chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site pain, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site pain and headache were recovered/resolved and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid area. By that same evening, the patient developed flu like symptoms, fever, chills, body aches, pain at injection site and headache. The patient reported these symptoms were lasted for 48 hours and then resolved. This is 1 of 2 cases, reported by the same reporter for same patient.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: The night after vaccination her arm got red and swollen along with flu like symptoms including fever. She reported to the pharmacy 2 days later explaining her reaction and that the redness and swelling was still spreading on her arm. We called her MD and got her an appointment that day to see the MD and advised her to take oral BENADRYL and ice the arm until she sees her doctor because she might need prednisone or some steroid based on her doctor's judgement.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: The patient states bruising & swelling started Wednesday, July 18, 2018. She came back into pharmacy Thursday, July 19th, with a bruise about the size of a baseball at suspected injected site & swelling with redness slightly below bruise. I recommended patient to be seen by family physician. Pt was seen Thursday,  July 19th. She diagnosed her with possible cellulitis secondary to vaccination. Dr's office recommended pt to use ice & take TYLENOL. They also gave pt a script for KEFLEX to start taking if it does not improve over weekend.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Peripheral swelling, Pyrexia
Clinical narrative: At 6pm and beyond had 101 fever, chills, body aches and pains, swelling of the arm the shot was in. As of today, fever down to 99, very tired and still body aches.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: Severe muscle aches, severe headache, nausea with vomiting, spent 24 hours unable to get out of bed. Symptoms completely resolved after 5 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe muscle aches, severe headache, nausea with vomiting, spent 24 hours unable to get out of bed. Symptoms completely resolved after 5 days.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Blood creatine phosphokinase increased, C-reactive protein increased, Computerised tomogram abnormal, Fasciitis, Injection site erythema
Clinical narrative: Extensive swelling to right thigh and right proximal lower leg. Mild redness distal to thigh on day 3 resolved on day 4. No fever, no limping, well appearing child. Elevated CK, CRP, and ESR. CT demonstrates fasciitis.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Red blood cell sedimentation rate increased
Clinical narrative: Extensive swelling to right thigh and right proximal lower leg. Mild redness distal to thigh on day 3 resolved on day 4. No fever, no limping, well appearing child. Elevated CK, CRP, and ESR. CT demonstrates fasciitis.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Respiratory tract congestion, Tongue pruritus
Clinical narrative: Approximately 10 minutes after the MMRII vaccine, pt stated that he had congestion in his throat, and the tip of his tongue was itchy. After another 10 minutes and a drink of water, patient said he thought he was okay, but I advised him to buy BENADRYL to take along with calling 911 if he felt that his airway was compromised. I spoke with patient about 6:30 and he reported no changes.  July 19th, patient contacted the pharmacy asking for documentation of his reaction. I advised him that it is subjective and that I would report it to VAERS. He then told me that he did in fact take BENADRYL 50mg every 6 hours for 2 days, for a total of 10 capsule. I advised him to follow up with his Primary Care Physician to discuss the reaction and if it is considered allergic or just a side effect.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Allergy test positive, Dizziness, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Approximately 10 minutes after the MMRII vaccine, pt stated that he had congestion in his throat, and the tip of his tongue was itchy. After another 10 minutes and a drink of water, patient said he thought he was okay, but I advised him to buy BENADRYL to take along with calling 911 if he felt that his airway was compromised. I spoke with patient about 6:30 and he reported no changes.  July 19th, patient contacted the pharmacy asking for documentation of his reaction. I advised him that it is subjective and that I would report it to VAERS. He then told me that he did in fact take BENADRYL 50mg every 6 hours for 2 days, for a total of 10 capsule. I advised him to follow up with his Primary Care Physician to discuss the reaction and if it is considered allergic or just a side effect.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Tongue pruritus
Clinical narrative: Approximately 10 minutes after the MMRII vaccine, pt stated that he had congestion in his throat, and the tip of his tongue was itchy. After another 10 minutes and a drink of water, patient said he thought he was okay, but I advised him to buy BENADRYL to take along with calling 911 if he felt that his airway was compromised. I spoke with patient about 6:30 and he reported no changes.  July 19th, patient contacted the pharmacy asking for documentation of his reaction. I advised him that it is subjective and that I would report it to VAERS. He then told me that he did in fact take BENADRYL 50mg every 6 hours for 2 days, for a total of 10 capsule. I advised him to follow up with his Primary Care Physician to discuss the reaction and if it is considered allergic or just a side effect.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient reports 104 degree fever night of vaccine. Patient presents to the office on 7/20/2018 with redness, warmth, and swelling at site of 5 cm x 10 cm. Patient complains of pain under arm and in armpit.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Patient reports 104 degree fever night of vaccine. Patient presents to the office on 7/20/2018 with redness, warmth, and swelling at site of 5 cm x 10 cm. Patient complains of pain under arm and in armpit.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Patient's arm developed redness that spread around the injection site. Arm was painful and patient experienced fever and chills. Patient took ADVIL for the pain. Patient states that symptoms are improving.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives, Welts, 1 on lower leg, 2 on feet and on stomach.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Mon 7/16/18 at about 1200: Pt rec'd SHINGRIX vaccine to left deltoid without incident. Pt describes local injection site pain that started later in the day following the vaccination. Tues 7/17/18: Pt describes more pronounced pain at injection site as well as swelling, erythema, warmth, tenderness and general malaise. Febrile at 101F that evening requiring ibuprofen. According to pt her normal body temp runs about 97.8. Wed 7/18/18: Symptoms continue at approximately the same severity. Pt describes low grade temp about 100F requiring ibuprofen. Thurs 7/19/19: Pt describes slight improvement in her symptoms. Afebrile. Less redness, swelling to site. Warmth and tenderness continues. Pt notes margin of local reaction has expanded and extends distally and medially from injection site. Margin is less well defined and part of the affected area is blanched in appearance. RXN area is greater than 5cmin diameter. Fri 7/20/18 at about 1130: Pt describes slight improvement in most symptoms. Afebrile. Area remains tender, slightly red/pink with an expanded area of local reaction remaining blanched and not well demarcated. Pt denies numbness of tingling to left extremity. Wed 7/18/18: Pt calls pharmacy and speaks with pharmacist to describe RXN. Thurs 7/19/18: Pharmacist calls pt to F/U. Fri 7/20/18: Pt to pharmacy. Pharmacist observes injection site reaction and documents. Patient to clinic for evaluation. Pharmacist completes VAERS form. Clinic prescribed short course of ABX and steroids.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Malaise, Pallor, Pyrexia
Clinical narrative: Mon 7/16/18 at about 1200: Pt rec'd SHINGRIX vaccine to left deltoid without incident. Pt describes local injection site pain that started later in the day following the vaccination. Tues 7/17/18: Pt describes more pronounced pain at injection site as well as swelling, erythema, warmth, tenderness and general malaise. Febrile at 101F that evening requiring ibuprofen. According to pt her normal body temp runs about 97.8. Wed 7/18/18: Symptoms continue at approximately the same severity. Pt describes low grade temp about 100F requiring ibuprofen. Thurs 7/19/19: Pt describes slight improvement in her symptoms. Afebrile. Less redness, swelling to site. Warmth and tenderness continues. Pt notes margin of local reaction has expanded and extends distally and medially from injection site. Margin is less well defined and part of the affected area is blanched in appearance. RXN area is greater than 5cmin diameter. Fri 7/20/18 at about 1130: Pt describes slight improvement in most symptoms. Afebrile. Area remains tender, slightly red/pink with an expanded area of local reaction remaining blanched and not well demarcated. Pt denies numbness of tingling to left extremity. Wed 7/18/18: Pt calls pharmacy and speaks with pharmacist to describe RXN. Thurs 7/19/18: Pharmacist calls pt to F/U. Fri 7/20/18: Pt to pharmacy. Pharmacist observes injection site reaction and documents. Patient to clinic for evaluation. Pharmacist completes VAERS form. Clinic prescribed short course of ABX and steroids.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Fatigue, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Fever as high as 101, low grade of 99.4-100.6 most of the time, started the morning after the injection. Full blown allergy attack with sneezing and runny eyes, even though I take allergy medicine regularly. An overall unwell feeling and tiredness, muscle soreness, arm is moderately sore. I am on day 4 now and a large sore red spot is about 2 inches below the injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia, Sneezing
Clinical narrative: Fever as high as 101, low grade of 99.4-100.6 most of the time, started the morning after the injection. Full blown allergy attack with sneezing and runny eyes, even though I take allergy medicine regularly. An overall unwell feeling and tiredness, muscle soreness, arm is moderately sore. I am on day 4 now and a large sore red spot is about 2 inches below the injection.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, having trouble moving left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Hyperaesthesia, Hypersomnia, Influenza like illness
Clinical narrative: Fever, chills, body aches, having trouble moving left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Malaise, Mobility decreased, Nausea, Oropharyngeal pain
Clinical narrative: Fever, chills, body aches, having trouble moving left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Pruritus generalised, Pyrexia
Clinical narrative: Fever, chills, body aches, having trouble moving left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Fever, chills, body aches, having trouble moving left arm.
Age: 99.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red and hot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, 3"diameter swelling, hot to touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Limb mass, Peripheral swelling, Swelling
Clinical narrative: Localized swelling, mass and lump, right upper limb requires KEFLEX, bacitracin and MOTRIN.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin induration, Skin warm
Clinical narrative: Arm became red, very hot, swollen, hard as a rock.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Pt C/O feeling sick after pneumonia vaccine. Arm is also very sore. Pt is sleeping so mom does not know if the area is red and hot. If it is she will take him to Urgent Care. Otherwise she will ice and give TYLENOL or MOTRIN for aches. No fever. If he worsens she will take him to Urgent Care. Will call with update. 07/19/18 (Thr Jul 19) 04:42 PM. 07/19/18 (Thr Jul 19) 05:24 PM, Pts mother calling back states pt has a fever of 102.4. Mother was made aware to take pt to Urgent Care.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye discharge, Eye irritation, Eye pain, Eyelid oedema
Clinical narrative: 61 days prior had 1st dose of the Shingles vaccine. Had a bit of soreness at injection site but nothing that was limiting. Ten years ago received ZOSTAVAX vaccine. Patient had Herpes in eye 20 years ago; not sure which eye it was. During vaccination the administration hurt more than 1st dose. Next morning felt shivers and chillsdid not feel well. Patient not sure if was running a fever. Saturday morning had discharge in right eye, it was sore, irritated, and lots of discharge. Patient thought she was getting conjunctivitis from a friend. On Sunday went to Urgent Care, NP prescribed erythromycin and did not run a stain test. The medicine did not help. Patient went to ophthalmologist on 7/17, ran test and confirmed it was shingles. Doctor prescribed valacyclovir, swelling is down, still light sensitive and closing eye more often. Patient is going for follow-up with eye specialist on 7/19. Initial soreness on arm went away pretty quick.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Ophthalmic herpes zoster, Photophobia
Clinical narrative: 61 days prior had 1st dose of the Shingles vaccine. Had a bit of soreness at injection site but nothing that was limiting. Ten years ago received ZOSTAVAX vaccine. Patient had Herpes in eye 20 years ago; not sure which eye it was. During vaccination the administration hurt more than 1st dose. Next morning felt shivers and chillsdid not feel well. Patient not sure if was running a fever. Saturday morning had discharge in right eye, it was sore, irritated, and lots of discharge. Patient thought she was getting conjunctivitis from a friend. On Sunday went to Urgent Care, NP prescribed erythromycin and did not run a stain test. The medicine did not help. Patient went to ophthalmologist on 7/17, ran test and confirmed it was shingles. Doctor prescribed valacyclovir, swelling is down, still light sensitive and closing eye more often. Patient is going for follow-up with eye specialist on 7/19. Initial soreness on arm went away pretty quick.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the pharmacy today and showed me her arm. There was an obvious redness around the area the shot was given. It looked very much like someone who swells up quite a bit from bug bites. She said the rash itself is not painful, but that her arm/muscle is still painful from the vaccine. The rash was only slightly warm to the touch and she said her husband that that it had gone down since she woke up and noticed it yesterday (7/19/18). I recommended she try some hydrocortisone cream and oral BENADRYL and advised her that if it did not go down or continued to spread/get worse through today, she should go into the doctor.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Induration, Local reaction
Clinical narrative: Severe local reaction 4-5 inches induration, redness warmth from deltoid into Biceps and had systemic reaction of chills, fever, drenching night sweats. Systemic reaction. Used TYLENOL.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Night sweats, Pyrexia, Skin warm
Clinical narrative: Severe local reaction 4-5 inches induration, redness warmth from deltoid into Biceps and had systemic reaction of chills, fever, drenching night sweats. Systemic reaction. Used TYLENOL.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: Underdose
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 7 year old patient of unknown gender. Information on his/her pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was in process of getting vaccinated with a dose of M-M-R II (lot # M044350 and expiry date: 04-NOV-2018) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot # M039641 and expiry date: 16-JAN-2019). The patient pulled away during administration resulting in less than full dose administered. No adverse effects were reported. There was no product quality complaint (PQC) reported.
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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-MAR-2010, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-SEP-2014, the patient was treated by a nurse practitioner for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-APR-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-MAY-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed VALTREX and prednisone for management of his painful symptoms and chronic pain. As a direct and proximate result of 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-SEP-2015, the patient was inoculated with ZOSTAVAX at a health services facility as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUL-2016, the patient was treated by a Nurse Practitioner at the same facility for the onset of a severe vesicular rash which was diagnosed as severe herpes zoster. She was prescribed acetaminophen and VALTREX for management of her painful symptoms and chronic pain. 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a Dermatologist for a persistent vesicular rash which was diagnosed as chronic 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  In 2016, the patient was treated at a facility (considered a physician's office) for a persistent and severe vesicular rash 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPVX, TD, YF
Symptoms: Condition aggravated, Dysphagia, Dyspnoea, Palpitations, Panic attack
Clinical narrative: Initial solicited report received on 01 June 2018 from an investigator participating in the below mentioned study. This non-serious case involves a 19-year-old female subject who had palpitations, sation of lump in throat- panic attack during the study participation. The subject had medical history of palpitation, anxiety and panic attacks. The subject received concomitant medications of MIRENA IUD inserted previously in uterus IUD in place for birth control (ongoing), alpha-amylase swine pancreas, cellulase, lipase, protease (Digestive enzyme) 01 cap QD orally for digestive health (ongoing). On 01 June 2018, same day after receiving 0.5 ml single subcutaneous dose of STAMARIL (batch number: N3H32) on 01 June 2018, 0.5 ml single intramuscular dose of Td Vaccine (batch number: U5883AA) on 01 June 2018, 0.5 ml single intramuscular dose of HPV vaccine (batch number:N019104) on 01 June 2018, 1.0 ml single intramuscular dose of Hepatitis A vaccine (batch number:4h374) on 01 June 2018, the subject had palpitations, sation of lump in throat- panic attack. Subject received four vaccine as above at 01:20 pm on that day. At 01.50pm, after coming cilic she developed acute onset of palpitations, fig of perpending dorm, sensation of lump in throat, felt like could not swallow/breath. Subject rened to clinic. Examined at 02 pm/ exam of- rrnl, hrnl,bp nl, heart/lungs clear, nish/urticarial/no swelling of throat/face. Observed in clinic for 45 mins. Symptoms resolved after 15 to 20 min. no evidence of reaction. Subject stated that to vaccines- she felt it was a panic attack. The corrective treatment was not reported. The event of palpitations, sation of lump in throat- panic attack was resolved on unknown date of June 2018. The causal relationship of the concomitant medication with the event was not reported. Relationship to investigational product according to company: not related. Relationship to investigational product according to company: not reportable. List of documents held by sender: none. Sender's Comments: A 19-year-old female subject who had palpitations, and sensation of lump in throat- panic attack, on same day after receiving STAMARIL Vaccine. She also received MMR vaccine, Td Vaccine and Hepatitis A vaccine concomitantly to study vaccine. She had significant history of palpitation, anxiety and panic attacks. Based on the available information, the sponsor assesses the event to be not related to the study vaccine, in agreement with the investigator.
Age: 19.0
Sex: F
Vaccine: HEPA, HPVX, TD, YF
Symptoms: Sensation of foreign body
Clinical narrative: Initial solicited report received on 01 June 2018 from an investigator participating in the below mentioned study. This non-serious case involves a 19-year-old female subject who had palpitations, sation of lump in throat- panic attack during the study participation. The subject had medical history of palpitation, anxiety and panic attacks. The subject received concomitant medications of MIRENA IUD inserted previously in uterus IUD in place for birth control (ongoing), alpha-amylase swine pancreas, cellulase, lipase, protease (Digestive enzyme) 01 cap QD orally for digestive health (ongoing). On 01 June 2018, same day after receiving 0.5 ml single subcutaneous dose of STAMARIL (batch number: N3H32) on 01 June 2018, 0.5 ml single intramuscular dose of Td Vaccine (batch number: U5883AA) on 01 June 2018, 0.5 ml single intramuscular dose of HPV vaccine (batch number:N019104) on 01 June 2018, 1.0 ml single intramuscular dose of Hepatitis A vaccine (batch number:4h374) on 01 June 2018, the subject had palpitations, sation of lump in throat- panic attack. Subject received four vaccine as above at 01:20 pm on that day. At 01.50pm, after coming cilic she developed acute onset of palpitations, fig of perpending dorm, sensation of lump in throat, felt like could not swallow/breath. Subject rened to clinic. Examined at 02 pm/ exam of- rrnl, hrnl,bp nl, heart/lungs clear, nish/urticarial/no swelling of throat/face. Observed in clinic for 45 mins. Symptoms resolved after 15 to 20 min. no evidence of reaction. Subject stated that to vaccines- she felt it was a panic attack. The corrective treatment was not reported. The event of palpitations, sation of lump in throat- panic attack was resolved on unknown date of June 2018. The causal relationship of the concomitant medication with the event was not reported. Relationship to investigational product according to company: not related. Relationship to investigational product according to company: not reportable. List of documents held by sender: none. Sender's Comments: A 19-year-old female subject who had palpitations, and sensation of lump in throat- panic attack, on same day after receiving STAMARIL Vaccine. She also received MMR vaccine, Td Vaccine and Hepatitis A vaccine concomitantly to study vaccine. She had significant history of palpitation, anxiety and panic attacks. Based on the available information, the sponsor assesses the event to be not related to the study vaccine, in agreement with the investigator.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Decreased appetite, Fatigue, Flushing, Hypophagia
Clinical narrative: Fever over 104 that comes down temporarily to 102 with OTC medicine (MOTRIN). Rash on chest that is getting progressively worse. Lack of appetite; refusing to eat and drinking very little. Cranky, tired, and weak. Very flushed cheeks and lips. Lack of appetite started two days ago and is remaining persistent. Fever and change in disposition started 26 hours ago, peaked yesterday evening (about 6 hours later), was slightly better this morning, and is back to its peak. Rash started today and is getting worse.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever over 104 that comes down temporarily to 102 with OTC medicine (MOTRIN). Rash on chest that is getting progressively worse. Lack of appetite; refusing to eat and drinking very little. Cranky, tired, and weak. Very flushed cheeks and lips. Lack of appetite started two days ago and is remaining persistent. Fever and change in disposition started 26 hours ago, peaked yesterday evening (about 6 hours later), was slightly better this morning, and is back to its peak. Rash started today and is getting worse.
Age: 0.75
Sex: M
Vaccine: IPV, PNC13
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Redness around injection site, irritability, mild fever.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient developed hives/rash all over his body approximately 40 minutes after Hepatitis A (first dose) and MENVEO (second dose) vaccine administration. BENADRYL and ATARAX were both administered to patient. Rash/Hives began to improve shortly after administration of BENADRYL and ATARAX.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient was seen to establish care and for annual evaluation on 5/18/18. In that office visit note it states "Would like HPV vaccine series. Questions if okay to receive the vaccine if she is pregnant. She is not pregnant but would like to conceive. Just finished menstruation this past week.". Patient was given initial HPV vaccine at that time and scheduled for dose #2 on 7/13/18. Patient presented for dose number 2 on 7/13/18 and RN reviewed the notes from 5/18/18 office visit and asked the patient "Are you pregnant or is there a chance you could become pregnant during the next month?" Patient responded No, however OV on 5/18/18 notes patient would like to conceive. Patient affirms that she is not pregnant at this time. Due date 3/26/19, last menses 6/19/18.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Two days after the patient received her second SHINGRIX shot, she noticed a red, itchy, blister like rash on the inside of her right arm. She came into the pharmacy the next day so that we could take a look at it. The patient had no fever, rash was itchy but not painful, and the patient said it looked better than it did yesterday. I told the patient to use hydrocortisone for the itchiness and to monitor the rash. If the rash gets worse, see a doctor.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Severe fatigue, severe chills, severe fever, severe muscle aches.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Pain over left deltoid where injection was given, unable to raise arm, onset within a few hours after immunization. Presents for follow up next day. Took single dose of ibuprofen 200mg without any improvement. On exam has tenderness of left deltoid muscle with slight induration at injection site. Pain with contraction of deltoid muscle, otherwise appears normal.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Pain over left deltoid where injection was given, unable to raise arm, onset within a few hours after immunization. Presents for follow up next day. Took single dose of ibuprofen 200mg without any improvement. On exam has tenderness of left deltoid muscle with slight induration at injection site. Pain with contraction of deltoid muscle, otherwise appears normal.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatinine, Blood pressure increased, Brain natriuretic peptide, Dry throat, Dysphonia
Clinical narrative: 7/16/18- only mild soreness in arm after injection. 7/17/18- headaches throughout the day. 7/18/18- woke up with elevated blood pressure and pulse. Very sore neck and shoulder muscles. Neck and shoulders feels very painful, stiff and swollen. Pain unrelieved by TYLENOL or FLEXERIL. Unable to sleep due to pain. 7/18/18- pain continues to neck and shoulder area. PCP notified, requested I take BENADRYL and if no improvement go to E.R. Took BENADRYL with no improvement. Went to E.R. around 9pm. EKG sinus tachycardia. B.P 187/110. IV started. IV TYLENOL given. Diazepam 5mg given to me by mouth for muscle swelling/spasm. Doctor ran labs and took xrays. Mentions that my left shoulder muscle is very swollen. WBC count normal, decides not to do spinal tap. E.R. doc gives me the option to stay overnight in hospital for observation or go home. He sends me home with a prescription of valium for muscle spasm. Still leave the E.R. in pain and discomfort. 7/20/18- Woke up in am with continued pain to neck and shoulder. Feels ache and stiff especially when I move or turn my head. Throat now very dry. Coughing up very thick yellow mucous and now voice is very hoarse. Hurts to talk, feels like is straining my vocal cords
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Headache, Heart rate increased, Limb discomfort, Metabolic function test
Clinical narrative: 7/16/18- only mild soreness in arm after injection. 7/17/18- headaches throughout the day. 7/18/18- woke up with elevated blood pressure and pulse. Very sore neck and shoulder muscles. Neck and shoulders feels very painful, stiff and swollen. Pain unrelieved by TYLENOL or FLEXERIL. Unable to sleep due to pain. 7/18/18- pain continues to neck and shoulder area. PCP notified, requested I take BENADRYL and if no improvement go to E.R. Took BENADRYL with no improvement. Went to E.R. around 9pm. EKG sinus tachycardia. B.P 187/110. IV started. IV TYLENOL given. Diazepam 5mg given to me by mouth for muscle swelling/spasm. Doctor ran labs and took xrays. Mentions that my left shoulder muscle is very swollen. WBC count normal, decides not to do spinal tap. E.R. doc gives me the option to stay overnight in hospital for observation or go home. He sends me home with a prescription of valium for muscle spasm. Still leave the E.R. in pain and discomfort. 7/20/18- Woke up in am with continued pain to neck and shoulder. Feels ache and stiff especially when I move or turn my head. Throat now very dry. Coughing up very thick yellow mucous and now voice is very hoarse. Hurts to talk, feels like is straining my vocal cords
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Muscle swelling, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: 7/16/18- only mild soreness in arm after injection. 7/17/18- headaches throughout the day. 7/18/18- woke up with elevated blood pressure and pulse. Very sore neck and shoulder muscles. Neck and shoulders feels very painful, stiff and swollen. Pain unrelieved by TYLENOL or FLEXERIL. Unable to sleep due to pain. 7/18/18- pain continues to neck and shoulder area. PCP notified, requested I take BENADRYL and if no improvement go to E.R. Took BENADRYL with no improvement. Went to E.R. around 9pm. EKG sinus tachycardia. B.P 187/110. IV started. IV TYLENOL given. Diazepam 5mg given to me by mouth for muscle swelling/spasm. Doctor ran labs and took xrays. Mentions that my left shoulder muscle is very swollen. WBC count normal, decides not to do spinal tap. E.R. doc gives me the option to stay overnight in hospital for observation or go home. He sends me home with a prescription of valium for muscle spasm. Still leave the E.R. in pain and discomfort. 7/20/18- Woke up in am with continued pain to neck and shoulder. Feels ache and stiff especially when I move or turn my head. Throat now very dry. Coughing up very thick yellow mucous and now voice is very hoarse. Hurts to talk, feels like is straining my vocal cords
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Productive cough, Troponin, Vocal cord dysfunction, White blood cell count normal
Clinical narrative: 7/16/18- only mild soreness in arm after injection. 7/17/18- headaches throughout the day. 7/18/18- woke up with elevated blood pressure and pulse. Very sore neck and shoulder muscles. Neck and shoulders feels very painful, stiff and swollen. Pain unrelieved by TYLENOL or FLEXERIL. Unable to sleep due to pain. 7/18/18- pain continues to neck and shoulder area. PCP notified, requested I take BENADRYL and if no improvement go to E.R. Took BENADRYL with no improvement. Went to E.R. around 9pm. EKG sinus tachycardia. B.P 187/110. IV started. IV TYLENOL given. Diazepam 5mg given to me by mouth for muscle swelling/spasm. Doctor ran labs and took xrays. Mentions that my left shoulder muscle is very swollen. WBC count normal, decides not to do spinal tap. E.R. doc gives me the option to stay overnight in hospital for observation or go home. He sends me home with a prescription of valium for muscle spasm. Still leave the E.R. in pain and discomfort. 7/20/18- Woke up in am with continued pain to neck and shoulder. Feels ache and stiff especially when I move or turn my head. Throat now very dry. Coughing up very thick yellow mucous and now voice is very hoarse. Hurts to talk, feels like is straining my vocal cords
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Induration, Myalgia, Pain in extremity
Clinical narrative: I woke up at 2AM with bad muscle pain and shivering so hard my hands were shaking. This did no happen with the first vaccine. My arm has a large sore swollen red hard warm area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Tremor
Clinical narrative: I woke up at 2AM with bad muscle pain and shivering so hard my hands were shaking. This did no happen with the first vaccine. My arm has a large sore swollen red hard warm area.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: Injection site Arm pain -started from time of injection- severe during night- could not lay down on arm; icing didn't help much. Muscle/complete body aches- fatigue-started  9pm on day of injection- prevented sleep during most of the night. Vomiting- 3am -7am- 7/19/2018. Very Severe headache- started during the early am hours- lasted through next day. Unable to stand - morning of 7/19/2018- through noon. Reactions were not mild or moderate- unable to feed/ care for the dog- never reacted to anything previously in my life.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Vomiting
Clinical narrative: Injection site Arm pain -started from time of injection- severe during night- could not lay down on arm; icing didn't help much. Muscle/complete body aches- fatigue-started  9pm on day of injection- prevented sleep during most of the night. Vomiting- 3am -7am- 7/19/2018. Very Severe headache- started during the early am hours- lasted through next day. Unable to stand - morning of 7/19/2018- through noon. Reactions were not mild or moderate- unable to feed/ care for the dog- never reacted to anything previously in my life.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site urticaria
Clinical narrative: Injection site Arm pain -started from time of injection- severe during night- could not lay down on arm; icing didn't help much. Muscle/complete body aches- fatigue-started  9pm on day of injection- prevented sleep during most of the night. Vomiting- 3am -7am- 7/19/2018. Very Severe headache- started during the early am hours- lasted through next day. Unable to stand - morning of 7/19/2018- through noon. Reactions were not mild or moderate- unable to feed/ care for the dog- never reacted to anything previously in my life.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Injection site Arm pain -started from time of injection- severe during night- could not lay down on arm; icing didn't help much. Muscle/complete body aches- fatigue-started  9pm on day of injection- prevented sleep during most of the night. Vomiting- 3am -7am- 7/19/2018. Very Severe headache- started during the early am hours- lasted through next day. Unable to stand - morning of 7/19/2018- through noon. Reactions were not mild or moderate- unable to feed/ care for the dog- never reacted to anything previously in my life.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: Patient called complaining of extreme pain in the arm that the shot was given in a few hours after.  I recommended ice for the pain. She called back another couple hours later and said that there was a knot/swelling in the arm at the injection site and the ice wasn't helping.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Aura, Biopsy artery abnormal, Blood test, C-reactive protein
Clinical narrative: Very bad pain and limited arm movement started within two hours of injection. Couldn't sleep. Sept 29, saw Dr. He said the vaccine possible allergic reaction. Gave prescription of FLEXERIL. Didn't help. Still very much pain, limited arm movement. Office visits Oct. 15, still in pain. Dr. put me in physical Therapy. Didn't help. More systems. Severe neck and shoulder pain from left side, night sweats, fever, jaw hurting, scalp tenderness, muscle and hip pain. Couldn't walk in mornings or bend over. Headaches. Blurry vision, auras, dizziness. Can't sleep more than 3 hours. Went on and on. Doctors and PA's couldn't figure out. Finally Jan. 11, Dr. knew what could be. Gave a blood test of ESR and C-reactive protein. Called me that evening with diagnosis of Polymyalgia Rheumatica and Temporal Arteritis, positive biopsy of temporal artery. Been on Prednisone for over two years. I have been in so much pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Gait disturbance, Headache, Insomnia, Mobility decreased
Clinical narrative: Very bad pain and limited arm movement started within two hours of injection. Couldn't sleep. Sept 29, saw Dr. He said the vaccine possible allergic reaction. Gave prescription of FLEXERIL. Didn't help. Still very much pain, limited arm movement. Office visits Oct. 15, still in pain. Dr. put me in physical Therapy. Didn't help. More systems. Severe neck and shoulder pain from left side, night sweats, fever, jaw hurting, scalp tenderness, muscle and hip pain. Couldn't walk in mornings or bend over. Headaches. Blurry vision, auras, dizziness. Can't sleep more than 3 hours. Went on and on. Doctors and PA's couldn't figure out. Finally Jan. 11, Dr. knew what could be. Gave a blood test of ESR and C-reactive protein. Called me that evening with diagnosis of Polymyalgia Rheumatica and Temporal Arteritis, positive biopsy of temporal artery. Been on Prednisone for over two years. I have been in so much pain.