chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RAB
Symptoms: Sleep disorder, Tremor, Vaccination complication
Clinical narrative: On 30-Nov-2017, the patient received the first dose of Rabipure (Inactivated Rabies Virus Vaccine, Batch number 641011E) and the first dose of co-suspect vaccine Ixiaro (Batch number JEV16D22B), both administered at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 13-Dec-2017 (13 days after the first dose- inappropriate schedule of vaccine administered), the patient received the second dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 64111E) and first dose of Nimenrix at an unknown dosage regimen, unknown route of administration and for unknown indication.  On 12-Jan-2018, (43 days after the first dose- inappropriate schedule of vaccine administered), the patient received the third dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch number 641011E) at an unknown dosage regimen, unknown route of administration and for an unknown indication.  On 19-Jan-2018, the patient received the second dose of co-suspect Ixiaro vaccine (Batch number JEV16F288) at an unknown dosage regimen, unknown route of administration and for unknown indication.  On an unknown date during Christmas Days in 2018, approximately 347 days after receiving the last dose of Rabipur and 340 days after the last dose of Ixiaro vaccinations, the patient developed cold problems with flu-like symptoms, limb pain, resting tremor of the hands *(explicitly coded as 'Tremor of hands)*, angiofibroma in the facial area *(explicitly coded as 'Angiofibroma')*, sleep disorders and migraines. Initially, a suspected diagnosis of an autoimmune reaction after vaccinations was revealed.   On 18-Jan-2019, approximately 1 year after receiving the last dose of Rabipur, the patient was diagnosed with chronic fatigue syndrome and myalgic encephalomyelitis, which made the patient incapacitated and is now suing for vaccination damage.  The reporter did not provide outcome for the events of chronic fatigue syndrome, myalgic encephalomyelitis, *resting tremor of the hands and angiofibroma in the facial area*.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Gait disturbance, Injection site erythema
Clinical narrative: 4/24/21 site of injection was swollen, red and sore 4/25/21 woke up at 3:30 am feeling feverish and had a feeling of nausea; got out of bed and was extremely dizzy and bumped into wall and stumbled on way  to bathroom.  Went back to bed and woke at 5:00 am feeling somewhat better and discovered body plastered with hives from knees to chin.  Was tired most of the day and felt off balance.  By the next day was feeling almost normal but still had rash from hives.   4/26/21 Hives clearing up and feeling no more adverse side effects of vaccination. Contacted doctor to let them know what had happened after my visit on 4/23 and was advised to contact disease control and report this.  Also informed me that I should not receive the 2nd shot.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia, Rash
Clinical narrative: 4/24/21 site of injection was swollen, red and sore 4/25/21 woke up at 3:30 am feeling feverish and had a feeling of nausea; got out of bed and was extremely dizzy and bumped into wall and stumbled on way  to bathroom.  Went back to bed and woke at 5:00 am feeling somewhat better and discovered body plastered with hives from knees to chin.  Was tired most of the day and felt off balance.  By the next day was feeling almost normal but still had rash from hives.   4/26/21 Hives clearing up and feeling no more adverse side effects of vaccination. Contacted doctor to let them know what had happened after my visit on 4/23 and was advised to contact disease control and report this.  Also informed me that I should not receive the 2nd shot.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 4/24/21 site of injection was swollen, red and sore 4/25/21 woke up at 3:30 am feeling feverish and had a feeling of nausea; got out of bed and was extremely dizzy and bumped into wall and stumbled on way  to bathroom.  Went back to bed and woke at 5:00 am feeling somewhat better and discovered body plastered with hives from knees to chin.  Was tired most of the day and felt off balance.  By the next day was feeling almost normal but still had rash from hives.   4/26/21 Hives clearing up and feeling no more adverse side effects of vaccination. Contacted doctor to let them know what had happened after my visit on 4/23 and was advised to contact disease control and report this.  Also informed me that I should not receive the 2nd shot.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin, Blood test, Rash
Clinical narrative: Vaccination given in right gluteoid area.  Rash later diagnosed as Sweet Syndrome began in right thigh on April 13, 2021 and then spread to both legs, upper arms, and shoulders. Though Sweet syndrome is usually accompanied by fever, in this case there was no fever. Began prednisone on April
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypotension, Myalgia, Nausea, Pallor
Clinical narrative: Fainted; Thirsty; Shaking; Look pale; Hypotension; Arm soreness; Nausea; CHILLS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy (environmental allergy) and Dust allergy (environmental allergy). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, MONTELUKAST for Asthma, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), THIRST (Thirsty), TREMOR (Shaking), PALLOR (Look pale), HYPOTENSION (Hypotension), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever). On 24-Apr-2021, SYNCOPE (Fainted), TREMOR (Shaking), PALLOR (Look pale) and HYPOTENSION (Hypotension) had resolved. At the time of the report, THIRST (Thirsty), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever) outcome was unknown.   The action taken with mRNA-1273 in response to the event was not applicable.  The treatment medications included Tylenol (paracetamol) and Advil (Ibuprofen).  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Thirst, Tremor
Clinical narrative: Fainted; Thirsty; Shaking; Look pale; Hypotension; Arm soreness; Nausea; CHILLS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy (environmental allergy) and Dust allergy (environmental allergy). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, MONTELUKAST for Asthma, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), THIRST (Thirsty), TREMOR (Shaking), PALLOR (Look pale), HYPOTENSION (Hypotension), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever). On 24-Apr-2021, SYNCOPE (Fainted), TREMOR (Shaking), PALLOR (Look pale) and HYPOTENSION (Hypotension) had resolved. At the time of the report, THIRST (Thirsty), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever) outcome was unknown.   The action taken with mRNA-1273 in response to the event was not applicable.  The treatment medications included Tylenol (paracetamol) and Advil (Ibuprofen).  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oligomenorrhoea, Pain
Clinical narrative: Extreme fatigue, moderate body aches , delayed menstrual cycle - no treatment
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Headache
Clinical narrative: Headache 4/10 left side.  Pt. stated that he still had a headache.  pt. informed that if symptoms persist or worsen to call 911.  Pt. told to follow up with primary care provider.  Pt. verbalized understanding.  Pt. A+Ox3.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling of body temperature change, Flushing, Headache
Clinical narrative: Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling exhausted and sore the second day after the vaccine. Feeling hot and flushed and then cold at times Headache
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling exhausted and sore the second day after the vaccine. Feeling hot and flushed and then cold at times Headache
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Unevaluable event
Clinical narrative: Patient was given vaccine dose although age was incorrectly input by patient.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at site, fever, chills, diarrhea, headache, tiredness
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at site, fever, chills, diarrhea, headache, tiredness
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Patient complained of body heat.  1:10pm Patient refused to take B/P.  Stated she is feeling better.  EMS informed patient if symptoms return to call 911 or primary care doctor. (Patient is alertx3).  Verbalized understanding.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Dizziness  exactly 7 days after shot.  I NEVER have dizziness.  And suddenly, I am feeling dizzy at time throughout the day.  It's worse when getting up out of a chair or bed, but also feel it when just staying still.   I can still function, but it is strange.  Also: a  day after the second shot (Day 2), I got "sick" for two days  (Day 2 and 3)-- sluggish, exhausted, unable to focus.  Spent two days in bed.  But was fine by Day 4..  Then the dizziness started on Day 8.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Sluggishness
Clinical narrative: Dizziness  exactly 7 days after shot.  I NEVER have dizziness.  And suddenly, I am feeling dizzy at time throughout the day.  It's worse when getting up out of a chair or bed, but also feel it when just staying still.   I can still function, but it is strange.  Also: a  day after the second shot (Day 2), I got "sick" for two days  (Day 2 and 3)-- sluggish, exhausted, unable to focus.  Spent two days in bed.  But was fine by Day 4..  Then the dizziness started on Day 8.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Completely swollen eye
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 9:45am dizziness 9:55am voiced that she was feeling better and left site. B/P 122/68, HR 72, O2Sat 98%, BS 86.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Contusion, Feeling hot, Pain in extremity
Clinical narrative: 2nd day arm pain started lasted 8 days. 2nd day bruise, currently have bruise it's the 12th day. Bruise larger than half dollar.  Left shoulder pain has lessened but still ongoing. Body gets very hot, sometimes followed by immediate chills started day 3 and continues currently (12 day today)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vaccine, I felt as if I?d taken cold medicine. I was slow to react, felt ?foggy?, I had trouble recalling words and the names of household objects I was staring at, my movements weren?t coordinated and I dropped a few things. During the night, I was tired but had trouble sleeping. The body aches worsened and really concentrated in my joints, especially my spine. I stayed either in bed or on the couch the whole day following my vaccine but my heart rate (as read by my smart watch) would go from the 70?s to as high as 129 just from sitting up higher in bed. My normal resting heart rate is in the upper 50?s/lower 60?s and I don?t see 120+ unless I?m working out for at least 20 minutes. I didn?t take Tylenol or Motrin until 7 PM on April 19th (I took 800mg of Motrin) about 34 hours after my vaccine. I had a low grade fever and my head ached so bad all my teeth were throbbing before I took the  Motrin. I started to feel better within a hour of taking Motrin and was fine from then on. I only took Motrin the one time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Memory impairment, Pain, Pyrexia, Spinal pain
Clinical narrative: About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vaccine, I felt as if I?d taken cold medicine. I was slow to react, felt ?foggy?, I had trouble recalling words and the names of household objects I was staring at, my movements weren?t coordinated and I dropped a few things. During the night, I was tired but had trouble sleeping. The body aches worsened and really concentrated in my joints, especially my spine. I stayed either in bed or on the couch the whole day following my vaccine but my heart rate (as read by my smart watch) would go from the 70?s to as high as 129 just from sitting up higher in bed. My normal resting heart rate is in the upper 50?s/lower 60?s and I don?t see 120+ unless I?m working out for at least 20 minutes. I didn?t take Tylenol or Motrin until 7 PM on April 19th (I took 800mg of Motrin) about 34 hours after my vaccine. I had a low grade fever and my head ached so bad all my teeth were throbbing before I took the  Motrin. I started to feel better within a hour of taking Motrin and was fine from then on. I only took Motrin the one time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vaccine, I felt as if I?d taken cold medicine. I was slow to react, felt ?foggy?, I had trouble recalling words and the names of household objects I was staring at, my movements weren?t coordinated and I dropped a few things. During the night, I was tired but had trouble sleeping. The body aches worsened and really concentrated in my joints, especially my spine. I stayed either in bed or on the couch the whole day following my vaccine but my heart rate (as read by my smart watch) would go from the 70?s to as high as 129 just from sitting up higher in bed. My normal resting heart rate is in the upper 50?s/lower 60?s and I don?t see 120+ unless I?m working out for at least 20 minutes. I didn?t take Tylenol or Motrin until 7 PM on April 19th (I took 800mg of Motrin) about 34 hours after my vaccine. I had a low grade fever and my head ached so bad all my teeth were throbbing before I took the  Motrin. I started to feel better within a hour of taking Motrin and was fine from then on. I only took Motrin the one time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Dyskinesia, Electric shock sensation, Heart rate increased
Clinical narrative: Three days after receiving my first Pfizer vaccine I began experiencing twitching and muscle spams all over by body. They spasms range from large jerking of my neck, head, spine, and legs, to small consist contractions and fluttering twitches all throughout my body. I am also experiencing rapid heart beats and massive amounts of anxiety as well as painful electric like shocks going through my feet and legs.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching, Pain in extremity
Clinical narrative: Three days after receiving my first Pfizer vaccine I began experiencing twitching and muscle spams all over by body. They spasms range from large jerking of my neck, head, spine, and legs, to small consist contractions and fluttering twitches all throughout my body. I am also experiencing rapid heart beats and massive amounts of anxiety as well as painful electric like shocks going through my feet and legs.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Muscle twitching, Myoclonus
Clinical narrative: Three days after receiving my first Pfizer vaccine I began experiencing twitching and muscle spams all over by body. They spasms range from large jerking of my neck, head, spine, and legs, to small consist contractions and fluttering twitches all throughout my body. I am also experiencing rapid heart beats and massive amounts of anxiety as well as painful electric like shocks going through my feet and legs.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Sleep disorder
Clinical narrative: 4 days of chills, nausea, not sleeping but constantly tired.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Nausea, Pain
Clinical narrative: Patient reported nausea at 1530 and cold sweats, aches, chills starting at 0200 5March2021.  For 2nd shot in series (8April2021 at 0830am): patient reported nausea at 0430, and cold sweats, aches, chills starting at 0300 on 9April2021).  Patient reports symptoms resolved but continued 'on and off headaches' as of 10April2021.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Patient reported nausea at 1530 and cold sweats, aches, chills starting at 0200 5March2021.  For 2nd shot in series (8April2021 at 0830am): patient reported nausea at 0430, and cold sweats, aches, chills starting at 0300 on 9April2021).  Patient reports symptoms resolved but continued 'on and off headaches' as of 10April2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pruritus, Injection site urticaria, Panic attack, Pruritus
Clinical narrative: Initial reaction was a large circle of raised, itching skin around the injection site. Rash including shingles like blisters across my chest and on my legs. Itching around my face and neck. At the one week mark, I had the first panic episode.  Since this time, I have had additional panic attacks.  I have never been prone to anxiety related issues prior to the Moderna vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Initial reaction was a large circle of raised, itching skin around the injection site. Rash including shingles like blisters across my chest and on my legs. Itching around my face and neck. At the one week mark, I had the first panic episode.  Since this time, I have had additional panic attacks.  I have never been prone to anxiety related issues prior to the Moderna vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Muscle fatigue, Myalgia
Clinical narrative: Long term muscle fatigue/pain. Primarily noticed when doing chest exercises in the gym (I.e. barbell flat bench). Largely only a problem during flat bench, no issues with incline dumbbell press. Pain/soreness is isolated to the medial deltoid where the injection occurred, and only in the left arm where the injection occurred. Only began after dose 2. Noticed the week following the dose, pain persists. No treatment action taken.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure during pregnancy, Mobility decreased, Periarthritis, Pregnancy
Clinical narrative: Extreme shoulder pain for 8 days, shoulder appears frozen and unable to rotate forward. Worse at rest. Believed it was due to improper injection site for both my husband and I. Received vaccine in room 15. RN misplaced injection, was very high and distal, almost in the shoulder joint instead of muscle.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Extreme shoulder pain for 8 days, shoulder appears frozen and unable to rotate forward. Worse at rest. Believed it was due to improper injection site for both my husband and I. Received vaccine in room 15. RN misplaced injection, was very high and distal, almost in the shoulder joint instead of muscle.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, sleeplessness, fatigue
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches, fever, sleeplessness, fatigue
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING R SIDE
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under arm and breast
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Bone pain, Cardiac flutter, Chills
Clinical narrative: 4/25, 4pm, 2nd dose of Pfizer.  Mass vax scheduling second dose 17days from  1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21  - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related,  HEART FLUBBING - mild.  Third day missed of work. Heading to doctor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Impaired work ability, Influenza like illness
Clinical narrative: 4/25, 4pm, 2nd dose of Pfizer.  Mass vax scheduling second dose 17days from  1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21  - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related,  HEART FLUBBING - mild.  Third day missed of work. Heading to doctor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: 4/25, 4pm, 2nd dose of Pfizer.  Mass vax scheduling second dose 17days from  1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21  - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related,  HEART FLUBBING - mild.  Third day missed of work. Heading to doctor.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Shortness of Breath-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: Patient states symptoms began the day following second dose administration; advised patient to seek medical follow-up as symptoms reported included shortness of breath. Patient agreed stating they had already contacted their doctor but wanted to let us know as well to report the adverse effects.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Shortness of Breath-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: Patient states symptoms began the day following second dose administration; advised patient to seek medical follow-up as symptoms reported included shortness of breath. Patient agreed stating they had already contacted their doctor but wanted to let us know as well to report the adverse effects.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING, LOCALIZED OR GENERALIZED URTICARIA
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Injection site pain, Injection site rash, Pain
Clinical narrative: Headache, slight fever, slight body aches, feeling "out of it" Injection site was really sore. Woke up @ 2am and could not fall asleep. Slightly hard to breathe, rash on injection site.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, slight fever, slight body aches, feeling "out of it" Injection site was really sore. Woke up @ 2am and could not fall asleep. Slightly hard to breathe, rash on injection site.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on left side of body
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling cold, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Joint Pain-Mild, Systemic: Weakness-Mild
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Joint Pain-Mild, Systemic: Weakness-Mild
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Unusual heavy and painful menstrual cycle.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Gave patient water, a snack, and had him sit in pharmacy for full 30 minutes before leaving.  He said he felt perfectly fine and was having no other continuing symptoms.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, constant for the past seven weeks, ongoing, currently on prednisone with some benefit
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered, Wrong technique in product usage process
Clinical narrative: Office manager calling to report adverse event with PROQUAD and VARIVAX. Caller states PROQUAD was inadvertently administered concomitantly with VARIVAX to a patient.; No additional AEs; This spontaneous report was received from a other concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S031883 and expiration date since it makes match with the autopopulated expiration date 07-APR-2021), 0.5 milliliter (route of administration and indication were not provided), and it was inadvertently administered concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX)  (lot # T002843 and expiration date since it makes match with the autopopulated expiration date 23-JAN-2022), 0.5 milliliter (route of administration and indication were not provided).  No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Shingles/rash on the left outside of foot, with painful red blisters and burning sensation in toes; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient suffered rash on the left outside of foot, with painful red blisters and burning sensation in toes and was diagnosed with Herpes Zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles/rash on the left outside of foot, with painful red blisters and burning sensation in toes; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient suffered rash on the left outside of foot, with painful red blisters and burning sensation in toes and was diagnosed with Herpes Zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling event.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-APR-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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); devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-MAR-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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); devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-APR-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 02-APR-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 02-APR-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: sore arm; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet, from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1803USA004866), concerning a currently 75-year-old female patient. The patient's medical history included chicken pox infection in 1955. The patient was a cigarette smoker since 1975 to 1995. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies provided.  On 18-JUN-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.  On an unknown date, the patient experienced sore arm as an adverse reaction to vaccination. The outcome of the event was unknown.  The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).   This is one of two reports regarding the same patient (MARRS# 1803USA004866).; Sender's Comments:  US-009507513-1803USA004866:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My friend got the shingles twice after getting the vaccine/ suspected vaccination failure; My friend got the shingles twice after getting the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The reporter stated that the patient got the shingles twice after getting the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: has shingles and has had 2 shots/ Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The reporter stated that the patient at the time of reporting had shingles and has had 2 shots, the original shingle shot and the newest one. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that after his/her 1st Shingles shot he/she got the shingles.  The follow-up would not possible as no contact details were available