chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site mass, Vomiting
Clinical narrative: Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 8th day post vaccination, injection site is red,  indurated, warm To touch and itchy. Mild discomfort associated with symptoms (4/10 on pain scale)
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Affect lability, Dizziness, Facial discomfort, Feeling cold, Feeling hot
Clinical narrative: Light-headedness, dizziness, headache.  Feelings of being cold/hot with high lability.  Facial pressure.  Exacerbating throughout the day and continuing into the following day.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Light-headedness, dizziness, headache.  Feelings of being cold/hot with high lability.  Facial pressure.  Exacerbating throughout the day and continuing into the following day.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Injection site pain, Muscular weakness
Clinical narrative: Fatigue, tired, muscle weakness, trouble breathing, pain in site of injection, clouded mind
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pallor
Clinical narrative: Left thigh:  reddened circle around injection site, 4 inches in diameter.  Skin appears  blanched around the outside border of the reddened area .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastrooesophageal reflux disease, Injection site pain, Pain
Clinical narrative: Moderna COVID?19 Vaccine EUA  Premedicated with benadryl and phenergan prior to injection.  No pain at time of injection. 2.5 hours later, arm started to be sore at site, fever of 101.4, diarrhea x 1 episode. Went outside and fresh air helped, felt much better.  Fatigue and very mild body aches, arm soreness (no more than flu shot, less than tetanus) .  630pm: Acid reflux was the worst side effect I experienced. I asked a co-worker who received the same vaccine the day prior to me. She also had bad reflux. Even with a history of GERD, I do not need to take PPI's any longer and I needed to take an omeprazole the night of my vaccine, which helped some. Took tylenol 500mg and went to bed. Woke up today (the following day after vaccine feeling normal with arm soreness which got better throughout the day.  I would describe my symptoms as mild. The MD I work with said I should report these to Moderna just so they can track all symptoms that people are experiencing post vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Moderna COVID?19 Vaccine EUA  Premedicated with benadryl and phenergan prior to injection.  No pain at time of injection. 2.5 hours later, arm started to be sore at site, fever of 101.4, diarrhea x 1 episode. Went outside and fresh air helped, felt much better.  Fatigue and very mild body aches, arm soreness (no more than flu shot, less than tetanus) .  630pm: Acid reflux was the worst side effect I experienced. I asked a co-worker who received the same vaccine the day prior to me. She also had bad reflux. Even with a history of GERD, I do not need to take PPI's any longer and I needed to take an omeprazole the night of my vaccine, which helped some. Took tylenol 500mg and went to bed. Woke up today (the following day after vaccine feeling normal with arm soreness which got better throughout the day.  I would describe my symptoms as mild. The MD I work with said I should report these to Moderna just so they can track all symptoms that people are experiencing post vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site warmth, Rash
Clinical narrative: Rash that began on vaccinated arm 24hrs later and spread to entire body lasting 48 hours. Took Benadryl for 2 days to combat symptoms. Then on 01/07/2021 a week after receiving the vaccine a large hot welt developed randomly at the vaccine site, temp of the welt was 104 degrees but body temperature was normal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nausea
Clinical narrative: Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle cramping worse in both legs (anterior thighs and calf?s) also hands and arms.  No treatment
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Nausea
Clinical narrative: Extreme soreness  and stiffening  to left shoulder, which continues as of now.  Nausea lasting only hours later that evening.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: The day after the vaccination I woke up extremely dizzy and after several hours realized it was vertigo. I?ve had vertigo ever since.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Irritability, Muscle twitching
Clinical narrative: 12-24 hours after vaccination:  high fever 102+,  chills,  nausea, fatigue, headache, arm occasionally twitching near injection site,  very sore arm, irritability
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: 12-24 hours after vaccination:  high fever 102+,  chills,  nausea, fatigue, headache, arm occasionally twitching near injection site,  very sore arm, irritability
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Pallor
Clinical narrative: -non-raised,  non-itchy, red rash on and around site of injection (asymmetrical). warm to touch. blanching. no pain. nsometimes soreness.  no other notable skin changes on arm. onset 1/7/2021, 8 days after injection. noticed around 18:30. has not significantly spread at time of submitting vaers (22:20). - no treatment at this time. monitoring. -arm soreness, onset day 1 after injection until day 4 after injection. no treatment. transient, resolved day 4
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Erythema, Headache, Pain
Clinical narrative: Redness, swelling, itching, burning within first 24 hours. Very painful large red hive like welp with big knot that progressed the first 24 hours. Redness hot to the touch.  Headache for 12-14 hours beginning 6-7 hours post injection. Body aches & chills, no fever during first 12 hours. Extra strength Tylenol did lessen symptoms (pain, aches, chills but not swelling or redness). 48 hours after injection: became very itchy, still firm knot at site with redness.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Redness, swelling, itching, burning within first 24 hours. Very painful large red hive like welp with big knot that progressed the first 24 hours. Redness hot to the touch.  Headache for 12-14 hours beginning 6-7 hours post injection. Body aches & chills, no fever during first 12 hours. Extra strength Tylenol did lessen symptoms (pain, aches, chills but not swelling or redness). 48 hours after injection: became very itchy, still firm knot at site with redness.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: 7/10 arm soreness, radiating pain to neck/temporal lobe on same side as shot. Duration of 1.5 days. No pain meds necessary.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Headache, muscle pain, minor neck stiffness
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site is swollen and red and looks like I was stung by a bee
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I was administered 5 times the recommended dose. At this time I am not experiencing any adverse effects to the vaccine.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, SARS-CoV-2 test negative
Clinical narrative: Severe chills, fatigue,  shivering.  Unable to do daily activities.  Symptoms started 5 days after the COVID vaccine and have lasted for 7 days so far.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Injection site pain  Muscle pain Headache Fatigue
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: I have not contacted my PCP or the facility where I received the covid vaccine since its not a "severe reaction".   The reaction happened at a trip to dentist after I was injected with lidocaine 2% and septocaine 4% , 7 days after receiving the covid vaccine. I started to feel pain to left jaw but figured it was due to dental work. By the time I got home I realized my left deltoid, where I received the covid vaccine was hot, red, swollen and with a itchy rash. Also it's very hard and stiff. Also my left cheek was very painful and hard. The pain to face was about 8/10. I iced it, took pain pill and fell asleep. When I woke up my left arm was hot itchy swollen and the arm and jaw were still very painful.    the reaction happened at a trip to dentist after I was injected with lidocaine 2% and septocaine 4% I started to feel pain to left jaw injection area. By the time I got home I realized my left deltoid, where I received the covid vaccine was hot, red, swollen and with a itchy rash. Also it's very hard and stiff. Also my left cheek is painful and hard. By the day I had my dental work done, I had no more pain to left deltoid, but after the dental work it was obvious that I was having an adverse reaction. I've had lidocaine and septicane injections before with no issues ever. It's 24 hours and the covid injection site (left deltoid) is still hard, painful red and with a rash. I'm tearting it with benadryl 25mg and hydrocortisone cream 1%to deltoid  2-3 times a day.  By the day I had my dental work done, I had no more pain to left deltoid, but after the dental work it was obvious that I was having an adverse reaction. I've had lidocaine and septicane injections before with no issues ever. It's now 24 hours and the covid injection site (left deltoid) is still hard, painful red and with a rash. My left cheek jaw area is tender but I'll assume it's from the dental work. I'm treating left arm  with benadryl 25mg and hydrocortisone cream 1% to deltoid  2-3 times a day. No changes at this time. It's starting to worry me because it feels like a hard mass that is painful and hot. (left deltoid).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain in jaw, Rash pruritic, Skin induration
Clinical narrative: I have not contacted my PCP or the facility where I received the covid vaccine since its not a "severe reaction".   The reaction happened at a trip to dentist after I was injected with lidocaine 2% and septocaine 4% , 7 days after receiving the covid vaccine. I started to feel pain to left jaw but figured it was due to dental work. By the time I got home I realized my left deltoid, where I received the covid vaccine was hot, red, swollen and with a itchy rash. Also it's very hard and stiff. Also my left cheek was very painful and hard. The pain to face was about 8/10. I iced it, took pain pill and fell asleep. When I woke up my left arm was hot itchy swollen and the arm and jaw were still very painful.    the reaction happened at a trip to dentist after I was injected with lidocaine 2% and septocaine 4% I started to feel pain to left jaw injection area. By the time I got home I realized my left deltoid, where I received the covid vaccine was hot, red, swollen and with a itchy rash. Also it's very hard and stiff. Also my left cheek is painful and hard. By the day I had my dental work done, I had no more pain to left deltoid, but after the dental work it was obvious that I was having an adverse reaction. I've had lidocaine and septicane injections before with no issues ever. It's 24 hours and the covid injection site (left deltoid) is still hard, painful red and with a rash. I'm tearting it with benadryl 25mg and hydrocortisone cream 1%to deltoid  2-3 times a day.  By the day I had my dental work done, I had no more pain to left deltoid, but after the dental work it was obvious that I was having an adverse reaction. I've had lidocaine and septicane injections before with no issues ever. It's now 24 hours and the covid injection site (left deltoid) is still hard, painful red and with a rash. My left cheek jaw area is tender but I'll assume it's from the dental work. I'm treating left arm  with benadryl 25mg and hydrocortisone cream 1% to deltoid  2-3 times a day. No changes at this time. It's starting to worry me because it feels like a hard mass that is painful and hot. (left deltoid).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion
Clinical narrative: Fatigue, congestion
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: 20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83.  Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg  once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83.  Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg  once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills beginning day of vaccination, resolved 3 days post-vaccination. No treatment required.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Swelling
Clinical narrative: shoulder pain, shoulder swelling, right axillary adenopathy
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: on the next day after the vaccine, he began to have a fever up to.  102 Fahrenheit rash spreads to this day throughout the body with itching, the child also has strange behavior, fatigue.  the attending physician denies us an appointment and tells us to call 911.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Pain, Pain in extremity
Clinical narrative: Almost 18 hours after the injection, my arm was painful, I began to run a fever above 102 degrees, I was so achey, I had to get help to get off the commode.  It hurt to roll over in bed.  I lost my taste and smell. It lasted approximately 24 hours.  I had Covid in June, 2020 and had all of the exact symptoms, 100 times worse than when I had Covid.  9 days later, I had fever above 102 again, chills, shaking for approximately 6 hours again.  Is this a normal reaction?
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Almost 18 hours after the injection, my arm was painful, I began to run a fever above 102 degrees, I was so achey, I had to get help to get off the commode.  It hurt to roll over in bed.  I lost my taste and smell. It lasted approximately 24 hours.  I had Covid in June, 2020 and had all of the exact symptoms, 100 times worse than when I had Covid.  9 days later, I had fever above 102 again, chills, shaking for approximately 6 hours again.  Is this a normal reaction?
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Restlessness
Clinical narrative: By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Sneezing, Swelling face
Clinical narrative: Approximately 20 to 30 minutes after receiving the vaccine, I had what appeared to be a seasonal allergic reaction, in which I could not stop sneezing and my eye tearing.  This continued throughout the evening and night but not as intense as when it first began.  I awoke at 1:00 AM to a very intense sneezing and eye tearing, but on only the left side of my face and eventually both sides.  I took Allegra D and did get relief.  The sneezing (allergic rhinitis) reaction continued but after almost an hour of taking the Allegra D , it was not as intense.  My face also appeared swollen but only with respect of atypical allergic rhinitis intense reaction.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site pain for 72 hours post injection (Dec 30-Jan 2) At injection site a raised red hard swelling 6cm round, very itchy. First noticed Jan 6 and is beginning to recede, but is still present.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red circle with raised edges at site of injection. Area continues to be slightly red. No other symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 2 days after vaccination had fever of 101.5, sore throat, and felt achy
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Chills, body & joint aches, headache, fatigue, malaise
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, body & joint aches, headache, fatigue, malaise
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever/chills, nausea
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Nausea, Syncope
Clinical narrative: I received the COVID 19, vaccine January 7, 2021. Around 12:30 AM on January 8 I felt nauseous, was very clammy and ending up fainting.  I will be calling out my primary due to this issue. I still need a second dose and unsure if I should get one now.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe headache one hour after injection.  Followed by nausea, chills, muscle aches and fever of 101.5
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Injection site pain, Nausea, Pain
Clinical narrative: Fever 102.9, chills, body aches, pain at injection site, nausea, cough
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102.9, chills, body aches, pain at injection site, nausea, cough
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: In the evening on the day of the vaccine and the following day my arm was sore and then my entire body.  Body was so sore that I had to take med to sleep.  It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days).   I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different.  I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain, Pain in extremity
Clinical narrative: Shot almost unnoticeable at time of injection and no discomfort on first day.  Arm a little sore on second and third day.  On by the fourth day arm was become uncomfortable with red raises area around injection site warm to the touch and lymph node involvement.  Arm and lymph node pain have continued to progress.  Red raised area about 3" diameter.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Culture, Eye discharge, Eye infection, Eyelid margin crusting
Clinical narrative: 4 days later after the vaccine my left eye turned really red with crust and mucus coming out. I went to walk in clinic and was being treated for pink eye. I was started on an antibiotic eye drop. A day later my right eye started to have the same problem. I scheduled an appt with a eye specialist where he examined both eyes and said I had a major infection. I was started on steroid eye drops which I am still taking but seems my eyes are not getting better. I have a follow up with another specialist next week for further testing. I have been out of work due to this matter.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Ocular hyperaemia, Ophthalmological examination
Clinical narrative: 4 days later after the vaccine my left eye turned really red with crust and mucus coming out. I went to walk in clinic and was being treated for pink eye. I was started on an antibiotic eye drop. A day later my right eye started to have the same problem. I scheduled an appt with a eye specialist where he examined both eyes and said I had a major infection. I was started on steroid eye drops which I am still taking but seems my eyes are not getting better. I have a follow up with another specialist next week for further testing. I have been out of work due to this matter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Persistent fatigue
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, nausea, vomitting, diarrhea,  and body aches
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills, fever, nausea, vomitting, diarrhea,  and body aches
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: one week after 1st round, 1/4/21, area where vaccinated was swollen, itchy, red and emanating heat
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever 101, body aches, severe headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus
Clinical narrative: HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB  WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO  ER
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: 12 hours after injection - arm in severe pain, severe headaches, fever, body aches, chills, generalized joint pains
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 12 hours after injection - arm in severe pain, severe headaches, fever, body aches, chills, generalized joint pains
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Cold chills, body aches, headache about 8 hours after the vaccinne was administered.  Symptoms subsided 20 hours later. At around 6:30 the following day the chills came back for about 8 hours.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Fever 12 hours after covid vaccine. Temp of 103.4 at highest. General fatigue, shivering and sweats.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Fatigue, Feeling cold
Clinical narrative: about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated,  BP dropped, HR wnl, After about 20 mins, I felt fine.  Went to work, did develop a migraine afterwards, some body ache and fatigue.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain
Clinical narrative: about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated,  BP dropped, HR wnl, After about 20 mins, I felt fine.  Went to work, did develop a migraine afterwards, some body ache and fatigue.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Chills, Hyperhidrosis, Seizure like phenomena
Clinical narrative: Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Rash
Clinical narrative: Sudden onset severe diarrhea, accompanied by nausea (no vomiting), chills, severe fatigue, and diffuse rash over LE initially, then to UE. No rash on trunk. Diarrhea resoled in 4 hours after 3 doses of Imodium. Remained afebrile.  Benadryl 25mg taken that night, and the next night as rash continued to be itchy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Sudden onset severe diarrhea, accompanied by nausea (no vomiting), chills, severe fatigue, and diffuse rash over LE initially, then to UE. No rash on trunk. Diarrhea resoled in 4 hours after 3 doses of Imodium. Remained afebrile.  Benadryl 25mg taken that night, and the next night as rash continued to be itchy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Nausea
Clinical narrative: Nausea, chills, constipation
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: She verbalize she develop headache, nausea, dizziness.  She was evaluated onsite by Rescue and released home feeling better at 10:25 am.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headache started at 1pm and was gone by 7:30pm Very sore arm  Then the nausea and diarrhea started and lasted until 5am   Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: 7 hours after first COVID-19 dose he experienced dysosmia x 1 hour which spontaneously resolved (not a/w dyspnea, cough, fever, lost of taste, nausea, or vomiting).  He did not seek medical attention.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Date of vaccination: annually; This spontaneous report as received from a laywer refers to a currently might be 69 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates (reported as annually), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).   This case was split from a case in litigation (link#2003USA008689).; Sender's Comments:  US-009507513-2003USA008689:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD stored at -5°C for 20 hours was administered to the patient; This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.      On 04-DEC-2020, the patient was vaccinated with an incorrect storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021302 (also reported as T0l 1302 which is non-valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) is valid for sitagliptin phosphate (XELEVIA)) , expiration date 19-DEC-2021, 0.5 milliliter for prophylaxis (route not reported). The temperature excursion occurred on 2 separate dates at -5 Celsius degrees (°C) for 20 hours. There was no previous temperature excursion. The call was made due to "data logger".  The register nurse also reported that varicella virus vaccine live (manufacturer unknown) had temperature excursion (temperature and time were not reported). It was unknown if this vaccine was administered.        This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2101USA003511:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature excursion incolving PROQUAD and VARICELLA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine underwent a temperature excursion; the storage temperature of the vaccine was -5 degrees Celsius (°C) for a time frame of 20 hours. There was no previous temperature excursion. Digital logger was involved  On 08-DEC-2020, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, (frequency, route and anatomical location were not provided, lot # T021302 (also reported as T011302) has been verified to be a valid lot number, expiration date 19-DEC-2020) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQCs reported; Caller informed Agent of the administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 05-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) (lot # T015598 and expiration date reported 02-NOV-2021) (dose, route, and anatomical location were not reported) for prophylaxis.  According to the reporter, the temperature was 20.5 degrees Fahrenheit for a time frame of 1 hour 54 minutes. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) vaccine had a previous temperature of excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 degrees Fahrenheit) for 23 hours, which was detected by a digital data logger. No additional adverse event (AE) was reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; fist dose administered at 15 weeks 0 days, 1 day too late; This spontaneous report was received from a other health professional refers to a 15-week-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters, administered orally, lot # 1684166, expiration date 27-JUN-2021 (strength, was not reported) for prophylaxis. At the time of vaccination, the patient was 15 weeks old (was past 14 weeks 6 days, so the patient received the first dose 1 day too late).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first GARDASIL 9 vaccine 2 years ago; This spontaneous report was received from a pharmacist who was reporting on 26-year-old male patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2018, also reported as 2 years ago, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (exact dose , lot number, expiration date, route of administration, anatomical location and strength were not provided) for prophylaxis. He did not receive consecutive doses yet (inappropriate schedule of vaccine administered), reported wanted to know if the patient needs to restart the series.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; other zoster-related conditions; other zoster-related conditions; Information has been received on 04-JAN-2021 from a lawyer regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers at hearing aid centers for hearing loss and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of hearing loss and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).  Upon internal evaluation, the event of hearing loss was determined to be medically significant.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 74-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about an unknown date in 2014, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a pharmacist at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: vision loss. The outcome of vision loss was not provided. The reporter considered the event of vision loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; death; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a 80 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.       On or about 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported)  for long-term prevention of shingles and zoster-related conditions.         On an unknown date (reported as "subsequent to vaccination"), the patient experienced shingles and was treated with unspecified medications. On 07-JUN-2016, the patient died. The caused of death and if an autopsy was performed were not reported.  The outcome of shingles was unknown.  The reporter considered death and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: a ROT ATEQ vaccine which had been improperly stored was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 28-DEC-2020, the patient was vaccinated with a improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength and route were not reported, lot # 1684157 has been verified as valid, expiration date 26-JUN-2021) for prophylaxis (product storage error). The excursion was supported as below 36 Fahrenheit (32.1 F) for 5 hours and 40 minutes. There were no previous temperature excursions. The vaccines were back in range at the reporting time. The digital data logger was involved.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: the child had a reaction to the product after the first dose; fever; rash; This spontaneous report as received from a nurse refers to a 5 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions/allergies were unknown.   On an unknown date in 2016, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, site of administration, lot number and expiration date were not provided) subcutaneously (SQ) for prevention of measles, mumps, and rubella.       On an unknown day in 2016 (reported as 5 years ago), the patient had a reaction to the product (adverse reaction) at one year of age after first dose and also experienced fever and rash. It was unknown if treatment was given, lab diagnostics/studies was performed, medical attention was sought or not. The outcome of adverse reaction, fever and rash was unknown. The action taken was not applicable.  The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: While still in bed, the room started to spin; This case was reported by a consumer via call center representative and described the occurrence of spinning sensation in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 2 days after receiving Shingrix, the patient experienced spinning sensation. On 2nd December 2020, the outcome of the spinning sensation was recovered/resolved.   It was unknown if the reporter considered the spinning sensation to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself. On 2nd December 2020 morning, while patient was still in bed, the room started to spin.  The patient felt ok at the time of reporting.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   The reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have Lot number or expiry date or brand name of flu shot. The patient had anaphylactic reactions to flu and pneumonia shots. The reporter considered the anaphylactic reaction to be related to PNEUMONIA VACCINE. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Syringe leaked of suspension: less than 0.5 given to patient; Syringe leaked of suspension: less than 0.5 given to patient; A report was received from a nurse concerning a patient of unreported age who was participating in the mRNA-1273 Emergency Use Program and experienced syringe leaked of suspension: less than 0.5 given to patient.  The patient's medical history was not provided. No concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020.   On 22 Dec 2020, while administering the first of the two planned doses of mRNA-1273 to the patient, some of the suspension dripped out of the syringe. The nurse was not aware of how much leaked out. She stated it was a dribble.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome for the event, experienced syringe leaked of suspension: less than 0.5 given to patient, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, experienced syringe leaked of suspension: less than 0.5 given to patient.; Reporter's Comments: This case concerns a patient of unreported age and sex, experienced an unexpected event of suspension leaked from the syringe: less than 0.5 given to patient. The event occurred on 22 Dec 2020 during administration of the first dose of the study medication. The sponsor considered the event as related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Not all of the dose was administered; A report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the pharmacist administered the mRNA-1273 vaccine to a patient.  During the administration, the needle fell off the syringe, and not all of the dose was administered.  The pharmacist stated that about three-quarters of the dose was received by the patient.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, incorrect dose administered.; Reporter's Comments: This case concerns a  patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of incorrect dose administration. The event occurred on 22 Dec 2020  during the administration of the first dose of mRNA-1273.  The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The needle came off syringe and the patient did not receive a full dose; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced the non-serious event the needle came off syringe and the patient did not receive a full dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the pharmacist reported that while administering the vaccine to the patient, the needle came off the syringe, and the patient did not receive a full dose. The patient had already left the office, and the pharmacist currently had no patient identifiers at the time. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, the needle came off syringe and the patient did not receive a full dose, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, the needle came off syringe and the patient did not receive a full dose.; Reporter's Comments: This case concerns a patient of unreported age and sex, who experienced an unexpected event of the needle coming off syringe and the patient did not receive a full dose.  The event occurred on 22 Dec 2020 during the administration of the first dose of the study medication. The sponsor considered the event as related  to the mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient.  During the administration, the syringe malfunctioned and leaked during administration.  The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event.  Action taken with mRNA-1273 in response to the event was not reported.   The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a  patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of syringe malfunctioned and leaking during administration. The event occurred on 22 Dec 2020  during administration of the first dose of the study medication. The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.