chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient stated she has been having extreme pain in her vaccinated arm.  There is no  swelling or redness.  She stated started about 2 days after receiving the vaccine.  It was relieved with anti-inflammatories but it has continued once those were stopped
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain,  Redness ,Swelling  Fever  Headache  Nausea Fatigue
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Injection site pain,  Redness ,Swelling  Fever  Headache  Nausea Fatigue
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Insomnia, Nausea, Pain
Clinical narrative: I started feeling achy in my body around 5pm and the symptoms got worse from there. The ache was so strong that I took two Tylenol Extra Strength before going to bed. That night, I felt feverish and chills. I ended up putting several blankets on, even though it was a warm evening. I experienced sleeplessness and nausea throughout the night. My appetite, which is usually quite good, was very poor today.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I started feeling achy in my body around 5pm and the symptoms got worse from there. The ache was so strong that I took two Tylenol Extra Strength before going to bed. That night, I felt feverish and chills. I ended up putting several blankets on, even though it was a warm evening. I experienced sleeplessness and nausea throughout the night. My appetite, which is usually quite good, was very poor today.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache
Clinical narrative: 99 degree temperature through out 12 hour period Bad headache through out 24 hour period Brief period of  shivering Lightheadedness throughout 12 hour period Treated all with Advil
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, X-ray limb
Clinical narrative: Shoulder pain & stiffness
Sex: U
Vaccine: PPV, TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Rash on arms, chest/Benadryl & Hydrocortisone  recommended seeking medical attention if no improvement
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Eye movement disorder, Mobility decreased, Tremor
Clinical narrative: Pt. became very dizzy, weak, and shaky. stated she felt like she couldn't open her eyes or move her legs. was placed in supine position with legs elevated. Pt only had some chips-nothing to eat. sugar water given with no improvement. VSS-pt taken to ER for further evaluation (by mother)
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash, fever, Irritability x 3 days
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Cold sweat, Dizziness
Clinical narrative: Pt. felt dizzy & weak after the vaccine administration within minutes. She was given O2 in office & legs elevated & felt a little clammy & then was fine. D/C in stable condition.
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient was administered VARIVAX intramuscularly rather than subcutaneously; This spontaneous report was received from a registered nurse, concerning to a currently 13-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 10-JUN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly for prophylaxis (dose, frequency, strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (incorrect route of product administration). The vaccine was reconstituted with sterile diluent (lot number and expiration date were unknown by the reporter). It was reported that the temperature excursion status was unknown for both the varicella virus vaccine live (Oka/Merck) (VARIVAX) and sterile diluent. The outcome of incorrect route of product administration was unknown.
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: The patient was administered VARIVAX intramuscularly rather than subcutaneously; This spontaneous report was received from a registered nurse, concerning to a currently 13-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 10-JUN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly for prophylaxis (dose, frequency, strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (incorrect route of product administration). The vaccine was reconstituted with sterile diluent (lot number and expiration date were unknown by the reporter). It was reported that the temperature excursion status was unknown for both the varicella virus vaccine live (Oka/Merck) (VARIVAX) and sterile diluent. The outcome of incorrect route of product administration was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Improperly stored dose of MMR II was administered to a patient; This spontaneous report was received from a consumer referring to a female patient of unknown age.   The patient's concurrent conditions, medical history or concomitant medications was not reported.   On 01-JUN-2020, dose of Measles, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) lot # S014430 and expiration date 09-MAY-2021 (dose, frequency and route of administration were not reported ) as prophylaxis, which was improperly stored (temperature unknown by reporter) in a timeframe of 20 hours was administered to the patient. The temperature was unspecified and it was mentioned that the vaccine did not experience temperature excursion or recorded by a data logger. It was reported that the call was not made due to data logger and no previous temperature excursion occurred.  No additional adverse effects reported by the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: painful reoccurring rash; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the vaccine, the pt suffered a painful reoccurring rash. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to being vaccinated. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the event was reported as not recovered; causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered rash to be a disabling event.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; patient inadvertently administered a dose of ROTATEQ that was expired; This spontaneous report was received from a medical assistant, referring to a 9 week old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 09-JUN-2020, the patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # R021649, expiration date 27-MAY-2020, for prophylaxis (strength, dose and frequency were not reported). No additional adverse event reported.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Smear cervix abnormal
Clinical narrative: Papanicolaou smear positive; she is unsure if she received the third dose of Gardasil; she is unsure if she received the third dose of Gardasil; This spontaneous report was received from a consumer concerning to herself a patient of unknown age. The patient's concurrent conditions, concomitant medications, pertinent medical history, previous drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient reported that she tested positive for a pap smear test (smear cervix abnormal). Additionally, the patient was unsure if she received the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (inappropriate schedule of product administration and circumstance or information capable of leading to medication error).    The outcome of smear cervix abnormal, inappropriate schedule of product administration and circumstance or information capable of leading to medication error was unknown.    The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the event of smear cervix abnormal was not reported.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; the patient was administered a dose of improperly stored PEDVAX HIB; This spontaneous report was received from a nurse, referring to a 3-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.   On 03-JUN-2020, the patient was vaccinated with a improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX HIB) (dose, route of administration, vaccination scheme, site of vaccination were not reported). Lot number S007072, and expiration date reported as 24-JAN-2022, were invalid for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), administered as prophylaxis (product storage error).    The vaccine was exposed to a temperature above 47 degrees Fahrenheit (F) for 10 min as recorded by the data logger. There were no previous tempeture excursions. No adverse symptoms were reported.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: By the evening, soreness in arms. Throughout the night, headaches, body aches, feverish, chills
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a Kinrix at 4 month well child exam, this vaccine is not recommend for this age. No adverse event noted, parent reports patient is doing fine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arrhythmia, Arthralgia, Back pain, Blood test, Burning sensation
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chiropractic, Coordination abnormal, Cough, Discomfort, Dysphagia
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Facial paresis, Fatigue, Gait disturbance, Hypertension
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Influenza, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain, Pain in extremity, Pain of skin, Paraesthesia
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Reflexes abnormal, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Cardiac failure congestive, Condition aggravated, Death, Dementia, Dysstasia
Clinical narrative: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Fall, Feeling abnormal, Feeling hot, Gait disturbance, Intensive care
Clinical narrative: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Malaise, Mobility decreased, Muscular weakness, Peripheral swelling, Walking aid user
Clinical narrative: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Confusional state, Death, Dysstasia, Feeling abnormal, Feeling hot
Clinical narrative: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Musculoskeletal disorder, Pyrexia
Clinical narrative: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt developed shingles rash that he says he found this morning after receiving the vaccination yesterday.  Not painful, not itchy, lies in T10/T11 dermatome along the left lower abdomen.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A patient received a dose of improperly stored VARIVAX; This spontaneous report was received from  nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions drug reactions or allergies and concomitant therapies was provided.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) had temperature excursions between - 9  degree Celsius (°C ) to 8°C (-8.2°C) for a time frame of 74 hours and 35 minutes. On 01-JUN-2020, the second excision occurred and the excursion details were: -10 ,4°C for 2 hours and 46 minutes. It was reported that on 03-JUN-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028921, expiration date 16-SEP-2021, (dose, route of administration were not reported).The vaccine was reconstituted with properly stored sterile diluent  on the same day. Digital data logger was involved.   No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to a 4 years-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.   It was reported that on 03-DEC-2019, varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 12-DEC-2019, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA001555:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005620:same reporter US-009507513-2006USA005618:same reporter US-009507513-2006USA005616:same reporter US-009507513-2006USA005617:same reporter
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 4 years-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 13-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-2006USA005616: US-009507513-2006USA005617: US-009507513-2006USA005618: US-009507513-1912USA001555: US-009507513-2006USA005620:
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: raised area on her arm at the injection site of the second dose of GARDASIL 9; This spontaneous report was received from a healthcare student concerning a 12 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not provided) for prevention of human papillomavirus.      On an unknown date, the patient experienced a raised area on her arm at the injection site of the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (injection site mass). At the time of the report, the outcome of the event was unknown. The causal relationship between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Injection site pain
Clinical narrative: The patient developed a sore arm near the injection site after receiving the vaccine.; A patient received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 09-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular route (strength, frequency, and anatomical location were unknown) with lot # R018741 and expiration date 06-APR-2020 for vaccination. Additionally, after receiving the vaccine, the patient developed a sore arm near the injection site (pain in extremity). No treatment was given to the patient due to the event because she did not seek for medical attention.  At the time of the report, the outcome of pain in extremity was unknown. The reporter did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R018741; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysstasia, Gait inability, Hyperhidrosis, Incomplete course of vaccination
Clinical narrative: beeing Sick; Unable to stand; Shivers; Sweating; "Felt like dying"; "Felt like horrible case of flu"; Unable to walk; he had to miss a day of work due to symptoms.; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix over a year ago and unable to remember the date when he got the first vaccination.  The patient had been sick, unable to stand, shivers, sweating, feeling like he was dying, feeling like he had a horrible case of the flu and being unable to walk and had to miss a day of work due to symptoms.  The reporter had questions about receiving the 2nd dose after the 6 month. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Provided him with CDC guidelines to receive 2nd dose as soon as possible. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Malaise
Clinical narrative: beeing Sick; Unable to stand; Shivers; Sweating; "Felt like dying"; "Felt like horrible case of flu"; Unable to walk; he had to miss a day of work due to symptoms.; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix over a year ago and unable to remember the date when he got the first vaccination.  The patient had been sick, unable to stand, shivers, sweating, feeling like he was dying, feeling like he had a horrible case of the flu and being unable to walk and had to miss a day of work due to symptoms.  The reporter had questions about receiving the 2nd dose after the 6 month. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Provided him with CDC guidelines to receive 2nd dose as soon as possible. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu-like symptoms; Body Aches; Tiredness; arm was sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fatigue and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm. The pateint expereinced flu-like symptoms which included body aches, tiredness but no fever. The reporter also stated their arm was sore.  All the symptoms began the following day of administration and lasted approximately a day.  The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills began around 11:30 p.m. and lasted about 7 hours. Fever peaked at 101° and chills were most severe about three hours in, at 2:30 a.m.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Laboratory test normal, Myalgia, Pain, Pyrexia
Clinical narrative: Body aches and chills. Muscles aches. Fever between 101-99.5. Been 24 hours since vaccine and still occurring.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count increased
Clinical narrative: Body aches and chills. Muscles aches. Fever between 101-99.5. Been 24 hours since vaccine and still occurring.
Age: 20.0
Sex: M
Vaccine: HEPA, MENB, MNQ, VARCEL
Symptoms: Dizziness, Feeling hot, Malaise, Pallor, Vomiting
Clinical narrative: After receiving shots, pt returned to the lobby to leave with his father. Father came back to the clinic door and knocked, states "He's about to pass out." Nurse went to lobby where pt was sitting in chair awake and alert; skin pale and ashen. Nurse asked pt how he felt, pt states "dizzy and sick, I don't know". States he cannot walk and is hot. Nurse and father fanned pt with nearby books. Pt asked to go to bathroom stating " I need to go to the bathroom badly". Pt father helped him up and went with him to the bathroom. Father returned to lobby after a few minutes stating "He threw up and is sitting on the toilet now using the bathroom, He says he felt better as soon as he vomited". Father states pt has not had anything to eat today, expresses concern that vaccines caused the reaction. Explained that this type of reaction can happen due to anxiety and adrenaline associated with needles and shots. Also explained that true vaccine allergies and reactions are more respiratory related. Offered pt water and crackers which he took. Pt returned to lobby stating he felt much better; asked if he should drive. Told pt it was probably best not to drive at this time; father states he would take him in his car and return later today to get the pts car. Pt and father sat for a few more minutes and then stated they felt ready to leave. Advised them to call with any concerns and to go to er or pcp if further complications arise. Both verbalized understanding at this time.