chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Rapid heartbeat; Chills; Sore arm; My entire left arm was sore; low blood pressure and my blood pressure was 81/51; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 14:20 (Batch/Lot Number: EN6198; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date , gastrointestinal disorder from an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for anticoagulant therapy, start and stop date were not reported.  The patient experienced rapid heartbeat, chills, sore arm, His entire left arm was sore, low blood pressure and his blood pressure was 81/51.  The patient underwent lab tests and procedures which included blood pressure measurement: low on blood pressure measurement: 81/51 on heart rate: 60 heart rate: rapid  83. Therapeutic measures were taken as a result of rapid heartbeat with Diltiazem. The outcome of the events was unknown.  Additional Context: Consumer stated "I am calling I had the Pfizer vaccine on 05Mar2021 and I have a heart condition and I am calling to report a side effect that occurred about 11 hours, I became aware about a side effect of rapid heartbeat for about 11 hours, it was during the night. Is this the number where I can (incomplete sentence). I wanted to know if this is a common adverse event, side effect?"  When confirmed the consumer wanted to report the side effects, consumer stated, "Yes I wanted to report the side effect, I have atrial fibrillation and I take medication for that and 11 hours after my first vaccine I had rapid heartbeat even though I had medicine (Unspecified Medication) in my blood stream. I take medicine 24/7 to control, to prevent rapid heartbeat. Usually my heart rate would be, and this was during the night I woke up and it was my pulse was 83 and that is very rapid for me especially since I am under the influence of the heart medicine (Unspecified Medication) to keep it down. Usually that time at night my heart rate would be about 60 and I had to take additional heart pills during for about 12 hours (further clarification unknown)." When informed the role of Pfizer Drug Safety, consumer stated, "But you don't, do you have any feedback or response from all this massive inoculation as to whether this is the, it was not a sudden fast heart rate and it was not sudden because I am under the medication 24/7." Consumer was informed about Pfizer Medical Information and offered the number. Consumer was provided with the number of Pfizer Medical Information # and was requested to select option 3, timings as and 8 am to 11 pm Monday to Sunday as per (EST). Email: Consumer stated, "I don't, the device is broken."   No follow-up attempts are Possible. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; tiredness; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 38-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in right arm on 24Mar2021 at 14:15 (at the age of 38 years) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in right arm on 03Mar2021 at 10:00 (at the age of 38 years) as 1stdose, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. On 25Mar2021 at 12:00, the patient experienced headache and tiredness. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: fr8727), via an unspecified route of administration into the left arm as a single dose on 23Mar2021 at 14:00 for COVID-19 immunization. Medical history included diabetes. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S), taken for an unspecified indication, start and stop date were not reported; metformin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B 12) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, valsartan (DIOVAN HCT) taken for an unspecified indication, start and stop date were not reported. No noted allergies to medications, food, or other products were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced vomiting on 24Mar2021 and diarrhea in May2021 date. Details were as follows: Vomiting was noted 18 hours after shot. Diarrhea was noted the next day. No treatment was given for the events.  The clinical outcome of vomiting and diarrhea was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Retching
Clinical narrative: Very sore left arm; Nausea; Bad headache; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204) via unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had allergy to sulfonamide. The patient did not medical history and did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and did not experience any side effects. Prior to vaccination, the patient did not test positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced very sore left arm, nausea and dry heaves (on the next day), headache on 25Mar2021 at 16:00. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, nausea, headache and dry heaves was recovering at the time of this report.                            No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Pain in extremity
Clinical narrative: My left upper arm where I got the vaccine abdomen and my face felt very itchy.; My left upper arm where I got the vaccine abdomen and my face felt very itchy.; congestion; fever; headache; felt pain around my upper arm going to my elbow; cough; sore throat; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6207, Expiration Date was not reported), via an unspecified route of administration, administered in upper left arm on 12Mar2021 08:40 (at the age of 59-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history included asthma and hypertension. Concomitant medications were not reported. The patient historical vaccine includes second shot of the shingles with a reaction to the second shot and experienced flu shot redness and heat at the injection site. The patient did not receive any prior vaccinations within 4 weeks. On 12Mar2021, the patient experienced Itching of arm, abdomen, and face, congestion, cough, sore throat, headache and fever. She started feeling itchy 45 min after receiving the vaccine. Her left upper arm where she got the vaccine abdomen and her face felt very itchy. She felt pain around her upper arm going to my elbow. Her fever was 1 degree above my normal temperature. Her congestion ended around 19-20th and fever around the 21. She wants to know if she was eligible to receive the second dose of the vaccine. She did not want to get a full blown COVID, she would rather get a weakened case. She states that it would be because of her age, high blood pressure, and asthma. She wants to know if the reactions she had to the PFIZER COVID shot were normal and if they will prevent her from getting the second shot. She was slammed with congestion and a fever that lasted about 10 days. She was taking Benadryl for the itching and it stopped. She also took Tylenol for the fever. She was concerned but went to get tested. The tests were rapid tests, both times. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Mar2021, sars-cov-2 test: negative on 17Mar2021. Therapeutic measures were taken as a result of left upper arm where she got the vaccine abdomen and my face felt very itchy, fever. The outcome of the event left upper arm where I got the vaccine abdomen and my face felt very itchy was resolved on 12Mar2021, for congestion it was resolved on 19Mar2021, for fever it was resolved on 21Mar2021 and outcome was unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: My left upper arm where I got the vaccine abdomen and my face felt very itchy.; My left upper arm where I got the vaccine abdomen and my face felt very itchy.; congestion; fever; headache; felt pain around my upper arm going to my elbow; cough; sore throat; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6207, Expiration Date was not reported), via an unspecified route of administration, administered in upper left arm on 12Mar2021 08:40 (at the age of 59-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history included asthma and hypertension. Concomitant medications were not reported. The patient historical vaccine includes second shot of the shingles with a reaction to the second shot and experienced flu shot redness and heat at the injection site. The patient did not receive any prior vaccinations within 4 weeks. On 12Mar2021, the patient experienced Itching of arm, abdomen, and face, congestion, cough, sore throat, headache and fever. She started feeling itchy 45 min after receiving the vaccine. Her left upper arm where she got the vaccine abdomen and her face felt very itchy. She felt pain around her upper arm going to my elbow. Her fever was 1 degree above my normal temperature. Her congestion ended around 19-20th and fever around the 21. She wants to know if she was eligible to receive the second dose of the vaccine. She did not want to get a full blown COVID, she would rather get a weakened case. She states that it would be because of her age, high blood pressure, and asthma. She wants to know if the reactions she had to the PFIZER COVID shot were normal and if they will prevent her from getting the second shot. She was slammed with congestion and a fever that lasted about 10 days. She was taking Benadryl for the itching and it stopped. She also took Tylenol for the fever. She was concerned but went to get tested. The tests were rapid tests, both times. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Mar2021, sars-cov-2 test: negative on 17Mar2021. Therapeutic measures were taken as a result of left upper arm where she got the vaccine abdomen and my face felt very itchy, fever. The outcome of the event left upper arm where I got the vaccine abdomen and my face felt very itchy was resolved on 12Mar2021, for congestion it was resolved on 19Mar2021, for fever it was resolved on 21Mar2021 and outcome was unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Has a rash on the same arm that he took the shot; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 73-years-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. Concomitant medication were not reported.On an unspecified date,the patient received his covid-19 shot and experienced has a rash on the same arm that he took the shot. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Dyspnoea, Heart rate irregular
Clinical narrative: Product use for unapproved combination; short of breath; really anxious; she slept a lot; it felt like her heart was beating out of her chest.; She reports taking her blood pressure and it showing that it was 198/117 and then state after a bit it went down to 170.; This is a spontaneous report received from a contactable consumer. Follow up received on: 30Mar2021 from same contactable consumer was processed together along with initial information.   A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 24Mar2021 (at the age of 67 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Patient received first CoVax 24Mar2021, day after reported "Rapid heartbeat," and high blood pressure. Took Benadryl and Lorazepam, went to doctor. The patient reported that she had to take her inhaler 3 times that day following the vaccination but otherwise felt "pretty good." She states that she normally was taking it for the past couple of days 1 to 2 times a day. She then reports that on Thursday she had short of breath and felt "really anxious." She states that she took Benadryl because it felt like her heart was beating out of her chest. She reports her blood pressure showed up 198/117 and then state after a bit it went down to 170. She states she went to an urgent care and was told that the anxiety was a side effect of the vaccine and her blood pressure came down to "158/79 something." She was instructed to take a Benadryl and Lorazepam and to "ride it out" for the next 2 to 3 days. She states on Friday her blood pressure kept going up and doing stating it was "155 then 170 then 40" and also reports that she slept a lot. Caller tells me that she is anxiety prone anyways and wonders if she needed her inhaler initially just because she was anxious but could not tell at that time. She tells me that she has read a medical report that stated 8 people who received the Pfizer BioNTech COVID-19 vaccine experienced similar anxiety attacks following the vaccine. Caller would like to know if, because of her side effects following the vaccine, she should get the second dose of the vaccine. The patient underwent lab tests and procedures which includes Blood pressure measurement with results of 198/117 which went down to 170, calm down to 158/79, 155, 170, 40. Outcome of the events was reported as unknown.   Follow attempts are needed. Further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Somnolence
Clinical narrative: Product use for unapproved combination; short of breath; really anxious; she slept a lot; it felt like her heart was beating out of her chest.; She reports taking her blood pressure and it showing that it was 198/117 and then state after a bit it went down to 170.; This is a spontaneous report received from a contactable consumer. Follow up received on: 30Mar2021 from same contactable consumer was processed together along with initial information.   A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 24Mar2021 (at the age of 67 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Patient received first CoVax 24Mar2021, day after reported "Rapid heartbeat," and high blood pressure. Took Benadryl and Lorazepam, went to doctor. The patient reported that she had to take her inhaler 3 times that day following the vaccination but otherwise felt "pretty good." She states that she normally was taking it for the past couple of days 1 to 2 times a day. She then reports that on Thursday she had short of breath and felt "really anxious." She states that she took Benadryl because it felt like her heart was beating out of her chest. She reports her blood pressure showed up 198/117 and then state after a bit it went down to 170. She states she went to an urgent care and was told that the anxiety was a side effect of the vaccine and her blood pressure came down to "158/79 something." She was instructed to take a Benadryl and Lorazepam and to "ride it out" for the next 2 to 3 days. She states on Friday her blood pressure kept going up and doing stating it was "155 then 170 then 40" and also reports that she slept a lot. Caller tells me that she is anxiety prone anyways and wonders if she needed her inhaler initially just because she was anxious but could not tell at that time. She tells me that she has read a medical report that stated 8 people who received the Pfizer BioNTech COVID-19 vaccine experienced similar anxiety attacks following the vaccine. Caller would like to know if, because of her side effects following the vaccine, she should get the second dose of the vaccine. The patient underwent lab tests and procedures which includes Blood pressure measurement with results of 198/117 which went down to 170, calm down to 158/79, 155, 170, 40. Outcome of the events was reported as unknown.   Follow attempts are needed. Further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; Stomach problem; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient had diarrhea and stomach problem. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: having pain in hands shoulder and knees; having pain in hands shoulder and knees; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A 65-year-old female patient received bnt162b2 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 65 years old) as single dose for covid-19 immunization; tofacitinib citrate (XELJANZ, Lot Number: DP7374), orally from an unspecified date to an unspecified date, at 1 Tablet by mouth daily for OTH Rheeumatoid Arthritis w Rheumatoid Fator mult site. Medical history included age-related Osteoporosis without current pathological fracture. Concomitant medications included ascorbic acid/ ferrous fumarate/ folic acid/retinol (PRENATAL), ertugliflozin pidolate (STEGLATRO), lisinopril, levothyroxine sodium (LEVO T), metformin hcl, flucytosine, curcuma longa (TURMERIC CURCUMIN), vitamins and minerals. The patient stated that she stopped taking the medication on 11Mar2021 due to receiving the COVID-19 vaccination, the MD told her to restart the medication 1 week after second vaccination scheduled for 09Apr2021, patient reported due to not being on medication, she was having pain in hands shoulder and knees, all questions and concerns addressed, patient agreed to follow up calls after she restarts the regimen. The action taken of tofacitinib citrate was unknown. The outcome of events was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (at a age of 71 year old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Mar2021 the patient experienced allergic reaction stated that between her first and second dose she had an allergic reaction to a different medication and was in the hospital. Last Friday (she said maybe it was the 25Mar2021) she went to get her second dose of the vaccine and they wouldn't give it to her, and she had to get confirmation from doctor that her reaction was not to the vaccine. Outcome of event was unknown.    Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021354364 similar report from same reporter
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: the injection site is red and swollen/swelling with red silver dollar spots; arm is sore; she had a very red and tender arm; the injection site is red and swollen; This is a spontaneous report from a contactable consumer (patient herself).   An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in right arm on 29Mar2021 14:20 (reported as Monday) (age at vaccination: 80 years) as DOSE 2, SINGLE for covid-19 immunization at Physician Office. The patient medical history was not reported. Concomitant medication included levothyrxoine sodium (SYNTHROID). The patient said that she was basically healthy. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in his right arm on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was was okay with the 1st Covid shot. The night after the second shot, she had a very red and tender arm. The next morning, it was red and swollen and redder. It has been the same for the last 2 days. The arm was sore with red patches the size of 2 silver dollars. Patient took a Benadryl thinking that would help and used an ice patch. The arm was a little redder this morning. Caller added that pain wise and everything, it was about the same.  The discomfort was about the same. The area was redder and the redness has worsened as in bigger than it was  last night.The patient had no prior vaccinations within 4 weeks. The outcome of the event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Thyroid function test
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiration date: Jul2021), via an unspecified route of administration in the left arm on 30Mar2021 at 08:15 or 08:30 (at the age of 38-year-old) as single dose for COVID-19 immunisation. Medical history included high blood pressure and hypertension from Aug2015 and ongoing; COVID on an unknown date in Dec2020 and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. No investigation assessment was provided. The patient stated she had the 1st dose of the Pfizer vaccine yesterday', 30Mar2021 and itching began at 17:00 that same day yesterday evening' and she was just itching, and it was a lot of itching all over and could not find anything in her system and did not see anything anywhere and she was not allergic to anything. She was asking if this was a possible side effect of the vaccine. She said that the itching got worse and started at 17:00 yesterday and now was about the same as when it began. The patient stated she has not yet had treatment, has not gone to the emergency room or to the HCP (health care professional) and was hoping the itching would go away; stated she was taking Benadryl unsure of the dosage and was hoping the itching would go away with Benadryl. She did take the Benadryl before she went to bed last night and took one tablet but does not know the dosage. She got the Pfizer vaccine because she just wanted to hurry up and get it because she had COVID on an unknown date in Dec2020. She was fine yesterday and prior to this right now she was doing testing on her thyroid but has no results to provide; stated she has not seen a specialist yet and was still waiting to see the specialist; stated her last blood work was on Thursday, 25Mar2021 and they were checking her levels, but she has no results. The event was not resulted in emergency room nor physician's office visit. The patient underwent lab tests and procedures which included thyroid function test: no results on 25Mar2021 - checking her levels but she has no results. The outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chest pain, Dyspnoea, Erythema
Clinical narrative: difficulty breathing/ issues breathing; hives; redness; Pressure on her chest; throat tightness; itching sensation in her skin and face/ itchy; burning sensation on her face; rash in her skin; mild discomfort on her throat; allergic reaction; she does not feel as bad as yesterday; chest pain has diminished; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. Patient received the Pfizer COVID-19 vaccine and had a severe reaction and she was no longer in the hospital, indicated that she should use a Blue Epinephrine injector 0.3 mg two unites in case she required it. She wanted to know if this product could cause another major allergic reaction. She took Prednisone (still taking it today) and Benadryl, the chest pain has diminished but since 11:30-12:30 and mentioned that a normal allergic reaction usually gone away after a wile but this one was returned after her treatment. During the call she mentioned that she was worried that she might die sooner if she used the Epipen. It was reported that patient experienced allergic reaction to Pfizer Covid Vaccine with issues breathing, and itchy hives requiring having to the hospital. Events resulted in Emergency room visit. Patient received treatment with Prednisone and Benadryl for the events. Therapeutic measures were taken as a result of pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. The outcome of chest pain has diminished was recovered on an unspecified date and other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Oropharyngeal discomfort, Pruritus, Rash
Clinical narrative: difficulty breathing/ issues breathing; hives; redness; Pressure on her chest; throat tightness; itching sensation in her skin and face/ itchy; burning sensation on her face; rash in her skin; mild discomfort on her throat; allergic reaction; she does not feel as bad as yesterday; chest pain has diminished; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. Patient received the Pfizer COVID-19 vaccine and had a severe reaction and she was no longer in the hospital, indicated that she should use a Blue Epinephrine injector 0.3 mg two unites in case she required it. She wanted to know if this product could cause another major allergic reaction. She took Prednisone (still taking it today) and Benadryl, the chest pain has diminished but since 11:30-12:30 and mentioned that a normal allergic reaction usually gone away after a wile but this one was returned after her treatment. During the call she mentioned that she was worried that she might die sooner if she used the Epipen. It was reported that patient experienced allergic reaction to Pfizer Covid Vaccine with issues breathing, and itchy hives requiring having to the hospital. Events resulted in Emergency room visit. Patient received treatment with Prednisone and Benadryl for the events. Therapeutic measures were taken as a result of pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. The outcome of chest pain has diminished was recovered on an unspecified date and other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: difficulty breathing/ issues breathing; hives; redness; Pressure on her chest; throat tightness; itching sensation in her skin and face/ itchy; burning sensation on her face; rash in her skin; mild discomfort on her throat; allergic reaction; she does not feel as bad as yesterday; chest pain has diminished; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. Patient received the Pfizer COVID-19 vaccine and had a severe reaction and she was no longer in the hospital, indicated that she should use a Blue Epinephrine injector 0.3 mg two unites in case she required it. She wanted to know if this product could cause another major allergic reaction. She took Prednisone (still taking it today) and Benadryl, the chest pain has diminished but since 11:30-12:30 and mentioned that a normal allergic reaction usually gone away after a wile but this one was returned after her treatment. During the call she mentioned that she was worried that she might die sooner if she used the Epipen. It was reported that patient experienced allergic reaction to Pfizer Covid Vaccine with issues breathing, and itchy hives requiring having to the hospital. Events resulted in Emergency room visit. Patient received treatment with Prednisone and Benadryl for the events. Therapeutic measures were taken as a result of pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. The outcome of chest pain has diminished was recovered on an unspecified date and other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed shingles , left side of my face, days after the first dose of the vaccine.; This is a spontaneous report from contactable consumer (patient herself). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6208, Expiry date: Unknown) via an unspecified route of administration in left arm on 25Mar2021 at 15:30 (at the age of 55-year-old) as 1st dose, single for COVID-19 immunization. Patient did not have any other medical history or known allergies to medications, food, or other products. Other medications (concomitant) the patient received within 2 weeks of vaccination included levothyroxine sodium (Synthroid 100 mcg) and escitalopram oxalate (Lexapro 10mg) both taken for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021, days after the first dose of the vaccine, patient developed shingles, left side of face. Reporter considered the event as non-serious. Therapeutic measures taken in response to the event included Valacyclovir. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling on her armpit; This is the spontaneous report from a contactable consumer (Patient). A female patient of unknown age received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot Number: unspecified), via an unspecified route of administration on 31Mar2021 (Wednesday), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Yesterday, on 01Apr2021, the patient experienced that she had swelling on her armpit and wants to know if this was normal. The outcome of the event was unknown. Follow-up (05Apr2021): This is a follow-up spontaneous report in response to mail trail send to translate the attached report.  No follow-up attempts are possible. Information about lot/ batch number cannot be requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Fatigue, Heart rate, Heart rate increased, Palpitations
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, SARS-CoV-2 test
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood creatine phosphokinase, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest X-ray, Contusion, Cytokine test, Dehydroepiandrosterone test
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Differential white blood cell count, Electrocardiogram, Electrocardiogram ambulatory, Epistaxis
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.