chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the third of five reports.  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Respiratory disorder
Clinical narrative: Adnopathy  Headache  Intermittent fever O2 sat fluctuates between 84-92% Joint pain  Fatigued
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Night sweats, Pyrexia
Clinical narrative: Abdominal pain starting next day evening, last 7 days, day 5 shivering at evening  with night sweet and low grade fever, day 6 evening high grade fever from 6pm to 12 am
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pain in extremity, Skin warm
Clinical narrative: red ness size of a quarter and has grown to about 3 inches around and is hot to touch.lump about size of a quarter has left after 7-10 days.redness has lightened but remains to date. Terrible bilateral leg pain from hips to feet  on a scale of 1-10 it is a nine . Took OTC tylenol  without relief. stomach pains  for 5 days but resolved.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fourth of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event  for different patients
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; she had felt weird; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fifth of five reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported on behalf of her sister (patient). It was reported that the patient called right before Christmas and she had gotten the Pfizer COVID Vaccine. She reported that she had felt weird and had side effects to the vaccine. The patient works in a nursing home type thing, and she said she has had people who have gotten the first dose of the vaccine, and then tested positive for COVID. The patient called to ask the reporter if they should still get the second dose. The only other details that her sister (patient) provided her was that this has happened with several people; 5 employees and several or 9 patients. She is unsure if she said several patients or 9 patients, but there were 5 employees. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Off label use, Product use issue
Clinical narrative: First vaccine dose: 18Dec2020, 2nd vaccine dose: 06Jan2021; First vaccine dose: 18Dec2020, 2nd vaccine dose: 06Jan2021; fatigue; chills; myalgias; Rash (hives) on both arms, on both sides of his chest and on both of his thighs; Rash (hives) on both arms, on both sides of his chest and on both of his thighs; This is a spontaneous report from a contactable physician (anesthesiologist, patient). A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot NO.: EJ1686) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (Batch/Lot NO.: EH9H99) on 18Dec2020 for COVID-19 immunization and experienced sore arm only after 1st shot. The patient experienced fatigue, chills, myalgias in Jan2021, 18 hours after 2nd vaccine dose, which lasted 2 days. Then 48 hours after 2nd vaccine dose he developed a rash (hives) on both arms, on both sides of his chest and on both of his thighs in Jan2021. He took an antihistamine and the symptoms went away a few hours later. The outcome of the events (fatigue, chills, myalgias, rash and hives) was recovered in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: First vaccine dose: 18Dec2020, 2nd vaccine dose: 06Jan2021; First vaccine dose: 18Dec2020, 2nd vaccine dose: 06Jan2021; fatigue; chills; myalgias; Rash (hives) on both arms, on both sides of his chest and on both of his thighs; Rash (hives) on both arms, on both sides of his chest and on both of his thighs; This is a spontaneous report from a contactable physician (anesthesiologist, patient). A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot NO.: EJ1686) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (Batch/Lot NO.: EH9H99) on 18Dec2020 for COVID-19 immunization and experienced sore arm only after 1st shot. The patient experienced fatigue, chills, myalgias in Jan2021, 18 hours after 2nd vaccine dose, which lasted 2 days. Then 48 hours after 2nd vaccine dose he developed a rash (hives) on both arms, on both sides of his chest and on both of his thighs in Jan2021. He took an antihistamine and the symptoms went away a few hours later. The outcome of the events (fatigue, chills, myalgias, rash and hives) was recovered in Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypokinesia, Malaise, Musculoskeletal stiffness
Clinical narrative: She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and hurting to the touch; Muscles in her body are heavy and she can not hardly move; So tired; has not been feeling well; Her body was like a rock; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730 and expiration date not reported), via an unspecified route of administration on the left arm, on 08Jan2021 at a single dose for Covid-19 immunization. There were no medical history and concomitant medications (no other medications and never goes to the doctor). The patient previously took her first dose of bnt162b2 (lot number EK5730) on 18Dec2020 for Covid-19 immunization. The patient just had the second dose of the COVID vaccine on Friday, 08Jan2021. She had to go home from work on Saturday afternoon. She has not been feeling well. Her muscles in her body are heavy and she cannot hardly move. She was asking if that is a side effect? She is also so tired, she just cannot go. Her symptoms also started on Friday, that night. It woke her up. She got out of bed and her muscles felt like she could not move. Her body was like a rock. She tried to get up but her muscles hurt so bad. They were hard to the touch. Her husband tried to touch her and it hurt so bad she told him not to. Then on Saturday she was better in the day, went to work, then she was totally wiped out. Her muscles were aching and hurting to the touch. On 09Jan2021, she was so weak and went home. The patient did not received treatment for the events. She is unsure if she should go to her doctor today. She wanted to call Pfizer to see if this was a side effect first, and would go away, of if she needs to go ahead and let her doctor know what is going on and go in. Outcome of the event of weak was unknown and other events were not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and hurting to the touch; Muscles in her body are heavy and she can not hardly move; So tired; has not been feeling well; Her body was like a rock; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730 and expiration date not reported), via an unspecified route of administration on the left arm, on 08Jan2021 at a single dose for Covid-19 immunization. There were no medical history and concomitant medications (no other medications and never goes to the doctor). The patient previously took her first dose of bnt162b2 (lot number EK5730) on 18Dec2020 for Covid-19 immunization. The patient just had the second dose of the COVID vaccine on Friday, 08Jan2021. She had to go home from work on Saturday afternoon. She has not been feeling well. Her muscles in her body are heavy and she cannot hardly move. She was asking if that is a side effect? She is also so tired, she just cannot go. Her symptoms also started on Friday, that night. It woke her up. She got out of bed and her muscles felt like she could not move. Her body was like a rock. She tried to get up but her muscles hurt so bad. They were hard to the touch. Her husband tried to touch her and it hurt so bad she told him not to. Then on Saturday she was better in the day, went to work, then she was totally wiped out. Her muscles were aching and hurting to the touch. On 09Jan2021, she was so weak and went home. The patient did not received treatment for the events. She is unsure if she should go to her doctor today. She wanted to call Pfizer to see if this was a side effect first, and would go away, of if she needs to go ahead and let her doctor know what is going on and go in. Outcome of the event of weak was unknown and other events were not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Daily Headaches
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever of 101.6; Body aches; Chills; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 08Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date at single dose for COVID-19 immunization. The nurse reported that her neighbor (patient) who is a nurse at a Hospital, mentioned this weekend that she received her second dose of the Pfizer vaccine on Friday, 08Jan2021, and had some side effects when she woke on Saturday, 09Jan2021 included fever of 101.6, body aches, and chills, her reaction subsequently improved on Saturday, 09Jan2021, around noon. The nurse (reporter) has read that these are expected reactions and the patient is feeling fine now, but nurse wanted to report this event. Outcome of the events was recovering.   Information on the Batch/Lot number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pyrexia, Somnolence
Clinical narrative: MODERNA COVID-19 Vaccine. Lymph node swelling around 6pm day of vaccination, Jan 16th. Fever, headache, injection site pain, fatigue upon waking up around 10am on Jan 17th. Symptoms continued majority of the 17th and subsided by the morning of Jan 18th.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Hypoaesthesia, Nausea
Clinical narrative: Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing.  Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash, Urticaria, Vomiting
Clinical narrative: Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing.  Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Influenza like illness, Nausea
Clinical narrative: fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension.  Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously 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. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension.  Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously 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. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash pruritic
Clinical narrative: itchy rash; swollen lymph node in the groin; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itchy rash and swollen lymph node in the groin on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself.   A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination.   After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Presyncope, Product use issue, Pyrexia
Clinical narrative: almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself.   A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination.   After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling face, Swollen tongue, Urticaria
Clinical narrative: hives, itching, facial swelling, tongue/throat swelling
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: I am being cold; I am in bed with the electric blanket, I was shaking with the side effects; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced being cold, she was in bed with the electric blanket, she was shaking that bad with the side effects on an unspecified date. She started getting shaking so bad when she was out of bed, she got colder. The outcome of events was unknown. A Product Complaint was filed.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: headache migraine over 60 hours post-vaccine: one side of the head, left sinus, left eye, and wrapping along the left side of her head to occipital lobe; This is a spontaneous report from a contactable healthcare professional. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3248/expiration date unknown) dose number 1, via an unspecified route of administration on 08Jan2021 16:00 at a single dose on the left arm for COVID-19 immunization. The vaccine was administered in a hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included birth control. On 09Jan2021, the patient experienced persistent headache migraine over 60 hours post-vaccine: one side of the head, left sinus, left eye, and wrapping along the left side of her head to occipital lobe. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and she was not tested for COVID-19 since the vaccination. The outcome of the event was not recovered. The event was assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Have been having dull headaches; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received bnt162b2 (lot number: EK5730 and Expiry Date: 31Mar2021), via an unspecified route of administration on 30Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid vaccine on December 30th. Since that day she has been having dull headaches. It has been 9 days. The patient does not want to take Tylenol for dull headaches. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient develop Covid-19 diagnosed by PCR about may be six or seven days after received the vaccine. The patient recovered from the event.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246 and expiry date unknown) via unspecified route of administration at right arm on 12Jan2021 11:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), metformin, and amlodipine; all from unspecified date for unspecified indication. On 12Jan2021 19:00, the patient experienced dizziness. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the event. The outcome of the event dizziness was not recovered. The event was reported was non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever of 100.0; fatigue; chills; headache; body aches; This is a spontaneous report from a contactable nurse(patient herself).  A 33-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK9231, expiry date unknown), via an unspecified route of administration in right arm on 07Jan2021 at a single dose  for COVID-19 immunisation.  Medical history included depression. The patient had no known allergies (NKA). Patient was not pregnant at the time of vaccination.   Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 17Dec2020 for COVID-19 immunization and experienced body aches and recovered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced with second shot fever of 100.0, chills, headache, body aches, fatigue on 08Jan2021 at 01:00 AM. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.0; fatigue; chills; headache; body aches; This is a spontaneous report from a contactable nurse(patient herself).  A 33-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK9231, expiry date unknown), via an unspecified route of administration in right arm on 07Jan2021 at a single dose  for COVID-19 immunisation.  Medical history included depression. The patient had no known allergies (NKA). Patient was not pregnant at the time of vaccination.   Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 17Dec2020 for COVID-19 immunization and experienced body aches and recovered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced with second shot fever of 100.0, chills, headache, body aches, fatigue on 08Jan2021 at 01:00 AM. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (Covid 19 Vaccine) lot no: EK9231, via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the vaccine on 30th December, the first dose and the patient got a rash. Outcome of the event was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: Date for the next shot: 22Jan2021; I broke out in hives all over; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history was not reported.   The patient's concomitant medication included montelukast sodium for Allergy and simvastatin for Cholesterol. 06Jan2021, the patient stated that "I called my doctor yesterday and said that I had an reaction from the shot, the first one. And they told me at my doctor's office to call this number to let you know that I had a reaction from it." The patient stated experienced "I broke out in hives all over." The patient took the first one on 04Jan2021 and date for the next shot was 22Jan2021. The patient was treated with Prednisone. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pharyngeal erythema, Pharyngeal swelling, Thirst, Throat irritation
Clinical narrative: I started feeling like my throat is scratchy and it looks like really red; I started feeling like my throat is scratchy and it looks like really red; I got really thirsty; I do feel like discomfort on the front of my throat; I can feel the swelling in the throat; This is a spontaneous report from a contactable consumer. A 32-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at a single dose for an unspecified indication. Medical history was not reported. Concomitant medication included ascorbic acid, (VITAMIN C), ergocalciferol (VITAMIN D) and retinol palmitate (VITAMIN A). It was reported by the patient that she started feeling like her throat is scratchy and she looked at it in the mirror and it looks like really red. She got really thirsty so she started drinking a lot of water and she had some ice that she is chewing on. She felt like discomfort on the front of her throat and swelling; all occurred in 08Jan2021. The outcome of the events was unknown. Information about batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Pain in extremity
Clinical narrative: Fever of 101; Dizzy/Lightheaded; Chills; Chest pain; I just had arm pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever of 101 (unit unspecified), felt dizzy, lightheaded, chills, chest pain and had arm pain; all on an unspecified date. The patient reportedly took paracetamol (TYLENOL) as treatment for the events reported. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101; Dizzy/Lightheaded; Chills; Chest pain; I just had arm pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever of 101 (unit unspecified), felt dizzy, lightheaded, chills, chest pain and had arm pain; all on an unspecified date. The patient reportedly took paracetamol (TYLENOL) as treatment for the events reported. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; General body pain; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: 31Mar2021) on 07Jan2021, via intramuscular at single dose for COVID-19 immunisation. The patient medical history reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunisation. It was reported that the patient received second shot today (07Jan2021) and now she was feeling, having fever and chills and just general body pain, so she just wanted to report her symptoms, there is a website so she was just calling and asking if she should just take regular Tylenol. She got the shot on 7th (Clarified as 07Jan2021) in the morning and its night there, so she got the fever at night (Clarified as 08Jan2021). She didn't have any symptoms right away. As treatment, patient just took Tylenol. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consumer (patient, "I am Dental"). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included hydrochlorothiazide, famotidine, and montelukast. The patient experienced lower part of head was swollen in the back on 07Jan2021. The patient stated, "I got my first vaccine on 22nd (22Dec2020) and I been feeling fine until this morning when I woke up and lower part of my head is swollen in the back so I don't know it's something related or not." Patient also stated, "Because I am in healthcare and I deal with lot of saliva all day working on teeth." No treatment received for the event. The outcome of the event was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient's medical history was reported as none.  There were no concomitant medications. It was reported that in the first dose, the patient just had arm pain. The outcome of the event was unknown. The patient received treatment for the event.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site swelling
Clinical narrative: My arm is kind of swollen in that area; My muscles and arms are so sore; My muscles and arms are so sore; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took flu shot and experienced muscles and arms were so sore. In Jan2021, the patient experienced arm was kind of swollen in area, and her muscles and arms were so sore. It was further reported that the patient was asking if it was normal because his/her arm was sore where patient had the shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: I have been sick just with a flu; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am just calling to see since my second dose was due today, but I was unable to get it because I was so sick and I have been sick just with a flu. I am just calling about the question for Covid-19 Vaccine from Pfizer." The outcome the event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Had only sore arm both times of one day with a 75% soreness reduction for second shot; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A patient of an unspecified gender in his/her 70's, working in the Pharmacy section, received the second 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 reported that "he/she opted with an early/late window of four days (08Jan2021)". The Facility has now begun their program of vaccinating the 75 years and above. The patient reported he/she had only sore arm both times of one day with a 75% soreness reduction for second shot. Event onset date was not reported. The event recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Energy increased, Fatigue, Pain in extremity
Clinical narrative: Had only sore arm both times of one day with a 75% soreness reduction for second shot; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A patient of an unspecified gender in his/her 70's, working in the Pharmacy section, received the second 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 reported that "he/she opted with an early/late window of four days (08Jan2021)". The Facility has now begun their program of vaccinating the 75 years and above. The patient reported he/she had only sore arm both times of one day with a 75% soreness reduction for second shot. Event onset date was not reported. The event recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever/Temperature taken 100 degrees Fahrenheit; chills; overall fatigue; headache; This is a spontaneous report from two contactable physicians. A 41-year-old male patient received second dose of bnt162b2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After taking his 2nd dose of the vaccine on 09Jan2021, the patient experienced a headache on 09Jan2021, then on 10Jan2021, also included a fever and chills and overall fatigue throughout the day on 10Jan2021. Although these were consistent with the educational pamphlet on the vaccine, we still wanted to report it. Patient was taking ibuprofen and paracetamol (TYLENOL) as needed. Temperature taken 100 degrees Fahrenheit. Event took place after use of product. The outcome of all the events was unknown.   Information about the lot/batch number has been requested.