chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: Developed wheezing, shortness of breath, hives starting a little over 30 minutes after vaccination and progressing to severe enough illness pt took her epipen and quickly get better, also took benadryl before vaccine.  Within an hour after using her epinephrine, she felt back to normal.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: As soon as I got the shot my left hand started to tingle and I was light headed. About 30 minutes later my throat started to it. 2 hours later my head started to hurt and my neck started to hurt.  Had trouble sleeping that night. The next day my throat hurt very bad 5 on the wong backer scale. All over body aches pain at about 5. My 3pm on april 15 I had 100.7 fever, body aches of about a 7. And developed a cold sore on my nose, Very tired: this lasted until April 16th had a phone call visit from the Covid clinic.  Throat hurt for 5 days, trouble sleeping continues cough started on day 4. Throat started to feel better. Thick mucus. I have not felt good since getting the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Increased viscosity of upper respiratory secretion, Insomnia, Oral herpes
Clinical narrative: As soon as I got the shot my left hand started to tingle and I was light headed. About 30 minutes later my throat started to it. 2 hours later my head started to hurt and my neck started to hurt.  Had trouble sleeping that night. The next day my throat hurt very bad 5 on the wong backer scale. All over body aches pain at about 5. My 3pm on april 15 I had 100.7 fever, body aches of about a 7. And developed a cold sore on my nose, Very tired: this lasted until April 16th had a phone call visit from the Covid clinic.  Throat hurt for 5 days, trouble sleeping continues cough started on day 4. Throat started to feel better. Thick mucus. I have not felt good since getting the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: As soon as I got the shot my left hand started to tingle and I was light headed. About 30 minutes later my throat started to it. 2 hours later my head started to hurt and my neck started to hurt.  Had trouble sleeping that night. The next day my throat hurt very bad 5 on the wong backer scale. All over body aches pain at about 5. My 3pm on april 15 I had 100.7 fever, body aches of about a 7. And developed a cold sore on my nose, Very tired: this lasted until April 16th had a phone call visit from the Covid clinic.  Throat hurt for 5 days, trouble sleeping continues cough started on day 4. Throat started to feel better. Thick mucus. I have not felt good since getting the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: As soon as I got the shot my left hand started to tingle and I was light headed. About 30 minutes later my throat started to it. 2 hours later my head started to hurt and my neck started to hurt.  Had trouble sleeping that night. The next day my throat hurt very bad 5 on the wong backer scale. All over body aches pain at about 5. My 3pm on april 15 I had 100.7 fever, body aches of about a 7. And developed a cold sore on my nose, Very tired: this lasted until April 16th had a phone call visit from the Covid clinic.  Throat hurt for 5 days, trouble sleeping continues cough started on day 4. Throat started to feel better. Thick mucus. I have not felt good since getting the vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: moderate to severe axillary pain in vaccinated arm. Lasted for 3 days then diminished by 5th day.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Sick relative
Clinical narrative: Attention please investigate my wife recieved the Pfizer Covid 19 vaccine and I got sick after she recieved the vaccine so did my little son who is 7 yrs old. We both have huge headaches and my wife who received both doses showed signs if being sick from the vaccine. Is there currently any trials to determine if people who get the vaccine can transmit the attenuated virus? I believe that the Pfizer vaccine got me and my son sick after my wife got the 2nd shot. Please investigate and stop this vaccine before it causes more transmission of the virus.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, resness, soreness on vaccine site
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Back pain, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up,  above, back, and neutral) very uncomfortable and painful. Pressing on the bump causes a dripping feeling under the skin near the left breast. Have a doctor's appointment coming up.   Lie bump (tonight ulcer), painful  Severe back pain (had to visit spine specialist), need further testing
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin ulcer, Ultrasound scan, X-ray
Clinical narrative: Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up,  above, back, and neutral) very uncomfortable and painful. Pressing on the bump causes a dripping feeling under the skin near the left breast. Have a doctor's appointment coming up.   Lie bump (tonight ulcer), painful  Severe back pain (had to visit spine specialist), need further testing
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: Began feeling dizzy almost 15 minutes after the injection. Gradually also felt nauseous and foggy.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Three (so far) episodes of VERY severe nosebleeds lasting up to 30 minutes. Not normal for me.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Pain in jaw, Tinnitus
Clinical narrative: had Covid in Jan, left ear jaw pain, slight tinnitus, tinnitus now significantly worse in both ears
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Wheezing
Clinical narrative: shortness of breath and wheezing, headache, chest tightness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Initially after the shot I just had a sore arm. Then Monday I started having fever and fatigue
Sex: M
Vaccine: PPV
Symptoms: Therapy non-responder
Clinical narrative: The IgG serology showed no titer response following a pneumococcal vaccination; This literature marketed report as received from the authors of a published literature article, titled as stated above, refers to a 49-year-old male patient with past medical history significant for mixed connective tissue disease, rheumatoid arthritis, and systemic lupus erythematosus.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumococcal vaccine) injection (dose, route of administration, anatomical location, lot # and expiry date were nor specified) for prophylaxis.  The patient's rheumatological symptoms were controlled by a combination of methotrexate weekly and rituximab every six months since 2008. However, the prolonged course of rituximab resulted in chronic pansinusitis which led to a diagnosis of acquired humoral deficiency. In 2017, the patient was referred by an otolaryngologist for an immunological evaluation because his chronic pansinusitis did not resolve with septoplasty and bilateral sinus surgery followed by several rounds of clarithromycin. His laboratory results revealed poor humoral function as demonstrated by peripheral lymphopenia with zero absolute CD19 count with an absence of IgA (<5 mg/dL) and IgM (<5 mg/dL), but a normal level of IgG (739 mg/dL). The IgG serology showed no titer response following a pneumococcal vaccination. His IgG subclass 1 was 599 mg/dL (normal), IgG subclass 2 89 mg/dL (low), IgG subclass 3 was 34 mg/dL (normal) and IgG subclass 4 was 13 mg/dL (normal).  The outcome of the event was not reported. The author considered the event to be related to the pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Computerised tomogram normal, Depression, Stress
Clinical narrative: Anxiety; depression; He has been under a lot of stress; This spontaneous report was received from a registered nurse concerning to her son-in-law, a 34-year-old male patient.   The reporter did not provide information on the patient's pertinent medical history, drug reactions, or allergies, nor concomitant therapies included.  Reporter stated that on unspecified date of March 2021(also reported as "one month ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (formulation, concentration, scheme and route of administration, lot numbers, and expiration dates were not reported).   Since that date the patient started experiencing anxiety and depression. Because of this he sought medical attention from a therapist and a psychiatrist. This also cause the patient to attend to an ER twice. He would have a follow up visit with a neurologist. Treatment involves finding the best medications to stabilize. It was also reported that he had been a lot of stress during COVID including being furloughed from his job and starting graduate school. Test included a Computerized tomogram (CAT) scan which result was reported as negative.  The patient's outcome of depression and anxiety was not recovered and the stress was unknown. The reporter did not provide a causal assessment between therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and anxiety, depression and stress.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE experiences reported by the patient; A patient had first injection 10/2016; second injection 02/2017 and is asking if she can get the third now, or doses she have to start all over with injection #1.; the reporter was unsure of which "Gardasil product" the patient received; the reporter was unsure of which "Gardasil product" the patient received; This spontaneous report was received from a physician and refers to a 26-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On an unspecified date in October 2016, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (reported as the reporter was unsure of which "Gardasil product" the patient received) (for both lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. On an unspecified date in February 2017, she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (for both lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. The patient was asking if she can get the third dose now with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), or it has to be start all over with the first injection. No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other information given at this time.; Medical assistant calls to report a temperature excursion/ The product were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 14-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other information given at this time.; Medical assistant calls to report a temperature excursion/ The product were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 18-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot /nowhave shingles / once there is an outbreak, it never goes away/suspected vaccination failure; got the shot /nowhave shingles / once there is an outbreak, it never goes away.; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient never had the shingles shot. The physician convinced patient to get the one and never had shingles before the shot. The patient got the shot and now had shingles. Once there was an outbreak, it never goes away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The information regarding consent to follow up was not reported. No further information available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: have shoulder and arm pain; have shoulder and arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced shoulder pain and pain in arm. On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had second shingles shot a few weeks ago from the day of reporting and now he/she had shoulder and arm pain that won't stop. The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION WORSE; COULDN'T SLEEP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced suspected covid-19 infection worse. On MAR-2021, the subject experienced couldn't sleep. Laboratory data included: Body temperature (NR: not provided) 99.6 F, 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't sleep and suspected covid-19 infection worse was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: SWOLLEN UPPER LIP; SLIGHTLY NUMB UPPER LIP; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced swollen upper lip. On 08-MAR-2021, the subject experienced slightly numb upper lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly numb upper lip on 08-MAR-2021, and was recovering from swollen upper lip. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Body temperature, Chills, Malaise
Clinical narrative: FEVER; LOWER BACK ACHE; FEELING UNWELL; CHILLS; ABDOMINAL PAIN RADIATING TO BACK; BODY ACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:00:00 for prevention of covid-19. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced abdominal pain radiating to back. Treatment medications included: paracetamol. On 08-MAR-2021, the subject experienced lower back ache. On 08-MAR-2021, the subject experienced feeling unwell. On 08-MAR-2021, the subject experienced chills. On 09-MAR-2021 02:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, lower back ache, and feeling unwell, and had not recovered from chills, body ache, and abdominal pain radiating to back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; LOWER BACK ACHE; FEELING UNWELL; CHILLS; ABDOMINAL PAIN RADIATING TO BACK; BODY ACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:00:00 for prevention of covid-19. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced abdominal pain radiating to back. Treatment medications included: paracetamol. On 08-MAR-2021, the subject experienced lower back ache. On 08-MAR-2021, the subject experienced feeling unwell. On 08-MAR-2021, the subject experienced chills. On 09-MAR-2021 02:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, lower back ache, and feeling unwell, and had not recovered from chills, body ache, and abdominal pain radiating to back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: CHILLS FOR 4 HOURS; NOT FEELING WELL; FEVER OF 102 F; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed along with additional information received on 10-MAR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular,  and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 10-MAR-2021, the subject experienced fever of 102 F. On 10-MAR-2021, the subject experienced chills for 4 hours. On 10-MAR-2021, the subject experienced not feeling well. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 102 F, and chills for 4 hours, and the outcome of not feeling well was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling hot, Malaise, Memory impairment
Clinical narrative: PRESSURE ON CHEST; FORGETFUL; FEELING HEAT GOING THROUGH BODY; THROAT BEGAN TO CLOSE; DIZZINESS; TINGLING SENSATION; THROAT HURTS; FEVER; NOT FEELING WELL; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 122 pounds, and height was 161 centimeters. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no drug abuse/illicit drug use. 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 12-MAR-2021 14:55 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling well. On 12-MAR-2021, the subject experienced tingling sensation. On 12-MAR-2021, the subject experienced throat hurts. On 12-MAR-2021, the subject experienced feeling heat going through body. On 12-MAR-2021, the subject experienced throat began to close. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced pressure on chest, and forgetful. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure on chest, forgetful, and dizziness on 15-MAR-2021, and feeling heat going through body, throat began to close, and fever, had not recovered from tingling sensation, and throat hurts, and the outcome of not feeling well was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia, Pyrexia, Throat tightness
Clinical narrative: PRESSURE ON CHEST; FORGETFUL; FEELING HEAT GOING THROUGH BODY; THROAT BEGAN TO CLOSE; DIZZINESS; TINGLING SENSATION; THROAT HURTS; FEVER; NOT FEELING WELL; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 122 pounds, and height was 161 centimeters. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no drug abuse/illicit drug use. 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 12-MAR-2021 14:55 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling well. On 12-MAR-2021, the subject experienced tingling sensation. On 12-MAR-2021, the subject experienced throat hurts. On 12-MAR-2021, the subject experienced feeling heat going through body. On 12-MAR-2021, the subject experienced throat began to close. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced pressure on chest, and forgetful. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure on chest, forgetful, and dizziness on 15-MAR-2021, and feeling heat going through body, throat began to close, and fever, had not recovered from tingling sensation, and throat hurts, and the outcome of not feeling well was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, Blood test, Cholecystectomy
Clinical narrative: FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diverticulitis, Echocardiogram, Nausea
Clinical narrative: FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Myalgia, Nausea, Pain
Clinical narrative: BODY ACHES; TEMPERATURE; CHILLS; NAUSEA; MUSCLE ACHE; This spontaneous report received from a patient concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, cholestrol, alcoholic, and non smoker, and other pre-existing medical conditions included no history of drug abuse, no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and  expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included atorvastatin non-company for cholesterol, lisinopril for high blood pressure, metoprolol for high blood pressure, minerals nos/vitamins nos for multivitamin, and ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide for vitamin supplement.  On MAR-2021, the subject experienced muscle ache. On 16-MAR-2021, the subject experienced temperature. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature, nausea, and muscle ache on MAR-2021, and chills on 17-MAR-2021, and was recovering from body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Headache, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: RAPID HEART RATE; SOME UNWANTED PALPITATION; FELT TINGLING ALL OVER THE FACE; STRONG MEDICINAL TASTE COMES IN MOUTH; SNEEZING OCCASIONALLY; EARS ITCHING; EAR RINGING; EYES WERE TWITCHING SOME; MUSCLE AND JOINT ACHES; HAD LOTS OF POST NASAL DRIP; TENDER ARM; ALLERGIC REACTION; OCCASIONAL HEADACHE; LEG CRAMPS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included seasonal hay fever, non alcoholic, and non smoker, and other pre-existing medical conditions included patient has no known drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg cramps. On MAR-2021, the subject experienced occasional headache. On 03-MAR-2021, Laboratory data included: Heart rate (NR: not provided) Above 100, and Oxygen saturation (NR: not provided) Normal. On an unspecified date, the subject experienced rapid heart rate, some unwanted palpitation, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, muscle and joint aches, had lots of post nasal drip, tender arm, and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, and occasional headache, and the outcome of allergic reaction, muscle and joint aches, tender arm, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, rapid heart rate, some unwanted palpitation and had lots of post nasal drip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal pain, Oxygen saturation, Pain in extremity, Palpitations
Clinical narrative: RAPID HEART RATE; SOME UNWANTED PALPITATION; FELT TINGLING ALL OVER THE FACE; STRONG MEDICINAL TASTE COMES IN MOUTH; SNEEZING OCCASIONALLY; EARS ITCHING; EAR RINGING; EYES WERE TWITCHING SOME; MUSCLE AND JOINT ACHES; HAD LOTS OF POST NASAL DRIP; TENDER ARM; ALLERGIC REACTION; OCCASIONAL HEADACHE; LEG CRAMPS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included seasonal hay fever, non alcoholic, and non smoker, and other pre-existing medical conditions included patient has no known drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg cramps. On MAR-2021, the subject experienced occasional headache. On 03-MAR-2021, Laboratory data included: Heart rate (NR: not provided) Above 100, and Oxygen saturation (NR: not provided) Normal. On an unspecified date, the subject experienced rapid heart rate, some unwanted palpitation, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, muscle and joint aches, had lots of post nasal drip, tender arm, and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, and occasional headache, and the outcome of allergic reaction, muscle and joint aches, tender arm, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, rapid heart rate, some unwanted palpitation and had lots of post nasal drip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Sneezing, Taste disorder, Tinnitus
Clinical narrative: RAPID HEART RATE; SOME UNWANTED PALPITATION; FELT TINGLING ALL OVER THE FACE; STRONG MEDICINAL TASTE COMES IN MOUTH; SNEEZING OCCASIONALLY; EARS ITCHING; EAR RINGING; EYES WERE TWITCHING SOME; MUSCLE AND JOINT ACHES; HAD LOTS OF POST NASAL DRIP; TENDER ARM; ALLERGIC REACTION; OCCASIONAL HEADACHE; LEG CRAMPS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included seasonal hay fever, non alcoholic, and non smoker, and other pre-existing medical conditions included patient has no known drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg cramps. On MAR-2021, the subject experienced occasional headache. On 03-MAR-2021, Laboratory data included: Heart rate (NR: not provided) Above 100, and Oxygen saturation (NR: not provided) Normal. On an unspecified date, the subject experienced rapid heart rate, some unwanted palpitation, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, muscle and joint aches, had lots of post nasal drip, tender arm, and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, and occasional headache, and the outcome of allergic reaction, muscle and joint aches, tender arm, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, rapid heart rate, some unwanted palpitation and had lots of post nasal drip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: RAPID HEART RATE; SOME UNWANTED PALPITATION; FELT TINGLING ALL OVER THE FACE; STRONG MEDICINAL TASTE COMES IN MOUTH; SNEEZING OCCASIONALLY; EARS ITCHING; EAR RINGING; EYES WERE TWITCHING SOME; MUSCLE AND JOINT ACHES; HAD LOTS OF POST NASAL DRIP; TENDER ARM; ALLERGIC REACTION; OCCASIONAL HEADACHE; LEG CRAMPS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included seasonal hay fever, non alcoholic, and non smoker, and other pre-existing medical conditions included patient has no known drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg cramps. On MAR-2021, the subject experienced occasional headache. On 03-MAR-2021, Laboratory data included: Heart rate (NR: not provided) Above 100, and Oxygen saturation (NR: not provided) Normal. On an unspecified date, the subject experienced rapid heart rate, some unwanted palpitation, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, muscle and joint aches, had lots of post nasal drip, tender arm, and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, and occasional headache, and the outcome of allergic reaction, muscle and joint aches, tender arm, felt tingling all over the face, strong medicinal taste comes in mouth, sneezing occasionally, ears itching, ear ringing, eyes were twitching some, rapid heart rate, some unwanted palpitation and had lots of post nasal drip was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Initial insomnia
Clinical narrative: ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING  HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Nausea, Nervousness, Oral pruritus, Pain in jaw
Clinical narrative: ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING  HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.