chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: SORE FEELS TENDER [BRUISED AREA]; BRUISING ON RIGHT UPPER THIGH TOWARDS THE KNEE CAP/CLUSTERS OF BRUISES; DIZZINESS; HEADACHE (ON AND OFF); ACHING ALL OVER SIMILAR TO AFTER FLU SHOT; TIRED [FOR 3 DAYS POST VACCINE] /EXHAUSTION; SORE INJECTION ARM SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced aching all over similar to after flu shot. On 09-APR-2021, the subject experienced tired [for 3 days post vaccine] /exhaustion. On 09-APR-2021, the subject experienced sore injection arm site. On 10-APR-2021, the subject experienced headache (on and off). On 24-APR-2021, the subject experienced dizziness. On 25-APR-2021, the subject experienced bruising on right upper thigh towards the knee cap/clusters of bruises. On 25-APR-2021, the subject experienced sore feels tender [bruised area]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching all over similar to after flu shot on 12-APR-2021, and tired [for 3 days post vaccine] /exhaustion, and sore injection arm site on 14-APR-2021, and was recovering from bruising on right upper thigh towards the knee cap/clusters of bruises, dizziness, sore feels tender [bruised area], and headache (on and off). This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Tenderness
Clinical narrative: SORE FEELS TENDER [BRUISED AREA]; BRUISING ON RIGHT UPPER THIGH TOWARDS THE KNEE CAP/CLUSTERS OF BRUISES; DIZZINESS; HEADACHE (ON AND OFF); ACHING ALL OVER SIMILAR TO AFTER FLU SHOT; TIRED [FOR 3 DAYS POST VACCINE] /EXHAUSTION; SORE INJECTION ARM SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced aching all over similar to after flu shot. On 09-APR-2021, the subject experienced tired [for 3 days post vaccine] /exhaustion. On 09-APR-2021, the subject experienced sore injection arm site. On 10-APR-2021, the subject experienced headache (on and off). On 24-APR-2021, the subject experienced dizziness. On 25-APR-2021, the subject experienced bruising on right upper thigh towards the knee cap/clusters of bruises. On 25-APR-2021, the subject experienced sore feels tender [bruised area]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching all over similar to after flu shot on 12-APR-2021, and tired [for 3 days post vaccine] /exhaustion, and sore injection arm site on 14-APR-2021, and was recovering from bruising on right upper thigh towards the knee cap/clusters of bruises, dizziness, sore feels tender [bruised area], and headache (on and off). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A) dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The outcome of side effects was not reported. This report was non-serious. This case, from the Others is linked to 20210448323.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Muscle spasms, Pain in extremity
Clinical narrative: SEVERE LEFT LEG CRAMP; PAIN IN LEFT ARM LYMPH NODES; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and paracetamol. On 25-APR-2021, the subject experienced severe left leg cramp. On 25-APR-2021, the subject experienced pain in left arm lymph nodes. On 25-APR-2021, the subject experienced pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe left leg cramp, pain in left arm and pain in left arm lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness. This report was non-serious.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Contusion, Headache, Joint swelling, Vision blurred
Clinical narrative: HEADACHE; BLURRED VISION; SWOLLEN ANKLES; BRUISED ARM/LEG/ANKLE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 44 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 19-APR-2021, the subject experienced swollen ankles. On 19-APR-2021, the subject experienced bruised arm/leg/ankle. On 20-APR-2021, the subject experienced blurred vision. On 23-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 22-APR-2021, and abdominal pain on 15-APR-2021, and had not recovered from headache, swollen ankles, and bruised arm/leg/ankle. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: PERSISTENT HEADACHE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced persistent headache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from persistent headache, and the outcome of mild fever was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia
Clinical narrative: SICK; FEVERISH; TIRED; This spontaneous report received from a consumer concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced sick. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, fever, and tired on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; TIREDNESS; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 02-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Nausea, Pain
Clinical narrative: ACHES; SLEEPLESS; CHILLS; JOINT PAINS; FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sleepless, chills, joint pains, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pains, sleepless, fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; SLEEPLESS; CHILLS; JOINT PAINS; FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sleepless, chills, joint pains, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pains, sleepless, fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: FELT LIKE CRAP; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 51 year old male. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 07-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt like crap. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced low grade fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like crap, chills, low grade fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscle ache was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Hypogeusia, Metabolic function test
Clinical narrative: SENSE OF SMELL DECREASED FROM NORMAL; SENSE OF TASTE DECREASED; LINGERING AFTERTASTE AND AFTER  SMELL SENSATION; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use (2 per week), and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient experienced ulcerative colitis when treated with adalimumab for ulcerative colitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced sense of smell decreased from normal. On 10-MAR-2021, the subject experienced sense of taste decreased. On 10-MAR-2021, the subject experienced lingering aftertaste and after smell sensation.  On 26-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 10-MAR-2021, and had not recovered from sense of smell decreased from normal, sense of taste decreased, and lingering aftertaste and after smell sensation. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia
Clinical narrative: SENSE OF SMELL DECREASED FROM NORMAL; SENSE OF TASTE DECREASED; LINGERING AFTERTASTE AND AFTER  SMELL SENSATION; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use (2 per week), and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient experienced ulcerative colitis when treated with adalimumab for ulcerative colitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced sense of smell decreased from normal. On 10-MAR-2021, the subject experienced sense of taste decreased. On 10-MAR-2021, the subject experienced lingering aftertaste and after smell sensation.  On 26-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 10-MAR-2021, and had not recovered from sense of smell decreased from normal, sense of taste decreased, and lingering aftertaste and after smell sensation. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Injection site pain, Magnetic resonance imaging head, Migraine
Clinical narrative: SEVERE MIGRAINE/MIGRAINE HEADACHE; DIZZINESS; LIGHT HEADEDNESS; THROBBING PAIN; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, seasonal allergy, and seafood allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included botulinum toxin type a for migraine. On APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN, MRI brain (NR: not provided) UNKNOWN, and Nuclear magnetic resonance angiography brain (NR: not provided) UNKNOWN. On 03-APR-2021, the subject experienced severe migraine/migraine headache. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced light headedness. On 03-APR-2021, the subject experienced throbbing pain. On 03-APR-2021, the subject experienced injection site pain. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine/migraine headache, had not recovered from dizziness, light headedness, throbbing pain, and nausea, and the outcome of injection site pain was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: SEVERE MIGRAINE/MIGRAINE HEADACHE; DIZZINESS; LIGHT HEADEDNESS; THROBBING PAIN; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, seasonal allergy, and seafood allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included botulinum toxin type a for migraine. On APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN, MRI brain (NR: not provided) UNKNOWN, and Nuclear magnetic resonance angiography brain (NR: not provided) UNKNOWN. On 03-APR-2021, the subject experienced severe migraine/migraine headache. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced light headedness. On 03-APR-2021, the subject experienced throbbing pain. On 03-APR-2021, the subject experienced injection site pain. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine/migraine headache, had not recovered from dizziness, light headedness, throbbing pain, and nausea, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypersensitivity
Clinical narrative: BACK PAIN; SHOULDER PAIN; AWFUL ALLERGIC REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, shoulder pain, and awful allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awful allergic reaction, shoulder pain, and back pain. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: I'm breastfeeding and my newborn since my 2nd dose has been vomiting and spitting up alot since the vaccine .
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body they were larger and worse on the side of my body where I received vaccine. Received vaccine at 10:20 and hives started at 11:00 . Immediately took 2 Benadryl tablets with some relief repeated every 6 hours. Today 4/27/21 I stopped taking the Benadryl and around 6pm I broke out in hives and extreme itching again.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face, Throat tightness, Urticaria
Clinical narrative: Pt. presented to clinic front desk at approx. 1300 hrs today (4/27/2021) w/ c/o full body pruritis and urticaria. Front desk staff notified nursing staff. Pt. escorted by nursing staff to treatment room for assessment and evaluation. No obvious respiratory distress noted. Pt. reported receiving 2nd dose of Moderna COVID -19 vaccine at 0845 today by staff during off-site, COVID-19 mass vaccination event. Notified MD; examined. At 1334hrs, 50mg diphenhydramine given orally per MD order. Pt. is did not endorse any previous reactions to vaccines. Did not endorse any history of  allergic reactions to medications.  Reported previous history of similar symptoms (urticaria and pruritis) that her provider indicated was due to "the wind". VSS at 102/58, HR 124, RR 20, 99% O2 sats. Observed urticaria with small welts to bilateral arms, chest, abdomen, and lower back; worsening in redness and welt size. Pt reported mild facial swelling, redness, and "tight throat". Airway patent; no distress noted. MD ordered to call EMS for transport to ED. At approximately 1345 hrs., mild improvement of urticaria. EMS arrived at 1400 hrs.; 1414 hrs transported via ambulance to ED.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: PATIENT STATED SHE WAS STILL EXPERIENCING PAIN IN HER ARM 2 WEEKS AFTER RECEIVING THE VACCINATION. PAIN WAS IN THE UPPER PART OF THE ARM AND RADIATING TOWARDS HER BACK.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cough, Death, Dyspnoea, Muscle spasms
Clinical narrative: My mom was very ill with fever like symptoms following her first vaccination on January 26th. The symptoms were even worse after her second vaccination March 2nd and included muscle cramping in her legs. Once she was recovered she only had a persistent cough which she attributed to allergies as the pollen count had been high. In the early morning hours of March 19th she was having difficulty breathing and chest pains. She was rushed to the emergency room where she subsequently died of cardio pulmonary embolism which the coroner indicated began within three weeks of her death.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: My mom was very ill with fever like symptoms following her first vaccination on January 26th. The symptoms were even worse after her second vaccination March 2nd and included muscle cramping in her legs. Once she was recovered she only had a persistent cough which she attributed to allergies as the pollen count had been high. In the early morning hours of March 19th she was having difficulty breathing and chest pains. She was rushed to the emergency room where she subsequently died of cardio pulmonary embolism which the coroner indicated began within three weeks of her death.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Red rash on arm and full body hives
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The day following the 1st dose vaccination, my left arm was sore and the vaccination site was red, tender, swollen for about 3 days total then went away. Approximately 1 week following the 1st dose vaccination, my arm felt sore again and I noticed that the area was red again along with the tenderness and swelling. This lasted for about 2 1/2 days. I  found the description for 'COVID-19 Arm' which is the return of swelling, redness, tenderness and soreness and vaccination site up to a week or more after the initial 1st dose. My primary doctor advised (via email) that I contact her if the redness spread. It did not and went away after 2 1/2 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Discomfort, Feeding disorder, Headache
Clinical narrative: The night of the vaccine I had normal symptoms - chills, discomfort, headache. The next day I vomited. For the 15 (FIFTEEN) days that followed I experienced severe nausea. I was unable to eat almost all solid food. I slept about 18 hours per day solid sleep. Blunt headache all the time. Diarrhea started week 2 and the intense nausea did not subside. It was not until a full 15 days later that the nausea finally subsided and I was able to get out of bed for more than a couple of hours at a time. Finally now April 27th I  feel almost back to my normal self.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Vomiting
Clinical narrative: The night of the vaccine I had normal symptoms - chills, discomfort, headache. The next day I vomited. For the 15 (FIFTEEN) days that followed I experienced severe nausea. I was unable to eat almost all solid food. I slept about 18 hours per day solid sleep. Blunt headache all the time. Diarrhea started week 2 and the intense nausea did not subside. It was not until a full 15 days later that the nausea finally subsided and I was able to get out of bed for more than a couple of hours at a time. Finally now April 27th I  feel almost back to my normal self.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen area where I had the vaccine hot to the touch.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: Client became anxious and unconscious x3 seconds in the observation area after vaccination of Pfizer.  MD assessed client on site and no injuries noted. Client left site with father driving him home via personal vehicle.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Sat 4/24/2021 13:00 - Vaccine received Sun 4/25/2021 00:15 - Chills, intense shivering/shaking; several episodes over the next 2 hours; temp 102F Sun 4/25/2021 daytime - Fatigue, maiaise, sore injection site, chills but no shivering; temp 101F Mon 4/26/2021 all day - Fatigue, malaise, and injection site soreness all somewhat reduced; temp fluctuated between 100.0 and 100.8 Tue 4/27/2021 - Mild fatigue, arm soreness; temp 97.8F ("normal" for me)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Sat 4/24/2021 13:00 - Vaccine received Sun 4/25/2021 00:15 - Chills, intense shivering/shaking; several episodes over the next 2 hours; temp 102F Sun 4/25/2021 daytime - Fatigue, maiaise, sore injection site, chills but no shivering; temp 101F Mon 4/26/2021 all day - Fatigue, malaise, and injection site soreness all somewhat reduced; temp fluctuated between 100.0 and 100.8 Tue 4/27/2021 - Mild fatigue, arm soreness; temp 97.8F ("normal" for me)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 11 days after my second injection, I developed a fever (100.9), intense body aches, chills, and severe fatigue that lasted roughly 36 hours, after which I was completely back to normal with no fever.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Retinal artery occlusion
Clinical narrative: left central retinal artery occlusion
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 15 at the time of administration of the vaccine. Patient's mother intentionally listed his birthday incorrectly on vaccine forms to make it seem the patient was 16 years old. Patient's real birthday is 10/11/2005. Mother listed the birthday on all forms as 10/11/2004. While processing the vaccine, the insurance rejected the claim due to invalid birthday. I contacted the patient's pediatrician's office, who confirmed the birthday as 10/11/2005. I spoke with the mother on 4/26/21, who confirmed that she lied about the patient's birthday so he could get a dose of vaccine. I advised that the vaccine is only approved for 16 and over and we would be unable to administer the 2nd dose of vaccine. I contacted the pediatrician's office on 4/27/21 to inform them of the incident.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus, Vertigo
Clinical narrative: On 4/7/2021 I woke up with tinnitus in my right ear slight deafness which has now improved and vertigo. The tinnitus has gotten louder 1 day after my second shot on 4/22/2021. I have been to the ENT 2x audiologist 2x allergist 1x and today to my primary, going for bloodwork ct of brain  and  carotid ultrasound with in the month. If I had know this was possible I never would have gotten vaccinated.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and headache. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Eye movement disorder, Feeling cold, Hyperhidrosis, Seizure like phenomena
Clinical narrative: THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT  HE HAD. HE STATED HIS CHEST FELT TIGHT.  HIS EYE MAY HAVE ROLLED BACK NOT SURE  AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER  WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER  FOR FURTHER OBSERVATION
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT  HE HAD. HE STATED HIS CHEST FELT TIGHT.  HIS EYE MAY HAVE ROLLED BACK NOT SURE  AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER  WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER  FOR FURTHER OBSERVATION
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Pt had her covid vaccine at a facility she signed up for on-line. Pfizer vaccine given on 4/15/21 and then 2 days later she complained of a wobbly sensation. She feels slightly dizzy when walking. Mom states when she walks she holds onto the wall or sofa. She feels like she can't walk on her own. She is still having this problem.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Injection site paraesthesia
Clinical narrative: Reported sudden "fast heartbeats with mild chest pain" lasted less than 2 mins with tingling of L arm where she received the injection. Stable, released from vaccination site.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: The day I got the vaccine was Day #1 of my period. I am not pregnant and no chance of being pregnant. My period vanished within 24 hours of getting the shot. I am on a pill and continued to take as normal.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: enlarged lymph node in cervical area and neck pain
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Ear congestion, Neurosensory hypoacusis
Clinical narrative: Sudden neurosensory loss in left ear. Feeling of fullness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area has been sore since the shot, which is to be expected,   However, it's been two weeks and now I am getting redness in the area and it feels hot, similar to my cellulitis infections I get in my right arm, but that one has lympedema and my left arm does not and should be fine.  It feels like an infection.  I marked the redness to see if it grows.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Headache, Malaise, Swollen tongue
Clinical narrative: She developed headache a few minutes after Vaccine administration.  After her 15 minutes she left and went to her office. within 15 minutes after being in her office, she reported that she was having chest pain, swollen tongue, and not feeling well.  I checked her throat and she said she has had this kind of reaction in past and doctors have not found out the reason to her reactions.  She said she was told she is showing some symptoms of pre-development of Lupus.  She has not done Allergen's testing for food or environmental factors due to Insurance not paying for it.  Her blood pressure and pulse were taken a few times as follows and she was gradually getting better until 4:13 pm where she felt normal again.  She said her chest felt better, fogginess was almost gone, her throat felt normal, and her headache was less.   3:44 pm, Blood pressure:  157/97, Pulse 82. 3:47 pm, Blood pressure:  149/92, Pulse 78 4:00 pm, 150/104, Pulse 73  (she was talking to me while her blood pressure being taken) 4:05 pm, 149/96, Pulse 71; 4:13 pm:  150/95,  Pulse 72  She felt okay at the last vitals being taken and I asked her to call us again if her symptoms get worse.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye irritation, Feeling cold, Hyperhidrosis, Lethargy
Clinical narrative: Muscle and joint aches all over, mild headache, lethargy, red and burning eyes, fever of 100.4, could not get warm (especially hands and feet), trouble falling asleep. Took 400mg IBU and went to bed. At ~2:00 AM on 03/17/2021, woke up sweating profusely. Got a drink of water, went back to sleep, woke up at ~6:00 AM with all symptoms resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular hyperaemia, Peripheral coldness, Pyrexia, Sleep disorder
Clinical narrative: Muscle and joint aches all over, mild headache, lethargy, red and burning eyes, fever of 100.4, could not get warm (especially hands and feet), trouble falling asleep. Took 400mg IBU and went to bed. At ~2:00 AM on 03/17/2021, woke up sweating profusely. Got a drink of water, went back to sleep, woke up at ~6:00 AM with all symptoms resolved.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased immune responsiveness, Pyrexia
Clinical narrative: VERY LOW IMMUNITY; FEVER; This spontaneous report received from a parent via a company representative concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced very low immunity, and fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and very low immunity was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Persistent pain in my right  calf getting my prominent.  Wondering if its a blood clot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual cycle started 2 days after the shot, which was about 5 days early for my usual cycle. Menstrual cycle lasted about 4 or 5 days longer than usual.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Injection site erythema
Clinical narrative: Injection site deltoid muscle left arm, within 3 hours of the shot, red, hot, swollen, painful. Next day after shot, chills for 24 hour period, with fatigue. Second day after shot, fever for 24 hour period. Third day after shot, numbness in left jaw, started on 4/12/2021, lasted 2 weeks. Left corner of mouth exterior, muscle twitching on 4/12/2020 for 24 hour period. Numbness spread from jaw joint on left side along mandible reaching to front teeth and numbness in left side of lower lip. Left side of lower lip is still numb.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscle twitching, X-ray normal
Clinical narrative: Injection site deltoid muscle left arm, within 3 hours of the shot, red, hot, swollen, painful. Next day after shot, chills for 24 hour period, with fatigue. Second day after shot, fever for 24 hour period. Third day after shot, numbness in left jaw, started on 4/12/2021, lasted 2 weeks. Left corner of mouth exterior, muscle twitching on 4/12/2020 for 24 hour period. Numbness spread from jaw joint on left side along mandible reaching to front teeth and numbness in left side of lower lip. Left side of lower lip is still numb.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I've had tinnitus in both ears about 1-hour after my first dose of Moderna.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Heart rate increased, Injection site swelling
Clinical narrative: Rapid heartbeat,  fatigue,  slight headache,  slight swelling in shot area, fever,  heaviness on chest  Took extra strength Tylenol
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rapid heartbeat,  fatigue,  slight headache,  slight swelling in shot area, fever,  heaviness on chest  Took extra strength Tylenol
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: Patient became hot and sweaty immediately and felt dizzy. The patient was given a glucose tablet has he said he had not eaten for the day yet. He felt slightly better and upon arriving home the patient had troubles breathing and explained it as a panic attack without actually having any anxiety. The patient consulted with a physician at a local clinic and was instructed to go to the emergency room. I have not had contact with the patient since arriving at the emergency room.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: STOMACH PAIN; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced stomach pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and stomach pain was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Contusion, Eye pain, Haemorrhage
Clinical narrative: Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body.  Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Magnetic resonance imaging normal, Migraine
Clinical narrative: Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body.  Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body.  Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: During 15 wait, after inoculation, I noticed some muffled hearing in my left ear, that I wrote off to head congestion.   Later that evening, I noticed the effect was sustained.  Woke up the next morning, 4/27, with some ringing in my left ear, and muffled hearing.  Worked on computer all day with no improvement, and no noticeable change.  Decided to report what may be a side effect. About 5 years ago, I had Ramsay Hunt Syndrome, with left side of face paralyzed, and very painful aural nerve attack in left ear, and loss of sense of sweet taste.  After about 8 weeks I had recovered 90%, or more.   No problems since then, as my sweet taste slowly returned.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine on 04/23 then began having complications on the morning  of 04/24 which included: body aches, fever, fatigue, runny nose, cough, soreness in elbows and wrists(left arm being worse), much limited range of motion in left arm, and pain and swelling at the site of injection.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient received vaccine on 04/23 then began having complications on the morning  of 04/24 which included: body aches, fever, fatigue, runny nose, cough, soreness in elbows and wrists(left arm being worse), much limited range of motion in left arm, and pain and swelling at the site of injection.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna given to patient in error - should have received Pfizer according to current CDC recommendations
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red splotches around injection site. Not a bumpy rash. Slight itching. About a 2 1/2 to 3 inch area. Moderna COVID?19 Vaccine EUA
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy uterus normal, Blood test normal, Heavy menstrual bleeding, Smear cervix normal, Ultrasound scan normal
Clinical narrative: I received both my pfizer vaccines at clinic.  I got my first 1/6/21 and second 1/29/21.  On February 15, 2021 I started extremely heavy menstrual bleeding that lasted 6 weeks.  I was evaluated by my regular doctor and all other causes were ruled out (had uterine biopsy and pap done along with an ultrasound).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Pruritus, Pyrexia, Rash
Clinical narrative: PT STATED HE HAD A MILD FEVER AND SOMEMILD FLU IKE SYMPTOMS THE FIRST 24 HIURS AND PAIN AT  IJECTION SITE THE WAS FINE, BUT AWOKE TODAY (THREE DAYS LATER) AND WAS ITCHY ALL OVER HIS BIDY AND WAS STARTING TO GET RASH.  HE STATED HE HAS NOT TRIED ANY NEW FOODS, DETERGENTS, CLOTHES, SKIN PRODUCTS OR BEEN OUTSIDE IN ALLERGENS.  PT BOUGHT BENADRYL AND CORTISONE CREAM AND WAS ADVISED TO SEE MD ESPECIALLY IF GOT ANY WORSE.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear discomfort, Tinnitus
Clinical narrative: 1st dose: 3/4/2021: a few days after ringing in both ears 2nd dose: 4/1/2021: a few days after ringing got much louder and is still present today.   Ringing in right ear more pronounced as well as occasional popping noise and the feeling of both ears being clogged or needing to be pressurized.   Second dose was Lot# EW0150