chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via other company (Merck). This case involves a female patient (age not reported) who experienced itching at the injection site, large area of swelling, redness, warmth at the injection site, swelling and redness of her face and swelling and redness of her face, while she received vaccine INFLUENZA VACCINE. The patient's past medical history and concomitant medication were not provided. On 31-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left arm. On an unknown date, The patient developed a non-serious itching at the injection site (vaccination site pruritus) following the administration of INFLUENZA VACCINE. On an unknown date, The patient developed a non-serious large area of swelling, redness, warmth at the injection site (vaccination site inflammation) following the administration of INFLUENZA VACCINE. On 01-Nov-2018, The patient developed a non-serious swelling and redness of her face (face oedema) 01 day following the administration of INFLUENZA VACCINE. On 01-Nov-2018, The patient developed a non-serious swelling and redness of her face (erythema) 01 day following the administration of INFLUENZA VACCINE. Final diagnosis was swelling and redness of her face, swelling and redness of her face, large area of swelling, redness, warmth at the injection site and itching at the injection site. No lab test was reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for itching at the injection site, as Recovering / Resolving for large area of swelling, redness, warmth at the injection site, as Recovered / Resolved on an unknown date for swelling and redness of her face and as Recovered / Resolved on an unknown date for swelling and redness of her face.
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via other company (Merck). This case involves a female patient (age not reported) who experienced itching at the injection site, large area of swelling, redness, warmth at the injection site, swelling and redness of her face and swelling and redness of her face, while she received vaccine INFLUENZA VACCINE. The patient's past medical history and concomitant medication were not provided. On 31-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left arm. On an unknown date, The patient developed a non-serious itching at the injection site (vaccination site pruritus) following the administration of INFLUENZA VACCINE. On an unknown date, The patient developed a non-serious large area of swelling, redness, warmth at the injection site (vaccination site inflammation) following the administration of INFLUENZA VACCINE. On 01-Nov-2018, The patient developed a non-serious swelling and redness of her face (face oedema) 01 day following the administration of INFLUENZA VACCINE. On 01-Nov-2018, The patient developed a non-serious swelling and redness of her face (erythema) 01 day following the administration of INFLUENZA VACCINE. Final diagnosis was swelling and redness of her face, swelling and redness of her face, large area of swelling, redness, warmth at the injection site and itching at the injection site. No lab test was reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for itching at the injection site, as Recovering / Resolving for large area of swelling, redness, warmth at the injection site, as Recovered / Resolved on an unknown date for swelling and redness of her face and as Recovered / Resolved on an unknown date for swelling and redness of her face.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 77-year-old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to underdose and syringe leak. It was reported that more than half through the injection when she noticed fluid leaking from the hub down the patient's arm. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Overdose
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a nine months old female patient who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT, lot UT6375NA, expiry date: 30-Jun-2019 via unknown route in the left thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was reported that MA had given a 9 month old patient, female, a .5ml dose of FLUZONE QUAD in the left thigh. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323313, 2018SA323314 and 2018SA323312 (same reporter). This case involves a 11 years old male patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) intramuscularly in left deltoid instead of 0.5 ml , on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. They accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVAENT instead of the 0.50mL dose. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA323313, 2018SA323314 and 2018SA323310 (same reporter). This case involves a 14 years old female patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) instead of 0.5 ml, on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. It was reported that they accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVALENT instead of the 0.50mL dose. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323313, 2018SA323312 and 2018SA323310 (same reporter). This case involves a 16 years old female patient who was vaccinated with 0.25ml FLUZONE QUADRIVALENT instead of 0.5 ml, on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Electrocardiogram, Hypertension
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 70 years old male patient who experienced high blood pressure, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were reported. On an unknown date (reported as 09-Nov-201), the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious high blood pressure (hypertension) (Unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. The patient went to a cardiologist a couple days ago and they performed EKG and advised him to keep monitoring readings. It was reported that his blood pressure increased in three days "from 120/70 to 150/100." Final diagnosis was high blood pressure. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for high blood pressure. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324609 (same reporter). This case involves a male patient of unknown age who received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB (expiry date: 31-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Right arm pain since shot in May, now in November.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Extreme Nausea and Vomiting, Dizziness.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity, X-ray limb
Clinical narrative: Approx 1 week after influenza vaccine patient developed pain in left arm and reduced range of motion. Patient complains that the pain is getting worse. Patient had had an xray of the L shoulder done. Seen by ortho and will follow up with PCP on Monday.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Headache, achy joints. Injection site: significant swelling, heat, tissue hardening, lumpiness to muscle still present after a week.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Headache, achy joints. Injection site: significant swelling, heat, tissue hardening, lumpiness to muscle still present after a week.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen area on left arm just below the injection area. Hot to the touch, and patient reports pain in joints.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: THIS VACCINE WAS ADMISTERED TO THE PATIENT AND IT WAS EXPIRED THE EXPRIRATION DATE IS 11/09/18.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: PATIENT HAD A RASH ON HER SHOULDER.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Lethargy, Pyrexia, Respiratory tract congestion
Clinical narrative: Screamed for over 3 hours after vaccine and ran a fever. He then was lethargic for a week; barely ate, didn't cry and seemed out of it. 24hrs after vaccine he developed congestion and runny nose.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Rhinorrhoea, Screaming
Clinical narrative: Screamed for over 3 hours after vaccine and ran a fever. He then was lethargic for a week; barely ate, didn't cry and seemed out of it. 24hrs after vaccine he developed congestion and runny nose.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Loss of personal independence in daily activities, Pain, Pruritus
Clinical narrative: Day after: tired, run down feeling. Body aches. Lasted full day. Couldn't do normal activities. Next day a little tired but much better. Took ibuprofen. Arm is still red after 3 days. Experiencing some itching by 3rd day. No rash.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports left arm pain since flu immunization. States pain has continued to be dull in left shoulder with occasional sharp, stabbing pain which radiates from neck to elbow. Reports is waking him from sleep, taking MOTRIN OTC with little effect. Unsure if pain is from vaccine but denies any other mechanism of injury. States vaccine given in tattoo which is not in area of bursa or joint. Does not remember needle hitting bone.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Location on right arm injection site redness noted, warm to touch.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and Erythema on right thigh, but no vesicles.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest discomfort, Dizziness, Dysgeusia, Feeling abnormal
Clinical narrative: Right after administering shot, patient said that she didn't feel quite right. Then she started feeling chest tightness and then a strange taste in her mouth. This was followed by dizziness. Then she said that she felt pain shooting down the middle of her back. She stated that she would not have been able to stand up at that point.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Right after administering shot, patient said that she didn't feel quite right. Then she started feeling chest tightness and then a strange taste in her mouth. This was followed by dizziness. Then she said that she felt pain shooting down the middle of her back. She stated that she would not have been able to stand up at that point.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient was unaware of pregnancy on the day of flu shot. Patient received the regular flu vaccine and not the preservative free. Nurse asked if patient is pregnant or planning to be pregnant. Patient responded with no. Regular QIV flu vaccine was given with no adverse effects noted. At a later time the patient went to her primary doctor for a checkup and found out she miscarried. She tried to think back to the possibility of being pregnant when receiving the flu shot, and remembered that she received the regular vaccine and not the preservative free vaccine. Patient was given information about the vaccines and had no previous reactions to regular QIV vaccine before. She was worried that due to the preservative she miscarried. Education was provided. Writer spoke with patient and patient understood information provided. No further follow up was done on behalf of writer.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chest pain, Diarrhoea, Dyspnoea, Erythema
Clinical narrative: Instant arm redness to elbow, swelling, pain. Next day severe abdominal pain for 1 week, 2 days radiating into chest with shortness of breath. 1 week of bilateral leg pain consistent with restless leg symptoms. Right heel pain feeling like gout for 3 days, multiple loose/liquid stools daily for 4 days.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Restless legs syndrome, Swelling
Clinical narrative: Instant arm redness to elbow, swelling, pain. Next day severe abdominal pain for 1 week, 2 days radiating into chest with shortness of breath. 1 week of bilateral leg pain consistent with restless leg symptoms. Right heel pain feeling like gout for 3 days, multiple loose/liquid stools daily for 4 days.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen and red went to urgent care given BENADRYL and KEFLEX.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Biopsy skin abnormal, Breast pain, Chest discomfort
Clinical narrative: 7/39/2018, extremely fatigued in morning; took 3+ hour nap in morning and tired rest of day. Also, digestive system felt off. By dinner, appetite and energy increased. 7/31/2018, awoke with indigestion and took famotidine. In afternoon, felt light pressure in chest but then subsided. Back pain developed in one spot on right shoulder blade area. Up part of night with strong pain in same spot on back.    Also, very sharp pains in right breast radiating into chest. During the night and into next day. Saw cardiologist on 8/2 and PCP on 8/3. Both checked for rash but none present. 8/4, awoke with no right back pain but same pain in chest. 8/5, awoke with shooting and intense pains on right side of back.   Developed rash on right side of back. 8/6, dermatologist Dr., said it was Shingles and did biopsy.  Confirmation of shingles Dx on 8/14.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Decreased appetite, Dyspepsia, Fatigue, Gastrointestinal disorder
Clinical narrative: 7/39/2018, extremely fatigued in morning; took 3+ hour nap in morning and tired rest of day. Also, digestive system felt off. By dinner, appetite and energy increased. 7/31/2018, awoke with indigestion and took famotidine. In afternoon, felt light pressure in chest but then subsided. Back pain developed in one spot on right shoulder blade area. Up part of night with strong pain in same spot on back.    Also, very sharp pains in right breast radiating into chest. During the night and into next day. Saw cardiologist on 8/2 and PCP on 8/3. Both checked for rash but none present. 8/4, awoke with no right back pain but same pain in chest. 8/5, awoke with shooting and intense pains on right side of back.   Developed rash on right side of back. 8/6, dermatologist Dr., said it was Shingles and did biopsy.  Confirmation of shingles Dx on 8/14.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Pain, Rash, Somnolence
Clinical narrative: 7/39/2018, extremely fatigued in morning; took 3+ hour nap in morning and tired rest of day. Also, digestive system felt off. By dinner, appetite and energy increased. 7/31/2018, awoke with indigestion and took famotidine. In afternoon, felt light pressure in chest but then subsided. Back pain developed in one spot on right shoulder blade area. Up part of night with strong pain in same spot on back.    Also, very sharp pains in right breast radiating into chest. During the night and into next day. Saw cardiologist on 8/2 and PCP on 8/3. Both checked for rash but none present. 8/4, awoke with no right back pain but same pain in chest. 8/5, awoke with shooting and intense pains on right side of back.   Developed rash on right side of back. 8/6, dermatologist Dr., said it was Shingles and did biopsy.  Confirmation of shingles Dx on 8/14.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Patient developed hives and itching 2-3 hours all over body.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Immunisation, Underdose
Clinical narrative: Administered pediatric dose to adult, Adult dose given today to correct.
Age: 0.5
Sex: M
Vaccine: FLU4, PNC13, RV5, TDAP
Symptoms: Wrong product administered
Clinical narrative: During 11/26/18 Well visit patient was given a Tdap instead of PEDIARIX. Vaccine error has been reported to the Health Dept. via VAERS thru records system. Voice report has been made as well. I have also spoken with health dept & patient will need to have the PEDIARIX repeated again. Patient has appointment for 12/27/18 for 2nd flu shot & will give Pediarix at that time. Health dept said that would be great timing. Thank you.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, tender, swollen.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye swelling, Wheezing
Clinical narrative: Patient developed left eye swelling, cough, wheezing, shortness of breath 4-5 hours after injection administration. Mother called EMS to take patient to hospital where he was treated for symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Herpes zoster, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 22-NOV-2016, the patient received the ZOSTAVAX for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered throbbing with occasional radiating muscle pain, numbness, difficulty swallowing, rash, and nausea. In or around December of 2016, the patient presented to an urgent care for these injuries and was diagnosed with an unspecified viral infection. In or around December of 2016, the patient presented to her physician for worsening of the same injuries and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations and pain not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and lasting personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Numbness, difficulty swallowing, nausea, shingles and unspecified viral infection were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Viral infection
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 22-NOV-2016, the patient received the ZOSTAVAX for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered throbbing with occasional radiating muscle pain, numbness, difficulty swallowing, rash, and nausea. In or around December of 2016, the patient presented to an urgent care for these injuries and was diagnosed with an unspecified viral infection. In or around December of 2016, the patient presented to her physician for worsening of the same injuries and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations and pain not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and lasting personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Numbness, difficulty swallowing, nausea, shingles and unspecified viral infection were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-OCT-2011, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 26-NOV-2016 the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. In 2014, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2014, the patient was treated by the same physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chest X-ray normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Head injury
Clinical narrative: My son received his vaccinations and passed out in the lobby of the doctors office as we were leaving. He hit his head on the cement floor and had to be taken to the ER.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Headache, Loss of consciousness
Clinical narrative: My son received his vaccinations and passed out in the lobby of the doctors office as we were leaving. He hit his head on the cement floor and had to be taken to the ER.
Age: 43.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Dyspnoea, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient became unconscious momentarily and started to have breathing difficulty and would not answer when tried to conversate. This happened immediately after giving the MMR shot. TWINRIX shot was given about 2 or 3 minutes prior to this shot.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Muscle tightness, Pain in extremity
Clinical narrative: PT REPORTS FEELING INTENSE PAIN TRAVELING DOWN LEFT ARM, STARTING ABOUT 2 HOURS AFTER VACCINATION. ALSO REPORTS INTENSE ABDOMINAL DISCOMFORT AND TIGHTNESS AROUND NECK AND TORSO. HAS "CHILLS" RUNNING DOWN LEFT ARM. PT DENIES DIZZINESS, SHORTNESS OF BREATH, DIFFICULTY BREATHING OR DIFFICULTY SWALLOWING.
Age: 36.0
Sex: U
Vaccine: UNK
Symptoms: Musculoskeletal pain
Clinical narrative: L shoulder has ongoing sorenesss since flu shot..no signs of infection, no redness, no swelling, no warmth..just general achiness.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: KINRIX given to a 4mth old. Intended for 4-6year old. No adverse reactions.
Age: 68.0
Sex: U
Vaccine: PNC13
Symptoms: Diarrhoea, Loss of consciousness, Rectal haemorrhage
Clinical narrative: Pt reported passed out for 1 hour had diarrhea and rectal bleeding.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Rash
Clinical narrative: The patient stated that her left arm (site of PNEUMOVAX 23) developed a large, hard, red spot near the injection site and that she woke up with a rash on her left leg the next day. No issues were identified on the right side of her body.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Injection site discolouration, Injection site induration, Injection site nodule
Clinical narrative: Pt has a round elongated dusky discoloration on the left thigh area starting at vaccine admin site extending to the Lt of injection site apprx 5 cm x 2 cm. Hardened knot SQ. No warmth or pain with evaluation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Swollen tongue, Tremor, Vomiting
Clinical narrative: Patient got vaccine at 7:45PM 11/28/18 and at 8:15PM that same night she experienced what she described to me on 11/29/18 as severe shaking. She stated she also vomited several times and had diarrhea. She said for a short period of time, she felt that her tongue was swelling but that resolved shortly without the aid of any medication. She did not seek medical attention and stated she feels completely fine today - just tired. I asked if there were any other differences in her routine that day and she said no. She said that she has had flu shots in the past without an issue.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Extreme tiredness. Headache. Nausea. Pain at injection site and further down arm. Weakness.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: Extreme tiredness. Headache. Nausea. Pain at injection site and further down arm. Weakness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pain
Clinical narrative: Patient states that the day she received the vaccine she felt like she was hit with the "flu"...when asked to elaborate, she stated that she has pain all over her body and red circular welts on the arm where she received the vaccine that has not gone away.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: Patient developed severe pain by shoulder bone area in the middle of the night. Patient also experienced redness. Site of reaction was 3 inches from injection site.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain
Clinical narrative: Pain down the patient's side.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling hot, Flushing
Clinical narrative: Pt had a significant increase in blood pressure up to 204/102 that evening following administration. She also said she was very flushed and hot all over.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Present with mother. Has a large red spot where he got his vaccinations yesterday. He removed the band aid last night and there was just a tiny spot where the needle had gone in. This morning the redness had spread, now it is larger. He hasn't acted sick, no fever, is eating and playing as usual. He hasn't been touching it. When questioned he says it hurts. Treatment diphenhydrAMINE 12.5 mg/5 ml oral liquid, 8.75 mg, 3.5 mL, ORAL, TID, PRN. Children's Vitamins with Iron oral tablet, chewable, 1 Tab, CHEW, DAILY, 5 refills. Hydrocortisone topical 2.5% ointment, 1 Applic, TOP, BID.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: Woke up next morning was very achy knee joints slight headache and fever of 100.4. Also significant soreness at the injection site beginning approximately one hour after the injection.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash generalised
Clinical narrative: Rash on arms, legs, back and stomach beginning 3 days after vaccination. Patient received 2 rounds of MEDROL dose-pak, but after completion both times the rash returned.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: Muscle soreness, shivering, no fever, kind of flu-like symptoms, no nausea. Going on 24 hours now, not ended yet.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient experienced tightening of the throat area, was concerned and was close to a fire department, where he entered and was given help. They called ambulance that transferred him to the emergency room. He was given a steroid to help control the reaction. Patient came into store with wife who had gotten a SHINGRIX to buy BENADRYL as precautionary.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient reported arm pain and numbness immediately following vaccine. The pain turned to stiffness and limited motion of raising the arm (right). She approached her doctor about a month later and he started her on physical therapy. The use and motion has improved, but the pain is still present.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injected limb mobility decreased, Injection site nerve damage, Injection site pain, Injection site reaction
Clinical narrative: Extreme pain at injection site during and after Flu shot. 5 days later, the site was spasming, the pain was excruciating and I couldn't lift the arm. Went to the Emergency Room the following morning. Dr. ran Blood Tests, took X-rays and determined I had been mistakenly injected in the Radial nerve.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Product administered at inappropriate site, X-ray
Clinical narrative: Extreme pain at injection site during and after Flu shot. 5 days later, the site was spasming, the pain was excruciating and I couldn't lift the arm. Went to the Emergency Room the following morning. Dr. ran Blood Tests, took X-rays and determined I had been mistakenly injected in the Radial nerve.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: I expected pain in my arm, but last night hurt all over and was cold. Couldn't sleep. Today had fever over 101. Typical fever symptoms. Headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I expected pain in my arm, but last night hurt all over and was cold. Couldn't sleep. Today had fever over 101. Typical fever symptoms. Headache.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Severe right arm pain. Decreased range of motion.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Fever, headache, are swelling and redness, general body aches, sore throat, nausea.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever, headache, are swelling and redness, general body aches, sore throat, nausea.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient stated that the day after the shot (11/27/18) her arm was sore to move and her range of motion was limited when she raised her arm at the shoulder. She stated the injection site was a bit swollen and the swelling increased to her shoulder area. Today(11/29/18)the area was getting better and she was able to move her shoulder more. She wanted to know if it would just take time. Suggested calling her physician also.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Vomiting
Clinical narrative: Pt vomited and had redness around the neck.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: 1 1/2 days later my left arm had swollen to a 1 inch welt that went half way around the circumference of my arm! I had asked for a quadravalent flu shot but was told by the pharmacist that he could only give me a high dose shot. I read online that the shot was equal to 4 adult flu shots. I think a secondary prodical should be written for those of us who overreact to vaccinations. Maybe I could have a booster shot in a month or something. Please do not make me take a high dose shot next year. Thanks for listening.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle soreness greater than 1 month post administration with pain intensifying when limb is hyper flexed. Stated that it is however slowly getting better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: Chills all night. Malaise.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in pharmacy on 11-2-18 to show me her upper left arm which was pink, warm to touch, swelling only on top upper arm, and mild pain. She received her shot on 11-19-18 but did not feel symptoms until 11-23-18. She asked me if these symptoms were related to her vaccine injection. I recommend.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Lethargy, Nausea
Clinical narrative: Chills, fever and flu-like symptoms, extreme exhaustion and lethargy, nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever and flu-like symptoms, extreme exhaustion and lethargy, nausea.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Injection site pain
Clinical narrative: Fatigue and nausea starting the evening of 11/27/18 and continuing until now (11/29/18) although these symptoms are slowly decreasing. Chills on 11/27/18 around 11pm, then I awoke in the middle of the night very sweaty. Unsure if I had a fever as I did not take my temperature. I felt as if I had the flu, felt somewhat better in the morning and did not have a fever.  The injection site and surrounding area was very sore but pain is steadily decreasing.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: Fatigue and nausea starting the evening of 11/27/18 and continuing until now (11/29/18) although these symptoms are slowly decreasing. Chills on 11/27/18 around 11pm, then I awoke in the middle of the night very sweaty. Unsure if I had a fever as I did not take my temperature. I felt as if I had the flu, felt somewhat better in the morning and did not have a fever.  The injection site and surrounding area was very sore but pain is steadily decreasing.
Age: 91.0
Sex: M
Vaccine: FLUA3
Symptoms: Dyspnoea, Injection site erythema, Injection site irritation, Injection site pain, Muscular weakness
Clinical narrative: Patients daughter-in-law, called me on 11-19-18 to report that after her father-in-law, received FLUAD on 10-14-18 from our pharmacy. He initially had a lot of redness and painful irritation at the injection site. She called us and we told her to put ice on it and use acetaminophen for the pain. She did that but it continued to hurt and the patient now had arm weakness in the vaccinated arm and can't raise his arm, hold a cup, or feed himself. His hand also shakes. Patient had an XRay done of his arm and it did not show any muscle damage. His health has also deteriorated since he had the flu shot-He not is having shortness of breath and is coughing up white and yellow phlegm. He now is having shortness of breath and is coughing up white and yellow phlegm. She is concerned since has never had a reaction to a flu shot before. She thinks the flu shot was given too high, close to his rotator cuff per daughter-in-law. She also thinks there was nerve damage from the flu shot that caused all these problems. Nurse told her this is very unusual to have this kind of reaction to a flu shot. She suggested she see a physician about the muscle weakness/breathing issues.
Age: 91.0
Sex: M
Vaccine: FLUA3
Symptoms: Productive cough, Tremor, X-ray
Clinical narrative: Patients daughter-in-law, called me on 11-19-18 to report that after her father-in-law, received FLUAD on 10-14-18 from our pharmacy. He initially had a lot of redness and painful irritation at the injection site. She called us and we told her to put ice on it and use acetaminophen for the pain. She did that but it continued to hurt and the patient now had arm weakness in the vaccinated arm and can't raise his arm, hold a cup, or feed himself. His hand also shakes. Patient had an XRay done of his arm and it did not show any muscle damage. His health has also deteriorated since he had the flu shot-He not is having shortness of breath and is coughing up white and yellow phlegm. He now is having shortness of breath and is coughing up white and yellow phlegm. She is concerned since has never had a reaction to a flu shot before. She thinks the flu shot was given too high, close to his rotator cuff per daughter-in-law. She also thinks there was nerve damage from the flu shot that caused all these problems. Nurse told her this is very unusual to have this kind of reaction to a flu shot. She suggested she see a physician about the muscle weakness/breathing issues.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Excessive eye blinking, Laboratory test, Tremor
Clinical narrative: Shaking episodes, started with slight jerking of her arms. Rapid eye blinking and shoulder shrugging, then whole body jerking.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Crying, Erythema, Pruritus, Skin warm, Swelling face
Clinical narrative: Patient received 3 vaccines around 1045AM. I returned to the exam room about 4 minutes later with a copy of vaccine record - patient was dressed and had his winter coat on - no issues noted. Around 11AM - patient and mother are at registration area - checking out - patient is crying, and scratching his body - clerk called triage nurse. Patient was given BENADRYL. Face swollen and body red, hot with hives EPIPEN Jr. administered approximately 1110 AM. Ambulance called to Health Center. Patient and mother transported to ECU.