chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Headache, Pneumonitis, SARS-CoV-2 antibody test
Clinical narrative: A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was  not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown.   Information on the Batch/Lot number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was  not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown.   Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: racing heart/Caller's heart rate is typically in the 50's, it went up to 65 and she "could feel it."; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who stated that after getting her first dose of the vaccine she experienced a racing heart. This was further clarified as a racing heart for her.  The patient's heart rate was typically in the 50's, it went up to 65 and she "could feel it."  The patient  questioned if she should get the second dose scheduled for 19Jan2021. The outcome of the events was unknown.   Information on Lot/Batch has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy/Enlarged Lymph node; This is a spontaneous report from a contactable physician. A 40-year-old male patient received bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine and also reported as Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration left deltoid (reported as once by injection on the left deltoid) on 18Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history and concomitant medications.  The physician reported that he got the COVID Vaccine on 18Dec2020 and he got Lymphadenopathy as a possible side effect of the vaccine. It was recently (03Jan2021), he noticed an enlarged lymph node (Lymph node is on left supraclavicular, so above the clavicle on the left side). It could be unrelated, but he was told to call and report it. He would like to know were there patients in the clinical trial who got lymphadenopathy (which part of the body). He did not received treatment. He knows that lymphadenopathy was reported in the study. The reported considered the event as non-serious. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site rash, Vaccination site urticaria
Clinical narrative: rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date  not reported), via an unspecified route of administration on 22Dec2020 14:00 at a single dose on Arm Left for COVID-19 immunization. Medical history included none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Dec2020 21:00, the patient experienced Rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear. Treatment was received for the adverse event which included Benadryl 50mg. The outcome of the events at the time of last observation was recovered/resolved on an unspecified date. 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 has not been tested for COVID-19. The events were considered as non-serious.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Injection site cellulitis, Migraine, Stridor
Clinical narrative: Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness  of breath, stridor and migraine,  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications.  This case will be reassessed once additional information is available.  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: Body temperature, Ear pruritus, Erythema
Clinical narrative: his ear got bright red and really really itchy; his ear got bright red and really really itchy; This is a spontaneous report from a contactable Pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The facility type vaccine was clinic. The patient medical history and concomitant medications were not reported. Within 5-10 minutes administering dose, patient ear got bright red and really really itchy and noticeable compared to the other ear. No fever and breathing is fine. The outcome of events was unknown. The pharmacist asked if this a reaction to the vaccine.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: to get Botox injection for her Dystonia; got her 1st dose of Covid vaccine last 04Jan and was scheduled to have her 2nd dose on 22Jan; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a 62-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her 1st dose of Covid vaccine last 04Jan2021 and was scheduled to have her 2nd dose on 22Jan2021, but she had an appointment 2 days prior this to get botulinum toxin type a (BOTOX) injection for her Dystonia. The patient wanted to know if it's ok for her to get 2nd dose of Covid vaccine after getting botulinum toxin type A. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: having swelling at the injection site to her arm 10 days after the injection of the vaccine; This is a spontaneous report from a contactable physician. A 7-decade-old (reported as in her 60's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported.  The reporter asked if it was normal for a patient to have delayed swelling at injection site on the arm after getting the vaccine. Reporter mentioned that she is a physician whose patient started having swelling at the injection site to her arm 10 days after the injection of the vaccine. Reporter asked should the patient receive the second dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Feeling abnormal, Headache
Clinical narrative: chills; Headaches; nausea; joint pain/pain in right wrist; numbness in left hand; feeling as if the room is moving sideways; pain in right wrist and finger; chest pain; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 23Dec2020 and ever since the patient had symptoms including chills, headaches, nausea, joint pain, numbness in left hand, pain in right wrist and finger, chest pain and then feeling as if the room is moving sideways from an unknown date. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: chills; Headaches; nausea; joint pain/pain in right wrist; numbness in left hand; feeling as if the room is moving sideways; pain in right wrist and finger; chest pain; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 23Dec2020 and ever since the patient had symptoms including chills, headaches, nausea, joint pain, numbness in left hand, pain in right wrist and finger, chest pain and then feeling as if the room is moving sideways from an unknown date. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Musculoskeletal stiffness, Pain in jaw
Clinical narrative: Head is pounding (migraine); Jaw hurting; Neck is stiff; Can't sleep (haven't slept); This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. In Jan2021, the patient's head was pounding (migraine); jaw was hurting; neck was stiff; and she could not sleep (have not slept). The outcome of the events, 'head was pounding', 'jaw was hurting', 'neck was stiff' and 'could not sleep', was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Night sweats, Pruritus, Pyrexia
Clinical narrative: Night sweats; Extreme nausea; Chills; Fever; Itch; This is a spontaneous report from a contactable Nurse (patient) reported for self. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse was asking for recommendations if she could get the 2nd dose of the vaccine after having adverse reactions on the 1st dose - experienced night sweats, extreme nausea, chills, fever, and itch. Nurse was also asking what are the signs of severe allergic reactions. The outcome of the events was not reported.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Head discomfort, Heart rate, Heart rate increased
Clinical narrative: SOB; feeling "panic-y"; increased HR; left lip numbness; pain down spine and neck; pain down spine and neck; weakness; head really heavy; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, lot no. and expiry date were unknown), via an unspecified route of administration in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given first round or shots 2-3 weeks ago. On unspecified date, the patient experienced SOB, feeling "panic-y", increased HR, left lip numbness (all of which resolved after a few hours). Then 4 days later she reported pain down spine and neck, weakness, head felt really heavy and hard to hold up which lasted several days to a week. The pharmacist was asking for extended stability of thawed vials in the refrigerator: at least 1 additional day would be helpful. The events resolved on unspecified date.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Neck pain, Panic reaction, Spinal pain
Clinical narrative: SOB; feeling "panic-y"; increased HR; left lip numbness; pain down spine and neck; pain down spine and neck; weakness; head really heavy; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, lot no. and expiry date were unknown), via an unspecified route of administration in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given first round or shots 2-3 weeks ago. On unspecified date, the patient experienced SOB, feeling "panic-y", increased HR, left lip numbness (all of which resolved after a few hours). Then 4 days later she reported pain down spine and neck, weakness, head felt really heavy and hard to hold up which lasted several days to a week. The pharmacist was asking for extended stability of thawed vials in the refrigerator: at least 1 additional day would be helpful. The events resolved on unspecified date.  Information on the batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Feeling dizzy; head hurt; fatigued; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old non-pregnant female patient received bnt162b2 (BNT162B2, lot no. and expiry date was unknown), via an unspecified route of administration in left arm on 03Jan2021 14:00 at single dose for Covid-19 immunization.  The patient medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling dizzy and her head hurt very bad and so fatigued on 05Jan2021. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was not recovered. The events were assessed as non-serious.  Information about Lot/Batch number is requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; This is a spontaneous report from a non-contactable Other-HCP. This Other-HCP reported for a 43-year-old female patient that received second dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL0142), via Intramuscular on 05Ja2021 02:00 PM at single dose on Left arm for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products: Sulfas and first dose of bnt162b2 (COVID 19) for covid-19 immunisation. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Flu like symptoms like headache, chills, body aches from 05Jan202108:00 PM. No covid prior vaccination. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Muscle tightness, Pain
Clinical narrative: aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching on arms and legs; Rash and itching on arms and legs; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), intramuscular, on 22Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The most recent COVID-19 vaccine was administered in a hospital. From 23Dec2020 to 27Dec2020, the patient experienced rash and itching on arms and legs. The patient took diphenhydramine hydrochloride (BENADRYL) to improve symptoms. The events were considered non-serious. The patient recovered from the events on 27Dec2020.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she tested positive 5 days after taking the first COVID19 Vaccine dose; she tested positive 5 days after taking the first COVID19 Vaccine dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive 5 days after taking the first COVID-19 vaccine dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills/rigors; Fever of 103; muscle pain; headache; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 05Jan2021 08:30 at a single for COVID-19 immunization at a hospital.  Medical history included hypothyroidism.  Patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and calcitriol.  The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration at the left arm on 15Dec2020 16:00 at a single dose for COVID-19 immunization. The patient experienced fever of 103, rigors, muscle pain, headache, and chills, lasted 12 hours on 6Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. The patient was recovering from the events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I have my armpit swollen; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1484), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  It was mentioned that the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899) as COVID-19 immunization and had no secondary effects. It was mentioned that with the second dose that was on 04Jan2021, he had armpit swollen (noted in Jan2021) but it doesn't hurt or anything but its swollen. Outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Peripheral swelling, Swelling face
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Toothache
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram normal, Confusional state, Dizziness, Electrocardiogram normal
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Headache, Heart rate decreased
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Limb discomfort, Loss of control of legs, Mobility decreased
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Palpitations, Paraesthesia, Peripheral swelling, Urine analysis
Clinical narrative: tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine.  Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Dec2020 at the first single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020.  The outcome of events was unknown.  Information about Lot/Batch has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on 05Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history included mononucleosis. The patient's concomitant medications were not reported.  In Jan2021, the patient experienced headache and sore arm with unknown outcomes. The patient was asking if she can resume her treatment with amoxicillin as she was supposed to be taking antibiotics.   Information on the Lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Incontinence
Clinical narrative: After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine administration, pt experienced severe diarrhea with incontinence.; This is a spontaneous report from a non-contactable pharmacist. A 78-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5730, intramuscular from 16Dec2020 to 16Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccine administration on 16Dec2020, The patient experienced severe diarrhea with incontinence. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever, at 103°F; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as Age: 28, Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient received the vaccine on 05Jan2021 and experienced fever at 103 F on 05Jan2021. She then asked if she should be alarmed or was it a reported side effect of the vaccine. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: muscle aches on legs; sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the COVID-19 vaccine yesterday (05Jan2021). She had a sore arm and muscle aches on legs that has been expectedly worse on an unspecified date in Jan2021. Outcome of the events was unknown. Patient was asking if it was okay to take TYLENOL for her adverse events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid19; tested positive for covid19; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 1st dose on 21Dec2020 and on 29Dec2020 she tested positive for covid19. She is coming up on 2nd dose on Friday (will be out of quarantine on the same day), she asked if she should get the vaccine. Her primary care physician advised her not to receive, within 30 days because there had been reports of people having reactions (ie: high fevers) to the vaccine. If she has a high fever she can't go to school. She asked if waiting 90 days make the vaccine not as effective and if she need to restart the series. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found 7 day following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved.  Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved.  Information on the Lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: unknown cause of diarrhea 2 days after; This is a spontaneous report from a contactable other HCP reported for self. This 47-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 29Dec2020 16:30 PM on Left arm at single dose (Lot # Ej1685) for covid-19 immunisation. Medical history was not provided. Concomitant medications included escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Known allergies: may be Dilaudid. She had unknown cause of diarrhea 2 days after on 31Dec2020. Last only one day. No other symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 01Jan2021.