chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Facial asymmetry, Facial paralysis, Feeling hot
Clinical narrative: A very slight droop of relaxed right lip (Smile is symmetrical and NO orbital involvement); tightness, swelling and tingling in right jaw; tightness, swelling and tingling in right jaw; tightness, swelling and tingling in right jaw; generalized itching; A small patch (dime-size)of non-raised erythema noted behind right ear; A brief period of feeling hot followed immediately by a chills; A brief period of feeling hot followed immediately by a chills; Rash; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 18Dec2020 at 08:45 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and seasonal allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within 2 weeks of vaccination, included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC). Other concomitant medications included an unspecified antihypertensive. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced a very slight droop of relaxed right lip (smile is symmetrical and no orbital involvement), tightness, swelling and tingling in right jaw, generalized itching, a small patch (dime-size) of non-raised erythema noted behind right ear, a brief period of feeling hot followed immediately by a chills, and rash on 18Dec2020 at 09:30. Therapeutic measures were taken as a result of the events, which included treatment with oral diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of a very slight droop of relaxed right lip (smile is symmetrical and no orbital involvement), tightness, swelling and tingling in right jaw, a small patch (dime-size) of non-raised erythema noted behind right ear, and a brief period of feeling hot followed immediately by a chills was not recovered and of generalized itching and rash was recovered on an unspecified date. It was reported that jaw tightness and slight asymmetry of relaxed lips continued on 18Dec2020 at 16:15. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the close temporal relationship, there is a possibility that the events are related to BNT162 vaccine. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia, Pruritus, Rash, Swelling face
Clinical narrative: A very slight droop of relaxed right lip (Smile is symmetrical and NO orbital involvement); tightness, swelling and tingling in right jaw; tightness, swelling and tingling in right jaw; tightness, swelling and tingling in right jaw; generalized itching; A small patch (dime-size)of non-raised erythema noted behind right ear; A brief period of feeling hot followed immediately by a chills; A brief period of feeling hot followed immediately by a chills; Rash; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 18Dec2020 at 08:45 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and seasonal allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within 2 weeks of vaccination, included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC). Other concomitant medications included an unspecified antihypertensive. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced a very slight droop of relaxed right lip (smile is symmetrical and no orbital involvement), tightness, swelling and tingling in right jaw, generalized itching, a small patch (dime-size) of non-raised erythema noted behind right ear, a brief period of feeling hot followed immediately by a chills, and rash on 18Dec2020 at 09:30. Therapeutic measures were taken as a result of the events, which included treatment with oral diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of a very slight droop of relaxed right lip (smile is symmetrical and no orbital involvement), tightness, swelling and tingling in right jaw, a small patch (dime-size) of non-raised erythema noted behind right ear, and a brief period of feeling hot followed immediately by a chills was not recovered and of generalized itching and rash was recovered on an unspecified date. It was reported that jaw tightness and slight asymmetry of relaxed lips continued on 18Dec2020 at 16:15. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the close temporal relationship, there is a possibility that the events are related to BNT162 vaccine. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Feeling hot, Panic reaction, Parosmia
Clinical narrative: experienced a strong medicine-like smell; a rush of warmth throughout my body; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; panicked; felt that my throat was tight but I didn't feel short of breath; My BP was elevated at 140s/80s; tachycardic; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscularly at the right arm on 18Dec2020 at 13:00 (1 pm) at single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma r/t environmental allergies, anxiety, and known allergies to PCN, Sulfa, grass, trees, ragweed, weeds, mold, dust mites, cat and dog. Concomitant medication included cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (VENLAFAXINE XR), colecalciferol (VITAMIN D), ibuprofen, and montelukast sodium (SINGULAIR). The patient received the vaccine on 18Dec2020 at approximately 1 pm (13:00) and 5 minutes later (18Dec2020 at 13:05), she experienced a strong medicine-like smell and a rush of warmth throughout her body. She then felt that her hands were swelling and slightly itchy but they did not appear to be swollen. She was panicked and felt that her throat was tight but she didn't feel short of breath. Her BP was elevated at 140s/80s and she was tachycardic. She gave herself an epinephrine injection and about 10 minutes later the occupational health nurse gave her 25 mg Benadryl at her request. The adverse events results in Emergency room/department or urgent care. The clinical outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The history of asthma, allergies, and anxiety may have been contributory.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia, Throat tightness
Clinical narrative: experienced a strong medicine-like smell; a rush of warmth throughout my body; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; felt that my hands were swelling and slightly itchy but they did not appear to be swollen; panicked; felt that my throat was tight but I didn't feel short of breath; My BP was elevated at 140s/80s; tachycardic; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscularly at the right arm on 18Dec2020 at 13:00 (1 pm) at single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma r/t environmental allergies, anxiety, and known allergies to PCN, Sulfa, grass, trees, ragweed, weeds, mold, dust mites, cat and dog. Concomitant medication included cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (VENLAFAXINE XR), colecalciferol (VITAMIN D), ibuprofen, and montelukast sodium (SINGULAIR). The patient received the vaccine on 18Dec2020 at approximately 1 pm (13:00) and 5 minutes later (18Dec2020 at 13:05), she experienced a strong medicine-like smell and a rush of warmth throughout her body. She then felt that her hands were swelling and slightly itchy but they did not appear to be swollen. She was panicked and felt that her throat was tight but she didn't feel short of breath. Her BP was elevated at 140s/80s and she was tachycardic. She gave herself an epinephrine injection and about 10 minutes later the occupational health nurse gave her 25 mg Benadryl at her request. The adverse events results in Emergency room/department or urgent care. The clinical outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The history of asthma, allergies, and anxiety may have been contributory.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Facial asymmetry, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: diagnosed with Bell's palsy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration in left arm on 19Dec2020 10:00 at single dose for COVID-19 immunization. No other vaccine administered in four weeks. Medical history included drug sulfa allergy. Concomitant medication included cetirizine, cetirizine hydrochloride (ZYRTEC) from 18Dec2020, and multivitamin from 18Dec2020. No Covid prior vaccination. No Covid tested post vaccination. About 40 min after the vaccine (19Dec2020 10:40) the patient developed left facial/ left tongue tingling/ numbness. By 20:30 at night (19Dec2020 20:30), the patient had a left sided facial droop as well, the patient was diagnosed with Bell's palsy. 20:30 (19Dec2020), she had facial asymmetry. She looked in the mirror and noticed her smile was not symmetrical. She then checked into the Emergency Room and the ER doctors diagnosed her with Bell's palsy. She was not admitted to the hospital. Steroids were given for treatment. The patient was still expirencing. Intermittent tingling but tingling was not constant. Smile was not normal yet. The outcome of event was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: diagnosed with Bell's palsy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration in left arm on 19Dec2020 10:00 at single dose for COVID-19 immunization. No other vaccine administered in four weeks. Medical history included drug sulfa allergy. Concomitant medication included cetirizine, cetirizine hydrochloride (ZYRTEC) from 18Dec2020, and multivitamin from 18Dec2020. No Covid prior vaccination. No Covid tested post vaccination. About 40 min after the vaccine (19Dec2020 10:40) the patient developed left facial/ left tongue tingling/ numbness. By 20:30 at night (19Dec2020 20:30), the patient had a left sided facial droop as well, the patient was diagnosed with Bell's palsy. 20:30 (19Dec2020), she had facial asymmetry. She looked in the mirror and noticed her smile was not symmetrical. She then checked into the Emergency Room and the ER doctors diagnosed her with Bell's palsy. She was not admitted to the hospital. Steroids were given for treatment. The patient was still expirencing. Intermittent tingling but tingling was not constant. Smile was not normal yet. The outcome of event was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded.  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: M
Vaccine: COVID19
Symptoms: Myalgia, Periorbital swelling, Pyrexia
Clinical narrative: bilateral periorbital swelling; Myalgia; Fever; This is a spontaneous report from a contactable physician.  A 49-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date  as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced bilateral periorbital swelling, myalgia and fever on an unspecified date, which were medically significant. Description was as followed:  patient went to the emergency department. The vaccines was given on a Wednesday afternoon, and patient presented with bilateral periorbital swelling this morning, myalgias, and fever.  Therapeutic measures were taken as a result of swelling, myalgia and fever; the only treatment given was diphenhydramine (BENADRYL) orally.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, periorbital swelling, myalgia and fever, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperhidrosis, Palpitations, Supraventricular tachycardia, Troponin
Clinical narrative: Diaphoresis; palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor.; palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor.; This is a spontaneous report from a contactable physician. A 56-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at 09:00 at single dose for covid-19 immunization. Medical history included hypertension, episode of SVT (supraventricular tachycardia) in the past. There were no concomitant medications. The patient experienced diaphoresis, and palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor on 18Dec2020. The events were reported as serious per medically significant. Event details: the patient received the vaccine 18Dec2020 at 09:00AM. About 40 minutes later the patient returned to hospital where he worked, where he received the vaccine, with diaphoresis, palpitations of 180-150 beats per minute, and SVT supraventricular tachycardia on the heart monitor. Reporter stated this was temporally related. Patient was given Adenosine 6mg IV with no response; then 12mg Adenosine with no response. Then the patient the spontaneously converted 10 minutes after the last dose of adenosine to 75 beats per minute and sinus rhythm, in one beat. The reporter was an emergency room (ER) physician and the patient was the ER right now. The patient was stable at time of reporting and expected to be discharged. The reporter did order a Troponin and cardiac workup. Troponin result was less than 6 which was normal. With regard to the Adenosine that didn't work reporter stated those vials usually went into a container and after consulting with another coworker stated the Adenosine vial had been discarded at this time and he was unable to provide NDC, lot or expiration date. The outcome of the events was resolved on 18Dec2020.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship and the description of the events,diaphoresis, palpitations and SVT, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: Immediate post-injection reaction, Syncope
Clinical narrative: fainted right after taking the vaccine; This is a spontaneous report from a non-contactable consumer (Pfizer company representative).  A female patient of an unspecified age received the bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; Batch/lot number, NDC number, Expiry Date: Unknown), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced fainted right after taking the vaccine (medically significant) on 17Dec2020. It was unknown if the patient received other products, and any investigation assessment was unknown. The clinical course was reported as follows: The reporter stated they had seen quite a bit on social media and on the (site name), where people have been sending around a video regarding a healthcare worker who fainted. The caller was just wondering " if Pfizer has been made aware of this. "Apparently, this was on the news. This healthcare worker was taking the COVID-19 vaccine and as she was talking to the press, she apparently fainted. It looks as if she fainted as one would do when taking blood tests or faint from fear of a shot or being worried. However, this video has been sent all over social media, as seen as an AE, and telling people to not take the vaccine." The reporter further clarified the healthcare worker was in (city name) and received the COVID-19 vaccine. As the healthcare worker was talking to the press, she fainted right after taking the vaccine. The reporter further clarified she was sent a link via (site name) from the news channel where it had the video recording. The reporter did not have a specific reporter. The reporter explained it was a " whole group that was talking about it." The reporter clarified she was in a (state name) group on (site name) with friends and family. The reporter also saw it on social media. " People are sending it left and right." When probed to determine if the reporter had any patient details or further details regarding the event, the caller stated the only information she had was that on (News name), and click on (City name) news and find the video of the healthcare worker taking the vaccine and fainting. The reporter clarified the news article was dated as 17Dec2020 "so this event must have happened yesterday." From the reporter's understanding from the news, the patient was fine, she got up.  "However, people are sending out on social media that she is dead", which the reporter did not think was the outcome. According to the news, when the reporter opened the link, it was just a regular fainting, it was not a death.  The reporter felt obligated to report and make sure Pfizer was aware of this since she had been seeing it everywhere on social media. The clinical outcome of the event, fainted right after taking the vaccine, was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Paraesthesia oral, Throat tightness
Clinical narrative: throat tightness; tingling of lips; allergic reaction; felt strange; This is a spontaneous report from a contactable Other-HCP (nurse practitioner). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC, lot/batch number and expiration date unknown), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization (She wanted to be vaccinated against COVID 19). Patient history was no. She has no other history no other history of reactions to vaccines or flu vaccines, no history of allergies noted before. She thought her weight was probably about 140. She did not have her height either, but she was about 5'4" probably. Concomitant medication included atorvastatin (LIPITOR) and thyroid medications. It was reported that they have an employee that received the COVID 19 vaccination and experienced an allergic reaction. It had to be a brief call but it was there crazy. Patient received the vaccine and within 30 minutes she had throat tightness and tingling of lips. This happened on 18Dec2020(today) about 20-30 minutes after receiving the vaccine. The throat tightness had resolved after giving Epinephrine (Epi). She said the tingling of her lips resolved as well after Epi. She just said she felt strange but that could be from the Epi. She said it was an employee vaccination so there was no prescriber. She took Lipitor and thyroid medications. She said those were just her routine medications. She did not have a start date for the Lipitor. She had not been on anything new. It was definitely just the COVID vaccine. Outcome of the events tingling of her lips, throat tightness and allergy reaction was recovered on 18Dec2020, of other event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events allergic reaction and throat tightness were related to BNT162b2 based on known drug safety profile and close temporal relationship. Based on the close temporal relationship, the association between the event tingling of lips with BNT162b2 can not be completely excluded.  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: Anaphylactic reaction, Arthralgia, Chest pain, Chills, Dysphonia
Clinical narrative: Anaphylactic Reaction; felt like something was in throat; felt tingling on both hands and fingers; voice started to change; face turning red to white to purple; everything in mouth as tongue felt like it was growing; having chest pain radiating to left scalpel, and jaw; couldn't think of the words to say as it was hard to breath; chills; heart rate is racing; This is a spontaneous report from a non-contactable nurse via internet source via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included had a lot of food allergies. The patient's concomitant medications were not reported. The nurse told that her manager (patient) had an anaphylactic reaction shortly after receiving Pfizer's COVID-19 BNT162b2 vaccine on 18Dec20. Patient stated via Social Media indicated that she received the Covid-19 vaccine right after work. Easy breezy didn't feel a thing. She was asked to wait for 15 minutes, 5-10 minutes of waiting, she felt like something was in throat, so she kept clearing it. Patient felt tingling on both hands and fingers. Her voice started to change. She informed the ER team there, the ER nurse described her face turning red to white to purple. ER nurse started an IV right on patient's right AC, gave her a shot of Benadryl, steroids and the epi pen right through pants. Patient felt everything in mouth as tongue felt like it was growing, but she can breath. Patient was route to the ED via wheelchair, everything started to look hazy, she was having chest pain radiating to left scalpel, and jaw. Patient couldn't think of the words to say as it was hard to breath. When got to the ED they gave her another dose of Benadryl, solumedrol, decadeon, HHN tx with epi and that worked. Patient felt her throat opening up and started talking but then came the chills. It took almost 3 hours to clear the symptoms, even though her heart rate is racing (prob due to the meds), she opted to go home. The outcome of "heart racing" was not recovered, of other events were recovered on 18Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reactions with tongue swelling/voice alteration/hard breath/tingling/something in throat/skin discoloration, chill and chest pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.   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: Dyspnoea, Erythema, Mental impairment, Pain, Pain in jaw
Clinical narrative: Anaphylactic Reaction; felt like something was in throat; felt tingling on both hands and fingers; voice started to change; face turning red to white to purple; everything in mouth as tongue felt like it was growing; having chest pain radiating to left scalpel, and jaw; couldn't think of the words to say as it was hard to breath; chills; heart rate is racing; This is a spontaneous report from a non-contactable nurse via internet source via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included had a lot of food allergies. The patient's concomitant medications were not reported. The nurse told that her manager (patient) had an anaphylactic reaction shortly after receiving Pfizer's COVID-19 BNT162b2 vaccine on 18Dec20. Patient stated via Social Media indicated that she received the Covid-19 vaccine right after work. Easy breezy didn't feel a thing. She was asked to wait for 15 minutes, 5-10 minutes of waiting, she felt like something was in throat, so she kept clearing it. Patient felt tingling on both hands and fingers. Her voice started to change. She informed the ER team there, the ER nurse described her face turning red to white to purple. ER nurse started an IV right on patient's right AC, gave her a shot of Benadryl, steroids and the epi pen right through pants. Patient felt everything in mouth as tongue felt like it was growing, but she can breath. Patient was route to the ED via wheelchair, everything started to look hazy, she was having chest pain radiating to left scalpel, and jaw. Patient couldn't think of the words to say as it was hard to breath. When got to the ED they gave her another dose of Benadryl, solumedrol, decadeon, HHN tx with epi and that worked. Patient felt her throat opening up and started talking but then came the chills. It took almost 3 hours to clear the symptoms, even though her heart rate is racing (prob due to the meds), she opted to go home. The outcome of "heart racing" was not recovered, of other events were recovered on 18Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reactions with tongue swelling/voice alteration/hard breath/tingling/something in throat/skin discoloration, chill and chest pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.   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: Swollen tongue, Throat clearing, Vision blurred
Clinical narrative: Anaphylactic Reaction; felt like something was in throat; felt tingling on both hands and fingers; voice started to change; face turning red to white to purple; everything in mouth as tongue felt like it was growing; having chest pain radiating to left scalpel, and jaw; couldn't think of the words to say as it was hard to breath; chills; heart rate is racing; This is a spontaneous report from a non-contactable nurse via internet source via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included had a lot of food allergies. The patient's concomitant medications were not reported. The nurse told that her manager (patient) had an anaphylactic reaction shortly after receiving Pfizer's COVID-19 BNT162b2 vaccine on 18Dec20. Patient stated via Social Media indicated that she received the Covid-19 vaccine right after work. Easy breezy didn't feel a thing. She was asked to wait for 15 minutes, 5-10 minutes of waiting, she felt like something was in throat, so she kept clearing it. Patient felt tingling on both hands and fingers. Her voice started to change. She informed the ER team there, the ER nurse described her face turning red to white to purple. ER nurse started an IV right on patient's right AC, gave her a shot of Benadryl, steroids and the epi pen right through pants. Patient felt everything in mouth as tongue felt like it was growing, but she can breath. Patient was route to the ED via wheelchair, everything started to look hazy, she was having chest pain radiating to left scalpel, and jaw. Patient couldn't think of the words to say as it was hard to breath. When got to the ED they gave her another dose of Benadryl, solumedrol, decadeon, HHN tx with epi and that worked. Patient felt her throat opening up and started talking but then came the chills. It took almost 3 hours to clear the symptoms, even though her heart rate is racing (prob due to the meds), she opted to go home. The outcome of "heart racing" was not recovered, of other events were recovered on 18Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reactions with tongue swelling/voice alteration/hard breath/tingling/something in throat/skin discoloration, chill and chest pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.   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, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: injection site pain; tiredness; headaches that come and go; muscle pain; few chill; severe joint pain; fever; This is a spontaneous report from a non-contactable healthcare professional (patient).  A female patient of an unspecified age (Age: 60; Unit: Unknown) received single dose of (BNT162B2, batch/lot number and exp date not reported), via an unspecified route of administration on 21Dec2020 (last Monday), around 11amfor immunization. The patient's medical history and concomitant medications were not reported. Patient reported experiencing 7 side effects after receiving the COVID-19 vaccine on an unspecified date in Dec2020. She experienced injection site pain, tiredness, headaches that come and go, muscle pain, few chill, severe joint pain, and fever. Her temperature ranged between 99.9-100, at the low grade. Patient asked how long the symptoms would last and to what point does she assume that they relate to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: injection site pain; tiredness; headaches that come and go; muscle pain; few chill; severe joint pain; fever; This is a spontaneous report from a non-contactable healthcare professional (patient).  A female patient of an unspecified age (Age: 60; Unit: Unknown) received single dose of (BNT162B2, batch/lot number and exp date not reported), via an unspecified route of administration on 21Dec2020 (last Monday), around 11amfor immunization. The patient's medical history and concomitant medications were not reported. Patient reported experiencing 7 side effects after receiving the COVID-19 vaccine on an unspecified date in Dec2020. She experienced injection site pain, tiredness, headaches that come and go, muscle pain, few chill, severe joint pain, and fever. Her temperature ranged between 99.9-100, at the low grade. Patient asked how long the symptoms would last and to what point does she assume that they relate to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, swelling, and itching at injection site 6 days after receiving the vaccine.; Developed redness, swelling, and itching at injection site 6 days after receiving the vaccine.; Developed redness, swelling, and itching at injection site 6 days after receiving the vaccine.; This is a spontaneous report from a non-contactable nurse reporting for a patient.  A 29-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK5730), via an unspecified route of administration on 16Dec2020 on left arm at single dose for COVID-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported. The patient was not pregnant. She had no known allergies, no Covid prior vaccination, no Covid tested post vaccination. The patient developed redness, swelling, and itching at injection site 6 days after receiving the vaccine (on 23Dec2020). No treatment was received for the adverse event. The outcome of the events was unknown. The report was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Fatigue, Paraesthesia
Clinical narrative: chills; extremely dry mouth where she feels like she has no saliva; extremely dry mouth where she feels like she has no saliva; extremely tired; had a strange sensation of tingling in her skull, back of neck, and up her skull. Tingling sensation is more left sided than right/the tingling sensation in her head; This is a spontaneous report received from a contactable nurse (who is also the patient). A 63-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: Mar2021), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she had a strange sensation of tingling in her skull, back of neck, and up her skull. Tingling sensation was more left sided than right. On24Dec2020, she experienced chills, which she knows is one of the normal effects. She also experienced an extremely dry mouth to where she feels like she has no normal saliva on 24Dec2020. She was constantly drinking ice water. She was also extremely tired. The patient reported that the most concerning to her is the tingling sensation in her head and the extreme dry mouth. The patient wanted to know if what she is experiencing is ok or not. She also reported that "if it's urgent she cannot wait until USMI reopens, she will go to the ER". The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: localized soreness in arm; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A male (nephew) patient of unknown age received on an unknown date BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the arm for COVID-19 shot. Medical history and concomitant medications were not reported. The patient, who is an ER doc, had localized soreness in arm from vaccination. Outcome was unknown. No follow up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: Got a strain of flu not being vaccinated against; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient with unknown demography who got a strain of flu (not being vaccinated against) (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a strain of (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: On an unknown date laboratory test showed strain of flu.  It was not reported if the patient received any corrective treatment or not.  It was reported that the patient tried various doses three years and got a strain of flue each year within a week of shot.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 14.0
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old male patient was given FLUBLOK instead of Flulaval, no AE; 14 year old male patient was given FLUBLOK , no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 year old male patient who inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  On 21-Dec-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Paraesthesia, Rash, Rash pruritic
Clinical narrative: Patient states that she waited her required 15min at the vaccine clinic.  She felt no symptoms.  One hour later however she felt tired so she took a nap.  That night she felt cold and had to grab a blanket.  Before bed she felt that the skin on her abdomen was feeling "tingly."  The next morning she noticed a rash on the abdomen that is itchy.  She already takes 25mg benadryl daily for allergies so she started taking it twice a day but that hasn't helped.  She now notices the rash in the b/l groin, left thoracic back and left arm (upper and forearm).  The rash is still present and itchy 5 days later so she came to my clinic today.  I prescribed her a 6 day dose pack of methylprednisolone and to continue benadryl.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain at injection site, fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, headache, bodyaches, low-grade fever, fatigue
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site swelling
Clinical narrative: First day had chills, headache, body ache, body sweat, fever, fatigue  for two-three days, first day slept for 21 hours, second day for 15 hours.  Didn't start feeling normal until the fifth day. Arm swollen where the shot was given on right arm, 3 inches size.  Today is the 6th day and still some visible swelling on the area down to two inches but itchy for two days now.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: First day had chills, headache, body ache, body sweat, fever, fatigue  for two-three days, first day slept for 21 hours, second day for 15 hours.  Didn't start feeling normal until the fifth day. Arm swollen where the shot was given on right arm, 3 inches size.  Today is the 6th day and still some visible swelling on the area down to two inches but itchy for two days now.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: rec'd vaccine on 12/3/2020 returned to pharmacy on 12/7/2020 after visiting MD who asked him to go to pharmacy with warm/hot arm, redness about 5 inches down his arm.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: felt tired and had left elbow pain
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Muscle twitching, Rash papular
Clinical narrative: Non-itchy slighlty raised rash that appeared about 24 hours after vaccine at location of shot that extended up to shoulder and down to elbow. It went away after another 24 hours.    1 week after vaccine, developed lip twitch on side of body that vaccine was administered. Still persists 1 week later, but is not as intense
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Swelling face, Tachycardia, Throat irritation
Clinical narrative: 0654 TACHYCARDIA. LIGHTHEADED, THROAT IRRITATION, HYPERTENSION, & FACIAL SWELLING
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Cough, Dizziness
Clinical narrative: Arthralgia, sore throat,  dry cough, congestion, pain to back of head and neck, leg pain, lower back pain, fatigue, fever 100.7 on 12/23/20 12/26/20- developed chest pain neck pain left shoulder pain lightheaded and nausea at night-resolved next morning
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Arthralgia, sore throat,  dry cough, congestion, pain to back of head and neck, leg pain, lower back pain, fatigue, fever 100.7 on 12/23/20 12/26/20- developed chest pain neck pain left shoulder pain lightheaded and nausea at night-resolved next morning
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arthralgia, sore throat,  dry cough, congestion, pain to back of head and neck, leg pain, lower back pain, fatigue, fever 100.7 on 12/23/20 12/26/20- developed chest pain neck pain left shoulder pain lightheaded and nausea at night-resolved next morning