chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2016, the patient was treated by a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 01-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 01-OCT-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the shingles and associated injuries. On an unknown date in 2016, the patient was treated for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash following the injection on an unspecified date with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date with outcome of unknown.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician. A 66-year-old female patient received PREVNAR 13, batch/lot number and expiration date), via an unspecified route of administration in left deltoid on 02Jul2018 at a single dose as precautionary. The vaccination was done in pharmacy. There were no relevant medical and concomitant medications. The patient experienced cellulitis post injection on an unspecified date. The outcome of the event was not recovered. The event was assessed as related and medically significant. The patient visited physician's office due to the event. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Based on a temporal association, a causal relationship between the event cellulitis post infection and pneumococcal 13-valent conjugated vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Red swollen bump with itching, tightness feeling. Right Upper Arm: There is a 10 by 10 cm area of erythema and induration with well demarcated borders that blanch to touch. There is no streaking. The area is warm. There are no vesicles appreciated. Patient advised to apply cold pack, which was provided. She is to take NSAID of choice for inflammation.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pallor, Pruritus, Skin tightness, Swelling
Clinical narrative: Red swollen bump with itching, tightness feeling. Right Upper Arm: There is a 10 by 10 cm area of erythema and induration with well demarcated borders that blanch to touch. There is no streaking. The area is warm. There are no vesicles appreciated. Patient advised to apply cold pack, which was provided. She is to take NSAID of choice for inflammation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eyelid oedema, Lip swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever and chills 12 hours after the shot, within 24 hours after the shot my eyes swelled shut, my face and lips swelled, and my throat swelled slightly.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Fever and chills 12 hours after the shot, within 24 hours after the shot my eyes swelled shut, my face and lips swelled, and my throat swelled slightly.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Localized reaction on the left leg injection site 4.5cm x 4.5cm non indurated bump shortly after vaccine was given. Full Range of movement of the left leg.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation
Clinical narrative: This is second vaccine. Patient reported same symptoms: Around 36 hours after vaccination pt had same burning sensation in soles of feet and a little bit in palms. Told to go to urgent care if worse. Went away in 12 hrs.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Seizure, Speech disorder
Clinical narrative: Parent states that the patient had seizure activity that lasted less than 2 mins. No neurological deficits, noted some odd speech after the incident but has now resolved.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Axillary mass, Axillary pain, Differential white blood cell count normal, Full blood count normal, Injection site erythema
Clinical narrative: VARIVAX administered on 06/25/2018. On 7/9/18, Patient contacted the Clinic with complaint of pain and redness at injection site post-injection. Patient is concerned at duration of pain and redness. Initially arm movement aggravated pain but this is no longer the case. Patient noticed pain and lump in left axilla on 7/3/18. At rest, pain is 3-4/10. With direct pressure in axilla, pain increases to 7. No fever or discharge at injection site. Non-tender. Upon exam, at injection site posterior left upper arm with patchy redness and increased warmth (approx. 3 cm diameter) are noted. No redness or skin changes or visible mass in left axilla.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site warmth, Pain, Tenderness
Clinical narrative: VARIVAX administered on 06/25/2018. On 7/9/18, Patient contacted the Clinic with complaint of pain and redness at injection site post-injection. Patient is concerned at duration of pain and redness. Initially arm movement aggravated pain but this is no longer the case. Patient noticed pain and lump in left axilla on 7/3/18. At rest, pain is 3-4/10. With direct pressure in axilla, pain increases to 7. No fever or discharge at injection site. Non-tender. Upon exam, at injection site posterior left upper arm with patchy redness and increased warmth (approx. 3 cm diameter) are noted. No redness or skin changes or visible mass in left axilla.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Chest pain, Echocardiogram abnormal, Pain, Troponin increased
Clinical narrative: Symptoms: WEAKNESS(R531), CHEST PAIN, UNSPECIFIED(R079). Aching.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Cold sweat, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: 2 July/1700ish: Administered Anthrax Vaccination. 3 July/am: Woke up with slight headache. Went for run, headache persisted. 3 July/am into pm: Continued headache, general feeling of weakness (felt weak/out of breath going up stairs). 3 July 1500: Felt extremely weak driving home. I was supposed to drive down to another town that afternoon (friend was already down there with my parents). 3 July 1600: Started to get cold sweats/continued weakness/dizziness/nausea. 3 July 1700: 102 fever persistent with cold/hot bouts. At this point walking would wear me out. I basically became one with the couch. Didn't make the trek to town. This persisted through the night. Following day still felt groggy/foggy/in and out of fever (controlled by MOTRIN). 85-90% better by morning of July 5th.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling of body temperature change, Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: 2 July/1700ish: Administered Anthrax Vaccination. 3 July/am: Woke up with slight headache. Went for run, headache persisted. 3 July/am into pm: Continued headache, general feeling of weakness (felt weak/out of breath going up stairs). 3 July 1500: Felt extremely weak driving home. I was supposed to drive down to another town that afternoon (friend was already down there with my parents). 3 July 1600: Started to get cold sweats/continued weakness/dizziness/nausea. 3 July 1700: 102 fever persistent with cold/hot bouts. At this point walking would wear me out. I basically became one with the couch. Didn't make the trek to town. This persisted through the night. Following day still felt groggy/foggy/in and out of fever (controlled by MOTRIN). 85-90% better by morning of July 5th.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pruritus
Clinical narrative: Big purple bruise near the injection site that was itching. She was counseled to use hydrocortisone cream to calm the itching.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Purpura, Respiratory arrest, Urticaria
Clinical narrative: Pt was given vaccine and then mother breast feed baby for about 10-15 min and pt then had hives, no breathing concerns and purpura like rash. BENADRYL was given and referral to allergy.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED "A HARD LUMP" AND SWELLING AT INJECTION SITE WHICH PRESENTED ABOUT 24 HOURS AFTER INJECTION. INJECTION SITE SWELLING WAS PAINFUL AND LASTED SEVERAL DAYS BEFORE RESOLVING COMPLETELY. APPROXIMATELY 3 DAYS AFTER INJECTION, THE PATIENT NOTICED BRUISING IN THE AXILLA AREA OF THE INJECTION ARM WHICH PROGRESSIVELY SPREAD FROM UNDER HER ARM TO AXILLA AND ONTO UPPER TORSO. THE BRUISING WAS NOT PAINFUL. TWO WEEKS POST-INJECTION, THE BRUISING IS STILL VISIBLE ON THE LOWER AXILLA/UPPER TORSO OF THE RIGHT SIDE BUT THE PATIENT REPORTS IT HAS IMPROVED SINCE ONSET.
Age: 27.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: PT RECEIVED PPSV23 SUBQ AFTER HER OFFICE VISIT, 10 MIN LATER SHE CALLS AND STATES AFTER SHE LEFT THE OFFICE SHE NOTICED THE AREA WAS ITCHING, WHEN SHE GOT HOME SHE NOTICED A RASH IN BACK OF HER ARM AND WENT UP INTO HER ARMPIT. ADVISED PT TO TAKE BENADRYL AND APPLY A COOL COMPRESS, CALL US BACK IF AREA GETS WORSE OR IF AFTER HOURS SEEK TREATMENT AT ER OR URGENT CARE.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that after the injection, the site became very swollen and painful. Pt now has a small hard nodule under the skin at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset unknown). The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 10-AUG-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as geniculate herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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. Upon internal review, geniculate herpes zoster was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-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. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2015, the patient was inoculated with the ZOSTAVAX at a shopping center, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. In 2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset unknown). The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On or about 14-JUL-2016, the patient was treated for a vesicular outbreak, which was diagnosed as geniculate herpes zoster (Ramsay Hunt Syndrome). The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. The outcome of the events is unknown. 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. Upon internal review, geniculate herpes zoster (Ramsay Hunt Syndrome) was determined to be medically significant. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Vaccination site rash
Clinical narrative: Pt's Home health aide called today updating that she noticed a quarter size rash on the left side of her neck and a nickel size rash on the upper left arm where the vaccine was given. No fever, chills swelling, warmth or discharge.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Patient reported noticing red itchy blister-like bumps that started three days after vaccination, mainly on torso, and some on right thigh. Patient described it as red patches that appeared like rashes or large chicken pox but not like shingles. She stated the bumps lasted for about a week before disappearing.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Sleep disorder, Tremor
Clinical narrative: Had expected arthralgia and myalgia for 5 days. Unexpectedly awoke from sleep with severe shaking chills about 12 hours post injection which resolve after an hour with the administration of oral TYELNOL. Chills did not recur.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Sleep disorder, Tremor
Clinical narrative: Expected arthralgia and myalgia for 4 days. Unexpected onset of severe shaking chills awakening from sleep which for persisted for about 1 hour after taking naproxen. Chills did not recur.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Allergy test positive, Anxiety, Chest pain, Dehydration, Fatigue
Clinical narrative: When patient received the first HPV shot she fainted and the doctor said she was just dehydrated. Patient hasn't been the same ever since she has had both shots... the second shot was 04-22-2013. Patient ended up having allergic reactions to all foods, and environmental.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Gastric disorder, Gastrooesophageal reflux disease, Hormone level abnormal, Hypersensitivity, Infection
Clinical narrative: When patient received the first HPV shot she fainted and the doctor said she was just dehydrated. Patient hasn't been the same ever since she has had both shots... the second shot was 04-22-2013. Patient ended up having allergic reactions to all foods, and environmental.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza, Malaise, Rash generalised, Skin disorder, Surgery
Clinical narrative: When patient received the first HPV shot she fainted and the doctor said she was just dehydrated. Patient hasn't been the same ever since she has had both shots... the second shot was 04-22-2013. Patient ended up having allergic reactions to all foods, and environmental.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: When patient received the first HPV shot she fainted and the doctor said she was just dehydrated. Patient hasn't been the same ever since she has had both shots... the second shot was 04-22-2013. Patient ended up having allergic reactions to all foods, and environmental.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Injection site pain, Pain
Clinical narrative: Patient reported having pain both local injection site and generalized body pain starting day after vaccination and continuing for several days. Also experienced cognitive impairment for several days.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Feeling hot, Musculoskeletal stiffness
Clinical narrative: (I am unsure about which meningococcal vaccine was given, and the clinic could not verify at this time. But it was her second in the series). The meningococcal vaccine was given first, followed by HAVRIX. Within 2 minutes, patient started feeling dizzy and said she was "seeing stars". Her mother was with her, and sat her down in a chair. Patient then quickly slumped over, her eyes rolled back, her arms went stiff, and she began to convulse (lasting probably less than a minute).  After coming around, patient noted that her hands were tingly and she felt hot. Her skin appeared grey. The staff quickly attended to her, and took her blood pressure (which was just a little lower than at the beginning of her appointment, and check her blood sugar, which was normal. The staff gave her crackers and orange juice, and provided instructions for what to watch for over the next 24-48 hours. Patient has no known medical conditions and has never had a seizure prior to today.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Paraesthesia, Posture abnormal, Seizure, Skin discolouration, Visual impairment
Clinical narrative: (I am unsure about which meningococcal vaccine was given, and the clinic could not verify at this time. But it was her second in the series). The meningococcal vaccine was given first, followed by HAVRIX. Within 2 minutes, patient started feeling dizzy and said she was "seeing stars". Her mother was with her, and sat her down in a chair. Patient then quickly slumped over, her eyes rolled back, her arms went stiff, and she began to convulse (lasting probably less than a minute).  After coming around, patient noted that her hands were tingly and she felt hot. Her skin appeared grey. The staff quickly attended to her, and took her blood pressure (which was just a little lower than at the beginning of her appointment, and check her blood sugar, which was normal. The staff gave her crackers and orange juice, and provided instructions for what to watch for over the next 24-48 hours. Patient has no known medical conditions and has never had a seizure prior to today.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Patient experienced increased fatigue, muscle and joint pain, and fever. Reports active shingles lesions in groin area. No anaphylactic reactions. Advised patient to use TYLENOL to reduce fever and pain and to report worsening of symptoms to PCP immediately and seek medical attention if symptoms of allergic reactions appear.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: Patient's mom was told to give the patient ibuprofen for pain as needed.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: PATIENT STARTED WITH A HEADACHE, NAUSEA, AND VOMITTING.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: C/O sore throat. Nausea/vomiting. Headache. Fever and tiredness.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: C/O sore throat. Nausea/vomiting. Headache. Fever and tiredness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, burning, warm to touch from injection site up to neck.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematoma, Mobility decreased, Nodule, Pain in extremity, X-ray abnormal
Clinical narrative: Patient called to complain of arm pain and inability to lift arm on 07/10/18. On 07/11/18 I called to check on patient and they stated they had gone to ER and been diagnosed with hematoma via X-ray. ER told patient to follow up with primary physician if no relief within 3 days. Patient stated a knot formed on 07/11/18.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: STRONG PAIN in arm after 2-3hrs. Monitoring for other events.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Insomnia
Clinical narrative: Pt complained that she had insomnia that night after the shot. She also experienced diarrhea, nausea, stomach cramps, headaches, muscle ache, fatigue. She could not sleep that evening. She needed to take TYLENOL PM to help with insomnia and pain.  She also mentioned that the 1st shot was worst and this 2nd shot was not as bad as the symptoms experienced in the 1st shot. She did not report of adverse effects after the 1st shot. But after getting 2nd shot, she remembered the effects of the 1st shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Pt complained that she had insomnia that night after the shot. She also experienced diarrhea, nausea, stomach cramps, headaches, muscle ache, fatigue. She could not sleep that evening. She needed to take TYLENOL PM to help with insomnia and pain.  She also mentioned that the 1st shot was worst and this 2nd shot was not as bad as the symptoms experienced in the 1st shot. She did not report of adverse effects after the 1st shot. But after getting 2nd shot, she remembered the effects of the 1st shot.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Headache, Malaise, Nausea
Clinical narrative: Patient stated she had a sore arm right after receiving the vaccine. Later that night, around 9pm, she fell ill- nausea, headache, joint pain, and could not walk. The next day - June 28, 2018 around 9am, patient arrived at the emergency room where her throat closed. BENADRYL and a breathing nebulizer were administered in addition to XANAX and ondansetron. Patient followed up with PCP, Dr. on 7/2/18 at which point no further action or care was taken.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Throat tightness
Clinical narrative: Patient stated she had a sore arm right after receiving the vaccine. Later that night, around 9pm, she fell ill- nausea, headache, joint pain, and could not walk. The next day - June 28, 2018 around 9am, patient arrived at the emergency room where her throat closed. BENADRYL and a breathing nebulizer were administered in addition to XANAX and ondansetron. Patient followed up with PCP, Dr. on 7/2/18 at which point no further action or care was taken.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness in injection site that night and worse the next morning with development of redness and swelling. Exquisite tenderness and swelling in the right Axilla. General myalgia and fatigue.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Tenderness in injection site that night and worse the next morning with development of redness and swelling. Exquisite tenderness and swelling in the right Axilla. General myalgia and fatigue.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced a fever for 24 hours post-vaccination, which then resolved.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test negative, Blood bicarbonate normal, Blood chloride decreased, Blood creatinine normal, Blood culture
Clinical narrative: Patient states she developed Pneumonia and is hospitalized and believes this is due to her vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: Patient states she developed Pneumonia and is hospitalized and believes this is due to her vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Electrocardiogram, Haemoglobin normal, Pneumonia, Respiratory viral panel
Clinical narrative: Patient states she developed Pneumonia and is hospitalized and believes this is due to her vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Viral test positive, White blood cell count normal
Clinical narrative: Patient states she developed Pneumonia and is hospitalized and believes this is due to her vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: According to mother, child vomited for 4 days after receiving Rotavirus vaccine. She did not seek care at the time of the events.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Painful, redness rash around injection site start happening day after injection. It has lasted for more than 1 week. After one week the pain went away, but still redness. The redness area has gone down since the beginning stages. No other symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Tremor
Clinical narrative: I drifted off to sleep around 9:45pm but I did not sleep long when I awoke. Realizing that I was shaking and had the chills but I felt like I was burning up, I got up just before 11:30pm and took my temperature. My oral thermometer registered somewhere between 100-101 degrees. I took 3-ADVIL (200 mg each) and went back to bed & covered up with all blankets & a quilt. Sometime during the night I awoke, realizing that I was no longer burning up. By 5:00am, I felt well again and was able to go to work.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Unusual tiredness, general malaise, and loose stools (after 36 hrs). At site of injection: raised, hard, sore, warm to the touch and bright red in a 1 1/2in radius around site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Unusual tiredness, general malaise, and loose stools (after 36 hrs). At site of injection: raised, hard, sore, warm to the touch and bright red in a 1 1/2in radius around site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient's left arm started hurting and radiated from the site of injection (left deltoid down to finger tips) ten days after she received the first dose of SHINGRIX. Patient's pain was reduced with use of NSAID but arm continued to hurt and patient's range of motion was reduced. Patient visited doctor two months after the pain began and found out she was experiencing bursitis. Prescriber gave patient a course of steroids (MEDROL dose pack) to help with the inflammation and she will be going to physical therapy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Erythema, Myalgia, Pain in extremity
Clinical narrative: Pt. recv'd shot at 11am by 9pm muscle/ joint ache, sore arm. After 1 hour of sleep woke to red swollen arm. Bedridden for 1 day. Arm was swollen & hurt for 1 week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt. recv'd shot at 11am by 9pm muscle/ joint ache, sore arm. After 1 hour of sleep woke to red swollen arm. Bedridden for 1 day. Arm was swollen & hurt for 1 week.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lymphadenopathy, Myalgia, Pyrexia, Renal disorder
Clinical narrative: Chills, fever, muscle ache, swollen glands...felt like kidneys swollen...lasted 3 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain, Migraine
Clinical narrative: Patient only stated that the shot "hurt" when being administered and had no other complaints. The next day patient had a migraine headache which lasted for about 5 days. Patient is now getting headaches 1-2 times weekly which prevent patient from going to work.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Extreme fatigue, chills, nausea and headache. Patient was concerned that symptoms were lasting several weeks into the 2nd and 3rd week after shot. Was concerned that might be worse due to recent Bell's palsy episode on 5/5/2018. She said she still had slight facial numbness when she got the shot. Her doctor had recommended shot since she's at risk for shingles. After 3 weeks patient felt better and is fine now.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash, Skin lesion
Clinical narrative: Patient claims she got Shingles from SHINGRIX. She noticed a patch of breakout on her abdomen and went to urgent care, where she was prescribed VALTREX. We dispensed the VALTREX on 7/3 and I followed up with her on 7/5 when she was feeling some tingling in her arm and face. I followed up again on 7/10 and she stated that she felt much better. She had no pain and the lesion was getting better.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: Patient claims she got Shingles from SHINGRIX. She noticed a patch of breakout on her abdomen and went to urgent care, where she was prescribed VALTREX. We dispensed the VALTREX on 7/3 and I followed up with her on 7/5 when she was feeling some tingling in her arm and face. I followed up again on 7/10 and she stated that she felt much better. She had no pain and the lesion was getting better.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Scab, Vaccination complication
Clinical narrative: Rash - abdomen/trunk. Dots w/fluid, now scabbed over. Reaction to vaccine.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Urticaria
Clinical narrative: Approx 1 hour after vaccine on 7-9-2018, mom said that his behavior was over exaggerated, speaking loudly, making strange faces. Woke up this AM on 7-10-2018 covered in hives (mostly on torso and neck) but continued to spread.
Age: 56.0
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Severe pain 10/10 redness 4-5 inches long 2 inches wide at injection site. 7-5-18 dx cellulitis-given doxycycline, BENADRYL.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: After getting the first SHINGRIX shot the pain that I had previously when I had shingles four years ago came back and continues. It is on my right side and is very debilitating and limits my activity. My doctor prescribed LYRICA, 450mg/day, but no help so far. I haven't had any of the rash of shingles but just severe nerve pain.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: After getting the first SHINGRIX shot the pain that I had previously when I had shingles four years ago came back and continues. It is on my right side and is very debilitating and limits my activity. My doctor prescribed LYRICA, 450mg/day, but no help so far. I haven't had any of the rash of shingles but just severe nerve pain.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: After getting the first SHINGRIX shot the pain that I had previously when I had shingles four years ago came back and continues. It is on my right side and is very debilitating and limits my activity. My doctor prescribed LYRICA, 450mg/day, but no help so far. I haven't had any of the rash of shingles but just severe nerve pain.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Condition aggravated, Decreased activity, Neuralgia, Pain
Clinical narrative: After getting the first SHINGRIX shot the pain that I had previously when I had shingles four years ago came back and continues. It is on my right side and is very debilitating and limits my activity. My doctor prescribed LYRICA, 450mg/day, but no help so far. I haven't had any of the rash of shingles but just severe nerve pain.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Axillary pain, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Patient states the reaction started with her breaking out in hives and itching. On 7/1/18 began having bone and joint pain. Hives/rash continued. He was taken to the ER and prescribed steroids. Patient's mother reported reaction to HD on 7/5/8 and said that the patient was still having new hives. Stated that he saw his PCP on 7/6 and received more steroids (Orapred).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Urticaria
Clinical narrative: Patient states the reaction started with her breaking out in hives and itching. On 7/1/18 began having bone and joint pain. Hives/rash continued. He was taken to the ER and prescribed steroids. Patient's mother reported reaction to HD on 7/5/8 and said that the patient was still having new hives. Stated that he saw his PCP on 7/6 and received more steroids (Orapred).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Urticaria
Clinical narrative: Patient states the reaction started with her breaking out in hives and itching. On 7/1/18 began having bone and joint pain. Hives/rash continued. He was taken to the ER and prescribed steroids. Patient's mother reported reaction to HD on 7/5/8 and said that the patient was still having new hives. Stated that he saw his PCP on 7/6 and received more steroids (Orapred).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Rash, Urticaria
Clinical narrative: Patient states the reaction started with her breaking out in hives and itching. On 7/1/18 began having bone and joint pain. Hives/rash continued. He was taken to the ER and prescribed steroids. Patient's mother reported reaction to HD on 7/5/8 and said that the patient was still having new hives. Stated that he saw his PCP on 7/6 and received more steroids (Orapred).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Middle insomnia, Myalgia, Skin warm
Clinical narrative: Started to feel muscle soreness. Got worse and worse, started shivering and feeling really cold but when I touched my skin it felt hot. Shivering went away for a little while and I was able to sleep but then I woke up around 1:45am and started to shiver uncontrollably. My husband checked to see if I had a fever and I didn't.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cold sweat, Cyanosis, Hypotonic-hyporesponsive episode, Unresponsive to stimuli
Clinical narrative: Had an episode where had cold sweats, turned purple around lips/mouth, was "unresponsive" for 30 to 40 seconds. Mom had been nursing, then was going to put her down in crib and noted she was unresponsive, immediately put her feet in cold water and she woke up. I did not evaluate the patient afterwards and in fact, did not see her until 2 months later at her next check up. This episode seemed consistent with HHE (hypotonic hyporesponsive episode) associated with DTAP vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, aches, headache.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of adult patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unspecified dates, the patients were vaccinated with a dose of PROQUAD for prophylaxis (dose, route of administration, lot number and expiration date were not reported), reconstituted with water sterile diluent (lot number and expiration date were not reported). No adverse effects were reported for any patients. This is one of the two reports received from the same reporter. As of 09-JUL-2018, all telephone attempts to obtain follow-up information have been unsuccessful. This case was previously considered non-valid, but per current process it was determined to be valid as age group of the patients was provided. Sender's Comments: US-009507513-1710USA016158.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date in 2016, the patient was vaccinated with a dose of PREVNAR 13. On an unspecified day in 2017 and again on 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 (for both: strength, dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 24-JAN-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938: US-009507513-1806USA007939: US-009507513-1806USA007940: US-009507513-1801USA006139: US-009507513-1806USA007937.
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the patient's father, concerning a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 18-JUN-2018, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) lot # reported as 001543 with expiration date on 15-JUL-2019, for prophylaxis; and also with DTAP-IPV lot # C5325BA with expiration date on 14-NOV-2019 (strength, dose, route of administration or anatomical location were not provided for neither of them). Late that night, he was running a high fever at approximately 101 (units not provided). The outcome of high fever and the causality assessment for the suspect vaccines were not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, concomitant medications and past therapies were not reported. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot number: M019924, expiry date: 02-SEP-2018 for prophylaxis whose dose and route of administration were not reported. No adverse effects were reported. It was reported that vaccine was subjected to a temperature excursion of 71 degree F for a time frame of 2 hours. There was a previous temperature excursion in the range of 47 degree F to 77 degree F for a duration of 30 minutes. It was reported that call was because of a data logger. There was no product quality complaint (PQC) involved in the report. "Lot number [M019924] is an invalid lot number for [hepatitis a vaccine, inactivated]."
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. Concomitant therapies included sterile diluent (MERCK). The patient's concurrent conditions and medical history were not reported. In approximately March 2018, reported as "about 3 months ago", the patient was vaccinated with a dose of VARIVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and in approximately 2018, reported as "one week later", the patient was administered a dose of M-M-R II for prophylaxis (strength, dose, route, frequency, therapy type, lot/batch # and expiration date were not reported). No adverse effects were reported.