chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 02-MAY-2014, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). On or about 17-NOV-2015, the patient was treated by a healthcare professional at the same medical branch 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
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 2009, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-OCT-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 zoster vaccine live (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: 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 20-OCT-2016, 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). On or about 30-OCT-2016, the patient was treated by his 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 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: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an approximately 64 year old  patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date in 2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, was not reported ) (lot # reported as N037669, expiration date 09-MAY-2018) , intramuscularly for prophylaxis. No adverse effects were reported. Lot number N037669 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a patient (age and gender were unknown). The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL (batch/lot#, expiration date and route were unknown) for prophylaxis. The patient would now like to received a third dose of GARDASIL 9 (batch/lot#, expiration date and route were unknown) for prophylaxis (interchange of vaccine products). No adverse symptoms reported. The outcome of the events was unknown. No PQC presented.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Fatigue, Injection site pain, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 70 years old female patient who experienced soreness at the injection site, right arm started to ache, the pain then moved up to the the right shoulder, back and rib cage on her back started to hurt and fatigue, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left upper arm. On an unknown date, the patient developed a non-serious soreness at the injection site (vaccination site pain) 24 hours following the administration of INFLUENZA VACCINE. Next the pain radiated to the Right Arm to a previous bruise that the patient obtained by bumping into something. Her Right Arm started to Ache more (Pain in arm) after the Flu Shot. The pain then moved up to the Right Shoulder (Shoulder pain) 3 days after the Flu Shot. The pain of her Right Arm was worse at night. Next her pathient's Back and Rib Cage on her Back started to hurt (Back discomfort) which started 5 days after the Flu Shot. The patient also experienced Fatigue for the last 2 weeks after obtaining the Flu Shot. (Other relevant tests included No lab data reported.) Final diagnosis was fatigue, back and rib cage on her back started to hurt , the pain then moved up to the the right shoulder, right arm started to ache and soreness at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 70 years old female patient who experienced soreness at the injection site, right arm started to ache, the pain then moved up to the the right shoulder, back and rib cage on her back started to hurt and fatigue, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left upper arm. On an unknown date, the patient developed a non-serious soreness at the injection site (vaccination site pain) 24 hours following the administration of INFLUENZA VACCINE. Next the pain radiated to the Right Arm to a previous bruise that the patient obtained by bumping into something. Her Right Arm started to Ache more (Pain in arm) after the Flu Shot. The pain then moved up to the Right Shoulder (Shoulder pain) 3 days after the Flu Shot. The pain of her Right Arm was worse at night. Next her pathient's Back and Rib Cage on her Back started to hurt (Back discomfort) which started 5 days after the Flu Shot. The patient also experienced Fatigue for the last 2 weeks after obtaining the Flu Shot. (Other relevant tests included No lab data reported.) Final diagnosis was fatigue, back and rib cage on her back started to hurt , the pain then moved up to the the right shoulder, right arm started to ache and soreness at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. List of documents held by sender: none.
Sex: U
Vaccine: MNQ, PNC13
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old unknown gender patient who received a dose of MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included was PREVNAR 13. It was a case of actual medication error due to inappropriate route of vaccination. Patient received MENACTRA subcutaneously instead of intramuscular.  It was not reported that if any adverse reaction was experienced 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.  Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other Health Professional. This case involves male patient who experienced injected limb mobility decreased and painful arm, 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported). On an unknown date, the patient developed a non-serious immobility after vaccine administration (injected limb mobility decreased) and significant arm pain (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was injected limb mobility decreased and painful arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for injected limb mobility decreased and painful arm. List of document held by sender: None.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional (office staff) by phone. This case involves a 24 months old female patient who was vaccinated with an expired 0.5 ml first dose of ACT-HIB (Batch number: UI821AAA and expiry date: 19-Nov-2018, route of administration were not reported) in the right thigh on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PEDIARIX on an unspecified date. It was a case of actual medication error due to expired vaccine used because the patient was administered with an expired dose. It was unknown if any adverse event occurred or not following the vaccination. 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: F
Vaccine: FLU4
Symptoms: Diarrhoea, Malaise
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced diarrhea and got sick, while she 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious got sick (malaise) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data was reported. Final diagnosis was got sick and diarrhea. It was not reported if the patient received any corrective treatment. The patient outcome is reported as Unknown for diarrhea and as Unknown for got sick. List of documents held by sender: none.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 months old female patient who was vaccinated with an expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included PREVNAR and ROTATEQ. On 21-Nov-2018, the patient received a dose of each suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (batch number not reported, Exp date: 29-Oct-2018) route, site not reported. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any 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.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne
Clinical narrative: Patient report having pimples on her back and arms ever since receiving the vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction, Erythema, Hypersensitivity, Lip swelling, Rash
Clinical narrative: The patient presents with allergic reaction, skin rash, hives, face swelling and not throat swelling. The onset was just prior to arrival. The course/duration of symptoms is constant. Location: diffuse. The character of symptoms is rash, redness and swelling. The degree at onset was severe. The degree at present is severe. Potential allergen(s) MMR vaccine. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including 1 mg/kg BENADRYL. Associated symptoms: none. Additional history: none. 4 YO female with PMH MR presenting to the ED with anaphylaxis. Apparently, just PTA, she was getting a MMRV vaccine when she broke out into diffuse hives and had lip swelling. She was given 1 mg/kg BENADRYL via her PEG tube and immediately wheeled to the ED from her PCP which is in-house. VSS on arrival. Mild lip swelling with diffuse erythema of her skin. 4 YO female presenting with anaphylaxis. Received EPI, BENADRYL, PEPCID, steroids and resolved. Watched for four hours with complete resolution of symptoms. VSS. Well appearing. Steroids, EPI pend and BENADRYL Rxed. Follow up given for allergist. Impression and Plan. Diagnosis: Allergic reaction: Discharge, Medical Plan Condition: Stable. Patient was given the following educational materials: Anaphylactic Reaction, Adult, Epinephrine Injection. Follow up with: Follow up with Specialist Within 3-5 days Please call to set up an appt with an allergist; Within 3-5 days.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: The patient presents with allergic reaction, skin rash, hives, face swelling and not throat swelling. The onset was just prior to arrival. The course/duration of symptoms is constant. Location: diffuse. The character of symptoms is rash, redness and swelling. The degree at onset was severe. The degree at present is severe. Potential allergen(s) MMR vaccine. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including 1 mg/kg BENADRYL. Associated symptoms: none. Additional history: none. 4 YO female with PMH MR presenting to the ED with anaphylaxis. Apparently, just PTA, she was getting a MMRV vaccine when she broke out into diffuse hives and had lip swelling. She was given 1 mg/kg BENADRYL via her PEG tube and immediately wheeled to the ED from her PCP which is in-house. VSS on arrival. Mild lip swelling with diffuse erythema of her skin. 4 YO female presenting with anaphylaxis. Received EPI, BENADRYL, PEPCID, steroids and resolved. Watched for four hours with complete resolution of symptoms. VSS. Well appearing. Steroids, EPI pend and BENADRYL Rxed. Follow up given for allergist. Impression and Plan. Diagnosis: Allergic reaction: Discharge, Medical Plan Condition: Stable. Patient was given the following educational materials: Anaphylactic Reaction, Adult, Epinephrine Injection. Follow up with: Follow up with Specialist Within 3-5 days Please call to set up an appt with an allergist; Within 3-5 days.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction, Dyspnoea, Swelling face, Urticaria
Clinical narrative: The patient presents with allergic reaction, skin rash, hives, face swelling and not throat swelling. The onset was just prior to arrival. The course/duration of symptoms is constant. Location: diffuse. The character of symptoms is rash, redness and swelling. The degree at onset was severe. The degree at present is severe. Potential allergen(s) MMR vaccine. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including 1 mg/kg BENADRYL. Associated symptoms: none. Additional history: none. 4 YO female with PMH MR presenting to the ED with anaphylaxis. Apparently, just PTA, she was getting a MMRV vaccine when she broke out into diffuse hives and had lip swelling. She was given 1 mg/kg BENADRYL via her PEG tube and immediately wheeled to the ED from her PCP which is in-house. VSS on arrival. Mild lip swelling with diffuse erythema of her skin. 4 YO female presenting with anaphylaxis. Received EPI, BENADRYL, PEPCID, steroids and resolved. Watched for four hours with complete resolution of symptoms. VSS. Well appearing. Steroids, EPI pend and BENADRYL Rxed. Follow up given for allergist. Impression and Plan. Diagnosis: Allergic reaction: Discharge, Medical Plan Condition: Stable. Patient was given the following educational materials: Anaphylactic Reaction, Adult, Epinephrine Injection. Follow up with: Follow up with Specialist Within 3-5 days Please call to set up an appt with an allergist; Within 3-5 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dyspnoea, Erythema, Eye pruritus, Eye swelling
Clinical narrative: Hives (itchy red spots on the skin), itching, nasal congestion (known as rhinitis), rash, scratchy throat, watery or itchy eyes, swelling of the face, eyes, or tongue, weakness, wheezing, difficulty breathing.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lacrimation increased, Nasal congestion, Pruritus, Rash, Swelling face
Clinical narrative: Hives (itchy red spots on the skin), itching, nasal congestion (known as rhinitis), rash, scratchy throat, watery or itchy eyes, swelling of the face, eyes, or tongue, weakness, wheezing, difficulty breathing.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swollen tongue, Throat irritation, Urticaria, Wheezing
Clinical narrative: Hives (itchy red spots on the skin), itching, nasal congestion (known as rhinitis), rash, scratchy throat, watery or itchy eyes, swelling of the face, eyes, or tongue, weakness, wheezing, difficulty breathing.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Injection site was red and swollen for 1.5 weeks post vaccination; muscle pain is still prominent 12/1/18.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness from shoulder to elbow.
Age: 36.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itching/burning rash at site.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Pt reported arm pain before Thanksgiving. I checked with her today if still had arm pain due to flu shot. She did. Pt will contact me in next 24 hours with her primary care doctors information..doctors on file are immediate care providers. Pt did not have primary care MD info available when asked today. Per Pt arm pain significant enough to warrant MD visit.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Patient had right knee joint pain from left arm tetanus shot that was given. He started noticing the pain the day after the shot was administered.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Gait inability, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Patient reports "a couple days" after vaccine experienced sore/stiff neck and shoulder on and off for roughly 7 to 10 days after vaccination date. Reports limited range of motion of left arm. After 7 to 10 days diminished to mild pain and has since resolved. Of note patient reports restarting tennis around this same time - 11-14 or 11/18? - after taking extending period of time off due to neuropathy/Parkinsons diagnoses. After shoulder/neck issue resolve pt reports pain moved to lower body and he experienced lower back discomfort. He reports history of back pain/problems but says this is different. He then experienced "sensation" in left leg and knee, and eventually severe thigh pain. The left leg pain prevented him from walking for several days. He reports he is now able to walk but the pain persists. Has used ointment with lidocaine on affected areas of knee, leg and buttocks and has seen improvement. Patient has appointment to meet with MD next Thursday 12/13/18.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Neck pain, Pain, Pain in extremity, Sensory disturbance
Clinical narrative: Patient reports "a couple days" after vaccine experienced sore/stiff neck and shoulder on and off for roughly 7 to 10 days after vaccination date. Reports limited range of motion of left arm. After 7 to 10 days diminished to mild pain and has since resolved. Of note patient reports restarting tennis around this same time - 11-14 or 11/18? - after taking extending period of time off due to neuropathy/Parkinsons diagnoses. After shoulder/neck issue resolve pt reports pain moved to lower body and he experienced lower back discomfort. He reports history of back pain/problems but says this is different. He then experienced "sensation" in left leg and knee, and eventually severe thigh pain. The left leg pain prevented him from walking for several days. He reports he is now able to walk but the pain persists. Has used ointment with lidocaine on affected areas of knee, leg and buttocks and has seen improvement. Patient has appointment to meet with MD next Thursday 12/13/18.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-NOV-2018, the patient was vaccinated with expired dose of RECOMBIVAX HB lot # L044917, expiry date 05-OCT-2018, administered intramuscularly for prophylaxis (exact dose was not reported). No adverse effects were reported. The outcome of the event was unknown.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. 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 2015, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 24-OCT-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 vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine.  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. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Ecchymosis, Erythema, Muscular weakness, Pain in extremity, Tenderness
Clinical narrative: Received flu vaccine on 11/27/2018. Pain in right arm after injection. Right lower arm distal to antecubital fossa ventral aspect 3.5 x 4 cm area of ecchymosis, mildly tender to touch. Also area proximal to wrist ulnar aspect 2 x 3 cm area of mild erythema, tender to palpation. Right hand strength decreased compared to left.
Age: 28.0
Sex: F
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Client was given pediatric dose of hep A, client notified.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypoaesthesia, Muscle spasms
Clinical narrative: No treatment. Left arm started going numb day after. Next day both arms would go numb from shoulders to hands together for a few seconds.  That would happen several times a day, for about 6 weeks. Shoulders cramping 2 days later, still mildly happening. Increased sweating under arms and feet immediately, still happening.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient reports feeling tingling in her right big toe later the same day of the vaccination. It lasted for 2-3 weeks after the vaccination before going away on its own.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Eczema, Lethargy, Pyrexia, Rash
Clinical narrative: 103.4 fever, lethargy, diarrhea for 2 days. Rash over chest and back for over a week followed by eczema.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperaesthesia, Malaise, Pain
Clinical narrative: Initially, diffuse skin burning, malaise, chills, fatigue. After 2 days, area at medial left elbow and volar surface of right forearm had burning pain and hyperesthesia that has persisted till present day. No rash. Skin tender in these areas.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Skin burning sensation
Clinical narrative: Initially, diffuse skin burning, malaise, chills, fatigue. After 2 days, area at medial left elbow and volar surface of right forearm had burning pain and hyperesthesia that has persisted till present day. No rash. Skin tender in these areas.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Feeling cold, Headache
Clinical narrative: First night: body muscle aches, significant upper right arm pain, sweating, nausea. Next 2 days: Slept most of the day, no appetite, nausea, fever stayed around 100 degrees, no energy, headache, couldn't move my arm due to pain, all over body aching, shivering from feeling cold.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Mobility decreased, Myalgia, Nausea
Clinical narrative: First night: body muscle aches, significant upper right arm pain, sweating, nausea. Next 2 days: Slept most of the day, no appetite, nausea, fever stayed around 100 degrees, no energy, headache, couldn't move my arm due to pain, all over body aching, shivering from feeling cold.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: First night: body muscle aches, significant upper right arm pain, sweating, nausea. Next 2 days: Slept most of the day, no appetite, nausea, fever stayed around 100 degrees, no energy, headache, couldn't move my arm due to pain, all over body aching, shivering from feeling cold.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Fatigue, Headache, Muscle spasms
Clinical narrative: MUSCLE/STOMACH CRAMPS, VOMITING, UPSET STOMACH, HEADACHE, TIRED.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: MUSCLE/STOMACH CRAMPS, VOMITING, UPSET STOMACH, HEADACHE, TIRED.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Pruritus, Urticaria
Clinical narrative: Facial itching and hives on both cheeks and chest pain. B/P: 180/100, HR: 100, O2 saturation: 100% BENADRYL 50mg capsules given.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient noticed continued soreness after the SHINGRIX vaccination was administered and has continue since 11-13-18. He was seen by Dr. and was told to use OTC TYLENOL and heat to treat. It help some but he has continued to have soreness since that date.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Upper respiratory tract infection
Clinical narrative: Severe URI symptoms.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Injection site granuloma, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: My daughter has been itching on both thighs, she got vaccines on both, this started few months after the vaccine mentioned above. There are large lumps under the skin which get smaller and then they return especially when she has some type of infection like a cold etc. These lumps get warm when they get bigger. There are no symptoms on the skin, no eczema, no rash, skin looks clear, you can feel the lumps when you touch it. She scratches both thighs every day usually after waking up. I have made my own research and learned that there were studies done and there are kids with exact same symptoms, the condition is called vaccine granuloma. According to the research, it is possible that my daughter has a reaction to the aluminum from vaccines, I worry that her body didn't get rid of this neurotoxin as it should have and now it is trapped in these lumps under the skin. There hasn't been enough research done to know what effects on the whole body it has so why are we still adding aluminum to vaccines?
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The patient has had left shoulder pain and has been unable to have full range of motion. Patient was seen by his primary care physician and an orthopedic physician. The shoulder pain may be due to a possible bone spur in the shoulder. The patient will be followed up by the orthopedic physician, who also was treating a hamstring issue of the patient. The physicians are not sure if the shoulder pain was due to the vaccination, but the pain did not start till after the initial shot was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Received 1st SHINGRIX vaccine 8/13/18 and had significant fatigue, body aches and a fever up to 102 degrees for 2 days. Patient states other sxs lasted 1 week.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test positive, Exposure via eye contact, Exposure via skin contact, Needle issue, No adverse event
Clinical narrative: This spontaneous report was received from a female physician who was reporting on herself. No information was provided regarding the physician's concomitant medications, pertinent medical history, drug reactions or allergies. On 16-NOV-2018, during the administration of VARIVAX to a child patient, the needle was not attached to the syringe properly and as a result some VARIVAX inadvertently squirted out of the syringe and into the physician's face and eyes at the end of vaccine administration. No adverse effect was reported for the physician. On an unknown date in November 2018, the physician had the varicella titer test and she was immune to varicella. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1812USA001633:
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Facial paralysis, Herpes zoster, Herpes zoster oticus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 02-DEC-2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered hearing loss, Bell's Palsy and shingles. As a result, the patient was diagnosed with Herpes zoster auricularis on or about 08-JUN-2017. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX vaccine, plaintiffs sustained severe and permanent personal injuries.  Further, 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. As a direct and proximate result, of ZOSTAVAX vaccine, patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster auricularis (considered as Ramsay-Hunt Syndrome) was unknown. Upon internal review, Herpes zoster auricularis was considered to be medically significant. Herpes zoster auricularis was disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebellar stroke, 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 07-NOV-2016, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). On or about 23-NOV-2016, the patient was treated by a healthcare professional at a medical clinic for left cerebellar stroke. 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. Upon internal review, left cerebellar stroke was determined significant medical event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient who was over 65 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with two separate doses of PNEUMOVAX 23 "within one year" (Inappropriate schedule of product administration) for prophylaxis (dose, frequency, route of administration, lot # and expiration date were not reported).
Age: 1.5
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Exposure via eye contact, Exposure via skin contact, Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to an 18-month-old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient was not ill at the time of vaccination. On 16-NOV-2018, the patient was vaccinated with the first dose of VARIVAX lot # R007695, subcutaneously for prophylaxis in unspecified thigh (exact dose was not reported). She was concomitantly vaccinated with HAVRIX A and RECOMBIVAX. During the administration of VARIVAX, the needle was not attached to the syringe properly and as a result some VARIVAX inadvertently squirted out of the syringe and into the physician's face and eyes. The physician felt the patient received the full dose of VARIVAX because "it was such a small amount" of VARIVAX that squirted out of the syringe (also reported as "the patient was unaffected and received the full dose of vaccine minus a small spray"). No adverse effect was reported for the patient. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1811USA007762:
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. About 1.5 year later, on an unspecified date, the patient experienced pneumonia. Event outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that  in the allergy section of the application the following was noted: pneumococcal vaccine. The outcome of the allergy was unknown.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who was vaccinated with first dose of 1.0 ml IMOVAX RABIES on 17-Oct-2018, and did not come for the rest of the injections. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incomplete course of vaccination. 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.
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hyperhidrosis, Injection site pain, Vomiting
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 66 years old male patient whose lymph glands, saliva glands and tear ducts were burning and were on fire, had sweating, vomiting and soreness that happens with injections, while he received vaccine FLUZONE HIGH DOSE. 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 dose of suspect Influenza USP Trival A-B High-Dose Subvirion Vaccine (lot number not reported) via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious lymph glands, saliva glands and tear ducts were burning and were on fire (pain), sweating (hyperhidrosis), vomiting and soreness that happens with injections (vaccination site pain) 5-6 hrs following the administration of Influenza USP Trival A-B High-Dose Subvirion Vaccine. No lab data was reported. Final diagnosis vaccination site pain, vomiting, sweating and burning pain. The patient was treated with BANOPHEN. The outcome was reported as Unknown for all the events. List of document held by sender: None.
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare professional (Office Staff). This case involves a 24 months old patient of unknown age who accidentally received 0.5ml dose instead 0.25 mL dose of vaccine FLUZONE QUADRIVALENT (batch number: UJ049AA, expiry date: 30-Jun-2019) (dose in series was not reported) via intramuscular route in the left thigh on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A vaccine for Immunization. It was a case of actual medication error case due to overdose. No adverse event was reported. 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: 3.0
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient of an unknown demographics who had been re-vaccinated with a POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was reported that patient had been re-vaccinated with a polio vaccine today 26-Nov-2018 that was deemed stable. It was not reported if the patient experienced any 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.