chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Exposure during pregnancy, Influenza, Malaise
Clinical narrative: patient lost her baby when she was pregnant; flu; ill; patient received the flu shot when she was three month-pregnant; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media.  This case involves a female patient of an unknown demographic who was vaccinated with INFLUENZA VACCINE when she was three months-pregnant (exposure during pregnancy) and lost her baby and was ill with the flu (abortion spontaneous), (malaise) and (influenza).  Data regarding this pregnancy was received retrospectively, i.e. after pregnancy outcome was known as patient lost her baby when she was three month-pregnant.  The gestation period was reported as three months of pregnancy.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's vaccination included Influenza Vaccine for prophylactic vaccination and patient came down with flu (influenza).  The patient's medical history, medical treatments and family history were not provided.   On an unknown date, the patient received a second dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had lost her baby (abortion spontaneous) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient was ill with the flu (influenza), (malaise) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was a case of vaccine exposure during pregnancy.   Relevant prenatal testing and corrective treatment were not reported.  At the time of reporting, outcome of influenza and malaise was unknown.   Information on the batch number was requested.; Sender's Comments: This case involves an adult female patient who had spontaneous abortion, malaise and influenza following vaccination with INFLUENZA VACCINE. The time to onset was not known. Further information regarding personal and family history, subject's obstetric history, condition at the time of vaccination, tolerance, laboratory investigations excluding alternative étiologies is needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Eye movement disorder, Irritability, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Per mother, today 10/21/2020, he had symptoms between 9/10/2020 - 09/15/2020. He had fever by touch for 2 days and on the second day of fever, stared up with eyes in one corner, not responsive for < 1 minute. He was in intermittently fussy x 4days too.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: "Itching" "@ about (1700) 5 clock" and the area "started getting big" - per employee
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm
Clinical narrative: pt presented with a large red patch on arm that was warm to the touch-
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Arm became very red, initially about the size of a baseball, but has grown over the last 6 days to encompass approximately 75% of her arm. Warm to the touch and low grade fever with body aches.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Blood pressure decreased, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Within a couple hours my arm become visibly swollen, red splotchy rash, and felt like my arm was asleep (all the way to my finger tips), the most intense aching pain for 3-4 days  I had a fever over 101.5 degrees F about 18 hours later, I continued to wake up having night sweats for about 10 consecutive nights along with diarrhea for multiple days,  the following two weeks at least I struggled with numerous episodes of light headedness, orthostatic hypotension to the point of my vision going dark.  I also experienced extreme headaches, fatigue, weakness that I have never felt from previous flu vaccine shots  I finally took acetaminophen for the fever which helped it come down to 100 F, all fluids ran right through me for multiple days, and I am still dealing with fatigue and my blood pressure dropping at random times .  The rash is no longer there and swelling has subsided
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Hypoaesthesia, Night sweats, Orthostatic hypotension, Pain in extremity
Clinical narrative: Within a couple hours my arm become visibly swollen, red splotchy rash, and felt like my arm was asleep (all the way to my finger tips), the most intense aching pain for 3-4 days  I had a fever over 101.5 degrees F about 18 hours later, I continued to wake up having night sweats for about 10 consecutive nights along with diarrhea for multiple days,  the following two weeks at least I struggled with numerous episodes of light headedness, orthostatic hypotension to the point of my vision going dark.  I also experienced extreme headaches, fatigue, weakness that I have never felt from previous flu vaccine shots  I finally took acetaminophen for the fever which helped it come down to 100 F, all fluids ran right through me for multiple days, and I am still dealing with fatigue and my blood pressure dropping at random times .  The rash is no longer there and swelling has subsided
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Peripheral swelling, Pyrexia, Rash macular, Sleep disorder, Visual impairment
Clinical narrative: Within a couple hours my arm become visibly swollen, red splotchy rash, and felt like my arm was asleep (all the way to my finger tips), the most intense aching pain for 3-4 days  I had a fever over 101.5 degrees F about 18 hours later, I continued to wake up having night sweats for about 10 consecutive nights along with diarrhea for multiple days,  the following two weeks at least I struggled with numerous episodes of light headedness, orthostatic hypotension to the point of my vision going dark.  I also experienced extreme headaches, fatigue, weakness that I have never felt from previous flu vaccine shots  I finally took acetaminophen for the fever which helped it come down to 100 F, all fluids ran right through me for multiple days, and I am still dealing with fatigue and my blood pressure dropping at random times .  The rash is no longer there and swelling has subsided
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Decreased appetite, Lethargy, Pyrexia, Vomiting
Clinical narrative: Mom states child began to lose appetite the evening of immunizations.  He had a fever of 103 F.  Tylenol and Motrin were given with resolution of the fever, but the child remained lethargic and with no appetite.  No pain evident.  On the morning of 10/21; the child vomited a couple times.  He continues to be lethargic with no appetite, but with no fever and no signs of pain.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Contusion, Illness, Pyrexia
Clinical narrative: Bruising and patient stated fever as well. General sickness per patient's report
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Moderate pain and soreness to left arm at injection site somewhat immediately, same evening mild fatigue and difficultly sleeping.  During night restless difficultly sleeping, severe headache, moderate body aches, muscle pain. Next day severe headache, moderate fatigue and weakness, general malaise, loss appetite and mild nausea.  24 hours after injection symptoms including headache, began to subside somewhat.  36 hours after injection pt just feeling mild fatigue at this time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Malaise, Myalgia, Nausea
Clinical narrative: Moderate pain and soreness to left arm at injection site somewhat immediately, same evening mild fatigue and difficultly sleeping.  During night restless difficultly sleeping, severe headache, moderate body aches, muscle pain. Next day severe headache, moderate fatigue and weakness, general malaise, loss appetite and mild nausea.  24 hours after injection symptoms including headache, began to subside somewhat.  36 hours after injection pt just feeling mild fatigue at this time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Restlessness
Clinical narrative: Moderate pain and soreness to left arm at injection site somewhat immediately, same evening mild fatigue and difficultly sleeping.  During night restless difficultly sleeping, severe headache, moderate body aches, muscle pain. Next day severe headache, moderate fatigue and weakness, general malaise, loss appetite and mild nausea.  24 hours after injection symptoms including headache, began to subside somewhat.  36 hours after injection pt just feeling mild fatigue at this time.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Magnetic resonance imaging brain normal, Seizure
Clinical narrative: Child had seizure on 10/10.  First seizure in lifetime.  Was seen and evaluated in ED and sent home.  On the next day, developed again seizure activity.  Admitted to the hospital.  MRI of head normal.  She was started on antiepileptic medication.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient described severe pain day after vaccine.  She said she was unable to lift arms over head and did not trust holding anything in each hand because unable to lift item up.  She explained that she thinks vaccine was given too high and close to shoulder.  Two days later she is still sore but slowly getting better
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: On the left arm where shingles shot was given:  a lot of pain (next day),  burning, itchy, red, warm splotchy areas started a few days after.  Stuffy nose started a few days later.    My husband had same shots a week earlier.  His shingle shot arm was worse than mine.  Softball size swollen sore arm.  Red and warm to the touch.  I'm not sure of the exact flu shot given.  Did not have any problem with that arm.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nasal congestion, Rash macular, Skin warm
Clinical narrative: On the left arm where shingles shot was given:  a lot of pain (next day),  burning, itchy, red, warm splotchy areas started a few days after.  Stuffy nose started a few days later.    My husband had same shots a week earlier.  His shingle shot arm was worse than mine.  Softball size swollen sore arm.  Red and warm to the touch.  I'm not sure of the exact flu shot given.  Did not have any problem with that arm.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Headache, Nausea, Vomiting
Clinical narrative: Headache 5 hrs after receiving shots. nausea and vomiting the following day. abdominal pain only when vomiting.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Feeling abnormal, Full blood count normal, Metabolic function test normal
Clinical narrative: On 9/15/19 - pt was in his room with dad - helping him clear off his desk when all of a sudden started spacing out and then had a seziure, lasting about 5 mins with 2 episodes of vomiting - 911 was called and taken to ER.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Urine analysis normal, Vomiting
Clinical narrative: On 9/15/19 - pt was in his room with dad - helping him clear off his desk when all of a sudden started spacing out and then had a seziure, lasting about 5 mins with 2 episodes of vomiting - 911 was called and taken to ER.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast swelling, Injected limb mobility decreased, Injection site swelling, Lymphadenopathy, Oedema peripheral
Clinical narrative: One day after immunization patient experienced severe swelling in left deltoid muscle as well as lymph nodes under her arm and down her entire side (ipsilateral to injection site). Her armpit was swollen up to roughly grapefruit-sized. Her breast was swollen and she was unable to lower her left arm due to severe pain. She is still having some residual swelling and pain from the injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: One day after immunization patient experienced severe swelling in left deltoid muscle as well as lymph nodes under her arm and down her entire side (ipsilateral to injection site). Her armpit was swollen up to roughly grapefruit-sized. Her breast was swollen and she was unable to lower her left arm due to severe pain. She is still having some residual swelling and pain from the injection.
Age: 0.42
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Heart rate increased, Muscle spasms, White blood cell count increased
Clinical narrative: My daughter splits her vaccines to have 2 every month instead of 4 every other month. Her plan is at ages 2,4,6, and 8 months to receive the DTaP, Hep B, Polio (combo vaccine) and an oral Rotavirus vaccine. At ages 3,5,7, and 9 month to receive the Prevnar and Hib vaccines.  After the initial Prevnar and Hib vaccines, my daughter began to have a bizarre spasm in her sleep. I rushed her back to the doctor, and Dr. confirmed it was not a seizure and to just monitor her. After the initial day of this behavior, it did not reappear. However, after her 5 month visit and receiving the  Prevnar and Hib vaccines, the behavior returned. Again, she would spasm in her sleep every minute on the minute. Along with this, she had an increased heart rate monitored using the owlet smart sock 3. The data for this monitoring is attached. https://docs.google.com/spreadsheets/d/1jXxkEHcnqpkfzvy9Gl9uIcX0glPN1DC8ESNslw3F0Zg/edit?usp=sharing
Age: 0.42
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyskinesia, Heart rate increased
Clinical narrative: My daughter splits her vaccines to have 2 every month instead of 4 every other month. Her plan is at ages 2,4,6, and 8 months to receive the DTaP, Hep B, Polio (combo vaccine) and an oral Rotavirus vaccine. At ages 3,5,7, and 9 month to receive the Prevnar and Hib vaccines.  After the initial Prevnar and Hib vaccines, my daughter began to have a bizarre spasm in her sleep. I rushed her back to the doctor, and Dr. confirmed it was not a seizure and to just monitor her. After the initial day of this behavior, it did not reappear. However, after her 5 month visit and receiving the  Prevnar and Hib vaccines, the behavior returned. Again, she would spasm in her sleep every minute on the minute. Along with this, she had an increased heart rate monitored using the owlet smart sock 3. The data for this monitoring is attached. https://docs.google.com/spreadsheets/d/1jXxkEHcnqpkfzvy9Gl9uIcX0glPN1DC8ESNslw3F0Zg/edit?usp=sharing
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature decreased, Dizziness, Fatigue, Pain
Clinical narrative: From about 24 hours through 48 hours, I had dizziness, aches, and fatigue.  No fever, actually my temperature taken at about 30 hours was below normal-95.3 degrees.  I took it again an hour or so later with different thermometer.  It was the same.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Chills, headache, dizzy, fever, joint pain. Pt has call into doctor.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: "Upon injection I had pain that shot down my arm from the injection site to my pinky finger. I continued to have a sore arm and also decreased mobility. I have lost strength in the arm. the symptoms have gradually worsened since the infection. I can no longer do my normal daily functions with my right arm. The pain wakes me up at night."
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: "Upon injection I had pain that shot down my arm from the injection site to my pinky finger. I continued to have a sore arm and also decreased mobility. I have lost strength in the arm. the symptoms have gradually worsened since the infection. I can no longer do my normal daily functions with my right arm. The pain wakes me up at night."
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal distension, Abdominal pain upper, Balance disorder, Dizziness, Feeding disorder
Clinical narrative: I had the vaccine at 3:45pm Thursday, Oct 8th, 2020.  While sleeping at about 11pm I awoke with nausea and starting to vomit. I had an bad stomach ache with bloating. I also had a very bad head ache. I do not normally get head aches. I could not fall back asleep. I tried to get up at 6am but was dizzy and unsteady. My husband helped me to the bathroom 4 feet away. Through out Friday I was dizzy, had a very bad head ache and continued to be bloated. I could not eat. Saturday I woke up feeling not as bloated but still with a mild stomach. Later in the day around 4pm I had heart palpitations while sitting out in the back yard. They only lasted about 2 minutes. On Sunday I broke out in a full body rash. Red raised splotches all over my body. I do get this reaction to a cold so I was not concerned. The rash finally started to go away on Tuesday.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Insomnia, Nausea, Palpitations, Rash
Clinical narrative: I had the vaccine at 3:45pm Thursday, Oct 8th, 2020.  While sleeping at about 11pm I awoke with nausea and starting to vomit. I had an bad stomach ache with bloating. I also had a very bad head ache. I do not normally get head aches. I could not fall back asleep. I tried to get up at 6am but was dizzy and unsteady. My husband helped me to the bathroom 4 feet away. Through out Friday I was dizzy, had a very bad head ache and continued to be bloated. I could not eat. Saturday I woke up feeling not as bloated but still with a mild stomach. Later in the day around 4pm I had heart palpitations while sitting out in the back yard. They only lasted about 2 minutes. On Sunday I broke out in a full body rash. Red raised splotches all over my body. I do get this reaction to a cold so I was not concerned. The rash finally started to go away on Tuesday.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash macular, Vomiting
Clinical narrative: I had the vaccine at 3:45pm Thursday, Oct 8th, 2020.  While sleeping at about 11pm I awoke with nausea and starting to vomit. I had an bad stomach ache with bloating. I also had a very bad head ache. I do not normally get head aches. I could not fall back asleep. I tried to get up at 6am but was dizzy and unsteady. My husband helped me to the bathroom 4 feet away. Through out Friday I was dizzy, had a very bad head ache and continued to be bloated. I could not eat. Saturday I woke up feeling not as bloated but still with a mild stomach. Later in the day around 4pm I had heart palpitations while sitting out in the back yard. They only lasted about 2 minutes. On Sunday I broke out in a full body rash. Red raised splotches all over my body. I do get this reaction to a cold so I was not concerned. The rash finally started to go away on Tuesday.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Electromyogram abnormal, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: Symptoms starting August 25 with right shoulder pain proceeding to muscular weakness of right shoulder. Diagnostics leading to diagnosis of ParsonageTurner syndrome which effected motor boy nerves and significant weakness and denervation of supraspinatus, infraspinatus,serrated anterior, teres minor and deltoid. Weakness ongoing at this time.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgic amyotrophy, Neuropathic muscular atrophy, X-ray limb normal
Clinical narrative: Symptoms starting August 25 with right shoulder pain proceeding to muscular weakness of right shoulder. Diagnostics leading to diagnosis of ParsonageTurner syndrome which effected motor boy nerves and significant weakness and denervation of supraspinatus, infraspinatus,serrated anterior, teres minor and deltoid. Weakness ongoing at this time.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Guillain Barre syndrome 5 days after receiving dose #1 of Shingrix
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Nasopharyngitis, Pruritus, Rash
Clinical narrative: rash- itchy  on torso  cold clammy
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Dyspnoea
Clinical narrative: patient said he had difficulty breathing. It felt like an asthma attack was precipitating
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Cold sweat, Diarrhoea, Feeling abnormal
Clinical narrative: About 12 hours afterwards, nauseated and passed out (fainted), fever 100, extreme diarrhea, clammy,  headache, then the aches began - every single muscle in body hurt, every joint ached, back was so tender.   Could not sleep I was so miserable and twitching muscles for the next 6 hours.  Every time I ate something for the next 24 hours had stomach cramps.  The aches and fever have continued (on day 3).  Arm where shot was given is extremely tender to the touch, but no rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Loss of consciousness, Muscle twitching, Myalgia
Clinical narrative: About 12 hours afterwards, nauseated and passed out (fainted), fever 100, extreme diarrhea, clammy,  headache, then the aches began - every single muscle in body hurt, every joint ached, back was so tender.   Could not sleep I was so miserable and twitching muscles for the next 6 hours.  Every time I ate something for the next 24 hours had stomach cramps.  The aches and fever have continued (on day 3).  Arm where shot was given is extremely tender to the touch, but no rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Syncope, Tenderness
Clinical narrative: About 12 hours afterwards, nauseated and passed out (fainted), fever 100, extreme diarrhea, clammy,  headache, then the aches began - every single muscle in body hurt, every joint ached, back was so tender.   Could not sleep I was so miserable and twitching muscles for the next 6 hours.  Every time I ate something for the next 24 hours had stomach cramps.  The aches and fever have continued (on day 3).  Arm where shot was given is extremely tender to the touch, but no rash.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Upper left arm swollen and extremely red, low grade fever and nausea at first.  After day 2, the fever and nausea subsided but on day 4, the redness has spread to the underside of my upper left arm, is swollen and hot to the touch.   I have been taking ibuprofen for pain as well as icing the area constantly and using Aloe Vera with lidocaine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: patient complaining of itchy rash over large portion of body, no trouble breathing. Recommended taking diphenhydramine which was showing benefit in resolving symptoms of itch. Also recommended hydrocortisone cream to intense itching areas for short period of time if needed
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle pain
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Chills, Cough, Dry eye, Eye discharge, Eye pain
Clinical narrative: About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Ocular hyperaemia, Pyrexia, Respiratory tract congestion, Swelling of eyelid
Clinical narrative: About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Arthralgia, Chills, Cough, Dry eye, Eye discharge
Clinical narrative: About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Eye pain, Neck pain, Ocular discomfort, Pain, Pain in extremity
Clinical narrative: About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Pyrexia, Swelling of eyelid, Upper respiratory tract congestion
Clinical narrative: About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Arm pain that happened right after vaccine was given and has continued for up to 1 month after and has not subsided.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Scleritis
Clinical narrative: Anterior scleritis of left eye treated by opthalmologist.  Treatment not finished yet.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Memory impairment
Clinical narrative: & memory impairment
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: An expired PROQUAD administered to a patient; This spontaneous report has been received from a nurse, reporting to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided.  On 12-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S008578, expiration date 16-SEP-2020, dose: 0.5 milliliter for prophylaxis (route and site of administration not reported) (expired product administered).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: fever; pain / body aches; nausea; fatigue; could not get out of bed; This case was reported by a physician via sales rep and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included methotrexate for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and methotrexate at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, nausea, fatigue and mobility decreased. The action taken with methotrexate was unknown. On an unknown date, the outcome of the fever, general body pain, nausea and fatigue were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, nausea, fatigue and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingrix at pharmacy, so the reporter did not knew the lot number, but patient only had 1 dose. The patient had pain, fever, body aches, nausea, fatigue that was 100 times the normal. For 4 days the patient could not get out of bed. The patient was on methotrexate and the reporter wondered if that drug caused the adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fever; Exhaustion; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever and exhaustion. On an unknown date, the outcome of the headache, fever and exhaustion were unknown.   It was unknown if the reporter considered the headache, fever and exhaustion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The caller reported to mention one of her friends had Shingrix shot and experienced headache, fever and exhaustion. The reporter said she declined to provide any information at all related to the events. The reporter did not consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion
Clinical narrative: excessive bruise right above her elbow; She also had shivering; This case was reported by a pharmacist via call center representative and described the occurrence of contusion of elbow in a 84-year-old female patient who received Herpes zoster (SHINGRIX) (batch number 4749N, expiry date 14th December 2021) for prophylaxis.   On 25th September 2020, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2020, less than a week after receiving SHINGRIX, the patient experienced contusion of elbow and shivering. On an unknown date, the outcome of the contusion of elbow was recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the contusion of elbow and shivering to be related to SHINGRIX.  Additional information was provided as follows: The patient received the 1st dose of SHINGRIX and 3 to 4 days later she developed an excessive bruise right above her elbow. She also had shivering. The bruise symptom was getting better but had not been resolved yet. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: her arm, from her elbow to 3/4th of the way up to her shoulder, was red; diagnosed with Cellulitis; it was kind of tender at the site; person giving the shot squeezed the patients skintight and was given the shot that way; This is a spontaneous report from a contactable consumer, the patient.  A 73-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 06Oct2020 in the left upper arm as a single dose for vaccination.  Medical history was not reported.  Concomitant medications included unspecified vitamins. On 06Oct2020, the patient experienced vaccination site tenderness. On 15Oct2020, the patient experienced vaccination site cellulitis. The clinical course was as follows: the patient said that the person giving the shot squeezed the patient's skintight and was given the shot that way. When she got the shot, she didn't feel anything except that it was kind of tender at the site. On 15Oct2020 in the morning upon waking, the patient her arm, from her elbow to 3/4th of the way up to her shoulder, was red. The patient stated that it was a little unusual and not what she expected. She stated that she did not feel sick and had not other physical symptoms other than the redness and warmth at the injection site. The patient arraigned a phone consultation with a doctor (Teledoc appointment). The patient was diagnosed with cellulitis and the physician had prescribed an antibiotic to treat cellulitis. The antibiotic was clindamycin (MANUFACTURER UNKNOWN) taken every 8 hours. As of the morning on 16Oct2020, the patient said her arm looked slightly better and was not as warm.  The clinical outcome of the vaccination site cellulitis was recovering, while that of the vaccination site tenderness was unknown. The patient further questioned if the cellulitis was due to the way the vaccine was administered as she never received shots in that way before.   The lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
Sex: U
Vaccine: PNC13
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza like illness
Clinical narrative: sick with flu like symptoms; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient who was sick with flu like symptoms (influenza like illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient was sick with flu like symptoms (influenza like illness) within 24-48 hours following the administration of INFLUENZA VACCINE. It was also reported that the patient thought that he/she was going to die. and the event lasted for 4 weeks.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on batch number for this case.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: SHINGLES OUTBREAK 2-3 DAYS AFTER THE VACCINE HAD NUMBNESS ON MY CHEST AND ON DAY 5-6 OF THE VACCINE DEVELOPED PAPULAR RASH WHICH AHS TURNED INTO VESICLES. TINGLING AND ITCHINESS ALONG THE LINE OF T5 DERMATOME.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash papular
Clinical narrative: SHINGLES OUTBREAK 2-3 DAYS AFTER THE VACCINE HAD NUMBNESS ON MY CHEST AND ON DAY 5-6 OF THE VACCINE DEVELOPED PAPULAR RASH WHICH AHS TURNED INTO VESICLES. TINGLING AND ITCHINESS ALONG THE LINE OF T5 DERMATOME.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy, Pain
Clinical narrative: Patient states left arm swelled up from elbow to shoulder.  Patient stated very lethargic/tired/body aches.  Patient states started about 4:00pm and really got worse at 7:00pm.  Patient stated taking acetaminophen and applying warm compresses to area.  Pharmacist suggested diphenhydramine and acetaminophen/ibuprofen.  Contacted patient on 10-15-20 and patient said doing better.  The swelling gone down.  Checked again on patient on 10-16-20.  Patient said a whole lot better.  Swelling all gone.  Just a little tender at actual injection site.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Chest discomfort, Chills, Cough, Dysphonia
Clinical narrative: Some itchness on face , sudden attack of coughing and wheezing followed by chills that last all night ( about 9 hours) follwed by severe headache, sharp shooting pain and left side of head near temple,  chest tightness, burning aching feeling in muscles of chest and neck, itchy eyes, nasal congestion with servere nasal drip horseless, , pain in throat and lungs, extreme fatigue.  1 week later still having bronchial imflamation and horsenesss and nasal congestion.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Some itchness on face , sudden attack of coughing and wheezing followed by chills that last all night ( about 9 hours) follwed by severe headache, sharp shooting pain and left side of head near temple,  chest tightness, burning aching feeling in muscles of chest and neck, itchy eyes, nasal congestion with servere nasal drip horseless, , pain in throat and lungs, extreme fatigue.  1 week later still having bronchial imflamation and horsenesss and nasal congestion.