chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Loss of personal independence in daily activities, Rash, Urticaria
Clinical narrative: Cried for the entire first 3 nights, would not nurse, extreme discomfort. Complete Loss of balance. Went from walking to not being able to take 2 steps without falling. He was not able to stand in one place alone, he constantly fell down. I bought him a helmet because he fell so many times, he would hit his head. He was so frustrated, it was awful for him and my family. We changed his shoes and everything. It has taken 4 months and he is up to 8 steps, still falls and balance is NOT 100%. Rash and welts day of shots and came back week 2 and week 3. Constant head banging for the first 5 weeks. He would bang his own head with his toys. He would bang his head on kitchen cabinets, and walls. Loss of speech. He used to say MAMA over 10 times a day. He has only said mama twice in the last 4 months. He used to say BALL 3 to 10 times a day. (Depending if he sees the ball he would pick it up and say BALL) He has never said the word ball since 1/26/18. Daycare said his behavior was aggressive for the first 3-4 weeks. Hitting and pushing kids, which he didn't do before. Constantly still cries and wants to be held all the time, loss of independence.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Upon vaccinating child with MMR, inserted needle into arm, began administration, needle and syringe separated and contents spilled onto patient. Uncertain if any amount was administered. Received order from physician to re-vaccinate.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever >102 degrees F, chills, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Apathy, Crying, Pain, Pyrexia, Urticaria
Clinical narrative: Sadly the doctor did not provide me any information about vaccines (name/type), etc other than: DTAP IPV + Polio. After the shots (in the morning), my son quickly developed fever and complained about body aches (few hours after the shots). Then apathy (barely moving/talking). He would only cry in pain. I gave him TYLENOL (recommended by Dr) and it would ease the pain every 4 hours. In the evening, he developed hives on the face (they would come and disappear as quickly as they came) and he would cry in pain. The next day, Dr told me it was an allergic reaction to the vaccine. Sadly he never told me anything else: never mentioned me there was this registry/reporting system, never told me what would be the next step (when my son will be 11 and due for the same vaccine, what will happen)?
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Colonoscopy, Electrocardiogram
Clinical narrative: Patient went for colonoscopy 2 days after receiving vaccine and was told that it was noticed that he was in afib while the colonoscopy was taking place. Patient went to the ER and was released and then followed up with his PCP for an EKG.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Respiration abnormal
Clinical narrative: 1st 18 hrs. - exhaling very deeply, almost labored, lightheaded, fatigued, SHIVERING, loss of appetite. On couch or bed all day. Next 12  hrs- same but shivering and heavy exhale stopped.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: 2nd dose of SHINGRIX resulted in severe headache, nausea, muscle aches, and chills with low grade fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: High fever, chills, severe muscle and joint pain 10 hours after the administration of SHINGRIX 50 Mcg injection. Fever and lessened body aches continued for 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pt. received SHINGRIX dose #1 on 5/11/18. On 5/12/18 noticed pain, redness, and saw PCP 5/16/18 for previously scheduled appt. Also examined by pt's daughter, an ER physician. Spoke to pt 5/21/18, still with some swelling/pain/itching at site, but resolving.
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician, received via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 15May2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced high fever, diarrhea, and pain in the arm. The outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. In 2000 (reported as "sometime in the 2000's"), the patient was vaccinated with RECOMBIVAX HB (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Then, after vaccination, a Hepatitis B titer test was performed, which showed a low hepatitis B titer (hepatitis b surface antibody negative). The outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 17-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-FEB-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-JUN-2012, the patient was treated by a nurse practitioner at a physician's office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed VALTREX, gabapentin and EMLA cream for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a from a Pfizer sponsored program IVR and Support for TRUMENBA Service Line, received from a contactable consumer (patient's mother). An 18-year-old female patient of an unspecified ethnicity started to receive TRUMENBA (lot number was not reported), via an unspecified route of administration on 30Apr2018 at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had missed 2 weeks of school and currently at home vomiting with fever. She initially had nausea that turned into vomiting. The patient was treated with prednisone for possible autoimmune response. The clinical outcome of the events of vomiting and fever were not recovered while unknown for the events of nausea and possible autoimmune response. The information on the batch number has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical facility/clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a medical facility/clinic (by an unspecified healthcare professional) for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Vaccine positive rechallenge
Clinical narrative: Patient said she had the same symptoms with the 1st shot but more extreme with the 2nd shot. Extreme chilling, some sweating. Chilling from the inside out - had never experienced that before! Ached from head to toe for 46 hours followed by headache for another 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Injection site erythema, Injection site swelling
Clinical narrative: SYMPTOMS STARTED THE EVENING OF THE VACCINE CHILL, FEVER, INJECTION SITE IS RED AND SWOLLEN, LACK OF ENERGY, LOSS OF APPETITE AND BODY ACHES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: SYMPTOMS STARTED THE EVENING OF THE VACCINE CHILL, FEVER, INJECTION SITE IS RED AND SWOLLEN, LACK OF ENERGY, LOSS OF APPETITE AND BODY ACHES.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Arm redness extending beyond elbow joint, c/o rash, and swelling. ED visit states rash onset was sudden and symptoms occurring 2 days. S/S x 48 hours after receiving vaccine.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Erythema, Full blood count, Injection site erythema, Injection site rash
Clinical narrative: Arm redness extending beyond elbow joint, c/o rash, and swelling. ED visit states rash onset was sudden and symptoms occurring 2 days. S/S x 48 hours after receiving vaccine.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Metabolic function test, Pain, Peripheral swelling, Rash, X-ray limb
Clinical narrative: Arm redness extending beyond elbow joint, c/o rash, and swelling. ED visit states rash onset was sudden and symptoms occurring 2 days. S/S x 48 hours after receiving vaccine.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Aggression, Asterixis, Decreased eye contact, Inappropriate affect
Clinical narrative: Arm flapping, innapropriate laughing, aggressive behavior, losing eye contact, entering in his own world  within a few weeks.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Full blood count, Headache, Injection site swelling
Clinical narrative: Swelling at injection site, headache, fatigue. nausea, fever, rigors.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urine analysis
Clinical narrative: Swelling at injection site, headache, fatigue. nausea, fever, rigors.
Age: 69.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Anxiety
Clinical narrative: Anxiety. Lasted approximately 1 week seemed to resolve than about a week later had another episode which lasted approximately 1 day. Took .5 mg ATIVAN 4 days into the reaction and took it for 3 days. It relieved the symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Rash generalised
Clinical narrative: 2 days after vaccination patient experienced redness, itching and hives at location of injection site and then the rash spread all over torso and body. Patient spoke to physician and was put on OTC hydrocortisone 1% and BENADRYL. Patient's have subsided since the treatment, still have a few hives and redness, but the severity has subsided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received the first dose of SHINGRIX on Friday, May 18. After several hours passed from the vaccine, patient complained of redness and soreness but the injection site became more and more swollen, raised and painful for the patient. Also, she started to develop severe headaches, nausea/vomitting, and severe diarrhea. The nausea/vomiting and diarrhea improved after 2 days but the injection site was still not decreasing in size, redness or pain. Patient tried some migraine medication like ADVIL and applied some hydrocortisone cream for now but will seek medical attention and question to her physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received the first dose of SHINGRIX on Friday, May 18. After several hours passed from the vaccine, patient complained of redness and soreness but the injection site became more and more swollen, raised and painful for the patient. Also, she started to develop severe headaches, nausea/vomitting, and severe diarrhea. The nausea/vomiting and diarrhea improved after 2 days but the injection site was still not decreasing in size, redness or pain. Patient tried some migraine medication like ADVIL and applied some hydrocortisone cream for now but will seek medical attention and question to her physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was an order entry error, patient received both VARIVAX and PROQUAD. Patient received 2 doses of chickenpox by mistake. Patient is not yet showing any type of adverse reaction.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received vaccination that was not recommended for her age group.
Age: 53.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Blood pressure increased, Headache, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: High temp of 99° - 103° for 3 days... left arm very swollen & inflamed... Swelling Non responsive to ice packs. Right arm swelling went down after icing. Blood pressure elevated & headaches. Dr. Suggested TYLNEOL for fever, it worked after 3 days. Left arm still very sore & swollen.
Age: 53.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: High temp of 99° - 103° for 3 days... left arm very swollen & inflamed... Swelling Non responsive to ice packs. Right arm swelling went down after icing. Blood pressure elevated & headaches. Dr. Suggested TYLNEOL for fever, it worked after 3 days. Left arm still very sore & swollen.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Lymph node pain, Malaise
Clinical narrative: Malaise; myalgia; fatigue; injection site pain; injection site erythema; painful lymph nodes in right armpit; fine red rash all over trunk, abdomen, and back. I don't see that rash has been reported previously. It's not in the package insert and not in Clinical Pharmacology.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Rash erythematous
Clinical narrative: Malaise; myalgia; fatigue; injection site pain; injection site erythema; painful lymph nodes in right armpit; fine red rash all over trunk, abdomen, and back. I don't see that rash has been reported previously. It's not in the package insert and not in Clinical Pharmacology.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Joint stiffness, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, joint stiffness, headache.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Full blood count, Nausea, Rash, Vomiting
Clinical narrative: Developed rash on L arm 2 days after injection and is also C/O fatigue and nausea with emesis.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients started therapy with ROTATEQ (lot # and expiry date were not reported) for prophylaxis. The nurse reported, some unspecified patients had received dose 2 or 3 of the series later than recommended (timing unspecified) due to unspecified family situations not related to the vaccine. No adverse effects were noted in these patients.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 17-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a 8 weeks old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (lot# N032566, expiration date 01-MAY-2019), for prophylaxis (strength, dose, frequency were not reported). The temperature excursion was of 9 Centigrade degrees (degrees C) to 25 degrees C (10.2 degrees C), during 52 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA008127.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a 1 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot# N026997, expiration date 10-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of 9 Centigrade degrees (°C) to 25 °C (10.2°C), during 52 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA007879.
Age: 1.25
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: KINRIX given to patient instead of DTaP #4.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Large welt at the injection site lasting about 7 days.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is a student and she came into the clinic on 5/18/18 at 8:45 AM to get her second dose of her Varicella vaccine for school. Patient was given screening checklist for contraindications to vaccines for Adults, consent form, and the VIS sheet. Patient signed VIS sheet as I had my back turned preparing to give injection. After vaccine was given and I was walking patient out the lobby, she then stated that she is pregnant. I told patient I will let the Doctor know what happened and let her know if there is anything that will need to be done. I told the doctor and he said that we have to let the supervisor and or Manager know of what happened. After sending an email to the supervisor I called patient to let her know that she should not have receive the varicella vaccine while pregnant. Patient stated that she is five months pregnant at this time. I told patient that we will be following up with her in regards to this matter.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient is a student and she came into the clinic on 5/18/18 at 8:45 AM to get her second dose of her Varicella vaccine for school. Patient was given screening checklist for contraindications to vaccines for Adults, consent form, and the VIS sheet. Patient signed VIS sheet as I had my back turned preparing to give injection. After vaccine was given and I was walking patient out the lobby, she then stated that she is pregnant. I told patient I will let the Doctor know what happened and let her know if there is anything that will need to be done. I told the doctor and he said that we have to let the supervisor and or Manager know of what happened. After sending an email to the supervisor I called patient to let her know that she should not have receive the varicella vaccine while pregnant. Patient stated that she is five months pregnant at this time. I told patient that we will be following up with her in regards to this matter.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Pain
Clinical narrative: After 12 hours, swollen and ache. After 24 hours slight hardness and reddening of the injection site.  Ache persisted/increased and red area kept on spreading with passing days. Itching developed. After 7 days, the redness spread over approximately 4.5 inches diameter that kept on itching. Currently there is no redness but occasional itching, and scaling off at several spots around the injection site.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Skin exfoliation, Swelling
Clinical narrative: After 12 hours, swollen and ache. After 24 hours slight hardness and reddening of the injection site.  Ache persisted/increased and red area kept on spreading with passing days. Itching developed. After 7 days, the redness spread over approximately 4.5 inches diameter that kept on itching. Currently there is no redness but occasional itching, and scaling off at several spots around the injection site.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: About 6 hours after receiving the immunization, the patient's arm and shoulder became red, swollen and painful. It continued into next day and then subsided with administration of an antihistamine and ibuprofen.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area is red and swollen. Patient states was 3 days on bed taking Ibuprofen 800 mg .
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Patient said his arm was extremely sore ("couldn't raise over head") and was very red, Lasted "a few days" but better today (5/21/18).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Insomnia, Pain
Clinical narrative: Arm pain, enough to keep her from sleeping at night. Swelling, splotchy redness at injection site. Flu like symptoms (she denies fever, though did not take her temp). Achy, especially in her legs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain, enough to keep her from sleeping at night. Swelling, splotchy redness at injection site. Flu like symptoms (she denies fever, though did not take her temp). Achy, especially in her legs.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Back pain, Borrelia test, Cardiac function test, Chest X-ray
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Laboratory test, Muscle spasms, Myocardial infarction, Myocarditis
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Painful respiration, Troponin increased
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arteriogram coronary normal, Asthenia, Borrelia test negative, Chest X-ray abnormal, Chest pain
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Ejection fraction decreased, Fatigue, Myocarditis
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor negative, Troponin increased
Clinical narrative: Per patient report to writer: On 5/18/18, patient awoke at 2 AM with muscle cramp; went away-back to sleep. At 4 AM she awoke with shortness of breath (SOB), pain across left shoulder and down left arm. She took 800 mg ibuprofen with little relief, but SOB went away. At about 7:30 AM she experienced back pain, pain with deep breath inspiration; this moved to substernal pain. She soaked in tub for a while, SOB and pain with inspiration worsened. She went to ER at this time. Cardiac protocol completed with labs, ECG and CT of chest; dx of MI by about 1:00 PM; transferred to advanced cardiac care about 6:00 PM. Received advance care, Diagnosis perimyocarditis; discharged home 5/21/18 with medications.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Asthenia, Back pain, Dizziness, Nausea
Clinical narrative: Per pt she experienced nausea with vomiting, weakness, dizziness, pain in her abdomen, arms, neck, and back. Pt offered an appointment to come to the office but declined.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Vomiting
Clinical narrative: Per pt she experienced nausea with vomiting, weakness, dizziness, pain in her abdomen, arms, neck, and back. Pt offered an appointment to come to the office but declined.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Facial paralysis, Full blood count, Metabolic function test
Clinical narrative: Bell's Palsy. 5 days of 40 mg. Prednisolone QD.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Tooth disorder
Clinical narrative: Pt was complaining of swollen jaw area (pointing right in front of her ear where sideburns would be) pt also claimed her teeth no longer lined up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Sore arm for 4 days. Red rash on arm at injection site that was about 2.5" in circumference. Shivers starting at about midnight and headache next day.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness, Injection site pain, Rash
Clinical narrative: PATIENT REPORTED FLU-LIKE SYMPTOMS AND THE SMALL RASH HE HAD PRIOR (WAS NOT REPORTED TO RPH UNTIL AFTER SHOT) GOT WORSE FOR UP TO 2 DAYS AFTER INJECTION. HE DID HAVE SHINGLES IN PAST. HE SAID THIS TIME IT WAS LIKE SHINGLES BUT MORE MILD, SHORTER DURATION OF SYMPTOMS. HE SAID LASTED ABOUT 2 DAYS AND HE WAS ALSO SORE AT INJECTION SITE.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced soreness in the immunization arm along with fever/chills. She reported symptoms 48 hours after they started and said they are subsiding, but her arm is still sore.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain 2 days after vaccination. Patient went to doctor and doctor prescribed cortisone shot after physical exam.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Diffuse and extensive hives.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Blood test, Dyspnoea, Foetal disorder, Laboratory test, Pharyngeal oedema
Clinical narrative: I was immediately sent to the ER and my arms and my chest and all over the back of my neck got covered in hives, my throat swelled and it was hard to breath I've been severely allergic since a child and was told never to receive another one. I had 2 other pregnancies where I never received the DTaP due to my anaphylactic allergy to it both my kids were full term. My due date for my 3rd pregnancy was Christmas Eve 2017 and I delivered prematurely on November 20th 2017 to a 4 pound baby girl. She was in distress after the DTaP shot and I was given steroids to help mature her lungs.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Premature delivery, Urticaria
Clinical narrative: I was immediately sent to the ER and my arms and my chest and all over the back of my neck got covered in hives, my throat swelled and it was hard to breath I've been severely allergic since a child and was told never to receive another one. I had 2 other pregnancies where I never received the DTaP due to my anaphylactic allergy to it both my kids were full term. My due date for my 3rd pregnancy was Christmas Eve 2017 and I delivered prematurely on November 20th 2017 to a 4 pound baby girl. She was in distress after the DTaP shot and I was given steroids to help mature her lungs.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient states his index finger on his left arm falls asleep.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Therapeutic procedure
Clinical narrative: SHINGLES OUTBREAK VERIFIED BY NURSE PRACTITIONER ON 5/21/18. NOTED THAT PATIENT HAD AN ELECTROSTIMULATOR PROCEDURE DONE ON SAME DAY AS VACCINATION OCCURRED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Starting about 8 hours after the vaccine injection, I started having every side effect that was listed...shivering, fever, headache, nausea, trouble breathing, body aches, writhing in pain, didn't sleep the whole night, foggy, injection site severe pain, itching, jaw and mouth pain, weakness, extreme tiredness and exhaustion. I was told I'd have a few of these side effects for a day or two, three days at the most but I suffered from them for one week!!! Two weeks went by and then I got a bad cold or sinus type infection which is three days in and still not going away. Might this have to do with the SHINGRIX vaccine side effects delayed effects? I've never had issues before and this was and is very scary.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Insomnia, Nasopharyngitis, Nausea
Clinical narrative: Starting about 8 hours after the vaccine injection, I started having every side effect that was listed...shivering, fever, headache, nausea, trouble breathing, body aches, writhing in pain, didn't sleep the whole night, foggy, injection site severe pain, itching, jaw and mouth pain, weakness, extreme tiredness and exhaustion. I was told I'd have a few of these side effects for a day or two, three days at the most but I suffered from them for one week!!! Two weeks went by and then I got a bad cold or sinus type infection which is three days in and still not going away. Might this have to do with the SHINGRIX vaccine side effects delayed effects? I've never had issues before and this was and is very scary.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Pain, Pain in jaw, Pruritus, Pyrexia
Clinical narrative: Starting about 8 hours after the vaccine injection, I started having every side effect that was listed...shivering, fever, headache, nausea, trouble breathing, body aches, writhing in pain, didn't sleep the whole night, foggy, injection site severe pain, itching, jaw and mouth pain, weakness, extreme tiredness and exhaustion. I was told I'd have a few of these side effects for a day or two, three days at the most but I suffered from them for one week!!! Two weeks went by and then I got a bad cold or sinus type infection which is three days in and still not going away. Might this have to do with the SHINGRIX vaccine side effects delayed effects? I've never had issues before and this was and is very scary.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: Starting about 8 hours after the vaccine injection, I started having every side effect that was listed...shivering, fever, headache, nausea, trouble breathing, body aches, writhing in pain, didn't sleep the whole night, foggy, injection site severe pain, itching, jaw and mouth pain, weakness, extreme tiredness and exhaustion. I was told I'd have a few of these side effects for a day or two, three days at the most but I suffered from them for one week!!! Two weeks went by and then I got a bad cold or sinus type infection which is three days in and still not going away. Might this have to do with the SHINGRIX vaccine side effects delayed effects? I've never had issues before and this was and is very scary.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: My child received 2 doses of the GARDASIL vaccine. After the 1st dose she developed amenorrhea over 3 months, and after the second vaccine she developed amenorrhea again. She is now being seen by gynecologist and endocrinologist for this issue. My child had normal menstrual cycles before this vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reason for visit showed, "11 yr WCC" old EMR records were checked and not checked thoroughly showing patient didn't received Tdap nor MCV4. Vaccines administered when I was notified that another record found Tdap and MCV4 were already given the yr before. 11yr vaccines given twice with no adverse reactions noted. Mom notified.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Fever at onset. Unmeasured. Erythema at site of injection. Generalised mild edema of upper arm. No excessive warmth or induration.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Redness - soreness at injection site. Pharmacist traced area - diag. cellulitis - RX Doxycycline. Pharmacist called and apologized (did not wear gloves or cleaned injection area). Area much improved by Sat 4/28.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Shot given left anterior thigh - redness and swelling started the next day covering the entire anterior thigh - redness and swelling resolved in 3 - 4 days. Pt. with temp. 100.5.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had been ill with the side effects for 48 hours now. The patient had everything listed except upset stomach.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Headache, general malaise and ache, fever and swelling on site of administration.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic shock, Dyspnoea, Erythema
Clinical narrative: Anaphylaxis shock, skin discoloration (redness); shortness of breath. Patient began taking KEFLEX an hour before anaphylaxis shock also.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) leg swollen, red, warm to touch. Started AUGMENTIN.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Acute respiratory failure, Apnoea, Hypothermia, Lethargy, Mental status changes
Clinical narrative: Given 5/14/18. Mom called on 5/15 at 3:46pm stated child was lethargic and temp rectally was 97.1 (F) MD was contacted and were referred to ER. PT admitted for apnea, altered mental status, hypothermia, for acute resp. failure.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Antiphospholipid antibodies positive, Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Cardiolipin antibody positive, Oedema
Clinical narrative: Reported that he was in good health and feeling well when he developed the first of many blood clots in 2006. He was evaluated in 2006 where he was diagnosed with APS. He has had multiple clots, including bilateral PE and now with pulmonary hypertension. He separated from his employer in 2007. He denies any previous medical problems and family history and feels that it is related to the anthrax vaccine he received. Edema.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Pulmonary hypertension, Pulmonary oedema, Thrombosis
Clinical narrative: Reported that he was in good health and feeling well when he developed the first of many blood clots in 2006. He was evaluated in 2006 where he was diagnosed with APS. He has had multiple clots, including bilateral PE and now with pulmonary hypertension. He separated from his employer in 2007. He denies any previous medical problems and family history and feels that it is related to the anthrax vaccine he received. Edema.
Age: 9.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Headaches, stomach pain. Possible seizure. Sent to Neuro 5/22/18 for a follow up.
Age: 9.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthma, Eye movement disorder, Hypersensitivity, Musculoskeletal stiffness, Seizure
Clinical narrative: Headaches, stomach pain. Possible seizure. Sent to Neuro 5/22/18 for a follow up.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Injection site abscess, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Lump on left arm since 5-13-18 PM pain to brush against, no discharge, no other lumps, no fevers. Exam findings - tender palpable lump deep in deltoid. Borders palpable, feels soft, deltoid muscle abscess, cutaneous absess, fatigue. Ordered CBC, ultrasound conclusive for abscess. Prescribed KEFLEX. If WBC is elevated will need surgical evaluation.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle abscess, Ultrasound abdomen
Clinical narrative: Lump on left arm since 5-13-18 PM pain to brush against, no discharge, no other lumps, no fevers. Exam findings - tender palpable lump deep in deltoid. Borders palpable, feels soft, deltoid muscle abscess, cutaneous absess, fatigue. Ordered CBC, ultrasound conclusive for abscess. Prescribed KEFLEX. If WBC is elevated will need surgical evaluation.
Age: 1.67
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: Red blotches around area of immunization. Pain in arm.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. The reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that several patients those received SHINGRIX doses at her pharmacy had local adverse reactions. The reporter reported that some had happened with first dose and some had happened with second dose only. Several patients were experienced a red, swollen and painful area around the site of injection. The patient was advised to use BENADRYL to treat. The reporter was unsure of the lot numbers involved with these cases.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: PATIENT CALLED ON 4/27/18 STATING ARM WAS SWOLLEN, RED, PAINFUL, AND COMPLAINING OF BODY ACHES, CHILLS, AND VOMITING. STATED HE WENT TO A LOCAL WALK IN FACILITY AND GOT NO RELIEF.  PATIENT WAS GIVEN APPOINTMENT WITH OUR FACILITY ON 4/27/18 AND PRESCRIBED BACTRIM FOR CELLULITITS OF ARM.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Pain, Pain in extremity
Clinical narrative: PATIENT CALLED ON 4/27/18 STATING ARM WAS SWOLLEN, RED, PAINFUL, AND COMPLAINING OF BODY ACHES, CHILLS, AND VOMITING. STATED HE WENT TO A LOCAL WALK IN FACILITY AND GOT NO RELIEF.  PATIENT WAS GIVEN APPOINTMENT WITH OUR FACILITY ON 4/27/18 AND PRESCRIBED BACTRIM FOR CELLULITITS OF ARM.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: PATIENT CALLED ON 4/27/18 STATING ARM WAS SWOLLEN, RED, PAINFUL, AND COMPLAINING OF BODY ACHES, CHILLS, AND VOMITING. STATED HE WENT TO A LOCAL WALK IN FACILITY AND GOT NO RELIEF.  PATIENT WAS GIVEN APPOINTMENT WITH OUR FACILITY ON 4/27/18 AND PRESCRIBED BACTRIM FOR CELLULITITS OF ARM.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: INJECTION GIVEN ON 4/26/18. PATIENT CALLED ON 5/2/18 TO REPORT SHE HAD REDNESS, SWELLING, SORENESS AND WARM TO TOUCH AT THE INJECTION SITE. PATIENT STATED IT WAS GOING AWAY AND DID NOT SCHEDULE A FOLLOW UP VISIT.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION GIVEN ON 4/26/18. PATIENT CALLED ON 5/2/18 TO REPORT SHE HAD REDNESS, SWELLING, SORENESS AND WARM TO TOUCH AT THE INJECTION SITE. PATIENT STATED IT WAS GOING AWAY AND DID NOT SCHEDULE A FOLLOW UP VISIT.