chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysgeusia, Erythema, Feeling abnormal, Pain in extremity
Clinical narrative: arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself).  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization.  The patient's medical history was not reported.  Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy.  The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL).  The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant.   On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly.  On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened.  The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown.  The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself).  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization.  The patient's medical history was not reported.  Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy.  The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL).  The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant.   On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly.  On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened.  The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown.  The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Tremor
Clinical narrative: After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Throat irritation
Clinical narrative: reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has  had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Loss of consciousness, Metabolic function test, Postictal state, Seizure
Clinical narrative: Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear infection, Eye discharge, Eye swelling, Nasopharyngitis
Clinical narrative: She had only planned on her arm being sore; head cold/she has a really bad headcold; swollen eye; runny eye; sneezing; runny nose; ear infection; low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 05Jan2021 around 09:00 am at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient would like to know what the duration of reported side effects she's experiencing since getting vaccine will be. Symptoms experiencing are : head cold, swollen eye, runny eye, sneezing, runny nose, feels like she has ear infection, low grade fever. Symptoms have been going on for 3 days. This X-ray Technician is the patient. She reported starting afternoon of 05Jan2021 she had onset of: feels like she has a really bad head cold; swollen eye; runny eye; runny nose; sneezing; feels like she has an ear infection; low grade fever. She asked what the expected duration of these side effects is, how long she is going to be sick with these. She had only planned on her arm being sore. This has not been just a little, these events have been really bad. Further described Low grade fever as just like 99.6. She has been doing Tylenol and Bayer Aspirin. When she had the Flu vaccine she felt kind of tired for a day; like a little cold; sneezing for a day. The outcome of the event She had only planned on her arm being sore was unknown. The outcome of the other events was not recovered.   Information on the LOT/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: She had only planned on her arm being sore; head cold/she has a really bad headcold; swollen eye; runny eye; sneezing; runny nose; ear infection; low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 05Jan2021 around 09:00 am at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient would like to know what the duration of reported side effects she's experiencing since getting vaccine will be. Symptoms experiencing are : head cold, swollen eye, runny eye, sneezing, runny nose, feels like she has ear infection, low grade fever. Symptoms have been going on for 3 days. This X-ray Technician is the patient. She reported starting afternoon of 05Jan2021 she had onset of: feels like she has a really bad head cold; swollen eye; runny eye; runny nose; sneezing; feels like she has an ear infection; low grade fever. She asked what the expected duration of these side effects is, how long she is going to be sick with these. She had only planned on her arm being sore. This has not been just a little, these events have been really bad. Further described Low grade fever as just like 99.6. She has been doing Tylenol and Bayer Aspirin. When she had the Flu vaccine she felt kind of tired for a day; like a little cold; sneezing for a day. The outcome of the event She had only planned on her arm being sore was unknown. The outcome of the other events was not recovered.   Information on the LOT/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophilia
Clinical narrative: Hypereosinophilia (31%) asymptomatic; This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and penicillin allergies. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypereosinophilia (31%) asymptomatic on an unspecified date. It was unknown if treatment was given as a result of the event. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swollen, red warm at injection site
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Chills, headache, diarrhea, nausea
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Laboratory test, Malaise
Clinical narrative: trouble breathing; She had bad pain in her chest; Her oxygen saturation dropped to 92 and it is usually 98 or 100; not been feeling well; A fast heartbeat 5-10 minutes after initial dose; This is a spontaneous report from a contactable healthcare professional (dental assistant) reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously had reactions with the flu shot in the past for immunisation and she only was able to take the vegan version of the flu shot due to the egg content in the regular version of the flu shot. She also stated not being able to take the flu shot in the arm, leg, hip etc. Patient stated she was scheduled to take her second dose of vaccine tomorrow. She received the first dose on 22Dec2020. She stated she was in the ER on Monday for 5 hours because she was unable to see her primary care physician because his office was filled with patients with Covid and they could not provide her with guidance. She stated after receiving the first dose of vaccine she had not been feeling well ever since. Stated she had had trouble breathing and this took her by surprise. She had bad pain in her chest and a fast heartbeat 5-10 minutes after initial dose (on 22Dec2020). Her oxygen saturation dropped to 92 and it was usually 98 or 100. She stated something inhibited her ability to breathe and this scared her because she was healthy prior to the vaccine and never been in hospital and wasn't born in the hospital. She stated the condition she was diagnosed with will take 6-12 months for her to recover from and go back to normal. She stated during her ER room visit there were a lot of tests done. She would like to know if she should receive the second dose of the vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dyspnea, chest pain, oxygen saturation decreased and other reported events  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 including chest x-ray, arterial blood gas and pulmonary function tests, counteractive treatment measures 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: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Reaction to previous exposure to any vaccine
Clinical narrative: trouble breathing; She had bad pain in her chest; Her oxygen saturation dropped to 92 and it is usually 98 or 100; not been feeling well; A fast heartbeat 5-10 minutes after initial dose; This is a spontaneous report from a contactable healthcare professional (dental assistant) reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously had reactions with the flu shot in the past for immunisation and she only was able to take the vegan version of the flu shot due to the egg content in the regular version of the flu shot. She also stated not being able to take the flu shot in the arm, leg, hip etc. Patient stated she was scheduled to take her second dose of vaccine tomorrow. She received the first dose on 22Dec2020. She stated she was in the ER on Monday for 5 hours because she was unable to see her primary care physician because his office was filled with patients with Covid and they could not provide her with guidance. She stated after receiving the first dose of vaccine she had not been feeling well ever since. Stated she had had trouble breathing and this took her by surprise. She had bad pain in her chest and a fast heartbeat 5-10 minutes after initial dose (on 22Dec2020). Her oxygen saturation dropped to 92 and it was usually 98 or 100. She stated something inhibited her ability to breathe and this scared her because she was healthy prior to the vaccine and never been in hospital and wasn't born in the hospital. She stated the condition she was diagnosed with will take 6-12 months for her to recover from and go back to normal. She stated during her ER room visit there were a lot of tests done. She would like to know if she should receive the second dose of the vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dyspnea, chest pain, oxygen saturation decreased and other reported events  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 including chest x-ray, arterial blood gas and pulmonary function tests, counteractive treatment measures 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.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Condition aggravated, Dysstasia, Hypotonia, Loss of personal independence in daily activities
Clinical narrative: On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Speech disorder
Clinical narrative: On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: having gas/bloating since receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient).  A 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 06Jan2021 at 10:30 AM at a single dose on the right arm for COVID-19 immunization. The patient was vaccinated in the nursing home/senior living facility. The patient was not administered any other vaccine in four weeks. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown), vitamin d (manufacturer unknown), zinc (manufacturer unknown), Claritin (unspecified generic name) and unspecified vitamins. The patient previously took amoxicillin and experienced allergies. It was reported that the patient has been having gas/bloating since receiving the vaccine on 07Jan2021 at 16:00 (reported as 4:00 PM). The patient received over the counter gas medicine as treatment 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 event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 7 days after initial IM injection--pain, pruritus, redness and warmth of left deltoid. Area felt indurated on palpation. Resolved after 2 days. Highly localized to injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dysphagia, Dyspnoea, Hyperhidrosis
Clinical narrative: Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: the reaction began about 45 minutes after Moderna vaccine. I began to notice tingling in my hands and feet first. My right foot felt a little stiff when picking it up from the gas to the break while driving home. I noticed shortly after I arrived home itching and tingling all over and more pronounced picking, burning, numbness in my mouth(tongue and chin), hands and feet,  No rash, no shortness of breath. I took a Benadryl hoping just a mild reaction that would clear up. Next morning my feet and hands woke me up from the tingling and cramping. Other symptoms off and on were spasms in my feet and pain in index and middle fingers when touching cold. I called my doctor on Monday morning to get in for an appointment after I was awakened with some cramping in my calves and was more concerned. Was told if it worsened or I had any SOB or weakness in extremities to go to the ER. My reflexes were checked and normal and no weakness in my muscles. No other tests done at that time. The symptoms persist with buzzing feeling in them off and on, feeling of stiffness and stabbing feeling on occasion, no more cramps in calves. It remains mostly ankles to feet but some numbness to below knees. Hands, no further than wrist, along with chin and tongue remain numb and tingling at times.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: the reaction began about 45 minutes after Moderna vaccine. I began to notice tingling in my hands and feet first. My right foot felt a little stiff when picking it up from the gas to the break while driving home. I noticed shortly after I arrived home itching and tingling all over and more pronounced picking, burning, numbness in my mouth(tongue and chin), hands and feet,  No rash, no shortness of breath. I took a Benadryl hoping just a mild reaction that would clear up. Next morning my feet and hands woke me up from the tingling and cramping. Other symptoms off and on were spasms in my feet and pain in index and middle fingers when touching cold. I called my doctor on Monday morning to get in for an appointment after I was awakened with some cramping in my calves and was more concerned. Was told if it worsened or I had any SOB or weakness in extremities to go to the ER. My reflexes were checked and normal and no weakness in my muscles. No other tests done at that time. The symptoms persist with buzzing feeling in them off and on, feeling of stiffness and stabbing feeling on occasion, no more cramps in calves. It remains mostly ankles to feet but some numbness to below knees. Hands, no further than wrist, along with chin and tongue remain numb and tingling at times.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Urticaria, Vital signs measurement
Clinical narrative: Had previous non- anaphylactic reaction with 1st dose of Pfizer vaccine.  Consulted her physician and was encouraged to get the 2nd dose.  Within 5 minutes of 2nd dose vaccination, patient experienced numbness and tingling in the face.  Vital signs within normal linits, but worsening paresthesias.  Sent to ED.  O2 sat in ED 99%.  No shortness of breath.  Noted with scattered hives to torso.  Given Benadryl and famotidine and improved.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Pain
Clinical narrative: Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; This is a spontaneous report from a contactable nurse. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (anatomical location: left arm) on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took levofloxacin (LEVOQUIN) and minocycline and experienced allergies. The patient experienced headache, body aches/rigors, loss of appetite and T-max 102 F (fever lasted 48 hours, did not go below 100 despite antipyretics) on 30Dec2020. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit then 100 fahrenheit on unspecified dates. Therapeutic measures were taken as a result of fever. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; This is a spontaneous report from a contactable nurse. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (anatomical location: left arm) on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took levofloxacin (LEVOQUIN) and minocycline and experienced allergies. The patient experienced headache, body aches/rigors, loss of appetite and T-max 102 F (fever lasted 48 hours, did not go below 100 despite antipyretics) on 30Dec2020. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit then 100 fahrenheit on unspecified dates. Therapeutic measures were taken as a result of fever. The outcome of the events was recovered on an unspecified date.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itchy,swollen, hot to touch injection site
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: develops symptomatic covid; develops symptomatic covid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptomatic Covid on an unspecified date. The patient received dose #1 of a Covid-19 vaccine and contracted Covid-19 prior to dose #2. The patient underwent lab test which included Covid-19 test in which he/she developed a symptomatic Covid-19 on an unknown date. Outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021014755 Same reporter/drug/event, different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Slight dizziness 20-25 mins after, achy arm (about 1 and 1/2 days)  and minor headaches for about half day
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Sensation of foreign body, Tongue disorder, Urticaria
Clinical narrative: flushed; hives; tongue felt "thick"; the lump in my throat feels bigger; This is a spontaneous report received from a contactable pharmacist. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0142), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 23-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to medications, food, or other products (unspecified). It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the vaccine. On 22Dec2020, approximately 8 minutes after vaccine administration, the patient began feeling flushed. She reported to the observation area, and the registered nurse noted hives on her left neck (22Dec2020). The patient was brought back for closer monitoring. The doctor evaluated the patient. Vital signs were monitored every 5 minutes (22Dec2020). The patient was given 50 mg diphenhydramine (BENADRYL) orally. Some improvement was noted in hives; however, the patient began to state her tongue felt "thick" and "the lump in my throat feels bigger" (both on 22Dec2020). Per doctor, 0.3 mg epinephrine (MANUFACTURER UNKNOWN) given intramuscularly with rapid improvement in hives. The patient reported feeling some improvement as well. The patient was taken to the emergency department for ongoing observation. The patient was released from emergency department after observation. The clinical outcome of flushed, hives, tongue felt "thick", and "the lump in my throat feels bigger" was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the events flushing, urticaria, tong disorder, sensation of foreign body are possibly related to suspect BNT162B2 administration. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Chills, Cough, Injection site bruising
Clinical narrative: Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site.  The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week.  On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Limb discomfort, SARS-CoV-2 test positive
Clinical narrative: Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site.  The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week.  On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site by the end of day; This is a spontaneous report from a non-contactable other HCP (patient).  This 56 year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date were not reported) on 05Jan2021 15:00 (at the age of 56-years) as single dose, unspecified route,  left arm  for COVID-19 immunisation.  Medical history included known allergy to latex, wheat intolerance, and seasonal allergies, and hypothyroidism. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine (LEVOTHYROXINE), colecalciferol (VIT D3), ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT) and zinc (ZINC). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 05Jan2021 at 21:00 AM the patient experienced soreness at injection site by the end of day.  The patient did not received treatment as a result of the event.  The outcome of soreness at injection site by the end of day was recovered with sequele.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Feeding disorder, Night sweats, Pyrexia, SARS-CoV-2 test
Clinical narrative: fevers; night sweats; aphthous ulcers in his mouth; difficulty eating; difficulty eating and talking; This is a spontaneous report from a pharmacist.  This adult male patient of unspecified age (18-64 Years) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was not reported) on 22Dec2020 15:15 (at unspecified age) as single dose, unspecified route for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  Concomitant medications were not reported.  Since the vaccination, it was unknown if the patient has tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2. On 25Dec2020 began having fevers, night sweats, and aphthous ulcers in his mouth so severe that he has difficulty eating and talking. It was unknown if the patient received treatment as a result of the events.  Lab data included Covid swab on 28Dec2020 which was negative. The outcome of event fevers was unknown, night sweats was unknown, and aphthous ulcers in his mouth so severe was unknown, he has difficulty eating was unknown and difficulty talking was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: fevers; night sweats; aphthous ulcers in his mouth; difficulty eating; difficulty eating and talking; This is a spontaneous report from a pharmacist.  This adult male patient of unspecified age (18-64 Years) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was not reported) on 22Dec2020 15:15 (at unspecified age) as single dose, unspecified route for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  Concomitant medications were not reported.  Since the vaccination, it was unknown if the patient has tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2. On 25Dec2020 began having fevers, night sweats, and aphthous ulcers in his mouth so severe that he has difficulty eating and talking. It was unknown if the patient received treatment as a result of the events.  Lab data included Covid swab on 28Dec2020 which was negative. The outcome of event fevers was unknown, night sweats was unknown, and aphthous ulcers in his mouth so severe was unknown, he has difficulty eating was unknown and difficulty talking was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error, Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Influenza like illness, Laboratory test, Oropharyngeal pain
Clinical narrative: Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness.  ER visit for chest pains, labs and testing done, heart attack ruled out.  Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed.  Patient reports feeling better.