chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Cough, Decreased appetite, Dizziness
Clinical narrative: Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Muscular weakness, Pain, Pyrexia
Clinical narrative: Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered.   Information on lot/batch number has been requested.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Her arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (tradename unspecified, lot number was unknown) solution for injection in pre-filled syringe, via an unspecified route of administration on an unspecified date at a single dose for pneumonia. Medical history included atrial fibrillation. Concomitant medications include heart medication every day and unspecified vitamins. The patient experienced her arm was a little sore on an unspecified date. Outcome of the events was unknown.    Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Sinus disorder
Clinical narrative: Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient started to receive BNT162B2 (also reported as " Pfizer COVID-19 Vaccine"), Lot number: EL0142, via an unspecified route of administration on 27Dec2020 18:45 at single dose (dose 1) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Medical history included food allergies: shrimp. Concomitant medication included guaifenesin (MUCINEX). On 28Dec2020 06:00, the patient experienced back of left eye hurts, sinus near left eye feels swollen and mild headache. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Red arm, soreness at site, swollen
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site swelling
Clinical narrative: Right arm Swollen and tender lymph node; Right arm Swollen and tender lymph node; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 28Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included psoriasis, psoriatic arthritis, chronic back pain and childhood asthma. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient known allergies was tramadol. On 29Dec2020, the patient experienced right arm swollen and tender lymph node. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site coldness, Vaccination site discomfort, Vaccination site hypoaesthesia
Clinical narrative: I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Eh9899), via intramuscular route of administration, on 19Dec2020 (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was Hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced cold, numbness and a dull ache in the arm of the injection. No treatment was received for the events cold, numbness and a dull ache in the arm of the injection. The outcome of the events cold, numbness and a dull ache in the arm of the injection was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Malaise
Clinical narrative: Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart burn for 48 hrs; One episode of watery diarrhea; One episode of vomiting; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in left arm, on 23Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included being overweight, prediabetes, hyperlipidaemia and Known allergies: Statins. Concomitant medication included fish oil, ergocalciferol (VITAMIN D), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (ARED-2 VITAMINS) and finasteride. The patient experienced arm soreness, malaise, fatigue and headache, severe heart burn for 48 hrs, one episode of watery diarrhea, one episode of vomiting and feeling of fever for 48 hrs (but no fever) all on 23Dec2020 at 10:00. Treatment included unspecified antacids and proton pump inhibitors (PPI). The patient did not have COVID prior to vaccination. The patient was tested for COVID on 25Dec2020 post vaccination (nasal swab for rapid test and antibody test on 25Dec2020 which resulted to negative). The outcome of the event Feeling of fever for 48 hrs (but no fever) was recovered on 25Dec2020 at 10:00 and the patient recovered from the remaining events on an unspecified date in Dec2020.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vomiting
Clinical narrative: Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart burn for 48 hrs; One episode of watery diarrhea; One episode of vomiting; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in left arm, on 23Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included being overweight, prediabetes, hyperlipidaemia and Known allergies: Statins. Concomitant medication included fish oil, ergocalciferol (VITAMIN D), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (ARED-2 VITAMINS) and finasteride. The patient experienced arm soreness, malaise, fatigue and headache, severe heart burn for 48 hrs, one episode of watery diarrhea, one episode of vomiting and feeling of fever for 48 hrs (but no fever) all on 23Dec2020 at 10:00. Treatment included unspecified antacids and proton pump inhibitors (PPI). The patient did not have COVID prior to vaccination. The patient was tested for COVID on 25Dec2020 post vaccination (nasal swab for rapid test and antibody test on 25Dec2020 which resulted to negative). The outcome of the event Feeling of fever for 48 hrs (but no fever) was recovered on 25Dec2020 at 10:00 and the patient recovered from the remaining events on an unspecified date in Dec2020.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid oedema
Clinical narrative: On 12/25/20 pt experience swelling of the R eyelid.  By 12/26 the eyelid was swollen shut.  Patient received treatment of antibiotics and MEdrol dose pack and swelling decreased.  As of 1/5 eyelid was still slightly swollen.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after getting the vaccine; testing positive for COVID after getting the vaccine; This is a spontaneous report from a contactable Other Health Professional reported for herself.  A female patient of an unspecified age (reported as 42) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after getting the vaccine in Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included COVID test in Dec2020: negative; positive. The reporter would like an explanation as to the rapidness of her testing positive for COVID after getting the vaccine. Can the vaccine cause false positive test results?  Information on interpretation of SARS-CoV-2 test results. The patient tested negative on Monday, got the vaccine on Monday. However tested positive today, asymptomatic.  Information about batch/lot 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Right arm: Painful; Swollen axilla lymph nodes; tender lymph node; Severe Pain at elbow; This is a spontaneous report from a contactable nurse (Patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140), via an unspecified route of administration in right arm on 21Dec2020 09:45 at single dose for covid-19 immunization in hospital. The patient's medical history was not reported and there was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced right arm painful, swollen axilla lymph nodes, tender lymph node and severe pain at elbow on 26Dec2020. The events was non-serious. Th events result in Doctor or other healthcare professional office/clinic visit. There was no treatment. The outcome of the events was unknown.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Ear swelling, Heart rate, Heart rate increased, Swelling face
Clinical narrative: Heart rate went to 133 at 12:45pm for 6 minutes; face and ears were swollen; face and ears were swollen; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 29Dec2020 11:15 at a single dose for COVID-19 immunization. The patient was obese with BMI of 32, known allergies were tree nuts, sunflower seeds sesame seeds. The patient was not pregnant at the time of vaccination. Concomitant medication includes vitamins nos (DAILY MULTIVITAMIN). On 29Dec2020, heart rate went to 133 at 12:45pm for 6 minutes. The patient took TYLENOL and BENADRYL and went to sleep. When she woke up her face and ears were swollen, heart rate is back to normal (29Dec2020). The patient also added that swelling was a reaction she normally gets when she eats something she was allergic too. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events face and ears were swollen was recovering; heart rate went to 133 at 12:45pm for 6 minutes recovered on 29Dec2020.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypoaesthesia, Palpitations
Clinical narrative: palpitations, numbness B/L UE, elevated BP
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Lymph node pain
Clinical narrative: elevated heart rate; shortness of breath; painful lymph nodes; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported that a patient of unspecified age and gender started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I had side effects for 4 days". this patient experienced elevated heart rate, shortness of breath and painful lymph nodes on an unspecified date. Outcome of events was reported as unknown. Patient was nervous about having the second dose but later stated s/he was all in.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Severe pain in arm where injection occurred, chills, aches, and low fever. Peaked around 6 hours after vaccination. Similar but less severe symptoms the second day in the evening
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Ek9231), via intramuscular route of administration, on 29Dec2020 at 08:45 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. Past drug history was allergy to Pediazole. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, at 07:30: AM, the patient experienced diarrhea, chills and vaccination site soreness. No treatment was received for the events diarrhea, chills and vaccination site soreness. The outcome of the events diarrhea, chills and vaccination site soreness was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Headache, Nausea
Clinical narrative: Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE).  The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Hot flush
Clinical narrative: Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Had the vaccine eventually then I ended up getting the virus; I ended up going through a rapid test that turned positive; This is a spontaneous report from a contactable consumer  reporting for himself.  A 53-years-old male patient started to receive bnt162b2 (BNT162B2; Lot # EK5730) vaccine , intramuscular in the left arm  on an unspecified date at single dose  for Covid-19 immunisation .  Medical history included hypothyroidism from an unknown date.  Concomitant medication included levothyroxine sodium (SYNTHROID).  The patient  stated that he does get test for the virus twice weekly. He did end up getting the Pfizer, the first round of Pfizer vaccine a week ago. The patient had a test, a virus test before, a swab test afterwards, both were negative but by Christmas eve the patient started getting, what he thought was side effect of the vaccine and he ended up going through a rapid test  and it turned out he was positive for the virus.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization.  Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events.   Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Flushing, Headache
Clinical narrative: Estimated due date: 02/07/2021. Will probably be induced a week earlier. I felt mild pain in my arm in the evening of the 31st and then the pain started from my elbow to my neck on my right side. I went to sleep and woke up with general malaise, chills, body ache, sore throat, headache. the same feeling I had when I had covid, a heaviness in my chest, almost like a shortness of breathe. I was flushed and felt feverish although I never had a fever. The symptoms lasted all day.  On the first also my arm pain was severe, I could not even lift it the whole day. I went to sleep on 01/01 and when I woke up on 01/02 the symptoms were all gone. I took Tylenol 3 times to help me with the symptoms. 3 grams total in 24 hrs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neck pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Estimated due date: 02/07/2021. Will probably be induced a week earlier. I felt mild pain in my arm in the evening of the 31st and then the pain started from my elbow to my neck on my right side. I went to sleep and woke up with general malaise, chills, body ache, sore throat, headache. the same feeling I had when I had covid, a heaviness in my chest, almost like a shortness of breathe. I was flushed and felt feverish although I never had a fever. The symptoms lasted all day.  On the first also my arm pain was severe, I could not even lift it the whole day. I went to sleep on 01/01 and when I woke up on 01/02 the symptoms were all gone. I took Tylenol 3 times to help me with the symptoms. 3 grams total in 24 hrs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Estimated due date: 02/07/2021. Will probably be induced a week earlier. I felt mild pain in my arm in the evening of the 31st and then the pain started from my elbow to my neck on my right side. I went to sleep and woke up with general malaise, chills, body ache, sore throat, headache. the same feeling I had when I had covid, a heaviness in my chest, almost like a shortness of breathe. I was flushed and felt feverish although I never had a fever. The symptoms lasted all day.  On the first also my arm pain was severe, I could not even lift it the whole day. I went to sleep on 01/01 and when I woke up on 01/02 the symptoms were all gone. I took Tylenol 3 times to help me with the symptoms. 3 grams total in 24 hrs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Paraesthesia, Pyrexia
Clinical narrative: Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on left arm on 16Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included obstructed sleep apnea, chronic sinusitis, and obesity. The patient has no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at a hospital and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experience muscle soreness in the arms, neck, and upper back as well as fatigue on 17Dec2020 12:00 (starting about 24 hours after the vaccination). The symptoms were resolved by the next day (Dec2020), or approximately 48 hours after the vaccination. No treatment was given for the events.   Information about lot/batch has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Impaired work ability
Clinical narrative: Monday, January 4 in the evening I became very fatigued, to the point where I couldn't stay awake.  When I woke up a few hours later, I noticed that I had a very bad headache and all-over body aches, and I felt like I had the flu.  Weak, nauseous and extremely tired.  I went to bed and slept through the night, when my alarm woke me at 7:00 am on Tuesday, January 5, I got up to use the bathroom and felt all the same symptoms from the night before, only worse.  I noticed that I had a rash on my left arm below the injection site.  I called in sick and went back to bed.  I slept from approximately 7:30 to 2:00 pm on January 5.  I felt a little better upon awakening, but had a very bad headache and no appetite.  The other body aches seemed better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site rash, Nausea, Pain, Somnolence
Clinical narrative: Monday, January 4 in the evening I became very fatigued, to the point where I couldn't stay awake.  When I woke up a few hours later, I noticed that I had a very bad headache and all-over body aches, and I felt like I had the flu.  Weak, nauseous and extremely tired.  I went to bed and slept through the night, when my alarm woke me at 7:00 am on Tuesday, January 5, I got up to use the bathroom and felt all the same symptoms from the night before, only worse.  I noticed that I had a rash on my left arm below the injection site.  I called in sick and went back to bed.  I slept from approximately 7:30 to 2:00 pm on January 5.  I felt a little better upon awakening, but had a very bad headache and no appetite.  The other body aches seemed better.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Musculoskeletal discomfort, Pain
Clinical narrative: I have been experiencing body ache throughout my whole body, pain if stay in one position to long on right hip or lower; headaches; I experienced dizziness, felt giddy/light headed; Then at night my whole body felt sore, ached on lower back and right side of my hip; Then at night my whole body felt sore, ached on lower back and right side of my hip; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm) on 29Dec2020 at 07:30 AM, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. Patient did not receive other vaccine four weeks prior COVID vaccination. The patient did not have COVID prior vaccination. The vaccine was administered in the hospital. Same day of shot, the patient experienced dizziness, felt giddy, then at night her whole body felt sore, ached on lower back and right side of her hip. In the morning of 30Dec2020, patient experienced body ache throughout my whole body, pain if stay in one position to long on right hip or lower back and legs, light headed and headaches. The patient did not receive treatment for the events. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: Severe stomach cramps; severe stomach cramps and bloating; This is a spontaneous report from a contactable other hcp (patient).  A 66-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EK9231), intramuscular on 29Dec2020 16:00 at single dose on right arm for COVID-19 immunization.  Medical history included penicillin allergy.  Concomitant medication included chondroitin;glucosamine, biotin, vitamin d nos, zolpidem tartrate (AMBIEN) and Women's Daily Vitamin.  The patient previously took codeine and experienced drug allergy. The patient experienced severe stomach cramps and bloating 19 hours after vaccine (30Dec2020 11:00). Took "Digestive Advantage" and symptoms let up after 1 hour. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration
Clinical narrative: Induration at the injection site
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Eye pain, Nausea, Pain in jaw
Clinical narrative: 7 minutes after receiving injection patient developed left jaw pain, pain behind eyes, dizziness, nausea and 2 episodes of vomiting. Given antiemetic medication and ibuprofen for symptomatic treatments. Monitored in the ED for several hours without new or worsening symptoms.  Of note, patient was seen for left jaw pain, pain behind eyes and dizziness on Dec 26 in the ED as well. States these symptoms were thought to be improving until dose of vaccine, symptoms returned. New symptom is N/V after dose of vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus rhythm, Vomiting
Clinical narrative: 7 minutes after receiving injection patient developed left jaw pain, pain behind eyes, dizziness, nausea and 2 episodes of vomiting. Given antiemetic medication and ibuprofen for symptomatic treatments. Monitored in the ED for several hours without new or worsening symptoms.  Of note, patient was seen for left jaw pain, pain behind eyes and dizziness on Dec 26 in the ED as well. States these symptoms were thought to be improving until dose of vaccine, symptoms returned. New symptom is N/V after dose of vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: 7 minutes after receiving injection patient developed left jaw pain, pain behind eyes, dizziness, nausea and 2 episodes of vomiting. Given antiemetic medication and ibuprofen for symptomatic treatments. Monitored in the ED for several hours without new or worsening symptoms.  Of note, patient was seen for left jaw pain, pain behind eyes and dizziness on Dec 26 in the ED as well. States these symptoms were thought to be improving until dose of vaccine, symptoms returned. New symptom is N/V after dose of vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician reporting for a nurse (patient) from a Pfizer-sponsored program Pfizer First Connect.  A 43-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation.  There were no medical history and concomitant medications. The physician was reporting that a nurse received the vaccine and had a headache after receiving it. She also tested positive for Covid 6 days after getting the vaccine (on 28Dec2020). He was asking if there was any connection with getting the first shot and testing positive. She was very keen with social distancing and wearing a mask. The physician is a medical oncologist. He was reporting on one of the nurses that worked at the hospital. She also developed nasopharyngeal congestion 4-5 days later. The nurse was at work today. She was disappointed because she had to go home. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Dec2020. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19  cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: has tested positive shortly after; has tested positive shortly after; This is a spontaneous report from a contactable pharmacist. A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The pharmacist asked for recommendation for the 2nd dose of the patient who had received the 1st dose but had tested positive shortly after. The outcome of the events was unknown.  information on the LOT/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Feverish Chills Fatigue  Runny nose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Initial insomnia, Insomnia, Poor quality sleep
Clinical narrative: Severe insomnia.  Started the night of 1/1/2021.  Was unable to fall asleep despite being tired.  This is not normal for me.  This has continued every night.  I am unable to fall asleep despite being exhausted.  Once asleep I am waking up  within an hour and a half to two hours and not able to go back to sleep.  Over the past 5 nights I have averaged 2 hours a sleep night and no day time naps.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Abdominal pain, Back pain, Breast tenderness, Vaginal haemorrhage
Clinical narrative: started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 30Dec2020 this case now contains all required information to be considered valid.  A contactable nurse (patient) reported a 56-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), intramuscular on the left deltoid on 17Dec2020 at SINGLE DOSE for COVID-19 vaccination at the hospital, estradiol (ESTRADIOL gel), oral from May2020 and ongoing at 1 mg, 1x/day for menopause and progesterone (PROGESTERONE tablet), oral from May2020 and ongoing at 100 mg, 1x/day for menopausal symptoms. Medical history included blood pressure issues since 2000 and ongoing. The patient was also menopausal (ongoing).  Concomitant medication included losartan (LOSARTAN) for blood pressure issues. On 28Dec2020, the patient experienced abdominal pain mild. She also had low back pain mild and breast tenderness noted on 29Dec2020. The patient also stated that she felt like she was going to have a period even she has not had a period in 3 years as she was on progesterone and estradiol. The patient will see doctor to make sure that it was not anything. On 30Dec2020, the patient reported that she started spotting this morning.  The patient did not receive any treatments for the events. The action taken in response for progesterone and estradiol as dose not change.  The patient recovered from abdominal pain mild on 28Dec2020; low back pain mild and breast tenderness on 29Dec2020. Stated that the spotting resolved at noon on 30Dec2020. The reporter considered the events as non-serious. The reporter also considered that the events were related to Pfizer BioNTech Vaccine while unrelated to estradiol and progesterone.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Dizziness, flushing
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Lymphadenopathy, Peripheral swelling
Clinical narrative: Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020.  No follow up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020.  No follow up attempts are needed. No further information is expected.