chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Day 1 extremely tired. Day 2 weak with flu like symptoms Day 3 moderate fever, weak mild headache, with nausea, threw up twice. Day 4 worst with chills and fever around 100 degrees. Sweating with chills. Called the medical centers emergency room and spoke to a Dr. about the side effects. He evaluated my complete medical history and clearly stated that I could go to the emergency room at anytime but recommend to wait one or two more days, I should experience recovery.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Severe pain in left arm, followed by severe muscle pain travelled down body from core and back to legs. Severe chills and starting. Lack of appetite. Loss of taste when I ate food. The severe muscle pain lasted 24-36 hours. Extreme fatigue.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain in left arm, followed by severe muscle pain travelled down body from core and back to legs. Severe chills and starting. Lack of appetite. Loss of taste when I ate food. The severe muscle pain lasted 24-36 hours. Extreme fatigue.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Muscle swelling, Rash erythematous
Clinical narrative: Patient reported swollen muscle where the vaccine was given and a red rash in the middle of the arm. She at first had tenderness at the injection site, then this morning she felt like her muscle was swollen. I advised her to apply a cold compress to the site for 15 minute intervals and to take ibuprofen to help with discomfort.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Tremor
Clinical narrative: Patient received the vaccine Saturday around noon, and that evening she began complaining of muscle aches, shaking, headache and fatigue (she described as general flu like symptoms), which continued into Sunday morning.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like effects. Mild fever, aches, light headed, tired, lack of appetite.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu like effects. Mild fever, aches, light headed, tired, lack of appetite.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash
Clinical narrative: Rash - 2 inch in diameter - still visible 7 weeks later - initially itching. Treated with hydrocortisone 1% and oatmeal poultices
Age: 77.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Electromyogram, Nerve conduction studies, Nuclear magnetic resonance imaging neck, Peripheral motor neuropathy
Clinical narrative: Slowly progressive motor polyneuropathy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: 04/14/19: GOT 1ST SHINGRIX DOSE. PT CAME IN ON 04/20/19 SAYING THAT AFTER HER SHOT SHE NOTICED THE AREA GETTING RED AND HOT TO THE TOUCH. BY WEDNESDAY THE 17TH, SHE WENT TO THE DR AND THEY DIAGNOSED HER WITH CELLULITIS AND PUT HER ON CEPHALEXIN. SHE SAID AT ITS GREATEST SIZE 4 INCHES AROUND. SHE WILL TALK TO HER DR ABOUT WHETHER OR NOT SHE SHOULD GET THE 2ND DOSE. SHE TRIED TO REPORT IT TO VAERS,  DEPT OF HEALTH, AND THE CDC WITH NO LUCK (SHE SAID SHE KEPT GETTING HUNG UP ON). EMPLOYEE WILL REPORT TO VAERS AND SHE WAS HAPPY WITH THAT.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: ON day 1 of receiving the vaccine, the patient had a local injection site reaction. On day 2 & 3, patient experienced chills, fever and nausea. The reaction site had a welt and was red. On day 4 it begin to itch. She Came to the pharmacy on Day 7 to report these advents and stated that she still did not have any energy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Local reaction, Nausea, Pyrexia
Clinical narrative: ON day 1 of receiving the vaccine, the patient had a local injection site reaction. On day 2 & 3, patient experienced chills, fever and nausea. The reaction site had a welt and was red. On day 4 it begin to itch. She Came to the pharmacy on Day 7 to report these advents and stated that she still did not have any energy.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Hypertension, Nausea, Tremor
Clinical narrative: Afternoon after receiving vaccine, he started with shaking, freezing, nausea and high blood pressure. Lasted 3 days. No local reaction.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Blister, Erythema, Skin discolouration
Clinical narrative: After 2 hours notices    redness on my forehead, and within 5 days blisters and redness on the right side of the face and eyes. Red blister and a black clusters.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: INJECTION SITE REACTION - AT TIME OF REPORTING TO PHARMACIST AROUND 3 PM 4/20/2019 (NEXT DAY). PT HAD ABOUT A 4 INCH IN DIAMETER RED CIRCLE SLIGHTLY WARMER THAN REST OF ARM SKIN. PT CITED BURNING AND ITCHING ONLY AT RED CIRCLE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient presented to the pharmacy with a red/swollen left deltoid 2 days after the vaccine was administered into the left deltoid. The swelling was approx. 5" in dia. at that time. She stated that the pain started the evening of the vaccine administration 4/7/19.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness
Clinical narrative: After receiving vaccine, patient was asked to sit on the bench in the front of the pharmacy for 10-15 minutes before leaving. I came back to the pharmacy to copy his paperwork and when I went back to check on him he stated he had passed out. I did not see him in the floor, but customers standing by in the store were helping him back to the bench. Once he was sitting again, we offered to call an ambulance and he declined. We gave him a cold water and just asked him to remain seated and to breathe slowly. In just a few minutes, he was fine. He stated he sat down on the bench, looked down at his phone and that was the last thing he remembered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Myalgia, Rash, Rash erythematous
Clinical narrative: Patient stated she suffered a rash which was red/warm and sore. She stated that her muscle became sore right away and could hardly move it for 2 days. There was a raised area which spread to the armpit. 3in long and 2 in wide.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Patient stated she suffered a rash which was red/warm and sore. She stated that her muscle became sore right away and could hardly move it for 2 days. There was a raised area which spread to the armpit. 3in long and 2 in wide.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pain, rash.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever when waking up, 101F, slight headache, and aching arm. Took 2 TYLENOL went back to bed. Fever down by 12 noon. Took another does of TYLENOL at 1 pm, went back to bed. Recovered by 4 pm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, CSF glucose normal, CSF protein increased, Chills, Confusional state
Clinical narrative: A 69 yo M presents to the ED via private vehicle c/o fever onset last night around 1630. Pt reports chills onset yesterday at 1630 accompanied by a 101F fever when his temperature was taken at 2200. Pt took 1 EXCEDRIN PM before bed and woke up afebrile but began feeling chills again around 0730 this AM. Pt's fever then returned accompanied by lightheadedness, nausea without vomiting, and sore throat. Pt took one more EXCEDRIN PM this AM. He did not have any other antipyretics at home to use, as he is travelling out of town currently. Pt also noticed a rash on his forehead, denies itching. Notes mild discomfort right anterior neck near jawline, was using heating pad to the area with relief. No stridor, no change in phonation. Wife reports pt is confused and was not oriented to the date and was talking about his SIL caring for his FIL, but the father in law has been deceased "for decades" states wife. Denies HA, CP, abd pain, SOB, cough, rhinorrhea, or sore throat. Pt and his wife received 2nd dose of SHINGRIX vaccine on Thursday (4/18) and reported mild arm pain that resolved, no other sx. Pt is a poor historian secondary to clinical condition and AMS, wife provided all details and is considered reliable.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Full blood count, Mental disorder, Musculoskeletal discomfort
Clinical narrative: A 69 yo M presents to the ED via private vehicle c/o fever onset last night around 1630. Pt reports chills onset yesterday at 1630 accompanied by a 101F fever when his temperature was taken at 2200. Pt took 1 EXCEDRIN PM before bed and woke up afebrile but began feeling chills again around 0730 this AM. Pt's fever then returned accompanied by lightheadedness, nausea without vomiting, and sore throat. Pt took one more EXCEDRIN PM this AM. He did not have any other antipyretics at home to use, as he is travelling out of town currently. Pt also noticed a rash on his forehead, denies itching. Notes mild discomfort right anterior neck near jawline, was using heating pad to the area with relief. No stridor, no change in phonation. Wife reports pt is confused and was not oriented to the date and was talking about his SIL caring for his FIL, but the father in law has been deceased "for decades" states wife. Denies HA, CP, abd pain, SOB, cough, rhinorrhea, or sore throat. Pt and his wife received 2nd dose of SHINGRIX vaccine on Thursday (4/18) and reported mild arm pain that resolved, no other sx. Pt is a poor historian secondary to clinical condition and AMS, wife provided all details and is considered reliable.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: A 69 yo M presents to the ED via private vehicle c/o fever onset last night around 1630. Pt reports chills onset yesterday at 1630 accompanied by a 101F fever when his temperature was taken at 2200. Pt took 1 EXCEDRIN PM before bed and woke up afebrile but began feeling chills again around 0730 this AM. Pt's fever then returned accompanied by lightheadedness, nausea without vomiting, and sore throat. Pt took one more EXCEDRIN PM this AM. He did not have any other antipyretics at home to use, as he is travelling out of town currently. Pt also noticed a rash on his forehead, denies itching. Notes mild discomfort right anterior neck near jawline, was using heating pad to the area with relief. No stridor, no change in phonation. Wife reports pt is confused and was not oriented to the date and was talking about his SIL caring for his FIL, but the father in law has been deceased "for decades" states wife. Denies HA, CP, abd pain, SOB, cough, rhinorrhea, or sore throat. Pt and his wife received 2nd dose of SHINGRIX vaccine on Thursday (4/18) and reported mild arm pain that resolved, no other sx. Pt is a poor historian secondary to clinical condition and AMS, wife provided all details and is considered reliable.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Shift to the left, White blood cell count increased
Clinical narrative: A 69 yo M presents to the ED via private vehicle c/o fever onset last night around 1630. Pt reports chills onset yesterday at 1630 accompanied by a 101F fever when his temperature was taken at 2200. Pt took 1 EXCEDRIN PM before bed and woke up afebrile but began feeling chills again around 0730 this AM. Pt's fever then returned accompanied by lightheadedness, nausea without vomiting, and sore throat. Pt took one more EXCEDRIN PM this AM. He did not have any other antipyretics at home to use, as he is travelling out of town currently. Pt also noticed a rash on his forehead, denies itching. Notes mild discomfort right anterior neck near jawline, was using heating pad to the area with relief. No stridor, no change in phonation. Wife reports pt is confused and was not oriented to the date and was talking about his SIL caring for his FIL, but the father in law has been deceased "for decades" states wife. Denies HA, CP, abd pain, SOB, cough, rhinorrhea, or sore throat. Pt and his wife received 2nd dose of SHINGRIX vaccine on Thursday (4/18) and reported mild arm pain that resolved, no other sx. Pt is a poor historian secondary to clinical condition and AMS, wife provided all details and is considered reliable.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Injection site erythema
Clinical narrative: Headache; Aching joints and muscles; Shivers; 103.1 temp. Lesions/blisters on tongue and in throat. Single shot 4 yrs. ago - arm became swollen and red - near site of injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Oropharyngeal blistering, Throat lesion, Tongue blistering
Clinical narrative: Headache; Aching joints and muscles; Shivers; 103.1 temp. Lesions/blisters on tongue and in throat. Single shot 4 yrs. ago - arm became swollen and red - near site of injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue disorder
Clinical narrative: Headache; Aching joints and muscles; Shivers; 103.1 temp. Lesions/blisters on tongue and in throat. Single shot 4 yrs. ago - arm became swollen and red - near site of injection.
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Joint range of motion decreased, Pain in extremity, Tenderness
Clinical narrative: This is a spontaneous case initially reported by other non-health professional (consumer) on 10-Apr-2019, concerning a 73-year-old, elderly male patient. The patient's historical condition included clinical depression and post-traumatic stress disorder (PTSD). The patient did not receive any concomitant medications. On 04-Oct-2018, the patient was administered FLUAD (TIV) [ egg derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783 and expiry date: 30-Apr-2019] for active immunization against influenza. On the same day, after vaccination, the patient lost use of his left arm and muscle strength. The patient also experienced pain in left arm and shoulder. The patient did not feel better even after taking the medication (unspecified) for controlling the pain. The patient administered 12 to 14 bottles of liniment (unspecified), it helped but it was persistent. The primary care doctor said if this did not improve in 7 days, it would need an MRI (magnetic resonance imaging). The patient visited emergency ward and was told that, arm was not right and caused the pain. On an unspecified date, the patient underwent 25 X-ray test and some MRI, but never sat down with a physician to explain. At the veteran's emergency ward, the patient was told that, the left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket. The outcome of all the events was not recovered except the event 'joint dislocation' for which outcome was recovering. The reporter assessed the case as non-serious.; Reporter's Comments: A 73-year-old, male patient with medical history (clinical depression and post-traumatic stress disorder) experienced pain in left arm and shoulder, lost use of his left arm and muscle strength, on the same day after administration of FLUAD (TIV) vaccine. Considering the plausible temporal relationship between vaccination and reported events, site-specific nature (injection arm) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The patients left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket on an unspecified day post vaccination (coded to Joint dislocation) and appears to be consequence of other reported events (lost use of his left arm and muscle strength) and was assessed as not related to suspect vaccine.The company assessed the case as serious (medically significant).
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Joint dislocation, Muscular weakness, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous case initially reported by other non-health professional (consumer) on 10-Apr-2019, concerning a 73-year-old, elderly male patient. The patient's historical condition included clinical depression and post-traumatic stress disorder (PTSD). The patient did not receive any concomitant medications. On 04-Oct-2018, the patient was administered FLUAD (TIV) [ egg derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783 and expiry date: 30-Apr-2019] for active immunization against influenza. On the same day, after vaccination, the patient lost use of his left arm and muscle strength. The patient also experienced pain in left arm and shoulder. The patient did not feel better even after taking the medication (unspecified) for controlling the pain. The patient administered 12 to 14 bottles of liniment (unspecified), it helped but it was persistent. The primary care doctor said if this did not improve in 7 days, it would need an MRI (magnetic resonance imaging). The patient visited emergency ward and was told that, arm was not right and caused the pain. On an unspecified date, the patient underwent 25 X-ray test and some MRI, but never sat down with a physician to explain. At the veteran's emergency ward, the patient was told that, the left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket. The outcome of all the events was not recovered except the event 'joint dislocation' for which outcome was recovering. The reporter assessed the case as non-serious.; Reporter's Comments: A 73-year-old, male patient with medical history (clinical depression and post-traumatic stress disorder) experienced pain in left arm and shoulder, lost use of his left arm and muscle strength, on the same day after administration of FLUAD (TIV) vaccine. Considering the plausible temporal relationship between vaccination and reported events, site-specific nature (injection arm) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The patients left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket on an unspecified day post vaccination (coded to Joint dislocation) and appears to be consequence of other reported events (lost use of his left arm and muscle strength) and was assessed as not related to suspect vaccine.The company assessed the case as serious (medically significant).
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity, X-ray
Clinical narrative: This is a spontaneous case initially reported by other non-health professional (consumer) on 10-Apr-2019, concerning a 73-year-old, elderly male patient. The patient's historical condition included clinical depression and post-traumatic stress disorder (PTSD). The patient did not receive any concomitant medications. On 04-Oct-2018, the patient was administered FLUAD (TIV) [ egg derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783 and expiry date: 30-Apr-2019] for active immunization against influenza. On the same day, after vaccination, the patient lost use of his left arm and muscle strength. The patient also experienced pain in left arm and shoulder. The patient did not feel better even after taking the medication (unspecified) for controlling the pain. The patient administered 12 to 14 bottles of liniment (unspecified), it helped but it was persistent. The primary care doctor said if this did not improve in 7 days, it would need an MRI (magnetic resonance imaging). The patient visited emergency ward and was told that, arm was not right and caused the pain. On an unspecified date, the patient underwent 25 X-ray test and some MRI, but never sat down with a physician to explain. At the veteran's emergency ward, the patient was told that, the left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket. The outcome of all the events was not recovered except the event 'joint dislocation' for which outcome was recovering. The reporter assessed the case as non-serious.; Reporter's Comments: A 73-year-old, male patient with medical history (clinical depression and post-traumatic stress disorder) experienced pain in left arm and shoulder, lost use of his left arm and muscle strength, on the same day after administration of FLUAD (TIV) vaccine. Considering the plausible temporal relationship between vaccination and reported events, site-specific nature (injection arm) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The patients left arm had elevated out of its joint due to the lack of the muscle control to keep the joint in the socket on an unspecified day post vaccination (coded to Joint dislocation) and appears to be consequence of other reported events (lost use of his left arm and muscle strength) and was assessed as not related to suspect vaccine.The company assessed the case as serious (medically significant).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Patient had a rash on her chest and abdomen that was red and had raised bumps.  Mother noticed the rash around midday- noonish.  the rash was less severe at 6:00 pm, and hardly noticeable at 8 pm.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with her last dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. The patient's previous dose was received over a year ago (Inappropriate schedule of vaccine administered). No adverse events reported. The outcome of the events was unknown.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Bone pain, Impaired driving ability, Injected limb mobility decreased
Clinical narrative: couldn't raise her left arm above her waist; the bones in her shoulder cuff hurt really bad down to the elbow; This spontaneous report was received from a 76 years old female consumer referring to herself. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown/ was not reported. The patient did not have any pertinent medical history and concomitant medication. The patient was sensitive to anesthetics, particularly sensitive to procaine hydrochloride (NOVOCAINE).  On an unknown date (reported as a few years ago), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, route, lot # and expiration date were not reported) for prophylaxis and without any problems or issues. However, on 26-MAR-2019, the patient was vaccinated with the second dose (reported as a follow-up booster shot) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5ml, intramuscularly in the left deltoid (reported as directly into the top muscle of her left shoulder) (lot # and expiration date were not reported) for prophylaxis (reported as pneumonia prevention).  On the same date within one hour of received the follow-up dose, the patient could not raise her left arm above her waist (injected limb mobility decreased). On an unknown date in March 2019, the patient experienced the bones in her shoulder cuff hurt really bad down to the elbow. On an unknown date in March 2019, the patient experienced more difficult to drive her car due to events, she could not drive without lifted her arm and put it on the steering well. The patient had sought medical attention. She contacted her nurse practitioner's office since get the follow up dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), and spoken to staff members but she had been unable to speak directly with her nurse practitioner yet since her nurse practitioner had not been available for the last couple of days. The patient received treatment for the events and drawn her blood work. The outcome of events was reported as recovering. The causality assessment between events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant professional referring to a currently approximately 18 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 19-FEB-2013, the patient was vaccinated with the first unspecified dose of GARDASIL (route, lot# and expiration date unknown), at age 12 years, for prophylaxis. On 08-APR-2019, the patient was in the office to receive the second dose in the HPV vaccination series, GARDASIL 9 (route, lot# and expiration date unknown)(interchange of vaccine products and inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: The patient received an expired dose of ROTATEQ; Information has been received from the patient's father referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and with concomitant medication were not reported.      On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (1 dosage (DS)  X 10 tubes) (lot # N022174 with expiration date 16-MAR-2019) orally for prophylaxis. No product quality complaint (PQC) was involved.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Herpes Zoster; Herpes Zoster; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 68 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-FEB-2016, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a nurse practitioner for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: Herpes Zoster.  The patient claimed damages as a result of: Injury to themselves; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages.  The outcome of the event was unknown. Causality assessments were related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Herpes Zoster; injuries resulting from Zostavax use: Herpes Zoster; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 68 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2011, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: Herpes Zoster.  The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported.; a patient was inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 10-APR-2019, the patient inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA), lot # N028444 with expiration date 09-APR-2019; strength and dose detail were not provided) subcutaneously for prophylaxis(expired product administered). No adverse effect reported. The causality of the event was not provided.
Sex: U
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 patient of unknown gender and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown. Causality assessments were related.
Sex: U
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 patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about  09-APR-2014, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Shingles; Shingles; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 71 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2017, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider. On an unknown date, the patient was treated for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles.  The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Shingles; Shingles; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 74 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles.  The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Herpes Zoster; injuries resulting from Zostavax use: Herpes Zoster; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 69 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2017, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: Herpes Zoster.  The patient claimed damages as a result of: Injury to themselves; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Shingles; injuries resulting from Zostavax use: Shingles; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 70 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-JAN-2009, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles.  The patient claimed damages as a result of: Injury to themselves; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
Sex: U
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 patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-DEC-2012, the patient was administered the ZOSTAVAX vaccine (strength, dose, frequency, route, lot# and expiration date were unknown). The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: Herpes zoster. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was unknown. Causality assessments were related.
Sex: U
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 patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX vaccine (strength, dose, frequency, route, lot# and expiration date were unknown). The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was unknown. Causality assessments were related.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On or about 22-JAN-2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles and post-herpetic neuralgia. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On 15-APR-2019, the patient was vaccinated with her first dose of GARDASIL 9 (route, dose, lot# and expiration date unknown) for HPV prevention. On the same day, after the injection of GARDASIL 9, the patient experienced an injection site reaction of redness, swelling and pain. The outcome of the events was unknown and the causality assessments were not provided.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Crying, Flatulence
Clinical narrative: and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; and seemed to have severe abdominal pain,crying, seemed to be gassy, pulling legs up; pulling legs up; This spontaneous report was received via a company representative from a medical assistant referring to a 4 months old female patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  On 15-APR-2019, the patient received a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R027272; strength, dose detail and expiration date were unknown) orally for prophylaxis (reported as prevention of rotavirus). On the same day,  the patient seemed to have severe abdominal pain, crying, seemed to be gassy, pulling legs up. On the same day, the parents brought the patient back to the office, and they were told to take the patient to the Emergency Room. It was unknown if the patient was given treatment for the events. It was unknown if the patient performed any lab diagnostics/studies. The outcome of all events was unknown. The causality between all events and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was not provided.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 14 year old patient received a dose of PROQUAD; No known adverse effects; Information has been received from a nurse referring to a 14 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(1 dosage form, strength, frequency, lot#, therapy type, expiration date were unknown) subcutaneously for prophylaxis(inappropriate age at vaccine administration). No known adverse effects.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; expired pneumovax 23 was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported. On 15-MAR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, lot # N020501, expiration date:03-MAR-2019(dose, dose number not reported) for prophylaxis. The pharmacist stated that expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was administered(expired product administered). No adverse effect was reported. The outcome of expired product administered and no adverse event were unknown. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received one dose of improperly stored PROQUAD; No adverse effects were reported.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N034561, expiration date 03-JUN-2019, 1 dose; route, strength and frequency were not reported) with properly stored sterile diluent (MERCK STERILE DILUENT) for prophylaxis.   The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13.3 degrees Celsius) for 26 minutes. The previous excursions were in the range of -14 degrees Celsius to -10 degrees Celsius (-13.1 degrees Celsius) for 31 minutes. The call was because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a medical assistant regarding to a patient of unknown age and gender.    There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On 17-APR-2019, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA)  25/0.5 (lot # R009952, expiry date: 17-MAR-2019) intramuscularly for prophylaxis.       No temperature excursion. No adverse effects were reported.