chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Syncope, Throat clearing, Throat tightness
Clinical narrative: A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently.  Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Ear discomfort, Electric shock, Musculoskeletal discomfort
Clinical narrative: A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently.  Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Presyncope, Throat irritation
Clinical narrative: A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently.  Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Nasopharyngitis, Pain
Clinical narrative: Hour long  bad Nose bleeds. I haven?t had a nose bleed since I was a kid. I?ve now had 3 since I got the 2nd dose of COVID vaccine only 3 days ago. I also had the typical cold chills and body ache for 24hours but that wasn?t too bad. I don?t know if these nose bleeds are related but thought I should report it Incase others are having the same problems because they are scary. Almost went to the ER because it wouldn?t stop.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Full blood count, Metabolic function test, Migraine, Tension headache
Clinical narrative: Severe migraine/intractable tension headache lasting over 7 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Neck pain, Pyrexia, Syncope
Clinical narrative: PT PRESENTED TO OUR OFFICE WITH SWELLING IN NECK ON RIGHT SIDE WHERE 2ND DOSE OF MODERNA VACCINE WAS GIVEN.  COMPLAINING OF DIZZINESS, HEADACHE, NAUSEA, FEVER AND SYNCOPE.  PT HAD NOTICEABLE SWELLING IN THE NECK BUT WAS NOT HAVING PROBLEMS COMMUNICATING AND VITALS WERE STABLE.  EMERGENCY SERVICES WAS CONTACTED FOR IMMEDIATE TRANSPORT TO LOCAL EMERGENCY DEPARTMENT.  WHILE DISCUSSING SYMPTOMS WITH PROVIDER, EMS ARRIVED AND PT WAS TRANSPORTED.  NO MEDICATION WAS ADMINISTERED IN OUR OFFICE.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coagulation test normal, Contusion, Epistaxis, Fibrin D dimer normal, Full blood count normal
Clinical narrative: Noticed spontaneous small bruises times 4 , seven -14 days after first dose. All blood work, including CBC, platelet count, D-Dimer, Fibrinogen, Coags normal. Took second dose 4/22/21. Noticed mild nose bleed on cleaning nose after suptaritpan nasal spray for migraine on 4/24/21. No bruises.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal
Clinical narrative: Noticed spontaneous small bruises times 4 , seven -14 days after first dose. All blood work, including CBC, platelet count, D-Dimer, Fibrinogen, Coags normal. Took second dose 4/22/21. Noticed mild nose bleed on cleaning nose after suptaritpan nasal spray for migraine on 4/24/21. No bruises.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: FEVER; WEAKNESS; DIZZINESS; DIFFICULTY BREATHING; VOMITING; HEART RATE INCREASED; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included renal insufficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm at approx 13:45 -14:15. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced heart rate increased. On 15-MAR-2021 04:30, the subject experienced dizziness. On 15-MAR-2021 04:30, the subject experienced weakness. On 15-MAR-2021 04:30, the subject experienced difficulty breathing. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness, weakness, difficulty breathing, vomiting, and heart rate increased. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER; WEAKNESS; DIZZINESS; DIFFICULTY BREATHING; VOMITING; HEART RATE INCREASED; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included renal insufficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm at approx 13:45 -14:15. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced heart rate increased. On 15-MAR-2021 04:30, the subject experienced dizziness. On 15-MAR-2021 04:30, the subject experienced weakness. On 15-MAR-2021 04:30, the subject experienced difficulty breathing. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness, weakness, difficulty breathing, vomiting, and heart rate increased. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram abdomen abnormal, Condition aggravated, Hepatic vein thrombosis, Liver disorder
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Transient ischaemic attack
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Blood test normal, Budd-Chiari syndrome, Chest pain
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Decreased appetite, Dizziness, Dyspnoea, Full blood count normal
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hemiplegic migraine, Lethargy, Lipids normal, Nausea
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Rash, Skin warm, Troponin normal
Clinical narrative: CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, no treatment or outcome as of yet
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus, no treatment or outcome as of yet
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain/cramping that went to a 7 in intensity mid-day on April 17 and eventually weened down to a 3. On April 18 the pain remained around a 2-3. On April 19 there was no pain. On April 23 there was mild pain again that went up to a 5. On April 24 the pain ranged from 2-4.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 101 fever, body aches, headache, fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: "Moderna COVID-19 Vaccine EUA" - Chills and nausea beginning at 4:30 am (12.5 hrs after vaccine); nausea dissipated about 7:30 am; chills remained until about 11:00 pm; also had dizziness for about 3 hours beginning at 8:00 am (fainted in the shower);  felt tired and weak the entire day following the vaccine; only treatment was taking it easy & resting throughout the day
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: "Moderna COVID-19 Vaccine EUA" - Chills and nausea beginning at 4:30 am (12.5 hrs after vaccine); nausea dissipated about 7:30 am; chills remained until about 11:00 pm; also had dizziness for about 3 hours beginning at 8:00 am (fainted in the shower);  felt tired and weak the entire day following the vaccine; only treatment was taking it easy & resting throughout the day
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Mild diarrhea began about 1 hour after receiving shot and lasted about 24 hours. About 24 hours after receiving shot, fatigue, muscle soreness, headache began and lasted for 3 days.  Fatigue persisted for 10 days post-shot.  Approximately 8 days after receiving shot, until present, lost sense of smell.  Sense of smell is still about 90% gone.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, hard lump, warm to touch
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope; patient was given water and was okay after.  she fainted in her chair. not hurt, no damage.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Heart rate increased, Injection site erythema
Clinical narrative: MUSCLE ACHE; TIREDNESS; GENERALIZED SWELLING ALL OVER HIS BODY; DIZZINESS; COLD SWEAT; RAPID HEART BEAT; INJECTION SITE REDNESS (UPPER LEFT ARM); HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included similar allergic reaction to tetanus shot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 16-MAR-2021 at upper left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced generalized swelling all over his body. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced cold sweat. On 16-MAR-2021, the subject experienced rapid heart beat. On 16-MAR-2021, the subject experienced injection site redness (upper left arm). On 16-MAR-2021, the subject experienced hives. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced tiredness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized swelling all over his body, dizziness, cold sweat, rapid heart beat, injection site redness (upper left arm), and hives on 16-MAR-2021, and had not recovered from muscle ache, and tiredness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Swelling, Urticaria
Clinical narrative: MUSCLE ACHE; TIREDNESS; GENERALIZED SWELLING ALL OVER HIS BODY; DIZZINESS; COLD SWEAT; RAPID HEART BEAT; INJECTION SITE REDNESS (UPPER LEFT ARM); HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included similar allergic reaction to tetanus shot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 16-MAR-2021 at upper left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced generalized swelling all over his body. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced cold sweat. On 16-MAR-2021, the subject experienced rapid heart beat. On 16-MAR-2021, the subject experienced injection site redness (upper left arm). On 16-MAR-2021, the subject experienced hives. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced tiredness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized swelling all over his body, dizziness, cold sweat, rapid heart beat, injection site redness (upper left arm), and hives on 16-MAR-2021, and had not recovered from muscle ache, and tiredness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Swelling, Urticaria
Clinical narrative: Swelling, redness and itchyness at injection site. Similar to a large mosquito bite welt.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness
Clinical narrative: Patient was approximately 5 mins post-vaccination seated in car when husband requested for assistance for her stating that she appeared to be passing out in car. RN assessment on arrival, patient was in lying in reclined position in car but was able to independently sit upright and A&O x 3. Denied complaints of dizziness or other issues other than feeling tired. P Vitals: Temp 97.5 HR 64 RR 16 BP 118/63. Patient was given oral fluids with gatorade and water and symptoms resolved .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear pain, Fatigue, Headache, Hypoacusis
Clinical narrative: On or about the fourth day after the vaccine, I experienced what I would describe as "cranial" pain. It occurred only in two particular areas of my cranium. The pain was severe, but localized. It lasted for about 48 hrs. on and off. I was very tired and sleepy for most of the week following the injection. Sleeping seemed to help my cranial pain, somewhat. Then, on or about the 10th day after the vaccine, I developed congestion in my right Eustachian tube, causing my hearing to be compromised in the right ear. On about the 12th day, I developed a mechanical-type hissing noise that is bothersome, particularly at night; I believe it to be tinnitus.  As of today, 18 days post 1st. vacc, cranial pain has disappeared, but I'm still experiencing pain in and around the inner ear/eustachian tube of my right ear. Plus, I continue to have persistent, low-level tinnitus most of the day. The hearing on the right ear is not what it was before the Pfizer vaccine. I certainly hope  neither the tinnitus, nor the hearing loss is permanent.  I'm really wondering if it's contra indicated for me to get the second vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: On or about the fourth day after the vaccine, I experienced what I would describe as "cranial" pain. It occurred only in two particular areas of my cranium. The pain was severe, but localized. It lasted for about 48 hrs. on and off. I was very tired and sleepy for most of the week following the injection. Sleeping seemed to help my cranial pain, somewhat. Then, on or about the 10th day after the vaccine, I developed congestion in my right Eustachian tube, causing my hearing to be compromised in the right ear. On about the 12th day, I developed a mechanical-type hissing noise that is bothersome, particularly at night; I believe it to be tinnitus.  As of today, 18 days post 1st. vacc, cranial pain has disappeared, but I'm still experiencing pain in and around the inner ear/eustachian tube of my right ear. Plus, I continue to have persistent, low-level tinnitus most of the day. The hearing on the right ear is not what it was before the Pfizer vaccine. I certainly hope  neither the tinnitus, nor the hearing loss is permanent.  I'm really wondering if it's contra indicated for me to get the second vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Urine output decreased, Vomiting
Clinical narrative: Spoke with the patient noting emesis starting 12 hours after the injections. Noting 13 episodes between today and yesterday. She is not able to keep any fluids down. Noting she urinated yesterday afternoon and then the next time was 7PM tonight. Noting she is very weak and sleeping most of the day along with feeling dizzy.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chest pain, Computerised tomogram thorax abnormal, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Patient received the Moderna shot on Tuesday (4/20/21), then had nausea and chest pain on Wednesday evening. Chest pain came and went with help of Motrin. Friday morning at 6 am, she had extreme chest pain that prompted an ER visit. They diagnosed her with pericarditis.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pericarditis, Troponin I increased
Clinical narrative: Patient received the Moderna shot on Tuesday (4/20/21), then had nausea and chest pain on Wednesday evening. Chest pain came and went with help of Motrin. Friday morning at 6 am, she had extreme chest pain that prompted an ER visit. They diagnosed her with pericarditis.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Patient received the Moderna shot on Tuesday (4/20/21), then had nausea and chest pain on Wednesday evening. Chest pain came and went with help of Motrin. Friday morning at 6 am, she had extreme chest pain that prompted an ER visit. They diagnosed her with pericarditis.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus right ear.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain, Pain of skin, Pyrexia
Clinical narrative: Fever, aches, painful skin sensitivity to touch
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; FATIGUE; 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-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on MAR-2021. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness in left lower arm and hand - lasted 7 days after injection.  Severe muscle pain in lower left leg on day 6 after injection, severe muscle pain in right leg day 7-8 after injection. Tingling and numbness in legs. Sharp pains in right arm and continued leg pain day 8. Overall body pain and sharp pains continued 7 days post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Numbness in left lower arm and hand - lasted 7 days after injection.  Severe muscle pain in lower left leg on day 6 after injection, severe muscle pain in right leg day 7-8 after injection. Tingling and numbness in legs. Sharp pains in right arm and continued leg pain day 8. Overall body pain and sharp pains continued 7 days post vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Inflammation, Injection site pain
Clinical narrative: 1 hr post injection - mild fever, chills, fatigue. area of injection felt sore for approximately 3-4 days. 6days post injection - around site of injection, skin became red, inflamed/swollen, warm and tender, very itchy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin warm, Tenderness
Clinical narrative: 1 hr post injection - mild fever, chills, fatigue. area of injection felt sore for approximately 3-4 days. 6days post injection - around site of injection, skin became red, inflamed/swollen, warm and tender, very itchy.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient came in with diffuse urticaria and some difficulty breathing which resolved after a few hours spontaneously
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: At approximately 10 minutes post-vaccination, pateint reported to wife in car that he felt faint and nauseated, At arrival of RN, patient was near-syncope vocalizing nausea and not feeling well. Per wife, 'this always happens."   Symptoms self-resolved after approximately 1 min of nursing supervision and assessment.  Vitals: Temp 98.1 HR 70, RR 18 BP 112/58
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Body temperature increased, Erythema, Muscular weakness, Pain
Clinical narrative: Tenderness of entire upper arm, arm fatigue. Body Fever over 101 onset 24 hours after vaccine checked via ear, area larger then adult palm that is red, swollen, painful and 2 degrees hotter then rest of body temp.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: Tenderness of entire upper arm, arm fatigue. Body Fever over 101 onset 24 hours after vaccine checked via ear, area larger then adult palm that is red, swollen, painful and 2 degrees hotter then rest of body temp.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Tremor
Clinical narrative: SHAKING; FEELING VERY COLD; 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: Unk) dose was not reported, administered on 18-MAR-2021 14:00 on left arm for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shaking. On 18-MAR-2021, the subject experienced feeling very cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, and the outcome of feeling very cold was not reported. This report was non-serious.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Received Moderna COVID vaccine 2nd dose to left deltoid at 10:00 am.  Approx 5mis later she stated she was feeling light headed, dizzy and sweating.  Also stated she felt nauseated and might throw up.  She remained in the facilty for and additional 30 mins with the nurse.  Stated her symptoms seemed to be improving but she still felt nauseated.  Encourage to eat some peanut butter crackers.  This made her nausea subside.  Her husband came to drive her home.  She stated she felt well enough to drive home with him following in his car.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chills, Ear pain, Hot flush, Insomnia, Nasopharyngitis
Clinical narrative: GOT CHILL; UNABLE TO SLEEP; SORE HEAD; RIGHT EAR ACHE; SHAKING; HOT FLASHES; COLD; 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, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for head sore, right ear ache, and shaking. No concomitant medications were reported. On 2021, the subject experienced got chill. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced sore head. On 2021, the subject experienced right ear ache. On 2021, the subject experienced shaking. On 2021, the subject experienced hot flashes. On 2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got chill, and cold on 2021, had not recovered from sore head, and hot flashes, and the outcome of unable to sleep, right ear ache and shaking was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Skin lesion, Tremor
Clinical narrative: GOT CHILL; UNABLE TO SLEEP; SORE HEAD; RIGHT EAR ACHE; SHAKING; HOT FLASHES; COLD; 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, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for head sore, right ear ache, and shaking. No concomitant medications were reported. On 2021, the subject experienced got chill. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced sore head. On 2021, the subject experienced right ear ache. On 2021, the subject experienced shaking. On 2021, the subject experienced hot flashes. On 2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got chill, and cold on 2021, had not recovered from sore head, and hot flashes, and the outcome of unable to sleep, right ear ache and shaking was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Myalgia
Clinical narrative: CHEST PAIN; HIPS AND SHOULDERS HURTS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 09:30 a.m. vaccinated at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 21:30 p.m., the subject experienced chest pain. On 17-MAR-2021 21:30 p.m., the subject experienced hips and shoulders hurts. On 17-MAR-2021 21:30 p.m., the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle aches, chest pain, and hips and shoulders hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: BRAIN FOG; DIZZINESS; JOINT SORENESS; MUSCLE SORENESS; FEVER; 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, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced brain fog. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced joint soreness. On 08-MAR-2021, the subject experienced muscle soreness. On 08-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, joint soreness, brain fog, dizziness, and muscle soreness. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face, Vomiting
Clinical narrative: FACE SWELLING; VOMITING; HEAD RASH; 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 was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced face swelling, vomiting, and head rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, face swelling and head rash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Urticaria
Clinical narrative: CHILLS; HIVES; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and hives was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Hangover, Headache, Pain
Clinical narrative: PAIN BEHIND HER EYES; FELT HUNG OVER; BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a 45 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: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced pain behind her eyes. On 17-MAR-2021, the subject experienced felt hung over. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain behind her eyes, felt hung over, body aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: INSOMNIA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included arrhythmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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 insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insomnia was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Pain
Clinical narrative: BODY ACHE; NO APPETITE; NAUSEA; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced no appetite. On 18-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, no appetite and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SIDE EFFECTS POST-INJECTION; This spontaneous report received from a patient via a company representative 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 was not reported, 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, the subject experienced side effects post-injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects post-injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Herpes simplex, Injection site pain
Clinical narrative: HSV BREAKOUT (SMALL LESIONS STARTED TO DEVELOP RIGHT POSTERIOR LOWER AND BACK OF JAW, FEVER, EXTREME FATIGUE, BODY ACHE, FEELING NAUSEOUS); PAIN AT INJECTION SITE; 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 hsv1, and concurrent conditions included spondylytis, and rheumatoid arthritis, and other pre-existing medical conditions included patient had a strep test, which was negative. 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 06-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, treatment medications included: naproxen, and valaciclovir hydrochloride. On 06-MAR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAR-2021, the subject experienced hsv breakout (small lesions started to develop right posterior lower and back of jaw, fever, extreme fatigue, body ache, feeling nauseous). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 10-MAR-2021, and the outcome of hsv breakout (small lesions started to develop right posterior lower and back of jaw, fever, extreme fatigue, body ache, feeling nauseous) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Insomnia, Nausea, Pain
Clinical narrative: FEELING ACHEY; TROUBLE SLEEPING; FLU LIKE SYMPTOMS; MILD HEADACHE; LOW GRADE FEVER; FELT NAUSEOUS; 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: 1805031) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling achey, trouble sleeping, flu like symptoms, mild headache, low grade fever, and felt nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and was recovering from feeling achey, mild headache, low grade fever, trouble sleeping, and felt nauseous. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING ACHEY; TROUBLE SLEEPING; FLU LIKE SYMPTOMS; MILD HEADACHE; LOW GRADE FEVER; FELT NAUSEOUS; 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: 1805031) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling achey, trouble sleeping, flu like symptoms, mild headache, low grade fever, and felt nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and was recovering from feeling achey, mild headache, low grade fever, trouble sleeping, and felt nauseous. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastroenteritis viral, Pain
Clinical narrative: STOMACH VIRUS; FATIGUE/TIRED; ACHY; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced achy. On 13-MAR-2021, the subject experienced stomach virus. On 13-MAR-2021, the subject experienced fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy on 12-MAR-2021, and had not recovered from fatigue/tired, and stomach virus. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210335420.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: SORE ARM; UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included left shoulder injury- a "spider fracture" of the "proximal humerus", and muscular pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced unexpected beneficial therapeutic response.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: DIZZY; CHILLS; HEADACHE; 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) dose was not reported, administered on 19-MAR-2021 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 dizzy, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, headache and chills was not reported. This report was non-serious.