chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to  go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and Diarrhea
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Erythema, Peripheral swelling
Clinical narrative: Bell's palsy; Firm red swollen arm; Firm red swollen arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed firm red (erythema), swollen arm (peripheral swelling) and bell's palsy.    The patient's medical history was not provided. No relevant concomitant medications were reported.     On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for prophylaxis of COVID-19 infection.    On 05 Jan 2021, the patient developed firm red swollen arm. On 22 Jan 2021, the patient experienced medically significant event of symptoms of bell's palsy.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events developed firm red (erythema), swollen arm (peripheral swelling) and Bell's palsy was not reported.  The outcome of the event firm red (erythema) and swollen arm (peripheral swelling) was resolved on an unspecified date. The outcome of the event bell's palsy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Confusional state, Dizziness, Full blood count normal
Clinical narrative: RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021.  ON 3/14/2021 SHE STARTED TO BECOME DIZZY, CONFUSED AND DEVELOPED MALAISE AND EVENTUALLY BECAME SO WEAK SHE COULD NOT MOVE.  PRIOR TO THIS SHE WAS VERY ACTIVE AND WAS WALKING AROUND FINE AND EVEN CLEANS HORSE STALLS AT HER HORSE BOARDING STABLES.  SHE WAS PHYSICALLY VERY ACTIVE  PRIOR RECEIVING THIS 2ND VACCINATION.  SHE IS CURRENTLY ADMITTED. SHE IS STILL CONFUSED AND AGITATED SHE CONTINUES TO BE WEAK AND CANNOT AMBULATE AT THIS TIME.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Malaise, Metabolic function test normal, Mobility decreased, Urine analysis
Clinical narrative: RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021.  ON 3/14/2021 SHE STARTED TO BECOME DIZZY, CONFUSED AND DEVELOPED MALAISE AND EVENTUALLY BECAME SO WEAK SHE COULD NOT MOVE.  PRIOR TO THIS SHE WAS VERY ACTIVE AND WAS WALKING AROUND FINE AND EVEN CLEANS HORSE STALLS AT HER HORSE BOARDING STABLES.  SHE WAS PHYSICALLY VERY ACTIVE  PRIOR RECEIVING THIS 2ND VACCINATION.  SHE IS CURRENTLY ADMITTED. SHE IS STILL CONFUSED AND AGITATED SHE CONTINUES TO BE WEAK AND CANNOT AMBULATE AT THIS TIME.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose less than 24 days from 1st dose, after only 23 days.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Malaise
Clinical narrative: Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chills, feeling unwell, slight fever, dizziness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chills, feeling unwell, slight fever, dizziness.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache
Clinical narrative: 1st shot was fine...2nd shot had minor side effects... slept okay Monday night after shot and Tuesday morning felt fine.. But around 1PM while watching TV got the chills and ate some soup but did not help. So I put sweats on and took a "nap" lasting to 5PM when I woke up too warm and took off my sweats. Felt tired/weak so stayed in bead till 8:30PM. Had dull headache that evening. No fever, no breathing issues no problem with taste smell. Just weak. Slept fine Tuesday night and woke up Wednesday morning feeling 90% better. By afternoon I was 100% fine on Wednesday and continue to be fine.
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Vitreous floaters
Clinical narrative: blindness in one eye; floater in eye; A spontaneous report was received from a consumer concerning a 72-year-old male patient of unknown race and ethnic group who received Modern's COVID-19 vaccine (mRNA-1273) and developed floater in eye and blindness in one eye.  The patient's medical history included diabetes and hypertension. Concomitant medications taken by the patient reported were blood pressure medications and diabetes medications.  On 18-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and at an unknown anatomical location for prophylaxis of COVID-19 infection.  On 01-Feb 2021, the patient was seeing floaters in eye. On 03-Feb-2021, the patient was blind in one eye and was hospitalized with the issue till the date of reporting.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome for floaters in eye was recovered on 02-Feb-2021 but the outcome for blindness in one eye was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: 1) Extremely sore arm after injection which is still moderately sore on day 3. 2) Fever, fatigue, headache evening of shot continuing through entire  day 2. Treated with Tylenol. Feel fine today, day 3.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Due to an error in mixing, the patient received the diluent only
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Hospice patient passed away within 60 days of receiving a COVID vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin mass, Tenderness
Clinical narrative: Reports: "I noticed a small lump on my clavicle on the same side my shot was administered (Left arm) It?s slightly painful to the touch, like a bruise kind of pain." She notified her healthcare provider. No known treatment provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness, CT states she gets anxious whenever she gets a vaccine
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Presyncope, Tinnitus
Clinical narrative: chills, body aches, near-syncope the following day, and tinnitus
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache, Nausea
Clinical narrative: Moderna COVID-19 vaccine EUA 12 hours after 2nd shot- chills, headache, nausea & heartburn lasting 36 hours 17 days later- itchy rash on arms, legs & torso lasting 5 days. Took Zyrtec 2X/day to relieve itching and reduce rash.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Fever, chills, sweating, body aches, stiff neck, headache and loss of appetite
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, sweating, body aches, stiff neck, headache and loss of appetite
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Eye haemorrhage, Injection site erythema, Injection site pruritus
Clinical narrative: blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased).  The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride.  On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient felt kind of sleepy.  On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site.   On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90.  He said his normal blood pressure was 20/70.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event of blood pressure was high at 160/90 was not resolved at the time of this report.   The outcome of  left eye blood covered inside, kind of sleepy, itching around injection site, and  injection site reddish and oval shaped was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased).  The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride.  On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient felt kind of sleepy.  On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site.   On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90.  He said his normal blood pressure was 20/70.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event of blood pressure was high at 160/90 was not resolved at the time of this report.   The outcome of  left eye blood covered inside, kind of sleepy, itching around injection site, and  injection site reddish and oval shaped was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy arm and rash
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Developed raised round inflamed tender area around injection site
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Cough, Dehydration
Clinical narrative: She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Feeling abnormal, Hypersomnia, Myalgia, Pain
Clinical narrative: She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sputum abnormal, Weight decreased
Clinical narrative: She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Productive cough, Pyrexia
Clinical narrative: She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Exhaustion - onging Swollen lymph node left arm pit - ongoing Lower back ache - ongoing Hair loss - ongoing
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Felt itching on my Left Upper arm,yesterday afternoon(03/18/21), and throughout the day. Today(03/19/21), observed a large circular redness covering my left deltoid muscle. There is some warmth at this site, no swelling detected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID arm
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Multiple sclerosis, Pyrexia
Clinical narrative: MS related symptoms; Shortness of breath; Headache; Fever; A spontaneous report was received from a consumer, concerning his wife, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced MS related symptoms/multiple sclerosis), shortness of breath, headache and fever/pyrexia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 03 Feb 2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, after vaccine administration in afternoon, the patient started to experience shortness of breath, headache, fever, and MS related symptoms and these side effects were currently ongoing. No treatment medications were reported.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, MS related symptoms, shortness of breath, headache and fever were considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Additional information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Employee received his first dose of the Pfizer Vaccine  and approximately 5-10 minutes after receiving his dose he began to feel very light-headed and faint. Vitals were taken. BP "higher than his usual" but within acceptable paramaters. Vaccine clinic staff continued to monitor, but he continued to report not feeling well. He was transported non-emergently to the ED for further evaluation.  In ED: highest BP charted was 178/90. Patient monitored in ED for 1 hour then discharged. No chest pain, headache, n/v/d, or rash. No antihypertensives administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Had chills and slight fever of 101 and headache for about 24 hours
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was 18 min post vaccination when she fainted in the observation area. Nursing staff and EMS on site attended to the patient. Nurse reports "patient was sitting in observation. Patine rolled out of her chair on to her stomach on the floor. Patient was unresponsive. Time was 16:50. Patient was rolled onto her back. Patient was sternal rubbed. Patient came to 16:52. She was oriented to person, place, and time." Carotid pulse strong and palpable, spontaneous breathing. EMS vital signs; BP 100/80, HR 92, O2 sat 97%. Pt assisted to wheelchair and taken to private EMS area where she was observed, called family for a ride home. Patient refused EMS transport to hospital.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Fatigue, Injection site erythema
Clinical narrative: After receiving 2nd dose: Redness, swelling,  pain, itching and "hot to the touch.  Redness injection site  4" diameter 5 days. Fever for 3 days. >than 102 at times Extreme chills, joint ache and muscle aches  Bowel cramping Increased fatigue after day 3
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: After receiving 2nd dose: Redness, swelling,  pain, itching and "hot to the touch.  Redness injection site  4" diameter 5 days. Fever for 3 days. >than 102 at times Extreme chills, joint ache and muscle aches  Bowel cramping Increased fatigue after day 3
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: After receiving 2nd dose: Redness, swelling,  pain, itching and "hot to the touch.  Redness injection site  4" diameter 5 days. Fever for 3 days. >than 102 at times Extreme chills, joint ache and muscle aches  Bowel cramping Increased fatigue after day 3
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccine positive rechallenge
Clinical narrative: Tingling and numbness of lips within 30 minutes of injection 25 mg benadryl within a few hours, numbness subsided  this also happened with first dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore.  The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and  the arm is swollen/inflammed.   Uncomfortable for daily activities like typing or eating.   Does respond to ibuprophen.   Trying to rest it and have it in sling to rest it.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin swelling, Urticaria
Clinical narrative: Itching on my legs. no welts or hives. just itchy skin overnight. when I woke up I did have welts and where any pressure is applied to my skin a welt forms and swells and itches. (example, I held my purse strap on my shoulder and when I put my purse down there was itchy redness and a welt where the strap applied pressure.) These welts are all over my body. Back, under my breasts, legs, arms etc. and one on my face.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Death, Dysstasia, Gait inability, Malaise
Clinical narrative: Death; not able to stand up or walk; extreme weakness; he did not feel well; not able to stand up or walk; A spontaneous report was received from the patient's wife concerning a male (age not provided) who experienced extreme weakness/asthenia, did not feel well/malaise, unable to walk/gait inability, and unable to stand/dysstasia.  The patient's medical history included lung disease which required oxygen support. Per patient's wife, no concomitant products were in use within two weeks of the event. The patient's wife also stated he does not take any daily medications.  On 21 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 ( Batch number 029L20A) by injection into his left arm for prophylaxis of Covid-19 infection.  After receiving the vaccine, the patient's wife stated he did not feel well. He experienced extreme weakness. He was not able to stand up or walk for the first few days after getting the shot. "He could not walk even 3 steps and get in the car".   On 09 Feb 2021, the patient felt a little bit better and could walk from one bedroom to another. No Medications were used to treat the patient's symptoms. No relevant medical tests were provided.  The patient had an appointment with his healthcare provider (date and time not provided) and was told he could not get the second dose of vaccine unless he got better.    The patient's wife stated she is not blaming the vaccine because her husband had a lung disease prior to getting the vaccine.  His doctor said, (per his wife) this lung disease had weakened him to the point he could not drive his car anymore. His brain was fine before the vaccine.  On 03 Mar 2021, the patient's wife called to say that the patient had finally passed away on 13 Feb 2021.   The second dose of mRNA-1273 was withheld in response to the events while waiting for the patient's condition to improve however; it was never given due to the patient's death.  The events of did not feel well, extreme weakness, unable to walk, and unable to stand were not resolved (presumably) prior to the patient's death. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.  Company Comment: The reported events, death, malaise, asthenia, gait inability, and dysstasia were considered possibly related to mRNA-1273.; Reporter's Comments: This is a case of  death in a male subject with a hx of lung disease requiring oxygen, who died 23 days after receiving first dose of vaccine. Very limited information is available and based on the reporter's causality assessment the event is considered unlikely related to the vaccine"; Reported Cause(s) of Death: cause of death unknown
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Meningitis aseptic, Mental status changes, Pyrexia
Clinical narrative: fever, altered mental status, aseptic meningitis.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cognitive disorder, Lumbar puncture, Magnetic resonance imaging, Pyrexia
Clinical narrative: fever, altered mental status, aseptic meningitis.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: 2/16/21 Rash that started on right chest wall. had physician assistant look at it and stated looks like herpes zoster. 2/17/21 did not progress and no pain did not think it was herpes zoster.  2/18/21 went to emergency department and diagnosed with shingles
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101 Chills Headache Body aches Fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever of 101 Chills Headache Body aches Fatigue
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Due to an error in mixing, the patient received the diluent only
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient became hot and receiving the injection and he passed out.  Upon arrival, patient was sweating profusely and was pale.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Fatigue, Headache, Pain in extremity
Clinical narrative: At abut 8am  March 11 - about 12 hours after receiving vaccine -  I got very achy, particularly in my arms and back.  I had a headache.  My temp reached 102.2 but went down by taking Tylenol.  I was very tired and slept most of the day.  The second day, March 12, I felt somewhat better but was still very tired and I slept about 3 hours.  By 6pm that night - 48 hours after having my vaccine - I felt fine.   Note:  I think I had Covid last November.  I was sick for about 5 days.  My test at that time was negative, my husband's positive.  We had the same symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose less than 24 days from 1st dose at only 23 days apart.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No sx, Pt not in the correct age range for this vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: She didn't receive the full dose; Red patch, is hot; It can be itchy; Arm is still red and swollen; Arm is still red and swollen; A spontaneous report (United States) was received from a consumer concerning a 64-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm has a big red patch/erythema, was hot/feeling hot, swollen/swelling, it can be itchy/pruritis and did not receive full dose/accidental underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 028L20a) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced the events big red patch, red patch was hot and swollen. The patient stated big red patch can be itchy. The doctor was concerned that some of the band aid went into arm or the patient did not received full dose.  Treatment details included cephalexin and a topical cream fluocinonide.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the event, accidental underdose was considered as resolved. The outcome of the events,  big red patch, red patch was hot and swollen and itchy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient stated that he felt faint and started to sweat profusely, got very pale in color.  as soon as he received his vaccine.  This was approximately 1140.  I then laid him back in the drivers seat, put a cold wet cloth on his neck and forehead.  Initial vital signs were: 97% 02, 60 pulse and 116/62 BP.  He states that he has high blood pressure.  Pressures taken every 5 minutes, 98%, 65 pulse 102/68 pulse, 1152: 118/70, 98, 71.  1156: 118/78, 98,81 1158: 124/84, 99%, 72
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pruritus
Clinical narrative: itching,bruising at injection site, down to elbow
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 09:55 --pt received injection (pt has hx of nausea but no vomiting with any needle injection including blood draw) 10:00--Pt reports nausea and dizziness ---Paramedics called.  Pt refused IV fluid --so no IV was inserted.  10:04---Pt vomits.   No blood noted. (B/P = 110/60, o2=99%, pulse = 80, R20 10:07--Paramedics arrived--Pt refused Paramedics.  B/P93/61 (pt reports that B/P is normal for her.  10:19 ----pt states that she feels better after the vomit --Discharged.  pt ambulated with no assistance.  denied any dizziness or nausea.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: Large irratating knots over my body mostly on the left side.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Headache, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: abnormal sensation throughout the left side of his face associated headache in the back left side of the head  normal examination
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Pt reported "feeling funny" several minutes after receiving the vaccine. The individual was moved from a vaccination pod to an observation area where she was monitored and observed for 30 minutes. Vitals: 1340 95/63, HR 82, 94% on room air; 1350 100/64, HR 70, 94% on room air. Pt verified symptoms resolved and was escorted via ambulation out of facility.
Sex: F
Vaccine: COVID19
Symptoms: Cytokine storm, Myositis, Neuritis
Clinical narrative: Cytoquin storm; Severe inflammation in nerves; Severe inflammation in muscle; A spontaneous report was received from a healthcare professional concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events cytokine storm, sever nerves inflammation (central nervous system inflammation) and severe muscle inflammation(myositis)  The patient's medical history was not reported.  Concomitant products information was not reported.  On unspecified date, prior to the onset of event the patient received their one of two planned doses of mRNA-1273 (batch number:unknown) for prophylaxis of COVID-19 infection.   On unspecified date after receiving vaccine the patient experienced the events cytokine storm, severe nerves and muscle inflammation.  Action taken with mRNA-1273 in response to the event was not provided.  Treatment information was not provided. On 26 Feb 2021 the outcome of the events cytokine storm, severe nerves and muscle inflammation was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out after receiving the Pfizer covid vaccine from a sitting chair position.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Pruritus
Clinical narrative: Left arm swelling, red patch (about 4 inches by 4 inches) near injection site, itching, painful gland under arm. Symptoms began 7 days after injection. Symptoms are improving.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea joint pain muscle pain headache tiredness
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS AND HEADACHES
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: In the same area as my shingles virus, which is well on its way to healing, I developed a rash about 6 or 7 hours after the vaccine.  The rash is small red markings that look like hives and it is unbelievably itchy.  I took benadryl which reduced the itching within 4 hours, but did not appear to impact the rash.  Today is day 1 after my vaccine, so I am watching the rash to see if and how it progresses over the next 48 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection
Clinical narrative: C. Diff bacterial infection; A spontaneous report was received from a consumer concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Clostridium difficile infection.  The patient's medical history included a broken nose in early January. No relevant concomitant medications were reported.  On 27 Jan 2021, approximately one week prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was hospitalized for Clostridium difficile infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event Clostridium difficile infection was not reported.  The outcome of the event Clostridium difficile infection was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metallic taste in mouth
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: NUMBNESS IN UPPER LIP AND NOSE, CHECKED OUT BY EMS AND VITALS TAKEN, MONITORED AND THE RELEASED
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Headache, body aches, fever, chills, light-headed, nauseous, heart rate went from  92-176 in a few minutes.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, body aches, fever, chills, light-headed, nauseous, heart rate went from  92-176 in a few minutes.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Due to an error in mixing, the patient received only the diluent
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site, large red area surrounding injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Micturition urgency, Pain in extremity
Clinical narrative: sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24hr
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: still having problems breathing; anaphylactic reaction; A spontaneous report was received from a consumer concerning a77-year-old, female patient who developed anaphylactic reaction and still having problems breathing (dyspnea).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received the unknown of two planned doses of mRNA-1273 (Batch number: 030M20A) on  24 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection.    On 24 Feb 2021 the patient experienced anaphylactic reaction (lips went numb, face went numb, blood pressure went up, heart rate went up, her throat closed, and she couldn't breathe or talk). An ambulance was called and the patient was transferred to the ER (emergency room) where they administered intravenous diphenhydramine.  Five hours later, the patient was okay, but reported that as of 25 Feb 2021, they are still having problems breathing. Treatment of the events included prednisone and diphenhydramine.    Action taken with mRNA-1273 in response to the event was not provided.  The event anaphylactic reaction was considered resolved. The outcome of the event, still having problems breathing, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test normal, Chills, Contusion, Disorientation
Clinical narrative: When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours.  I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Feeling abnormal, Headache
Clinical narrative: When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours.  I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pyrexia, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours.  I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Rash erythematous, Swelling
Clinical narrative: Large area swollen, dark red rash, dizziness, sick feeling
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Slight fever, chills, nausea.  Lasted about 10 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Day of vaccine - violent vomiting; Day 3 - Forearms began to itch, rash appeared during evening.  I applied Hydrocortisone; Day 4 to present -rash has spread over arms, down my legs, and lower back region.  Today - I applied Hydrocortisone and took a Benadryl pill.  This rash itches!!
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Eye swelling, Urticaria
Clinical narrative: Pt developed hives on his back and his eyes started to swell 3 hours after administration. MOP gave pt Benadryl and symptoms subsided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Injection site pain, Oral pruritus
Clinical narrative: I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin burning sensation, Swollen tongue, Throat irritation
Clinical narrative: I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
Age: 74.0
Sex: F
Vaccine: IPV
Symptoms: Unevaluable event
Clinical narrative: None stated.