chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Bone pain, Dizziness, Headache
Clinical narrative: Patient stated to me on 11/24/ 18 that  the adverse events she experienced on 11/23/18 were as follows: boneaches, headache, stomachache/ nauseous dizziness, backache. She said she didn't sleep well the night she received the immunization because her entire body ached. She has not received any treatment. She explained  that the headache and nauseous feeling had eased up by her lunchtime, but not the backache. As a pharmacist, I had a consultation with her about the patient information sheet on SHINGRIX which addresses the possibility of the adverse reactions she has experienced and it further states that these reactions normally resolve on their own within 2 to 3 days. If they haven't resolved within such time period, she would need to seek medical advice.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Poor quality sleep
Clinical narrative: Patient stated to me on 11/24/ 18 that  the adverse events she experienced on 11/23/18 were as follows: boneaches, headache, stomachache/ nauseous dizziness, backache. She said she didn't sleep well the night she received the immunization because her entire body ached. She has not received any treatment. She explained  that the headache and nauseous feeling had eased up by her lunchtime, but not the backache. As a pharmacist, I had a consultation with her about the patient information sheet on SHINGRIX which addresses the possibility of the adverse reactions she has experienced and it further states that these reactions normally resolve on their own within 2 to 3 days. If they haven't resolved within such time period, she would need to seek medical advice.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Localized rash developed at right thigh injection site on 11/20/18. Rash grew in size over three day period but remained on leg only. As of 11/24/18, local rash primarily disappeared, however a diffusely raised and erythematous rash developed to bilateral buttocks, thighs, and calves. Benadryl was given, response currently unknown. Will be seeking follow up in medical clinic/ER if adverse reaction persists despite treatment.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Diet refusal, Lethargy, Pyrexia, Screaming
Clinical narrative: Fever of 103, sluggish, lethargic, not eating or drinking for 3 days. Up all night. Crying and screaming a lot.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Sluggishness
Clinical narrative: Fever of 103, sluggish, lethargic, not eating or drinking for 3 days. Up all night. Crying and screaming a lot.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Rash below the injection site that ran from below the injection site to the end of the arm,rash also developed on the leg, back of the calf and knee, very itchy. Patient tried creams that he had at home and taking BENADRYL. BENADRYL helped for awhile, thought it may be from the injection and not a preexisting condition since his creams did not help. BENADRYL stopped working Friday. Tried hydrocortisone at home, got some relief. Came to pharmacy to get more. I encouraged him to call MD since he is leaving for trip tomorrow. Went to see MD, MD thinks from the shot gave him prednisone to take with him if it doses not continue to get better. Currently is getting better.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Alopecia, Sinusitis, Upper respiratory tract infection
Clinical narrative: My hair started falling out 10/20/2018-it filled the sink, the counter top, floor, my hair brush, I have several bald spots on my head, this happened last year after I receive the flu shot 11/2/2017 (FLUZONE HIGH DOSE) which I was told I would be terminated if I refuse. this year I was so scared it would happen again & I was told I would get sritten up if I refused. this also happened after my first flu shot EVER 10/12/2016 (FLUZONE QUADRIVALENT, lot# U1678AE). I also developed sinus infection & upper respiratory infection after each injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Pain radiating out from injection site in all directions. Muscle aches and weakness in arms, legs torso and neck. Started the day following injection.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood test normal, Condition aggravated, Dyskinesia, Fatigue, Myoclonus
Clinical narrative: Day of vaccine, runny nose worsened, congestion, poor sleep, by 3-4 days past vaccine, runny nose was a sinus infection; 4 days past vaccine, child developed a fever of 101. Fever lasted approximately 48 hours and peaked at 105 in spite of treatment with ibuprofen and acetaminophen at direction of care provider. During days 5-6 following vaccination, when fever was aggressive, child experienced staring and jerking (dozens of myoclonic-like jerks) while waking and sleeping. These were not febrile seizures; each jerk lasted <1-2 seconds. On day 6, child was seen by pediatrician who noticed no physical signs of infection, nor did infection or inflammation present in bloodwork. Fever and jerking subsided by day 7 after vaccination when rash started to appear. Rash covering trunk, neck, upper arms and legs lasted two days (day 7-9). Child remained extremely fatigued from day 5-day day 9.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Poor quality sleep, Pyrexia, Respiratory tract infection, Rhinorrhoea, Sinusitis
Clinical narrative: Day of vaccine, runny nose worsened, congestion, poor sleep, by 3-4 days past vaccine, runny nose was a sinus infection; 4 days past vaccine, child developed a fever of 101. Fever lasted approximately 48 hours and peaked at 105 in spite of treatment with ibuprofen and acetaminophen at direction of care provider. During days 5-6 following vaccination, when fever was aggressive, child experienced staring and jerking (dozens of myoclonic-like jerks) while waking and sleeping. These were not febrile seizures; each jerk lasted <1-2 seconds. On day 6, child was seen by pediatrician who noticed no physical signs of infection, nor did infection or inflammation present in bloodwork. Fever and jerking subsided by day 7 after vaccination when rash started to appear. Rash covering trunk, neck, upper arms and legs lasted two days (day 7-9). Child remained extremely fatigued from day 5-day day 9.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Staring
Clinical narrative: Day of vaccine, runny nose worsened, congestion, poor sleep, by 3-4 days past vaccine, runny nose was a sinus infection; 4 days past vaccine, child developed a fever of 101. Fever lasted approximately 48 hours and peaked at 105 in spite of treatment with ibuprofen and acetaminophen at direction of care provider. During days 5-6 following vaccination, when fever was aggressive, child experienced staring and jerking (dozens of myoclonic-like jerks) while waking and sleeping. These were not febrile seizures; each jerk lasted <1-2 seconds. On day 6, child was seen by pediatrician who noticed no physical signs of infection, nor did infection or inflammation present in bloodwork. Fever and jerking subsided by day 7 after vaccination when rash started to appear. Rash covering trunk, neck, upper arms and legs lasted two days (day 7-9). Child remained extremely fatigued from day 5-day day 9.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature fluctuation, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient presented on Saturday (3-4 days later) with slight redness, slight swelling, and warm to the touch injection site reaction. Was approx the size of the ring of a small cup (2-3 inch in diameter).....then 1 day later reported low grade fever that was alleviated by ibuprofen and/or TYLENOL. Temperature fluctuated between 99-100 degrees.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Headache, slight fever, malaise, soreness.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Pt describes a red rash, nonclustered, nonspreading, prutritic "pinhead" rash that presented very soon after vaccine administration. Pt contacted MD for treatment of rash and was given permethrin. Pt then contacted Dr. (dermatologist) for further treatment. Dermatologist prescribed premethrin (rule out scabies), methylpredinsolone dose pak and triamcinolone cream. The rash has not resolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: I was administered the annual flu shot. I've never had any reaction to my annual flu shot and I've been getting the flu shot each year for over 20 years. At the time of the inoculation, I had the sensation it was being administered high on my arm, closer to my shoulder; however, it was administered in the normal location as I confirmed by the placement of the bandage. The reaction to this was severe. My arm became completely numb/paralyzed. I iced the arm, and soaked it. In order for me to move my arm, I had to use my opposite hand to do that. I did not have any other symptoms...i.e. fever or upset stomach or any other aches. The shot was done on a Saturday. I treated at home all day Sunday. Monday I was fine and able to go to work! Very puzzling. I did report this to the local Pharmacy. I did not contact the pharmacy where I was injected. The pharmacy store is not one I have used before (or since). It was convenient to use that location because of my travel that day. I DO NOT KNOW ANY OF THE INFORMATION ABOUT WHICH FLU SHOT WAS ADMINISTERED. I'M SURE YOU COULD OBTAIN THAT INFO FROM THE PHARMACY.
Age: 77.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Myalgia
Clinical narrative: Patient stated that throughout the whole day he was doing just fine, but woke up in the middle of the night with severe body (muscle) aches. He had access to a hot tub that he got in during the night that he said helped a bit with the body aches. Denied any shortness of breath or breathing problems.  He felt that it could have been due to getting both the flu shot and SHINGRIX shot at the same time as he has not had any issues with the flu shot in the previous years or with the ZOSTAVAX shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness and redness with raised areas covering most of the left upper arm.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Erythema, Hyperhidrosis, Visual impairment
Clinical narrative: Pt received her Flu shot from Pharmacist, on Sunday 11/25/18 around 11:00AM. Pt had forewarned she gets dizzy from vaccines while reviewing consent form. Pt received shot in our immunization room while sitting on armed chair while her father was next to her. Pt's father and pharmacist remained in room. After administering shot in her left shoulder, and placing bandage, pt claimed she was fine.  After about 1 minute, she started sweating profusely on face/neck and her face became visibly red.  During conversation, she stated her vision was impairing as her view of her dad's face was becoming hazy/fuzzy, and her speech was slurred while stating that. Pharmacist gave bottle of cold water. After drinking water, she started to feel better. Redness on face was visibly lessening and patient reported not feeling sweaty any longer. After about 3 more minutes, patient was able to converse clearly and visibly looked less weak. After another 2 minutes, when patient stated she was "much better", pharmacist informed pt/Father to remain in room for another 5 minutes and went inside pharmacy.  After a few minutes, when pt/Father left the immunization room, pharmacist asked them report back to pharmacy after their shopping trip is complete just to ensure pt was fine. After 10 minutes or so, once their shopping was completed, pt and her father waved bye to pharmacist in pharmacy on their way out.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Patient experienced fever, which has been reported. But she also has a strange and painful red streak going down her arm that has not improved. The fever improved, but the streak has not.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Approximately 1-5 seconds after receiving the immunization, the patient rested her forehead down and proceeded to lose consciousness. The patient slid from the chair and knocked her head on the floor. Our facility's protocol was initiated and 911 called. Since the patient was underage authorities spoke with her father/guardian who waved and ambulance/fire being dispatched.  Patient was given water and remained seated with reporter and father for ~30 minutes. Father then took the patient home after waving any other services being called with the understanding he needed to take her to the emergency department if her condition worsened or any vomiting/headache occurs.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site scab, Injection site swelling
Clinical narrative: The patient experienced redness, swelling and tenderness in the area that the vaccine was given. She stated that the arm felt hot to touch and this continued for a few days. She stated that once this resolved the area of the vaccine became itchy and continues to make a scab over where she can see that the needle went into the arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The patient experienced redness, swelling and tenderness in the area that the vaccine was given. She stated that the arm felt hot to touch and this continued for a few days. She stated that once this resolved the area of the vaccine became itchy and continues to make a scab over where she can see that the needle went into the arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt said she had hives for days. She has had them before with her reaction to allergy with penicillin.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Crying, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Both vaccines were done it right arm per pt request. Her arm was painful as if hit by a bar. She was crying, pain down to ribs, flu like symptoms, fatigue, chills, little dizzy one time, diarrhea and nausea. Pt initially called pharmacy the next day to report how she was feeling. She went to doctor on Monday following the shots and explained how she felt, but no treatment was received.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Influenza like illness, Musculoskeletal chest pain, Nausea, Pain in extremity
Clinical narrative: Both vaccines were done it right arm per pt request. Her arm was painful as if hit by a bar. She was crying, pain down to ribs, flu like symptoms, fatigue, chills, little dizzy one time, diarrhea and nausea. Pt initially called pharmacy the next day to report how she was feeling. She went to doctor on Monday following the shots and explained how she felt, but no treatment was received.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose decreased, Blood pressure decreased, Disorientation, Dizziness, Loss of consciousness
Clinical narrative: Approximately 2 minutes after receiving the vaccine, patient started complaining of not feeling well, feeling faint, nauseous and went to sit down. Gave patient water to drink but patient then completely lost consciousness and started shaking, almost in a seizing type way. Called 911 immediately. He regained consciousness after about 15 seconds and was very disoriented. Mom was with patient and stated he had no medical issues, no BP, blood sugar, brain tumor, stroke hx. I took BP and per automatic cuff BP was 65/35. Paramedics came and began to assess the patient. It was determined his blood sugar was low at 67 and patient had not ate at all during the day. Patient was instructed to follow up with primary care doctor and to eat.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Tremor
Clinical narrative: Approximately 2 minutes after receiving the vaccine, patient started complaining of not feeling well, feeling faint, nauseous and went to sit down. Gave patient water to drink but patient then completely lost consciousness and started shaking, almost in a seizing type way. Called 911 immediately. He regained consciousness after about 15 seconds and was very disoriented. Mom was with patient and stated he had no medical issues, no BP, blood sugar, brain tumor, stroke hx. I took BP and per automatic cuff BP was 65/35. Paramedics came and began to assess the patient. It was determined his blood sugar was low at 67 and patient had not ate at all during the day. Patient was instructed to follow up with primary care doctor and to eat.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Pt's mom called about 2 hours after vaccine administered to report intense pain in the entire arm and ability to close hand. Mom was advised to instruct patient to begin Ibuprofen at a 600mg dose around the clock to help improve inflammation and to contact RPh if symptoms worsened. I followed up with Mom the morning of 11/25. Mom reported that symptoms are improving and pain is less intense today and patient can close their hand. Pt is still in discomfort mainly due to sore arm as of 11/25.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Myalgia, Pain
Clinical narrative: Patient is experiencing strong muscle and body aches all over for 8 weeks so far starting 3 days after shot was administered.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient is complaining of pain at injection site and hot touch.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site warmth, Rash erythematous
Clinical narrative: Diffuse, pale red to pink rash. Patient also some itching and and initial feeling of warmth at the injection site. Symptoms appeared 15-18 hours after injection. Upon checking with patient days later, patient reported that all symptoms and skin reactions had disappeared within 7 days (11/24/2018).
Age: 50.0
Sex: M
Vaccine: FLUR4
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 24 hours after receiving the vaccine, the patient noticed redness about 4 inches below the injection site. The red area was about 4" x 3". It was warm to the touch. Patient stated "it feels like a bee sting". He also complained of abdominal pain on his right side; like he had been punched. Patient went to the doctor and was prescribed Prednisone.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash erythematous, Ulcer
Clinical narrative: Day after vaccination (11/13) had fever, body aches, chills which improved by 11/14. On 11/17 patient noticed an open sore and red rash on upper left side of back accompanied by burning pain. By 11/25 some improvement noted in burning sensations.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt fainted head first upon walking out of the store. Called 911 and the medical team assessed the patient.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: The patient got her flu shot on 11/8/18. On 11/25/18 she was shopping at another Pharmacy and reported that her arm was still sore. The other store called me so I could report the incident and she was instructed to follow up with her doctor.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Coordination abnormal, Dizziness
Clinical narrative: Patient stood up after getting the vaccine. He was not coordinated, said he was dizzy, and about to faint. He was guided back to a chair, and monitored. After a long time, he said, he was back to normal .
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Immunization was given on 11/18/2018 at 1833. Donor began feeling nauseous with chills and a fever the next day in the afternoon. Symptoms lasted for approximately a day and a half. Donor has felt fine since resolution of symptoms. The event was reported today. No treatment provided.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Gaze palsy, Heart rate decreased, Loss of consciousness, Seizure
Clinical narrative: Soon after vaccines were given by MA, patient had syncopal event and MA came to get me. When I arrived he was altered, had eye deviation, head turn and upper extremity shaking consistent with a seizure. He then seemed to come to normal state of consciousness for a short time and then had another brief seizure. Patient remained in and out of normal consciousness for the next 20 minutes before EMS arrived. Transported to ER by medic, observed and returned to baseline and was sent home.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Soon after vaccines were given by MA, patient had syncopal event and MA came to get me. When I arrived he was altered, had eye deviation, head turn and upper extremity shaking consistent with a seizure. He then seemed to come to normal state of consciousness for a short time and then had another brief seizure. Patient remained in and out of normal consciousness for the next 20 minutes before EMS arrived. Transported to ER by medic, observed and returned to baseline and was sent home.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Patient called to report a hive at the injection site that was about 1/2 dollar in size. Informed patient to take BENADRYL and apply hydrocortisone cream to hive. If symptoms worsen to call PCP and use back.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The pain started at the injection site with 2 hours. The patient said her arm is still hurting after 1 month and cannot go above her head.
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm, Tremor
Clinical narrative: Hot, red, swollen warm arm, shakes, fever.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Haemorrhage subcutaneous, Peripheral swelling, Petechiae, Tenderness
Clinical narrative: Patient had extreme redness, swelling, blood under the skin, petechiae, tenderness from shoulder all the way to the elbow.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-NOV-2008, the patient was inoculated with ZOSTAVAX by a health care provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date Patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. On or about 14-AUG-2009, the patient was treated by a health care provider for shingles (Herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, Patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was reported as related.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension
Clinical narrative: Immediately after ended up in hospital and urgent care. High blood pressure and heart palpitations.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Electrocardiogram, Feeling hot
Clinical narrative: Immediately after ended up in hospital and urgent care. High blood pressure and heart palpitations.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Gait inability, Hypertension, Nausea, Syncope
Clinical narrative: Immediately after ended up in hospital and urgent care. High blood pressure and heart palpitations.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Cardiac imaging procedure abnormal, Chest X-ray normal, Hypertension, Immediate post-injection reaction
Clinical narrative: Immediately after ended up in hospital and urgent care. High blood pressure and heart palpitations.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Palpitations
Clinical narrative: Immediately after ended up in hospital and urgent care. High blood pressure and heart palpitations.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: My left arm became very red, swollen and painful and by Saturday 10/27/18 redness was spreading down my arm to my elbow. Went right to Urgent Care and they said I had a skin infection and prescribed a 10 day antibiotic and MOTRIN. Saw improvement after 4-5 days. After 10 days on antibiotic it resolved.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin infection
Clinical narrative: My left arm became very red, swollen and painful and by Saturday 10/27/18 redness was spreading down my arm to my elbow. Went right to Urgent Care and they said I had a skin infection and prescribed a 10 day antibiotic and MOTRIN. Saw improvement after 4-5 days. After 10 days on antibiotic it resolved.
Age: 34.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: The flu shot was administered too high up in my arm. I have experienced arm pain for over a month. I tried taking anti-inflammatory medicine for 10 days that was prescribed by my primary doctor but the pain came back afterwards.
Age: 34.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: The flu shot was administered too high up in my arm. I have experienced arm pain for over a month. I tried taking anti-inflammatory medicine for 10 days that was prescribed by my primary doctor but the pain came back afterwards.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Breath sounds abnormal, Electroencephalogram normal, Fall, Feeling abnormal, Laboratory test normal
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 15-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number HY5Y7, expiry date 30th June 2019) for prophylaxis. On 7th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 9th November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (HY5YZ) for FLULAVAL QIV did not exist and was updated to HY5Y7, according to sales database.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 15-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number HY5Y7, expiry date 30th June 2019) for prophylaxis. On 7th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 9th November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (HY5YZ) for FLULAVAL QIV did not exist and was updated to HY5Y7, according to sales database.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Blood test normal, Electroencephalogram normal, Feeling abnormal, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 15-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number HY5Y7, expiry date 30th June 2019) for prophylaxis. On 7th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 9th November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (HY5YZ) for FLULAVAL QIV did not exist and was updated to HY5Y7, according to sales database.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Seizure, Snoring
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 15-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number HY5Y7, expiry date 30th June 2019) for prophylaxis. On 7th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 9th November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (HY5YZ) for FLULAVAL QIV did not exist and was updated to HY5Y7, according to sales database.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Seizure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 15-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number HY5Y7, expiry date 30th June 2019) for prophylaxis. On 7th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 9th November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (HY5YZ) for FLULAVAL QIV did not exist and was updated to HY5Y7, according to sales database.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain
Clinical narrative: Muscular pain on lower back, from center of back radiating to right side.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood creatinine, Blood urea, Computerised tomogram, Differential white blood cell count
Clinical narrative: INDICATION: Swollen of the right side of the cheek of parotid area. Swollen of the right soft tissue of the inside arm of the area. Fatigue. Day by day and week by week symptoms started to become worse and brought into an emergency room a few times with a high temperature, difficulty of swollen, talking, eating, muscle pain, joint pain over the whole body. FINDINGS: Marker overlying the right premaxillary region. Minimal right premaxillary skin thickening and subcutaneous soft tissue edema. Mild asymmetric thickening of the right masseter musculature and right parotid duct with adjacent inflammation. No obstructing calculus identified. Mild asymmetric thickening and edema of the right pharyngeal and lingual tonsils. Mild effacement of the right parapharyngeal fat. Right submental 19 x 11 mm (anteroposterior x transverse) lymph node. IMPRESSION: Mild right parotid duct dilatation with adjacent inflammation extending into the right masticator space and subcutaneous soft tissues. Prominent right submental lymph node, likely reactive in etiology.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Eating disorder, Fatigue, Full blood count, Human chorionic gonadotropin, Myalgia
Clinical narrative: INDICATION: Swollen of the right side of the cheek of parotid area. Swollen of the right soft tissue of the inside arm of the area. Fatigue. Day by day and week by week symptoms started to become worse and brought into an emergency room a few times with a high temperature, difficulty of swollen, talking, eating, muscle pain, joint pain over the whole body. FINDINGS: Marker overlying the right premaxillary region. Minimal right premaxillary skin thickening and subcutaneous soft tissue edema. Mild asymmetric thickening of the right masseter musculature and right parotid duct with adjacent inflammation. No obstructing calculus identified. Mild asymmetric thickening and edema of the right pharyngeal and lingual tonsils. Mild effacement of the right parapharyngeal fat. Right submental 19 x 11 mm (anteroposterior x transverse) lymph node. IMPRESSION: Mild right parotid duct dilatation with adjacent inflammation extending into the right masticator space and subcutaneous soft tissues. Prominent right submental lymph node, likely reactive in etiology.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Noninfective sialoadenitis, Nuclear magnetic resonance imaging, Parotid gland enlargement, Peripheral swelling, Pharyngeal oedema
Clinical narrative: INDICATION: Swollen of the right side of the cheek of parotid area. Swollen of the right soft tissue of the inside arm of the area. Fatigue. Day by day and week by week symptoms started to become worse and brought into an emergency room a few times with a high temperature, difficulty of swollen, talking, eating, muscle pain, joint pain over the whole body. FINDINGS: Marker overlying the right premaxillary region. Minimal right premaxillary skin thickening and subcutaneous soft tissue edema. Mild asymmetric thickening of the right masseter musculature and right parotid duct with adjacent inflammation. No obstructing calculus identified. Mild asymmetric thickening and edema of the right pharyngeal and lingual tonsils. Mild effacement of the right parapharyngeal fat. Right submental 19 x 11 mm (anteroposterior x transverse) lymph node. IMPRESSION: Mild right parotid duct dilatation with adjacent inflammation extending into the right masticator space and subcutaneous soft tissues. Prominent right submental lymph node, likely reactive in etiology.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Scan with contrast, Soft tissue disorder, Speech disorder, Swelling
Clinical narrative: INDICATION: Swollen of the right side of the cheek of parotid area. Swollen of the right soft tissue of the inside arm of the area. Fatigue. Day by day and week by week symptoms started to become worse and brought into an emergency room a few times with a high temperature, difficulty of swollen, talking, eating, muscle pain, joint pain over the whole body. FINDINGS: Marker overlying the right premaxillary region. Minimal right premaxillary skin thickening and subcutaneous soft tissue edema. Mild asymmetric thickening of the right masseter musculature and right parotid duct with adjacent inflammation. No obstructing calculus identified. Mild asymmetric thickening and edema of the right pharyngeal and lingual tonsils. Mild effacement of the right parapharyngeal fat. Right submental 19 x 11 mm (anteroposterior x transverse) lymph node. IMPRESSION: Mild right parotid duct dilatation with adjacent inflammation extending into the right masticator space and subcutaneous soft tissues. Prominent right submental lymph node, likely reactive in etiology.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: The patient was asked if was pregnant at the time of vaccination and stated she was not pregnant.  She was vaccinated with MMR and Varicella to satisfy immigration requirements.  She subsequently found out she was pregnant and likely was about 3 weeks pregnant at the time of vaccination.  LMP 14 October 2018, has irregular periods and due to fertility issues did not think she could get pregnant.  No symptoms after vaccination, no fever/rash/suspected viremia.  No adverse event noted but VAERS recommended on CDC website due to receipt of Varicella vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: After 4-5 hours, soreness at injection site began. After 7 hours, body began feeling as though fight low fever and flu-like fatigue; patient then took 1-500 mg TYLENOL. Both symptoms above continued to worsen during following 12 hours and added headache; at hour 21, patient took second 500 mg TYLENOL. During day 2, patient slowly began recovering; by late day 2 (after second night's sleep) patient felt fully recovered.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Wheezing
Clinical narrative: Patient called around midnight complaining of severe wheezing, he called again in the morning adding headache to his symptoms. I advised patient to go to the hospital at his first phone call.
Sex: F
Vaccine: HPV4
Symptoms: Gait inability, Pain
Clinical narrative: Information has been received from a physician via a company field representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as a few years back), the patient was vaccinated with GARDASIL (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis. On an unknown date (reported as later), the patient went to the emergency room with symptoms of body aches and pains and the inability to walk. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of the events was unknown. Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Injection site warmth, Muscle contusion
Clinical narrative: This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2018, the patient was vaccinated with GARDASIL 9 (strength, dose, dosage schedule, lot # and expiry date were not provided) for prophylaxis. On an unspecified date in 2018 (reported as an unspecified amount of time after receiving a dose of GARDASIL 9), the patient developed injection site pain, warmth, and bruising, as well as a raised knot at the injection site; the patient also reported that it felt like her arm muscles were bruised and that it hurt to raise her arm and the pain woke her up at night. The patient stated that all symptoms resolved except the raised knot until 11-NOV-2018 (reported as yesterday) when all other symptoms returned. The patient reported there was no explanation for the return of the symptoms as she had not injured her arm in any other way. The outcome of the events was not resolved. The reporter's causality assessment between GARDASIL 9 with injection site pain, pain in extremity, muscle contusion, injection site nodule, injection site bruising and injection site warmth was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Pain, Sleep disorder
Clinical narrative: This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2018, the patient was vaccinated with GARDASIL 9 (strength, dose, dosage schedule, lot # and expiry date were not provided) for prophylaxis. On an unspecified date in 2018 (reported as an unspecified amount of time after receiving a dose of GARDASIL 9), the patient developed injection site pain, warmth, and bruising, as well as a raised knot at the injection site; the patient also reported that it felt like her arm muscles were bruised and that it hurt to raise her arm and the pain woke her up at night. The patient stated that all symptoms resolved except the raised knot until 11-NOV-2018 (reported as yesterday) when all other symptoms returned. The patient reported there was no explanation for the return of the symptoms as she had not injured her arm in any other way. The outcome of the events was not resolved. The reporter's causality assessment between GARDASIL 9 with injection site pain, pain in extremity, muscle contusion, injection site nodule, injection site bruising and injection site warmth was not reported.
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Insomnia, Pneumonia, Pyrexia, Somnolence
Clinical narrative: This spontaneous report was received from the patient's wife via a specialty pharmacy regarding to a 77 years old male patient. The patient's medical history included allergy to morphine, related nonsteroidal anti-inflammatory drugs (NSAIDS) and opium (hypersensitivity). His concomitant medications included lisinopril, amlodipine besylate, finasteride, folic acid, acyclovir, bimatoprost (LUMIGAN), doxazosin and ibuprofen. On 22-FEB-2013 (reported as five years ago), the patient started therapy with ruxolitinib phosphate(JAKAFI) tablets, 20 mg, bid, taken orally, lot # 6026224 with expiration date 30-JUN-2020 and lot # 5996751 with expiration date 31-JUL-2020 for iron deficiency.  On 20-MAR-2018, the patient had outpatient surgery of his back to repair the bones around the top of the spine (spinal disorder). Furthermore, it was reported that more surgery was planned to repair bones around the same area on an unspecified date in June 2018. On 18-OCT-2018 at 3:00pm (also reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for pneumonia prophylaxis. Furthermore, the patient developed pneumonia. On the same date at 9:30 pm, the patient woke up with a fever and started to shake violently (tremor). He felt strange (abnormal feeling) and could not sleep during the night, but when the morning came he felt asleep and had hard time waking up (sleep disorder). At the reporting time, the patient was recovering from the spinal disorder, and was not recovered from the following events: pneumonia, tremor, abnormal feeling and sleep disorder.  The causal assessment of spinal disorder, anemia, pneumonia, pyrexia, tremor, abnormal feeling and sleep disorder with PNEUMOVAX 23 was not provided. Upon internal review, pneumonia event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Spinal disorder, Tremor
Clinical narrative: This spontaneous report was received from the patient's wife via a specialty pharmacy regarding to a 77 years old male patient. The patient's medical history included allergy to morphine, related nonsteroidal anti-inflammatory drugs (NSAIDS) and opium (hypersensitivity). His concomitant medications included lisinopril, amlodipine besylate, finasteride, folic acid, acyclovir, bimatoprost (LUMIGAN), doxazosin and ibuprofen. On 22-FEB-2013 (reported as five years ago), the patient started therapy with ruxolitinib phosphate(JAKAFI) tablets, 20 mg, bid, taken orally, lot # 6026224 with expiration date 30-JUN-2020 and lot # 5996751 with expiration date 31-JUL-2020 for iron deficiency.  On 20-MAR-2018, the patient had outpatient surgery of his back to repair the bones around the top of the spine (spinal disorder). Furthermore, it was reported that more surgery was planned to repair bones around the same area on an unspecified date in June 2018. On 18-OCT-2018 at 3:00pm (also reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for pneumonia prophylaxis. Furthermore, the patient developed pneumonia. On the same date at 9:30 pm, the patient woke up with a fever and started to shake violently (tremor). He felt strange (abnormal feeling) and could not sleep during the night, but when the morning came he felt asleep and had hard time waking up (sleep disorder). At the reporting time, the patient was recovering from the spinal disorder, and was not recovered from the following events: pneumonia, tremor, abnormal feeling and sleep disorder.  The causal assessment of spinal disorder, anemia, pneumonia, pyrexia, tremor, abnormal feeling and sleep disorder with PNEUMOVAX 23 was not provided. Upon internal review, pneumonia event was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored VARIVAX (lot# N034559, expiration date: 05-DEC-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent (Product storage error). The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality compliant involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored VARIVAX (lot# N034559, expiration date: 05-DEC-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent. The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality compliant involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored PROQUAD (lot # R015739, expiration date: 02-DEC-2019; lot # R011216, expiration date: 15-OCT-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent. The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.