chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear congestion, Ear pain, Middle ear effusion, Tinnitus, Vertigo
Clinical narrative: 10/07/2020 02:00AM Vertigo, unsteadiness, unbalanced, ear stuffiness, ear pain, tinnitus, back pain, neck pain, spinal pain, shoulder muscular pain, tingles in r hand; 10/07/2020 afternoon  ---Tylenol dose 325 mg , no relief,  10/08/2020 ear fluid determined in urgent care visit -- hyrdroxyzine 50mg. 10/19/2020 Doctor visit -- l ear no more fluid, r ear some fluid --  Zipro 500mg Drop treatment, Zyrtec 10mg,  Meclizine 25 mg. Nuerosurgeon referral/visit -- MRI neck, results -- normal; Xray neck, results -normal , ENT visit 11/17/2020 - no fluid in ear, referral to PT; appointment 01/04/2020 vestibular therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Balance disorder, Ear congestion, Ear pain
Clinical narrative: 10/07/2020 02:00AM Vertigo, unsteadiness, unbalanced, ear stuffiness, ear pain, tinnitus, back pain, neck pain, spinal pain, shoulder muscular pain, tingles in r hand; 10/07/2020 afternoon  ---Tylenol dose 325 mg , no relief,  10/08/2020 ear fluid determined in urgent care visit -- hyrdroxyzine 50mg. 10/19/2020 Doctor visit -- l ear no more fluid, r ear some fluid --  Zipro 500mg Drop treatment, Zyrtec 10mg,  Meclizine 25 mg. Nuerosurgeon referral/visit -- MRI neck, results -- normal; Xray neck, results -normal , ENT visit 11/17/2020 - no fluid in ear, referral to PT; appointment 01/04/2020 vestibular therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Myalgia, Neck pain, Paraesthesia, Spinal pain
Clinical narrative: 10/07/2020 02:00AM Vertigo, unsteadiness, unbalanced, ear stuffiness, ear pain, tinnitus, back pain, neck pain, spinal pain, shoulder muscular pain, tingles in r hand; 10/07/2020 afternoon  ---Tylenol dose 325 mg , no relief,  10/08/2020 ear fluid determined in urgent care visit -- hyrdroxyzine 50mg. 10/19/2020 Doctor visit -- l ear no more fluid, r ear some fluid --  Zipro 500mg Drop treatment, Zyrtec 10mg,  Meclizine 25 mg. Nuerosurgeon referral/visit -- MRI neck, results -- normal; Xray neck, results -normal , ENT visit 11/17/2020 - no fluid in ear, referral to PT; appointment 01/04/2020 vestibular therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus, Vertigo, X-ray normal
Clinical narrative: 10/07/2020 02:00AM Vertigo, unsteadiness, unbalanced, ear stuffiness, ear pain, tinnitus, back pain, neck pain, spinal pain, shoulder muscular pain, tingles in r hand; 10/07/2020 afternoon  ---Tylenol dose 325 mg , no relief,  10/08/2020 ear fluid determined in urgent care visit -- hyrdroxyzine 50mg. 10/19/2020 Doctor visit -- l ear no more fluid, r ear some fluid --  Zipro 500mg Drop treatment, Zyrtec 10mg,  Meclizine 25 mg. Nuerosurgeon referral/visit -- MRI neck, results -- normal; Xray neck, results -normal , ENT visit 11/17/2020 - no fluid in ear, referral to PT; appointment 01/04/2020 vestibular therapy.
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Bursitis, Magnetic resonance imaging, Pain
Clinical narrative: A couple hours after the vaccine was administered I started feeling a little more pain and restriction of motion more than normal.  By that evening I could not move my arm much at all and significant pain. Since then I've had persistent pain difficulty lifting/moving my arm and doing simple activities at daily living such as getting dressed, brushing, hair showering.  Symptoms got a little better with ibuprofen but never got back to normal. I went to occupational health for an evaluation, an MRI was ordered with the results showing  deltoid subacromial bursitis, Subscapularis tendonitis, and a bone spur.  Currently have had two episodes of physical therapy with slight improvement.
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Bursitis, Exostosis, Magnetic resonance imaging abnormal, Mobility decreased, Pain
Clinical narrative: A couple hours after the vaccine was administered I started feeling a little more pain and restriction of motion more than normal.  By that evening I could not move my arm much at all and significant pain. Since then I've had persistent pain difficulty lifting/moving my arm and doing simple activities at daily living such as getting dressed, brushing, hair showering.  Symptoms got a little better with ibuprofen but never got back to normal. I went to occupational health for an evaluation, an MRI was ordered with the results showing  deltoid subacromial bursitis, Subscapularis tendonitis, and a bone spur.  Currently have had two episodes of physical therapy with slight improvement.
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: A couple hours after the vaccine was administered I started feeling a little more pain and restriction of motion more than normal.  By that evening I could not move my arm much at all and significant pain. Since then I've had persistent pain difficulty lifting/moving my arm and doing simple activities at daily living such as getting dressed, brushing, hair showering.  Symptoms got a little better with ibuprofen but never got back to normal. I went to occupational health for an evaluation, an MRI was ordered with the results showing  deltoid subacromial bursitis, Subscapularis tendonitis, and a bone spur.  Currently have had two episodes of physical therapy with slight improvement.
Age: 77.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: patient has swelling in arm, high fever for 2 days and red spots
Age: 77.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: patient has swelling in arm, high fever for 2 days and red spots
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: About 5-10 minutes the vaccine I began to get tingling and a itchiness in the back of my throat , notified personnel and vitals were checked and stable.  The tingling and numbing sensationent away and came back and benedryl was given.  The symptoms came in waves of about ever 2-3 minutes so I was transported to ER and somumedrol was given was monitor for 1-1.5 hrs and the numbness and tingling sensation continued for about an 1-2 hours and finally subsided and was released  to go home
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: About 5-10 minutes the vaccine I began to get tingling and a itchiness in the back of my throat , notified personnel and vitals were checked and stable.  The tingling and numbing sensationent away and came back and benedryl was given.  The symptoms came in waves of about ever 2-3 minutes so I was transported to ER and somumedrol was given was monitor for 1-1.5 hrs and the numbness and tingling sensation continued for about an 1-2 hours and finally subsided and was released  to go home
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Eye swelling, Feeling hot, Ocular discomfort, Paraesthesia
Clinical narrative: (1145) Left eyelid swelling 15 minutes after vaccination. (1155) b/l superior periorbital edema and erythema, b/l ear erythema and burning, and b/l hand tingling. (1200) Oral Benadryl 25 mg was given. (1230) symptoms improved and I was able to leave.  While riding in the car on the way home started to have chills w/ goosebumps and nausea in short waves.  Took an nap b/c my chills worsened and slept until 1630. Work up b/c of worsening chills, shivering, chest tightness, nausea,  b/l hand numbness and tingling, right foot burning and stinging, and constant throat clearing b/c throat felt thick.  Called the nurse on-call number provided in vaccine packet and was transferred to virtual care and report was given. Medical team advised me to go to the ED. (1900) Arrived at ED and temp was 101 and the chills, numbness, foot burning,  and chest heaviness were worse and my eyes were burning and heavy.  I was given oral Pepcid and an IV was started.  After an IVP of Benadryl and Solu-Medrol I experienced severe burning  starting in my head, neck, chest, and stomach. Then it felt like my veins were on fire all the way to my fingers and toes. This was followed by strong nausea w/o vomiting. I was then given IVP of Zofran and Ativan and NS drip. (1940-2020) Chills, burning around eyes, and vertigo continued other symptoms were improving .(2020) Provider returned and reported that labs were normal and I was probably having a reaction to the vaccine. (2035) Discharged from ED. Experienced chills, hand and foot numbness and tinging after discharge but was able to go to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenopia, Burning sensation, Chest discomfort, Chest pain, Chills
Clinical narrative: (1145) Left eyelid swelling 15 minutes after vaccination. (1155) b/l superior periorbital edema and erythema, b/l ear erythema and burning, and b/l hand tingling. (1200) Oral Benadryl 25 mg was given. (1230) symptoms improved and I was able to leave.  While riding in the car on the way home started to have chills w/ goosebumps and nausea in short waves.  Took an nap b/c my chills worsened and slept until 1630. Work up b/c of worsening chills, shivering, chest tightness, nausea,  b/l hand numbness and tingling, right foot burning and stinging, and constant throat clearing b/c throat felt thick.  Called the nurse on-call number provided in vaccine packet and was transferred to virtual care and report was given. Medical team advised me to go to the ED. (1900) Arrived at ED and temp was 101 and the chills, numbness, foot burning,  and chest heaviness were worse and my eyes were burning and heavy.  I was given oral Pepcid and an IV was started.  After an IVP of Benadryl and Solu-Medrol I experienced severe burning  starting in my head, neck, chest, and stomach. Then it felt like my veins were on fire all the way to my fingers and toes. This was followed by strong nausea w/o vomiting. I was then given IVP of Zofran and Ativan and NS drip. (1940-2020) Chills, burning around eyes, and vertigo continued other symptoms were improving .(2020) Provider returned and reported that labs were normal and I was probably having a reaction to the vaccine. (2035) Discharged from ED. Experienced chills, hand and foot numbness and tinging after discharge but was able to go to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Ear discomfort, Erythema, Eye irritation, Full blood count normal
Clinical narrative: (1145) Left eyelid swelling 15 minutes after vaccination. (1155) b/l superior periorbital edema and erythema, b/l ear erythema and burning, and b/l hand tingling. (1200) Oral Benadryl 25 mg was given. (1230) symptoms improved and I was able to leave.  While riding in the car on the way home started to have chills w/ goosebumps and nausea in short waves.  Took an nap b/c my chills worsened and slept until 1630. Work up b/c of worsening chills, shivering, chest tightness, nausea,  b/l hand numbness and tingling, right foot burning and stinging, and constant throat clearing b/c throat felt thick.  Called the nurse on-call number provided in vaccine packet and was transferred to virtual care and report was given. Medical team advised me to go to the ED. (1900) Arrived at ED and temp was 101 and the chills, numbness, foot burning,  and chest heaviness were worse and my eyes were burning and heavy.  I was given oral Pepcid and an IV was started.  After an IVP of Benadryl and Solu-Medrol I experienced severe burning  starting in my head, neck, chest, and stomach. Then it felt like my veins were on fire all the way to my fingers and toes. This was followed by strong nausea w/o vomiting. I was then given IVP of Zofran and Ativan and NS drip. (1940-2020) Chills, burning around eyes, and vertigo continued other symptoms were improving .(2020) Provider returned and reported that labs were normal and I was probably having a reaction to the vaccine. (2035) Discharged from ED. Experienced chills, hand and foot numbness and tinging after discharge but was able to go to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Metabolic function test normal, Nausea, Pain, Paraesthesia
Clinical narrative: (1145) Left eyelid swelling 15 minutes after vaccination. (1155) b/l superior periorbital edema and erythema, b/l ear erythema and burning, and b/l hand tingling. (1200) Oral Benadryl 25 mg was given. (1230) symptoms improved and I was able to leave.  While riding in the car on the way home started to have chills w/ goosebumps and nausea in short waves.  Took an nap b/c my chills worsened and slept until 1630. Work up b/c of worsening chills, shivering, chest tightness, nausea,  b/l hand numbness and tingling, right foot burning and stinging, and constant throat clearing b/c throat felt thick.  Called the nurse on-call number provided in vaccine packet and was transferred to virtual care and report was given. Medical team advised me to go to the ED. (1900) Arrived at ED and temp was 101 and the chills, numbness, foot burning,  and chest heaviness were worse and my eyes were burning and heavy.  I was given oral Pepcid and an IV was started.  After an IVP of Benadryl and Solu-Medrol I experienced severe burning  starting in my head, neck, chest, and stomach. Then it felt like my veins were on fire all the way to my fingers and toes. This was followed by strong nausea w/o vomiting. I was then given IVP of Zofran and Ativan and NS drip. (1940-2020) Chills, burning around eyes, and vertigo continued other symptoms were improving .(2020) Provider returned and reported that labs were normal and I was probably having a reaction to the vaccine. (2035) Discharged from ED. Experienced chills, hand and foot numbness and tinging after discharge but was able to go to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital oedema, Piloerection, Swelling of eyelid, Throat clearing, Vertigo
Clinical narrative: (1145) Left eyelid swelling 15 minutes after vaccination. (1155) b/l superior periorbital edema and erythema, b/l ear erythema and burning, and b/l hand tingling. (1200) Oral Benadryl 25 mg was given. (1230) symptoms improved and I was able to leave.  While riding in the car on the way home started to have chills w/ goosebumps and nausea in short waves.  Took an nap b/c my chills worsened and slept until 1630. Work up b/c of worsening chills, shivering, chest tightness, nausea,  b/l hand numbness and tingling, right foot burning and stinging, and constant throat clearing b/c throat felt thick.  Called the nurse on-call number provided in vaccine packet and was transferred to virtual care and report was given. Medical team advised me to go to the ED. (1900) Arrived at ED and temp was 101 and the chills, numbness, foot burning,  and chest heaviness were worse and my eyes were burning and heavy.  I was given oral Pepcid and an IV was started.  After an IVP of Benadryl and Solu-Medrol I experienced severe burning  starting in my head, neck, chest, and stomach. Then it felt like my veins were on fire all the way to my fingers and toes. This was followed by strong nausea w/o vomiting. I was then given IVP of Zofran and Ativan and NS drip. (1940-2020) Chills, burning around eyes, and vertigo continued other symptoms were improving .(2020) Provider returned and reported that labs were normal and I was probably having a reaction to the vaccine. (2035) Discharged from ED. Experienced chills, hand and foot numbness and tinging after discharge but was able to go to sleep.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphonia, Rash, Swollen tongue, Tachycardia, Throat irritation
Clinical narrative: Anaphylaxis requiring ER admission and administration of epinephrine x2 doses, steroids, antihistamines, IV fluid, singular.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Tryptase
Clinical narrative: Anaphylaxis requiring ER admission and administration of epinephrine x2 doses, steroids, antihistamines, IV fluid, singular.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Paraesthesia oral
Clinical narrative: Anaphylaxis requiring ER admission and administration of epinephrine x2 doses, steroids, antihistamines, IV fluid, singular.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased
Clinical narrative: 5-7 min after injection she felt flushed face and "as if they were checking my pacer"  "so my heart rate revved up a little"   She sat down and the feeling resolved within 15 min
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Human chorionic gonadotropin, Palpitations, Sinus tachycardia
Clinical narrative: 5 minutes after receiving vaccine I felt like I was going to pass out. They took me to the ER. Heart rate went up to 160 at one point. Was given steroids, Benadryl, and Pepcid and that helped. This helped and then heart rate went up again. Tremors and BP was up.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Tremor
Clinical narrative: 5 minutes after receiving vaccine I felt like I was going to pass out. They took me to the ER. Heart rate went up to 160 at one point. Was given steroids, Benadryl, and Pepcid and that helped. This helped and then heart rate went up again. Tremors and BP was up.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Flushing, Hunger, Malaise
Clinical narrative: 16 minutes following injection, weakness, tachycardia at 180 and BP of 186/93. Call initiated by medical personnel to 911.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: 16 minutes following injection, weakness, tachycardia at 180 and BP of 186/93. Call initiated by medical personnel to 911.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Metabolic function test
Clinical narrative: 16 minutes following injection, weakness, tachycardia at 180 and BP of 186/93. Call initiated by medical personnel to 911.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Troponin T
Clinical narrative: 16 minutes following injection, weakness, tachycardia at 180 and BP of 186/93. Call initiated by medical personnel to 911.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; One unspecified patient received a dose of PNEUMOVAX 23 that was improperly stored; Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (lot number T00974 with expiration date on 28-JAN-2022) (dose, frequency scheme, route of administration and anatomical location were not reported).  It was reported that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion at a temperature range of 49.1 degrees Fahrenheit (F) for the time frame of 12 hours. There was no previous temperature excursion and the call was because of a data logger. No additional adverse effects reported.  Lot number T00974 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Follow-up information has been received from the pharmacist on 15-DEC-2020.  It was reported that the patient was a 77-year-old male. His medical conditions included high blood pressure. The reported did not know of any other medications that patient was taking. On 25-SEP-2020, he was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the left deltoid (lot # T009744 has been verified to be valid, expiration date reported and validated as 28-JAN-2022) (dose number, dose and frequency scheme were not reported). Additionally, he received a dose of influenza virus split virion 4v vaccine inactivated (FLUZONE HD).  It was reported that the patient was fully recovered from the adverse event. He was vaccinated at a pharmacy and the vaccine was purchased with private funds.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA007563:
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: improperly stored vaccine had been administered; late shipment; This spontaneous report as received from a medical assistant referring to a 44-year-old female patient. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.     The reporter complained about late shipment of product. It was supposed to come on 27-OCT-2020 but the product actually arrived 2 days late on 29-OCT-2020. The caller stated when she first received the vaccines, she for some reason thought the current date of receipt was actually 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. She immediately placed the product into the freezer. Since then, the caller was informed that the product was actually received 2 days late. On 03-NOV-2020, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T014309, expiration dare was 24-APR-2022 (conflicting information: also reported as 24-APR-2024), dose was 0.5 milliliter, single dose, route unknown) in the right upper arm (RUA) for prophylaxis. The operator was trained. The vaccine was used according to the instruction leaflet. The vaccine was not available for return/evaluation. The patient did not reported any additional adverse experiences as a result of receiving the improperly stored vaccine. The reporter stated that when she opened the package, the information and logger inside the package stated the product was "ok" but she does not have any of that paperwork at this time as when it was found "ok", she did not think twice and discarded the paperwork.  This is one of the six cases from the same reporter.; Sender's Comments:  US-009507513-2011USA013851: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013200: US-009507513-2011USA013293:
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; 1 dose of GARDASIL was administered following the improper storage; This spontaneous report was received from a nurse referring to a 13 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-DEC-2020, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1637648 expiring on 19-JUN-2022, for prophylaxis (dose, route and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of 33F for 120 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursion.  There was no adverse effect reported and no product quality complaint involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing Loss; zoster-related conditions; zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about in 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX)was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to the inoculation), the patient was treated by healthcare providers for hearing loss, and other zoster-related conditions. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, hearing loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Blindness, Deafness
Clinical narrative: loss of vision; loss of hearing; balance issues; Information has been received regarding a case in litigation from a lawyer and the pt on 11-DEC-2020, referring to a currently 70 year old pt. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JUN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: loss of vision, loss of hearing and balance issues. The outcome of loss of vision, loss of hearing and balance issues was unknown. The causality assessment between loss of vision, loss of hearing and balance issues with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, loss of vision and loss of hearing were determined to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; ill-defined disorder; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In 2016, Plaintiff was inoculated with zoster vaccine live(ZOSTAVAX), as prescribed and/or administered by a pharmacist at Pharmacy for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, subsequent to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician, for shingles, and other zoster-related conditions.  As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Inappropriate schedule of product administration, Syncope, Underdose
Clinical narrative: First dose 20-JUL-2017, Second dose 05-JUN-2019, Third dose 14-DEC-2020.; 19 yr old female received a smaller volume ofGARDASIL 9, it was  administered 0.4 mL out of 0.5 mL to patient.; The patient "gets kind of fainty.; The patient fainted at the time she received her 2nd dose; This spontaneous report was received from a  medical assistant referring to a 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On  20- JUL-2017 and on 05-JUN-2019, the patient was vaccinated with her first and second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.         On 05-JUN-2019, the patient fainted (syncope) at the time she received her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Subsequently, on 14-DEC-2020 (reported as "today"), the patient was vaccinated with her third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The medical assistant reported that she administered 0.4 mL out of 0.5 mL to patient, she inquiring about validity of dosage. Additionally, she reported that the patient got kind of fainty (dizziness) after vaccination.   At the time of the report, the outcome of syncope and dizziness was unknown. The reporter did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Caller is a medical assistant calling to report a temperature excursion.; Product Name: ROTATEQ / Dose/Frequency: 0.5 ml; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 14-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 0.5 milliliter (incorrect dose administered), administered by oral route (formulation, strength and vaccination scheme were not reported; lot number S040483, which has been verified to be valid, expiration date reported and validated as 19-JUN-2021), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), administered at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T001206, which has been verified to be valid, expiration date reported and validated as 03-JUN-2022), both vaccines were administered as prophylaxis, and experienced temperature excursion.  This is one of several reports received from the same reporter.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; One unspecified patient received a dose of PNEUMOVAX 23 that was improperly stored; Information has been received from a pharmacist regarding a 75-year-old female patient. Her current conditions included high blood pressure, high cholesterol, and estrogen replacement therapy. Concomitant therapies included gabapentin, diclofenac, losartan potassium (manufacturer unknown), amlodipine besylate (NORVASC) and paroxetine. The patient's medical history, drug allergies and reactions were not reported.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered intramuscularly in the left deltoid as prophylaxis (lot number T009744 has been verified to be valid, expiration date reported and validated as 28-JAN-2022) (dose, dose number, and frequency scheme were not reported). Additionally, he received a dose of influenza virus split virion 4v vaccine inactivated (FLUZONE HD).  It was reported that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion at a temperature range of 49.1 degrees Fahrenheit (F) for the time frame of 12 hours. There was no previous temperature excursion and the call was because of a data logger. No additional adverse effects reported.  It was reported that the patient was considered fully recovered from any adverse event. The vaccine was purchased with private funds.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA011084:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Caller is a medical assistant calling to report a temperature excursion.; Product Name: ROTATEQ / Dose/Frequency: 0.5 ml; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 14-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 0.5 milliliter (incorrect dose administered), administered by oral route (formulation, strength and vaccination scheme were not reported; lot number S040483, which has been verified to be valid, expiration date reported and validated as 19-JUN-2021), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), administered at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T001206, which has been verified to be valid, expiration date reported and validated as 06-MAR-2022), both vaccines were administered as prophylaxis, and experienced temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA008083:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: My dosing interval was interrupted by Covid-19 / It has been 13 months since dose #1.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 13 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The patient dosing interval was interrupted by Covid-19.  It had been 13 months since 1st dose. The provider said the patient should continue with 2nd dose rather than start over.  The patient asked guidance.
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: miscarriage; Exposure during pregnancy; This retrospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of miscarriage in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Influenza vaccine Quadrivalent unspecified season at an unknown time during the pregnancy. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced miscarriage (serious criteria GSK medically significant) and vaccine exposure during pregnancy. On an unknown date, the outcome of the miscarriage and vaccine exposure during pregnancy were unknown. The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present.   It was unknown if the reporter considered the miscarriage to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The patient had a miscarriage very few days after receiving flu vaccine. The patient stated that, people make fun of her and tell her that it was only a coincidence. The patient would never take one again.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Facial paralysis, Neurological symptom
Clinical narrative: Bell's palsy/Facial Droop; stroke; Neuro deficit; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for product used for unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  The initial information was received on 10 Dec 2020 via medical record (case is now medically confirmed). As per pharmacy record, Patient ingested with shingrix vial from 31 October 2019 to 15 January 2020. On 03 feb 2020, CT of head without contrast performed which shows patient had facial droop and storke, Neuro deficit.
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site pain, Pruritus
Clinical narrative: local pain at the injection site after vaccination; post vaccination induration; post vaccination itchiness; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient [age unspecified] who experienced, local pain at the injection site (vaccination site pain), post vaccination induration (vaccination site induration) and post vaccination itchiness (vaccination site pruritus), while she received FLUZONE HIGH DOSE [INFLUENZA VACCINE TRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious local pain at the injection site (vaccination site pain), post vaccination induration (vaccination site induration) and post vaccination itchiness (vaccination site pruritus) unknown latency following the administration of [INFLUENZA VACCINE TRIVALENT]  It was reported that, worsening of the condition if she ate eggs and wondered if patient was experiencing an egg allergy reaction.  Details of laboratory data not reported.   It was reported that, it was not sure patient should be treated with steroids.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Poliomyelitis
Clinical narrative: Getting a polo shot didn't prevent me from getting the disease; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved adult patient who reported that getting a "polo shot" didn't prevent him/her from getting the disease (Influenza), while patient received INFLUENZA VACCINE.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that getting a polo shot didn't prevent him/her from getting the disease (Influenza), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: feel ill; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who feel ill (malaise), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious feel ill (malaise) usually for one or two days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: patient had a reaction in 2016 to the flu shot, required hospitalization; Initial information received on 15-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient). This case involves a patient with an unknown age and gender who had a reaction in 2016 (adverse reaction), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  The patient taken vitamins and supplements.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2016, the patient had a reaction (adverse reaction) unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown, at the time of reporting.  Information regarding the batch number was requested for the case.; Sender's Comments: This case involves patient with an unknown age who had reported adverse reaction after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies were needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza like illness
Clinical narrative: the patient had flu like symptoms; Initial information regarding this unsolicited valid non-serious social media  case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient who experienced flu like symptoms, after receiving vaccine INFLUENZA VACCINE.  It was reported that 5 years ago the patient got Influenza vaccine shot and experienced Guillain-Barre syndrome.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms (influenza like illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza like illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given 0.5ml of the liquid component of the Pentacel vaccine with no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who received 0.5ml of the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ406AA, expiry date: 09-Oct-2021) via unknown route in the right thigh on 18-Nov-2020 for prophylactic vaccination (product preparation error).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and Rotavirus vaccine  It was an actual medication error due to Active ingredient not added to diluent (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.