chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Thyroxine free normal, Urine analysis normal, Vitamin D
Clinical narrative: 3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little.  3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain at the injection site, chills, low-grade fever (100.1 was the highest recorded), body aches, extreme fatigue.  All symptoms lasted approximately 60-72 hours then felt completely back to normal.  Onset of symptoms was 10 hours after receiving the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: this was the first vaccine and it left me with a stiff neck and overall muscle pain that went away with the administration of the second dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: Body aches; chest pain; left armpit/axillary lymph node swelling; brain fog
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, nausea, dizziness, sore arm from 2nd shot
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: Headache, nausea, foggy brain starting about 20 hours after vaccine, lasting up until around 32 hours after vaccine. Staying very hydrated seemed to help minimize the nausea a bit.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Moderately sore arm (a little more sore than with the flu shot), minor-moderate fatigue/low-energy, moderate headache (but note that I have chronic headaches, so hard to connect this to the vaccine). All in all, this was no problem at all: I simply took it easy for a while. I'm only reporting because I know the CDC is trying to get a full picture. After dose 1, I had only a sore arm, and the soreness was much less than for dose 2 (and less than for the flu shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: Could not work for two days had to go to urgent care still have sx to this day.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Ear pain, Electrocardiogram
Clinical narrative: At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and pulse high stayed for 30 minutes and felt better. Over weekend experience dizziness and pain in ear unwell feeling fast heart rate spike to pcp Monday on Tuesday had called dispatch health heart rate high n fast  they called ambulance cuz I was tachycardia and high blood and having tremors.  Was released under this was anxiety related pcp n cardio dr increased my metoprolol but currently still suffering wit tremors or tics of body . I have no control over movement and not sure when or if this will end. This was only my first dose and not comfortable with getting second and not sure what to do to manage these symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Tachycardia, Tic, Tremor, Urine analysis
Clinical narrative: At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and pulse high stayed for 30 minutes and felt better. Over weekend experience dizziness and pain in ear unwell feeling fast heart rate spike to pcp Monday on Tuesday had called dispatch health heart rate high n fast  they called ambulance cuz I was tachycardia and high blood and having tremors.  Was released under this was anxiety related pcp n cardio dr increased my metoprolol but currently still suffering wit tremors or tics of body . I have no control over movement and not sure when or if this will end. This was only my first dose and not comfortable with getting second and not sure what to do to manage these symptoms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Nausea, Pyrexia
Clinical narrative: Chills. Fever.   Can barely walk Nauseous Headache
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Erythema, Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: At 9pm on 3/30/21 my left ear was red and very warm to the touch leading up to going to bed around 1030pm. The next day around 10am I felt a tingling in the lower left side of my face it felt like novocaine was wearing off after being at the dentist. My mouth and cheek were slightly numb. The next day I noticed that nothing had changed in my face but my left hand fingers were also slightly numb along with my left shoulder blade.  Arm was sore at injection site throughout. I went to see my primary Dr. at 3:30pm on 4/1/21 and after having me do facial exercises she said I had a mild case of Bell's Palsy and prescribed a steroid and an anti-viral since I had recently been sick the week prior.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin warm
Clinical narrative: At 9pm on 3/30/21 my left ear was red and very warm to the touch leading up to going to bed around 1030pm. The next day around 10am I felt a tingling in the lower left side of my face it felt like novocaine was wearing off after being at the dentist. My mouth and cheek were slightly numb. The next day I noticed that nothing had changed in my face but my left hand fingers were also slightly numb along with my left shoulder blade.  Arm was sore at injection site throughout. I went to see my primary Dr. at 3:30pm on 4/1/21 and after having me do facial exercises she said I had a mild case of Bell's Palsy and prescribed a steroid and an anti-viral since I had recently been sick the week prior.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Dizziness, Pruritus
Clinical narrative: 3 hours after shot itching on entire left side small itchy rash on left ankle.  12 hours after shot low grade fever,  dizzy, shaking, chills, induced asthma attack had to use rescue inhaler for several hours, hurt to expand lungs  extreme joint pain .  This lasted for 24 hours.  Took advil for fever and joint pain relief
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic, Tremor
Clinical narrative: 3 hours after shot itching on entire left side small itchy rash on left ankle.  12 hours after shot low grade fever,  dizzy, shaking, chills, induced asthma attack had to use rescue inhaler for several hours, hurt to expand lungs  extreme joint pain .  This lasted for 24 hours.  Took advil for fever and joint pain relief
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Pain in extremity
Clinical narrative: Currently pregnant 29wks due date 6/17th  When I was getting up from my seat at the observation deck both of my calfs became sore like I just had a strenuous workout or like they were about to go into spasm. Also, while I was driving home, about 15mins into my drive I all of a sudden got a dizzy spell like I was about to lose consciousness and I almost had to pull over but it went away. Then throughout the day I was just extremely tired with a little light headedness. Slept for most of the day.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Nausea, Rash
Clinical narrative: Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain in extremity, Rash pruritic
Clinical narrative: Soreness in arm, warm to touch and redness at injection site for a day after vaccine. Fatigue also. Felt like a bad cold. Then, red, swollen, itchy rash at injection site 8 days later. Ongoing issue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Soreness in arm, warm to touch and redness at injection site for a day after vaccine. Fatigue also. Felt like a bad cold. Then, red, swollen, itchy rash at injection site 8 days later. Ongoing issue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy, Pain
Clinical narrative: Headache, lethargy, body aches, joint pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Within four hours after vaccine administered I developed shaking chills, low grade fever, body aches, headache (lasted almost a week), and severe tiredness?all persisted for about 36 hours. By Tuesday, March 30 ( five days after vaccination), lymph nodes in my left armpit and along my neck on left side and in left groin area were suddenly swollen (to a noticeable degree under my arm, so much I thought initially it was a lump and needed to see my doctor) and painful. This lasted several days. I also suddenly began my menstrual cycle a full two weeks ahead of schedule?the same day as onset of lymph swelling.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Within four hours after vaccine administered I developed shaking chills, low grade fever, body aches, headache (lasted almost a week), and severe tiredness?all persisted for about 36 hours. By Tuesday, March 30 ( five days after vaccination), lymph nodes in my left armpit and along my neck on left side and in left groin area were suddenly swollen (to a noticeable degree under my arm, so much I thought initially it was a lump and needed to see my doctor) and painful. This lasted several days. I also suddenly began my menstrual cycle a full two weeks ahead of schedule?the same day as onset of lymph swelling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash, Rash pruritic, Sleep disorder
Clinical narrative: Large (twice the size of a silver dollar) red swollen welt, extremely painful enough to keep me from sleeping for three days.  Then the pain subsided.  Still has swelling, patchy rash, very itchy.  It's been over a week and it doesn't look to be going away.  Very nervous to get the second shot.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Large (twice the size of a silver dollar) red swollen welt, extremely painful enough to keep me from sleeping for three days.  Then the pain subsided.  Still has swelling, patchy rash, very itchy.  It's been over a week and it doesn't look to be going away.  Very nervous to get the second shot.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Rash vesicular, Swelling face
Clinical narrative: Swelling or welt under both eyes. Blister-like bumps on swelling when I 1st noticed it, but they have lessened. But the welt is still there, and I feel the swelling more so now than I did last night. It's now been about 38 hours since receiving vaccine. It doesn't seem to be getting worse, aside from now being able to feel the swelling. Also, like I said, the blister-like bumps, on the welt/swelled area, have dissipated, so that got better. My face is also breaking out with acne since the shot. I do occasionally get acne break outs tho.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: That night after I got the shot, I started getting muscle pains throughout my body and extreme fatigue. That night, I had really disturbing vivid dreams and kept waking up, and feeling feverish (my head feels warm), fatigue, strong head pain, muscle pain throughout, and very strong pain at my injection site.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: That night after I got the shot, I started getting muscle pains throughout my body and extreme fatigue. That night, I had really disturbing vivid dreams and kept waking up, and feeling feverish (my head feels warm), fatigue, strong head pain, muscle pain throughout, and very strong pain at my injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site pain, Myalgia
Clinical narrative: did not get my second dose (COVID)); firmness at the site; Pain at the site; Headache; Myalgia; This case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 23rd March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site induration, injection site pain, headache and myalgia. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the injection site induration, injection site pain, headache, myalgia and social problem were unknown.   It was unknown if the reporter considered the injection site induration, injection site pain, headache and myalgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received the 2nd dose of Shingrix and had the funky symptoms in a bad way which was myalgia, headache, pain and firmness at the site. The patient received 2nd dose of Shingrix later than the recommended schedule because of COVID. Note: As the patient already received 1st dose in November 2019, thus the dose received on 23rd March 2021 was considered as 2nd dose although it was reported as a 1st dose. Thus, case was considered for the 2nd dose considering that it was a typo error.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site pain, Myalgia
Clinical narrative: First Shingrix dose November 2019 and did not get my second dose (COVID); This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the outcome of the coronavirus infection was unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself via chat function. The age at vaccination was not reported. The patient did not get her 2nd dose of Shingrix because of COVID infection. The patient mentioned that, a day before reporting, she received first dose (unspecified vaccine) and had the funky symptoms in a bad way which was myalgia, headache, pain and firmness at the site. Specialist attempted to gather further details and asked whether safety could follow up, but the patient disconnected the chat. Specialist unable to obtain additional information. Since the specialist had no way of knowing what other vaccine the patient was referencing thus it was in reference to an unknown, unspecified vaccine. The reporter did not consent to follow up. Note: Clarification was raised regarding "COVID". If this refers to COVID pandemic situation or COVID infection. However as per reply it was not clear that if patient referred COVID situation or developed COVID infection, thus considering worst approach COVID-19 was captured as an event as reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070310:Same reporter
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: SHE BLACKED OUT; FELL DOWN  BUT CAME AROUND QUICKLY WITHIN 15 TO 30 SECONDS AND SAT DOWN ON THE CHAIR; This spontaneous report received from a health care professional concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805031 expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the she blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and blacked out and fell down as related. Company causality between covid-19 vaccine ad26.cov2.s,blacked out and fell down was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210314164-JANSSEN COVID-19 VACCINE-Blacked Out. This event is considered unassessable. The event 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.     .
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Chest pain, Erythema
Clinical narrative: BLOOD PRESSURE ABNORMAL; CHEST PAIN (BELOW THE BREAST) AFTER AN HOUR OF VACCINATION; AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST; FEVER; FATIGUED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast) , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified), 177/80 (units unspecified), and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain (below the breast), redness of face and chest, fever, fatigued was possible. Company causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain, redness of face and chest, fever, fatigued was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :20210317973-COVID-19 VACCINE AD26.COV2.S -Blood Pressure Abnormal . This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: BLOOD PRESSURE ABNORMAL; CHEST PAIN (BELOW THE BREAST) AFTER AN HOUR OF VACCINATION; AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST; FEVER; FATIGUED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast) , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified), 177/80 (units unspecified), and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain (below the breast), redness of face and chest, fever, fatigued was possible. Company causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain, redness of face and chest, fever, fatigued was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :20210317973-COVID-19 VACCINE AD26.COV2.S -Blood Pressure Abnormal . This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Chest pain, Erythema, Fatigue, Pyrexia
Clinical narrative: BLOOD PRESSURE ABNORMAL; CHEST PAIN (BELOW THE BREAST) AFTER AN HOUR OF VACCINATION; AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST; FEVER; FATIGUED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast) , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified), 177/80 (units unspecified), and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain (below the breast), redness of face and chest, fever, fatigued was possible. Company causality between covid-19 vaccine ad26.cov2.s and blood pressure abnormal, chest pain, redness of face and chest, fever, fatigued was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :20210317973-COVID-19 VACCINE AD26.COV2.S -Blood Pressure Abnormal . This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: BREASTFEEDING EXPOSURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced breastfeeding exposure. The reporter was not informed that the mother of the patient was lactating, The reporter received a call on 10-Mar-2021 and was informed that the mother of the patient is breastfeeding and would like to know if she could continue breastfeeding after getting vaccinated. No side effect were reported  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding exposure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and breastfeeding exposure as related. Company causality between covid-19 vaccine ad26.cov2.s, and breastfeeding exposure was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210320488-covid-19 vaccine ad26.cov2.s-Breast feeding exposure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Product label issue
Clinical narrative: HYPOTENSION; PACKAGE INSERT WAS BLANK; This spontaneous report received from a health care professional concerned multiple patients (five patients) of unspecified age and sex. The patient's height and weight were not reported. The patient's medical history or concurrent conditions were not reported. The reporter stated that, none of the 5 patients had a history of cardiovascular issues. The patient's received JANSSEN COVID-19 VACCINE Ad26.COV2.S (suspension for injection, unspecified route, batch number: 1805022 expiry: 25-MAY-2021), dose was not reported, administered on 11-MAR-2021 for COVID-19 vaccination. No concomitant medications were reported.  On 08-MAR-2021, it was noted that, the package insert was blank. On 11-MAR-2021, five patients experienced hypotension, and were hospitalized. A public health manager reported that, she had 5 cases of hypotension after administering Janssen COVID 19 vaccine. The action taken with COVID-19 vaccineAd26.COV2.S was not reported. The patients were recovering from hypotension and the outcome of package insert was blank was not reported. The report was associated with product quality complaint number 90000172674. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 Based on the reported information, the event of hypotension is considered related at this time. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event than the vaccine. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis on her whole bicep; A spontaneous report was received from a consumer and a healthcare professional concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cellulitis on her whole bicep - left arm/cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-Jan-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving first dose of mRNA-1273, the patient developed cellulitis on her whole bicep - left arm. The event was assessed as medically significant as per IME list. Treatment details included ice pack, antibiotic and steroid.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of event, cellulitis on her whole bicep - left arm was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Vaccination complication
Clinical narrative: felt weak; some side effects from the vaccine; lethargic; This spontaneous case was reported by a physician concerning a 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt weak/asthenia, lethargic/lethargy.  No Medical History information was reported.  Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, 3 days after receiving mRNA-1273, patient just felt weak, lethargic, had some side effects, and patient was taken to hospital and has been in the hospital for 3 weeks now. Doctors could not find anything wrong with them; they're going through the last set of labs which they think is going to be normal also. Caller's mother got the vaccine through the primary contact on this case. Treatment was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events felt weak, had some side effects, and lethargic is unknown..; Reporter'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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: hives around the chest area; redness around the chest area; A spontaneous report was received from a pharmacist,  concerning a 42-year-old female patient who developed hives around the chest area/urticaria and redness around the chest area/erythema.  The patient's medical history is unknown. Products known to have been used by the patient concomitantly is unknown.  On 11-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 11-MAR-2021, the patient experienced hives and redness around the chest area resulting in hospitalization. The patient was prescribed prednisone.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the events, hives around the chest area/urticaria and redness around the chest area/erythema were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer concerning a 64 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy/ facial paralysis.  The patient's medical history, as provided by the reporter, included rheumatoid arthritis.  Concomitant product use was not provided.  On 03 Mar 2021, approximately 10 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch 025A21A) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced symptoms of Bell's palsy. At the time of this report, she is still experiencing symptoms on the left side of her face.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Bell's palsy was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-060392:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Colitis, Constipation, Diarrhoea, Rectal haemorrhage
Clinical narrative: She was diagnosed with colitis at ER; Patient started with abdominal discomfort 4 days after receiving 2nd dose; Patient started with constipation; Patient started with diarrhea; Patient started with rectal bleeding; A spontaneous report was received from a reporter like a consumer concerning a 55 year old female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like patient started with abdominal discomfort 4 days after receiving 2nd dose/ abdominal discomfort, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000.  The patient's medical history included blood pressure. Concomitant medications included blood pressure medication and fluoxetine hydrochloride.  On 11 March 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position in the left arm for prophylaxis of COVID-19 infection. On 15Mar2021, she started with abdominal discomfort followed with constipation, diarrhea and rectal bleeding. On 17Mar2021,abdominal pain returned and she went to ER. Her white blood cell count was over 20,000. She was diagnosed with colitis at ER. Out of these events rectal bleeding, abdominal pain returned and went to ER were medically significant.  Laboratory details included white blood cell count.  Treatment information included metronidazole, levofloxacin.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events,  patient started with abdominal discomfort 4 days after receiving 2nd dose, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000 was considered as unknown.; Reporter's Comments: Little information about lab tests and other diagnostic procedures is available but all of the events are "unlisted" and "Possible Causality" related to the vaccine as there is a clear temporal relationship.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: She was diagnosed with colitis at ER; Patient started with abdominal discomfort 4 days after receiving 2nd dose; Patient started with constipation; Patient started with diarrhea; Patient started with rectal bleeding; A spontaneous report was received from a reporter like a consumer concerning a 55 year old female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like patient started with abdominal discomfort 4 days after receiving 2nd dose/ abdominal discomfort, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000.  The patient's medical history included blood pressure. Concomitant medications included blood pressure medication and fluoxetine hydrochloride.  On 11 March 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position in the left arm for prophylaxis of COVID-19 infection. On 15Mar2021, she started with abdominal discomfort followed with constipation, diarrhea and rectal bleeding. On 17Mar2021,abdominal pain returned and she went to ER. Her white blood cell count was over 20,000. She was diagnosed with colitis at ER. Out of these events rectal bleeding, abdominal pain returned and went to ER were medically significant.  Laboratory details included white blood cell count.  Treatment information included metronidazole, levofloxacin.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events,  patient started with abdominal discomfort 4 days after receiving 2nd dose, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000 was considered as unknown.; Reporter's Comments: Little information about lab tests and other diagnostic procedures is available but all of the events are "unlisted" and "Possible Causality" related to the vaccine as there is a clear temporal relationship.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: irregular heart beat; pulse rate was high; She would wake up in the middle of the night with her heart pounding like crazy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and 2 patients. This is the first of three reports.   A female patient of an unspecified age (age: 65, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included heart attack in 2020. The patient's concomitant medications were not reported. Patient received the first dose of the vaccine on 04Mar2021 and had a reaction to it 2 days later, on 06Mar2021: irregular heart beat and pulse rate was high. She would wake up in the middle of the night with her heart pounding like crazy in Mar2021. She has never had that happen before. She noticed this difference in her heart about 3 days in (as reported). Her doctor will be putting her on a heart monitor tomorrow (unspecified date). She goes back 25Mar2021 for results which is the same day she is supposed to get the second vaccine. Patient asked whether it is okay to wait until 29Mar2021 to get the second vaccine. Her pharmacist told her that his father in law experienced the exact same thing she did. She added that a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the patient. Outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297868 same drug/event, different patient;US-PFIZER INC-2021297869 same drug/event, different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Cerebellar stroke, Magnetic resonance imaging, Weight
Clinical narrative: admitted with a cerebellar stroke; This is a spontaneous report from a contactable physician. A 73-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. Medical history included ongoing Hypertension, ongoing Diabetes, ongoing Cholesterol, ongoing Chronic UTI, gastrooesophageal reflux disease, depression, diabetic neuropathy, blood pressure abnormal. Concomitant medications includes, atorvastatin taken for blood cholesterol from an unspecified start date and ongoing; omeprazole taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; pregabalin taken for diabetic neuropathy from an unspecified start date and ongoing; losartan taken for blood pressure measurement from an unspecified start date to 15Mar2021; captopril, hydrochlorothiazide taken for blood pressure measurement from an unspecified start date to 15Mar2021; glimepiride taken for diabetes mellitus from an unspecified start date to 15Mar2021; cefalexin taken for urinary tract infection from an unspecified start date to 15Mar2021; metformin taken for diabetes mellitus from an unspecified start date to 15Mar2021; dulaglutide taken for diabetes mellitus. It was reported that, they have been holding her blood pressure and diabetes medicine during her admission. On 15Mar2021, patient was admitted with cerebellar stroke. It was reported that, condition has improved slightly and she would most likely discharge to a skilled nursing facility. Patient did not believe that she did receive any other vaccinations on 27Feb2021, but was unsure. On 15mar2021, the patient underwent lab tests and procedures which included angiogram: stroke, magnetic resonance imaging: stroke on 15Mar2021. As therapeutic measures for cerebellar stroke, the patient was put on Aspirin, Plavix and the dose of atorvastatin was increased to 80 mg. The outcome for the event was recovering.  Follow-up activities have been completed and no further information is expected.; Sender's Comments: The event of cerebellar stroke is assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Embolism, Magnetic resonance imaging
Clinical narrative: documented MRI stroke; Appears to be thromboembolic; This is a spontaneous report from a contactable physician (reported for himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 04Jan2021 07:00 as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. On 27Jan2021 14:00, it was reported that patient had documented MRI stroke, and appeared to be thromboembolic. Patient have no risk factors for CVA, and stroke occurred. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on 27Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency visit and disability or permanent damage. Therapeutic measures were taken in response to the events which included patient had started on aspirin. The patient was not tested for covid post vaccination. The outcome of the events stroke and thromboembolic was recovering.   Information about lot/batch number is requested.; Sender's Comments: The causal association cannot be excluded between the reported events of "MRI stroke and appeared to be thromboembolic" and  BNT162B2 use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Dry mouth, Heart rate, Hypersensitivity
Clinical narrative: severe allergic reaction; has a drop foot that felt rubbery; Dizziness; Dry mouth; This is a spontaneous report received from two contactable consumers (once is patient himself). A 79-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection and Lot Number: EN6208), via an unspecified route of administration in the left arm on 15MAR2021 15:15 (at the age of 79-years-old) at a single dose for COVID-19 immunization. Patient medical history included Diabetes ongoing, patient has had three heart attacks. The first was over 20 years ago. He is waiting to have a stress test prior to having an angioplasty and Heart condition ongoing. Concomitant medications were reported as none. Lab data includes patient had all kinds of testing at the emergency room, test results that he had at the emergency room were all negative. They checked his heart and did a CT scan on 15Mar2021. Patient received the first dose of the COVID-19 vaccine on 15Mar2021. He received the vaccine at 3:15 pm. Within a minute after getting the vaccine he was getting dizzy. He was monitored for 15 minutes. He thought the dizziness went along with it. On the way home the dizziness was really hard to explain. He has never gotten this dizzy. It took his whole head over. It wasn't a spinning dizziness. He is 79 years old and has a lot of physical problems. He has a drop foot on his good leg. When he got home his drop foot felt rubbery. It is not usually like this. He also had a dry mouth. The papers said this is under the severe allergic reaction. Patient's daughter called the doctor and was told to go to the emergency room. He had all kinds of testing at the emergency room. 3-4 hours later the dizziness dry mouth went away. His foot was back to normal. He is wondering about the second dose. He is asking if the second dose will be stronger than the first. Patient received first dose of vaccine on 15Mar2021 and experienced dizziness, he believes it was a severe allergic reaction. His symptoms subsided a few hours later. He has a history of diabetes and heart issues. Event has already been reported to Pfizer. Patient has a Nuclear cardiac stress test on 01Apr2021. His second dose is schedule for 06Ap2021. He would like to know is it safe to get second dose considering his side effects. Outcome of event (severe allergic reaction) was unknown and recovered on 15Mar2021.   No follow-up attempts are possible and no further information was provided