chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling cold, Feeling hot, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, chills, general body pain and sleeplessness. On 26th October 2018, the patient experienced headache, runny nose, mobility decreased and feeling cold. On 27th October 2018, the patient experienced erythema of extremities and feeling hot. On 29th October 2018, the patient experienced tenderness. The patient was treated with TYLENOL. On 26th October 2018, the outcome of the chills was recovered/resolved. On 27th October 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the pain in arm and tenderness were unknown and the outcome of the sleeplessness, headache, runny nose, erythema of extremities, feeling hot, mobility decreased and feeling cold were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, general body pain, sleeplessness, headache, runny nose, erythema of extremities, feeling hot, tenderness, mobility decreased and feeling cold to be related to SHINGRIX. Additional details were reported as follows: On 25th October 2018 at around 9:30 AM, the patient received a first dose of SHINGRIX. On the same day, late that afternoon the patient experienced arm was really sore and at night she experienced chills, shivering and body aches that prevented her from sleeping. On 26th October 2018, in the morning the patient had a bad headache so she took TYLENOL. The patient also experienced runny nose and the patient felt she had a cold. The patient's shivering had stopped and the body aches were less, but her arm was very painful and she could not lift it above her shoulder. On 27th October 2018, the patient's headache and runny nose was less severe. The patient had no chills or body aches and her arm was less sore. The patient looked first time at her arm and noticed a red circle about 2 inches in diameter that was hot to touch. On 28th October 2018, the patient's symptoms continued to decrease, the red spot on her arm was only 1 inch in diameter though still warm to touch. On Monday, 29th October 2018, the patient was mostly back to normal.  There was no defined circle on her arm, but it was pinkish and tender to touch. No consent for follow up was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, chills, general body pain and sleeplessness. On 26th October 2018, the patient experienced headache, runny nose, mobility decreased and feeling cold. On 27th October 2018, the patient experienced erythema of extremities and feeling hot. On 29th October 2018, the patient experienced tenderness. The patient was treated with TYLENOL. On 26th October 2018, the outcome of the chills was recovered/resolved. On 27th October 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the pain in arm and tenderness were unknown and the outcome of the sleeplessness, headache, runny nose, erythema of extremities, feeling hot, mobility decreased and feeling cold were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, general body pain, sleeplessness, headache, runny nose, erythema of extremities, feeling hot, tenderness, mobility decreased and feeling cold to be related to SHINGRIX. Additional details were reported as follows: On 25th October 2018 at around 9:30 AM, the patient received a first dose of SHINGRIX. On the same day, late that afternoon the patient experienced arm was really sore and at night she experienced chills, shivering and body aches that prevented her from sleeping. On 26th October 2018, in the morning the patient had a bad headache so she took TYLENOL. The patient also experienced runny nose and the patient felt she had a cold. The patient's shivering had stopped and the body aches were less, but her arm was very painful and she could not lift it above her shoulder. On 27th October 2018, the patient's headache and runny nose was less severe. The patient had no chills or body aches and her arm was less sore. The patient looked first time at her arm and noticed a red circle about 2 inches in diameter that was hot to touch. On 28th October 2018, the patient's symptoms continued to decrease, the red spot on her arm was only 1 inch in diameter though still warm to touch. On Monday, 29th October 2018, the patient was mostly back to normal.  There was no defined circle on her arm, but it was pinkish and tender to touch. No consent for follow up was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Skin warm, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, chills, general body pain and sleeplessness. On 26th October 2018, the patient experienced headache, runny nose, mobility decreased and feeling cold. On 27th October 2018, the patient experienced erythema of extremities and feeling hot. On 29th October 2018, the patient experienced tenderness. The patient was treated with TYLENOL. On 26th October 2018, the outcome of the chills was recovered/resolved. On 27th October 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the pain in arm and tenderness were unknown and the outcome of the sleeplessness, headache, runny nose, erythema of extremities, feeling hot, mobility decreased and feeling cold were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, general body pain, sleeplessness, headache, runny nose, erythema of extremities, feeling hot, tenderness, mobility decreased and feeling cold to be related to SHINGRIX. Additional details were reported as follows: On 25th October 2018 at around 9:30 AM, the patient received a first dose of SHINGRIX. On the same day, late that afternoon the patient experienced arm was really sore and at night she experienced chills, shivering and body aches that prevented her from sleeping. On 26th October 2018, in the morning the patient had a bad headache so she took TYLENOL. The patient also experienced runny nose and the patient felt she had a cold. The patient's shivering had stopped and the body aches were less, but her arm was very painful and she could not lift it above her shoulder. On 27th October 2018, the patient's headache and runny nose was less severe. The patient had no chills or body aches and her arm was less sore. The patient looked first time at her arm and noticed a red circle about 2 inches in diameter that was hot to touch. On 28th October 2018, the patient's symptoms continued to decrease, the red spot on her arm was only 1 inch in diameter though still warm to touch. On Monday, 29th October 2018, the patient was mostly back to normal.  There was no defined circle on her arm, but it was pinkish and tender to touch. No consent for follow up was given.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 89-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. On 22nd October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, several days after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shortness of breath, sore throat and runny nose. On an unknown date, the outcome of the shortness of breath, sore throat and runny nose were unknown. It was unknown if the reporter considered the shortness of breath, sore throat and runny nose to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that she received a flu vaccine (unknown brand) and experienced shortness of breath, sore throat and a runny nose a few days later.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced flu like symptoms. No other details were provided. The pharmacist did not consent to follow up. The registered pharmacist (RPH) does not want to be contacted and did not want to report the adverse event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced hallucination. On an unknown date, the outcome of the hallucination was recovered/resolved. It was unknown if the reporter considered the hallucination to be related to SHINGRIX. Additional details were provided as follows: In the evening after receiving SHINGRIX, the patient developed psychotic symptoms (hallucinations). The pharmacist consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX and the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was resolved with sequelae. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient took the SHINGRIX vaccine, but still had the shingles. This case was considered as suspected vaccination failure cases as the time to event onset and laboratory results were unknown at the time of reporting. The patient consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Speech disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hoarseness in a 74-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced hoarseness and speech disorder. On an unknown date, the outcome of the hoarseness and speech disorder were not recovered/not resolved. It was unknown if the reporter considered the hoarseness and speech disorder to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX in the left deltoid. Within 24 hours after receiving the vaccine the patient developed hoarseness and could barely speak. When the patient first woke up in the morning, his voice was almost normal. However, within five minutes after waking up, he became hoarse again and could not speak. The patient gave permission for his physician to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 2nd dose of SHINGRIX. On 7th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he got his SHINGRIX shot on left arm. The patient had arm soreness at the injection site on the day of reporting and wanted to know if he could lift weights. The patient was referred to his physician. The patient did not consent to follow-up. The patient declined to provide demographics or details. The patient did not know the lot number.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Apnoea, Body temperature increased, Choking, Cyanosis, Electrocardiogram normal
Clinical narrative: Pt seen for 4 month well check 11/9/18. Doing well. No illness before. Fully well at well check. Normal exam. Received normal 4 month vaccines. Seemed well all afternoon and early /mid evening. Mom noticed later that eve around 9 pm that pt acted hungry but did not want to nurse when offered. When placing down to change diaper, pt vomited solids from earlier that day. Immediately then pt turned pale, white, limp all body, lips started turning blue eyes were always open but appeared lethargic. Mom picked up and gave back slaps. Pt responded and then gradually became more alert. EMS had been called- brought to ER noted to have normal exam, all vital signs stable - monitored over 2 hours. No local vaccine reaction at thighs. Felt likely apnea reaction to choking. Dx Unexplained event. Note pt has mild GE reflux- no past episodes before per mom. No new exposures. No cough, congestion, rashes, diarrhea or other symptoms. Temp at ER -99.  Discharged as seemed well. Temp next day 11/10- low grade 99-100, breastfeeding overall well although not quite himself, no other symptoms, no more vomiting. 11/11 and 11/12- fully well, nursing well, no fever, no vomiting, seemed well. Seen in clinic 11/12/18- alert, comfortable, normal exam. FH of mom with passing out as child with pain, MGM with WBW and A fib-  EKG done for pt in office- normal.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Gastrooesophageal reflux disease, Hypotonia, Lethargy, Pallor, Vomiting
Clinical narrative: Pt seen for 4 month well check 11/9/18. Doing well. No illness before. Fully well at well check. Normal exam. Received normal 4 month vaccines. Seemed well all afternoon and early /mid evening. Mom noticed later that eve around 9 pm that pt acted hungry but did not want to nurse when offered. When placing down to change diaper, pt vomited solids from earlier that day. Immediately then pt turned pale, white, limp all body, lips started turning blue eyes were always open but appeared lethargic. Mom picked up and gave back slaps. Pt responded and then gradually became more alert. EMS had been called- brought to ER noted to have normal exam, all vital signs stable - monitored over 2 hours. No local vaccine reaction at thighs. Felt likely apnea reaction to choking. Dx Unexplained event. Note pt has mild GE reflux- no past episodes before per mom. No new exposures. No cough, congestion, rashes, diarrhea or other symptoms. Temp at ER -99.  Discharged as seemed well. Temp next day 11/10- low grade 99-100, breastfeeding overall well although not quite himself, no other symptoms, no more vomiting. 11/11 and 11/12- fully well, nursing well, no fever, no vomiting, seemed well. Seen in clinic 11/12/18- alert, comfortable, normal exam. FH of mom with passing out as child with pain, MGM with WBW and A fib-  EKG done for pt in office- normal.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Hyperhidrosis, Immediate post-injection reaction, Tremor, Unresponsive to stimuli
Clinical narrative: Patient in to clinic 11/13/2018 for two scheduled vaccines. 0840; Vaccine #1 given in left arm, 08: 42 vaccine #2 given in right arm. Patient immediately became diaphoretic and shaky, closed her eyes and did not respond to questions for about 5 seconds before opening her eyes and talking. PHN directed third nurse to notify emergency services. At this time Public Health Nurse and PHN were able to move patient to lying position. Cool compresses applied and vital signs: B/P 93/65 Pulse - 76. Patient remained in lying position for 5 minutes and then moved to sitting position. Continued cool compresses and at this time offered juice and water. Patient states she did eat breakfast this am and consumed the juice. EMS arrived and report given to staff. Patient states she feels better at this point but EMS encouraged her to sit in the ambulance in parking lot. Mom agreed to this. Patient transported to ambulance via stretcher, rested and then went home in moms vehicle. 11;28 PHN called mother to follow up with her re: status of patient. Voicemail left at this time. 11/14/18 - Follow up phone call made. 12:01: Mom called back and stated after the vaccine yesterday she did not follow up with Primary care physician. She states that patient has had headaches on and off but was able to go to school this am. PHN did encourage mom to follow up with PMD, RN.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Redness to left arm and chest.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports she received PREVNAR 13 vaccine on 11/8/18. The following evening (11/9/18), pt states she had redness, swelling, itching and warmth around the injection site (left upper arm).  She also had an elevated temperature for which she took Aleve. Pt states that arm has continued to be red, hot swollen, and painful. Pt prescribed Deltasone 20mg and Keflex 500mg. Advised to use cool compresses and NSAIDs PRN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt reports she received PREVNAR 13 vaccine on 11/8/18. The following evening (11/9/18), pt states she had redness, swelling, itching and warmth around the injection site (left upper arm).  She also had an elevated temperature for which she took Aleve. Pt states that arm has continued to be red, hot swollen, and painful. Pt prescribed Deltasone 20mg and Keflex 500mg. Advised to use cool compresses and NSAIDs PRN.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus
Clinical narrative: Itching approximately 5 cm from injection site less than 15 minutes after injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Swelling and redness at injection site. Extreme soreness at injection site, nausea, headache.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen arm and pain above the elbow, below the injection site.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site warmth, Nuclear magnetic resonance imaging abnormal
Clinical narrative: C/o of pain at the injection site upon influenza vaccination administration. Local soreness and warm to touch at injections site. She was evaluated by her pcp and ruled out an infection. She continues to have limited upper arm movement.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient  started developing hives on back, arms and legs with itching from vaccine. Patient was given 50 mg of BENADRYL liquid and BENADRYL cream to apply to the itchy areas. Patient reported no difficulty breathing, throat swelling or chest heaviness. Patient was monitored for 20 more minutes and then decided to leave with daughter who was driving her. I called patient an hour later to check on her and daughter stated she was resting and feeling better now. I also reported ADR to patient's PCP.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 1 day after influenza vaccination, he had extreme soreness to his upper arm and stiffness. He claims he had limited range of motion which has mostly resolved at this time, stating "I have 80-90% use back".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Pain, Pyrexia
Clinical narrative: Fever 101F. Body aches. Fatigue, headache unable to go to work and because I'm still running fever on day two I will not be going in tomorrow.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: Patient reports fever body aches, chills and uncontrolled shaking that kept pt awake pt states just now feeling better only took TYLENOL for symptoms. Pt said felt worse than normal side effects from a flu shot. Reported no swelling or redness at injection site just mild tenderness like last years shot.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient reports fever body aches, chills and uncontrolled shaking that kept pt awake pt states just now feeling better only took TYLENOL for symptoms. Pt said felt worse than normal side effects from a flu shot. Reported no swelling or redness at injection site just mild tenderness like last years shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Injection site pain, Pain in extremity
Clinical narrative: PATIENT RECEIVED 2ND SHINGRIX DOSE ON 11/8/18  AT APPROXIMATELY 10 AM. AT 12 AM ON 11/9/18, PATIENT REPORTS HE WOKE UP IN A DEEP SWEAT ON THE FLOOR OF HIS BEDROOM, PANTING HEAVILY "LIKE A DOG" AND EXPERIENCED LOSS OF BLADDER CONTROL. THESE SYMPTOMS CONTINUED FOR APPROXIMATELY AN HOUR WHILE THE PATIENT LIED ON BEDROOM FLOOR IN FRONT OF A FAN, THEN MOVING BACK TO HIS BED WHERE HE EXPERIENCED CHILLS AND SEVERE SHIVERING UNTIL HE FELL ASLEEP A SHORT TIME LATER. PATIENT REPORTS HE THEN WOKE UP APPROXIMATELY 7 HOURS LATER WITHOUT PREVIOUS SYMPTOMS, EXCEPT FOR INJECTION SITE TENDERNESS AND ARM SORENESS.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: PATIENT RECEIVED 2ND SHINGRIX DOSE ON 11/8/18  AT APPROXIMATELY 10 AM. AT 12 AM ON 11/9/18, PATIENT REPORTS HE WOKE UP IN A DEEP SWEAT ON THE FLOOR OF HIS BEDROOM, PANTING HEAVILY "LIKE A DOG" AND EXPERIENCED LOSS OF BLADDER CONTROL. THESE SYMPTOMS CONTINUED FOR APPROXIMATELY AN HOUR WHILE THE PATIENT LIED ON BEDROOM FLOOR IN FRONT OF A FAN, THEN MOVING BACK TO HIS BED WHERE HE EXPERIENCED CHILLS AND SEVERE SHIVERING UNTIL HE FELL ASLEEP A SHORT TIME LATER. PATIENT REPORTS HE THEN WOKE UP APPROXIMATELY 7 HOURS LATER WITHOUT PREVIOUS SYMPTOMS, EXCEPT FOR INJECTION SITE TENDERNESS AND ARM SORENESS.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Basophil percentage, Blood creatine phosphokinase normal, C-reactive protein increased
Clinical narrative: 2 days after receiving the HPV vaccine, patient had weakness, tingling in both legs and bilateral knee pain and had difficulty ambulating. She was taken to ER.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Eosinophil percentage, Gait disturbance, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage
Clinical narrative: 2 days after receiving the HPV vaccine, patient had weakness, tingling in both legs and bilateral knee pain and had difficulty ambulating. She was taken to ER.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Monocyte percentage, Neutrophil percentage, Paraesthesia, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: 2 days after receiving the HPV vaccine, patient had weakness, tingling in both legs and bilateral knee pain and had difficulty ambulating. She was taken to ER.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: White blood cell count normal, X-ray limb normal
Clinical narrative: 2 days after receiving the HPV vaccine, patient had weakness, tingling in both legs and bilateral knee pain and had difficulty ambulating. She was taken to ER.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pain, burning from shot site all the way down the arm. Lasted 5 days. Itching also.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Redness, pain, burning from shot site all the way down the arm. Lasted 5 days. Itching also.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Blood glucose normal, Headache, Skin laceration, Suture insertion, Syncope
Clinical narrative: Fainting (hit head and needed a few stitches) was out for a few seconds.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Fainting (hit head and needed a few stitches) was out for a few seconds.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Soft tissue swelling
Clinical narrative: Soft tissue swelling, tenderness injection site, and edema.
Age: 82.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient exhibits symptoms of Guillain-Barre syndrome per Healthcare Provider.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 69 year old female patient. The patient had no historical condition, concomitant medications and drug reactions or allergies to be reported. On 22-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular for prophylaxis (reported as vaccination) lot # N013521, and expiration date 23-JUN-2019 (dose and anatomical location were not reported). The pharmacist reported that patient returned on 24-OCT-2018, and explained that beginning on 23-OCT-2018, it hurt to pick up her arm (pain in arm). Pharmacist also reported that there was swelling at the injection site (injection site swelling), redness (injection site redness), and the site was "hot to the touch" (hot at inj site post vaccination). Also reported that the patient applied ice to the affected area for an unspecified amount of time, and patient took an unspecified dose of ibuprofen (MOTRIN) for pain. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The causality between injection site swelling, injection site warmth, injection site erythema and pain in extremity and PNEUMOVAX 23 was unknown.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: This spontaneous report was received from a medical assistant, via company representative, concerning a 17 year old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies and it was stated that she had not any concomitant medication. On 07-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis, on her right arm, lot #1586749 and expiration date 13-FEB-2021 (strength, dose, frequency and route of administration were not reported). On the same date, while still in the office, the patient fell over and hit her head on the ground (head injury) and was unconscious for about 30 seconds. It was reported that the patient was transported by ambulance to the hospital. The reporter advised that the event was not life threatening but it was unknown what happened at the hospital. It was reported that the patient recovered from the loss of consciousness the same day after 30 seconds and from falling and hitting her head and  on an unspecified date in November 2018. The casual relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporter. Upon internal review, loss of consciousness was determined to be a medically significant event.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2016, reported as two years ago at 13 years of age, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that the patient never came back to the office to complete series. Currently, the patient was 15 years old and would like to receive the second dose of GARDASIL 9. No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-OCT-2014, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 15-JUN-2016, the patient was treated by a physician at an internal medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Ophthalmological examination abnormal, Photophobia, Photopsia, Retinal haemorrhage
Clinical narrative: Immediately after vaccine was administered I had vision changes with extreme sensitivity to light in left eye, which continued for 48 hours. After 48 hours, I began having flashing lights and floaters in left eye.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Visual impairment, Vitreous detachment, Vitreous floaters
Clinical narrative: Immediately after vaccine was administered I had vision changes with extreme sensitivity to light in left eye, which continued for 48 hours. After 48 hours, I began having flashing lights and floaters in left eye.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Dizziness, feeling faint.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt presented today with a red rash on chest, neck and arms. The rash was not itching or causing pain to patient just more annoying in appearance. Patient was advised to begin Diphenhydramine if rash worsens, but patient was resistant to start because of possible drowsiness.
Age: 17.0
Sex: M
Vaccine: FLU4, IPV, MMR, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Client reported feeling dizziness and faint following receiving all listed immunizations were completed. Client was alert and orientated during incident. Client facial appearance was pale and client reported to be sweaty. Public Health staff had client lower head, offered juice which client drank without incident 2 small juice boxes, client given a ice pack for the back of his neck and damp paper towel to wipe off face. Public Health staff remained with client until he reported he was feeling better and could walk to waiting room. The incident lasted approximately 15 mins. Client was observed in waiting room for a period of time with no further incident.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Fatigue, Joint stiffness, Restlessness, Sleep disorder
Clinical narrative: Patient states felt very fatigued the evening of 11/6/2018. Did not sleep well, restless. Felt very fatigued the next day, 11/7/18 and had trouble focusing, concentrating in class and her finger joints felt stiff, but did not note swelling. States felt "disconnected". Denies headache, f/c, dizziness, rash, visual sx. States slept well that night. Symptoms were essentially resolved 11/8/2018 except mild fatigue. Has never had an influenza vaccine
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Delirium, Dizziness
Clinical narrative: Patient states following the flu vaccine, he had the chills, low appetite, felt delirious, weak, and dizzy. He had 2 accidents from not being able to make it to the bathroom in time. He also had fever, headache, and swelling at the injection site. Patient reports that these symptoms have improved significantly. (This info was recorded 10/11/18, the day following vaccination).
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Incontinence, Injection site swelling, Pyrexia
Clinical narrative: Patient states following the flu vaccine, he had the chills, low appetite, felt delirious, weak, and dizzy. He had 2 accidents from not being able to make it to the bathroom in time. He also had fever, headache, and swelling at the injection site. Patient reports that these symptoms have improved significantly. (This info was recorded 10/11/18, the day following vaccination).
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Eye pruritus, Feeling of body temperature change, Generalised erythema, Headache
Clinical narrative: It started with rash/hives all over my body- head to toe I'm all red and Itching, running nose, itching eyes, sneezing, headache, shivers, hot and cold all the time, feel my head and face hot. I dont have fever don't had in more than 20 years, but it feels like i have a fever.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash generalised, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: It started with rash/hives all over my body- head to toe I'm all red and Itching, running nose, itching eyes, sneezing, headache, shivers, hot and cold all the time, feel my head and face hot. I dont have fever don't had in more than 20 years, but it feels like i have a fever.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: The patient came in to pharmacy with mom. They said he had redness and warm patch on arm that flu shot was given in. The redness was about golf ball size ring, no swelling, warm to touch, and not really itchy. It was not at injection site. The spot was about 3 inches from injection site. The mom said she will watch and see if the redness gets worse or not, if so will seek medical attention if needed.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Pt presented to clinic on 11/14/18 and parents stated he developed a diffuse rash 2 days prior (11/12/18, 4 days after receiving his 1 year old vaccinations). The rash was described as starting throughout the body but did worsen over the course of 2 days. Rash was pruritic. On exam the rash consisted of small flesh colored to erythematous papules throughout the chest, abdomen, back, arms, and legs - no oral involvement, no evidence of blistering lesions. Pt prescribed symptomatic care (cetirizine, hydrocortisone).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Cannot reach behind my back with left arm, cannot carry a purse with my left arm, cannot lean on left arm, slight pain from shoulder to elbow most of time, rolling over in sleep to left side and awakened with pain.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenitis
Clinical narrative: Patient came back on 11/14/18 around 2:00PM with swelling under left armpit. Patient will go to see her MD.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted for a few seconds after injection. Patient's sister assisted patient while patient was in chair. Patient recovered within a few seconds and said they were ok and sometimes fainted at the sight of blood. Patient did not want 911 to be called. Patient remained seated for 15 minutes, stated they were ok and left with her sister who was driving.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated her arm "was not the same since flu shot was given". Patient was diagnosed with cellulitis on 11/12/18. Patient's arm was red, swollen, and complained of itchiness.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient got PNEUMOVAX 23 on 10/19/2018 in left arm. Patient's daughter called today (11/14/18) saying that patient has had increasing pain in left upper arm since day after the vaccination. Patient's daughter says it has gotten to the point where patient cannot even sleep on left side. Informed patient's daughter to take patient to quickcare if no relief. Advised ice/heat + OTC pain relievers in meantime. Will report to VAERS and let RXManager know. Also asked patient's daughter to update us with findings if/when patient goes to quickcare. Patient has no PCP at this time to report reaction to.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: PATIENT WAS ASKED IF SHE HAD AN ALLERGY TO EGGS AND SHE SAID NO. WENT AHEAD AND GAVE THE FLUCELVAX AND SHE REPORTED TODAY TO HAVE BROKEN OUT INTO RASH IMMEDIATELY AFTER SHE GOT THE SHOT ON 11/11/18 ON HER EXTREMITIES. BOTH ARMS AND LEGS BILATERALLY. AT THE REPORT OF REACTION TODAY, SHE STATES SHE HAS AN EGG-INTOLERANCE AND USUALLY GETS AN UPSET STOMACH/TENSE STOMACH WHEN SHE EATS THEM.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Pharyngeal oedema, Rash generalised, Rash pruritic, Swollen tongue
Clinical narrative: Itchy rash on entire body, throat and tongue swelling.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Insomnia, Rhinorrhoea
Clinical narrative: Patient states running nose and cough, couldn't sleep (insomnia), pain across hips.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Dyspnoea, Wheezing
Clinical narrative: Breathing difficulty, wheezing, asthma flare up resulting in doctors' appointments. Doctor prescribed antibiotics and steroids to help control breathing. On 80 mg Prednisone daily and getting worse. Now told to go to an ER to be evaluated.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity, Skin irritation, X-ray normal
Clinical narrative: After 3 days patient experienced severe pain in arm and limited mobility...mobility has been improved but still painful. Patient saw doctor on 11/13/18. X-rays were negative, doctor noted some skin irritation.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Fatigue, Hyperaesthesia, Pain of skin
Clinical narrative: 24 hours of total skin sensitivity/pain (not muscular), tiredness and depression.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Dizziness, Headache, Loss of consciousness, Memory impairment
Clinical narrative: After vaccine, Pt stated feeling dizziness, weakness. Patient reported feeling "passed out"  for a few seconds. Pt remained sitting. Pt had foggy memory after, stated experiencing neck pain, headache.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Neck pain
Clinical narrative: After vaccine, Pt stated feeling dizziness, weakness. Patient reported feeling "passed out"  for a few seconds. Pt remained sitting. Pt had foggy memory after, stated experiencing neck pain, headache.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Anti-ganglioside antibody positive, Dysgraphia, Electromyogram, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome numbness in both hands and feet, trouble walking and writing, weakness in arms and legs. Started just in fingertips 10/20 and progressed to diagnosed on 10/31 at its worst. Treated at hospital for 5 days with IVIG and released on 11/4/2018 recovering presently at home. Regaining strength in arms and legs and able to walk better. Still numbness in fingers and feet. Will be starting physical therapy and followup with neurologist in 4 weeks.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Guillain Barre Syndrome numbness in both hands and feet, trouble walking and writing, weakness in arms and legs. Started just in fingertips 10/20 and progressed to diagnosed on 10/31 at its worst. Treated at hospital for 5 days with IVIG and released on 11/4/2018 recovering presently at home. Regaining strength in arms and legs and able to walk better. Still numbness in fingers and feet. Will be starting physical therapy and followup with neurologist in 4 weeks.
Age: 42.0
Sex: M
Vaccine: FLU4, HIBV, MENB, MNQ, PPV
Symptoms: Cellulitis, Chest pain, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had began having symptoms of L arm pain, redness, swelling and chest pain, the night after his vaccines were administered. Member was taken to ER and was Diagnosed with Cellulitis.  Member only had symptoms to L arm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states she has an intermittent pain in her shoulder that goes down to her elbow. She has not sought treatment at this time. The pain comes and goes.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: I was diagnosed with shingles on 10/24/2018. Symptom of pain only in midsection began on evening of 10/21/2018. Rash was not noticed but was present at time of diagnosis. Never got blisters. Did receive anti-viral. My concern is whether steroid shot made me more vulnerable to getting shingles with the shot.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: One spot of the shingles did show up. He will see the doc next week. The spot size is decreasing. He does not remember the date he noticed the spot. I could not pass that question.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported swelling and redness at the injection site, also experienced lightheadedness and sick to her stomach.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: About a week after I noticed a red knot at the injection site. At work many other people that got the vaccine at the same time were saying they also had a knot showing up. The HR department was giving out the phone number of the clinic that gave the vaccine to anyone with side effects to call in antibiotics. I took the antibiotics with no improvement. On Nov 6th the clinic put out a letter to all employees that they were investigating the conditions. At this time I went to my normal doctor and got a round of prednisone and have completed without improvement.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: About a week after I noticed a red knot at the injection site. At work many other people that got the vaccine at the same time were saying they also had a knot showing up. The HR department was giving out the phone number of the clinic that gave the vaccine to anyone with side effects to call in antibiotics. I took the antibiotics with no improvement. On Nov 6th the clinic put out a letter to all employees that they were investigating the conditions. At this time I went to my normal doctor and got a round of prednisone and have completed without improvement.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: About a week after I noticed a red knot at the injection site. At work many other people that got the vaccine at the same time were saying they also had a knot showing up. The HR department was giving out the phone number of the clinic that gave the vaccine to anyone with side effects to call in antibiotics. I took the antibiotics with no improvement. On Nov 6th the clinic put out a letter to all employees that they were investigating the conditions. At this time I went to my normal doctor and got a round of prednisone and have completed without improvement.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Vaccine positive rechallenge
Clinical narrative: Pt reported sudden onset of neuropathy in left fingers and arm approximately 15 minutes after administration of vaccine. Patient had identical reaction in 2017 from Influenza vaccine and was informed of risk this year. She willingly and knowingly agreed to get vaccinated for flu shot this year. Unfortunately, the patient developed an identical neuropathic reaction from vaccine this year as reported last year.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Intense pain in right arm, patient described it as "feeling like bursitis", decreased range of motion in right arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Neck pain, Pain
Clinical narrative: Patient stated shortly after receiving the vaccine, she started having severe muscle aches in her lower back, hips, neck and joints. Described the pain as an 8 out of 10 at onset. She was tired and achy. I spoke with her one week after receiving the vaccine and she still states she has pain all over, but it has decreased to a 6 out of 10. Says she was feeling fine prior to getting the shot.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis of arm; Mother of child removed bandaid one day post vaccination and noticed the area to be red, warm and painful. Patient was taken Urgent care and diagnosed with cellulitis, rx for KEFLEX given.