chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Within 5 minutes I had a rash through my body (hot tot he touch) and as quickly as that came it went away. I sat for a little bit and the same thing happen again. My BP started going up and my face started getting red and I just did not feel well, they got concerned with that it progressed to the insides of my cheeks and we were concerned about throat swelling, so they sent me to the ER where I got Benadryl by IV and they also gave me Epi and some other meds and I don't remember what they were. I was there for about 4 hours.  About 2AM it started coming back again, inside my cheeks started feeling like it was swelling again and I took Benadryl (I was home). I took another dose in the morning and in the afternoon. In fact I kept taking Benadryl pretty regularly for the next 3-4 days. I decided to go to my PCP and he prescribed something else that made me really drowsy, so I went back to the Benadryl and it took another couple of days to feel that the cheeks stopped with the feeling of swelling.  (PCP at the hospital. At this time I still feel tired,  energy levels are just not what used to be before vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Headache, Myalgia
Clinical narrative: Trying to conceive since June 2019. First consulted my OBGYN for fertility in June 2020. Started seeing a fertility specialist 9/2020. Completed 2 cycles of ovulation induction therapy with letrazole 10/2020 and 11/2020, which did not result in pregnancy. Switched fertility specialist in 1/2021. Received first dose of vaccine 12/18/2020 and second dose of vaccine 1/8/2021. Found out I was pregnant naturally on 1/17/2021 and miscarried 1/22/2021 (chemical pregnancy reported in previous VAERS report # 323192). On 2/24/2021 I found out I was pregnant naturally again by home urine pregnancy test, confirmed that day with blood work.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy, Pregnancy test urine positive
Clinical narrative: Trying to conceive since June 2019. First consulted my OBGYN for fertility in June 2020. Started seeing a fertility specialist 9/2020. Completed 2 cycles of ovulation induction therapy with letrazole 10/2020 and 11/2020, which did not result in pregnancy. Switched fertility specialist in 1/2021. Received first dose of vaccine 12/18/2020 and second dose of vaccine 1/8/2021. Found out I was pregnant naturally on 1/17/2021 and miscarried 1/22/2021 (chemical pregnancy reported in previous VAERS report # 323192). On 2/24/2021 I found out I was pregnant naturally again by home urine pregnancy test, confirmed that day with blood work.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Progesterone increased
Clinical narrative: Trying to conceive since June 2019. First consulted my OBGYN for fertility in June 2020. Started seeing a fertility specialist 9/2020. Completed 2 cycles of ovulation induction therapy with letrazole 10/2020 and 11/2020, which did not result in pregnancy. Switched fertility specialist in 1/2021. Received first dose of vaccine 12/18/2020 and second dose of vaccine 1/8/2021. Found out I was pregnant naturally on 1/17/2021 and miscarried 1/22/2021 (chemical pregnancy reported in previous VAERS report # 323192). On 2/24/2021 I found out I was pregnant naturally again by home urine pregnancy test, confirmed that day with blood work.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Chest pain, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Trying to conceive since June 2019. First consulted my OBGYN for fertility in June 2020. Started seeing a fertility specialist 9/2020. Completed 2 cycles of ovulation induction therapy with letrazole 10/2020 and 11/2020, which did not result in pregnancy. Switched fertility specialist in 1/2021. Received first dose of vaccine 12/18/2020 and second dose of vaccine 1/8/2021. Found out I was pregnant naturally on 1/17/2021 and miscarried 1/22/2021 (chemical pregnancy reported in previous VAERS report # 323192). On 2/24/2021 I found out I was pregnant naturally again by home urine pregnancy test, confirmed that day with blood work.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Myalgia
Clinical narrative: Trying to conceive since June 2019. First consulted my OBGYN for fertility in June 2020. Started seeing a fertility specialist 9/2020. Completed 2 cycles of ovulation induction therapy with letrazole 10/2020 and 11/2020, which did not result in pregnancy. Switched fertility specialist in 1/2021. Received first dose of vaccine 12/18/2020 and second dose of vaccine 1/8/2021. Found out I was pregnant naturally on 1/17/2021 and miscarried 1/22/2021 (chemical pregnancy reported in previous VAERS report # 323192). On 2/24/2021 I found out I was pregnant naturally again by home urine pregnancy test, confirmed that day with blood work.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: itchy; fever; erythematous area with multiple wheals; multiple wheals filled out with a yellowish fluid; This case was reported by a nurse via patient support programs and described the occurrence of erythema urticarial in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number HD3K2, expiry date 7th May 2022) for prophylaxis.   On 9th January 2021, the patient received Shingrix .5 ml. On 9th January 2021, less than a day after receiving Shingrix, the patient experienced fever. On 11th January 2021, the patient experienced pruritus. In January 2021, the patient experienced erythema urticarial and pustular rash. On an unknown date, the outcome of the erythema urticarial, pustular rash, fever and pruritus were unknown.   It was unknown if the reporter considered the erythema urticarial, pustular rash, fever and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and on the same day, had fever. Two days after receiving Shingrix, the patient experienced itching. The physician described the physical examination right deltoid muscle external aspect noted less than a week after receiving Shingrix, erythematous area with multiple wheals filled out with a yellowish fluid. The reporter has agreed for GSK's Safety team follow-up with them via postal mail.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Physical examination, Pruritus, Pyrexia, Rash pustular, Urticaria
Clinical narrative: itchy; fever; erythematous area with multiple wheals; multiple wheals filled out with a yellowish fluid; This case was reported by a nurse via patient support programs and described the occurrence of erythema urticarial in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number HD3K2, expiry date 7th May 2022) for prophylaxis.   On 9th January 2021, the patient received Shingrix .5 ml. On 9th January 2021, less than a day after receiving Shingrix, the patient experienced fever. On 11th January 2021, the patient experienced pruritus. In January 2021, the patient experienced erythema urticarial and pustular rash. On an unknown date, the outcome of the erythema urticarial, pustular rash, fever and pruritus were unknown.   It was unknown if the reporter considered the erythema urticarial, pustular rash, fever and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and on the same day, had fever. Two days after receiving Shingrix, the patient experienced itching. The physician described the physical examination right deltoid muscle external aspect noted less than a week after receiving Shingrix, erythematous area with multiple wheals filled out with a yellowish fluid. The reporter has agreed for GSK's Safety team follow-up with them via postal mail.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chest pain, Hypoaesthesia, Loss of personal independence in daily activities, Neck pain
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, Brain natriuretic peptide normal, Chest pain, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Troponin I normal
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Costochondritis, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Red blood cell sedimentation rate normal, Troponin normal
Clinical narrative: Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Respiratory distress
Clinical narrative: This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm.  Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms.  Nurse came over and gave her epi pen at 1515 and sent to ER.    In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F.  Lungs CTA in ER.   Headache worsened, but no difficulty breathin
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dry throat, Dyspnoea, Headache
Clinical narrative: This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm.  Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms.  Nurse came over and gave her epi pen at 1515 and sent to ER.    In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F.  Lungs CTA in ER.   Headache worsened, but no difficulty breathin
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper
Clinical narrative: tongue itchy   chest heaviness&tight removed mask deep breathes, drinking Cleared within just a dew minutes
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Tongue pruritus
Clinical narrative: tongue itchy   chest heaviness&tight removed mask deep breathes, drinking Cleared within just a dew minutes
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Diarrhoea, Hypotension, Myalgia, Nausea
Clinical narrative: VOMITTING,FEVER, RASH OVER ENTIRE BODY, NAUSEA,CHILLS AND SWEATS.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: VOMITTING,FEVER, RASH OVER ENTIRE BODY, NAUSEA,CHILLS AND SWEATS.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chills, Hyperhidrosis, Nausea
Clinical narrative: VOMITTING,FEVER, RASH OVER ENTIRE BODY, NAUSEA,CHILLS AND SWEATS.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Ultrasound scan, Vomiting
Clinical narrative: VOMITTING,FEVER, RASH OVER ENTIRE BODY, NAUSEA,CHILLS AND SWEATS.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Fatigue, Pyrexia
Clinical narrative: put on a little weight; feeling sick; headache; chills; Ache; diarrhea; arm got sorer and sorer; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. E10142, via an unspecified route of administration (administered to the left arm) on 19Jan2021 10:30 at a single dose for Covid vaccination administered at facility. Medical history included 100% disabled, Covid from Jul2020, hospitalized from 21Jul2020 to 26Jul2020, blood plasma, and sore. No relevant family medical history relevant to AEs. Concomitant medications included unspecified medications. The patient previously took remdesivir. The patient called to report side effects after getting the first Pfizer COVID vaccination. He got it on 19Jan2021. He had COVID before. Last summer he hadn't left the house for 20 plus weeks and their son who was living with them brought the COVID virus in to them. His son and wife were asymptomatic and suffered at the house and he was completely disabled, with underlying conditions had to drag himself to the facility. He eventually had to be hospitalized on 21Jul2020. He had blood plasma and remdesivir and stayed in the hospital from Tuesday through Sunday. After getting the treatment, he felt like superman. On 20Jan2021, he next day, about 24 hours later he started feeling sick again, he felt like when he had COVID back in Jul2020. It lasted for 24 hours, terrible headache, chills, aches, and a little diarrhea. He said after he got the vaccine, 24 hours later, his arm got sorer and sorer. He had 99.9 F fever and a terrible headache. He also put on a little weight on an unspecified date. No emergency room visit. No relevant tests. He called the facility the next morning and they told him to rest. He slept all day and the next day he felt like superman again. He called the facility that Thursday morning and they instructed him to relax and that it seemed to affect people who have had the COVID virus before, they have that reaction, and it should subside and it did. He stated his side effects were about 20% of what they were when he actually had COVID. The clinic told him that if he had any reaction to call and that Thursday he just relaxed. No other vaccines given the same day or 4 weeks prior. Never had any problems with shots, not really. He remembered when he went to specific area they gave him a whole bunch of shots with these guns and he was just sore a couple days, but that was it, no big deal. The patient underwent lab test which included COVID-19 positive Jul2020. The outcome of feeling sick, headache, chills, ache, diarrhea was recovering while outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107344 Same reporter/drug, similar events, different patient
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: put on a little weight; feeling sick; headache; chills; Ache; diarrhea; arm got sorer and sorer; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. E10142, via an unspecified route of administration (administered to the left arm) on 19Jan2021 10:30 at a single dose for Covid vaccination administered at facility. Medical history included 100% disabled, Covid from Jul2020, hospitalized from 21Jul2020 to 26Jul2020, blood plasma, and sore. No relevant family medical history relevant to AEs. Concomitant medications included unspecified medications. The patient previously took remdesivir. The patient called to report side effects after getting the first Pfizer COVID vaccination. He got it on 19Jan2021. He had COVID before. Last summer he hadn't left the house for 20 plus weeks and their son who was living with them brought the COVID virus in to them. His son and wife were asymptomatic and suffered at the house and he was completely disabled, with underlying conditions had to drag himself to the facility. He eventually had to be hospitalized on 21Jul2020. He had blood plasma and remdesivir and stayed in the hospital from Tuesday through Sunday. After getting the treatment, he felt like superman. On 20Jan2021, he next day, about 24 hours later he started feeling sick again, he felt like when he had COVID back in Jul2020. It lasted for 24 hours, terrible headache, chills, aches, and a little diarrhea. He said after he got the vaccine, 24 hours later, his arm got sorer and sorer. He had 99.9 F fever and a terrible headache. He also put on a little weight on an unspecified date. No emergency room visit. No relevant tests. He called the facility the next morning and they told him to rest. He slept all day and the next day he felt like superman again. He called the facility that Thursday morning and they instructed him to relax and that it seemed to affect people who have had the COVID virus before, they have that reaction, and it should subside and it did. He stated his side effects were about 20% of what they were when he actually had COVID. The clinic told him that if he had any reaction to call and that Thursday he just relaxed. No other vaccines given the same day or 4 weeks prior. Never had any problems with shots, not really. He remembered when he went to specific area they gave him a whole bunch of shots with these guns and he was just sore a couple days, but that was it, no big deal. The patient underwent lab test which included COVID-19 positive Jul2020. The outcome of feeling sick, headache, chills, ache, diarrhea was recovering while outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107344 Same reporter/drug, similar events, different patient
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test, Vaccination site pain, Weight, Weight increased
Clinical narrative: put on a little weight; feeling sick; headache; chills; Ache; diarrhea; arm got sorer and sorer; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. E10142, via an unspecified route of administration (administered to the left arm) on 19Jan2021 10:30 at a single dose for Covid vaccination administered at facility. Medical history included 100% disabled, Covid from Jul2020, hospitalized from 21Jul2020 to 26Jul2020, blood plasma, and sore. No relevant family medical history relevant to AEs. Concomitant medications included unspecified medications. The patient previously took remdesivir. The patient called to report side effects after getting the first Pfizer COVID vaccination. He got it on 19Jan2021. He had COVID before. Last summer he hadn't left the house for 20 plus weeks and their son who was living with them brought the COVID virus in to them. His son and wife were asymptomatic and suffered at the house and he was completely disabled, with underlying conditions had to drag himself to the facility. He eventually had to be hospitalized on 21Jul2020. He had blood plasma and remdesivir and stayed in the hospital from Tuesday through Sunday. After getting the treatment, he felt like superman. On 20Jan2021, he next day, about 24 hours later he started feeling sick again, he felt like when he had COVID back in Jul2020. It lasted for 24 hours, terrible headache, chills, aches, and a little diarrhea. He said after he got the vaccine, 24 hours later, his arm got sorer and sorer. He had 99.9 F fever and a terrible headache. He also put on a little weight on an unspecified date. No emergency room visit. No relevant tests. He called the facility the next morning and they told him to rest. He slept all day and the next day he felt like superman again. He called the facility that Thursday morning and they instructed him to relax and that it seemed to affect people who have had the COVID virus before, they have that reaction, and it should subside and it did. He stated his side effects were about 20% of what they were when he actually had COVID. The clinic told him that if he had any reaction to call and that Thursday he just relaxed. No other vaccines given the same day or 4 weeks prior. Never had any problems with shots, not really. He remembered when he went to specific area they gave him a whole bunch of shots with these guns and he was just sore a couple days, but that was it, no big deal. The patient underwent lab test which included COVID-19 positive Jul2020. The outcome of feeling sick, headache, chills, ache, diarrhea was recovering while outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107344 Same reporter/drug, similar events, different patient
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Deep vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chills, Erythema, Fatigue
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Influenza like illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound scan abnormal
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chills, Fatigue, Influenza
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Myalgia, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, Vaccination site pain
Clinical narrative: right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood blister, Gait disturbance, Pain, Pain in extremity
Clinical narrative: 1 tiny red blister on her mother's abdomen/she had a couple of blisters in her torso, feet, and especially on her hands; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the nurse noticed one tiny red blister on her mother's abdomen. In the morning of 02Feb2021, she had a couple of blisters on her torso, feet, and especially on her hands. The nurse said her mother's blisters are tender to touch, and she wanted to know if there had been reports of blisters from the Pfizer vaccine and she would like some information she could take with her for her mother's doctor's appointment on 03Feb2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: 1 tiny red blister on her mother's abdomen/she had a couple of blisters in her torso, feet, and especially on her hands; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the nurse noticed one tiny red blister on her mother's abdomen. In the morning of 02Feb2021, she had a couple of blisters on her torso, feet, and especially on her hands. The nurse said her mother's blisters are tender to touch, and she wanted to know if there had been reports of blisters from the Pfizer vaccine and she would like some information she could take with her for her mother's doctor's appointment on 03Feb2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Immediate post-injection reaction, Laboratory test
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Nausea, Nonspecific reaction, Rash, Swollen tongue
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anxiety, Blood glucose decreased, Computerised tomogram, Dyspnoea
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling jittery, Full blood count, Immediate post-injection reaction, Metabolic function test, Paraesthesia oral
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face, Swollen tongue, Tremor, Urticaria
Clinical narrative: 2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea.  She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED.  Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Facial paralysis, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: bilateral facial paralysis; This is a spontaneous report from contactable consumers (including patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 08Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history included hemochromatosis. The patient had no known allergies. There were no concomitant medications. The patient had no other medications in two weeks and had no other vaccine in four weeks. On 09Feb2021 at 16:00 (04:00 PM), the patient experienced bilateral facial paralysis. The event resulted in emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 6 days on Feb2021. Therapeutic measures were taken as a result of bilateral facial paralysis which included Immune Globulin 5 fusions, steroid treatment, and vira (as reported). The patient was tested for COVID post vaccination which was a nasal swab with negative result on 12Feb2021. The outcome of the event was recovering.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, SARS-CoV-2 test
Clinical narrative: bilateral facial paralysis; This is a spontaneous report from contactable consumers (including patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 08Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history included hemochromatosis. The patient had no known allergies. There were no concomitant medications. The patient had no other medications in two weeks and had no other vaccine in four weeks. On 09Feb2021 at 16:00 (04:00 PM), the patient experienced bilateral facial paralysis. The event resulted in emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 6 days on Feb2021. Therapeutic measures were taken as a result of bilateral facial paralysis which included Immune Globulin 5 fusions, steroid treatment, and vira (as reported). The patient was tested for COVID post vaccination which was a nasal swab with negative result on 12Feb2021. The outcome of the event was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Hypotension
Clinical narrative: Fatigue, high heart rate, high blood pressure, weakness, and muscle stiffness
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Heart rate increased, Hypertension, Musculoskeletal stiffness
Clinical narrative: Fatigue, high heart rate, high blood pressure, weakness, and muscle stiffness
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Patient was admitted for a scheduled cardiac catheterization. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac
Clinical narrative: Patient was admitted for a scheduled cardiac catheterization. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Fatigue, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: First 3-4 days, fever, sore arm, fatigue , aches, cough, rash around injection site, gums inflamed, purple bruising below injection site on arm  Fever, headaches, fatigue, lack of concentration for past four weeks
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: First 3-4 days, fever, sore arm, fatigue , aches, cough, rash around injection site, gums inflamed, purple bruising below injection site on arm  Fever, headaches, fatigue, lack of concentration for past four weeks
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Cytomegalovirus test positive, Disturbance in attention, Fatigue, Full blood count
Clinical narrative: First 3-4 days, fever, sore arm, fatigue , aches, cough, rash around injection site, gums inflamed, purple bruising below injection site on arm  Fever, headaches, fatigue, lack of concentration for past four weeks