chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling, Laboratory test, Lumbar puncture, Noninfective encephalitis
Clinical narrative: My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Nuclear magnetic resonance imaging, Peripheral swelling, Pyrexia, Screaming, Strabismus
Clinical narrative: My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient complained of frozen limbs both legs and arms 2 to 3 hours after vaccination symptoms resolved completely after 24 hours pt has history of Sjogren's syndrome-autoimmune disease.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Hallucination, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 9/15/15 mom reported thighs swollen, tender, warm to touch. Area size of child's palm. Didn't want to walk. Also night vaccines were given child felt warm (temp not taken) and experienced vomiting and hallucinations. Treatment - rest, cool compresses, ADVIL.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Skin warm, Vomiting
Clinical narrative: 9/15/15 mom reported thighs swollen, tender, warm to touch. Area size of child's palm. Didn't want to walk. Also night vaccines were given child felt warm (temp not taken) and experienced vomiting and hallucinations. Treatment - rest, cool compresses, ADVIL.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red, rash, 1.5 in cm in deiameter starting 24 hours after ADM.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal oedema
Clinical narrative: Pt described having throat swelling. Gave pt EPIPEN shot, called 911 for ambulance. Pt received BENADRYL on the ambulance ride and received steroid treatment at the hospital. Discharged after a few hrs. (S/P to pt 10/4/15 2:19 PM).
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Started out as spots and then spread out to entire arm. Red, swollen - possible cellulitis. Pt went to hospital and treated with amoxicillin 875mg BID and steroid dose pack.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 year old husband. The patient's pertinent medical history and drug allergies were none. On 01-JUL-2015, the patient was vaccinated with ZOSTAVAX injection (Dose/Frequency: 1 time) in the left arm. Concomitant medications were none. On 02-JUL-2015, the patient had developed a reaction, which was reaching from elbow to shoulder, dark red, raised and warm to the touch. The patient sought medical attention and no treatment was provided for the events. The outcome of the events was reported as recovered/resolved (reported as lasted 2 weeks). The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 year old husband. The patient's pertinent medical history and drug allergies were none. On 01-JUL-2015, the patient was vaccinated with ZOSTAVAX injection (Dose/Frequency: 1 time) in the left arm. Concomitant medications were none. On 02-JUL-2015, the patient had developed a reaction, which was reaching from elbow to shoulder, dark red, raised and warm to the touch. The patient sought medical attention and no treatment was provided for the events. The outcome of the events was reported as recovered/resolved (reported as lasted 2 weeks). The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-SEP-2015, the patient was vaccinated subcutaneously in the arm with PNEUMOVAX 23 (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. The next day, on 10-SEP-2015, the patient developed a rash and experienced redness and swelling on the same arm in which the shot was given. Due to the pain from the redness and swelling, the patient went to the Emergency Room (ER). The reporter stated that the patient was recovering and the pain and swelling had subsided. The relatedness between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-SEP-2015, the patient was vaccinated subcutaneously in the arm with PNEUMOVAX 23 (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. The next day, on 10-SEP-2015, the patient developed a rash and experienced redness and swelling on the same arm in which the shot was given. Due to the pain from the redness and swelling, the patient went to the Emergency Room (ER). The reporter stated that the patient was recovering and the pain and swelling had subsided. The relatedness between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness
Clinical narrative: The flu vaccine was short on his left arm, now his left hand pinky (baby) finger has a little force when it is pulled, the right hand one is fine.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm to touch at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Injection site swelling, Oral pruritus, Pharyngeal oedema
Clinical narrative: Fever, mouth itch, throat closed, sweaty, dizzy, swelling at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, mouth itch, throat closed, sweaty, dizzy, swelling at injection site.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Rash on body.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Patient states he developed a red raised rash on his right arm at the brachial site, 3 red raised welts or hives.  On his right abdomen he had a more extensive red raised rash/hives with white center this did not spread out onto the skin he stated.  He applied Benadryl cream to the areas and was gone the next day.  Patient received his flu shot in his left arm.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Lower back pain/stiffness.  Hurt most when sitting.  Standing and walking did not hurt.  The pain lasted about 12 hours. Took 2 tablets of naproxen sodium upon onset of pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Feeding disorder, Pain in jaw, Vision blurred
Clinical narrative: Very blurry vision, almost unable to see. Extreme Jaw Pain, unable to eat.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Red, swollen lump at injection site.
Age: 26.0
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Dyspnoea, Urticaria
Clinical narrative: Hives on left lower eye lid, shortness of breath, anxious feelings, took 50mgs of PO Benadryl on onset of symptoms at 9:15 am.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Joint range of motion decreased, Malaise, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Pain in shoulder and surrounding muscles - tricep, bicep, deltoid. Felt pain through the night and into the next two to three days. Realized the pain was going on too long. Pain spread to pectoral muscles and was affecting range of motion and sleep. Took Aleve and Tylenol, didn't help much. Saw chiropractor who massaged it - it felt better for about 4 hours, pain returned. Tried taking Arnica tablets and using Arnica cream. Helped some but wore off. Generalized pain and stiffness in areas of right shoulder and arm, still affecting sleep. General malaise and agitation.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Pruritus generalised, Sleep disorder
Clinical narrative: Pain in shoulder and surrounding muscles - tricep, bicep, deltoid. Felt pain through the night and into the next two to three days. Realized the pain was going on too long. Pain spread to pectoral muscles and was affecting range of motion and sleep. Took Aleve and Tylenol, didn't help much. Saw chiropractor who massaged it - it felt better for about 4 hours, pain returned. Tried taking Arnica tablets and using Arnica cream. Helped some but wore off. Generalized pain and stiffness in areas of right shoulder and arm, still affecting sleep. General malaise and agitation.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Limb discomfort, Pain, Pruritus
Clinical narrative: Localise pain, erythema, itching, heaviness in the affected left arm.
Age: 50.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: VIIth nerve paralysis
Clinical narrative: Went to ER in early a.m. on 9/23/2015 due to left side of face drooping-diagnosed with Bells Palsy and given steroids to take po to improve symptoms.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypoaesthesia oral, Peripheral swelling, Urticaria
Clinical narrative: Red swollen arm: Wheal = 3/4 inch. Flare = 3 inches. Numb lips and tongue.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Cough, Dyspnoea, Headache, Injection site pain
Clinical narrative: 103 Fever, pain (at injection site, across shoulders and chest into opposite arm), swelling at injection site (area was about 7"x4" welt), headache, watery eyes, unable to take deep breath without coughing, unable to move arm and difficulty breathing by night time. Same symptoms next day, 10/04/2015, with slightly lesser intensity. Treated with Motrin and Benadryl at home.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling, Lacrimation increased, Mobility decreased, Musculoskeletal pain
Clinical narrative: 103 Fever, pain (at injection site, across shoulders and chest into opposite arm), swelling at injection site (area was about 7"x4" welt), headache, watery eyes, unable to take deep breath without coughing, unable to move arm and difficulty breathing by night time. Same symptoms next day, 10/04/2015, with slightly lesser intensity. Treated with Motrin and Benadryl at home.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: 103 Fever, pain (at injection site, across shoulders and chest into opposite arm), swelling at injection site (area was about 7"x4" welt), headache, watery eyes, unable to take deep breath without coughing, unable to move arm and difficulty breathing by night time. Same symptoms next day, 10/04/2015, with slightly lesser intensity. Treated with Motrin and Benadryl at home.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Peripheral swelling, Rash
Clinical narrative: Initial unsolicited report received from a pharmacist on 25 September 2015. This case involves a female patient (age not reported) who was vaccinated with a 0.5 ml intramuscular dose of FLUZONE (batch number, site of administration were not reported, from prefilled syringe) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date, within hours following the vaccinations, the patient experienced rash and swelling near her elbow. The patient went to her physician where it was diagnosed as cellulitis. Lab data and corrective treatments were not reported. The outcome of events was unknown. Reporter causality for the event cellulitis was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event: Cellulitis. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: No symptoms reported but MD confirmed on 10/2/15 that pt has been hospitalized at hosp.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy skin abnormal, Hypersensitivity, Hypersensitivity vasculitis, Rash, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable consumer. An 86-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2015, at single dose. The patient had never had this vaccine before. Relevant medical history included arthritis. Concomitant medications included vitamin D, TYLENOL for arthritis and meloxicam (unspecified trade name) since 3 years. Previously the patient received flu vaccine, every year. The patient mentioned that she had a very bad adverse reaction to PREVNAR 13 that lasted for two and a half month. On an unspecified date she had a skin biopsy done which showed that it was hypersensitivity vasculitis condition due to drugs and the vaccination that she had got, it took about 2 weeks for it and she was "bubbled out" constantly. Therapeutic measures were taken as a result of this event and included treatment with Prednisone in the middle of Aug. Outcome of this event was recovered. The patient was also highly allergic to certain things and this went on for two and a half month and it started out with hives and rash and it would 50 to 60% of her body was covered. She had to go to emergency room two different times.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer. An 86-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2015, at single dose. The patient had never had this vaccine before. Relevant medical history included arthritis. Concomitant medications included vitamin D, TYLENOL for arthritis and meloxicam (unspecified trade name) since 3 years. Previously the patient received flu vaccine, every year. The patient mentioned that she had a very bad adverse reaction to PREVNAR 13 that lasted for two and a half month. On an unspecified date she had a skin biopsy done which showed that it was hypersensitivity vasculitis condition due to drugs and the vaccination that she had got, it took about 2 weeks for it and she was "bubbled out" constantly. Therapeutic measures were taken as a result of this event and included treatment with Prednisone in the middle of Aug. Outcome of this event was recovered. The patient was also highly allergic to certain things and this went on for two and a half month and it started out with hives and rash and it would 50 to 60% of her body was covered. She had to go to emergency room two different times.
Age: 57.0
Sex: F
Vaccine: FLU4, HEP, PNC13, FLU4, HEP, PNC13
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a physician received via a sales representative. A 57-years-old other ethnic group female patient received PREVNAR 13 (lot L99271, Exp. date 30Mar2017), intramuscular on arm on 23Sep2015 at 0.5 ml, single dose. Medical history included ongoing diabetes mellitus, hypothyroidism, hypertension, glaucoma, blood cholesterol increased. On the same date the patient received also a dose of FLUZONE QUADRIVALENT (lot U1443AC) and ENGERIX-B (lot 9937B) both intramuscular on left arm. On 24Sep2015 the patient experienced cellulitis, fever and chills. The patient outcome was reported as recovering for cellulitis and recovered on unknown date for fever and chills. Therapeutic measures were taken as a result of the events. The patient went to the emergency room with cellulitis and fever after receiving the vaccines but was not admitted and was put on an antibiotic.
Age: 57.0
Sex: F
Vaccine: FLU4, HEP, PNC13, FLU4, HEP, PNC13
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a physician received via a sales representative. A 57-years-old other ethnic group female patient received PREVNAR 13 (lot L99271, Exp. date 30Mar2017), intramuscular on arm on 23Sep2015 at 0.5 ml, single dose. Medical history included ongoing diabetes mellitus, hypothyroidism, hypertension, glaucoma, blood cholesterol increased. On the same date the patient received also a dose of FLUZONE QUADRIVALENT (lot U1443AC) and ENGERIX-B (lot 9937B) both intramuscular on left arm. On 24Sep2015 the patient experienced cellulitis, fever and chills. The patient outcome was reported as recovering for cellulitis and recovered on unknown date for fever and chills. Therapeutic measures were taken as a result of the events. The patient went to the emergency room with cellulitis and fever after receiving the vaccines but was not admitted and was put on an antibiotic.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Pain, Rash, Urticaria
Clinical narrative: Pt states was feeling fatigued and had body aches, as well as a rash/hives that formed on the same arm as vaccination but not at the vaccination site.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Cold sweat, Dizziness, Retching
Clinical narrative: Severe dizziness. Dry heaves. Cold sweats. Lasting about 3 hours.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reaction began with pain and warmth at the injection site then pt noticed redness and swelling.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pyrexia, Sinus congestion
Clinical narrative: Chills, fever, head congestion & limitation to arm movement. Took Benadryl for congestion & Advil for fever.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Pain
Clinical narrative: Admin PREVNAR (9/21) on Wed (9/23) admitted to hospital with high fever, chills, weakness, decreased appetite, then after rash, soreness, redness followed.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Admin PREVNAR (9/21) on Wed (9/23) admitted to hospital with high fever, chills, weakness, decreased appetite, then after rash, soreness, redness followed.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Chills, Confusional state
Clinical narrative: Patient received the flu vaccine on Friday 9/18/2015 at approx 11AM-she developed shaking chills at 8:30PM Fri evening temp 100.6 degrees given TYLENOL XST 2 tabs-at 9:30PM temp increased 103 degrees she was delirious, confused, limp when gotten out of bed->to hospital by ambulance-received IV fluids, vancomycin IV-stress dose cortisone in ER. Admitted to hospital-discharged 9/20/15.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Delirium, Differential white blood cell count, Full blood count, Hypotonia, Tremor
Clinical narrative: Patient received the flu vaccine on Friday 9/18/2015 at approx 11AM-she developed shaking chills at 8:30PM Fri evening temp 100.6 degrees given TYLENOL XST 2 tabs-at 9:30PM temp increased 103 degrees she was delirious, confused, limp when gotten out of bed->to hospital by ambulance-received IV fluids, vancomycin IV-stress dose cortisone in ER. Admitted to hospital-discharged 9/20/15.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Developed Type 1 diabetes mellitus-diagnosis 6/8/15 3 wks after vaccination.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Malaise
Clinical narrative: Temp 104+ chills, fever, (too sick to take again). BP 225/125 sweating, vomiting. HR 115 severe pain (even my fingernails hurt!) extreme fatigue, rash felt I was dying (I was alone).
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Temp 104+ chills, fever, (too sick to take again). BP 225/125 sweating, vomiting. HR 115 severe pain (even my fingernails hurt!) extreme fatigue, rash felt I was dying (I was alone).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose, route of administration and indication were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No symptoms.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Injection site warmth, Neuralgia
Clinical narrative: Pt states on Thursday evening she noticed right deltoid was tender to the touch with a lump. Pt states she tried to squeeze the lump to see if something would come out but nothing did. Pt states the site became warm to the touch on Saturday with "nerve" pain going down to elbow.
Age: 21.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Arthralgia, Cyst, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: 07/10/2015 radiologists MRI Cervical Spine [C-4 C-5 very mild bulging discs and osteophyte still does not correlate to arm severe arm weakness and growing paralysis. 07/10/2015 Dr Arm is growing more painful and increasing muscle atrophy and paralysis of motion. Reads shoulder MRI prescribes PERCOCET/orders MRI of neck. 07/08/2015 physical therapy PT. 07/06/2015 physical therapy PT. 07/02/2015 physical therapy PT. 07/01/2015 physical therapy PT. 06/27/2015 chiro adjustment no change. 06/26/2015 Physical therapy PT; 06/24/2015 physical therapy PT. 06/29/2015 Physical therapy PT. 06/17/2015 Physical therapy PT. 06/17/2015 radiologists MRI or right shoulder [mild tendonitis/insignificant cysts) Findings in report did not correlate to severity of symptoms. 06/16/2015 Chiro adjustment no change requested MRI right shoulder. 06/15/2015 Physical therapy PT. 06/13/2015 Dr 4 weeks physical therapy/continue ALEVE. 06/08/2015 Surgical specialty Xray again showed no significant injury. 06/08/2015 Dr ortho consult prescribed prednisone med pac and ALEVE. 06/07/2015 xray [did not show structural damage/prescribed naproxen 500 mg. 06/08/2015 chiro adjustment no relief. 06/04/2015 home Onset of severe arm pain beginning in elbow and working down to fingers and up to shoulder, scapula and neck. May/June '15 coach arm was progressively weakening and more painful with activity. Initially attributed to over use. March/April '15 coach arm was progressively weakening and more painful with activity. Initially attributed to over use. 1/9/2015 clinic Flu shot in right deltoid Sanofi FLUZONE Lot UI198AD Meningococcal in left deltoid Novartis MENVEO Lot M14082.
Age: 21.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Pain, Pain in extremity, Tendonitis
Clinical narrative: 07/10/2015 radiologists MRI Cervical Spine [C-4 C-5 very mild bulging discs and osteophyte still does not correlate to arm severe arm weakness and growing paralysis. 07/10/2015 Dr Arm is growing more painful and increasing muscle atrophy and paralysis of motion. Reads shoulder MRI prescribes PERCOCET/orders MRI of neck. 07/08/2015 physical therapy PT. 07/06/2015 physical therapy PT. 07/02/2015 physical therapy PT. 07/01/2015 physical therapy PT. 06/27/2015 chiro adjustment no change. 06/26/2015 Physical therapy PT; 06/24/2015 physical therapy PT. 06/29/2015 Physical therapy PT. 06/17/2015 Physical therapy PT. 06/17/2015 radiologists MRI or right shoulder [mild tendonitis/insignificant cysts) Findings in report did not correlate to severity of symptoms. 06/16/2015 Chiro adjustment no change requested MRI right shoulder. 06/15/2015 Physical therapy PT. 06/13/2015 Dr 4 weeks physical therapy/continue ALEVE. 06/08/2015 Surgical specialty Xray again showed no significant injury. 06/08/2015 Dr ortho consult prescribed prednisone med pac and ALEVE. 06/07/2015 xray [did not show structural damage/prescribed naproxen 500 mg. 06/08/2015 chiro adjustment no relief. 06/04/2015 home Onset of severe arm pain beginning in elbow and working down to fingers and up to shoulder, scapula and neck. May/June '15 coach arm was progressively weakening and more painful with activity. Initially attributed to over use. March/April '15 coach arm was progressively weakening and more painful with activity. Initially attributed to over use. 1/9/2015 clinic Flu shot in right deltoid Sanofi FLUZONE Lot UI198AD Meningococcal in left deltoid Novartis MENVEO Lot M14082.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Feeling abnormal, Feeling hot, Pruritus, Skin reaction
Clinical narrative: One week later getting vaccine large (3 1/2 in) skin reaction - hot, raised, red, itching reaction - applied cool pack and applied triamcinolone ointment. Arm stayed red, hot to warm, itching for 5 days. Also I didn't make the connection at the time - about 3 days after the injection I felt really bad - even hot all day - never dreamed it could be the shot.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm
Clinical narrative: One week later getting vaccine large (3 1/2 in) skin reaction - hot, raised, red, itching reaction - applied cool pack and applied triamcinolone ointment. Arm stayed red, hot to warm, itching for 5 days. Also I didn't make the connection at the time - about 3 days after the injection I felt really bad - even hot all day - never dreamed it could be the shot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Full blood count normal, Henoch-Schonlein purpura, Urine analysis normal
Clinical narrative: 11-3-14, pt dx'd with Henoch-Schonlein purpura after receiving vaccines on 9-23-14.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling hot, Local reaction, Rash macular, Swelling
Clinical narrative: Local reaction to PPSV23 vaccine in the right arm. Patient experienced swelling, redness, and warmth starting about 30 minutes after receiving the vaccine. Day 2 her symptoms were worse, better day 3 with Benadryl, and even better day 4 (but still has red and blotchy skin). Steadily improving since day 2, as of 10/5/15.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Fatigue, Full blood count
Clinical narrative: Felt joint pain alomost immediately. Followed by diffuse joint aches and muscle weakness and extreme fatigue for months.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Metabolic function test, Muscular weakness, Red blood cell sedimentation rate
Clinical narrative: Felt joint pain alomost immediately. Followed by diffuse joint aches and muscle weakness and extreme fatigue for months.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Impaired work ability, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Swelling in her lymph nodes in Left axilla and cervical area, general malaise.  She states she can not do her job because her arm is sore.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Impaired work ability, Local swelling, Lymphadenopathy, Malaise, Oedema peripheral
Clinical narrative: Swelling in her lymph nodes in Left axilla and cervical area, general malaise.  She states she can not do her job because her arm is sore.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Patient presented to Occupational Health services with hematoma in left arm, arm pain, tingling sensation in arm, and inability to raise arm after more than one week of symptoms.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Hypoaesthesia
Clinical narrative: Right eye swelling, numbness R face.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling approx 2 inch diameter. Fever approx 101F lasting 3 days, continuing on through time of this report.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Crying, Full blood count abnormal, Irritability, Pyrexia, White blood cell count increased
Clinical narrative: Louder cry than usual - not high pitched. Very irritable. Fever up to 101.8.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Erythema, Face oedema, Periorbital oedema, Rash, Urticaria
Clinical narrative: Acute onset rash a few hours after receiving MENVEO and quadrivalent flu vaccine. Rash on face and neck with urticaria, erythema, mild left cheek and periorbital edema, rash on neck fine papular. No rash at injection sites.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Erythema and hive on the site of VARIVAX and Hep A injection (Rt thigh). Erythema on the site of MMR injection (left) thigh.
Age: 4.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, painful, red, and warm to touch. Child states it "itches".
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hyperhidrosis, Ocular hyperaemia, Pyrexia, Tremor
Clinical narrative: 3 hrs after shot I had the shakes, very cold, bloodshot eyes, low grade fever and sweating. Lasted all night. I fell asleep at 9:30.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Fever > 102 degrees, shaking x 90 minutes. Body aches and pain - sxs started to present 12-24 hours after administration.
Age: 51.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash with hives started approximately 8 hours after flu vaccination. Off/on over next 48-72 hours.
Age: 79.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: Entire arm hurts, trouble moving it, taking ADVIL and it helps. Patient experienced burning feeling overnight.
Age: 79.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Entire arm hurts, trouble moving it, taking ADVIL and it helps. Patient experienced burning feeling overnight.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Neck pain
Clinical narrative: Within 24 hours, redness, swelling and heart at site of administration. Muscle pain radiating up into neck area.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: First day, could bearly move my left arm (9-14-15) as of today (9-28-15) very painful and radiates from shoulder to and including my hand.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Redness and swelling of (L) arm 2 days after vaccine, hives to face. Has had flu 6 x before and never reacted. Can tolerate baked eggs.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Feeling hot, Flushing, Injection site reaction, Paraesthesia
Clinical narrative: Red rash around injection site. Next day - awoke throat tight and itching. Later morning face hot, flushed and prickling more difficulty swallowing.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Throat irritation, Throat tightness
Clinical narrative: Red rash around injection site. Next day - awoke throat tight and itching. Later morning face hot, flushed and prickling more difficulty swallowing.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Musculoskeletal discomfort, Neck pain
Clinical narrative: Soreness, "nerve" pain, discomfort on side of injection - up neck and shoulder some nerve discomfort of face.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Soreness, "nerve" pain, discomfort on side of injection - up neck and shoulder some nerve discomfort of face.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling around injection site plus or minus 4 inches around.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: Headache within 20 min. Generalized aches. Felt terrible through out night. Follow-up 9/29 pt felt better symptoms resolved with 24 hours.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: Redness and visible bump at injection site, rash on left arm at the inner elbow on the right side of his neck. Sore throat.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash
Clinical narrative: Nauseous rash.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Vertigo
Clinical narrative: Flu-like symptoms -> vertigo -> ER visit.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Animal bite, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 26 year old male patient with asthma who was an illegal drug user. The patient had no drug reactions or allergies. On 28-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies were not reported. Since the date of vaccination (reported as "since then"), the patient experienced an injection site reaction with a swollen and red unspecified upper arm. On an unknown date, in 2015, the patient experienced an unspecified dog bite and was subsequently admitted to the hospital due to this event (date of the hospitalization was not provided). The patient sought medical attention and he was given a warm compress as a treatment for the events. No lab diagnostic studies were carried out. The outcomes of the events were not reported. Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Cerebrovascular accident, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old male patient. No information about the patient's pertinent medical history was provided. The patient had no known allergies and was not currently taking any other medications. On 28-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On the same day (reported as "since then"), the patient experienced an injection site reaction with a swollen and red unspecified upper arm. On an unknown date in approximately 2015, the patient experienced cerebral vascular accident and subsequently was admitted to hospital (in 2015, exact dates not provided). Outcomes of the events were not reported. Relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review the event of cerebral vascular accident was considered to be medically significant. This is one of several reports from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: 10/2/15 at 8:15 AM employee presents to office with a 65 mm size erythemic area to flu injection site. States slight itching and soreness.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chest discomfort, Dizziness, Nausea, Throat tightness
Clinical narrative: Complaint-lightheaded, nausea, throat0chest tightness. to ED for evaluation-released home.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Urine analysis, Vaccination complication
Clinical narrative: Complaint-lightheaded, nausea, throat0chest tightness. to ED for evaluation-released home.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site cellulitis, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness of arm, difficulry sleeping, very swollen red arm. Went to hospital - diagnosed with cellulitis of upper left arm.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Drug administered at inappropriate site, Erythema, Insomnia, Local reaction
Clinical narrative: Soreness of arm, difficulry sleeping, very swollen red arm. Went to hospital - diagnosed with cellulitis of upper left arm.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: Soreness of arm, difficulry sleeping, very swollen red arm. Went to hospital - diagnosed with cellulitis of upper left arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Blood pressure increased, Deafness transitory, Dizziness, Hypertension
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a "16 or 17 year old" female patient. The patient's concurrent conditions included an undiagnosed allergy (also reported as no drug/reactions allergies), medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). On 30-JUL-2015, the patient was vaccinated with the second dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided), immediately, the patient experienced dizziness and "10 or 15 minutes" following the vaccination, she could not see or hear, so her blood pressure was immediately measured and it was elevated an unspecified value. The patient was sent to the emergency department of an unspecified hospital, but she was not admitted as a patient. The patient reported, after she fully recovered and regained consciousness, that she experienced similar symptoms after she received the first dose of GARDASIL on an unspecified date. The outcome of the following events that the patient experienced with the first dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on an unspecified date. The outcome of the following events that the patient experienced with the second dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on 30-JUL-2015. The reporter did not assess the relatedness of deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient with GARDASIL. The reporting physician believed that those symptoms could be related with an undiagnosed allergy. The patient's mother did not want her daughter to receive any additional doses of GARDASIL. Additional information has been requested.