chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Feeling hot, Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Follow up information was received from an unspecified reporter on 29-DEC-2015, regarding on the female patient. The patient's medical history also included allergy to unspecified nonsteroidal anti-inflammatory drug (NSAIDS), statins, valsartan and warfarin. The reporter stated that the patient was vaccinated on 22-SEP-2015 at 14:45, with the first dose of ZOSTAVAX (lot # L021602, expiration date not reported) by subcutaneous route in the left deltoid. On 22-SEP-2015 (previously reported as 23-SEP-2015), the patient experienced erythema reported as redness moved towards to elbow, headache reported as "HA", mild pain, blistering of skin below injection site, injection site redness, nausea and feeling hot. The reporter stated that the patient required medical intervention (unspecified). At the reporting time, the outcome of erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was reported as recovered on an unspecified date in 2015. Erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was considered to be medically significant by the reporter. Additional information is not expected as all information has been collected. General information, patient information, products, events and narrative were updated.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Nausea, Pain, Skin warm
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Follow up information was received from an unspecified reporter on 29-DEC-2015, regarding on the female patient. The patient's medical history also included allergy to unspecified nonsteroidal anti-inflammatory drug (NSAIDS), statins, valsartan and warfarin. The reporter stated that the patient was vaccinated on 22-SEP-2015 at 14:45, with the first dose of ZOSTAVAX (lot # L021602, expiration date not reported) by subcutaneous route in the left deltoid. On 22-SEP-2015 (previously reported as 23-SEP-2015), the patient experienced erythema reported as redness moved towards to elbow, headache reported as "HA", mild pain, blistering of skin below injection site, injection site redness, nausea and feeling hot. The reporter stated that the patient required medical intervention (unspecified). At the reporting time, the outcome of erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was reported as recovered on an unspecified date in 2015. Erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was considered to be medically significant by the reporter. Additional information is not expected as all information has been collected. General information, patient information, products, events and narrative were updated.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received BOOSTRIX. On 12th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site pain, injection site nodule and wrong injection technique. On an unknown date, the outcome of the injection site pain and injection site nodule were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injection site pain and injection site nodule to be related to BOOSTRIX. Additional details provided were as follows: This case was reported by the patient's wife. This report could be a follow up of a previous case reported. The reporter called previously GlaxoSmithKline to ask where to send his bills as they are requesting reimbursement of medical expenses. The reporter believes that, the patient has already reported the above information to the company, but she does not believe the patient received a follow up letter related to the initial report. Due to the limited information provided, no duplicate report has been identified. The patient received the BOOSTRIX vaccine in the left arm. The patient experienced pain and knot at the injection site. The reporter was provided with the address for GlaxoSmithKline Legal Department. The reporter did not have all the details for answering the questions on this report. She stated she does not know when the side effects began and does not have the date of the patient's visit to the emergency room (ER). The reporter stated, the patient was told by the ER or healthcare provider that the vaccination was given at a nerve site or that the vaccine was pressing on a nerve. This led to the wrong injection technique. No further information was available.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received BOOSTRIX. On 12th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site pain, injection site nodule and wrong injection technique. On an unknown date, the outcome of the injection site pain and injection site nodule were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injection site pain and injection site nodule to be related to BOOSTRIX. Additional details provided were as follows: This case was reported by the patient's wife. This report could be a follow up of a previous case reported. The reporter called previously GlaxoSmithKline to ask where to send his bills as they are requesting reimbursement of medical expenses. The reporter believes that, the patient has already reported the above information to the company, but she does not believe the patient received a follow up letter related to the initial report. Due to the limited information provided, no duplicate report has been identified. The patient received the BOOSTRIX vaccine in the left arm. The patient experienced pain and knot at the injection site. The reporter was provided with the address for GlaxoSmithKline Legal Department. The reporter did not have all the details for answering the questions on this report. She stated she does not know when the side effects began and does not have the date of the patient's visit to the emergency room (ER). The reporter stated, the patient was told by the ER or healthcare provider that the vaccination was given at a nerve site or that the vaccine was pressing on a nerve. This led to the wrong injection technique. No further information was available.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Chills, Confusional state, Decreased appetite, Fatigue
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Feeling abnormal, Hyperhidrosis, Injection site pain, Malaise, Muscular weakness
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Blood test normal, Chills, Condition aggravated, Decreased appetite
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Depression, Dizziness, Dyspepsia, Dyspnoea, Ear congestion
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Gastroenteritis viral, Hyperhidrosis, Muscle tightness, Muscle twitching, Night sweats
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Sinus disorder, Weight decreased
Clinical narrative: Initial unsolicited report received from consumer on 12 November 2015 and additional information received on 15 December 2015 and 17 December 2015. This case involves a 27-year-old male patient who was vaccinated with a first dose of FLUZONE QIV MDV (batch number UI482AD, expiry date was not reported) intramuscularly in left deltoid on 09 November 2015. There was no illness at time of vaccination and pre-existing physician diagnosed allergies and medical conditions included no known allergy (NKA) and history of anxiety in past. On 09 November 2015, in the afternoon, few days following the vaccination patient experienced stomach virus symptoms, he had no appetite, chills, fever, sweating, a general feeling of anxiety, dizziness, night sweats, weight loss, muscle tightness especially in glutes and quads, random muscle twitching at various locations on his body. It was reported that 1-2 days following the vaccination, patient had sinus issues and fullness in ears. On an unspecified date post vaccination, the patient was worried he had mercury poisoning from the vaccine. He had depression, anxiety, difficulty breathing and digestive issues from the day he received the vaccine. Other laboratory investigation involved blood work but everything came back within normal limits (WNL). Corrective treatment was not reported. It was suggested that he would begin medications for anxiety and depression. It was reported that there was no significant improvement and the patient had not recovered from the events. Upon internal review, the company decided to consider the event serious because of the important medical events: mercury poisoning, random muscle twitching at various locations on his body, depression, a general feeling of anxiety and digestive issues. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Autism, Brain injury, Regressive behaviour
Clinical narrative: This spontaneous consumer report from social media (initial receipt 16-Dec-2015) concerns a 2 year old male patient. It was reported that the patient was fine before the vaccinations. On an unspecified date, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) and MMR vaccine (measles, mumps, rubella and varicella vaccine, manufacturer and batch number not reported). After his MMR and flu shot, the patient regressed into autism. 'He took a bullet for the herd' and resulted in an injury to his brain. The outcome was not reported. Reporter's Comments: Reporter's comments: CDC stated that individuals immune response varies from child to child, not all children fare well. Sender's Comments: Company comments:  Seriousness: Serious. Disability. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria US Product Information, all events are unlisted. Causality: Unrelated.  Autism is a spectrum of disorders that has a genetic and environmental component. To date, no mechanistic or epidemiologic evidence supports the link between influenza vaccine and autism.
Age: 38.0
Sex: F
Vaccine: ANTH, FLU4, TYP
Symptoms: Abdominal distension, Asthenia, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Patient stated body bloating, fever, weakness, swelling of hands, feet, and face.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from Sanofi Pasteur MSD (SPM) (MFR# 2015453388) on 29-DEC-2015. This spontaneous report as received from a Nurse Practitioner via Pfizer (MFR# 2015427765) refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (route, lot# and dose were unknown). On an unknown date the patient experienced allergy reaction. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: Bursitis from immunization (FLUARIX) administered high on the upper arm. Physical therapy and rest as treatments.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Hyperhidrosis, Injection site oedema, Lethargy, Loss of consciousness
Clinical narrative: Received vaccination approximately 2 PM. Arrived home 6P. Local edema at site noted. Laying on cough watching TV fell asleep "passed out" awoke 3 H later diaphoretic and muscle aches, fatigue and lethargic.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Myalgia
Clinical narrative: Received vaccination approximately 2 PM. Arrived home 6P. Local edema at site noted. Laying on cough watching TV fell asleep "passed out" awoke 3 H later diaphoretic and muscle aches, fatigue and lethargic.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Pain in extremity, X-ray limb normal
Clinical narrative: For three and half months, had constant pain, soreness, and lost strength in right arm. Went to doctor and was x-rayed. Needed to go to rehab for two and half months for twice a week treatments.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Right shoulder pain that has lasted over a month.
Age: 44.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, redness, swelling greater than half dollar size, hot to touch.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle twitching, Pyrexia, Seizure
Clinical narrative: Developed fever of 101 and parent describes "weird facial expressions". Parent states "mouth seizures but ER told mom "No seizure."
Age: 38.0
Sex: F
Vaccine: FLU3, HIBV, MNQ, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Developed cellulitis in left arm.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Joint swelling
Clinical narrative: Left upper arm is swollen and reddened. 9.5 x 10.5 cm. Including elbow joint.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Two inch diameter redness at injection site, left deltoid, otherwise patient is asymptomatic.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Rash, Rash papular, Rash pruritic
Clinical narrative: Arm was initially red the day of the injection and then the redness improved by the next day but the entire upper arm developed a papular rash that itches and persisted for 7 days. Is not improving.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Red blood cell sedimentation rate, Skin warm
Clinical narrative: Work at hospital. Mandatory flu shots. Received my shot morning of 9/10/15 w/in 48 hrs hands were swollen, could not shut my hands, red, hot. Within 5 day shoulder.
Age: 24.0
Sex: M
Vaccine: FLUX, HPVX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: During the night of 12/21/15-12/22/15 I developed a large amount of swelling on my right shoulder (The site of two vaccinations). This was in addition to a red circle approximately three inches in diameter that was warm to the touch. Pain and limitation of the movement of my shoulder also developed during this time. Swelling began to go down beginning 12/27/15. Pain still persists - Slight improvement in ability to move shoulder.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain, Tenderness
Clinical narrative: Two days after receiving vaccine - experienced (L) arm tenderness. By Nov 27, pain increased - very painful to move arm, stiff and now shoulder and neck are both sore.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypersensitivity, Insomnia, Paraesthesia, Swelling face
Clinical narrative: Severe allergic reaction includes: hives swollen/grainy tongue, swollen face with pins on face, neck, both arms, and head. Feeling of electricity on head and face. Very fast heart beat, insomnia.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Severe allergic reaction includes: hives swollen/grainy tongue, swollen face with pins on face, neck, both arms, and head. Feeling of electricity on head and face. Very fast heart beat, insomnia.
Age: 0.76
Sex: M
Vaccine: PNC13
Symptoms: Crying, Insomnia, Restlessness, Screaming
Clinical narrative: Screaming, crying, unable to sleep, restless, could not settle. Continued all night and through the next day. Now over 48 hours and still unable to settle for periods longer than 2 hours.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: No s/s. Patient passed away at daycare.
Age: 10.0
Sex: M
Vaccine: HPVX
Symptoms: Erythema, Eye swelling, Ocular hyperaemia
Clinical narrative: Left eye swelling with red streak from eye down to cheek. A bit redder this morning on 12/30/2015.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Pain, Vaccination complication
Clinical narrative: PATIENT FELT USUAL ADVERSE EFFECTS FROM FLU IMMUNIZATION SORENESS WHERE THE SHOT WAS GIVEN, HEADACHE AND ACHES.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: There is a red rash about 2.5 inches in diameter around the injection site. Pt. says it feels warm to the touch.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pruritus generalised, Urticaria
Clinical narrative: Hives all over her body. Complained of itched and pains all over her body.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Blood calcium decreased, Blood chloride normal, Blood creatinine increased, Blood glucose normal
Clinical narrative: Pt had a generalized convulsion while at work.  Movement was noted in all 4 extremities.  Pt initially unresponsive to first responders, then agitated once awake.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Blood potassium normal, Blood sodium normal, Computerised tomogram head normal, Full blood count normal, Liver function test normal
Clinical narrative: Pt had a generalized convulsion while at work.  Movement was noted in all 4 extremities.  Pt initially unresponsive to first responders, then agitated once awake.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure, Unresponsive to stimuli, White blood cell count increased
Clinical narrative: Pt had a generalized convulsion while at work.  Movement was noted in all 4 extremities.  Pt initially unresponsive to first responders, then agitated once awake.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR
Symptoms: Dizziness
Clinical narrative: Patient became light headed.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Patient came in the pharmacy the next day and reported swollen lip and swollen right eye that developed about four hours after his FLUZONE HIGH DOSE flu shot.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Pt said, her arm swelled up from shoulder to elbow.  She took ibuprofen and iced it the night of shot and swelling went down, advised take Benadryl too in case allergic reaction when she called me on 12/30/15.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Pain
Clinical narrative: Persistent shoulder joint pain since injection 2 weeks ago. Cannot lift arm without significant pain.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Corrective lens user, Laboratory test, Nuclear magnetic resonance imaging, Optical coherence tomography
Clinical narrative: Starting on Friday, Saturday, Sunday I noticed that my vision was not as clear as my right and my left eye felt different from my right.  On  Monday, 10/26/15 I went to my optician office and had testing performed and was referred to neurologist ophthalmologist.  On 10/28/15 I saw the specialist who prescribed Dexamethasone, 4mg, and ordered MRI's, carotid ultrasound, lab work.  On 10/29/15 the tests were performed.  On 11/4/15 - I had an appt. with my PCP who ordered a chest x-ray, additional lab work and referred me to a Rheumatologist due to 1989 I was diagnosed with sarcoidosis.  11/6/15 - Appt. with rheumatologist - negative for sarcoidosis. 12/29/15 - I had an appointment for a second opinion with neurologist ophthalmologist.  At this appointment, slight improvement although I do not notice it with my vision.  I wore the mono vision contact lenses and with my current vision in my left eye, I cannot continue to wear them because they do not help with my current vision and my job requires me to be at the computer.  I have an appointment this coming Monday to get a new prescription to help me with my current vision status to see better.  Hopefully, in a few months my vision will return and some of the darkness will be gone.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Retinogram, Sarcoidosis, Tear break up time test, Ultrasound scan, Vision blurred
Clinical narrative: Starting on Friday, Saturday, Sunday I noticed that my vision was not as clear as my right and my left eye felt different from my right.  On  Monday, 10/26/15 I went to my optician office and had testing performed and was referred to neurologist ophthalmologist.  On 10/28/15 I saw the specialist who prescribed Dexamethasone, 4mg, and ordered MRI's, carotid ultrasound, lab work.  On 10/29/15 the tests were performed.  On 11/4/15 - I had an appt. with my PCP who ordered a chest x-ray, additional lab work and referred me to a Rheumatologist due to 1989 I was diagnosed with sarcoidosis.  11/6/15 - Appt. with rheumatologist - negative for sarcoidosis. 12/29/15 - I had an appointment for a second opinion with neurologist ophthalmologist.  At this appointment, slight improvement although I do not notice it with my vision.  I wore the mono vision contact lenses and with my current vision in my left eye, I cannot continue to wear them because they do not help with my current vision and my job requires me to be at the computer.  I have an appointment this coming Monday to get a new prescription to help me with my current vision status to see better.  Hopefully, in a few months my vision will return and some of the darkness will be gone.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Visual field tests
Clinical narrative: Starting on Friday, Saturday, Sunday I noticed that my vision was not as clear as my right and my left eye felt different from my right.  On  Monday, 10/26/15 I went to my optician office and had testing performed and was referred to neurologist ophthalmologist.  On 10/28/15 I saw the specialist who prescribed Dexamethasone, 4mg, and ordered MRI's, carotid ultrasound, lab work.  On 10/29/15 the tests were performed.  On 11/4/15 - I had an appt. with my PCP who ordered a chest x-ray, additional lab work and referred me to a Rheumatologist due to 1989 I was diagnosed with sarcoidosis.  11/6/15 - Appt. with rheumatologist - negative for sarcoidosis. 12/29/15 - I had an appointment for a second opinion with neurologist ophthalmologist.  At this appointment, slight improvement although I do not notice it with my vision.  I wore the mono vision contact lenses and with my current vision in my left eye, I cannot continue to wear them because they do not help with my current vision and my job requires me to be at the computer.  I have an appointment this coming Monday to get a new prescription to help me with my current vision status to see better.  Hopefully, in a few months my vision will return and some of the darkness will be gone.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patient got vaccine on 12/19/15 and had reported swelling, pain in arm near injection site about 6 days after Boostrix (tdap) vaccine was given. Patient went to get seen by physician on 12/26/15 and was given a antibiotic. She did not know the name of antibiotic given to her. However, after being on the antibiotic for 3 days she stated she felt better and the swelling went down.
Age: 50.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, VARCEL
Symptoms: Dysphagia, Dyspnoea, Headache
Clinical narrative: Patient was given TDAP, FLU SHOT (IM) and VARICELLA (SQ) on the right arm and TWINRIX (IM) on the left arm. After patient was given vaccines, patient stated she was not feeling well. She stated her head was hurting and was having trouble swallowing and trouble breathing. I called the RN into my office and she asked the patient if she had ever had a reaction to a vaccine and patient stated no. Then RN gave patient Benadryl 20 ml and administered an EPIPEN at 2:05 PM , 911 was called immediately. Paramedics checked patient vitals and after patient vitals were stable she was asked to be transported to the hospital by ambulance, but patient denied. She stated she wanted her husband to take her to the hospital and she was advised to go to the nearest hospital as soon as possible, due to EPIPEN was administered.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles, V1.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Malaise, Pain in extremity
Clinical narrative: Patient states she was sick for two days in bed after the vaccines and her arm has been sore since.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: Pt. received (client or employee) Influenza vaccine 0.5 ml intradermally. Nurse took influenza vial from container that was labeled for Mantoux Vaccine. Mantoux vaccine was intranasal. (R) forearm, where influenza vaccine was administered became swollen, red, and warm for a few hours. S/S decreased after by AM.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Fatigue, Influenza like illness, Paraesthesia oral
Clinical narrative: Patient came to our pharmacy and want a Flu vaccine for his work. I administer the vaccine after he answer all questionnaire. He left and 30 minutes later called and swoll he experience Flu-like symptom; fatigue, tingling lip, metallic.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Chills, Influenza, Malaise, Myalgia
Clinical narrative: Chills, Fever, Vomiting, Muscle pains, shaking. Treatment included- Tylenol, Ibuprofen, Zofran and Morphine all administrated at the ER. Upon arrival pain scale was surpassed that of 1-10, but was at 15! Was present at the ER for over five hours, blood and urine tests were taken, test came back normal. Was recommended to treat as if it was the flu!
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor, Urine analysis normal, Vomiting
Clinical narrative: Chills, Fever, Vomiting, Muscle pains, shaking. Treatment included- Tylenol, Ibuprofen, Zofran and Morphine all administrated at the ER. Upon arrival pain scale was surpassed that of 1-10, but was at 15! Was present at the ER for over five hours, blood and urine tests were taken, test came back normal. Was recommended to treat as if it was the flu!
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Severe rash and hives.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site rash, Local reaction, Peripheral swelling
Clinical narrative: Caller: patient's mother.  4:20 pm.  Patient had local reaction to varicella.  Left arm swollen to baseball size yesterday, pain and rash at site as well.  Resolving today (day 2) about 1/3 of the size it was yesterday and more "lumpy, not a solid mass like yesterday". Mother states patient has had no painkillers or antihistamines.  Advised of what to watch for in anaphalaxis (breathing, swallowing difficulties) would warrant emergency medical care (ER) and otherwise can use a cold compress (bagged frozen peas or something similar) for short times to ease the swelling and discomfort. Advised VAERS will be filed and she may receive a call from CDC r/t this.  Mom states older brother was vaccinated at same visit in our office with no reaction other than "a little soreness" but no redness or swelling.  I checked and same lot number of varicella vaccine was used for both siblings. Nurse who vaccinated both boys states no difference other than the 2 boys are built differently-one more muscular and thinner than the other. Patient also received HPV9 and hepatitis A in the right arm at this visit on 12/16. Mom states he had no reaction to it whatsoever. Not even complaint of soreness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: CSF glucose normal, CSF protein decreased, CSF red blood cell count, CSF white blood cell count negative, Crying
Clinical narrative: On 12-21 August received his routine 4 m/o vaccinations. The following morning he developed inconsolable crying and a bulging anterior fontanelle. Seen here, then referred to ER where an LP was performed and CSF studies were normal. ID services advised that vaccine reaction most likely cause. Fontanelle bulging resolved that evening.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging
Clinical narrative: On 12-21 August received his routine 4 m/o vaccinations. The following morning he developed inconsolable crying and a bulging anterior fontanelle. Seen here, then referred to ER where an LP was performed and CSF studies were normal. ID services advised that vaccine reaction most likely cause. Fontanelle bulging resolved that evening.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Approximately 23 days after administration of HPV 9 in left deltoid patient noted a painful lump at the site of injection. No systemic symptoms. No treatment recommended.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis - on KEFLEX and BENADRYL temp 101.3 seen in E/R.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Inflammation, swelling of (R) thigh treatment with antibiotics, diphenhydramine and ibuprofen.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Ageusia, Anosmia, Asthma, Bronchitis, Chills
Clinical narrative: Felt chills, tired, not feeling good at all. Saw MD said I had bronchitis. Lost my taste and smell. Went back to Dr. Said I have asthma and allergies. Worse now. I have a sinus infection. Still don't feel well. Dr. visits from Nov 12, 2105-Dec 22, 2015.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Hypersensitivity, Malaise, Sinusitis
Clinical narrative: Felt chills, tired, not feeling good at all. Saw MD said I had bronchitis. Lost my taste and smell. Went back to Dr. Said I have asthma and allergies. Worse now. I have a sinus infection. Still don't feel well. Dr. visits from Nov 12, 2105-Dec 22, 2015.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Pt called stating had developed swelling and redness that was warm to the touch. Hives and itching from shoulder to elbow in the vaccinated arm 8 days after (12/30/15). Pt was instructed to take BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Injection was given in top of shoulder, felt like balloon was expanding in shoulder, increase in pain and decrease in range of motion and strength in left arm over the weeks to follow.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: X-ray
Clinical narrative: Injection was given in top of shoulder, felt like balloon was expanding in shoulder, increase in pain and decrease in range of motion and strength in left arm over the weeks to follow.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling all around vaccinated area (3 - 4 inches), redness down my arm and all around the vaccinated area, very painful.  These symptoms lasted for three days. After redness and swelling subsided, pain persisted for five days.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous, Skin discolouration, Urticaria
Clinical narrative: Hives - initially under arm on side where I previously had radiation.  By 12/19/15, I had red rash behind knees and under both arms.  By 12/20/15, I had about 6 inches of raised red rash on tops of both thighs.  I treated with topical and oral OTC antihistamines.  Rash is still present on thighs today (12/30/15), but receding, darker brown, less raised.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis - on KELFEX and BENADRYL.
Age: 79.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Eye swelling, Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Patient states she had an approx 3 in circle that was red and warm to the touch the day after she got the shot. The spot is now approx 1 in in dia. Her right arm is swollen 1/2 inch greater than her left (circumf). She states it gave her a fever, but she was not able to take her temp because she doesn't have a thermometer. She has also noticed swelling in her ankles and around her eyes.
Age: 79.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Skin warm
Clinical narrative: Patient states she had an approx 3 in circle that was red and warm to the touch the day after she got the shot. The spot is now approx 1 in in dia. Her right arm is swollen 1/2 inch greater than her left (circumf). She states it gave her a fever, but she was not able to take her temp because she doesn't have a thermometer. She has also noticed swelling in her ankles and around her eyes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No SSx reported. Pt was given 2nd Flu vaccine by mistake. 1st FLUZONE given 10/2015. 2nd high dose given 12/29/15.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypotension, Pallor
Clinical narrative: After receiving HPV vaccine patient became pale diaphoretic and was lowered to the floor. Hypotensive. After 15 mins. he left office with mom.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Received PREVNAR 12/16/15. Returned to office 12/23/15 with c/o rash on left arm since shot received. Itchy red and swelling at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient got shot 12-21-15. Developed rash on back and by armpit 12-23-15 was seen and given Rx for VALTREX. No fever or other symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen arm, redness, pain from injection site to elbow. Treated with ibuprofen and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to Lt. arm.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Balance disorder, Borrelia test negative, Cerebellar ataxia, Full blood count normal, Gait disturbance
Clinical narrative: Fever. Cerebellar ataxia - unsteady gait, poor balance. Referred to neurologist.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Fever. Cerebellar ataxia - unsteady gait, poor balance. Referred to neurologist.