chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site cellulitis, Injection site irritation, Injection site joint pain, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (for tolerance refer case US2018GSK228829).  On 4th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, erythema of extremities, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm. On an unknown date, the patient experienced injection site irritation. The patient was treated with clindamycin. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine on her right shoulder. The nurse might have gone too high on her shoulder she said because it was very painful and worse than the first.  It became hot, red, irritated and by the 6th, she took a picture. The patient shoulder was as big as a tennis ball. She went to visit the physician who prescribed clindamycin 300mg four times daily if the site did not calm down. On 7th December 2018, the patient started taking clindamycin on afternoon. The patient suspected she had cellulitis. On the date of reporting the redness was lessened but the redness might spread down her arm a bit. Her bicep on her right arm was swollen and hurts all over at the time of reporting. The reporter gave consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (for tolerance refer case US2018GSK228829).  On 4th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, erythema of extremities, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm. On an unknown date, the patient experienced injection site irritation. The patient was treated with clindamycin. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, erythema of extremities, injection site irritation, injection site swelling, injection site cellulitis, injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine on her right shoulder. The nurse might have gone too high on her shoulder she said because it was very painful and worse than the first.  It became hot, red, irritated and by the 6th, she took a picture. The patient shoulder was as big as a tennis ball. She went to visit the physician who prescribed clindamycin 300mg four times daily if the site did not calm down. On 7th December 2018, the patient started taking clindamycin on afternoon. The patient suspected she had cellulitis. On the date of reporting the redness was lessened but the redness might spread down her arm a bit. Her bicep on her right arm was swollen and hurts all over at the time of reporting. The reporter gave consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain, Pruritus, Swelling
Clinical narrative: Severe pain in arm at injection site began about 12 hours after the vaccine was administered. Redness, swelling, itching, pain to the touch began the next day. Three days have passed and the pain, redness and swelling have not subsided.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Within 24 hrs. I began to experience pain in my left shoulder. Over the next 3 days the pain began in my right shoulder, then in both hip joints. Over the next 3 weeks the pain increased in severity. Mobility became more and more difficult. Getting in a vehicle, into bed, sitting, standing, and bending over increased in difficulty and pain level. As of this date, my freedom of movement is about half of what it was prior to the shot. ADVIL, ALEVE, BC-POWDERS give temporary relief from the pain but continued use of these products is not in my best interest.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-NOV-2018, the patient was vaccinated with a dose of PROQUAD lot # N028445 with expiration date on 09-APR-2019 (exact dose, dose number and route of administration were not reported) . The vaccine was reconstituted with a sterile diluent. On the same day, he patient was concomitantly vaccinated  with a dose of VARIVAX lot# 006221 with expiration date on 29-FEB-2020 (exact dose and route of administration were not reported), for prophylaxis. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a 1-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 26-NOV-2018 at 03:38, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R010466 with expiration date 10-APR-2020, (frequency, strength, anatomical location or route of administration were not provided), administered subcutaneously for prophylaxis. The storage temperatures of the VARIVAX were reported as between -14 and -10 degrees Celcius for a time frame of 30 minutes. There was no previous temperature excursion. The call was due to a data logger. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were unknown. On 01-DEC-2018, the patient was vaccinated with VARIVAX via intramuscular instead of the subcutaneous route (incorrect route of product administration) (lot # R018140 and expiry date: 25-JUN-2020) for prophylaxis (dose, frequency and anatomical location not reported). No adverse effect reported (no adverse event). No product quality complaint. Outcome of incorrect route of product administration was not reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative regarding a female patient of unknown age. Patient's medical history, current conditions and concomitant therapies were not provided. On an unknown date in November 2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were unknown) as routine vaccination. On an unknown date, the patient experienced injection site to be swollen (infusion site swelling) and a hard knot (injection site nodule). Outcome and causality not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Antibody test negative, Maternal exposure before pregnancy
Clinical narrative: This spontaneous report was received from a 40 year old female consumer referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On an unknown date in 1996, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot # and expiration date were not reported) for chicken pox. In June 2018 (reported as 6 months ago), the patient experienced a miscarriage (vaccine exposure before pregnancy). The patient reported that her fertility doctor checked her immunity to varicella via "blood work" on an unspecified date in 2018.  In approximately November 2018 (reported as about a month ago), the patient reported she had a negative titer for varicella. It was also reported that she had not yet received another dose of varicella vaccine because she was unable to locate a doctor or pharmacy who would administer the dose to an adult. No treatment was given and the patient had sought medical attention from the physician. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter. Upon internal review, miscarriage was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, A pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, 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 vaccine, 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 was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s), a pharmacist at a pharmacy  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 17-JUN-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 17-DEC-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Vaccination site pain
Clinical narrative: This spontaneous report was received from a 68-year-old male patient and refers to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-DEC-2018 (reported as yesterday), the patient was vaccinated with a dose of PNEUMOVAX 23 in the left shoulder muscle (dose, route of administration, lot # and expiration date were not provided) for pneumonia prevention. On the same date, approximately one hour after being administered the vaccine, the patient had some routine blood work drawn around his left elbow area (results were not provided). On the same date (reported as later that night), the patient's left area where he got the vaccination shot became surprisingly sore. No treatment was given to the patient. The patient did not seek medical attention. The outcome of the event was reported as recovering. The relatedness between the event and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a healthcare facility/office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). Later in 2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 11-OCT-2013, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided).  In November 2013, the patient was treated by a healthcare provider at a primary care office 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.
Sex: M
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 male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 08-SEP-2009, a physician at a family practice administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 14-JUL-2014, 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 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case linked to 2018SA388039 (cluster). This case involves a three years old male patient (98.425 cm and 15.238 kg) who received IPV (VERO) [IPOL] lot N1K921M, expiry date: 14 Nov 2019 via intramuscular route in unknown administration site on 15-Nov-2018 which was exposed max temp of 10 c for three hours one min. The patient's past medical history included Iron deficiency. It was also reported that, the patient had no known drug allergy. The patient's past vaccination(s) included BCG VACCINE. The patient's past medical treatment(s) and family history were not provided. Concomitant medications included 15 mg FERROUS SULPHATE [FERROUS SULFATE] for iron deficiency (PO) on 12 Apr 2018. It was actual medication error due to incorrect product storage. It was reported that the patient received the vaccine which was out of the acceptable temperature range. It was reported that the patient did not experienced any adverse event. It was also reported that, the patient did not need to be revaccinated. 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. Follow up information received on 04-Dec-2018 regarding an unsolicited non-valid non-serious case received from a physician. No new information updated. Follow up information was received on 04-Dec-2018 received from a physician. Patient details, patient history details, concomitant medication, product details were updated and adverse event description updated along with linked case. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old patient who received the 0.5 ml FLUZONE QUAD instead of the 0.25 ml, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a once 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260AA via unknown route in the left thigh. It was a case of actual medication error due to overdose. The patient outcome is reported as Not Applicable for 9 month old patient received the 0.5 ml FLUZONE QUAD instead of the 0.25 ml. 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.
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received vaccine PENTACEL (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; PREVNAR for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On an unknown date, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U1953AAA via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. Pentacel given to a patient and afterwards the practice received an email that shipment was delayed. It was unknown whether adverse event occurred or not. 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: Product dose omission
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who had male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to missed dose. Final diagnosis was male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose. 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.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, headache, joint pain and stiffness, soreness in right arm at injection site, mild red rash at injection site, fatigue.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Joint stiffness, Pyrexia
Clinical narrative: Fever, headache, joint pain and stiffness, soreness in right arm at injection site, mild red rash at injection site, fatigue.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: The client was given PEDIARIX and IPV during the same visit.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea
Clinical narrative: The student was vaccinated during a morning flu clinic at school. She returned to class and came back down to the clinic and said she felt dizzy and nauseous. She laid down, elevated legs and had water. Temp was 98.1. She returned to class 12 minutes later.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Chest X-ray normal, Lethargy, Mobility decreased, Pyrexia
Clinical narrative: Patient showed lethargy and a low grade fever. It then progressed to him refusing to move or babble. And all he did was glare into space. I am filing this because although the pediatricians and doctors were unsure of what caused this, I believe it was a reaction and it needs documented and added to statistics of other children who encountered this "event".
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Staring, Ultrasound abdomen normal, Urine analysis normal
Clinical narrative: Patient showed lethargy and a low grade fever. It then progressed to him refusing to move or babble. And all he did was glare into space. I am filing this because although the pediatricians and doctors were unsure of what caused this, I believe it was a reaction and it needs documented and added to statistics of other children who encountered this "event".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Extreme muscle aches, nausea, dizziness, fever, extreme fatigue.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Generalized urticarial rash on face, abdomen, back.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of the left arm, Keflex 500mg 1 capsule four times daily, Prednisone 20 mg 2 tabs daily.
Age: 44.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Macule, Skin lesion
Clinical narrative: Two macular erythematous lesion 0.5 x 1 cm; another 0.5 x 0.5 cm diameter. Both on the left upper extremity.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Disorientation, Hypotonia, Pallor, Pulse abnormal, Rash macular
Clinical narrative: Patient received all above reported vaccines. Within 5 minutes after last vaccine given patient became pale. Said room was spinning and became limp. Ammonia was used and began to perk up a little. Pulse was 40 and weak. Remained conscious but disoriented. Able to state his name. Laid patient down. Recheck of pulse 4 minutes later 56 and regular. B/p  98/64. Patient began to feel better after laying for 10 minutes. Color back. Said his vision was normal. Denies any feeling of room spinning. B/P in lying position 100/68, sitting 110/64 and standing 120/70. Noted some splotchiness of hands. This improved in approximaetly 15 min. Dad refused to have a squad called or transport to hospital to have checked. Said if reoccurance of symptoms he would take him, but that he didnt have any insurance. Patient released from office 45 min. after event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Vertigo
Clinical narrative: Patient received all above reported vaccines. Within 5 minutes after last vaccine given patient became pale. Said room was spinning and became limp. Ammonia was used and began to perk up a little. Pulse was 40 and weak. Remained conscious but disoriented. Able to state his name. Laid patient down. Recheck of pulse 4 minutes later 56 and regular. B/p  98/64. Patient began to feel better after laying for 10 minutes. Color back. Said his vision was normal. Denies any feeling of room spinning. B/P in lying position 100/68, sitting 110/64 and standing 120/70. Noted some splotchiness of hands. This improved in approximaetly 15 min. Dad refused to have a squad called or transport to hospital to have checked. Said if reoccurance of symptoms he would take him, but that he didnt have any insurance. Patient released from office 45 min. after event.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 20-NOV-2018, the patient was vaccinated with expired dose of GARDASIL 9 lot # M024261, expiry date: 30-JUL-2018 (dose and route of administration were not reported) for prophylaxis. No adverse symptoms were reported.
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Differential white blood cell count normal, Full blood count, Immune thrombocytopenic purpura, Petechiae
Clinical narrative: This spontaneous report was received from a consumer via a company representative, and refers to her 3 year old female child. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-DEC-2018 (reported as 8 days ago), the patient received PROQUAD injection (the reporter assumed that the administered dose was 0.5 mL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was reported that a sterile diluent was used. On an unspecified date in December 2018, the patient experienced bruising and petechiae. On follow up, the patient appeared to have idiopathic thrombocytopenia (ITP) on her presentation. Complete blood count (CBC) with differential, performed in December 2018, showed a platelet of 9 (units not provided), but all other cell lines were normal. By the time of the report, the outcome of idiopathic thrombocytopenia was not reported. In addition, the relatedness between the event and PROQUAD was reported as possibly related.
Sex: F
Vaccine: MMRV
Symptoms: Platelet count decreased
Clinical narrative: This spontaneous report was received from a consumer via a company representative, and refers to her 3 year old female child. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-DEC-2018 (reported as 8 days ago), the patient received PROQUAD injection (the reporter assumed that the administered dose was 0.5 mL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was reported that a sterile diluent was used. On an unspecified date in December 2018, the patient experienced bruising and petechiae. On follow up, the patient appeared to have idiopathic thrombocytopenia (ITP) on her presentation. Complete blood count (CBC) with differential, performed in December 2018, showed a platelet of 9 (units not provided), but all other cell lines were normal. By the time of the report, the outcome of idiopathic thrombocytopenia was not reported. In addition, the relatedness between the event and PROQUAD was reported as possibly related.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 12-DEC-2018, the patient was vaccinated with VARIVAX lot # R017641, expiration date 20-JUN-2020, intramuscularly (dose, dose number and anatomical location were not provided). The VARIVAX was reconstituted with sterile diluent, lot number M024765, expiration date 20-FEB-2019. The outcome of incorrect route of product administration and no adverse event was unknown.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 76-year-old female patient. The patient had no known pertinent medical history and drug reaction or allergies. On 27-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R012976, expiration date 25-JAN-2020, in the left arm, one injection to avoid pneumococcal disease. On 27-NOV-2018 (reported as "a few hours later"), the patient developed a bump at the injection site, which spread towards the elbow and became red and swollen. The patient applied warm compresses and VICKS VAPORUB (reported as VICKS), which provided mild relief. The patient visited the medical office on 30-NOV-2018 and the swelling and redness had gone down a little. The patient returned to the medical office on 07-DEC-2018 and was fully recovered. There was no lab diagnostics and studies performed. The causality assessment between the events and the suspected therapy was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers 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 16-JUL-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider 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 vaccine, 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 considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2014, the patient was treated by a healthcare provider at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 26-MAR-2009, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 27-MAR-2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever to 103, diarrhea.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Alopecia, Dry skin, Erythema, Inflammation
Clinical narrative: Dry red patches at the bridge of the nose and above the eye lid, at the tip of the nose, inside the elbows, and on the thighs. Also my scalp got very inflamed with the same dry skin patches and some hair loss. I take the Flurbiprofen for osteoarthritis in my hands and noticed that when I took it, only used when needed, it started to alleviate the condition and when I didn't take it, it would come back. So I started taking the full dose daily, 1 pill twice a day. It has not completely alleviated the problem but has dramatically improved it. So this has been going on since End of September and continues but appears to be going away. My plan is to continue to take the Flurbiprofen until it does. It looks about 90% gone as of today, progress is very slow.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Started approximately 11 hours after shot with flu-like symptoms including headache, chills and muscle/joint aches and fatigue for a period lasting 24 hours. Severe pain at the site of shot including large patch of redness and swelling which is still occurring at this time approximately 40 hours after shot.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Started approximately 11 hours after shot with flu-like symptoms including headache, chills and muscle/joint aches and fatigue for a period lasting 24 hours. Severe pain at the site of shot including large patch of redness and swelling which is still occurring at this time approximately 40 hours after shot.
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Chest X-ray normal, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: The patient is a healthy 19 yo male with a history of CP who received SPV #1 (ACA Lot number the V03019C) on 26 September, 2018 to his R upper arm in addition to Hep B (SKB lot #1034864), typhoid (lot #N1k12) & Anthrax (MIP #FAV570A). He reports he has a history of chest pain intermittent sharp fleeting 1-2 times a month at mid chest he reports he did not take time to have this evaluated. He reports approximately 1 week after SPV receipt he developed new severe sharp, aching near continuous chest pain midsternal and periphery to the heart area 8-9 out of 10. He reports it was worse supine and would wake him from sleep. It continued throughout the day and worsened at night. It would improve after sitting up and have episodes of 10-15 seconds of worsening pain. He states he experienced shortness of breath prior to this onset that would improve with deep breathing and that this was worsened with the onset of his pain. He describes palpitations when awoken at night with the pain which have improved. He denies peripheral edema, nausea or vomiting, or diaphoresis. He saw PCP day 7, but had normal exam & EKG. He was seen again on day 16 and had EKG ST elevation changes consistent with pericariditis.
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram normal, Full blood count normal, Influenza A virus test positive
Clinical narrative: The patient is a healthy 19 yo male with a history of CP who received SPV #1 (ACA Lot number the V03019C) on 26 September, 2018 to his R upper arm in addition to Hep B (SKB lot #1034864), typhoid (lot #N1k12) & Anthrax (MIP #FAV570A). He reports he has a history of chest pain intermittent sharp fleeting 1-2 times a month at mid chest he reports he did not take time to have this evaluated. He reports approximately 1 week after SPV receipt he developed new severe sharp, aching near continuous chest pain midsternal and periphery to the heart area 8-9 out of 10. He reports it was worse supine and would wake him from sleep. It continued throughout the day and worsened at night. It would improve after sitting up and have episodes of 10-15 seconds of worsening pain. He states he experienced shortness of breath prior to this onset that would improve with deep breathing and that this was worsened with the onset of his pain. He describes palpitations when awoken at night with the pain which have improved. He denies peripheral edema, nausea or vomiting, or diaphoresis. He saw PCP day 7, but had normal exam & EKG. He was seen again on day 16 and had EKG ST elevation changes consistent with pericariditis.