectiveness of measles post-exposure prophylaxis (PEP) was limited and variable. The authors examined the effectiveness of measles, mumps, and rubella vaccine (MMR) and immune globulin (IG) PEP among children exposed to measles during an outbreak in 2013. Contacts were identified by the Department of Health and Mental Hygiene between 13-MAR-2013 and 30-JUN-2013. Immunity to measles and receipt of PEP was determined for contacts. PEP effectiveness [(1- relative risk of developing measles) x 100] was calculated for MMR, IG, and any PEP (MMR or IG) for nonimmune contacts aged less than19 years. Of the contacts included, 44 received MMR PEP and 77 received IG PEP. Effectiveness of MMR PEP was 83.4% (95% confidence interval [CI], 34.4%, 95.8%). No contact who received IG PEP developed measles; effectiveness of IG PEP was 100% (approximated 95% CI, 56.2%, 99.8%). Effectiveness of receiving any PEP (MMR or IG) was 92.9% (95% CI, 56.2%, 99.8%). The authors concluded that contacts who received PEP were less likely to develop disease. Their findings supported current recommendations for administration of PEP following exposure to measles. These results highlighted the importance of a rapid public health outbreak response to limit measles transmission following case identification. This case refers to an infant patient of unknown gender, aged 6 to less than 12 months. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. In approximately 2013, the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) (dose, route and lot # not reported) for measles PEP. After receiving MMR, on an unknown date, the patient met the clinical case definition and was confirmed to have wild-type measles infection through virus genotyping. Developing measles after MMR was considered as effectiveness issues by the author. The outcome of the events was unknown. Upon internal review, measles after MMR was considered to be medically significant. This is one of two reports received from the same article (related case ID: 1712USA004133).; Sender's Comments: US-009507513-1712USA004133:
Sex: F
Vaccine: FLU4
Symptoms: Dry eye, Eye pruritus, Malaise
Clinical narrative: Initial unsolicited report received from a nurse on 19-Oct-2017. This case involves a 33-year-old female patient was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT) (dose, form, route, lot number, expiry date were unknown) on an unknown date. Patient medical history was no reported. Concomitant medications include DUPIXENT 600 mg subcutaneously on an unknown date and 300 mg SQ every other week since an unknown date for Atopic Dermatitis. On an unknown date, after the vaccination, the patient developed itchy and slightly dry eyes, getting really sick. Lab data and corrective treatment were not reported. The patient's outcome was recovered for the events itchy and slightly dry eyes and unknown for getting sick at the time of reporting. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Injection site erythema, Nausea
Clinical narrative: Had the PREVNAR 13 vaccine applied at Pharmacy on Friday 12/8/2017 at around midday. That evening began to experienced chills, redness at site of injections, joint pain, nausea, complete loss of appetite. These symptoms continued in its majority until Tuesday, 12/12/2017. The chills, nausea, joint pain completely gone, however high redness at site of injection still present today 12/13/2017.
Sex: M
Vaccine: DTAP
Symptoms: Asthma, Dyspnoea, Ear infection, Immune system disorder, Nasopharyngitis
Clinical narrative: After vaccination of my son on 10/27/2016, he had pneumonia and ear infection twice (First in November 2016 and second in January 2017). 2017 is constant cold and breathing problems. His immune system went down so badly after vaccination that we started Albuterol in January 2017 because of asthmatic components with pneumonia and we still on it plus Budesonide with each single cold my son has. Before vaccination he never had cold or other respiratory distresses. It is so vivid that cause of our problems now is the vaccine.
Sex: M
Vaccine: DTAP
Symptoms: Pneumonia
Clinical narrative: After vaccination of my son on 10/27/2016, he had pneumonia and ear infection twice (First in November 2016 and second in January 2017). 2017 is constant cold and breathing problems. His immune system went down so badly after vaccination that we started Albuterol in January 2017 because of asthmatic components with pneumonia and we still on it plus Budesonide with each single cold my son has. Before vaccination he never had cold or other respiratory distresses. It is so vivid that cause of our problems now is the vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise, Myalgia
Clinical narrative: Patient experienced several weeks of cough, muscle aches, and malaise beginning three days after receiving FLUZONE vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paresis
Clinical narrative: Student reported that she noticed that her smile was lopsided on 12/13/17. Was evaluated at school clinic 12/14/17. Mild weakness was noted on left side of face. No other accompanying sxs. Student also reported that at night, the head of her bed is by a window and cold air blows on the left side of her face - possible significance if this is a facial nerve inflammation. Student was referred to her PCP for further evaluation and was being seen 3 hours after initial eval at HC.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Wife of patient reported numbness on side of face and part of tongue, late last night and still numb today.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site induration, Rash erythematous, Urticaria
Clinical narrative: Urticaria-neck/chest/back/inner thighs (walk in visit 12/14/17) Bil arms. Redness and induration (R) deltoid injection site. Tx-Prednisone x3 days-OTC ALLEGRA, OTC BENADRYL.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Patient is pregnant, LMP 10-05-2017. Doctor ordered a Preservative Free Flu Shot for patient however the Nurse gave the patient a High Dose Influenza Vaccine in error. Doctor and Supervisor notified immediately, Doctor has contacted the patient to inform her of the error. Patient has not experienced any issues at this time. Will contact Sanofi Pasteur as well to get direction.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: RED, HOT, PAINFUL, WELT AT INJECTION SITE 2" X 6".
Age: 18.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Pt developed 3 quarter size hives, hot to the touch the evening after receiving the varicella vaccine in the LA. Area very itchy.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash generalised
Clinical narrative: Full body rash 2 days after vaccines and 1 week after amoxicillin. Questionable vaccine vs. allergic reaction. Very prominent rash at.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 month old male patient with tongue tie. The patient's drug reactions or allergies were not reported. On 13-NOV-2017, the patient was accidentally vaccinated on the right leg with an expired dose of M-M-R II lot number: L043704 (expiration date: 04-NOV-2017), first dose, subcutaneously, for prophylaxis (strength and dosage schedule were not reported). On the same day, the patient was also vaccinated with VAQTA (lot number: N012324, expiration date: 05-APR-2018) on the right vastus lateralis, PREVNAR 13 (lot number: R73811) on the left vastus lateralis and VARIVAX (lot number: MO3208) on the left vastus lateralis for prophylaxis. No adverse effects or problems were reported. The nurse contacted an agent, who informed him that the vaccine was okay and there was no need to revaccinate.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX subcutaneous injection, intramuscularly, lot# reported as N0220016 (confirmed to be an invalid lot #), expiration date reported as 17-JUL-2019 for prophylaxis. The nurse reported that the patient was vaccinated "intramuscularly rather than subcutaneously". No adverse effects were reported.
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Diarrhoea, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from non-healthcare professional (company representative) on 03 Dec 2017 and live follow up was received on 06 Dec 2017. This case involves 27 years old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLU) (batch number: UI886AB, expiry date: 30 Jun 2018, route and site of administration were not reported) on 02 December 2017. The patient's medical history and concomitant medication were not reported. On an unknown date (events reported to company representative on 03 Dec 2017), following the vaccination the patient experienced redness and swelling around the injection site causing some discomfort and pain- the area was marked and overtime, swelling, redness seamed to spread, diarrhea. On an unknown date, the patient was diagnosed with cellulitis. Laboratory investigation was not reported. Patient was on a 10 day regimen of antibiotic as corrective treatment. Outcome of events was not reported. Upon internal review the case was considered as serious due to important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This is a poorly documented case in which patient was diagnosed with cellulitis post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset (1 day) is compatible with the role of vaccine. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from non-healthcare professional (company representative) on 03 Dec 2017 and live follow up was received on 06 Dec 2017. This case involves 27 years old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLU) (batch number: UI886AB, expiry date: 30 Jun 2018, route and site of administration were not reported) on 02 December 2017. The patient's medical history and concomitant medication were not reported. On an unknown date (events reported to company representative on 03 Dec 2017), following the vaccination the patient experienced redness and swelling around the injection site causing some discomfort and pain- the area was marked and overtime, swelling, redness seamed to spread, diarrhea. On an unknown date, the patient was diagnosed with cellulitis. Laboratory investigation was not reported. Patient was on a 10 day regimen of antibiotic as corrective treatment. Outcome of events was not reported. Upon internal review the case was considered as serious due to important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This is a poorly documented case in which patient was diagnosed with cellulitis post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset (1 day) is compatible with the role of vaccine. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Rhabdomyolysis
Clinical narrative: Initial unsolicited report received from a nurse on 05-Dec-2017. This case involves a 34-year-old male patient who was vaccinated with 0.5 ml single intramuscular dose of FLUZONE QIV (Batch number: U5958AA, expiration date: 30-Jun-2018, and dose in series were not reported) in the left deltoid on 17-Nov-2017. Patient's medical history was not reported. As concomitant medications, the patient also recently was started on Hydrochlorothiazide. On an unknown date, after the vaccination, the patient had experienced symptoms of Rhabdomyolysis. On an unknown date, 10 days following the vaccination, patient required doctor visit with symptoms of Rhabdomyolysis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as not recovered. Upon internal review, the company decided to consider the case as serious due to important medical event: symptoms of Rhabdomyolysis. List of documents held by sender: none. Sender's Comments: This case concerns a patient who had symptoms of rhabdomyolysis post vaccination with FLUZONE QIV. Time to onset is compatible with the role of vaccine. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, confirmed diagnosis, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Paraesthesia, Tenderness
Clinical narrative: Developed redness, tenderness and tingling of right forearm shortly after receiving vaccines. Was treated with antibiotics after office visit on 12/12/17, diagnosis: cellulitis.
Age: 1.5
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: This was her 3rd or 4th dose of PREVNAR. She got the injection in the morning, and by evening her thigh was noticeably swollen, even though pants. It was warm to the touch, and very tender to the point she wasn't putting full weight when standing or walking. Two days later her walking seems normal, but it is still pretty swollen. Might have gone down a little. I also noticed red splotches on her thigh (not at the injection site) on the evening of day two. Still there the morning of day three.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red, hot rash on upper arm that the shot was given in for 2 days that is self resolving.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Cough, Dyspnoea, Sensory loss, Urticaria
Clinical narrative: Patient called the office the afternoon of Thursday, 12/14/2017 to report the he "had a reaction to the shot" he was given in our clinic. Stated that "about an hour and a half after I got the shot I started having trouble breathing". "I started coughing and felt like I was having an asthma attack and I don't have asthma." "My mom wanted to call 911, but I told her not to because I was still able to get a little air." "It also felt like I lost sensation in all my limbs." Patient was instructed that calling 911 would have been the right thing to do under those circumstances. "I live in the country and it would have taken them 30 minutes to get here anyway and I was ok by that time (within 30 minutes). Patient states he developed significant hives from head to toe and it was still present. Patient stated he contacted his PCP following his reaction, but did not see her in person.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Red, raised "welt" at the injection site.
Age: 78.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Drug administered at inappropriate site, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: Patient was given his immunization very high up on his arm and is experiencing pain enough to keep him awake at night a month later. Shoulder pain.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle ache, redness/tenderness at injection site.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Immediate post-injection reaction, Pain, Tenderness, Vaccination site pain
Clinical narrative: PAIN IMMEDIATELY AT VACCINATION SITE, THEN INTERMITTENTLY POSTERIOR RIGHT SHOULDER PAIN WITH ACTIVE MOTION. PAIN MAINLY IN ACTUAL JOINT, BUT SLIGHTLY TENDER POINT OVER POSTERIOR SUPERIOR SHOULDER.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Patient stated she felt nauseous and sick to the stomach.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to right thigh started 1 day after vaccines were given.
Age: 11.0
Sex: F
Vaccine: FLU4, HEP, HPV9, MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Pt was here for a WCC and needed her 11 yrs vaccines pt was doing fine during the procedure was left in the room for observation for 15 mins when pt was going to be discharged but began with intense headache and lightheadedness Provider was notified and provider came back to exam patient. Ibuprofen was and 15 minutes after all symptoms were resolved. Provider followed up with mother the next day and stated that patient was doing well. (Weight: 127 lbs).
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperventilation, Pruritus generalised, Syncope, Urticaria
Clinical narrative: Approx. 4 hours after vaccination patient was driving and became extremely itchy over his entire body. He states that he pulled over and  developed "welts" over his body. Patient hyperventilated and had a syncopal event. EMS was called. Patient took 2 BENADRYL and is doing well today.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Chills, Ecchymosis, Erythema, Induration
Clinical narrative: Patient had swelling, redness with burning, chills and fever after receiving injection. Called to report and sent to walk in care on 09/10/17. Did have erythema, swelling and area showed ecchymosis. Was given Ibuprofen to take for pain and to use warm oil massages. To f/u with PCP in 3 days. She did follow up with Dr. on 9/13/17 and c/o of same symptoms with swelling, redness. Arm had large induration. Was told to take BENADRYL and Ibuprofen. Called back on 9/28 with difficulty moving arm. Was told to take prednisone. No call back till patient came to see doctor for routine appointment and she stated she wanted manufacturer aware of SE.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pyrexia, Swelling
Clinical narrative: Patient had swelling, redness with burning, chills and fever after receiving injection. Called to report and sent to walk in care on 09/10/17. Did have erythema, swelling and area showed ecchymosis. Was given Ibuprofen to take for pain and to use warm oil massages. To f/u with PCP in 3 days. She did follow up with Dr. on 9/13/17 and c/o of same symptoms with swelling, redness. Arm had large induration. Was told to take BENADRYL and Ibuprofen. Called back on 9/28 with difficulty moving arm. Was told to take prednisone. No call back till patient came to see doctor for routine appointment and she stated she wanted manufacturer aware of SE.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Body aches, congestion, fever, headache, cough.
Age: 1.17
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Pt c/o HA, dizziness 10 min after HPV vaccine; water and cookies offered; resolved within 30 min.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Peripheral swelling, Rash erythematous
Clinical narrative: Pt received vax at 3:40 pm. Approximately midnight she went to ER with swollen arm (approximately apple size knot) and red rash. Dr prescribed prednisone and advised to avoid vax in future due to allergy. (Had PCV13 2 years ago).
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient received 2 vax in 1 arm. Next day had red, swollen rash at (L) upper arm. He didn't seek med attention. Told RPh 12/9. Had PPV13 1 yr prior.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Heart rate increased, Injection site pain, Nausea, Vertigo
Clinical narrative: Increased heart rate up to 120 bpm, dizziness/vertigo, nausea, stinging/burning at site. Symptoms started within 30 min. post injection and lasted for 2 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt noticed redness and a small patch of swelling around area next day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Local reaction, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Local reaction at vaccine site-left deltoid. Redness of about 31/2 in. in diameter, mild swelling, warmth over area mild pruritis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: Injection site rash, Pyrexia, Wrong drug administered
Clinical narrative: ZOSTAVAX vaccine given in error, no adverse reactions. ZOSTAVAX given inadvertently instead of VARIVAX. Next day patient had rash at injection site and fever (101F).
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, shaking, fever, vomiting, headache, sore muscles and joints all over, very tired, - at time of reporting I am still having these symptoms.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Chills, shaking, fever, vomiting, headache, sore muscles and joints all over, very tired, - at time of reporting I am still having these symptoms.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Erythema, Pain in extremity, Tenderness, Ultrasound scan normal
Clinical narrative: Patient presented 5 days after vaccination with pain/tenderness in upper left arm radiating to chest.  Later radiated to antecubital/forearm area along the vein tract. Redness was observed in the antecubital fossa. Imaging was performed and rest and heat was recommended. Following initial presentation and imaging, the patient presented again with no improvement in symptoms. Ibuprofen every 6-8 hours was recommended upon evaluating renal function.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Pain, Paraesthesia, Rash maculo-papular, Skin lesion
Clinical narrative: Shingles like rash, more maculopapular than vesicular rash starting on the back of the L arm. Lesions spread to torso, abdomen and R arm. Pt reports the other lesions are healing but the original ones remain. Pt reports all over body pain that is burning/tingling/throbbing and not helped by medication.