chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Lethargy, Malaise
Clinical narrative: Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Pain of skin, Pulmonary oedema
Clinical narrative: Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Mar2021 11:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from 19Mar2021 (Batch/Lot number was not reported) to 19Mar2021, at 10 mL for an unspecified indication. Medical history included allergy to bees, hornets, all insects with a stinger and egg allergy; all ongoing. The patient's concomitant medications were not reported. The patient experienced anaphylactic shock within 10 minutes after her first dose on 19Mar2021. Patient took children's Benadryl 10 ml one hour before vaccination like ger doctor suggested but still went to anaphylactic shock. She ended up in the emergency room for 6 hours because her mouth still felt funny and they were waiting until she was breathing and swallowing better, and stated that for a week and a half up to two weeks afterward, she still had trouble breathing and swelling of mouth and throat. The clinic gave her a Benadryl shot when her reaction happened and the Emergency Room gave her one also. Emergency Room also gave her three other medications in her IV.  She thinks the Benadryl shots she received were 25mg; but isn't sure. Patient was not admitted to the hospital. Outcome of the event was recovered on an unspecified date in 2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: welts in the arm and in the leg; This is a spontaneous report from a contactable consumer (Patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN0151), via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. After 2 days he got small scratches on my hands, arms, neck, chest and face at 11:30 those of the hand disappeared those of the arm lasted two days together with those of the neck those on the chest, a very large slot was made from the size of the hand to the height of the heart and he still have it tomorrow it is already a week of the second dose of the vaccine those on the face on the right side disappeared after 2 days, those on the left side swelled up or grows a lot have gone decreasing but are still present and he started to leave today welts on my arm and leg on 05Apr2021. Treatment received with Benadryl. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: It has been between 102 and 103; Fever is going up; Chills; Headache; Achy; Nausea; This is a spontaneous report received from a contactable consumer(patient). A 46-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in Arm Right on an unspecified date at 11.45 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included High blood pressure. Concomitant medications included lisinopril; metoprolol. Patient got the second shot at 11.45 and then woke up in the morning with chills, headache, achy, nausea and a fever, it has been between 102 and 103. Patient just rest and take some medicine, how high does my fever have to be before going in. Fever is going up but patient just took the medicine Tylenol. Events outcome were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: It has been between 102 and 103; Fever is going up; Chills; Headache; Achy; Nausea; This is a spontaneous report received from a contactable consumer(patient). A 46-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in Arm Right on an unspecified date at 11.45 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included High blood pressure. Concomitant medications included lisinopril; metoprolol. Patient got the second shot at 11.45 and then woke up in the morning with chills, headache, achy, nausea and a fever, it has been between 102 and 103. Patient just rest and take some medicine, how high does my fever have to be before going in. Fever is going up but patient just took the medicine Tylenol. Events outcome were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Emotional distress, Headache, Hyperhidrosis
Clinical narrative: Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself.   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Hypertension, Illness, Pain, Parosmia
Clinical narrative: Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself.   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Taste disorder, Weight, Weight decreased
Clinical narrative: Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself.   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden loss of hearing; This is a spontaneous report from a contactable consumer.   A 53-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On 09Apr2021 (one week after taking the vaccine), the patient experienced sudden loss of hearing. The patient went to the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care due to the event and received steroids as treatment. The patient was recovering from the event.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration, administered in the left arm on 15-Apr-2021 08:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 25-Mar-2021 08:00 AM administered in the left arm for Covid-19 immunization at the age of 38-years-old. There were no other vaccines received in four weeks. The patient did not have Covid prior vaccination. The patient experienced syncope on 16-Apr-2021 12:30 AM (00:30 military time) with outcome of unknown. No treatment was received for the adverse event. The patient was not tested for Covid post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported syncope cannot be excluded based on a temporal relationship.  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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID illness; tested positive for COVID illness; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband). This is the second (husband) of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history included came in contact with COVID-19 on Apr2021. The patient's concomitant medications were not reported. The reporter and her husband (patient) received their first doses of the Pfizer-Biontech Covid19 vaccine 2 weeks ago (Apr2021) and have since tested positive for COVID illness. They believed their exposure was the day they received their vaccination (on Apr2021). The reporter wanted to know the guidance for this situation. It was reported that the patient came in contact with COVID-19 the same day. The patient had 2 negative tests then they both tested positive, all on Apr2021. It was reported that their second doses are scheduled for 23Apr2021, but their quarantine last longer than that. The reported asked for guidance if they can't get their second doses at 21 days as scheduled. The outcome of the event tested positive for COVID illness was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021416805 Same reporter/drug/ event, different patient
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary infarction, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism with pulmonary infarction; Pulmonary embolism with pulmonary infarction; This is a spontaneous report from a contactable physician. A 38-year-old male patient received second dose of BNT162B2 (Batch/Lot number was not reported), intramuscular on Apr2021, at 38 years old, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 intramuscular on Mar2021 at 38 years old as single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced pulmonary embolism with pulmonary infarction and patient was hospitalized for 1 day. The events resulted in Emergency room/department or urgent care and Hospitalization. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination and medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Apr2021.  Therapeutic measures were taken as a result of pulmonary embolism with pulmonary infarction which included anticoagulation. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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 Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program and Medical Information Team. A female 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 15Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient's arm was little sore in Apr2021 from receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diarrhoea, Lack of spontaneous speech, Polymerase chain reaction, Vomiting
Clinical narrative: stroke; he could not speak; diarrhea; vomiting; This is a spontaneous report from a contactable physician. A 63-years-old male patient received bnt162b2 (BNT162B2), intramuscular on 12Mar2021 as single dose for COVID-19 immunization at a workplace clinic. Medical history was reported as none. There was no known allergies. There was no vaccine administered in four weeks. There were no concomitant medications.  On 13Mar2021, the patient experienced diarrhea and vomiting for 8 hours and 2 days later on 15Mar2021, he could not speak so patient went to the hospital and was told he had a stroke. The patient underwent lab tests and procedures which included SARS-COV-2 test, pcr swab test: negative on 14Mar2021. Therapeutic measures were taken as a result of the events which included aspirin, clopidogrel (PLAVIX), atorvastatin calcium (LIPITOR), evolocumab (RAPATHA). The events caused hospitalization. The patient recovered from the events on an unknown date.  Information on batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the reported events of diarrhea, vomiting, could not speak and stroke cannot be excluded. The case will be reassessed once more information become 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: Arthralgia, Chills, Erythema, Fatigue, Feeling hot
Clinical narrative: hearing disability and a broken foot; hearing disability and a broken foot; she woke up at 1:30 am to her knee caps aching and pounding like no tomorrow; About 8 hours later, she experienced a sore arm; very tired; chills worse than the one she got from the 1st dose; low grade fever; her face was red and hot as well as her legs; her face was red and hot as well as her legs; Had a bad reaction to both of my shots; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular on 13Apr2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included polyethylene glycol 3350. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 21Mar2021 and experienced faint, stroke, meningitis, diarrhea, could not swallow, menstrual cramps, getting sick, extreme fatigue, felt hands to be freezing, severe headache, flu-like chills, body ache, sore throat, feeling dehydrated, sinus pain, face and eyebrows hurt, throw up viscously, not understood well, profusely sweating, ice-cold ends, painful arm, neck pain, losing her mind, sheer panic, and swollen glands under her jaw. The patient experienced hearing disability and a broken foot. On 13Apr2021, about 8 hours after vaccination, she experienced a sore arm, she was very tired, chills worse than the one she got from the 1st dose, a low grade fever which felt like her whole body was on fire, her face was red and hot as well as her legs, she woke up at 1:30 am to her knee caps aching (14Apr2021) and pounding like no tomorrow. The patient had a bad reaction to both of the shots in Apr2021. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Foot fracture, Hearing disability, Pain in extremity, Pyrexia, Vaccination site reaction
Clinical narrative: hearing disability and a broken foot; hearing disability and a broken foot; she woke up at 1:30 am to her knee caps aching and pounding like no tomorrow; About 8 hours later, she experienced a sore arm; very tired; chills worse than the one she got from the 1st dose; low grade fever; her face was red and hot as well as her legs; her face was red and hot as well as her legs; Had a bad reaction to both of my shots; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular on 13Apr2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included polyethylene glycol 3350. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 21Mar2021 and experienced faint, stroke, meningitis, diarrhea, could not swallow, menstrual cramps, getting sick, extreme fatigue, felt hands to be freezing, severe headache, flu-like chills, body ache, sore throat, feeling dehydrated, sinus pain, face and eyebrows hurt, throw up viscously, not understood well, profusely sweating, ice-cold ends, painful arm, neck pain, losing her mind, sheer panic, and swollen glands under her jaw. The patient experienced hearing disability and a broken foot. On 13Apr2021, about 8 hours after vaccination, she experienced a sore arm, she was very tired, chills worse than the one she got from the 1st dose, a low grade fever which felt like her whole body was on fire, her face was red and hot as well as her legs, she woke up at 1:30 am to her knee caps aching (14Apr2021) and pounding like no tomorrow. The patient had a bad reaction to both of the shots in Apr2021. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: noticed has swelling underneath the armpit on the side of the injection site and it's hurting; noticed has swelling underneath the armpit on the side of the injection site and it's hurting; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient noticed swelling underneath the armpit on the side of the injection site and it's hurting. The patient did not have anything after 1st dose. The patient asked whether she could take anything or should go to the ER. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, COVID-19
Clinical narrative: very severe COVID symptoms starting 8 days after my second vaccine shot; seven days later I am bedridden; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported. A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated to experience very severe COVID symptoms starting 8 days after my second vaccine shot. I have all symptoms except for loss of taste & swell, and still seven days later I am bedridden. My question is what is the time spread post shot where symptoms can show. My dr follows 2-3 days but I believe this is the norm and that I may be an outlier. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes on his right arm; This is a spontaneous report from a contactable consumer (patient's wife). A 55-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in right arm on 13Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that his husband had experienced swollen lymph nodes on his right arm, the same site as the vaccine was administered. She was just wondering if this is a normal side effect of the vaccine. She mentioned she had this reported to safety already. The outcome of the event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Severe headache; Fever; Chills; Soreness at injection site; Malaise; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 at an unspecified date. Patient took Advil for symptoms after receiving the second dose of the COVID-19 vaccine and reported the Advil helped to reduce discomfort. Patient takes low dose oral contraceptives but reports taking no other medications. The patient experienced severe headache, fever, chills, soreness at injection site and malaise on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula
Clinical narrative: swollen uvula; This is a spontaneous report from a contactable consumer reported for his wife (patient).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that he and his wife, already received their 1st dose of the Pfizer COVID Vaccine 3 weeks ago and have been doing well. He mentioned that they have completed the side effect text tracker things. They were due for their 2nd dose on Monday and he mentioned that his wife came down with a swollen uvula the morning after getting vaccinated with their 1st dose. According to him, it might not be related to the vaccine and maybe caused by her snoring or other things. He is asking if this is going to be contraindicated for the 2nd dose. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; having been miserable the last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date and received the second dose on 16Mar2021; both dose via an unspecified route of administration at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr. The patient also reported that she completely understood that the vaccine would not prevent her from contracting, rather protect against serious illness. The patient also mentioned that her purpose in reaching out was that she was very willing to participate in any research to help further understand breakthrough cases. If she could even provide a small amount info to further science, it out weighs having been miserable the last week. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: facial tingling and numbness; facial tingling and numbness; This is a spontaneous report received from contactable consumer (patient) reported for herself. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Apr2021 (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. Caller reported that she received her first vaccine dose 1 week ago on April 5th, and afterwards she experienced facial tingling and numbness which went away but then came back on Wednesday. She reported that she had no other symptoms but went to see her Primary doctor who considered this to be a reaction to the vaccine and advised her to call Pfizer for guidance on getting the second vaccine dose given her symptoms. The patient stated that she had a side effect after the first dose of the vaccine. She asked whether she should get the second dose. She asked if there was any guidance available for delaying the second vaccine dose after having a reaction to the first vaccine dose. Caller reports that she already spoke with safety, no reference number was provided. They informed her that as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform this decision. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Head discomfort, Headache, Hordeolum
Clinical narrative: eye was "really swollen on the bottom" and it "looked like a sty"; eye was "really swollen on the bottom" and it "looked like a sty"; "hurt to blink", and the inner corner of eye start to hurt; "hurt to blink", and the inner corner of eye start to hurt; felt pressure and headache at the left upper side of the face or head area; felt pressure and headache at the left upper side of the face or head area; This is a spontaneous report received from a contactable consumer (reporting on herself). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, patient received the first dose of the BNT162B2. By the evening, patient reported to have felt pressure and headache at the left upper side of the face or head area. When patient woke up on 15Apr2021, her eye was really swollen on the bottom and it looks like a sty. Eventually, patient mentioned that it hurts to blink, and the inner corner of eye start to hurts. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: eye was "really swollen on the bottom" and it "looked like a sty"; eye was "really swollen on the bottom" and it "looked like a sty"; "hurt to blink", and the inner corner of eye start to hurt; "hurt to blink", and the inner corner of eye start to hurt; felt pressure and headache at the left upper side of the face or head area; felt pressure and headache at the left upper side of the face or head area; This is a spontaneous report received from a contactable consumer (reporting on herself). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, patient received the first dose of the BNT162B2. By the evening, patient reported to have felt pressure and headache at the left upper side of the face or head area. When patient woke up on 15Apr2021, her eye was really swollen on the bottom and it looks like a sty. Eventually, patient mentioned that it hurts to blink, and the inner corner of eye start to hurts. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a Program. This contactable year-old female consumer (patient) received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported)  as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, the patient experienced fatigue. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected