chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstruation irregular, Off label use
Clinical narrative: Spotting while not on period- post second dose, 2-7 days; dose number: 1 administration date 07Apr2021, dose number: 2 administration date: 24Apr2021; dose number: 1 administration date 07Apr2021, dose number: 2 administration date: 24Apr2021; This is a spontaneous report from a contactable consumer (patient). A 30-year-old Female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8730, on 07Apr2021 13:15 at single dose in left arm, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0172, on 24Apr2021 14:00 at single dose in right arm for COVID-19 immunization. Medical history was none. The patient had no allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included ibuprofen (ADVIL 12 HOUR), caffeine, paracetamol (EXCEDRIN ASPIRIN FREE), melatonin, ethinylestradiol, norethisterone acetate (JUNEL FE 24), and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 27Apr2021, the patient had Spotting while not on period- post second dose, 2-7 days. No treatment was received. The outcome of the event was resolving.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Disruption of menstrual period: first period post-vaccine was late by nearly a week; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular, administered in arm left on 22Feb2021 at 11:00 as unknown, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. The patient experienced disruption of menstrual period: first period post-vaccine was late by nearly a week, then the next three periods have come early by 7-20 days on 22Feb2021. There was no treatment received for the event. The outcome of the event was recovering.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Oligomenorrhoea
Clinical narrative: prolonged menstrual cycle; got her period two weeks early and she is still bleeding; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She would like to know whether 'their' side effect, prolonged menstrual cycle (unknown date), is related to the COVID vaccine. The patient received vaccine on 21Apr2021. The next day (on 22Apr2021), the patient got her period two weeks early and she is still bleeding. She says she has seen multiple reports of women online with the same experience as hers. Saw a healthcare professional but they were not concerned. The outcome of the event prolonged menstrual cycle was unknown, while other event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: 1st vaccine started menstrual cycle same day, no problems other than longer than usual; This is a spontaneous report from a contactable Physician (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 10Jan2021 10:00 (Lot Number: EL3246) as single dose for COVID-19 immunisation. Medical history included asthma from Aug2020 and ongoing. The patient's concomitant medications were not reported. On 10Jan2021 1st vaccine started menstrual cycle same day, no problems other than longer than usual in Jan2021. 2nd vaccine on 31Jan2021, on 01Feb2021 (day 20 of cycle) period started with very heavy bleeding and clotting that lasted 10 days. Event was reported as non-serious. The outcome of event was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Foggy head; Sore arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150 and Expiration was not reported) via an unspecified route of administration in Arm Left on 08Apr2021 13:00, as 1st dose, single for COVID-19 immunization. Medical history included seasonal allergy, hypersensitivity, food, food allergy all from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); mometasone furoate (ASMANEX) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after the first dose of the vaccine she had a foggy head, sore arm. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain/back pain; This is a spontaneous report from a contactable consumer (patient's sister-in-law) received via medical information team. An approximately 49-year-old female patient (reported as almost 50-years-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at second dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lower back pain/back pain on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: her menses started 12 days early, within 18 hours of the second shot; This is a spontaneous report from a contactable consumer (Pfizer Colleague). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's menses started 12 days early, within 18 hours of the second shot on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tiredness and fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non hcp reported for her partner. The consumer reported for two different patients, it is the 2nd of the two reports. A 24-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced tiredness and fatigue on 25Apr2021 with outcome of recovered in Apr2021, arm soreness on 24Apr2021 with outcome of recovered in Apr2021. The events didn't result Emergency Room/ Physician Office.  Clinical course: Reporter adds her partner started to have the arm soreness on 24Apr2021; tiredness and fatigue 25Apr2021 then she started her period and pretty much got over everything after that.   No follow up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: contracted a cold; This is a spontaneous report received from a contactable consumer (the patient) from Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she should reschedule her second dose of the COVID vaccine. She contracted a cold from her daughter, on an unspecified date. She tested negative for COVID, on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Gait disturbance, Headache, Hypokinesia
Clinical narrative: he's not doing well/ he felt so sick that he could not walk to go to work this morning/ Still can't function well; I can hardly move/ took him 20 minutes to get out of bed and get dressed; couldn't move and struggled to get through work; he felt so sick that he could not walk to go to work this morning/ Could hardly walk, it took over his whole body, back, legs, and speech; nausea; head, back pain/ Headache; head, back pain; stiffness in his legs; Fever; like the flu, worse than the flu; fatigued; fell asleep; This is a spontaneous report from a contactable consumer and other hcp from a Pfizer sponsored program Pfizer RxPathways. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 64 years, on 04May2021 14:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing single functional kidney. The patient's concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 13Apr2021 for COVID-19 immunization and experienced pain in arm. The patient received the 2nd dose of the covid vaccine yesterday and said he felt so sick that he could not walk to go to work this morning, fatigued, nausea, head/ back pain and stiffness in his legs which were categorized as severe on 05May2021. The patient's wife called and stated "My husband got the Pfizer vaccination, the second dose yesterday and he's not doing well." The patient than got on the phone and stated "I had an adverse reaction, I can hardly move." He also stated he could hardly walk, it took over his whole body, back, legs, and speech; still can't function well and been in bed since he got home. The patient was calling about the Pfizer Covid Vaccine and stated he received his second shot yesterday, 04May2021. He stated after he received the shot, he felt fatigued (04May2021) and fell asleep (May2021). He stated he works nights and when he got up at 02:00, it took him 20 minutes to get out of bed and get dressed. He stated he was home now, and he has a headache, fever, he still can't function well, and it is like the flu, worse than the flu. He stated at 02:00 a.m., he couldn't move and struggled to get through work and he still has a fever and is fatigued. The outcome of the events back pain, stiffness in his legs, fell asleep and nausea were unknown while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Malaise, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: he's not doing well/ he felt so sick that he could not walk to go to work this morning/ Still can't function well; I can hardly move/ took him 20 minutes to get out of bed and get dressed; couldn't move and struggled to get through work; he felt so sick that he could not walk to go to work this morning/ Could hardly walk, it took over his whole body, back, legs, and speech; nausea; head, back pain/ Headache; head, back pain; stiffness in his legs; Fever; like the flu, worse than the flu; fatigued; fell asleep; This is a spontaneous report from a contactable consumer and other hcp from a Pfizer sponsored program Pfizer RxPathways. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 64 years, on 04May2021 14:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing single functional kidney. The patient's concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 13Apr2021 for COVID-19 immunization and experienced pain in arm. The patient received the 2nd dose of the covid vaccine yesterday and said he felt so sick that he could not walk to go to work this morning, fatigued, nausea, head/ back pain and stiffness in his legs which were categorized as severe on 05May2021. The patient's wife called and stated "My husband got the Pfizer vaccination, the second dose yesterday and he's not doing well." The patient than got on the phone and stated "I had an adverse reaction, I can hardly move." He also stated he could hardly walk, it took over his whole body, back, legs, and speech; still can't function well and been in bed since he got home. The patient was calling about the Pfizer Covid Vaccine and stated he received his second shot yesterday, 04May2021. He stated after he received the shot, he felt fatigued (04May2021) and fell asleep (May2021). He stated he works nights and when he got up at 02:00, it took him 20 minutes to get out of bed and get dressed. He stated he was home now, and he has a headache, fever, he still can't function well, and it is like the flu, worse than the flu. He stated at 02:00 a.m., he couldn't move and struggled to get through work and he still has a fever and is fatigued. The outcome of the events back pain, stiffness in his legs, fell asleep and nausea were unknown while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: he's not doing well/ he felt so sick that he could not walk to go to work this morning/ Still can't function well; I can hardly move/ took him 20 minutes to get out of bed and get dressed; couldn't move and struggled to get through work; he felt so sick that he could not walk to go to work this morning/ Could hardly walk, it took over his whole body, back, legs, and speech; nausea; head, back pain/ Headache; head, back pain; stiffness in his legs; Fever; like the flu, worse than the flu; fatigued; fell asleep; This is a spontaneous report from a contactable consumer and other hcp from a Pfizer sponsored program Pfizer RxPathways. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 64 years, on 04May2021 14:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing single functional kidney. The patient's concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 13Apr2021 for COVID-19 immunization and experienced pain in arm. The patient received the 2nd dose of the covid vaccine yesterday and said he felt so sick that he could not walk to go to work this morning, fatigued, nausea, head/ back pain and stiffness in his legs which were categorized as severe on 05May2021. The patient's wife called and stated "My husband got the Pfizer vaccination, the second dose yesterday and he's not doing well." The patient than got on the phone and stated "I had an adverse reaction, I can hardly move." He also stated he could hardly walk, it took over his whole body, back, legs, and speech; still can't function well and been in bed since he got home. The patient was calling about the Pfizer Covid Vaccine and stated he received his second shot yesterday, 04May2021. He stated after he received the shot, he felt fatigued (04May2021) and fell asleep (May2021). He stated he works nights and when he got up at 02:00, it took him 20 minutes to get out of bed and get dressed. He stated he was home now, and he has a headache, fever, he still can't function well, and it is like the flu, worse than the flu. He stated at 02:00 a.m., he couldn't move and struggled to get through work and he still has a fever and is fatigued. The outcome of the events back pain, stiffness in his legs, fell asleep and nausea were unknown while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 20Apr2021 at age of 48-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced delayed menstrual cycle after receiving Pfizer COVID vaccine dose one. 37 days later and she has not gotten here period yet. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Experienced her normal menstrual cycle, two days before her first dose of vaccine, and bleeding has not stopped, and continues after second vaccine; This is a spontaneous report received from contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 14:30 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) (38-year-old) at first dose, single in upper arm left; on 30Apr2021 14:30 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021) (38-year-old) at second dose, single in upper arm left for COVID-19 immunisation. The patient's medical history and concomitant medications (other products) were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on the same day, no prior vaccination within 4 weeks. The patient's mother told her to get the vaccine. The patient experienced her normal menstrual cycle, two days before her first dose of vaccine, and bleeding has not stopped, and continued after second vaccine on 07Apr2021. She had 4 or 5 days where the bleeding was light last week, but then on Sunday, it came back with a vengeance. Her normal menstrual cycle was usually 3 light days and her periods were not like she is experiencing now. She had had moderate to heavy bleeding for 3 weeks until 17Apr2021, the next week it was lighter, and than the bleeding got heavier again on 24Apr2021. No family medical history related to the event. No investigation assessment. No emergency room and physician office visit. No relevant test. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Discomfort
Clinical narrative: mild Discomfort; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer Sponsored Program. This 74-year-old-male patient received at 14:00 13Jan2021 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL2418) at the age of 74-years in right arm  as a single dose for COVID-19 immunization. Medical history included COPD. Concomitant medications included ivermectin on 19Jan2021 and fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, start date not provided. Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was given in right arm at 9:00 04Feb2021 Lot: EL9264 for COVID-19 immunization. In 2021, around the end of Febr2021 beginning of Mar2021 he had an antibody test done and it showed 23 antibodies. He then did another antibody test on 03May2021 which showed only 5, so he was saying it was negative. The patient on 14Jan2021, in the morning, had a mild discomfort. It lasted a couple of hours. No events occurred after second dose. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Localised oedema, Pain, Rash erythematous
Clinical narrative: Left subclavicular fullness; Left subclavicular fullness, very painful; Left subclavicular fullness, very painful, rash, redness; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 (Lot Number: EW0165) as single dose for covid-19 immunisation.  Medical history included Hpylori (H.pylori gastrointestinal disease).The patient did not have known allergies. There were no concomitant medications as the patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 lot number EW0150 on 09Apr2021 at left arm for COVID-19 immunisation. 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 patient experienced Left subclavicular fullness, very painful, rash, redness on 30Apr2021 20:00 with outcome of not recovered. Therapeutic measures were taken as a result of all the events including antibiotics. The events resulted in "Emergency room/department or urgent care" and "Doctor or other healthcare professional office/clinic visit". The patient was not hospitalized.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Fatigue, Feeling hot, Palpitations
Clinical narrative: anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. 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 patient previously took levofloxacin and experienced allergy.  The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body height, Depression, Fatigue, Influenza like illness
Clinical narrative: critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea; lethargy; body ache; fatigue (he is tired all the time and cannot get off the couch); This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 22Apr2021 (Batch/Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN) taken for neuropathy peripheral, start and stop date were not reported.  Patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine on 22Apr2021, he has been terribly sick, he feel like his dying. He had nausea, lethargy, body ache, critical sadness like never before, fatigue (he was tired all the time and cannot get off the couch) and it was not going away on 23Apr2021. He had seen three doctors, tested negative to Covid-19 and his blood tests were normal. He had flu like symptoms for 13 days since 23Apr2021, and it never goes away. The symptoms seem to get better and then he exercises a lot and they come back. Patient has been nauseated, had extreme lethargy, sadness and depression, and body aches. The patient was on a plethora of medications now because of this. He wanted to know what does it say about his immune system? He was scared that he was dying, it feels like he's dying. He has worn two masks and not socialized at all and does not understand what has happened, he has done everything right. His inflammatory response was checked on 04May2021 which has not come back yet. The patient underwent lab tests and procedures which included blood test: normal on 06May2021, body height: 175 cm on 06May2021, platelet count: normal on 04May2021, red blood cell count: normal   on 04May2021, sars-cov-2 test: negative on 04May2021, weight: 195-200 on 06May2021. He wanted to know when will these side effects go away and he will start getting better, and asked if he should get the second dose. Outcome of the events was not recovered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lethargy, Malaise, Nausea, Pain
Clinical narrative: critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea; lethargy; body ache; fatigue (he is tired all the time and cannot get off the couch); This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 22Apr2021 (Batch/Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN) taken for neuropathy peripheral, start and stop date were not reported.  Patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine on 22Apr2021, he has been terribly sick, he feel like his dying. He had nausea, lethargy, body ache, critical sadness like never before, fatigue (he was tired all the time and cannot get off the couch) and it was not going away on 23Apr2021. He had seen three doctors, tested negative to Covid-19 and his blood tests were normal. He had flu like symptoms for 13 days since 23Apr2021, and it never goes away. The symptoms seem to get better and then he exercises a lot and they come back. Patient has been nauseated, had extreme lethargy, sadness and depression, and body aches. The patient was on a plethora of medications now because of this. He wanted to know what does it say about his immune system? He was scared that he was dying, it feels like he's dying. He has worn two masks and not socialized at all and does not understand what has happened, he has done everything right. His inflammatory response was checked on 04May2021 which has not come back yet. The patient underwent lab tests and procedures which included blood test: normal on 06May2021, body height: 175 cm on 06May2021, platelet count: normal on 04May2021, red blood cell count: normal   on 04May2021, sars-cov-2 test: negative on 04May2021, weight: 195-200 on 06May2021. He wanted to know when will these side effects go away and he will start getting better, and asked if he should get the second dose. Outcome of the events was not recovered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Red blood cell count, SARS-CoV-2 test, Weight
Clinical narrative: critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea; lethargy; body ache; fatigue (he is tired all the time and cannot get off the couch); This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 22Apr2021 (Batch/Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN) taken for neuropathy peripheral, start and stop date were not reported.  Patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine on 22Apr2021, he has been terribly sick, he feel like his dying. He had nausea, lethargy, body ache, critical sadness like never before, fatigue (he was tired all the time and cannot get off the couch) and it was not going away on 23Apr2021. He had seen three doctors, tested negative to Covid-19 and his blood tests were normal. He had flu like symptoms for 13 days since 23Apr2021, and it never goes away. The symptoms seem to get better and then he exercises a lot and they come back. Patient has been nauseated, had extreme lethargy, sadness and depression, and body aches. The patient was on a plethora of medications now because of this. He wanted to know what does it say about his immune system? He was scared that he was dying, it feels like he's dying. He has worn two masks and not socialized at all and does not understand what has happened, he has done everything right. His inflammatory response was checked on 04May2021 which has not come back yet. The patient underwent lab tests and procedures which included blood test: normal on 06May2021, body height: 175 cm on 06May2021, platelet count: normal on 04May2021, red blood cell count: normal   on 04May2021, sars-cov-2 test: negative on 04May2021, weight: 195-200 on 06May2021. He wanted to know when will these side effects go away and he will start getting better, and asked if he should get the second dose. Outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: Some of the vaccine had come out after the injection with some blood / A little fluid came out of her arm after getting the injection; Some of the vaccine had come out after the injection with some blood / A little fluid came out of her arm after getting the injection; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female consume received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in the arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient noticed that some of the vaccine had come out after the injection with some blood. A little fluid came out of her arm after getting the injection. She stated she had no side effects to report or anything like that. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Full blood count, SARS-CoV-2 antibody test
Clinical narrative: He had no idea where all his energy went; fatigue; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US support. A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm right on 21Feb2021 12:00 (Lot Number: EM9210; Expiration Date: Jun2021) as 2nd dose, single at age of 75-years-old for covid-19 immunization. The patient medical history was none. The patient had no symptoms of a possible COVID19 infection prior getting the vaccine. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 28Jan2021 (Lot Number: EL9262, Route: Intramuscular, Anatomical Location: Arm, Right) for covid-19 immunization. No other prior vaccinations (within 4 weeks). The patient had a strong reaction to the second COVID-19 Vaccine shot. He said he got his second COVID-19 Vaccine and was told by the hospital staff to not plan to do anything the following day because he would likely have a reaction to the COVID-19 Vaccine. After he got his second COVID-19 Vaccine, it was exactly as he was told it would be. He clarified he didn't want to get out of bed the next day (22Feb2021). He said he was warned about fatigue, and a variety of other reactions. He couldn't get moving the day after his second COVID-19 Vaccine (22Feb2021). He said he had no idea where all his energy went. The patient considered what he experienced to be the fatigue that he was told he would likely experience after getting the second COVID-19 vaccine. Fatigue lasted for approximately 24 hours, and by the next morning (23Feb2021), he was fine. He said he had no fever, and didn't even need to take Tylenol. Reported on 05May2021 he had a CBC performed for a cardiologist appointment he had scheduled at the end of May2021. No further details provided. The event did not require a visit to emergency room or physician office. Declined any treatment for fatigue. The patient had a Quest Diagnostic antibody test (for blood work drawn on 05May2021): SARS-COV-2 AB (IGG spike, Semi-QN) Test Result: 4.26 (High), Antibody Test: 1.00 (positive). Outcome of the events was recovered on 23Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Feeding disorder
Clinical narrative: Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids, Hyperhidrosis, Inflammation, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia, Tremor
Clinical narrative: Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Minor allergic reaction to vaccine.; small patches of acute hives appearing and disappearing throughout the arms, legs, and back; This is a spontaneous report received from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 05May2021 14:45 (Lot Number: EW0158) as first dose, single for covid-19 immunisation. The patient medical history was not reported.  patient was not pregnant. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor allergic reaction to vaccine. The main symptom to confirm this is small patches of acute hives appearing and disappearing throughout the arms, legs, and back on 06May2021 08:30 AM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: I usually bleed lightly now its heavy and clot as well.; menstruation heavy lasting over week; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 29Apr2021 11:00 (Lot Number: EW0151) at the age of 41-year-old as single dose for covid-19 immunization.  Medical history included none. The patient had known allergies. The patient's concomitant medications were not reported. 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. Patient experienced menstruation heavy lasting over week on 04May2021 12:00, it started on 25Apr-28Apr normal 3 day. The patient had shot taken on 29Apr2021. It (menstruation) restarted 30th and continues still of day of 05May2021. She usually bleed lightly now its heavy and clot as well on 04May2021 12:00. No treatment was received for events. Outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea; Muscle aching; Chills; soreness in the arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not reported, expiry date- 31Aug2021), via an unspecified route of administration on 07May2021 in the morning (at the age of 72-year-old) as 1st dose, single for COVID-19 immunization. Medical history included gout in feet (reported as not any more), sinusitis and blood pressure increased. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure increased, losartan taken for blood pressure increased, Montelukast taken for sinusitis, allopurinol taken to prevent gout. The patient experienced soreness in the arm on evening of 07May2021 and nausea, muscle aching and chills on 08May2021 02:00 am. The patent wanted to know if it was okay to take Tylenol for the symptoms. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: His left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side); His left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side); This is spontaneous report received from a contactable consumer (patient) reported for himself.  A 56-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0175; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Deltoid left on 06May2021 as 2nd dose, single for COVID-19 immunisation. The medical history was Covid-19 immunization for first dose. The patient's concomitant medications were not reported. After 2 days of vaccination, left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side) on May2021. Patient was asked for recommendations on what to do. Report transmit - Unable to warm transfer the call to Reporter due high call volume - Caller is willing to wait on the line - Provided INT for reference. Seriousness of event was unspecified. Outcome of the patient experienced his left side part of the face became swollen when he woke up - it is like a size of a golf ball as he described going from nose to his lips (left side) (lip swelling) was unknown. upon Follow-up on (08May2021): This is spontaneous report received from a contactable consumer. This male consumer (patient) reported for himself that included Advised to see doctor for treatment guidance and Report - Previous INT E-transmitted upon follow up on Follow-up 2 (PRD 08May2021/ SRD09May2021): This is spontaneous report received from a contactable consumer. This 56-year-old male consumer (patient) reported for himself that included patient age at time of onset of reaction, weight, height, onset date was unknown, medical history, outcome of events.  No follow-up attempts are possible, information on batch numbers cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache
Clinical narrative: Headache; Stomach discomfort; Diziness; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: unknown), via intramuscular, administered in left arm on 13apr2021 at 15.30 (at the age of 42-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not undergo COVID-19 test prior to vaccination and Since the vaccination the patient has not been tested for COVID-19. On 13apr2021, 04:00, the patient experienced Headache, dizziness and a little stomach discomfort. The reporter assessed all events as non-serious. The outcome of the events Headache, dizziness and a little stomach discomfort was not recovered.  No follow-up attempts possible. No further information expected.