chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: my left leg started killing me, I cannot put it in the floor anymore; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second shot bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date (reported as 21st) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization and was ok. The patient reported that "I had got this injection on the 21st and I never had any problems but yesterday, my left leg started killing me, I cannot put it in the floor anymore Is this a thing from the injection?" The patient had this vaccination on 21st, the first shot ok and nothing happed to the patient but yesterday the patient's left leg is bothering the patient and the patient can hardly walk. The patient inquired that can this be because of the vaccination. The patient added that "That's all I want to know. It is really killing me." The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the Corona; That's a shock, I got the Corona; I got the Corona; That's a shock, I got the Corona; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot of COVID 19 vaccine and had to leave the country. Patient stated, "I got the Corona. That's a shock, I got the Corona and I am not going to be able to get out from here maybe for another 2 weeks because I have to be in currently in here. So, now what's going on with my first shot and what's going on my second, I have to make an appointment for my second shot or what else?" Patient added, "tomorrow I have the second shot, but I am not there, and I have the corona anyhow." Outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haematoma
Clinical narrative: he passed blood in urine; hematoma formation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as "Age:79, Unit: Unknown") received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 at single dose COVID-19 immunization; and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included blood in urine in 2020 (about a year ago). The patient's concomitant medications were not reported. The patient was on Eliquis. He received the COVID vaccine on 30Jan2021. On the 06Feb2021 and 09Feb2021, he passed blood in urine. He reported a similar experience about a year ago for the 1st time after which he saw a urologist who told him it was okay. He is also scheduled to see his urologist on the 25th for a 1-year follow-up. The patient would like to know what the connection is between the COVID vaccine and being on a blood thinner. On unspecified date in Feb2021, the patient had hematoma formation. The action taken in response to the events for suspect drug apixaban was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Swollen tongue, Tremor
Clinical narrative: tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19.  She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site infection, Vaccination site pain
Clinical narrative: No problem at first 9 days after injection I woke up with a very sore spot of the injection/his arm is hurting, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in/could be a sign of an infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El3247; expiration date: unknown) at vaccination age of 76-year-old via an unspecified route of administration in the left arm on 02Feb2021 12:00 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/veterans administration facility. The patient reported that there was no problem at first 9 days after injection. He woke up with a very sore spot on the injection on 11Feb2021. The event did not received treatment for the adverse event. The patient considered the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient further stated that got the Pfizer Covid vaccination on 02Feb2021, but he had no reaction and everything was fine. He mentioned that this morning (11Feb2021) which was 9 days later, his arm was hurting. He stated that it was his left shoulder and arm, the same arm he received the injection in which was given the injection by the employer. The patient wanted to know if it is normal to experience this type of reaction 9 days later. He was wondering if it could be a sign of an infection. The patient was encouraged to reach out to his healthcare provider. The outcome of the events was not recovered.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Loss of control of legs, Pain in extremity
Clinical narrative: lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), on the right arm, via an unspecified route of administration on 25Jan2021 at 13:45 at single dose for COVID-19 immunisation. Medical history was reported as none. No family medical history. Concomitant medication included denosumab (PROLIA) given on 06Jan2021. No additional vaccine administered at the same date as BNT162B2 and no prior vaccinations within 4 weeks. No tests were done. On 26Jan2021, it was reported that her arm hurt a little but not much. A day or so later on 27Jan2021, the patient started to experience a lightheadedness, not sure of her footing and not walking as forcefully as usual. When she turned around she felt like she didn't have control. Adds she felt like she walking through a field of marshmallows. She is scheduled to receive the next dose of the vaccine on 15Feb2021 at 14:00. The events did not require physician office or emergency room visit. The vaccine was administered in a school. The outcome of the event arm hurt a little was recovered on 27Jan2021 while for the rest of the events was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (lot number: EL3248), via an unspecified route of administration on the left arm on 28Jan2021 at 08:15 at a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in four weeks. No other medications was given in two weeks. No covid prior vaccination. No covid test was done post vaccination. The patient experienced Left lower portion of leg ached. It felt like similar to growing pains experienced as a child. Lasted only one night, the same day as when I received the shot. No treatment was received in response to the adverse event. The next day (29Jan2021) the pain was gone. The patient was not allowed to contact hcp. The patient recovered from the event on 29Jan2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Flatulence, Lip swelling, Paraesthesia oral
Clinical narrative: feeling in tongue had changed; skin turned rosy on face; lip swollen; digestive issues; gas; Itchy skin; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:00 at 73-years-old at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient experienced events and outcomes: feeling in tongue had changed (non-serious) with outcome of recovering, skin turned rosy on face (non-serious) with outcome of recovering, lip swollen (non-serious) with outcome of not recovered, digestive issues (non-serious) with outcome of not recovered, gas (non-serious) with outcome of not recovered, itchy skin (non-serious) with outcome of not recovered; all of which required an emergency room (ER) visit. The patient stated that immediately after the vaccination, he came down with a mild reaction. The patient stated the feeling in his tongue felt off, skin turned rosy, lower lip was swollen, and he has had some gas and digestive issues. The patient stated that he spent an hour and a half in the emergency room (ER), and everything calmed down there, and he was able to go home. The patient stated that he may not take the second dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: feeling in tongue had changed; skin turned rosy on face; lip swollen; digestive issues; gas; Itchy skin; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:00 at 73-years-old at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient experienced events and outcomes: feeling in tongue had changed (non-serious) with outcome of recovering, skin turned rosy on face (non-serious) with outcome of recovering, lip swollen (non-serious) with outcome of not recovered, digestive issues (non-serious) with outcome of not recovered, gas (non-serious) with outcome of not recovered, itchy skin (non-serious) with outcome of not recovered; all of which required an emergency room (ER) visit. The patient stated that immediately after the vaccination, he came down with a mild reaction. The patient stated the feeling in his tongue felt off, skin turned rosy, lower lip was swollen, and he has had some gas and digestive issues. The patient stated that he spent an hour and a half in the emergency room (ER), and everything calmed down there, and he was able to go home. The patient stated that he may not take the second dose.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache
Clinical narrative: Headaches; no taste or smell; no taste or smell; This is a spontaneous report from a non-contactable consumer.  A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. Medical history included barretts esophagus. The patient's concomitant medications were not reported.  The patient experienced headaches on 30Jan2021, no taste or smell on 30Jan2021. No treatment received. The events outcome was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (Pfizer COVID 19 vaccine), lot no. EL0142 with expiry date Mar2021, via an unspecified route of administration (left arm) on 03Feb2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient got the COVID vaccine today (03Feb2021). She had an adverse reaction. She didn't have it within 15 minutes. She had it several couple of hours later. She had swelling to the upper lip on 03Feb2021. She took a Tylenol and Benadryl. The outcome of the event was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Diarrhoea, Erythema
Clinical narrative: Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash, Vaccination site pain
Clinical narrative: Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain
Clinical narrative: Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient).  This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient).  This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at vaccination site; This is a spontaneous report received from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiry date unknown), via an unspecified route of administration, on 19Feb2021 09:15, at single dose, for COVID-19 immunization. Medical history included asthma and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Feb2021 at 11:00, the patient experienced arm soreness at vaccination site. Treatment included Aspirin. The outcome of the event was unknown. The reporter assessed the event as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN2600) on left arm, via an unspecified route of administration on 18Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced redness at injection site on day 2 on 20Feb2021 13:30. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The event was reported as non-serious. The outcome of the event was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pain, SARS-CoV-2 test
Clinical narrative: covid test result was Positive/sore throat and headache; aches; Still sick; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of bnt162b2 (lot number EL9262), via an unspecified route of administration in right arm on 13Feb2021 13:00 at single dose for covid-19 immunization. Medical history included Diabetes. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, patient had been tested for COVID-19. The Nasal Swab (Aegis) was tested on 13Feb2021. The covid test result was Positive. In Feb2021, the patient had aches, sore throat and headache. Came down with full blown Covid moderate to severe. Still sick. Patient was reluctant to get his second shot and was sure it serves no purpose. No treatment received for events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe explosive diarrhea; This is a spontaneous report from a contactable female other health professional reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at 15:45 (Lot number: EL9269) via an unspecified route of administration in the left arm at single dose for COVID-19 Immunization in the Public Health Clinic. The patients medical history included She had sulfa and latex allergy. The patients concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after vaccination. On 14Feb2021 04:30 the patient had severe explosive diarrhoea within 12 hours of injection. Diarrhoea, several times per day, accompanied by loud rumbling, bowel sounds. Bowel movements would be watery and worsen with the ingestion of any form of solid foods. No bloating or cramps. The event assessed as serious (medically significant). The patient didn't receive treatment. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relation, the association between the event diarrhea and the administration of the vaccine cannot be completely ruled out. 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 adverse events. 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: Flu-like symptoms; joint pain; This is a spontaneous report from a contactable other-HCP. A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient medical history included breast cancer. The patient concomitant mediations included palbociclib (IBRANCE, strength: 125mg) by mouth at 125mg once daily at cycle: 21 days on, 7 days off from 2019 and ongoing for breast cancer. The patient previously received the first dose of bnt162b2 on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient experienced flu like symptoms and joint pain after the injection but had now resolved (on unknown date). It was unknown if MD is aware but the patient was advised to notify MD of any symptoms.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Patient was hospitalized for covid pneumonia (positive for covid infection); This is a spontaneous report from a contactable physician. A 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunization. Medical history included patient's wife had contracted covid infection the week prior the patient received his first dose, in Jan2021, and patient did not have symptoms of covid infection at time of 1st dose vaccine. Concomitant medications were not reported. Patient experienced covid pneumonia in Feb2021 (positive for covid infection in Feb2021) and was hospitalized on 08Feb2021. Patient received treatments as follows: 12L O2, steroid, remdesivir and convalescent plasma. Patient was fully recovered from the event in Feb2021.   Information on the lot/batch number has been requested.; Sender's Comments: Covid 19 pneumonia is assess as an intercurrent medical condition based on patients exposure to a patient who is positive for Covid 19 prior to vaccination.   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 adverse events. 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: Pulmonary embolism; Multiple clots in his lungs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient wife). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown and expiration date not reported), via an unspecified route of administration on 10Feb2021 at a single dose for Covid-19 immunization.  The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 (EL8982) on 19Jan2021. The reporter (wife) stated that she and her husband both took the Covid vaccine. The patient (husband) is the one who have the adverse reactions. On 19Jan2021, she and her husband had the first shot, the Pfizer Covid shot. On 10Feb2021, they had the second shot. Just today she picked her husband from the hospital, they dismissed him for today because on 18Feb2021, she had to take him to emergency room because he had pulmonary embolism. He has multiple clots in his lungs. This is nothing that they dealt before with him. The reporter is afraid that it might be related to have taken the vaccine. Reporter stated that when she took him to the emergency room, it was 18Feb2021. Now he had a little shortness of breath for few days before the 18th but they didn't realize that he was having a big problem. He fully developed this on 18Feb2021. The reason for hospitalization was pulmonary embolism and blood clots in his lungs. He is little bit slow like the reporter said she got him to the hospital where he stayed 3 days she guess with pulmonary embolism, from 18Feb2021 to 21Feb2021. He had lot a of lab work while he was in hospital on these days the wife described. He had blood work, Echocardiogram, CAT scan, Ultrasounds, Chest X-ray, Covid rapid test, they haven't got back the result yet. Outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Pulmonary embolism; Multiple clots in his lungs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient wife). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown and expiration date not reported), via an unspecified route of administration on 10Feb2021 at a single dose for Covid-19 immunization.  The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 (EL8982) on 19Jan2021. The reporter (wife) stated that she and her husband both took the Covid vaccine. The patient (husband) is the one who have the adverse reactions. On 19Jan2021, she and her husband had the first shot, the Pfizer Covid shot. On 10Feb2021, they had the second shot. Just today she picked her husband from the hospital, they dismissed him for today because on 18Feb2021, she had to take him to emergency room because he had pulmonary embolism. He has multiple clots in his lungs. This is nothing that they dealt before with him. The reporter is afraid that it might be related to have taken the vaccine. Reporter stated that when she took him to the emergency room, it was 18Feb2021. Now he had a little shortness of breath for few days before the 18th but they didn't realize that he was having a big problem. He fully developed this on 18Feb2021. The reason for hospitalization was pulmonary embolism and blood clots in his lungs. He is little bit slow like the reporter said she got him to the hospital where he stayed 3 days she guess with pulmonary embolism, from 18Feb2021 to 21Feb2021. He had lot a of lab work while he was in hospital on these days the wife described. He had blood work, Echocardiogram, CAT scan, Ultrasounds, Chest X-ray, Covid rapid test, they haven't got back the result yet. Outcome of the events was unknown.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: The patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (Reference number- 00487421) and transmitted to Sanofi on 22-FEB-2021.  This case involves a 3 months and 27 days old female patient who was administered 0.5 ml second dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ179AAB, expiry date: 20-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination on 22-Feb-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMONIA-13 for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Developed a large, itchy rash approximately 1and1/2 inch below the injection site 4 days after injection.  Applied 1% cortisone ointment to site for 2 days.  Symptoms subsided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia oral, Nausea, Pain in extremity
Clinical narrative: Tongue, roof of mouth, inside of cheeks, uvula, and back of throat went numb about 20 minutes after vaccination. It's currently 11pm and the numbness is still present in all areas.  (mild nausea, mild headache, mild chills, moderate arm pain present but I'm not concerned about those since they're published side effects)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: Tongue, roof of mouth, inside of cheeks, uvula, and back of throat went numb about 20 minutes after vaccination. It's currently 11pm and the numbness is still present in all areas.  (mild nausea, mild headache, mild chills, moderate arm pain present but I'm not concerned about those since they're published side effects)
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Injection site erythema, Injection site pain
Clinical narrative: Beginning 03/06 0900: 101 degree fever, unresponsive to tylenol or ibuprofen. Joint pain and intense headache persisted throughout entire day. Fever did not break. BP @ 1200p - 130/76 100bpm, @ 08:00p - 140/84 80bpm.   03/07 am: Awoke with 100 degree fever, came down to 99.6-99.8 for the remainder of the day with 2 tylenol. Persistent headache, unresponsive to tylenol.  Red vertical oblong patch surrounding injection site 3?x6?. Site painful and tender to the touch. Joint aches subsiding gradually but still present at 22:00. Unusual chest pain upper right.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Beginning 03/06 0900: 101 degree fever, unresponsive to tylenol or ibuprofen. Joint pain and intense headache persisted throughout entire day. Fever did not break. BP @ 1200p - 130/76 100bpm, @ 08:00p - 140/84 80bpm.   03/07 am: Awoke with 100 degree fever, came down to 99.6-99.8 for the remainder of the day with 2 tylenol. Persistent headache, unresponsive to tylenol.  Red vertical oblong patch surrounding injection site 3?x6?. Site painful and tender to the touch. Joint aches subsiding gradually but still present at 22:00. Unusual chest pain upper right.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Rash erythematous, Skin warm
Clinical narrative: I had a red rash that appeared 11 days after the first dose of the Moderna vaccine. It is hot, red and itchy. This is also accompanied by diarrhea.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling of tongue. Vitals within normal limits. Had tongue tingling after 1st dose of Pfizer vaccine that resolved with Benadryl 25 mg PO. Given Benadryl 25 mg PO for this adverse event.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Chest pain, Chills, Exposure during pregnancy
Clinical narrative: Mar 5-2:30pm: arm began to feel sore. Mar6-12:00am  I can barely lift my left arm above chest level. The soreness has traveled from the injection site down to my wrist and fingers. The injection site is slightly pink, not really noticeable, and warm to the touch. I start to feel a little nauseous and also starting to get body aches and chills. From 12:00am-4:00am i constantly wake up because of arm soreness and body aches. At 4:00am, I woke up  to use the restroom and realized even the bottom of my feet hurt with every step I took. Took my temperature and it was at 101.5.  I went back to bed and fell asleep even though I kept waking. At 7:00am, the migraine started. I was trying to avoid taking meds just to be able to get a clear picture of how my body responds to the vaccine, But by 9:30am (22hrs post vaccine) I ended up taking Tylenol for severe migraine. It feels like someone is stabbing my temples with a very sharp object. Turning or even slightly moving my head strengthens the migraine. My arm is still so sore that I can barely move it!  Tylenol brings temperature down to 100.7°. 10:30am I began with extreme fatigue. By 12:30pm I went back to bed because I couldn?t stand my body aches and migraine. I slept until 4:00pm woke up feeling a little better. Migraine was still there but not as bad. At 8:00pm I began to feel pressure on my chest. That pressure slowly turned into pain. By 9:20pm I was in excruciating pain, I was in tears and I literally thought I was going to die. It hurt to breath. I checked into the ER by 9:30pm the pain was sharp and it would come, last a few minutes, then slowly ease off a bit. On a scale of 1-10 if was definitely a TEN!!!! The ER said it wasn?t cardiac so they sent me home. The DR did say that the chest pain could have possibly been caused by the vaccine, as many have seen different symptoms and everyone has reacted differently. I was home by 1:15am. The pains continued until 3:00am. By 8:30am on Sunday Mar 7, the only thing I was suffering from was soreness in the arm and my chest was sore from the pain. The pain in my chest was a 1 or 2 compared to the 10 that it was when I went to the ER, And that pain/discomfort has lingered all day.  I?m currently 22weeks 4days pregnant with a boy and expected to deliver July 7th. I?ve been pregnant 19 times have 4 living children and suffered 14miscarriages.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site warmth, Migraine, Mobility decreased
Clinical narrative: Mar 5-2:30pm: arm began to feel sore. Mar6-12:00am  I can barely lift my left arm above chest level. The soreness has traveled from the injection site down to my wrist and fingers. The injection site is slightly pink, not really noticeable, and warm to the touch. I start to feel a little nauseous and also starting to get body aches and chills. From 12:00am-4:00am i constantly wake up because of arm soreness and body aches. At 4:00am, I woke up  to use the restroom and realized even the bottom of my feet hurt with every step I took. Took my temperature and it was at 101.5.  I went back to bed and fell asleep even though I kept waking. At 7:00am, the migraine started. I was trying to avoid taking meds just to be able to get a clear picture of how my body responds to the vaccine, But by 9:30am (22hrs post vaccine) I ended up taking Tylenol for severe migraine. It feels like someone is stabbing my temples with a very sharp object. Turning or even slightly moving my head strengthens the migraine. My arm is still so sore that I can barely move it!  Tylenol brings temperature down to 100.7°. 10:30am I began with extreme fatigue. By 12:30pm I went back to bed because I couldn?t stand my body aches and migraine. I slept until 4:00pm woke up feeling a little better. Migraine was still there but not as bad. At 8:00pm I began to feel pressure on my chest. That pressure slowly turned into pain. By 9:20pm I was in excruciating pain, I was in tears and I literally thought I was going to die. It hurt to breath. I checked into the ER by 9:30pm the pain was sharp and it would come, last a few minutes, then slowly ease off a bit. On a scale of 1-10 if was definitely a TEN!!!! The ER said it wasn?t cardiac so they sent me home. The DR did say that the chest pain could have possibly been caused by the vaccine, as many have seen different symptoms and everyone has reacted differently. I was home by 1:15am. The pains continued until 3:00am. By 8:30am on Sunday Mar 7, the only thing I was suffering from was soreness in the arm and my chest was sore from the pain. The pain in my chest was a 1 or 2 compared to the 10 that it was when I went to the ER, And that pain/discomfort has lingered all day.  I?m currently 22weeks 4days pregnant with a boy and expected to deliver July 7th. I?ve been pregnant 19 times have 4 living children and suffered 14miscarriages.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: Mar 5-2:30pm: arm began to feel sore. Mar6-12:00am  I can barely lift my left arm above chest level. The soreness has traveled from the injection site down to my wrist and fingers. The injection site is slightly pink, not really noticeable, and warm to the touch. I start to feel a little nauseous and also starting to get body aches and chills. From 12:00am-4:00am i constantly wake up because of arm soreness and body aches. At 4:00am, I woke up  to use the restroom and realized even the bottom of my feet hurt with every step I took. Took my temperature and it was at 101.5.  I went back to bed and fell asleep even though I kept waking. At 7:00am, the migraine started. I was trying to avoid taking meds just to be able to get a clear picture of how my body responds to the vaccine, But by 9:30am (22hrs post vaccine) I ended up taking Tylenol for severe migraine. It feels like someone is stabbing my temples with a very sharp object. Turning or even slightly moving my head strengthens the migraine. My arm is still so sore that I can barely move it!  Tylenol brings temperature down to 100.7°. 10:30am I began with extreme fatigue. By 12:30pm I went back to bed because I couldn?t stand my body aches and migraine. I slept until 4:00pm woke up feeling a little better. Migraine was still there but not as bad. At 8:00pm I began to feel pressure on my chest. That pressure slowly turned into pain. By 9:20pm I was in excruciating pain, I was in tears and I literally thought I was going to die. It hurt to breath. I checked into the ER by 9:30pm the pain was sharp and it would come, last a few minutes, then slowly ease off a bit. On a scale of 1-10 if was definitely a TEN!!!! The ER said it wasn?t cardiac so they sent me home. The DR did say that the chest pain could have possibly been caused by the vaccine, as many have seen different symptoms and everyone has reacted differently. I was home by 1:15am. The pains continued until 3:00am. By 8:30am on Sunday Mar 7, the only thing I was suffering from was soreness in the arm and my chest was sore from the pain. The pain in my chest was a 1 or 2 compared to the 10 that it was when I went to the ER, And that pain/discomfort has lingered all day.  I?m currently 22weeks 4days pregnant with a boy and expected to deliver July 7th. I?ve been pregnant 19 times have 4 living children and suffered 14miscarriages.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint stiffness, Pain, Pain in extremity
Clinical narrative: Aches, stiff joints, headache, very tired & very, very sore arm
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills lasting about 36 hours
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Nausea, Oropharyngeal discomfort
Clinical narrative: Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe abdominal pain, nausea, dizziness, headache, fatigue, fever
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe abdominal pain, nausea, dizziness, headache, fatigue, fever
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: Itching of tongue
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Heart rate increased, Hyperhidrosis, Nocturia
Clinical narrative: Vaccinated at approx 1300 hrs.  I began feeling chilled 6 hours later. Chills continued for hours.   I developed a significant headache.  Also experienced some body aches.   Took my temperature via oral thermometer at 10:00 PM and it was 101.5.   Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets.  Chills continued, but then I also began sweating profusely.   I did not rest well and was up approx every hour drinking water and urinating.  I noticed an elevated heart rate for several hours through the night.   cont'd below