chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; Stuffy nose and ears; Stuffy nose and ears; Short of breath; Loss of appetite; Headache; Headache; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 08Jan2021 07:15 at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 28Dec2020 at right arm, at single dose for covid-19 immunization, and experienced mild headache and mild arm soreness. The patient received the second dose, and experienced extreme fatigue, uncontrollable chills for 3 hours, flu-like symptoms (headache, generalized muscle soreness, stuffy nose and ears), short of breath, loss of appetite, all at 08Jan2021 13:00. The outcome of the events was recovering. No treatment was received for all events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Eye disorder, Headache
Clinical narrative: profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Meningism, Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Enlarged lymph node under left armpit (site of injection); This is a spontaneous report from a contactable consumer (patient). A 27-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 30Dec2020 at a single dose on the left arm (reported as left armpit) for COVID-19 immunization in a hospital. Medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received an unspecified birth control within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021, the patient experienced enlarged lymph node under left armpit (site of injection). The patient was not given any treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fever; myalgia; arthralgia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative.  A 29-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received their first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced headache, fever, myalgia and arthralgia on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: Very sore arm with first COVID-19 Vaccine; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899) via an unspecified route of administration on the left arm on an unspecified date at a single dose for COVID-19 immunization. The patient had no medical history. Family medical history of high blood pressure. There were no concomitant medications. On an unspecified date, the patient experienced very sore arm with first COVID-19 Vaccine. Patient stayed home, didn't go to primary. Her weight was between 130lbs and 140lbs. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done. Outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a non-contactable nurse (patient). A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021, the patient started vomiting 12 hours after injection. The event was considered non-serious. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: sore arm; painful stiff neck; painful stiff neck; chills; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), 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. On 10Jan2021, the patient experienced sore arm, painful stiff neck, and chills. Patient could not lift arm above shoulder height or turn head. At the time of report, still have some neck pain but better than yesterday. Patient was able to turn head today. No chills and arm was still sore. The outcome of the event sore arm was not recovered, painful stiff neck was recovering and recovered from the event chills.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chapped lips, Eye allergy, Fatigue, Headache
Clinical narrative: Tired; Headache; Feverish; Eyes felt allergy like; Lips felt chapped; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) at single dose for COVID-19 immunisation. On 08Jan2021, the patient was tired, had headache, was feverish (but not elevated temp), eyes felt allergy like, and lips felt chapped. All were mild. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tired; Headache; Feverish; Eyes felt allergy like; Lips felt chapped; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) at single dose for COVID-19 immunisation. On 08Jan2021, the patient was tired, had headache, was feverish (but not elevated temp), eyes felt allergy like, and lips felt chapped. All were mild. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise, Pain in extremity
Clinical narrative: arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Chills, Headache, Off label use
Clinical narrative: Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue.  Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue, Pyrexia
Clinical narrative: Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue.  Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician reported for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date was not reported), via an unspecified route of administration on the left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient received 'rovoustatin' within two weeks of vaccination. The patient experienced shingles on 27Dec2020. The patient received Valtrex as treatment for the event. The patient did not receive any other vaccine within four weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient recovered from the event on an unspecified date.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient).  This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder.  The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date.  Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature.  Outcome was not recovered.  No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable.  About causality, nurse stated Yeah, most definitely.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient).  A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none.  The patient's concomitant medications were not reported.  The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer Sponsored program. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a bit of sore arm in Jan2021. The outcome was unknown  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Mild arm pain; Headache; Fatigue; This is a spontaneous report from non-contactable nurse (patient) received via a Pfizer sales representative. A patient of unspecified age and gender 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 medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild arm pain, headache and fatigue. The patient outcome of the events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: soreness in upper arm; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received  bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration from on 06Jan2021 at single dose  for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient experienced soreness in upper arm  on Jan2021 with outcome of unknown.  Information about Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: localized pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at a single dose to prevent COVID-19. The patient had no medical history. There were no concomitant medications. The patient got the second dose of the Covid-19 vaccine on Friday, 08Jan2021 (lot number: EK9231, expiration date: Apr2021). She didn't have a fever or chills, but she had localized pain which she also had with the first dose. She still has pain in her armpit, to the touch and when she moves it, but there is no swelling, lumps or bumps. The pain has decreased; it's not as bad as it was when she first noticed it. The localized pain at the injection site was worse with the first injection in Dec2020; she just did not have the underarm pain and she didn't have any pain until the day after she got the first dose. She got the 2nd dose at 5:30pm, and had pain at around 8pm or 9pm that night. The following day was the height of the pain for the second dose, and it has been decreasing since then. She got both doses in her left arm. Outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Injection site tenderness for first 24 hours; swollen lymph glands; This is a spontaneous report from a non-contactable  consumer (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 18Dec2020 11:00 at single dose for COVID-19 immunization. Medical history included tumor removal from left thigh and depression. The patient had no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), drospirenone, ethinylestradiol (OCELLA), clonazepam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 02Jan2020, patient reported injection site tenderness for first 24 hours. In less than 24 hours she had developed tenderness under her left arm, into her armpit and it continued to spread downward and also toward her breast. Patient also developed swollen lymph glands in the same areas. No treatment received in response to the events. The patient had no COVID prior to vaccination and not COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were reported as non-serious. The patient received her second dose of bnt162b2 on 08Jan2021 11:00 in the left arm. Outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Injection site pain, Injection site swelling
Clinical narrative: minor side effect: night of injection had vivid dream, and 2nd night after injection had another vivid dream when I do not typically have dreams  minor side effect of some chills 13 hours after injection that slight worsened, persisting until 36 hours after injection (resolved 1.5 days after injection) moderate pain at site of injection, onset 5 hours after injection and lasting until 2.5 days after injection
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization.  Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away.  It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Peripheral swelling
Clinical narrative: 100° temp Swollen hands and feet Headache
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gait disturbance, Hypoaesthesia, Myalgia, Presyncope
Clinical narrative: limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications.  The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; This is a spontaneous report from a contactable physician (patient) and a consumer (patient's spouse). A 67-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), 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 physician had a question. As a patient, he received the first dose of Pfizer BioNTech vaccine and on an unspecified date, two days later, he developed symptoms for Covid and tested positive after receiving the vaccine. He stated this had nothing to do with vaccine but had to do with the timing. He wanted to know if should take or delay vaccine. He is doing fine now. His second dose is coming up next week. The outcome of the events was recovered on an unspecified date.; Sender's Comments: The association between the event lack of effect (he developed symptoms for COVID and tested positive) with BNT162b2 can not be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Malaise, Parosmia, Pyrexia
Clinical narrative: First dose administered on 18Dec2020; received second dose at Day 20; Low grade fever; Malaise; Change in smell/sense of smell worse; Change in smell/sense of smell worse; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 for COVID-19 immunization, and had severe malaise, muscle aches, pain in injection site (arm), and had change in smell which was described as a foul burnt smell. The patient had received the second dose of the vaccine on 06Jan2021 (day 20). In Jan2021, the patient had low grade fever; malaise; and change in smell/sense of smell had worsened. The patient's COVID-19 test was non-detectable on an unspecified date. The outcome of the events, 'low grade fever', 'malaise', 'change in smell/sense of smell had worsened' and 'received the second dose of the vaccine on 06Jan2021 (day 20)', was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: First dose administered on 18Dec2020; received second dose at Day 20; Low grade fever; Malaise; Change in smell/sense of smell worse; Change in smell/sense of smell worse; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 for COVID-19 immunization, and had severe malaise, muscle aches, pain in injection site (arm), and had change in smell which was described as a foul burnt smell. The patient had received the second dose of the vaccine on 06Jan2021 (day 20). In Jan2021, the patient had low grade fever; malaise; and change in smell/sense of smell had worsened. The patient's COVID-19 test was non-detectable on an unspecified date. The outcome of the events, 'low grade fever', 'malaise', 'change in smell/sense of smell had worsened' and 'received the second dose of the vaccine on 06Jan2021 (day 20)', was unknown.  Information on lot number/batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: got the first vaccine and then tested positive for the virus; got the first vaccine and then tested positive for the virus/fairly sick; This is a spontaneous report from Pfizer-sponsored Program IBCC (Inbound Call Center for HCPs). A contactable physician reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), 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 reporter is a cardiologist. He is inquiring about the COVID-19 vaccine. He had several patients (pending clarification) who got the first vaccine and then tested positive for the virus. He is asking when can they get the second dose after testing positive. He had two patients that are fairly sick now. He has had patients who have monochromal antibodies (pending clarification). He is asking when they can get the vaccine after that treatment. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.,Linked Report(s) : US-PFIZER INC-2021022171 same reporter, similar suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: got the first vaccine and then tested positive for the virus; got the first vaccine and then tested positive for the virus/fairly sick now; This is a spontaneous report from Pfizer-sponsored Program. A contactable physician reported similar events for two patients. This is the second of two reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), 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 reporter is a cardiologist. He is inquiring about the COVID-19 vaccine. He had several patients (pending clarification) who got the first vaccine and then tested positive for the virus. He is asking when can they get the second dose after testing positive. He had two patients that are fairly sick now. He has had patients who have monochromal antibodies (pending clarification). He is asking when they can get the vaccine after that treatment. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.,Linked Report(s) : US-PFIZER INC-2021022153 same reporter, similar suspect drug and event; different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Parosmia, Taste disorder
Clinical narrative: altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Somnolence
Clinical narrative: Pt developed headache a few hours after vaccine that persisted for 3 days despite over the counter analgesics and greatly improved after an IM injection of Toradol 30mg on 1/14/21. Pt also had myalgias and grogginess that was self-limited.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very sore left arm for a day; a very sore left arm for a day and swelled up a little; This is a spontaneous report from a contactable nurse.  A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:15 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient was menopausal. Ongoing medical histories included gastrooesophageal reflux disease (GERD), iron deficiency (reported as iron supplementation), sinus disorder, hypersensitivity; and hair disorder, nail disorder and immune system disorder (reported as help with hair and nail and immune system). Ongoing concomitant medications included fexofenadine hydrochloride (ALLEGRA) since unknown date (reported as taking for a year) for sinus and allergies, calcium (CALCIUM) since unknown date (reported as taking for a year) for menopause, famotidine (FAMOTIDINE) since unknown date (reported as taking for a year) for GERD, cyanocobalamin (VITAMIN B12) since unknown date (reported as taking for a year) to help with hair and nail and immune system, colecalciferol (VITAMIN D 3) since unknown date (reported as taking for a year or two) for menopause and multivitamin since unknown date (taking for 5 years at least). The patient received the first dose of the Pfizer COVID 19 vaccine on 19Dec2020 at 1615PM in the left arm. She then reported of a very sore left arm for a day and it swelled up a little on that same day. She then felt some fatigue a little the next day (20Dec2020) on Sunday but it didn't prevent her from going to work. On 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low-grade fever for a maybe 12 hours but she couldn't find a thermometer and doesn't know her temperature. She also developed a reddening on her face on the nasal labial area or smile line area but not very pronounced on 20Dec2020 (noticed it for about 8 to 12 hours). All of her symptoms resolved by the 21Dec2020. The events does require a visit to physician office or emergency room (ER).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: chills; felt icky; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. Historical vaccine included BNT162B2 for covid-19 immunization (1st dose). The patient experienced chills and felt icky on an unspecified date after the second dose. The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Malaise, Myalgia, Pyrexia
Clinical narrative: fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: unknown), via an unspecified route of administration on 09Jan2021 15:50 at a single dose for COVID-19 immunization. Medical history included menopausal, GERD, sinus disorder, and allergies. Concomitant medications included colecalciferol (VITAMIN D 3) taking for a year or two for menopausal, cyanocobalamin (VITAMIN B12) taking for a year to help with hair, nail, and immune system, calcium taking for a year for supplementation and menopausal, famotidine taking for a year for GERD, fexofenadine hydrochloride (ALLEGRA) taking for a year for sinus and alllergies, and unspecified multivitamin taking for 5 years at least for iron supplementation. The patient received the first dose of bnt162b2 (lot number: EJ1685) on 19Dec2020 at 16:15PM in the left arm. She had a very sore left arm for a day and it swelled up a little. She felt some fatigue a little the next day on 20Dec2020 Sunday but it didn't prevent her from going to work. 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low grade fever for maybe 12 hours but she couldn't find a thermometer and did not know her temperature. She developed a reddening on her face, but it was not very pronounced, on the nasal labial area or smile line area. It was more pronounced on the first dose, she noticed it for about 8 to 12 hours Sunday 20Dec2020. All of her symptoms resolved by 21Dec2020.  She received the second dose 9Jan2021 at 15:50PM in the left arm. She noticed nothing right away but maybe 6 hours later, her left arm was very sore. She had more of a fever which she measured at 99.4 Fahrenheit on 10Jan2021. Her normal is 97.1 to 97.5 Fahrenheit which she knew because she had to get screened at work. This time, after the second dose, she also noticed she had bone and muscle aches but was all short lived on 10Jan2021. She went to church and wasn't feeling good from about 10:00AM to about 19:00PM. She did treat the fever and muscle/bone aches with Tylenol extra strength rapid relief 500mg each. She took two by mouth once 3 hours before the vaccine and again once during the night and once yesterday 10Jan2021 afternoon for a total of three times and it did help. She also rested on Sunday 10Jan2021 afternoon, took extra fluids so by the time she had to go to work she felt normal. The vaccine was not administered at military facility. No additional vaccines were administered on same date of bnt162b2. The adverse events did not require a visit to the physician's office or ER. There were no prior vaccinations (within 4 weeks). The patient had no family medical history relevant to the adverse events. Outcome of the event wasn't feeling good was unknown and of the other events was recovered on 10Jan2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Oropharyngeal discomfort, Pain, Pain in extremity
Clinical narrative: chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.