chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Tachycardia, Vomiting
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Breast pain, Chest pain, Chills
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Injection site pain, Migraine, Musculoskeletal chest pain
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oophorectomy bilateral, Ovarian disorder, Pain, Pelvic pain
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: After the shot, my arm was burning and aching. Around 6 pm, I had a shooting pain from my left side down to my hip area. At 7 pm, I felt tired, weak, achy, had a headache, and was nauseous. At 10 pm, I felt body chills and pain in my hip as well as a migraine. I ended up throwing up.   Around 12:30 am, I had a watch that detected my heart rate and the watch said my heart rate was too high, even though I was sleeping. The watch went off three or four times, that my heart rate was way too high. At 4 am, I was drenched in sweat and completely wet. My mattress was completely drenched. I took Tylenol at 7 am. I still felt tired and achy throughout the day but had a little relief.   The migraines came back in the evening but after taking Tylenol the headache went away. I went to the ER the next day. I was sent home afterwards and told to take muscle relaxers and to not lift anything heavy. On March 18th, I was able to breathe better. On the 19th, there was pain under my right breast and right above my ribcage. The pain remained for days. I went back the ER, March 28th and had unbearable and jabbing pain. I was very dizzy, lightheaded, and in extreme pain in my pelvic area.   I don't know if this is related but I went back to the ER that night and had a problem with my ovaries. I had surgery and had my ovaries removed. The chest pain still lingered a month after the surgery.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Wheezing
Clinical narrative: following morning started with allergy symptoms around 8 with rash on face, mostly right side. Followed by rash turning into hives, then a red rash  and itching starting at top of head, going through neck. Tingling and tightening in throat. From the start to throat tightening, around 45 minutes - 1 hour. Took 100 mg of Benadryl when rash turned to hives. Called doctor immediately. Put on Prednisone, famotidine, Benadryl and Zyrtec for a 7 day course.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia, Pruritus, Rash, Rash erythematous, Throat tightness
Clinical narrative: following morning started with allergy symptoms around 8 with rash on face, mostly right side. Followed by rash turning into hives, then a red rash  and itching starting at top of head, going through neck. Tingling and tightening in throat. From the start to throat tightening, around 45 minutes - 1 hour. Took 100 mg of Benadryl when rash turned to hives. Called doctor immediately. Put on Prednisone, famotidine, Benadryl and Zyrtec for a 7 day course.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: following morning started with allergy symptoms around 8 with rash on face, mostly right side. Followed by rash turning into hives, then a red rash  and itching starting at top of head, going through neck. Tingling and tightening in throat. From the start to throat tightening, around 45 minutes - 1 hour. Took 100 mg of Benadryl when rash turned to hives. Called doctor immediately. Put on Prednisone, famotidine, Benadryl and Zyrtec for a 7 day course.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, CSF glucose decreased, CSF lymphocyte count, CSF monocyte count, CSF neutrophil count positive
Clinical narrative: Unknown if associated, however the patient has developed a basal ganglia/diencephalic predominant brain encephalitis.   his cognitive symptoms started 2 weeks after his vaccination and a progress the point where he is  obtunded, intubated and ventilator dependent.  brain biopsy suggests against volume malignancy however the exact nature of his brain inflammation is unknown at this time.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF white blood cell count increased, Confusional state, Encephalitis, Magnetic resonance imaging head normal
Clinical narrative: Unknown if associated, however the patient has developed a basal ganglia/diencephalic predominant brain encephalitis.   his cognitive symptoms started 2 weeks after his vaccination and a progress the point where he is  obtunded, intubated and ventilator dependent.  brain biopsy suggests against volume malignancy however the exact nature of his brain inflammation is unknown at this time.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parkinsonism, Pyrexia, White blood cell count increased
Clinical narrative: Unknown if associated, however the patient has developed a basal ganglia/diencephalic predominant brain encephalitis.   his cognitive symptoms started 2 weeks after his vaccination and a progress the point where he is  obtunded, intubated and ventilator dependent.  brain biopsy suggests against volume malignancy however the exact nature of his brain inflammation is unknown at this time.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy brain, CSF test normal, Cognitive disorder, Dependence on respirator, Depressed level of consciousness
Clinical narrative: Unknown if associated, however the patient has developed a basal ganglia/diencephalic predominant brain encephalitis.   his cognitive symptoms started 2 weeks after his vaccination and a progress the point where he is  obtunded, intubated and ventilator dependent.  brain biopsy suggests against volume malignancy however the exact nature of his brain inflammation is unknown at this time.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Encephalitis, Endotracheal intubation, Laboratory test normal, Lumbar puncture, Noninfective encephalitis
Clinical narrative: Unknown if associated, however the patient has developed a basal ganglia/diencephalic predominant brain encephalitis.   his cognitive symptoms started 2 weeks after his vaccination and a progress the point where he is  obtunded, intubated and ventilator dependent.  brain biopsy suggests against volume malignancy however the exact nature of his brain inflammation is unknown at this time.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions noted.  Pt was out of the age range for the vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions noted.  Pt was out of the age range for the vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Chills, Diarrhoea, Fatigue
Clinical narrative: flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Limb discomfort, Lymph node pain
Clinical narrative: flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Paraesthesia, Vaccination site pain
Clinical narrative: flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler
Clinical narrative: FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year  old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with  Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Joint swelling, Muscle spasms, Pain
Clinical narrative: FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year  old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with  Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound Doppler
Clinical narrative: FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year  old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with  Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Muscle spasms, Swelling, Thrombosis
Clinical narrative: FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year  old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with  Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Skin exfoliation
Clinical narrative: Itching, pigments in skin changing still, headaches, feels like even warm water sets my skin on fire, my skin is calling off. I get ask by people everywhere asking what's wrong. It t is wearing me down. I've been on several meds and three different doctors.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pigmentation disorder, Pruritus, Skin burning sensation
Clinical narrative: Itching, pigments in skin changing still, headaches, feels like even warm water sets my skin on fire, my skin is calling off. I get ask by people everywhere asking what's wrong. It t is wearing me down. I've been on several meds and three different doctors.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Itching, pigments in skin changing still, headaches, feels like even warm water sets my skin on fire, my skin is calling off. I get ask by people everywhere asking what's wrong. It t is wearing me down. I've been on several meds and three different doctors.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anion gap, Anticoagulant therapy, Basophil count decreased, Basophil count increased
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urea normal, Carbon dioxide normal, Coagulation time normal, Eosinophil count normal, Glomerular filtration rate increased
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Haemoptysis, Immature granulocyte count, Increased viscosity of upper respiratory secretion
Clinical narrative: blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-116374 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.