chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included SHINGRIX. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling. On 24th October 2018, 1 day after receiving SHINGRIX, the patient experienced headache, fever, injection site swelling, neck pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, fever, local swelling, injection site swelling, neck pain and pain in arm were unknown. It was unknown if the reporter considered the headache, fever, local swelling, injection site swelling, neck pain and pain in arm to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the left arm. The patient experienced adverse events with both doses of SHINGRIX. After receiving SHINGRIX, the patient experienced fever of 99.2 degree F, arm pain, swelling at injection site, headache, and neck pain. All of these events were noted to be worse on 25th October 2018. The patient's daughter also noticed a bump on patient's head, that the mother denied any type of fall or injury. The pharmacist reported that she encouraged an emergency room visit for the bump on the head because the prescribing information did not mention this as a side effect. This case has been linked with case US2018GSK205413, reported by same reporter for same patient.
Age: 72.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Corneal oedema, Eye irritation, Vaccination complication
Clinical narrative: Corneal irritation and swelling resulting in visit with optometrist three days after receiving the vaccine. The optometrist identified problem and asked if patient had recently received SHINGRIX vaccine. Patient was treated with antibiotic eye drop. Has improved since.
Age: 72.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Corneal irritation, Eye swelling
Clinical narrative: Corneal irritation and swelling resulting in visit with optometrist three days after receiving the vaccine. The optometrist identified problem and asked if patient had recently received SHINGRIX vaccine. Patient was treated with antibiotic eye drop. Has improved since.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Nausea, Pain, Pyrexia
Clinical narrative: ACHINESS FEVER 100.2 NASUEA STOMACH BLOATING.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry skin, Rash
Clinical narrative: "Mandatory flu vaccine was administered on Friday, Nov. 9, 2018. On Saturday after only a breakfast of an egg and ham omelet noticed around 1300 hrs my face was extremely dry. I looked in the mirror and noticed this rash on my face. I have never broke out on my face. My face is still scared with a rash." No known treatment given.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Dizzy, near-syncope, fevers, chills, myalgias, weakness, local pain and redness, parasthesias, diarrhea, confusion.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Full blood count normal, Myalgia, Pain, Paraesthesia
Clinical narrative: Dizzy, near-syncope, fevers, chills, myalgias, weakness, local pain and redness, parasthesias, diarrhea, confusion.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope, Pyrexia
Clinical narrative: Dizzy, near-syncope, fevers, chills, myalgias, weakness, local pain and redness, parasthesias, diarrhea, confusion.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Erythema, Malaise, Pain in extremity
Clinical narrative: On 10/29/18 patient received both FLUARIX QUAD and PNEUMOVAX 23 (indicated for COPD) in the right arm. No adverse reactions at the time of administration. The patient returned to pharmacy 11/13/18 to pick up other medications, and at this time let me know that he normally tolerates the flu shot well. However this time, after receiving both vaccines, he did not feel well at all. He claims his arm was red, sore, and he was "unable to get out of bed" for two days. He claims it must have been the PNEUMOVAX vaccine because he normally tolerates the flu vaccine well. He is feeling better at this time, but just wanted to let us know so we can report it through VAERS.
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Influenza like illness, Injection site bruising, Injection site mass, Nausea
Clinical narrative: Information has been received from a 50 year old female patient referring to herself. Concomitant therapies included bupropion hydrochloride(WELLBUTRIN), Ranitidine (reported as renidadine), levothyroxine and celecoxib(CELEBREX). The patient had raw tomatoes, contrast dyes and lobster allergy. The patient had no pertinent medical history. On 20-JUN-2018, the patient was vaccinated with M-M-R II (1 dosage form; strength, route, lot# and expiration date were not reported) on left arm for prophylaxis. Unspecified tests prior to the vaccination revealed there was no measles or chicken pox exposure. On 21-JUN-2018 (reported as a day after vaccination), the patient had nausea, flu-like symptoms and was "dry heaving foamy vomit" for 3 days. The patient said that after those symptoms went away she was feeling yucky for about a week. After vaccination she developed a golf ball sized lump at the injection site that gradually got smaller and went down to the size of a quarter a month ago and two weeks ago disappeared. The patient said she still has a dime-sized bruise with a black dot in the middle at the injection site. The patient said the bruise appeared to be fading. The patient treated the injection-site lump with cortisone creams and took acetaminophen (TYLENOL) for her flu-like symptoms. The outcome of the events was reported as recovered. The causality between the events and M-M-R II was not reported.
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Information has been received from a 50 year old female patient referring to herself. Concomitant therapies included bupropion hydrochloride(WELLBUTRIN), Ranitidine (reported as renidadine), levothyroxine and celecoxib(CELEBREX). The patient had raw tomatoes, contrast dyes and lobster allergy. The patient had no pertinent medical history. On 20-JUN-2018, the patient was vaccinated with M-M-R II (1 dosage form; strength, route, lot# and expiration date were not reported) on left arm for prophylaxis. Unspecified tests prior to the vaccination revealed there was no measles or chicken pox exposure. On 21-JUN-2018 (reported as a day after vaccination), the patient had nausea, flu-like symptoms and was "dry heaving foamy vomit" for 3 days. The patient said that after those symptoms went away she was feeling yucky for about a week. After vaccination she developed a golf ball sized lump at the injection site that gradually got smaller and went down to the size of a quarter a month ago and two weeks ago disappeared. The patient said she still has a dime-sized bruise with a black dot in the middle at the injection site. The patient said the bruise appeared to be fading. The patient treated the injection-site lump with cortisone creams and took acetaminophen (TYLENOL) for her flu-like symptoms. The outcome of the events was reported as recovered. The causality between the events and M-M-R II was not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report has been received from a 65 year old male consumer who was allergic to penicillin referring to himself. In 2017, the patient received a dose of flu vaccine and PREVNAR and nothing happened. Concomitant medication included unspecified cholesterol medicine and metoprolol. On 11-OCT-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 in left arm to avoid pneumonia (strength, route of administration, frequency, batch/lot # and expiration date were not reported). The patient was also vaccinated with an unspecified influenza vaccination in the same arm. On 12-OCT-2018 (reported as next day after vaccination), the patient had a fuzzy head, fever and chills and the injection site was red and hot. The patient said that the head symptoms, fever and chills were resolved two days later but he still had a big red hive at the injection site and a big red band that started at the injection site and ran across his arm, which was gradually fading but still hurt. On 13-OCT-2018 (reported as Saturday), the patient began to experience insomnia and he lied awake both Saturday and Sunday night and UNISOM did not help his insomnia. The patient had not spoken to a physician about his side effects. No lab diagnostics/studies were performed. No causality assessment was provided.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Insomnia, Pyrexia
Clinical narrative: This spontaneous report has been received from a 65 year old male consumer who was allergic to penicillin referring to himself. In 2017, the patient received a dose of flu vaccine and PREVNAR and nothing happened. Concomitant medication included unspecified cholesterol medicine and metoprolol. On 11-OCT-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 in left arm to avoid pneumonia (strength, route of administration, frequency, batch/lot # and expiration date were not reported). The patient was also vaccinated with an unspecified influenza vaccination in the same arm. On 12-OCT-2018 (reported as next day after vaccination), the patient had a fuzzy head, fever and chills and the injection site was red and hot. The patient said that the head symptoms, fever and chills were resolved two days later but he still had a big red hive at the injection site and a big red band that started at the injection site and ran across his arm, which was gradually fading but still hurt. On 13-OCT-2018 (reported as Saturday), the patient began to experience insomnia and he lied awake both Saturday and Sunday night and UNISOM did not help his insomnia. The patient had not spoken to a physician about his side effects. No lab diagnostics/studies were performed. No causality assessment was provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (intramuscular, lot# N003701, expiration date: 01-NOV-2019; dose was not reported) following a temperature excursion for prophylaxis. No adverse effects were reported in the patient. Temperature/time frame and 47 Fahrenheit to 77 Fahrenheit (9 degrees centigrade to 25 degrees centigrade) (51.6 Fahrenheit) for 42 minutes. Previous temperature excursions, 47 Fahrenheit to 77 Fahrenheit (9 degrees centigrade to 25 degrees centigrade) (57.4 Fahrenheit ) for 40 minutes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M044350 with expiration date on 04-JUL-2018, subcutaneously for prophylaxis and was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). However, no adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was unknown. On 03-NOV-2018, the patient was vaccinated with M-M-R II (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-NOV-2018, the patient began experiencing an unspecified rash at the injection site (injection site rash). On the same date, the patient came to the pharmacy to ask about the rash. The patient was given an unspecified antihistamine to alleviate her symptoms, however it was unknown if that alleviated the symptoms. It was also unknown if laboratory diagnostic studies were performed. The outcome of injection site rash was unknown. The causality between the event and therapy with M-M-R II was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 13 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R018143, expiry date: 25-JUN-2020) (dose and frequency were not reported) subcutaneously for prophylaxis. The VARIVAX was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1811USA002375:Original Case : 1811USA002232; US-009507513-1811USA002232:Original Case : 1811USA002232; US-009507513-1811USA002374:Original Case : 1811USA002232; US-009507513-1811USA002371:Original Case : 1811USA002232; US-009507513-1811USA002372:Original Case : 1811USA002232; US-009507513-1811USA005285:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 5 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R018143, expiry date: 25-JUN-2020) (dose and frequency were not reported) subcutaneously for prophylaxis. The VARIVAX was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1811USA002375: Original Case : 1811USA002232 US-009507513-1811USA002232: Original Case : 1811USA002232 US-009507513-1811USA002374: Original Case : 1811USA002232 US-009507513-1811USA002371: Original Case : 1811USA002232 US-009507513-1811USA002372: Original Case : 1811USA002232 US-009507513-1811USA005284:
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Insomnia, Nausea, Pain
Clinical narrative: Pain at site, nausea, HA, achy, low grade fever, unable to sleep.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pain at site, nausea, HA, achy, low grade fever, unable to sleep.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient received adult dose of hepatitis A vaccine instead of pediatric dose.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Conjunctivitis, Myalgia, Pyrexia
Clinical narrative: Conjunctivitis, muscle and joint aches, fever, chilling.
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 concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015 , a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-AUG-2015, 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 zoster vaccine live (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); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. On or about 26-FEB-2009, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-MAY-2013, the patient was treated by a her healthcare providers at a medical office for shingles. She 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 provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by her healthcare provider 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. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Axillary mass, Axillary pain, Full blood count, Metabolic function test
Clinical narrative: Patient show up with a enlarged lump on his left armpit 3 days after the shot on left deltoid. Painful and about 2-3cm. Pt was sent to check CBC/CMP.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in the upper arm with limited mobility beginning within 24 hours. No visible swelling or redness.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Bronchospasm, Chest X-ray normal, Dyspnoea, Influenza A virus test negative, Influenza B virus test
Clinical narrative: I ended up having an adverse reaction to the shot per the ER provider. My body was trying fight it. I ended up not being able to breathe Sat, Sun, Mon and Tuesday. All with flu-like symptoms. Yesterday decided after calling off work Mon and Tuesday to go to the ER to see if they could help give me something to breathe. After 2 chest x-rays for pneumonia, nasal swabs for the flu, it all came up negative. Diagnosis: Bronchospasm, swollen lymph nodes. Treatment while in ER: Albuterol 5 mg once, ipratropium (ATROVENT) 0.02%, ketrolac (TORADOL) 60 mg, dexamethasone (DECADRON) 10 mg.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza like illness, Influenza virus test negative, Lymphadenopathy, Polymerase chain reaction, Respiratory syncytial virus test negative
Clinical narrative: I ended up having an adverse reaction to the shot per the ER provider. My body was trying fight it. I ended up not being able to breathe Sat, Sun, Mon and Tuesday. All with flu-like symptoms. Yesterday decided after calling off work Mon and Tuesday to go to the ER to see if they could help give me something to breathe. After 2 chest x-rays for pneumonia, nasal swabs for the flu, it all came up negative. Diagnosis: Bronchospasm, swollen lymph nodes. Treatment while in ER: Albuterol 5 mg once, ipratropium (ATROVENT) 0.02%, ketrolac (TORADOL) 60 mg, dexamethasone (DECADRON) 10 mg.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: Stuffy nose, sore throat, overall not feeling well.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient reported "golf ball sized" lump in arm at the injection site as well as redness, pain and warmth to the touch.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Cough, Drooling, Fall, Retching
Clinical narrative: Patient was calm, sitting up on patient bed when I left the room following the visit. Nursing reportedly entered room and administered flu shot, left room. Brother says that patient was sitting up after flu shot, stood up to get ready to leave, and then fell forward onto the patient bed. When I entered the room, nursing was present and Dr was examining patient. On my arrival, patient was slumped forward over the patient bed drooling onto bed paper. Responsive to voice, able to gesture towards his chest indicating right chest pain. Able to lay supine onto bed, responsive to commands, difficulty talking. Coughing with intermittent gagging, continued to gesture towards right chest pain, denied throat tightening. No stridor. Started on albuterol nebulizer treatment when EMS arrived. Patient was taken to ED for further management.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Soreness at site of injection, headache, fever.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea
Clinical narrative: Pt complaining of nausea and headache since receiving vaccine. Encouraged oral hydration, rest and Tylenol.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: By 9:00pm, pt reports redness, pain, swelling and heat at site of injection site. Within 24 hrs, the area around the injection site had swollen to approx. 4" X 4 1/2", with a raised welt along one edge of the swelling.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Depression
Clinical narrative: Depression.
Age: 72.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abdominal pain, Dysstasia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness fingers-Abd pain. Acute pain (R) leg. Unable to walk-no feeling (L) leg. Unable to stand. Guillain Barre.
Age: 72.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Sensory loss
Clinical narrative: Numbness fingers-Abd pain. Acute pain (R) leg. Unable to walk-no feeling (L) leg. Unable to stand. Guillain Barre.
Age: 72.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Antinuclear antibody positive, Blood test, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Numbness fingers-Abd pain. Acute pain (R) leg. Unable to walk-no feeling (L) leg. Unable to stand. Guillain Barre.
Age: 72.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Muscular weakness, Peroneal nerve palsy
Clinical narrative: Numbness fingers-Abd pain. Acute pain (R) leg. Unable to walk-no feeling (L) leg. Unable to stand. Guillain Barre.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash left side of face...at time of reporting: one week post vaccination, rash continues.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle pain, tiredness.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: It's a really minor thing, but my primary care physician said she never heard of this and I should report it as a side effect. I can taste something for a few minutes every time I get a shot or have any medication introduced through an IV. It's not really a metallic taste and it's difficult to describe. I guess the best word would be "medicine-y". It's not life threatening or even inconvenient. It only came up as a matter of fact comment I made at the time. It doesn't matter what type of shot or medicine, as it happens every time. It's probably nothing, since we already know my body is weird and doesn't work the way it's supposed to.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Malaise
Clinical narrative: Anaphylactic reaction, characterized by mild difficulty breathing, diffuse erythema over body, malaise. Given EPIPEN, SOLUMEDROL, and BENADRYL in office which resolved problem.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient reported bruising for the past 7 days since the injection. She was concerned that the injection was given SC as she reports that the administering pharmacist pulled the needle back, and that she felt the medication stung as it was being pushed. The bruising was evident, with a greenish bruise around the perimeter and a darker purple in the center. Patient was advised that we would be reporting to VAERS and to let us know if bruising does not resolve.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Syncope
Clinical narrative: Immunization given at 2:10pm on 11/13/18. On 11/14/18 at 9:30 am, patient's husband contacted the pharmacy and talked to the pharmacist. He stated that overnight she woke up and got up and fainted. She is fine now, other than feeling a little weak.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chest X-ray, Chest discomfort, Disturbance in attention, Dizziness
Clinical narrative: My symptoms started a few hours after I was vaccinated. I tried to work through my symptoms. Therefore, I became short of breath along with having right side chest discomfort. I began to experience feeling of anxiousness, not able to concentrate on small task. Dizziness became severe days leading up to going into urgent care. I was treated for shortness of breath and given medications called prednisone with a inhaler VENTOLIN HFA.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: My symptoms started a few hours after I was vaccinated. I tried to work through my symptoms. Therefore, I became short of breath along with having right side chest discomfort. I began to experience feeling of anxiousness, not able to concentrate on small task. Dizziness became severe days leading up to going into urgent care. I was treated for shortness of breath and given medications called prednisone with a inhaler VENTOLIN HFA.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Was given an adult Hep A with no adverse affect.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a nurse and refers to a 76 years old male patient with sleep apnoea. The patient's medical history included pneumonia on an unknown date in 1960. The patient had no concomitant medications and no known drug reactions or allergies. On 10-OCT-2018, the patient was vaccinated with injection PNEUMOVAX 23 lot # R012360, expiration date 15-JAN -2020 (dose and route of administration were not reported). On 12-OCT-2018, the patient reported that his arm was swollen, red, and warm to touch, he also had a fever of 100.5 F, and achy joints, hips, legs and back. It was reported that an unspecified physician advised the patient to take ibuprofen and use ice on the arm. The nurse reported that since unknown date in October 2018, the patient no longer had a fever or achy joints and his arm was not swollen. The outcome of all the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-SEP-2018, the patient was vaccinated with a dose of ROTATEQ orally exact (dose, lot number, expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse effects was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 65 year old male patient, regarding himself. The patient's medical history included shingles about 40 years ago. There were no concurrent conditions, drug reactions/allergies and concomitant medications reported. Approximately in 2016, the patient was vaccinated with ZOSTAVAX (dosing details not provided) for prevention of shingles. On 18-OCT-2018, the patient experienced shingles. He sought medical attention and visited his physician on an unknown date. He was treated with unspecified antiviral medication and gabapentin for about 1 week. Outcome of the event was reported as recovering. Causality assessment 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 provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2008, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by her healthcare provider 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. 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 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 08-JUN-2009, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-SEP-2015, 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. 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. 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 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 04-MAR-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX 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. 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 medical history or concomitant medications. In 2015, the patient was administered ZOSTAVAX by a healthcare provider at a family medical center (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by healthcare providers at a the same 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: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-JUN-2008, a healthcare provider at a community clinic administered ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-JUL-2008, the patient was treated by a healthcare provider at the same community clinic 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 was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Immune-mediated adverse reaction
Clinical narrative: This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. Reported Cause(s) of Death: Immune-mediated adverse reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Immune-mediated adverse reaction
Clinical narrative: This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. This case was 1 of the 10 cases, reported by same reporter. Reported Cause(s) of Death: Immune-mediated adverse reaction.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of PREVNAR 13 (reported as PREVNAR 23, pending clarification), via an unspecified route of administration at left arm on 29Oct2018 13:45 at single dose for immunization. The patient had no other vaccines administered with suspect. Prior vaccinations within 4 weeks: None. Medical history included carotid artery surgery from Feb2018, strokes from 1997 (she had her first stroke in 1997, then had two more after her carotid artery surgery), arm was sore from 2017 to an unknown date (her arm was sore but nothing like this. She did not have a NDC, lot number or expiration date for the vaccine she got last year). The patient's concomitant medications were not reported. The patient previously took first dose of PREVNAR 13 (also reported as PREVNAR 23) for immunization in Dec2017 at pharmacy. The patient experienced sick and horribly sore, lost 4 pounds, on 29Oct2018. In evening of the 29Oct2018, she got extremely tired and her arm was real sore. During that night, she woke up and her whole left side was excruciatingly sore and she couldn't lay on that side or her back. She just couldn't sleep, she said that pain went from the shot area to her shoulder to her shoulder blade. Then down her side to under her left arm and into her back. On that Tuesday (30Oct2018), patient had chills and slept all day on her right side. She couldn't eat anything as she had no appetite and was nauseated. On that Tuesday night, she couldn't sleep again because the pain was so bad. Then yesterday (31Oct2018) she slept until about 10 am and woke up thinking she was feeling better. She felt better last night and could feel the pain going away on her left side. At time of report, she was fine but she said that she did lose 4 pounds since 29Oct2018.  The patient said that she was just about great at time of report, this was the first day she was well. There was no any event required a visit to emergency room or physician's office. The outcome of events sick and horribly sore was recovering, the outcome of the other events was unknown.