chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Angiogram normal, Blood electrolytes normal, Confusional state, Dysarthria, Echocardiogram normal
Clinical narrative: On 6/4/2020 he had onset of TIA like sxs.  Arm numbness, slurred speech, drooping of the face, mental confusion.  He presented to local ER where his sxs had subsided spontaneously however he was transferred to Hospital for further workup.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Facial paralysis, Full blood count normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: On 6/4/2020 he had onset of TIA like sxs.  Arm numbness, slurred speech, drooping of the face, mental confusion.  He presented to local ER where his sxs had subsided spontaneously however he was transferred to Hospital for further workup.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Transient ischaemic attack
Clinical narrative: On 6/4/2020 he had onset of TIA like sxs.  Arm numbness, slurred speech, drooping of the face, mental confusion.  He presented to local ER where his sxs had subsided spontaneously however he was transferred to Hospital for further workup.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Differential white blood cell count normal, Dyskinesia, Electroencephalogram normal, Excessive eye blinking, Lumbar puncture normal
Clinical narrative: ABOUT 36 HOURS AFTER THE VACCINES WERE GIVEN, PT WOKE UP FROM NAP AND HAD JERKING OF RIGHT ARM, TWITCHING /BLINKING OF EYES, LIP SMACKING. NO EYE DEVIATION. PT SEEMED ALERT AND RESPONSIVE. HE WENT TO THE ED. AFTER EVALUATION HERE HE WAS SENT TO HOSPITAL.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Magnetic resonance imaging normal, Metabolic function test normal, Muscle twitching, Tardive dyskinesia, White blood cell count increased
Clinical narrative: ABOUT 36 HOURS AFTER THE VACCINES WERE GIVEN, PT WOKE UP FROM NAP AND HAD JERKING OF RIGHT ARM, TWITCHING /BLINKING OF EYES, LIP SMACKING. NO EYE DEVIATION. PT SEEMED ALERT AND RESPONSIVE. HE WENT TO THE ED. AFTER EVALUATION HERE HE WAS SENT TO HOSPITAL.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Developed 11x18mm left supraclavicular reactive lymp node.   The node is slightly firm, but not hard or rubbery and is slightly tender
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: pt states she blacked out the next day and fell down stairs, hit her head and was hospitalized
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reports severe pain in arm, unable to lift arm, and pain between her shoulder blades.  Patient took a pain pill but stated that that did not even touch the pain.  She was encouraged to seek medical advice from a healthcare practitioner.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dermatitis atopic, Injection site rash, Rash, Rash papular
Clinical narrative: papular rash, initially appearing on the face and then spreading to the legs. tele-visit only secondary to COVID19 limitations (so entire visit obtained via audio history only) will treat as atopic dermatitis - emollient use recommended.  recommend photo-documentation from parent monitor -- if worsening, recommend in-person or video visit to review rash. FH of eczema.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: 6 days after vaccines child woke up with a fever at 6:00 AM. Mother gave 2.5ml of tylenol and 1.25ml  of motrin. Fever continued when medication wore off for 36 hours.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Pain
Clinical narrative: 2 days post injection onset of pain in rat shoulder join that has persistent up to this point and seemed to get progressively worse over time. Excruciating at times and only when performing certain movements. Worse at night time
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood
Clinical narrative: Significant Hematochezia. Discussed with a GI specialist. Sent to emergency room for evaluation and treatment.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Feeling cold, Malaise, Pain in extremity, Tremor
Clinical narrative: Extreme shaking from feeling cold. Put on sweat pants and extra blankets and took acetaminophen Lasted half an hour. Soreness of arm and general sense of malaise. Began last night and lasting into this morning.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: At moment of vaccination and after vaccination patient seems normal and stable. Then, 3 days after vaccination, the patient contacted the pharmacy for a consult because of possibility of a post vaccine reaction.  The patient indicated that later that day of vaccination, at night, she started feeling dizzy, with nausea and vomiting, making it for her impossible to get out of bed. The other day of vaccination, the area where Pneumovax 23 vaccine was administered (left deltoid) was swollen, red, and with pain. These symptoms last a few days as she stated.  She came to the pharmacy seeking for treatment for her arm and Benadryl 25mg capsules three times daily and Benadryl cream three times daily was dispensed. Patient was contacted few days later for monitoring and she did not responded. Then,  1 week later and she answered and she indicated that symptoms improved, she was fine and stable.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: At moment of vaccination and after vaccination patient seems normal and stable. Then, 3 days after vaccination, the patient contacted the pharmacy for a consult because of possibility of a post vaccine reaction.  The patient indicated that later that day of vaccination, at night, she started feeling dizzy, with nausea and vomiting, making it for her impossible to get out of bed. The other day of vaccination, the area where Pneumovax 23 vaccine was administered (left deltoid) was swollen, red, and with pain. These symptoms last a few days as she stated.  She came to the pharmacy seeking for treatment for her arm and Benadryl 25mg capsules three times daily and Benadryl cream three times daily was dispensed. Patient was contacted few days later for monitoring and she did not responded. Then,  1 week later and she answered and she indicated that symptoms improved, she was fine and stable.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: slight headache, nausea, weakness, slight dizziness, muscle aches, no energy
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: Fever, aches & pains, loss of appetite for 2 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling and redness, pain, and a fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Dizziness, Fatigue, Presyncope, Pyrexia
Clinical narrative: The morning of 6/5/2020 I awoke with fever (100.5 degrees), dizziness, significant fatigue, and loss of vision (pre-fainting) when I got up from bed. My arm at the injection site was also sore all night and into today. I rested and/or slept in bed most of 6/5/2020; my fever went down (99.5 in the afternoon) with a single dose of acetaminophen, but lightheadedness and significant fatigue persisted through the day and into the night. On 6/6/2020 (today), I awoke with some lightheadedness; went to take a shower and nearly fainted in the shower from lightheadedness, dizziness, and loss of vision (including the visual sensation of waves of dim light when my eyes remained closed) for about 10 minutes. I returned to bed, rested most of today, and felt somewhat better in the afternoon. Lightheadedness is gone; fatigue is less than yesterday (about 75% less). But this a.m. I awoke to find itchy hives near my bellybutton and across my lower back, with a few on either side of my hips. It might be related to the vaccine; or it might be a result of a mountain hike I took on Thursday. I don't know. I did not take any pain or fever medication today; my temperature was normal this morning.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme, Rash erythematous
Clinical narrative: Pt was seen at ER ( per discharge summary) on 5/27/2019 wtih "red targetoid rash consistent with erythema multiforme. The rash is likely to be a reaction to his vaccines on 5/22". ER Attending at time of visit- Dr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 100.3 F Chills Myalgia Tiredness Muscle pain
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Emotional distress, Loss of consciousness, Respiratory rate decreased, Syncope
Clinical narrative: Patient fainted shortly after receiving the second vaccine (menveo). Breathing was slowed while he was unconsciousness but he did not stop breathing. Patient was sitting in the chair and did not fall out. He regained consciousness after a few seconds. He said he felt light headed and that it had not happened previously to him. He said he was fine but had patient wait around (seated) for about 10-15 minutes to assure no other adverse events occurred. Patient appeared alert and oriented but he seemed rather embarrassed. Patient stated he felt fine after I had him wait around. Patient was wearing a mask during the immunization process and when he fainted, but took it off after he regained consciousness.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: Outbreak of an still ongoing event of genital herpes. This was the first outbreak in more than ten years and only the second in thirty years. The outbreak has not been reduced despite medical treatment since February 22, 2020. Took 1000 mg Valtrex (twice normal dose) Feb 22-March 6; then reduced to 500 mg. Since March 10 continuously taking 1000 mg except for three four days periods in late March and April. Situation was worse after second dose on April 29. On advice of Ob Gyn increase dose to 2000 mg between May 15-19, then reduced it to 1000 mg. Since May 23 have continued at 2000 mg. Have consulted the Ob Gyn three times in this period and she does not know what to make of the situation. On June 4 she took a biopsy to assess other potential impacts.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Genital herpes
Clinical narrative: Outbreak of an still ongoing event of genital herpes. This was the first outbreak in more than ten years and only the second in thirty years. The outbreak has not been reduced despite medical treatment since February 22, 2020. Took 1000 mg Valtrex (twice normal dose) Feb 22-March 6; then reduced to 500 mg. Since March 10 continuously taking 1000 mg except for three four days periods in late March and April. Situation was worse after second dose on April 29. On advice of Ob Gyn increase dose to 2000 mg between May 15-19, then reduced it to 1000 mg. Since May 23 have continued at 2000 mg. Have consulted the Ob Gyn three times in this period and she does not know what to make of the situation. On June 4 she took a biopsy to assess other potential impacts.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Dry eye
Clinical narrative: Headache began within 20miutes, Gradually increasing in pain over 2 hours. Dizzyness began around 2 hours. Pain in shoulder and neck became excruciating and 2 Extra Strength Tylenol were taken for pain at 9 PM to little effect. At 11 PM shivering began in back muscles, quickly ramped up to full body uncontrollable seizures which caused my back to bend backwards and made walking and arm use impossible and breathing difficult. This lasted for THREE HOURS. Finally subsided back to normal shivering. Fever of 100.3 was noted at 5AM on 6/04. ALL joints painful, eyes and mouth very dry, long bones in legs and arms hurt to touch. Headache very bad and shoulder of injection site and neck felt like broken glass. Joint pain and headache very bad all day. Fever stayed up until 5pm on  6/05,  and then subsided to 99.8. On 5AM of 6/05 fever and headache was gone but joint pain and residual stiffness and pain in spine and joints remain to this day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Dyspnoea, Gait disturbance, Headache, Joint stiffness
Clinical narrative: Headache began within 20miutes, Gradually increasing in pain over 2 hours. Dizzyness began around 2 hours. Pain in shoulder and neck became excruciating and 2 Extra Strength Tylenol were taken for pain at 9 PM to little effect. At 11 PM shivering began in back muscles, quickly ramped up to full body uncontrollable seizures which caused my back to bend backwards and made walking and arm use impossible and breathing difficult. This lasted for THREE HOURS. Finally subsided back to normal shivering. Fever of 100.3 was noted at 5AM on 6/04. ALL joints painful, eyes and mouth very dry, long bones in legs and arms hurt to touch. Headache very bad and shoulder of injection site and neck felt like broken glass. Joint pain and headache very bad all day. Fever stayed up until 5pm on  6/05,  and then subsided to 99.8. On 5AM of 6/05 fever and headache was gone but joint pain and residual stiffness and pain in spine and joints remain to this day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Neck pain, Opisthotonus, Pain
Clinical narrative: Headache began within 20miutes, Gradually increasing in pain over 2 hours. Dizzyness began around 2 hours. Pain in shoulder and neck became excruciating and 2 Extra Strength Tylenol were taken for pain at 9 PM to little effect. At 11 PM shivering began in back muscles, quickly ramped up to full body uncontrollable seizures which caused my back to bend backwards and made walking and arm use impossible and breathing difficult. This lasted for THREE HOURS. Finally subsided back to normal shivering. Fever of 100.3 was noted at 5AM on 6/04. ALL joints painful, eyes and mouth very dry, long bones in legs and arms hurt to touch. Headache very bad and shoulder of injection site and neck felt like broken glass. Joint pain and headache very bad all day. Fever stayed up until 5pm on  6/05,  and then subsided to 99.8. On 5AM of 6/05 fever and headache was gone but joint pain and residual stiffness and pain in spine and joints remain to this day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Seizure, Spinal pain
Clinical narrative: Headache began within 20miutes, Gradually increasing in pain over 2 hours. Dizzyness began around 2 hours. Pain in shoulder and neck became excruciating and 2 Extra Strength Tylenol were taken for pain at 9 PM to little effect. At 11 PM shivering began in back muscles, quickly ramped up to full body uncontrollable seizures which caused my back to bend backwards and made walking and arm use impossible and breathing difficult. This lasted for THREE HOURS. Finally subsided back to normal shivering. Fever of 100.3 was noted at 5AM on 6/04. ALL joints painful, eyes and mouth very dry, long bones in legs and arms hurt to touch. Headache very bad and shoulder of injection site and neck felt like broken glass. Joint pain and headache very bad all day. Fever stayed up until 5pm on  6/05,  and then subsided to 99.8. On 5AM of 6/05 fever and headache was gone but joint pain and residual stiffness and pain in spine and joints remain to this day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural, Malaise, Myalgia, Pain in extremity
Clinical narrative: Fever (100 F, even with ibuprofen, 2 days duration). Myalgia, general malaise, arm moderately sore.  Lightheaded and dizzy upon standing.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (100 F, even with ibuprofen, 2 days duration). Myalgia, general malaise, arm moderately sore.  Lightheaded and dizzy upon standing.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Tiredness (exhausted), Light headed (thought I was going to pass out), fever 102, shivering, nausea, dizziness,  My arm was very very red and lots of heat (fever).  Slept totally first day, fever broke about 36 hours later after the symptoms started on 5/28/20.  Fever and redness in arm lasted almost a week.  I literally slept for almost 4 days.  Took a week to get my strength back.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Nausea, Pyrexia
Clinical narrative: Tiredness (exhausted), Light headed (thought I was going to pass out), fever 102, shivering, nausea, dizziness,  My arm was very very red and lots of heat (fever).  Slept totally first day, fever broke about 36 hours later after the symptoms started on 5/28/20.  Fever and redness in arm lasted almost a week.  I literally slept for almost 4 days.  Took a week to get my strength back.
Age: 1.33
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV
Symptoms: Wrong product administered
Clinical narrative: DTAP  was ordered by physician dtap/ipv or Kinrix - was administered in error
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: ERRONEOUS VACCINE MMR, VARICELL AND PREVNAR ORDERD MMRV, VARICELLA AND PREVNAR ADMINISTERED IN ERROR REC'D TWO VARICELLA VACCINE AND MMRV AT 12MO OF AGE
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pain
Clinical narrative: Within 12 hours severe pain in entire body.  9 out of 10. All nerve endings .  After 12 hours of pain had another 12 hours of aching pain and upset stomach and fatigue then the next day felt normal
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient has swelling of whole arm about 5 hours after injection. It was the arm that was vaccinated and it swole from her shoulder all the way down to her fingers. Patient also reported pain from the injection as well. The patient was then told to take Benadryl upon calling the pharmacist and to go to an after hours clinic to be evaluated and some possible steroids. The after hour clinic sent the patient home and advised patient to take Benadryl for the reaction as well.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Headache,  muscle aches in back arms neck.    Sore and slightly swollen at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Mobility decreased, Skin discolouration
Clinical narrative: Numbness and inability to move her left thumb occurring within minutes after getting the vaccine, which resolved on it own over the course of a week. Then a shingles outbreak occurred at the site of the numbness (base of the left thumb), which was diagnosed upon seeing her physician for treatment. The shingles outbreak resolved on its own without permanent nerve damage and only slight discoloration at the location.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: pt had a shot on 9/15/2019 said that 3 weeks after she had pain in her neck. md thinks it might be a side effect to vaccine
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint swelling, Peripheral swelling, Vaccination complication
Clinical narrative: Patient presented 2 days post vaccine with swelling in arm and elbow region. Patient saw a doctor and received a prednisone order to help. There was no bruising or adverse signs of vaccine not being administered correctly. It was very evident that it was a reaction to the shot itself. Patient had no reactions to prevnar 13 vaccine given a year ago.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presented 2 days post vaccine with swelling in arm and elbow region. Patient saw a doctor and received a prednisone order to help. There was no bruising or adverse signs of vaccine not being administered correctly. It was very evident that it was a reaction to the shot itself. Patient had no reactions to prevnar 13 vaccine given a year ago.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Widespread redness, swelling, and feeling hot to the touch and itchy across entire top of thigh.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Autopsy, Death, Decreased activity, Epistaxis, Feeling abnormal
Clinical narrative: My daughter was fine and her normal self at 1:30 pm was her appointment they did her shots around 2 pm as soon as we left the dr office she fell asleep and slept a while. The rest of the day she wasn?t really her playful she had a slight fever so I gave her infant Tylenol the was around 4 pm. Around 10:30 she dozed off and woke up like 5 minutes later breathing funny and acting dazed like none coherent so me, her godmother, her son, my son and another friend just stood watching her for about 30 minutes talking to her and looking at her chest and breathing pattern. She finally started acting normal and breathing good. So my friend was like take her home give her a breathing treatment and watch her. When we got in the car I gave her her inhaler and buckled her in and we left. Me and my son who is 11 left and it took us all of 15 minutes to get home so we were home around 11:30 my timing may be a little off but we got home got out I grabbed her bag and car seat thinking she was sleep. Went in the house sat the car seat down unbuckled her and it looked like her nose was running so I took her baby rag wiped her nose and noticed blood so I grabbed her up so fast and ran in my brother room and said she has blood coming out her nose he then asked was she breathing I said no and called 911 he said we not waiting cause the hospital up the road so we left she had no heartbeat when we got there and they tried everything possible They pronounced her dead at 12 something am April 9th
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Incoherent, Laboratory test, Pulse absent, Pyrexia, Respiration abnormal
Clinical narrative: My daughter was fine and her normal self at 1:30 pm was her appointment they did her shots around 2 pm as soon as we left the dr office she fell asleep and slept a while. The rest of the day she wasn?t really her playful she had a slight fever so I gave her infant Tylenol the was around 4 pm. Around 10:30 she dozed off and woke up like 5 minutes later breathing funny and acting dazed like none coherent so me, her godmother, her son, my son and another friend just stood watching her for about 30 minutes talking to her and looking at her chest and breathing pattern. She finally started acting normal and breathing good. So my friend was like take her home give her a breathing treatment and watch her. When we got in the car I gave her her inhaler and buckled her in and we left. Me and my son who is 11 left and it took us all of 15 minutes to get home so we were home around 11:30 my timing may be a little off but we got home got out I grabbed her bag and car seat thinking she was sleep. Went in the house sat the car seat down unbuckled her and it looked like her nose was running so I took her baby rag wiped her nose and noticed blood so I grabbed her up so fast and ran in my brother room and said she has blood coming out her nose he then asked was she breathing I said no and called 911 he said we not waiting cause the hospital up the road so we left she had no heartbeat when we got there and they tried everything possible They pronounced her dead at 12 something am April 9th
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Respiratory arrest, Somnolence
Clinical narrative: My daughter was fine and her normal self at 1:30 pm was her appointment they did her shots around 2 pm as soon as we left the dr office she fell asleep and slept a while. The rest of the day she wasn?t really her playful she had a slight fever so I gave her infant Tylenol the was around 4 pm. Around 10:30 she dozed off and woke up like 5 minutes later breathing funny and acting dazed like none coherent so me, her godmother, her son, my son and another friend just stood watching her for about 30 minutes talking to her and looking at her chest and breathing pattern. She finally started acting normal and breathing good. So my friend was like take her home give her a breathing treatment and watch her. When we got in the car I gave her her inhaler and buckled her in and we left. Me and my son who is 11 left and it took us all of 15 minutes to get home so we were home around 11:30 my timing may be a little off but we got home got out I grabbed her bag and car seat thinking she was sleep. Went in the house sat the car seat down unbuckled her and it looked like her nose was running so I took her baby rag wiped her nose and noticed blood so I grabbed her up so fast and ran in my brother room and said she has blood coming out her nose he then asked was she breathing I said no and called 911 he said we not waiting cause the hospital up the road so we left she had no heartbeat when we got there and they tried everything possible They pronounced her dead at 12 something am April 9th
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Feeling hot
Clinical narrative: POST VACCINATION AS PT WAS LEAVING SAID HE STARTED TO FEEL WARM IN FACE, AND THEN HAD SHARP LOWER BACK PAINS. PT WAS SEATED BACK PAINS CONTINUED FOR APPROXIMATELY 3-5 MIN. EMS SERVICES WERE CALLED AND PATIENT WAS EVALUATED
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Sensation of foreign body
Clinical narrative: Pt states she has a feeling of a rock in the arm, slightly bruised, but has full mobility in the arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: About 2 days after receiving the Shingrix IMZ pt noticed red itchy areas. When she scratched those areas the red spots spread. She now has approximately 20 itchy red spots and some are raised red areas. They are on her wrists, arms, left shoulder, inner thighs, right leg (behind the knee), left leg (front of the ankle). Has not taken any medication to sooth the itching until today took 1 tablet of Zyrtec.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Injection site pain
Clinical narrative: extreme pain injection site then pain traveled up and down my arm stuck in elbow for 5 weeks now I cant do many things (P.U. any thing that wieghs. No grip stregnth - cant clip fingernails, cant spray a bottle, use remote, feels like my arm has cerebral palsy.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Acupuncture, Arthralgia, Grip strength decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: extreme pain injection site then pain traveled up and down my arm stuck in elbow for 5 weeks now I cant do many things (P.U. any thing that wieghs. No grip stregnth - cant clip fingernails, cant spray a bottle, use remote, feels like my arm has cerebral palsy.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: extreme pain injection site then pain traveled up and down my arm stuck in elbow for 5 weeks now I cant do many things (P.U. any thing that wieghs. No grip stregnth - cant clip fingernails, cant spray a bottle, use remote, feels like my arm has cerebral palsy.
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: no additional adverse effects; patient received V ARIV AX on 05/01/2020 and found out she was pregnant on 05/05/2020.; This spontaneous prospective pregnancy report has been received from a nurse, referring to a 30 years old female patient. The patient had no concomitant medication and drug reactions or allergies. The patient's pertinent medical history included asthma.  On 01-MAY-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005077 with 19-FEB-2021; subcutaneous, dose and strength) for prophylaxis (work related immunization). Other suspect therapies included sterile diluent (dose, strength, frequency, route, indication, lot number and expiration date were unknown).   On 05-MAY-2020, the patient was found out pregnant (exposure during pregnancy). No additional adverse effects. The patient did not seek medical attention. In May 2020, the home pregnancy test was performed. The last menstrual period (LMP) was in 21-APR-2020 and estimated date of delivery (EDD) was in 26-JAN-2021. Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 1 week(s). The pregnancy outcome was outcome pending.
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no additional adverse effects; patient received V ARIV AX on 05/01/2020 and found out she was pregnant on 05/05/2020.; This spontaneous prospective pregnancy report has been received from a nurse, referring to a 30 years old female patient. The patient had no concomitant medication and drug reactions or allergies. The patient's pertinent medical history included asthma.  On 01-MAY-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005077 with 19-FEB-2021; subcutaneous, dose and strength) for prophylaxis (work related immunization). Other suspect therapies included sterile diluent (dose, strength, frequency, route, indication, lot number and expiration date were unknown).   On 05-MAY-2020, the patient was found out pregnant (exposure during pregnancy). No additional adverse effects. The patient did not seek medical attention. In May 2020, the home pregnancy test was performed. The last menstrual period (LMP) was in 21-APR-2020 and estimated date of delivery (EDD) was in 26-JAN-2021. Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 1 week(s). The pregnancy outcome was outcome pending.
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site joint pain, Injection site joint swelling, Measles antibody negative
Clinical narrative: approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; Nurse practitioner reported the mumps and rubella titers showed immunity, where the measles titer did not show immunity; This spontaneous report was received from a nurse practitioner (also reported as Nurse Prescriber), referring to a 26-year-old female patient. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were unknown by the reporter.  On an unknown date, the patient received her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, and anatomical location were not reported; and route of administration, lot number and expiration date were unknown by the reporter) as immunization for graduate school (prophylaxis). On an unknown date (also reported as approximately two weeks later), the patient experienced painful, swollen joints and bruising at the injection site (injection site joint pain, injection site joint swelling and injection site bruising). On an unknown date, the patient saw an unspecified physician, who advised her that she could receive the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unspecified date, the reporter stated that the patient had titers drawn for measles, mumps and rubella, and reported the mumps and rubella showed immunity, while the measles titer, less than 13.5 (units not provided) did not show immunity (measles antibody negative).  It was unknown by the reporter if any treatment was given for the adverse events.  The reporter considered the events as no life threatening.  The outcome of injection site joint pain, injection site joint swelling, injection site bruising and measles antibody negative was unknown by the reporter. The causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events was not provided.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Cardiac operation, Feeling abnormal, Head discomfort, Headache, Nausea
Clinical narrative: Severe sensitivity to flu or pneumococcal vaccine; Open heart surgery last summer (2019); The patient "felt like his head would explode , was nauseated and was miserable"; Severe headache; The patient fever goes to 104 degrees Fahrenheit; The patient "felt like his head would explode , was nauseated and was miserable"; This spontaneous report was received from a reporter referring to her husband, a male patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On multiple unspecified dates, the patient had received flu vaccine influenza virus vaccine unspecified (manufacturer unknown) or Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and had developed severe sensitivity to them.   On 15-JUN-2012 (reported as the most recent vaccination date), the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage, route of administration, lot #, expiration date, frequency not reported) and within 2 hours after being vaccinated the patient fever went to 104° degrees F and he experienced a severe headache. The patient felt like his head would explode and miserable (feeling abnormal) and was nauseated. The reporter mentioned that those symptoms lasted for 12 hours and then went out of it on the next day (16-JUN-2012).  On an unspecified date during summer of 2019, the patient had an open-heart surgery, however, additional information regarding this event was not provided.  The outcome for the open heart surgery was not reported.   The causality between flu vaccine influenza virus vaccine unspecified (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)  and pyrexia, headache, nauseam feeling abnormal and cardiac operation was not reported.   Upon internal reviewopen heart surgery was considered as medically significant event.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Severe sensitivity to flu or pneumococcal vaccine; Open heart surgery last summer (2019); The patient "felt like his head would explode , was nauseated and was miserable"; Severe headache; The patient fever goes to 104 degrees Fahrenheit; The patient "felt like his head would explode , was nauseated and was miserable"; This spontaneous report was received from a reporter referring to her husband, a male patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On multiple unspecified dates, the patient had received flu vaccine influenza virus vaccine unspecified (manufacturer unknown) or Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and had developed severe sensitivity to them.   On 15-JUN-2012 (reported as the most recent vaccination date), the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage, route of administration, lot #, expiration date, frequency not reported) and within 2 hours after being vaccinated the patient fever went to 104° degrees F and he experienced a severe headache. The patient felt like his head would explode and miserable (feeling abnormal) and was nauseated. The reporter mentioned that those symptoms lasted for 12 hours and then went out of it on the next day (16-JUN-2012).  On an unspecified date during summer of 2019, the patient had an open-heart surgery, however, additional information regarding this event was not provided.  The outcome for the open heart surgery was not reported.   The causality between flu vaccine influenza virus vaccine unspecified (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)  and pyrexia, headache, nauseam feeling abnormal and cardiac operation was not reported.   Upon internal reviewopen heart surgery was considered as medically significant event.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Cardiac operation, Feeling abnormal, Head discomfort, Headache, Hypersensitivity
Clinical narrative: Severe sensitivity to flu or pneumococcal vaccine; Open heart surgery last summer (2019); The patient "felt like his head would explode , was nauseated and was miserable"; Severe headache; The patient fever goes to 104 degrees Fahrenheit; The patient "felt like his head would explode , was nauseated and was miserable"; This spontaneous report was received from a reporter referring to her husband, a male patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On multiple unspecified dates, the patient had received flu vaccine influenza virus vaccine unspecified (manufacturer unknown) or Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and had developed severe sensitivity to them.   On 15-JUN-2012 (reported as the most recent vaccination date), the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage, route of administration, lot #, expiration date, frequency not reported) and within 2 hours after being vaccinated the patient fever went to 104° degrees F and he experienced a severe headache. The patient felt like his head would explode and miserable (feeling abnormal) and was nauseated. The reporter mentioned that those symptoms lasted for 12 hours and then went out of it on the next day (16-JUN-2012).  On an unspecified date during summer of 2019, the patient had an open-heart surgery, however, additional information regarding this event was not provided.  The outcome for the open heart surgery was not reported.   The causality between flu vaccine influenza virus vaccine unspecified (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)  and pyrexia, headache, nauseam feeling abnormal and cardiac operation was not reported.   Upon internal reviewopen heart surgery was considered as medically significant event.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe sensitivity to flu or pneumococcal vaccine; Open heart surgery last summer (2019); The patient "felt like his head would explode , was nauseated and was miserable"; Severe headache; The patient fever goes to 104 degrees Fahrenheit; The patient "felt like his head would explode , was nauseated and was miserable"; This spontaneous report was received from a reporter referring to her husband, a male patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On multiple unspecified dates, the patient had received flu vaccine influenza virus vaccine unspecified (manufacturer unknown) or Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and had developed severe sensitivity to them.   On 15-JUN-2012 (reported as the most recent vaccination date), the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage, route of administration, lot #, expiration date, frequency not reported) and within 2 hours after being vaccinated the patient fever went to 104° degrees F and he experienced a severe headache. The patient felt like his head would explode and miserable (feeling abnormal) and was nauseated. The reporter mentioned that those symptoms lasted for 12 hours and then went out of it on the next day (16-JUN-2012).  On an unspecified date during summer of 2019, the patient had an open-heart surgery, however, additional information regarding this event was not provided.  The outcome for the open heart surgery was not reported.   The causality between flu vaccine influenza virus vaccine unspecified (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)  and pyrexia, headache, nauseam feeling abnormal and cardiac operation was not reported.   Upon internal reviewopen heart surgery was considered as medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; 2 patients received improperly stored PROQUAD since unspecified date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, current conditions, concomitant medication and drug reactions or allergies were not reported.     On 01-JUN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number S031884, which has been verified to be valid, expiration date reported and validated as 07-APR-2021 (strength, dose, vaccination scheme, anatomical location and route of admnistration were not reported), as prophylaxis (product storage error); which was reconstitued with a properly stored sterile diluent. It was stated that the vaccine was exposed to a temperature of 37 degrees Fahrenheit (F) for a timeframe of 70 hours. There was no previous excursion. Digital data logger was involved. No additional adverse effect reported.; Sender's Comments:  US-009507513-2006USA000690:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; Improperly stored dose of PROQUAD was administered  to the patient on 01-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 01-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: patient experienced severe pain in her left arm and left shoulder; patient experienced severe pain in her left arm and left shoulder; This spontaneous report was received from a registered nurse referring to a 90 year old female patient with hypertension, osteoporosis and gastrooesophageal reflux disease. Historical drug included oxybutynin which made her felt dizzy. The patient's pertinent medical history was not provided. Concomitant therapies included losartan potassium (manufacturer unknown), omeprazole, potassium (unspecified), beclomethasone dipropionate (QVAR), furosemide, aspirin and calcium (unspecified).       On an unspecified date in 1995, the patient started vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection by intramuscular route, as routine booster. Then, on 27-MAY-2020, patient was administered another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route, in her left arm, lot #S034299 with an expiration date on 01-JUL-2021, as routine booster. One day after, on 28-MAY-2020, the patient experienced severe pain in her left arm (pain in extremity) and left shoulder (musculoskeletal pain). There was no redness or swelling of the left arm or shoulder. Patient's caregiver called the office and patient received acetaminophen (TYLENOL) as treatment; no laboratory studies were performed.  A lot check of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was requested and nurse requested a response as quickly as possible.  At reporting time, the outcome of musculoskeletal pain and pain in extremity was unknown. The causality assessment was not provided.  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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S034299; expirationdate: 01-JUL-2021; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2006USA001609:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 03-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 20-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703: