chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Shortly after receiving vaccine started getting warts - per mom. Worse after 2nd GARDASIL.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient of unknown gender and unknown age. The registered nurse reports that on 28-JAN-2013, she administered to the patient (Merck) PROQUAD instead of separate dose of MMRII and (Merck) VARIVAX. The registered nurse stated that this was an  staff error only. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome for the patient events is unknown. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Maternal exposure during pregnancy, Throat tightness
Clinical narrative: Difficulty breathing, throat tightening. Started 15 minutes after co-adminitration of Tdap and attenuated influenza (preservative free). Pt 34 weeks pregnant at this time.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Haemorrhoid operation, Haemorrhoids, Hyperhidrosis, Impaired work ability
Clinical narrative: Initial vaccine caused fever, chills, and profuse sweating. Prior to the vaccine I have had consistent subcutaneous nodules that appear at the injection sites. After receiving 6 vaccines and have since gone from a healthy man to a disabled one. I had severe spondylosis and osteoarthritis in my lumbar spine. I was released from work due to my condition and have since been unable to work due to the pain in my spine. I had a lumbar spinal fusion in Aug. 2012 and since having the initial vaccine I have had reoccurring severe hemorrhoids that have caused me to have several surgeries as well.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site reaction, Pyrexia, Spinal fusion surgery, Spinal osteoarthritis, Spinal pain
Clinical narrative: Initial vaccine caused fever, chills, and profuse sweating. Prior to the vaccine I have had consistent subcutaneous nodules that appear at the injection sites. After receiving 6 vaccines and have since gone from a healthy man to a disabled one. I had severe spondylosis and osteoarthritis in my lumbar spine. I was released from work due to my condition and have since been unable to work due to the pain in my spine. I had a lumbar spinal fusion in Aug. 2012 and since having the initial vaccine I have had reoccurring severe hemorrhoids that have caused me to have several surgeries as well.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Subcutaneous nodule
Clinical narrative: Initial vaccine caused fever, chills, and profuse sweating. Prior to the vaccine I have had consistent subcutaneous nodules that appear at the injection sites. After receiving 6 vaccines and have since gone from a healthy man to a disabled one. I had severe spondylosis and osteoarthritis in my lumbar spine. I was released from work due to my condition and have since been unable to work due to the pain in my spine. I had a lumbar spinal fusion in Aug. 2012 and since having the initial vaccine I have had reoccurring severe hemorrhoids that have caused me to have several surgeries as well.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm, Tenderness
Clinical narrative: Left arm red, warm, swollen, and tender. Pt. afebrile, small fine rash to area.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient returned to pharmacy after feeling faint while shopping with mother.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein normal, Full blood count normal, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Arm, shoulder and leg pain, no fever within several minutes of vaccination.  Recommended oral hydration and NSAIDs.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Arm, shoulder and leg pain, no fever within several minutes of vaccination.  Recommended oral hydration and NSAIDs.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: REDNESS, WARM, PAIN, TENDER TO RIGHT ARM.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Extreme and prolonged soreness in upper arm where vaccine was given. It was very sore for at least a couple of weeks and is still sore when pressed on after 8 months.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Herpes zoster
Clinical narrative: First of all, I am reporting an efficacy issue with the Shingles vaccine, as all links on the FDA and CDC websites for reporting to VAERS are not working. I have tried both and used different computers. There is also no link to report technical problems. I find this rather disconcerting. So.. problem #1: The real reason I am writing though is to add to the body of knowledge regarding after market efficacy of the vaccine for shingles. I received the vaccine in May of 2012 at the age of 60. Around January 10, 2013, I began to experience left sided chest pains and tingling sensations under my left breast, left side of my chest and up the left back shoulder blade. The skin felt sunburned or raw, but, there was no visible sign of anything. The chest pains were intermittently intense and felt like electrical charges. By Sunday the 13th, they intensified and were frequent. I mentioned it to my family and this resulted in an immediate trip to the local ER. They thought I might be having a heart attack; All of the appropriate tests were done to rule out MI, including EKG, extensive blood work, chest x-ray, monitoring of vitals, physical exam. All of these were negative for heart related issues. The attending physician in the ER suggested that perhaps I was in the early stages of developing shingles, as in some cases, people can experience pain that mimics heart attack. He told me to be aware and on the look out for a rash and to follow-up with my private physician. Eight days later, Monday Jan 21, I developed a small rash precisely in the location of the most palpable skin pain on my left side. It was a holiday -MLK Day-, so I was seen in the the walk-in clinic and was prescribed acyclovir 800 mg/5 times per day. I have completed 2 days worth of acyclovir and am just beginning to feel some improvement. It is interesting that I experienced anything because 1- I had the vaccine and 2- I take a daily dose of NEURONTIN for chronic sciatica. The combination of these 2 things, may have masked a potentially very severe infection, but, I still felt like I might be having a heart attack and incurred thousands of dollars of tests in the ER, a rash, and probably several weeks of pain and discomfort -2 weeks so far...no end in sight yet-.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: First of all, I am reporting an efficacy issue with the Shingles vaccine, as all links on the FDA and CDC websites for reporting to VAERS are not working. I have tried both and used different computers. There is also no link to report technical problems. I find this rather disconcerting. So.. problem #1: The real reason I am writing though is to add to the body of knowledge regarding after market efficacy of the vaccine for shingles. I received the vaccine in May of 2012 at the age of 60. Around January 10, 2013, I began to experience left sided chest pains and tingling sensations under my left breast, left side of my chest and up the left back shoulder blade. The skin felt sunburned or raw, but, there was no visible sign of anything. The chest pains were intermittently intense and felt like electrical charges. By Sunday the 13th, they intensified and were frequent. I mentioned it to my family and this resulted in an immediate trip to the local ER. They thought I might be having a heart attack; All of the appropriate tests were done to rule out MI, including EKG, extensive blood work, chest x-ray, monitoring of vitals, physical exam. All of these were negative for heart related issues. The attending physician in the ER suggested that perhaps I was in the early stages of developing shingles, as in some cases, people can experience pain that mimics heart attack. He told me to be aware and on the look out for a rash and to follow-up with my private physician. Eight days later, Monday Jan 21, I developed a small rash precisely in the location of the most palpable skin pain on my left side. It was a holiday -MLK Day-, so I was seen in the the walk-in clinic and was prescribed acyclovir 800 mg/5 times per day. I have completed 2 days worth of acyclovir and am just beginning to feel some improvement. It is interesting that I experienced anything because 1- I had the vaccine and 2- I take a daily dose of NEURONTIN for chronic sciatica. The combination of these 2 things, may have masked a potentially very severe infection, but, I still felt like I might be having a heart attack and incurred thousands of dollars of tests in the ER, a rash, and probably several weeks of pain and discomfort -2 weeks so far...no end in sight yet-.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, MMR, PNC13, VARCEL
Symptoms: Convulsion, Full blood count normal, Laboratory test normal, Status epilepticus, Upper respiratory tract infection
Clinical narrative: Status Epilepticus (40 minutes GTC), no documented fevers prior to, during or after event, but had mild URI symptoms, normal CBC, SMA-7 and PE 6hrs post and discharged home from ED. Seizure was 9 days after vaccines (MMR, Varicella, DTAP, PCV, and influenza).  Patient also had history of complex febrile seizure 10 days after vaccines in May of 2011, (Pentacel, PCV, Rotavirus) given and complex febrile seizure was 10 days later (30 min long), also had URI/fever during this seizure.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient describes very painful range of motion movement. Patient states right arm is very painful to move since October.
Age: 3.0
Sex: F
Vaccine: TYP
Symptoms: Gait disturbance, Injection site pain
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 24 February 2012. A 3-year-old female patient had received an injection in the thigh of TYPHIM Vi, sanofi pasteur SA (lot number, route and date of vaccination unknown) and an unspecified amount of time later developed sore less and had difficulty walking for next 1-2 days. The patient's past medical history was unknown. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Penile pain, Pyrexia, Urine analysis normal
Clinical narrative: Exactly 24 hours after vaccine administration, spiked fevers of 104 degrees, swelling & erythema around injection site. Penile pain. H/O Kawasaki presenting symptom penile pain w/fever & swelling.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous
Clinical narrative: Right arm over bicep and deltoid area and anterior chest with reddened sunburn appearing rash. Fever 102.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, Headache, Injection site pain, Optic neuritis
Clinical narrative: The day of vaccine pt developed headache & soreness at site. Two days after vaccine he started to lose sight in right eye. Four days after vaccine he had nearly complete loss of vision in right eye and severe headache. Diagnosed with optic neuritis.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wheezing, shortness of breath.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain, from below shoulder down toward elbow.  The pain has occurred intermittently to this time.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test, Chest X-ray, Convulsion, Drooling, Gaze palsy
Clinical narrative: At 12:01 AM she woke up with a fever of 102.5 so we gave her Tylenol and waited for the fever to go under 100 and put her back to bed. The only other symptom she had at this time was hyperactivity. Then at 4 am I awoke to a noise and went to her crib and she was having a seizure, drooling, eyes rolled back, and unresponsive. I picked her up and immediately took her to bathtub to splash some water on her to try to get a reaction. Nothing happened. We rushed her to the hospital and they took care of her from there.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Nuclear magnetic resonance imaging, Psychomotor hyperactivity, Pyrexia, Unresponsive to stimuli
Clinical narrative: At 12:01 AM she woke up with a fever of 102.5 so we gave her Tylenol and waited for the fever to go under 100 and put her back to bed. The only other symptom she had at this time was hyperactivity. Then at 4 am I awoke to a noise and went to her crib and she was having a seizure, drooling, eyes rolled back, and unresponsive. I picked her up and immediately took her to bathtub to splash some water on her to try to get a reaction. Nothing happened. We rushed her to the hospital and they took care of her from there.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Chest X-ray abnormal, Convulsion, Drooling, Dyskinesia, Febrile convulsion
Clinical narrative: At 12:01 AM she woke up with a fever of 102.5 so we gave her Tylenol and waited for the fever to go under 100 and put her back to bed. The only other symptom she had at this time was hyperactivity. Then at 4 am I awoke to a noise and went to her crib and she was having a seizure, drooling, eyes rolled back, and unresponsive. I picked her up and immediately took her to bathtub to splash some water on her to try to get a reaction. Nothing happened. We rushed her to the hospital and they took care of her from there.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Gaze palsy, Pneumonia, Pyrexia
Clinical narrative: At 12:01 AM she woke up with a fever of 102.5 so we gave her Tylenol and waited for the fever to go under 100 and put her back to bed. The only other symptom she had at this time was hyperactivity. Then at 4 am I awoke to a noise and went to her crib and she was having a seizure, drooling, eyes rolled back, and unresponsive. I picked her up and immediately took her to bathtub to splash some water on her to try to get a reaction. Nothing happened. We rushed her to the hospital and they took care of her from there.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Hair texture abnormal
Clinical narrative: After taking a shower in the morning I was combing and brushing my hair and blow drying it due to the cold weather. When brushing my hair I clumps of it started falling out at the roots around my face and at the scalp. It has been continuing to fall out ever since the 21st of December. My hair also feels extremely dry like straw especially the bangs. My hair used to feel like cornsilk, however now it is completely dried out and my hair cannot be styled. It is still falling out.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Soreness at injection site. Stiffness and pain in neck and back on same side as injection. As of today pt says is better not completely gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt stated left arm was very swollen and extreme arm pain the night of injection (I do not know the exact time).  Arm on 1/31/13 when examined by nurse was no longer swollen.  Pt stated "it doubled in size" swelling was below the injection site just above the elbow.  When I examined his arm there was only sunburn type redness in that area.  Pt stated pain much improved, although still having some tolerable pain.
Age: 1.69
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform, Upper respiratory tract infection
Clinical narrative: Fever, URI symptoms, followed by rash appearing to be measles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Pain, Pain in extremity, Pruritus
Clinical narrative: Swelling, red rash, itching and stinging that covered under arm area from the arm pit to elbow. Low grade fever with chills and body aches in late morning and at night on 01/30/13 and early morning and at night on 1/31/13.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Swelling, red rash, itching and stinging that covered under arm area from the arm pit to elbow. Low grade fever with chills and body aches in late morning and at night on 01/30/13 and early morning and at night on 1/31/13.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Feeling abnormal, Malaise
Clinical narrative: Patient has malaise, feels weak, and head is foggy.
Age: 0.7
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Convulsion, Pyrexia
Clinical narrative: T of 103.5F which resulted in seizure.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Vaccines given 1-28-13. Mother reports swelling in (L) upper arm 1-29-13 pm. Saw dr 1-29-13, steroid inj given.
Age: 57.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 16 July 2012. A 57-year-old female patient with no reported medical history and concomitant medications had received first doses of both YF vax vaccine (Batch number UH296AB) subcutaneously in left upper arm and TYPHIM Vi (batch number G0508) intramuscularly in left deltoid region on 09 July 2012. On 15 July 2012, 6 days post vaccination, the patient experienced redness, swelling and warmth at the YF injection site. The patient was involved in physical activity on the day she noticed the events. The patient did not seek any medical intervention nor did she self treat. Laboratory investigations were none. As of 16 July 2012, the patient had recovered from the events; however the date of recovery was unspecified. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Initial report received from a healthcare professional on 06 August 2012. A female patient whose medical history included no illness at the time of vaccination, and had no known allergies and whose concomitant medications were not reported, had received second dose of IMOVAX rabies Sanofi Pasteur Ltd. (lot number not reported) in the left deltoid on an unspecified date. The patient's receiving per exposure rabies vaccination; first dose 7 days before second dose. On an unspecified date, the patient developed redness, warmth and induration at the site of vaccination. Corrective medications and laboratory investigations were not reported. The patient's outcome was recovered on unspecified date. List of documents held by sender: None. Follow-up information was received on 16 November 2012. The patient's concomitant medications included ORTHO TRI-CYCLEN, CELEXA, UNISOM, AND AMBIEN. The patient had received Dose 1 of IMOVAX rabies vaccine on 10 July 2012 (lot number G1109-2) intramuscularly in left deltoid. On 17 July 2012, the patient received dose 2 of IMOVAX rabies vaccine intramuscularly in left deltoid (lot number G1109-2, site left). The patient had received dose 3 of IMOVAX Rabies vaccine on 07 August 2012 (lot number G1109-2) intramuscularly in right deltoid. On 10 July 2012, the patient had received subcutaneous IPOL (lot number H1330, site left), Sanofi Pasteur ltd, TYPHIM V vaccine on right deltoid intramuscularly (lot number : G1130), Yellow fever vaccine subcutaneously (lot number UH348AA, site right) and MENVEO vaccine (manufacturer Novartis, lot number M11073) intramuscularly on right deltoid.
Sex: F
Vaccine: ANTH, TYP
Symptoms: Cough
Clinical narrative: Initial report received from a healthcare professional on 07 November 2012. A female patient (age and date of birth were not reported), whose medical history included PCN (Penicillin) and latex allergy, and illness at the time of vaccination was reported as unknown, concomitant medications was not reported, had received a dose of TYPHIM VI (batch number, dose, number in series, route and site of administration were not reported) also received Anthrax vaccine other manufacturer (batch number, dose number, route and site of administration were unknown) on 05 November 2012. On 05 November 2012, 15 minutes after receiving the vaccines the patient started coughing. The reporter was concerned whether it was bronchospasm. The patient corrective treatment details were not reported and laboratory details were reported as unknown. The patient's outcome was unknown at the time of this report. List of documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Malaise, Pharyngeal erosion, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 44 years old female patient with allergy to every antibiotic. No Medical History reported. On 25-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # 06524E, expiration date November-2014) intramuscularly. No other co-suspects were reported. No concomitant medications were reported. On 27-JAN-2013 the patient developed a high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash and itching. The patient sought unspecified medical attention. The patient was treated with TYLENOL. At the time of the report the physician stated that all symptoms have resolved and now the patient only reported having erosion in the back of her throat. At the time of the report the patient was recovering from erosion in the back of her throat. There were no laboratories diagnostic studies performed. The relationship between high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash, itching and erosion in the back of her throat with GARDASIL was unknown. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 44 years old female patient with allergy to every antibiotic. No Medical History reported. On 25-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # 06524E, expiration date November-2014) intramuscularly. No other co-suspects were reported. No concomitant medications were reported. On 27-JAN-2013 the patient developed a high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash and itching. The patient sought unspecified medical attention. The patient was treated with TYLENOL. At the time of the report the physician stated that all symptoms have resolved and now the patient only reported having erosion in the back of her throat. At the time of the report the patient was recovering from erosion in the back of her throat. There were no laboratories diagnostic studies performed. The relationship between high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash, itching and erosion in the back of her throat with GARDASIL was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender who on 25-JAN-2013 was vaccinated with live (Merck) VARIVAX (lot # 0101AA, exp 13-JAN-2013). No other co-suspects were reported. No concomitant medications were reported. The nurse stated there was no adverse effect. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with first dose of GARDASIL (lot number unspecified) 5 years ago, in approximately January 2008 and would be in the office to this week, in approximately January 2013 to received their second dose. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: TD
Symptoms: Lip swelling, Oedema mouth, Urticaria
Clinical narrative: Patient experienced generalized hives and swollen lips and mouth. Patient went to the doctor's office on 04/10/12 and was treated with prednisone and an intramuscular injection of DEPO-MEDROL. The symptoms lasted for a couple of days after treatment. Patient recovered.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: The patient experienced pain and soreness in the left upper arm and shoulder. Over the next several days, patient experienced a tingling feeling in the fingers of her left hand as well as worsening arm pain with motion. On 08/02/12, the patient returned to the healthcare facility and was prescribed nabumetone (500mg); on 08/21/12, was advised to take ADVIL. Follow-up received 10/23/12: Patient recovered.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Patient experiences generalized hives. Patient went to the doctor's office on 04/23/12 and was treated with prednisone and an intramuscular injection of DEPO-MEDROL. The symptoms lasted a coupled of days after treatment. Patient recovered.
Sex: F
Vaccine: TD
Symptoms: Morphoea
Clinical narrative: A female patient reported worsening morphea following a 2001 vaccination against tetanus (type unspecified); vaccination and event specifics are unknown. MassBiologics did not receive patient information, except for gender and patient's initials. The source of the event indicated that provider did not have a complete record regarding event, and MassBiologics was not given permission to contact provider directly. MassBiologics' Td vaccine could not be ruled out.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Electromyogram normal, Injection site pain, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Patient received Td vaccine on 08/12/09. In January 2010, the patient reported left deltoid and should pain since receiving the Td vaccine (onset date unknown). The patient was referred to an orthopedic doctor for further treatment. Follow-up obtained 12/14/12: Patient is currently being treated for a rotator cuff tear, believed to be unrelated to the vaccination with Td. Patient is not disabled by the arm pain.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood glucose fluctuation, Lethargy, Visual impairment
Clinical narrative: Pt believes that her fluctuations in blood glucose were caused by AFLURIA. She was sight impaired for a period and lethargic and unable to do anything over the weekend.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Moments after injection patient reported feeling faint, like she was going to pass out. She did black out, she was seated in a chair and did not fall. She soon came to, but fainted again about 5 minutes later and again a few minutes later. We had patient lie down and she felt better. We had ambulance check her out - not taken to hosp.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Paraesthesia
Clinical narrative: (R) arm swollen, tingling down arm and having hard time moving arm. 25mg BENADRYL PO - ice pack to arm. VS 100/66 72 98.2 99% RA - pt d/c home.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives - both arms. Mom gave pt BENADRYL. Occurred about 4 hrs. after vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cough, Erythema, Pain, Paranasal sinus hypersecretion
Clinical narrative: Sinus drainage, asthma type cough, itching, welt fever like blister, skin peeling, redness, sore. Dr's report attached. It has not gotten better from Oct 5th to Jan 28th 2013 saw Dr on Jan 28th on same again.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin exfoliation, Urticaria
Clinical narrative: Sinus drainage, asthma type cough, itching, welt fever like blister, skin peeling, redness, sore. Dr's report attached. It has not gotten better from Oct 5th to Jan 28th 2013 saw Dr on Jan 28th on same again.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea
Clinical narrative: Few hours after PNEUMOVAX injection into deltoid - patient developed severe nausea, muscle pains, prompting visit to ER. Symptoms controlled with ZOFRAN and PERCOCET.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient presented to Immediate Care with an area of redness & tenderness to the right upper arm for 1 day. Pt had ADACEL & ZOSTAVAX vaccination at pharmacy on 1/25/13 and developed redness, itching and warmth on 1/30/13 to the right upper arm. Pt prescribed Cephalexin 500mg QID x 7 days for cellulitis by Dr.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Pt reported that her arm started to swell up on 1/25/13. She also has redness and itching to the area. Pt came in the office on 1/31/13, swelling & redness has gone down. PCP evaluated her. No acute distress at this time.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, & tenderness 4 cm at site of Hep A injection. Symptomatic treatment only.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Maternal exposure during pregnancy
Clinical narrative: I am in the 15th week of pregnancy and suffer from partial seizures as well. I took a flu shot on 1/26/2013. FLUZONE 9 Mcg/Strain. The one without preservatives. After about 3 hr of taking the flu shot, I had a seizure and over the next 18 hr I had 5 more seizures at regular intervals. Please contact me for more details.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Patient reports swollen glands, severe sore throat and other flu-like symptoms. 7 days after injection patient developed a round area of redness and heat about 2 inches in diameter at the injection site, along with tenderness at site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Patient reports swollen glands, severe sore throat and other flu-like symptoms. 7 days after injection patient developed a round area of redness and heat about 2 inches in diameter at the injection site, along with tenderness at site.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: When pt came into the vaccine room she was accompanied with the sister and mother. Sister was making jokes and making fun of the patient regarding the vaccines. Pt was already sweating and nervous before and I while I was giving her the PPD and when I finish her giving her the HPV and the other shots the pt started feeling dizzy and fainted. I called the doctor we given her oxygen pt then woke up and we did her vitals. Then we placed her in a room where after 10 minutes more pt stated to be OK and left the location.
Age: 1.1
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, PNC13
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had radiating pain during administration of FLUZONE vaccine. Her left shoulder, neck, and ear are affected. This has persisted for 20 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 56 years old female patient. The patient was vaccinated with lot # (H020000) live ZOSTAVAX into right arm on 15-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. There was no illness at time of vaccination. On 17-JAN-2013 the patient experienced injection site swelled to baseball size and was red and warm. The patient was advised to take BENADRYL as directed and apply cold compress. The outcome of the events was unknown. The relatedness for the events was unknown for live ZOSTAVAX. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Burning sensation, Ear pain, Fatigue, Headache
Clinical narrative: The same night as I received my flu shot, I got a bad headache. It lasted three days, and I had bad fatigue and insomnia. On day 4 (Monday), I woke up with an enlarged occipital lymph node on my right side. On day 5 (Tuesday), the right side of my head and scalp + ear was sensitive and very tender, sore. On day 6 (Wed) in the evening, I noticed a rash forming above my right eyebrow and next to my right eye, on the inside of my nose. The morning of day 7 (TODAY) the rash started burning and hurting bad, with my face swelling and tons of small clustered blisters around my eye, eyebrow and right-forehead, plus an inflamed lump on the right side of my scalp. My ear and right side of my head was also very sore and throbbing (still). I went to the doctor and he diagnosed Shingles. I am totally convinced it was caused by the flu shot (I had NO symptoms prior and am otherwise very healthy). My doctor said it was entirely possible given the timeline of events.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Hyperaesthesia, Inflammation, Insomnia, Lymphadenopathy
Clinical narrative: The same night as I received my flu shot, I got a bad headache. It lasted three days, and I had bad fatigue and insomnia. On day 4 (Monday), I woke up with an enlarged occipital lymph node on my right side. On day 5 (Tuesday), the right side of my head and scalp + ear was sensitive and very tender, sore. On day 6 (Wed) in the evening, I noticed a rash forming above my right eyebrow and next to my right eye, on the inside of my nose. The morning of day 7 (TODAY) the rash started burning and hurting bad, with my face swelling and tons of small clustered blisters around my eye, eyebrow and right-forehead, plus an inflamed lump on the right side of my scalp. My ear and right side of my head was also very sore and throbbing (still). I went to the doctor and he diagnosed Shingles. I am totally convinced it was caused by the flu shot (I had NO symptoms prior and am otherwise very healthy). My doctor said it was entirely possible given the timeline of events.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Mass, Pain, Pain of skin, Rash, Swelling face
Clinical narrative: The same night as I received my flu shot, I got a bad headache. It lasted three days, and I had bad fatigue and insomnia. On day 4 (Monday), I woke up with an enlarged occipital lymph node on my right side. On day 5 (Tuesday), the right side of my head and scalp + ear was sensitive and very tender, sore. On day 6 (Wed) in the evening, I noticed a rash forming above my right eyebrow and next to my right eye, on the inside of my nose. The morning of day 7 (TODAY) the rash started burning and hurting bad, with my face swelling and tons of small clustered blisters around my eye, eyebrow and right-forehead, plus an inflamed lump on the right side of my scalp. My ear and right side of my head was also very sore and throbbing (still). I went to the doctor and he diagnosed Shingles. I am totally convinced it was caused by the flu shot (I had NO symptoms prior and am otherwise very healthy). My doctor said it was entirely possible given the timeline of events.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: The same night as I received my flu shot, I got a bad headache. It lasted three days, and I had bad fatigue and insomnia. On day 4 (Monday), I woke up with an enlarged occipital lymph node on my right side. On day 5 (Tuesday), the right side of my head and scalp + ear was sensitive and very tender, sore. On day 6 (Wed) in the evening, I noticed a rash forming above my right eyebrow and next to my right eye, on the inside of my nose. The morning of day 7 (TODAY) the rash started burning and hurting bad, with my face swelling and tons of small clustered blisters around my eye, eyebrow and right-forehead, plus an inflamed lump on the right side of my scalp. My ear and right side of my head was also very sore and throbbing (still). I went to the doctor and he diagnosed Shingles. I am totally convinced it was caused by the flu shot (I had NO symptoms prior and am otherwise very healthy). My doctor said it was entirely possible given the timeline of events.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I was vaccinated with ZOSTAVAX for shingles in 2009 and I have just had another breakout of shingles....Should there be a 2nd. Vaccine given when this happens?
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a patient of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with a dose of live ZOSTAVAX, (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient had a small outbreak of zoster. The outcome of the event was unknown. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 years old male patient. On 23-JAN-2013, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. The pharmacist reported that on the evening of 27-JAN-2013, the patient began to experience pain in his arm at the injection site. The patient sought medical attention (the patient came to the pharmacy on 28-jan-2013). No treatment was given. The pharmacist reported that the patient might wish to take some acetaminophen or ibuprofen but has not taken either of them. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 2 months old male patient. She reported that the patient was to receive his first dose of live, oral ROTATEQ (2ml) today(on 28-JAN-2013). No other co-suspects were reported. No concomitant medications were reported. She reported that 'two drops" of an expired dose of live, oral ROTATEQlot# unspecified, expiration date was in August 2012, no adverse experience reported. The patient was then given a full dose of live, oral, ROTATEQ (2 ml) lot# was reported a s1539aa, expiration date was on 15-JUN-2013. On 29-JAN-2013, follow up was received from consumer stated her niece's infant son, reported the event of the patient again. Consumer stated even though the child was a restful night last night, and no adverse effects, they are very worried if the child had a overdose of live, oral ROTATEQ. The outcome of event is unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patients of unknown age and sex, who stated that patients in her practice receive doses of GARDASIL (days, dose and route of administration unknown), outside of the recommended schedule. The reporter did not have any specific patient's information at the time of the report, but she was agreeable to follow up report. No adverse experience was known and there was no additional information currently available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose (standard dose per hospital protocol) of PNEUMOVAX23 (lot number and expiry date reported as H018380 and 12-MAR-2014 respectively), intramuscularly per hospital protocol. No concomitant medications were reported. On an unknown date, the patient experienced increased level of cellulitis that occurred within the past few months. The patient sought medical attention (patient already in the hospital, reason for hospitalization and hospitalization date unspecified). Pharmacist did not known if the event prolonged the stay of the patient in the hospital. The pharmacist did not have a lot of information for the report because she received this information from her pharmacy supervisor who received it from a nurse. Pharmacist requested for a lot check to see if there were an increase level of cellulitis associated with this lot number. The outcome of increased level of cellulitis was unknown. The relatedness for increased level of cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 37 years old female patient. The patient was vaccinated with dose the first dose of 0 .5 ml live (Merck) VARIVAX on 21-SEP-2012. The patient was vaccinated with dose the second dose of 0 .5 ml live (Merck) VARIVAX on 21-OCT-2012. The patient was vaccinated with dose the third dose of 0 .5 ml live (Merck) VARIVAX (Lot reported as H0114272, Exp. date:25-JUL-2014) on 14-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-JAN-2013 the patient had negative varicella antibody titers. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was unknown for live (Merck) VARIVAX. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 64 years old female patient with sulfa allergy regarding herself. The patient's medical history included Hashimoto's thyroditis. On 09-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported) in her right arm. No concomitant medications were reported. On 09-JAN-2013, approximately 4 hours following administration of a dose of PNEUMOVAX23 the patient right arm began to hurt from "shoulder to fingertips". Consumer reports that the pain was excruciating initially and had diminished somewhat in intensity. Consumer reports that over time her arm began to hurt only from shoulder to elbow and that at the time of the call it only hurt near the shoulder joint. Consumer reports that the actual injection site never hurt. Consumer reports that on an unspecified date in November 2012, she received doses of influenza vaccine and whooping cough vaccine brand names and manufacturers unspecified into the right arm. Consumer reports that she treated the pain in her arm by use of over the counter analgesics, topical creams such as Biofreeze, Blue cold gel, tiger balm and by use of a hot water bottle all of which diminished the intensity of the pain temporarily, but did not resolve it. The outcome of her right arm began to hurt from "shoulder to fingertips" was reported as recovering. The relatedness for her right arm began to hurt from "shoulder to fingertips" was unknown for PNEUMOVAX23. Patient sought medical attention(office visit on 11-JAN-2013). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a 2 years old female patient with allergies and eczema. The patients medical history included urinary tract infection. The patient was allergic to penicillin and amoxicillin. On 14-JAN-2013, the patient was vaccinated with a first dose of 0.5 milliliter (ml) VAQTA(lot number was reported as H010106 and expiry date was 21-FEB-2015) intramuscularly. Other suspect therapies included M-M-R II, (Merck) VARIVAX, influenza virus vaccine (manufacturer unknown) on 14-JAN-2013. On 21-JAN-2013, the patient had visited another clinic for another visit and received ACTHIB and PREVNAR(Lot number, expiry date, route and dose were not reported for all) but inadvertently received the second dose of VAQTA (lot number was reported as H010106 and expiry date was 21-FEB-215)that had the same lot and expiration date as that of the one which was administered on 14-JAN-2013. No concomitant medications were reported. On 21-JAN-2013, the patients parents contacted the clinic stating that the patient had swelling, redness on right leg and fever. The patient sought medical attention for the same and on 22-JAN-2013, the patient was seen in the emergency department of hospital for swelling , redness on right leg and fever. The patient was prescribed BACTRIM and BENADRYL. Approximately on an unknown date in January 2013, the event were recovered and the patient was doing well. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician refers to a patients of unknown age (gender unspecified). On an unknown date, the patients were vaccinated with a dose of 0.5 ml M-M-R II, (lot number, expiration date and route intramuscularly) which had been left out at unspecified room temperature for 7 days. The reporter could not specify whether any of the exposed doses were administered to patients. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient (gender and age unknown). Approximately in 2011, the patient was vaccinated with the first dose of GARDASIL (lot# and expiration date unspecified by the reporter)(0.5ml, intramuscular, site unspecified)by another practice. On 25-JAN-2013, the patient was at the physician's office to receive the second dose of GARDASIL (lot# and expiration date unspecified by the reporter)(0.5ml, intramuscular, site unspecified). No other c0-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. In 2011, the patient was vaccinated with ZOSTAVAX (dose, route, lot number). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles while on ZOSTAVAX. No treatment information was reported. The outcome of the events was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3 inch area of redness and itching around injection site. No induration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Respiratory disorder
Clinical narrative: Pt had upper respiratory sxs starting 2 wks after vaccine. At that time felt it was no different than usual winter cold. Has had several respiratory issues since and claims it is all related to that flu vaccine.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oral herpes, Pyrexia
Clinical narrative: Fever 102 degrees 5 hrs post vaccine. Fever blisters on up & lower lips on 1/25. Headache on 1/23.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: About 9:42 am - Customer middle finger on opposite hand seems swollen.