chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Myalgia, Pyrexia
Clinical narrative: He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer.  A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020  as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date.  Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a  fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up,  he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of  the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Weight
Clinical narrative: He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer.  A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020  as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date.  Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a  fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up,  he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of  the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 22-year-old female patient receive bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm/deltoid on 19Dec2020 at 0.3 mL, single for Covid-19 immunisation (as protection). Medical history included ulcerative colitis. The patient's concomitant medications were not reported. On 28Dec2020, the patient was positive for COVID-19 test after receiving COVID-19 vaccine. She informed she contracted COVID-19 due to an exposure from a co-worker. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Tachycardia
Clinical narrative: next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Dyspnoea, SARS-CoV-2 antibody test, Vaccination site erythema
Clinical narrative: mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician.  A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician.  A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: fatigue; She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad; the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose; pain in the administration site; She said that she had severe intense pain in her arm; she had large lump occur at the injection site about the size of egg; She could not lift her arm; This is a spontaneous report from a contactable consumer (patient) and contactable physician received via Medical Information Team.  A 66-year-old female patient received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), first dose on Nov2017 and second dose on Nov2018, both intramuscular at single dose for immunization. The patient medical history included paraplegia (T10-T11 ) from Sep1969 and ongoing, ongoing high blood pressure (diagnosed between 2005-2010), ongoing acid reflux (esophageal), ongoing Raynaud's syndrome (diagnosed in the 1980's), ongoing low grade bladder infection (the patient had a indwelling catheter), the patient has been diagnosed with limited scleroderma in 2010 unknown if ongoing (the patient said that she does not show any symptoms). There were no concomitant medications.  It was reported that the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose, on Nov2018 after second dose administered the patient experienced "a very bad reaction to PREVNAR 13", the patient reported "pain in the administration site, she had a large lump occur at the injection site about the size of egg. It traveled down her arm below the elbow. It started after receiving the injection and it was dissipated. The pain started subsiding late. She had severe intense pain in her arm. She could not lift her arm and could not reach across the sink to turn the faucet on. It was very debilitating. She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad. She was really tired and after reading the side effects, she assumed it was part of the fatigue that comes with the shot. She stated that she does not remember any chills or fever or anything like that". The patient outcome of large lump and pain was recovered on an unspecified date, and the outcome of fatigue was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypertension, Hypotension
Clinical narrative: Dizziness,Weakness, very low and then High blood pressure.(Uncontrollably)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dizziness, Electrocardiogram normal, Feeling hot
Clinical narrative: After left the clinic - 35 minutes post injection felt lightheaded, warm and some chest pressure.  Clinic had ended.  Sent to the ED for evaluation.  EKG and Chest xray done - within normal limits.  Discharged from the ED  with a discharge note of likely vasovagal response
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: After left the clinic - 35 minutes post injection felt lightheaded, warm and some chest pressure.  Clinic had ended.  Sent to the ED for evaluation.  EKG and Chest xray done - within normal limits.  Discharged from the ED  with a discharge note of likely vasovagal response
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immediate post-injection reaction
Clinical narrative: Sudden fatigue lasting 3 hours then gradually went away.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received his first dose of the vaccine and tested positive for Covid yesterday; received his first dose of the vaccine and tested positive for Covid yesterday; This is a spontaneous report from a contactable healthcare professional.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that the patient received his first dose of the vaccine on 17Dec2020 and tested positive for Covid yesterday (28Dec2020).  He is scheduled to have his second dose in January.  The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role BNT162B2 vaccine cannot be completely excluded for event "tested positive for COVID".
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID positive; COVID-19 virus test positive; This is a spontaneous report from a contactable Other Health Professional (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number: EH9899, via an unspecified route of administration on 17Dec2020 at 0.3 mL, single for covid-19 immunisation. Medical history was none.  There were no concomitant medications. The patient received his 1st dose of the COVID vaccine on 17Dec2020. He ended up testing positive for COVID yesterday on 28Dec2020 with unknown outcome. The patient had COVID-19 virus test done on 28Dec2020 with positive result. He was scheduled for his second vaccine on 07Jan2021. He was wondering if he should continue as recommended or not get the vaccine now and if there are other reports of this. The patient asked if he will have a massive immune response if he gets the second dose.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID-19 virus test based on the known safety profile. However the short duration of 11 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: NAUSEA THE SAME DAY AND DAY AFTER THE INJECTION. A WEEK LATER, I AM EXPERIENCE  SWOLLEN, HOT, RED AND ITCHY AT THE INJECTION SITE.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache
Clinical narrative: headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous report via a Pfizer Sponsored Program, Pfizer First Connect from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm 21Dec2020 at single dose for Covid prevention.  Medical history included blood pressure and can't see to read without her glasses.  Concomitant medication included amlodipine.  The patient stated, "she got the Covid vaccine on 21Dec2020 and had a headache for 1-2 days. After she got the vaccine, she was exposed to someone who had Covid, and wants to know if she can still get the second dose. She has had no symptoms after being exposed (Dec2020) but is about to be tested just in case she gets the virus. Her co-worker was positive and they were all in the breakroom without a mask. A couple other nurses are also concerned and don't know whether to get the second shot. They test at the hospital every Wednesday and wanted to know if she still can be tested before she gets the second shot. She had slight headaches on the 22nd, so she took some EXCEDRIN and it went away". The outcome of headache was recovered on 22Dec2020 and other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518688 same reporter/drug, similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Flushing, Heart rate, Heart rate increased
Clinical narrative: he was flushed; light headed; tingling around mouth; 3-4 minutes after my blood pressure was high; heart rate was 120 or so; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the first dose of BNT162B2 (lot number unknonwn), 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 stated that he received the first dose of the vaccine 11 days ago in Dec2020 and had a reaction. He stated probably 3 minutes after when he was getting ready to leave the area he was flushed and light headed and tingling around mouth. The staff in the area sat him down and 3-4 minutes after his blood pressure was high and heart rate was 120 or so. Those symptoms lasted about 10 minutes and went away on their own and he did not get epi pen or Benadryl. The patient's vital signs were normal after an hour or so and there was no intervention at any point and have had no issues subsequently. He stated that they said it wasn't technically an anaphylactic reaction but that it is hard to put a name to this description. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Paraesthesia oral, Vital signs measurement
Clinical narrative: he was flushed; light headed; tingling around mouth; 3-4 minutes after my blood pressure was high; heart rate was 120 or so; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the first dose of BNT162B2 (lot number unknonwn), 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 stated that he received the first dose of the vaccine 11 days ago in Dec2020 and had a reaction. He stated probably 3 minutes after when he was getting ready to leave the area he was flushed and light headed and tingling around mouth. The staff in the area sat him down and 3-4 minutes after his blood pressure was high and heart rate was 120 or so. Those symptoms lasted about 10 minutes and went away on their own and he did not get epi pen or Benadryl. The patient's vital signs were normal after an hour or so and there was no intervention at any point and have had no issues subsequently. He stated that they said it wasn't technically an anaphylactic reaction but that it is hard to put a name to this description. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle fatigue, Nausea
Clinical narrative: Nausea and chills starting about 12 hours post injection, lasting a few hours. Fatigue and muscle fatigue the day after injection lasting into the second day after injection (today).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after the first dose; tested positive for COVID after the first dose; This is a spontaneous report from a contactable Pharmacist reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she had the COVID-19 vaccine exactly a week ago (22Dec2020). However, she was tested positive for COVID (Dec2020) after the first dose. The outcome of the events tested positive for COVID after the first dose was unknown. The patient asked if she can take the second dose.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report from a non-contactable nurse practitioner.  An adult male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 14Dec2020 at 17:00 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced headaches (non-serious). The clinical course was reported as follows: The patient was a nurse practitioner who received the Pfizer vaccine. The patient reported getting headaches 15 days (as reported) after the first shot. The patient had no idea if the event was related to the vaccination, but he had no history of headaches. The patient took 600mg of ibuprofen (ADVIL) "to try to get the HA." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. It was unknown, since the vaccination, if the patient had been tested for COVID-19. Therapeutic measures were taken as a result of headaches. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Erythema, Headache, Peripheral swelling
Clinical narrative: ADR to Moderna Vaccine History of allergic reactions.  Took diphenhydramine 25 mg prior to injection.  Facial and finger swelling along with redness noted 40 minutes later.  Took second dose of diphenhydramine.    Was decreasing when patient returned to clinic.  Has allergy treatment plan form allergist and felt comfortable going home.  Developed metal taste soon after vaccine.  Several hours later developed heahache and chills a couple hours later.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: ADR to Moderna Vaccine History of allergic reactions.  Took diphenhydramine 25 mg prior to injection.  Facial and finger swelling along with redness noted 40 minutes later.  Took second dose of diphenhydramine.    Was decreasing when patient returned to clinic.  Has allergy treatment plan form allergist and felt comfortable going home.  Developed metal taste soon after vaccine.  Several hours later developed heahache and chills a couple hours later.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; This is a spontaneous report from a contactable pharmacist (Pharmacy Intern) via Pizer-sponsored program: A patient of unspecified age and gender received first single dose of BNT162B2 (lot number, and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine, then 7days later tested positive for COVID-19 (date unspecified). It was asked if patient needed to wait 90 days to receive the 2nd Vaccine dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number and exp date not reported), via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first Covid vaccine and on 26Dec2020, tested positive for Covid. Patient asked when if it was safe for her to get second dose. Asked if she get it on 21 days or if she had to wait. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site reaction, Injection site warmth, Myalgia
Clinical narrative: Headache, nausea, diarrhea, nerve-like pain, muscle pain. Took Advil and otc anti-diarrheal. Continues to have nerve pain, headache, and muscle pain. Today she obtained a red hot rash to injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuralgia, Rash erythematous
Clinical narrative: Headache, nausea, diarrhea, nerve-like pain, muscle pain. Took Advil and otc anti-diarrheal. Continues to have nerve pain, headache, and muscle pain. Today she obtained a red hot rash to injection site.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: had covid and also received the Pfizer covid 19 vaccine.; had covid and also received the Pfizer covid 19 vaccine.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender started received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. They have a patient that meets the criteria to receive product bamlanivimab. The patient had Covid and received the Pfizer covid 19 vaccine. The nurse asked if patient can still get the bamlanivimab after receiving vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it is unclear if Covid developed after BNT162B2 Pfizer covid 19 vaccine, pending further clarification, at this moment, the Company would handle the reported COVID related to the suspect, BNT162B2, for reporting purpose.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Haematospermia
Clinical narrative: Hematospermia, with no hematuria, dysuria, or dyspareunia. No recent sex, one female partner, oral sex only. Unlikely to have recent covid or other infection; I've been on vacation (at home, no travel) but did 2 days in non-COVID19 ICU on 1/5 and 1/6. Last intercourse one week ago, with no symptoms. ROS otherwise negative. On self-physical exam, no tenderness of testes, penis, suprapubic region, CVAT. Exam otherwise negative; unable to perform prostate exam on self.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020  at 18:00 as single dose for COVID-19 immunization.  Medical history included herpes simplex  1 (HSV1) from an unknown date.  The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products.   On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious.  Therapeutic measures were taken as a result of  the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle swelling, Nausea
Clinical narrative: Swelling deltoid muscle, headache, nausea
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 28Dec2020 at 11:45 at 62-years-old at SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced: stomach cramping and diarrhea; which was assessed as non-serious. The clinical course was reported as follows: The patient stated she had the vaccine on 28Dec2020 at 11:45 and "maybe an hour later", her stomach start cramping and then had diarrhea. The patient wanted to know if that was something "to be concerned about." In regard to having any laboratory test, the patient stated, "I went in November sometime for my annual checkup I think it was November" (as reported). When the patient was asked if they received any treatment for the events, the patient stated, "No. I am still at work, I got it today, I haven't taken anything but I was thinking that to just get some "Caper" (as reported) and "gentian soda" (as reported)." The clinical outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Systemic scleroderma, Undifferentiated connective tissue disease
Clinical narrative: flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); This is a spontaneous report from a contactable physician.  A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular on 22Dec2020 16:15 (04:15 PM) at a single dose on the left arm as COVID-19 vaccine. Medical history included autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); secondary Raynaud's phenomenon with calcinosis; known allergies to sulfa drugs, pine nuts. Concomitant medications included mycophenolate mofetil (MMF) 1000mg bid (twice a day), hydroxychloroquine sulfate (PLAQUENIL) 300mg qd (once a day), and prednisone 15mg daily (received within 2 weeks of vaccination). The patient had an adverse event (AE) of flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) on 23Dec2020 09:00 PM (also reported as flare began about 36-48 hours after vaccine) which required increased daily dose of prednisone (higher dose) up to 80mg total daily dose (80mg daily x3d, then tapered down) (treatment received for AE) and lasted about 4-5 days. The patient was not pregnant at the time of vaccination. She had no other vaccine in four weeks (did not receive other vaccine within four weeks prior to the COVID vaccine). She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The outcome of the events was recovered on Dec2020.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) and the administration of BNT162B2, based on the plausible temporal association.   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 agencys, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: NO ADVERSE REACTION WITHIN FIRST HOUR OF VACCINE ADMINISTRATION. PT. REPORTS LOSS OF SENSE OF TASTE WITHIN HOURS OF RECEIVING THE VACCINE.     PER PT. EMAIL REPORT, "I noticed when I got home yesterday while eating supper I could not TASTE anything. I was eating a really garlicy meal and I kept putting more garlic on it as I couldn?t figure out why I couldn?t taste it. I am still having the same problem today. I am sure it will go away, but you said to let you know of any symptoms."
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Palpitations; tachycardia; This is a spontaneous report from a contactable nurse (patient).  A 31-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ej1685), via an unspecified route of administration on the left deltoid on 22Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital.  It was reported that prior to vaccination the patient was diagnosed with COVID-19 (unknown date). The patient's concomitant medications were not reported.  The patient had palpitations and tachycardia on 23Dec2020 (also reported as second day post vaccine) which resulted to doctor or other healthcare professional office/clinic visit. The patient received unspecified beta blocker as treatment. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: within 15 minutes of receiving vaccine, developed hives and became itchy, Benadryl was taken by the employee.   Declined treatment.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at a single dose as vaccine. Medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020 and 2 days later on 21Dec2020, she developed symptoms. Her symptoms had been mild. She thought the symptoms were from the vaccine but turned out she did test positive for Covid on Dec2020. She inquired what would happen if you get the vaccine and you test positive. She also inquired if her symptoms would be worse. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: 8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: positive for Covid/ symptoms of Covid; positive for Covid/ symptoms of Covid; This is a spontaneous report from a contactable nurse (reported for himself). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the first dose of the vaccine on 17Dec2020 and then around Christmas he developed symptoms of Covid (Dec2020). On 27Dec2020, he came back positive for Covid and wanted to know if he skip the second dose. Patient questioned what percentage of persons obtained immunity after the first product dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 by PCR the following day and developed covid symptoms; tested positive for COVID-19 by PCR the following day and developed covid symptoms; This is a spontaneous report from a contactable physician (patient). 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 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-biontech covid-19 vaccine and tested positive for COVID-19 by PCR the following day and developed COVID symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID-19 by PCR after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Patient developed a rash at site of injection approximately 3 inches wide and 4 inches long in size. Patient did not have or express any symptoms like itching or fever. Patient self treated with hydro- cortisone cream topically and benadryl 25mg orally. Duration of rash is still present but less than on 1/5/2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation.  Medical history included Meniere's disease (reported 'Meniere's disease in my left ear').  The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation.  Medical history included Meniere's disease (reported 'Meniere's disease in my left ear').  The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Nausea, Throat tightness, Vomiting
Clinical narrative: Per patient, he started to feel mild nausea after vaccine once he was home on 01/05/21. Starting 01/06/201 patient nausea has worsened and has vomited multiple times and has lost appetite. He also reports a dry cough and slight tightness in airway but patient unsure if it is due to vomiting or cough. Patient able to speak complete sentences and able to ambulate independently with no shortness of breath.