chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Cardiac failure, Fatigue
Clinical narrative: To FDA, I'm not happy with reports from Dr.'s they did not include the fact that I have heart failure-found when I went to clinic. Also blood test showed 127 they explained that normal rate is 100. On my next to Dr. Blood test showed 149 higher than the first test. I told them I needed and echo because blood test was so high-they said 149 just happens sometimes. I will try to get the blood tests from both visits. I can't believe they were not included. The pain I felt was so bad for 2 days I thought I might die. When I was better I went to emergency center and then the next week I went to Dr.- I don't feel they took me seriously. P.S. enclosed blood test which were high. It took me 3-4 weeks to get back to normal. 11/27/2017 The patient is a 67 year old female who presents with a complaint of Weakness. The onset of the weakness has been acute and has been occurring in a persistent pattern for 10 days. The course had been recurrent. The weakness is located over the entire body. The weakness is on both sides symmetrically. The symptoms have been associated with arthralgia and muscle pain, while the symptoms have not been associated with alcohol abuse, dark urine, dyspnea, fasciculations, muscle cramps, muscle tenderness, muscle twitching, nausea, numbness, skin rash, tingling or urinary bladder dysfunction. Pt related she had a Pneumococcal vaccination on 11-17-17 and she related she developed some weakness, bodyaches, headache and arthralgias. She relates some improvement but due to the weakness and tiredness she comes in today. She wonders if she is allergic to the pneumococcal vaccine. Some nasal congestion. No fever or chills. No otalgias or eye pain. No sore throat, chest pains, palpitations, SOB, wheezing, nausea, vomiting, diarrhea, hematuria, polyuria, polydipsia, peripheral edema. No rashes.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Myalgia, Nasal congestion, Pain
Clinical narrative: To FDA, I'm not happy with reports from Dr.'s they did not include the fact that I have heart failure-found when I went to clinic. Also blood test showed 127 they explained that normal rate is 100. On my next to Dr. Blood test showed 149 higher than the first test. I told them I needed and echo because blood test was so high-they said 149 just happens sometimes. I will try to get the blood tests from both visits. I can't believe they were not included. The pain I felt was so bad for 2 days I thought I might die. When I was better I went to emergency center and then the next week I went to Dr.- I don't feel they took me seriously. P.S. enclosed blood test which were high. It took me 3-4 weeks to get back to normal. 11/27/2017 The patient is a 67 year old female who presents with a complaint of Weakness. The onset of the weakness has been acute and has been occurring in a persistent pattern for 10 days. The course had been recurrent. The weakness is located over the entire body. The weakness is on both sides symmetrically. The symptoms have been associated with arthralgia and muscle pain, while the symptoms have not been associated with alcohol abuse, dark urine, dyspnea, fasciculations, muscle cramps, muscle tenderness, muscle twitching, nausea, numbness, skin rash, tingling or urinary bladder dysfunction. Pt related she had a Pneumococcal vaccination on 11-17-17 and she related she developed some weakness, bodyaches, headache and arthralgias. She relates some improvement but due to the weakness and tiredness she comes in today. She wonders if she is allergic to the pneumococcal vaccine. Some nasal congestion. No fever or chills. No otalgias or eye pain. No sore throat, chest pains, palpitations, SOB, wheezing, nausea, vomiting, diarrhea, hematuria, polyuria, polydipsia, peripheral edema. No rashes.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a fine pink rash on arms, cheeks and abdomen one day after influenza vaccine. Using Loratadine for symptom relief.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Hard tender "bubble" under skin at inj site.
Age: 1.58
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bilat lateral thigh redness, swelling, warmth - (R) worse. (R) thigh is from just below greater trochanter to knee. (L) in golf ball size; there were scratch marks; no drainage. No fevers. Started 1 day after vaccine admin - worse today; no similar hx. Received all vaccines prior.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Round, red rash with center blister on left arm.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache and bodyaches the same day vaccine was administered. Fever resolved but bodyaches continued the next day. TYLENOL was given to treat.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR
Symptoms: Decreased eye contact, Injection site granuloma, Injection site induration, Injection site swelling, Slow response to stimuli
Clinical narrative: Granuloma (hardened swelling) at injection site in one thigh for at least one or two months after the shot, loss of eye contact, blank, vacant look in the face; slower to respond to mother and father's voice.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR
Symptoms: Staring
Clinical narrative: Granuloma (hardened swelling) at injection site in one thigh for at least one or two months after the shot, loss of eye contact, blank, vacant look in the face; slower to respond to mother and father's voice.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site mass, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Extreme swelling in area where the shot was administered, pain in arm everytime I would lift it or move it in general, the swelling lasted about 8 days, swelling has gone down but there is still a noticeable lump on my arm where the shot was given. Normal pregnancy, estimated due date is 3/22/2018.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: 1 week after injection, the muscle site on upper right arm became sore, even to the touch. As time went on, the muscle became more and more painful when moving my right arm. I have difficulty moving my right arm when arm is in certain positions; and continues to be sore.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: I do not know the type of flu shot I received, on my paperwork all it states is "Influenza Vaccine (Quad) PF".  The nurse seemed grumpy and in a rush, she grabbed my arm and injected higher up and more anterior than my usual flu shot. Three hours after the injection I could not lift my left arm and was in severe pain, I called my doctors' office and spoke with the nurse and she said it was normal.  She told me to just move my arm around, when I told her that this never happened with any other flu shot I had before, the nurse became very defensive and stated she has "been doing this for over 30 years" and she "knew what she was doing" and basically blew me off. The office did not report an adverse reaction that I know of and never gave me a follow up call. Following the injection I was not able to lift my left arm more than 1" from my side and was in extreme pain. Ice and motrin did not help. It was nearly impossible to put a shirt over my head, wash my hair, or lift anything over 25 lbs.  Over the next 1.5 months I would wake up at 3 am with stabbing pain my left shoulder; during the day I could not lift my arm and was in pain when I tried to move it.  I took 3 over the counter Aleve tablets every 4 hours to reduce the pain. I still now have pain and have limited movement.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: I do not know the type of flu shot I received, on my paperwork all it states is "Influenza Vaccine (Quad) PF".  The nurse seemed grumpy and in a rush, she grabbed my arm and injected higher up and more anterior than my usual flu shot. Three hours after the injection I could not lift my left arm and was in severe pain, I called my doctors' office and spoke with the nurse and she said it was normal.  She told me to just move my arm around, when I told her that this never happened with any other flu shot I had before, the nurse became very defensive and stated she has "been doing this for over 30 years" and she "knew what she was doing" and basically blew me off. The office did not report an adverse reaction that I know of and never gave me a follow up call. Following the injection I was not able to lift my left arm more than 1" from my side and was in extreme pain. Ice and motrin did not help. It was nearly impossible to put a shirt over my head, wash my hair, or lift anything over 25 lbs.  Over the next 1.5 months I would wake up at 3 am with stabbing pain my left shoulder; during the day I could not lift my arm and was in pain when I tried to move it.  I took 3 over the counter Aleve tablets every 4 hours to reduce the pain. I still now have pain and have limited movement.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Anger, Crying, Decreased appetite, Diarrhoea, Discomfort
Clinical narrative: Outbursts, Much Sleepier/lethargic, Sleeping longer periods, Jittery, Lack of appetite for solid foods, Periods of Crying for no reason in the floor, Fussiness, Screaming, Irritable, Severely Uncomfortable, Diarrhea for 2 days, Throwing things.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Feeling jittery, Hypersomnia, Irritability, Lethargy, Screaming
Clinical narrative: Outbursts, Much Sleepier/lethargic, Sleeping longer periods, Jittery, Lack of appetite for solid foods, Periods of Crying for no reason in the floor, Fussiness, Screaming, Irritable, Severely Uncomfortable, Diarrhea for 2 days, Throwing things.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Somnolence
Clinical narrative: Outbursts, Much Sleepier/lethargic, Sleeping longer periods, Jittery, Lack of appetite for solid foods, Periods of Crying for no reason in the floor, Fussiness, Screaming, Irritable, Severely Uncomfortable, Diarrhea for 2 days, Throwing things.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Irritability, Pyrexia
Clinical narrative: 18 hours later, very tender injection sites, redness, and low to mid grade fever. 101.5/102. Extreme fussiness. TYLENOL worked extremely well. Just thought I'd report the fever in case the data helps.
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported the area around the injection site swelled to the size of a tennis ball and was bright red, hot to the touch and burned. This continued for a couple of weeks after the vaccination. Patient reported putting heating pads on the area but no other treatment was received. She reported that she has gotten the flu shot for the past 12 years and usually it becomes slightly red in a small area around the injection site but this was much worse. When she presented to the pharmacy on 1/27/18 the swelling and redness had subsided and the area was back to normal. Pharmacy was not made aware of this incident until 1/27/18 by patient.
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Injection site erythema
Clinical narrative: Patient reported the area around the injection site swelled to the size of a tennis ball and was bright red, hot to the touch and burned. This continued for a couple of weeks after the vaccination. Patient reported putting heating pads on the area but no other treatment was received. She reported that she has gotten the flu shot for the past 12 years and usually it becomes slightly red in a small area around the injection site but this was much worse. When she presented to the pharmacy on 1/27/18 the swelling and redness had subsided and the area was back to normal. Pharmacy was not made aware of this incident until 1/27/18 by patient.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: PATIENT HAVE ERYTHEMA AND GENERALIZED PAIN IN LEFT ARM. REDNESS IS NOT LOCALIZED IN THE AREA OF INJECTION. PAIN PRESENT IN AREA OF INJECTION. SYMPTOMS AND SIGNS OCCURRED NEXT DAY EARLY IN THE MORNING WHILE SHE WAS SLEEPING. NO PHARMACOLOGICAL TREATMENT AT THE MOMENT.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Herpes zoster, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient started feeling warm in the evening of the immunization was given, the area around turned red and swollen. Next morning the area from elbow up was swollen, beet red, burning, painful to touch. The redness, burning, swelling lasted several days (approximately one week). On 1/25/18 patient got rash on the same upper arm, that was later diagnosed by he physician as shingles. Patient was prescribed and is currently taking Zovirax 800 #14 1bid
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient started feeling warm in the evening of the immunization was given, the area around turned red and swollen. Next morning the area from elbow up was swollen, beet red, burning, painful to touch. The redness, burning, swelling lasted several days (approximately one week). On 1/25/18 patient got rash on the same upper arm, that was later diagnosed by he physician as shingles. Patient was prescribed and is currently taking Zovirax 800 #14 1bid
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic, Urticaria
Clinical narrative: 80 small itchy bumps occurred 2 days after shot at injection site. Patient put steroid cream on site with no relief. Bumps were "hive-like" but not red.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Crying, Eye swelling, Irritability, Pyrexia, Swelling face
Clinical narrative: Patient's left eye and cheek were extremely swollen. He was irritable and crying with a fever.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Pallor
Clinical narrative: Pt was very nervous about receiving the shot. Right after its administration, pt noted that she felt her left arm hurt a lot, then the left side of her body felt numb - arm leg and left cheek. The left arm was pale as was pt's face. She was conversant throughout this event with no LOC no change in phonation, no lip or tongue swelling, no hives. She was asked to lie back down - her arm and cheeks pinked back up, her strength was strong and equal in her arms and legs and her face showed no asymmetry, tongue was midline, smile without a droop. Per NP in the room, this appeared to be a vasovagal reaction in an anxious pt -  pt recovered quickly once lay down, had sips of water and lollipop and was back to normal within 15 minutes. Initial skin pallor of left arm and left cheek pinked quickly once laying down. Per mom, an RN, this felt different, more like an allergic reaction. Mo noted three small pink dot rash on her left cheek a few minutes after pt was laying down. There were not raised like hives and did not itch, and resolved by the evening time. Given mo's strong concern that this is an allergic reaction, I am reporting this event to VAERS, with her knowledge.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope, Rash, Rash erythematous
Clinical narrative: Pt was very nervous about receiving the shot. Right after its administration, pt noted that she felt her left arm hurt a lot, then the left side of her body felt numb - arm leg and left cheek. The left arm was pale as was pt's face. She was conversant throughout this event with no LOC no change in phonation, no lip or tongue swelling, no hives. She was asked to lie back down - her arm and cheeks pinked back up, her strength was strong and equal in her arms and legs and her face showed no asymmetry, tongue was midline, smile without a droop. Per NP in the room, this appeared to be a vasovagal reaction in an anxious pt -  pt recovered quickly once lay down, had sips of water and lollipop and was back to normal within 15 minutes. Initial skin pallor of left arm and left cheek pinked quickly once laying down. Per mom, an RN, this felt different, more like an allergic reaction. Mo noted three small pink dot rash on her left cheek a few minutes after pt was laying down. There were not raised like hives and did not itch, and resolved by the evening time. Given mo's strong concern that this is an allergic reaction, I am reporting this event to VAERS, with her knowledge.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Alopecia, Blood thyroid stimulating hormone, Full blood count
Clinical narrative: Four days after receiving the 3 vaccines stated (HepA, HPV and Meningo) my daughter noticed a significant patch of her hair had fallen out/was missing. The area where this occurred was on the right side of her head just behind her right ear. The patch was roughly the size of a 50-cent piece.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Altered state of consciousness, Blood test, Computerised tomogram, Confusional state, Fatigue
Clinical narrative: Flu shot... i was a pilot and scuba diver.... at grocery store.. felt like movie scene where the hall way goes stretching out.. i didn't pass out.. i fought it... talking breathing walking.. could find front of store.. i could see but didn't recognize anything... just kept talking loud trying to get someones attention...i went on for about  45 minutes i fought it till ambulance came... i refused to let myself pass out.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Fear, Feeling abnormal, Urine analysis, X-ray
Clinical narrative: Flu shot... i was a pilot and scuba diver.... at grocery store.. felt like movie scene where the hall way goes stretching out.. i didn't pass out.. i fought it... talking breathing walking.. could find front of store.. i could see but didn't recognize anything... just kept talking loud trying to get someones attention...i went on for about  45 minutes i fought it till ambulance came... i refused to let myself pass out.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Flushing, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Immediate redness/flushing of arm that received the injection. The neck then turned red and the patient had difficulty breathing. An itchy throat and some peripheral swelling were experienced. Patient was given 50 mg of BENADRYL 5 minutes after injection. Emergency services were called and patient was taken to the Emergency Room via ambulance. She was observed for several hours over which time the symptoms subsided.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Immediate redness/flushing of arm that received the injection. The neck then turned red and the patient had difficulty breathing. An itchy throat and some peripheral swelling were experienced. Patient was given 50 mg of BENADRYL 5 minutes after injection. Emergency services were called and patient was taken to the Emergency Room via ambulance. She was observed for several hours over which time the symptoms subsided.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pain in extremity, Skin discolouration, Swelling
Clinical narrative: Received flu vaccine 1/25 in office. Started with redness/swelling a couple hours later. Was seen in urgent care 1/26 and started on BACTRIM. Has taken BACTRIM and BENADRYL last night and this morning. Mom concerned due to darker appearance at upper deltoid area. Redness extending now slightly below elbow. Painful to move, flex, or press on arm. Referred to ED on 1/27/18 for compartment pressures.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Received flu vaccine 1/25 in office. Started with redness/swelling a couple hours later. Was seen in urgent care 1/26 and started on BACTRIM. Has taken BACTRIM and BENADRYL last night and this morning. Mom concerned due to darker appearance at upper deltoid area. Redness extending now slightly below elbow. Painful to move, flex, or press on arm. Referred to ED on 1/27/18 for compartment pressures.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received flu shot. Patient's mother returned shortly after stating her daughter should sit down because she felt she was going to pass out. Patient fainted after being seated. When patient lost conciousness, 911 was called. Patient may have also seized for a brief moment . Before 911 call finished, patient fully regained conciousness. Vitals taken once before paramedics arrived. Paramedics arrived and took family to the ambulance for observation. Ultimate outcome is unknown, patient's family not reachable - phone #'s in profiles not working.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Palpitations, Tremor
Clinical narrative: Patient presented with pregrant wife for Tdap vaccine. Vaccine was administered per clinic guidelines. Since patient and wife stated that this is their first Tdap, per clinic guidelines asked them if they can wait 15 mins psot vaccination and agreed. 10mins post vaccination went to check found patient diaphoretic, shaky and stated that he feels his HR is racing. Checked his Vital signs his BP was 140/80 with HR 60's, RR 20's and Ox sat 99%. Completed the rest of the assessment such as Neuro, all stable except pt appears to be slow to respond but wife and pt denied. Activated EMS by calling 911. Brought patient to the room and sat on the examination table. Recked his vital signs BP 160/90, HR 110, and RR 20's with Ox 99%. Offered Epi pt refused. EMS arrived and complete their assessment and offered pt if it is ok for them to take him to ED for further evaluation. Patient agreed and walked to the stetcher steady, alert and talking.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, Tenderness
Clinical narrative: The night of vaccination patient reported pain/tenderness in the arm/shoulder that received the vaccine. Upon arrival to the pharmacy the next day (today) I inspected the patient's arm and saw no signs of redness/inflammation. Her arm was painful to move and needed help to show it to me. Advised to rest arm and ice. Also, stated she could take an OTC anti-inflammatory to help control pain.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nausea, Pruritus, Rash, Vomiting
Clinical narrative: Approximately 6 weeks post immunization patient experiencing rash on front and rear torso area, itching as well as nausea and vomiting. Was seen by primary care physician and per patient reaction is attributed to vaccine.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Neck pain
Clinical narrative: Extreme joint pain in hips, knees, hands, wrists, ankle and neck. Pain rated 10/10.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient state that his right arm started to get really sore around 8pm on 1/25/18 that he can't even move the arm. He had taken off work the next day because he can't even move his arm. He stopped by the pharmacy around 2pm to report the adverse events. on 1/27/18, I called him back to ask how he's doing. He said he's still sore but he can at least move his arm now.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Flushing, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: REDNESS/FLUSHING AND WARMTH OF SKIN AROUND AND EXTENDING 6 INCHES PLUS BLOW INJECTION SITE, INCLUDING MOST OF THE UPPER ARM.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site swelling
Clinical narrative: Patient had more than typical bleeding after injection and slight swelling at injection site. He denied any burning, itching, dizziness, or malaise when questioned. He was told what to do in case any other symptoms occurred and redressed with new bandages. Left with no assistance.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever. Nausea/vomiting/dizziness. Strong joint pain.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Was ill 2 days before influenza IZ - resolved with no more loose stool or vomiting (had only one vomiting). Received IZ after well approximately 10 hrs, went to sleep and awoke 9 hrs later with fever 102 degrees, vomiting many times for 2 days. No diarrhea, had normal formed stool x 1 today. Fever 101.5 in clinic with emesis.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abdominal pain upper, Lethargy, Pyrexia
Clinical narrative: My baby experienced lethargy, fever up to 101 and stomach cramping. She was just comforted at home, no meds were given. Her fever broke sometime in the early morning but she still experienced stomach pains through the next day; January 26th.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Affect lability, Autism spectrum disorder, Developmental regression, Hyperaesthesia, Speech disorder developmental
Clinical narrative: Loss or developmental regression in expressive speech and increase in inability to regulate emotions by self soothing or accepting caregivers soothing comforts. Increased sensitivity and insensitive to environmental input. Lack of pain response and increase in sensitivity to soft touch and oral stimuli subsequentally diagnosed as Autism.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unresponsive to stimuli
Clinical narrative: Loss or developmental regression in expressive speech and increase in inability to regulate emotions by self soothing or accepting caregivers soothing comforts. Increased sensitivity and insensitive to environmental input. Lack of pain response and increase in sensitivity to soft touch and oral stimuli subsequentally diagnosed as Autism.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Clumsiness, Decreased appetite, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Nausea, feeling clumsy and shaky, no appetite, pain in arm, swollen and hard at injection site. Red rash at site.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Nervousness, Pain in extremity, Rash erythematous
Clinical narrative: Nausea, feeling clumsy and shaky, no appetite, pain in arm, swollen and hard at injection site. Red rash at site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain, Middle insomnia, Neck pain
Clinical narrative: A few hours after injection I had severe pain in r. arm...no range of motion, after icing and ibuprofen with no improvement, I contacted my dr. and was seen by his P.A. and prescribed a steroid pack with helped about 50%.  But it is now January 28th and still having pain in arm shoulder, lats, pecs, and some neck pain. Having physical therapy and although improving range of motion, still in pain which wakes me up during night. I believe this shot was administered too high in the arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: A few hours after injection I had severe pain in r. arm...no range of motion, after icing and ibuprofen with no improvement, I contacted my dr. and was seen by his P.A. and prescribed a steroid pack with helped about 50%.  But it is now January 28th and still having pain in arm shoulder, lats, pecs, and some neck pain. Having physical therapy and although improving range of motion, still in pain which wakes me up during night. I believe this shot was administered too high in the arm.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Dry eye, Urticaria
Clinical narrative: EMPLOYEE STATED THAT HER EYES STARTED TO DRY UP AND SHE DIDN'T NOTICE TILL SHE GOT HOME THAT SHE HAD HIVES ON HER LEGS AND BACK. DONOR PUT BENADRYL CREME ON EFFECTED AREAS.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Dyspnoea, Pharyngeal oedema
Clinical narrative: Patient describes within two hours after receiving the vaccine, that he felt his throat swelling. No shortness of breath, no reaction at the injection site or other rashes. The feeling he had was similar to the oral/pharyngeal symptoms he has with his oral allergy syndrome. He tool his allergy medications as usual, with the symptoms persisting until examination the following morning. He was able to swallow, although it was uncomfortable. It was difficult to breath through his throat while exercising, although it did not feel like his asthma.
Age: 72.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: THE NEXT DAY AFTER VACCINATION THE AREA OF INJECTION OF ZOSTAVAX PATIENT DESCRIBED IT WAS SWELL, RED, ITCHINGAND HAD PAIN IN HER ARM. THEN SHE COMES AT THE PHARMACY IN 01/28/2018 DESCRIBING THE SAME SYMPTOMS IN THE AREA OF INJECTION OF PREVNAR. SHE DESCRIBED SYMPTOMS IN THE AREA OF INJECTION OF ZOSTAVAX HAVE IMPROVE WITH SOM HARDNESS STILL IN THE AREA.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Lumbar puncture, Muscular weakness
Clinical narrative: Development of Guillan Barre Syndrome with severe upper and lower extremity weakness. Hospitalization and prolonged rehabilitation. Treated with IVIG, plasma exchange.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Development of Guillan Barre Syndrome with severe upper and lower extremity weakness. Hospitalization and prolonged rehabilitation. Treated with IVIG, plasma exchange.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm became extremely painful and swelled up; Pain moved up to the shoulder and my arm was sensitive and very hot to the touch. I could not raise my left arm above my left shoulder for at least  day and a half. Went back to the clinic where I had received the shots and was told that that could happen. After some discussion, I was given a handout on each shot that had been given. Right arm was fine and not a problem.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Left arm became extremely painful and swelled up; Pain moved up to the shoulder and my arm was sensitive and very hot to the touch. I could not raise my left arm above my left shoulder for at least  day and a half. Went back to the clinic where I had received the shots and was told that that could happen. After some discussion, I was given a handout on each shot that had been given. Right arm was fine and not a problem.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Dyspnoea exertional, Feeling jittery, Palpitations
Clinical narrative: Within 2 hours patient noticed overall jitteriness, difficulty breathing...."shortness of breath with exertion" and mild palpitations. Following day, patient noticed chest tightness. She initially took a BENADRYL and then 1 day later took prednisone 10mg-4 tablets at one time. This did help her. The allergist told her to repeat the dose of prednisone in 3 days if needed. She did not feel her breathing was severe enough to go to the ER on 01/22/18. Spoke with pt 01/28/18-took 2 days to resolve. Did not need the 2nd dose of prednisone.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient came into pharmacy 1/18/2018 and reported that his arm from his flu shot was still hurting. He had checked with this orthopedic doctor and they had sent him into us. We filled out an incident report and told him that pharmacy would be in contact with him.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity, Swelling, Ultrasound scan
Clinical narrative: Achy arm in the night and then very weak and unable to use for full range of motion. Sharp pain in arm and unable to reach back or raise arm over head. Hurt during walking over 30 minutes. Went to chiropractor in November 14th and November 17 -ultrasound to reduce swelling in area of injury. In December went to MD and had Xray -showed no fractures, wanted MRI but declined by MD.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: Achy arm in the night and then very weak and unable to use for full range of motion. Sharp pain in arm and unable to reach back or raise arm over head. Hurt during walking over 30 minutes. Went to chiropractor in November 14th and November 17 -ultrasound to reduce swelling in area of injury. In December went to MD and had Xray -showed no fractures, wanted MRI but declined by MD.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head abnormal, Death, Loss of consciousness
Clinical narrative: Approximately 8 hours after the injection, patient suffered a massive right cerebral hemisphere stroke. He was unconscious when taken to emergency room. He did not regain full consciousness and died on 11/17/2017.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Approximately 8 hours after the injection, patient suffered a massive right cerebral hemisphere stroke. He was unconscious when taken to emergency room. He did not regain full consciousness and died on 11/17/2017.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: I was working for a home care business, and was provided a flu shot by them through Pharmacy. The person who gave the shot had some difficulty figuring out how to give the shot in my left shoulder. My arm was swollen and tender for some weeks after the shot. Gradually the swelling and warmth dissipated, but the area is still sore and achy more than a year after receiving the vaccine. I was afraid to have another flu shot this year.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: The next morning there was pain and redness at the injection site. The area felt warm. The area was hard like a knot. The pain has subsided but it is still painful when touched. On Sunday, the redness was estimated to be about 6 to 7 cm. The patient says it feels like it is slowly getting better.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Delirium, Pneumonia, Pyrexia
Clinical narrative: Patient had no fever at time of vaccines. 12-14 hours after vaccines, spiked a high fever with delirium. Was taken to hospital and admitted for pneumonia. Son informed us 01/27/18 to make us aware of the situation.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Fatigue, Feeling of body temperature change, Immediate post-injection reaction
Clinical narrative: Patient was given an IMZ (Influenz/FLUZONE QUAD). Immediately after injection patient said that he felt dizzy and nauseated. Stated that his heart felt like it was racing and that he felt hot then cold off and on. Pt was instructed to stay seated and RPh began monitoring blood pressure and heart rate. 5:45pm bp 128/70 hr 109, 5:55pm bp 134/78 hr 105, 6:05pm bp 122/71 hr 100, 6:15pm bp 134/80 hr 114. During this time patient said he felt nervous and anxious. He also stated that he felt extremely tired and felt weak - like it was hard to lift his arms. Stated he had been to the hospital within the last few days for a panic attack. He stated it felt a little like that but different. Code WHITE was called and patient declined to have EMS called. He had a friend with him and said he would have his friend drive him to the hospital.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Nausea, Nervousness, Palpitations
Clinical narrative: Patient was given an IMZ (Influenz/FLUZONE QUAD). Immediately after injection patient said that he felt dizzy and nauseated. Stated that his heart felt like it was racing and that he felt hot then cold off and on. Pt was instructed to stay seated and RPh began monitoring blood pressure and heart rate. 5:45pm bp 128/70 hr 109, 5:55pm bp 134/78 hr 105, 6:05pm bp 122/71 hr 100, 6:15pm bp 134/80 hr 114. During this time patient said he felt nervous and anxious. He also stated that he felt extremely tired and felt weak - like it was hard to lift his arms. Stated he had been to the hospital within the last few days for a panic attack. He stated it felt a little like that but different. Code WHITE was called and patient declined to have EMS called. He had a friend with him and said he would have his friend drive him to the hospital.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Headache, Nausea, Pain
Clinical narrative: 12/19/17 Vaccine given at 1:30pm. At 3:30pm, son complained of nausea and leg pain, HA. By 4:30pm, son w Extreme HA, body aches, nausea, vomiting, temp 103 oral, sensitivity to light, shaking/ chills. MD called. Recommended Tylenol or Motrin w food. Unable to keep water or food down. By 6:15pm, he could tolerate ice chips and took Tylenol. 7:30pm temp 102 PO, still w body aches, nausea, HA. Slept through night, but still w nausea, HA. 12/20/17 Wednesday 9AM nausea w vomiting,temp 101 po, HA, body aches, taking soda and ice chips. Refuses Tylenol. 2:30 PM Feeling less nausea, so Tylenol Temp 99.4 at 10:30PM. Thursday temp 98.6 and HA, body aches nausea gone.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Photophobia, Tremor, Vomiting
Clinical narrative: 12/19/17 Vaccine given at 1:30pm. At 3:30pm, son complained of nausea and leg pain, HA. By 4:30pm, son w Extreme HA, body aches, nausea, vomiting, temp 103 oral, sensitivity to light, shaking/ chills. MD called. Recommended Tylenol or Motrin w food. Unable to keep water or food down. By 6:15pm, he could tolerate ice chips and took Tylenol. 7:30pm temp 102 PO, still w body aches, nausea, HA. Slept through night, but still w nausea, HA. 12/20/17 Wednesday 9AM nausea w vomiting,temp 101 po, HA, body aches, taking soda and ice chips. Refuses Tylenol. 2:30 PM Feeling less nausea, so Tylenol Temp 99.4 at 10:30PM. Thursday temp 98.6 and HA, body aches nausea gone.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: The patient was given the AFLURIA NDC: 33332-0017-02. Lot number# XT33908 on 01/20/2018 at Pharmacy. The patient came back on 01/28/2018 with a big bruise on her arm, saying that the bruise started the same day she got the vaccine but it got darker over the week with pain that doesn't seem to go away even a week after. Asked the patient if taking any prescription drugs the answer was no. Asked if the patient had a flu shot before and the answer was yes( many times) without a problem.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Ageusia, Anosmia, Cough, Deafness
Clinical narrative: Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dysphagia, Dysphonia, Eye pruritus, Influenza
Clinical narrative: Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal disorder, Nasal congestion
Clinical narrative: Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Nasal pruritus, Nausea, Oropharyngeal pain, Pain, Paranasal sinus discomfort
Clinical narrative: Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rhinorrhoea, Sinus pain
Clinical narrative: Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever that lasted a day. Rash that looks like the measles.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Month long diarrhea and excessive vomiting after every meal (he is exclusively breastfed).
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 14-APR-2016, the patient was vaccinated with an expired dose of ROTATEQ oral liquid (lot# J015063, expiry date 24-OCT-2015; exact dose was not reported). There were no concomitant therapies reported. The reporter stated that the dose of ROTATEQ administered to the patient did not have any previous temperature excursion. No adverse symptoms were reported. There was no product quality complaint involved. Follow-up information was received from the certified medical assistant on 20-MAY-2016 and refers to a 5 month year-old male patient. The patient had no pre-existing allergies, none birth defects and no medical conditions. The number of siblings was reported as 1. On 14-APR-2016 at 03:00 p.m. o' clock, the patient was vaccinated with the first dose of ROTATEQ oral liquid (lot# also reported as J0115063) at the private doctor's office/hospital. The patient was in a good health condition. None adverse reaction/effect was present or reported by parents. The monitoring of the patient was continued and no adverse effect have been found. Lot# J0115063 has been verified to an invalid lot# for rotavirus vaccine, live, oral, pentavalent (however, previously reported lot# J015063 has been verified to be valid lot# for rotavirus vaccine, live, oral, pentavalent). Additional information is not expected, as all scheduled correspondence was received. On 24-JAN-2018, a call was placed to the nurse, who stated that, "it was three years implant expired" when patient conceived and confirmed implant has since been removed. Narrative has been updated.; Sender's Comments:  MERCK 1604USA011058:Mfr number.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: Case number PHHY2016US176742, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 648688) website on 21 Dec 2016. This report refers to a 49 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (seasonal influenza vaccine batch number: 185284) intramuscularly in left arm on 19 Aug 2016. On the same day 1 hour after vaccination, the patient experienced face red while in car. It was reported that, patient went to his doctors office and his vitals were checked. Patient was offered an injection of diphenhydramine, but he opted to buy over the counter OTC oral tabs (unknown) instead. His red face symptoms subsided and was discharged from physicians clinic. The patient visited the emergency room. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as on non serious. The causality of the even was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Myalgia
Clinical narrative: Case number PHHY2016US176101, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 650845) website on 21 Dec 2016. This report refers to a female patient of unspecified age. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date, after vaccination the patient experienced myalgia and felt sick. The outcome, seriousness and causality of the events were not reported.
Age: 69.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2016US180744, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 652017) website on 21 Dec 2016. This report refers to a 69-years-old female patient. Past medical history was not reported. Current condition included AUGMENTIN allergy which causes gastrointestinal upset and no allergies to penicillin's. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619401) intramuscularly in left arm on 30 Aug 2016. The patient also vaccinated with PREVNAR 13 (batch number: M94708) intramuscularly in left arm on 30 Aug 2016. On 03 Sep 2016, 03 days after vaccination the patient experienced rash, swelling and redness surrounding left arm injection site. The outcome of the events were reported as complete recovery. The seriousness and causality of the events were not reported.