chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: very tired (fatigue); Headache; This is a spontaneous report from a contactable consumer (patient). This 69-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left deltoid on an unspecified date (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL3246) in Jan2021 (at the age of 69-years-old) for COVID-19 immunisation and experience pain in arm and vaccination site pain; flu shot on an unknown date for immunisation and experienced pain; and shingles shot on an unknown date for immunisation and experienced pain. The patient reported that on the third day after the second injection she was very tired (fatigue) for a short period of time. A few days after, she experienced headache for a short period of time. The clinical outcomes of very tired (fatigue) and headache were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever; chills; Feeling unwell; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced fever, chills and feeling unwell on 02Mar2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a contactable consumer (patient) received from a sponsored program. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included had 20 surgeries from an unknown date and unknown if ongoing, and unhealthy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported having both Pfizer shots and on an unspecified date  after the second shot the patient was getting nauseous; further reporting she did not know if her side effects were coming from the vaccines. The clinical outcome of nauseous was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (the patient) from a 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 02Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a headache after the vaccine. She asked if she was able to take paracetamol (TYLENOL). The outcome of headache was unknown.   Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on his arm; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a male of unspecified age received the second dose BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route in the arm on 08Mar2021 in the morning, for COVID-19 immunisation. There was no medical history or concomitant medications reported. The patient previously received the first dose of BNT162b2 (batch/lot and expiry information not provided) on 08Feb2021. The patient inquired if he can take medication for the pain on his arm after getting the second dose of the vaccine on 08Mar2021, reported as this morning. It was unknown if any treatment was received for the event. The outcome of the event pain in the arm was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Alopecia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: fatigue; fever; headache; pain; dizzy; hair loss; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 12Mar2021 at 13:30 at 58-years-old (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization, at a workplace clinic; apixaban (ELIQUIS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; levothyroxine sodium (TIROSINT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; liothyronine (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; zinc (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; also reported "other medications in two weeks: D, B, C, A", with no other details provided. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included gluten sensitivity from an unknown date and unknown if ongoing, contrast media allergy (CAT dye) from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (prior to vaccination). Concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy; start and stop dates were not reported. On 12Mar2021 at 18:00, the patient experienced: fatigue (non-serious), fever (non-serious), headache (non-serious), pain (non-serious), dizzy (non-serious), hair loss (non-serious). There was no treatment received in regard to the events. The action taken in response to the events for apixaban, levothyroxine sodium, liothyronine, and zinc was unknown. The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Pyrexia
Clinical narrative: fatigue; fever; headache; pain; dizzy; hair loss; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 12Mar2021 at 13:30 at 58-years-old (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization, at a workplace clinic; apixaban (ELIQUIS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; levothyroxine sodium (TIROSINT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; liothyronine (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; zinc (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; also reported "other medications in two weeks: D, B, C, A", with no other details provided. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included gluten sensitivity from an unknown date and unknown if ongoing, contrast media allergy (CAT dye) from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (prior to vaccination). Concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy; start and stop dates were not reported. On 12Mar2021 at 18:00, the patient experienced: fatigue (non-serious), fever (non-serious), headache (non-serious), pain (non-serious), dizzy (non-serious), hair loss (non-serious). There was no treatment received in regard to the events. The action taken in response to the events for apixaban, levothyroxine sodium, liothyronine, and zinc was unknown. The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lumbar radiculopathy
Clinical narrative: she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms; she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms; This is a spontaneous report from a contactable physician (patient) via the sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on 12Mar2021 2:00 PM (received at the age of 69-years-old) for COVID-19 immunization. Medical history included osteoporosis, benign head tremor, ongoing lumbar radiculopathy and lives with pain and tingling every day of her life. The patient explained that her history is due to an injury years ago. She had Lumbar radiculopathy in the right leg that involved tingling, occasional pain going on every day for a number of years. She also has osteoporosis and was on Prolia every 6 months and the only other thing she has is benign head tremor She had a head concussion number of years ago but other than that she stated that she is in pretty good shape. Concomitant medications included denosumab (PROLIA) for osteoporosis. The patient reported that she received the first Pfizer covid 19 vaccine on Friday 12Mar2021. She stated that through the night she experienced tingling in the face, nose, cheek, chin and tingling in her arm. The tingling in her right leg intensified on Saturday 13Mar2021. Also, along with that, she had some tingling in her face that came in length in her nose and her chin on the left side that kind of comes and goes. She stated that she is getting better at the time of the report 15Mar2021. She further stated that she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms. She reported that she has been experiencing she has the pain and tingling in her legs, she had this before, but the vaccine has increased her symptoms, so she is having more flare up and more pain. She was also experiencing the pain down both of her legs and pain and tingling in her face. She stated that she did not see this in the contraindications. She is concerned about taking the second dose. She wanted to know do these symptoms go away and should she get the second dose. At the time of report, it was getting a little better, but she wanted to report this because she thinks Pfizer needs to know this. She said she did not read this in any other side effects of this particular vaccine. Outcome of the events was recovering.  Information on batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Extrasystoles, Palpitations
Clinical narrative: Feeling very weak; heart palpitations; heart would skip a beat; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old male patient received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265) via an unspecified route of administration in the left arm on 04Feb2021 09:15 AM at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient had unspecified concomitant medications (other medications in two weeks). He had no other vaccine in four weeks. On 05Feb2021 01:00 AM, the patient was feeling very weak and heart palpitations. He felt so weak that he had to retire to bed for rest. Periodically, he still felt weak and his heart would skip a beat since 05Feb2021 01:00 AM. He had been to his doctor and the emergency room of the hospital (doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care). Everything checked out okay; however, they had him on a 30 day heart monitor (heart monitor for 30 days). It was noted that the patient had the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) in the left arm on 27Feb2021. The patient had no COVID prior to vaccination and has not had COVID tested post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Flushing, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: arm stiffness; redness; flushing; itchiness on her chest area; some joint pain; charley horse in her left foot; This is a spontaneous report from a non-contactable consumer. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amlodipine (MANUFACTURER UNKNOWN) and experienced flushing from an unspecified date to an unspecified date, contrast dye (MANUFACTURER UNKNOWN) and experienced mild reaction in 2009. On an unspecified date, the patient experienced arm stiffness (non-serious). On 28Feb2021, the patient experienced: some joint pain (non-serious), Charley horse in her left foot (non-serious). On 04Mar2021, the patient experienced: redness (non-serious), flushing (non-serious), and itchiness on her chest area (non-serious).  The patient had received her first Pfizer COVID vaccine on the 26Feb2021.  The patient was scheduled to receive her second vaccine dose on 19Mar2021 and wanted to find out if Pfizer would recommend for her to get this second dose.  After the first vaccination, the patient had a little arm stiffness that went away on its own with no treatment.  On 28Feb2021, following the first vaccine, the patient also had some joint pain and a Charley horse in her left foot. On 04Mar2021, 6 days after receiving the vaccine, the patient had some redness, flushing and itchiness on her chest area which also had resolved.  The patient would occasionally experience flushing due to the amlodipine 5mg (MANUFACTURER UNKNOWN) she takes. About 12 years ago, she had a test done and received IV contrast dye (MANUFACTURER UNKNOWN) and experienced a mild reaction to this and was treated with diphenhydramine hydrochloride (BENADRYL) and the reaction resolved.  The patient also took low dose of atorvastatin (MANUFACTURER UNKNOWN). Therapeutic measures were not taken as a result of arm stiffness; and not reported for the other events. The clinical outcome of the events: musculoskeletal stiffness, erythema, flushing, pruritus was recovered on an unspecified date. The clinical outcome of the event, arthralgia, muscle spasms was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: arm stiffness; redness; flushing; itchiness on her chest area; some joint pain; charley horse in her left foot; This is a spontaneous report from a non-contactable consumer. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amlodipine (MANUFACTURER UNKNOWN) and experienced flushing from an unspecified date to an unspecified date, contrast dye (MANUFACTURER UNKNOWN) and experienced mild reaction in 2009. On an unspecified date, the patient experienced arm stiffness (non-serious). On 28Feb2021, the patient experienced: some joint pain (non-serious), Charley horse in her left foot (non-serious). On 04Mar2021, the patient experienced: redness (non-serious), flushing (non-serious), and itchiness on her chest area (non-serious).  The patient had received her first Pfizer COVID vaccine on the 26Feb2021.  The patient was scheduled to receive her second vaccine dose on 19Mar2021 and wanted to find out if Pfizer would recommend for her to get this second dose.  After the first vaccination, the patient had a little arm stiffness that went away on its own with no treatment.  On 28Feb2021, following the first vaccine, the patient also had some joint pain and a Charley horse in her left foot. On 04Mar2021, 6 days after receiving the vaccine, the patient had some redness, flushing and itchiness on her chest area which also had resolved.  The patient would occasionally experience flushing due to the amlodipine 5mg (MANUFACTURER UNKNOWN) she takes. About 12 years ago, she had a test done and received IV contrast dye (MANUFACTURER UNKNOWN) and experienced a mild reaction to this and was treated with diphenhydramine hydrochloride (BENADRYL) and the reaction resolved.  The patient also took low dose of atorvastatin (MANUFACTURER UNKNOWN). Therapeutic measures were not taken as a result of arm stiffness; and not reported for the other events. The clinical outcome of the events: musculoskeletal stiffness, erythema, flushing, pruritus was recovered on an unspecified date. The clinical outcome of the event, arthralgia, muscle spasms was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Throat irritation
Clinical narrative: On13Mar2021, she started experiencing swelling of the lip/mainly the left side pretty much of her lips; Itching and swelling on the throat; Itching and swelling on the throat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6198, expiration date: Jun2021), via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There were no problems, no symptoms, no pain or nothing on the day of vaccination. On 13Mar2021, the patient started experiencing swelling of the lip at around 08:30 or 09:00 and itching and swelling on the throat. She didn't wake up then, she went to sleep and she slept until about 05:45 and she thought it would just go away but there was much more swelling. She took Benadryl but she is concerned about the swelling, it was still there. She took another Benadryl at 04:00 on Sunday and she took one the previous night at 12 o'clock and the swelling has diminished a lot but it was not gone away all together. She was concerned because of 2 reasons, one she was due for another shot in a couple weeks and another reason was she wanted to know if it came from the vaccine. She clarified that the swelling was on her lips, mainly the left side pretty much of her lips. It started with the bottom lip and it was kind of so now that it was the top and bottom, it was both lips on the left side. She gave a lot of thought to this and that night she did have some frozen blueberries and bananas. She never ate blueberries on their own she usually puts them in oatmeal or something like that, so she thought maybe it could be the results of the blueberries since she has never had that. The patient asked whether lip swelling was an expected side effect and whether there was any issue with receiving one dose instead of the two doses.  Limited information was available over the call.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: The test for antibody its negative; This is a spontaneous report from a contactable physician (patient) for a patient enrolled in Pfizer sponsor program and from a Pfizer sponsored program .   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Jan2021 (Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (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 experienced the test for antibody its negative on 10Mar2021. The antibody was checked on 10Mar2021 and the test for antibody its negative. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got a sore arm/left arm was sore/their arms hurt; This is a spontaneous report received from a contactable consumer (patient's wife), who reported for her husband (patient) that a 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 70-years, via an unspecified route of administration in left arm at 10:00 on 11Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis. No additional vaccines administered on same date of BNT162B2. Concomitant medications were not reported. In the evening on 11Mar2021, the patient got a sore arm/left arm was sore. Consumer mentioned that their arms hurt. Confirmed that she was referring to her husband. Her husband and she had that same thing in common, it was not catastrophic. If there is soreness, need to know how to gauge the symptoms. She states why would she call if it was common and expected, like a sore arm, not to the point where she would have to take medication or something. Clarified caller and her husband's arms hurt after the COVID vaccine. No treatment. No emergency room or physician office. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer.   A 67-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 17:00 (Batch/Lot Number: EL9266), at the age of 67-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing blood pressure high has had for about 2-3 years. Concomitant medications included amlodipine 10mg once daily taken for hypertension, start and stop date were not reported.  The patient got Bell's palsy on 12Mar2021 in the evening. States that he saw his doctor on 18Mar2021, and the doctor didn't have a problem with him getting his 2nd dose, which is scheduled on 23Mar2021. She is assuming it's okay for him to get the 2nd one. The outcome of the event was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse, Vertigo
Clinical narrative: Relapse of Multiple Sclerosis symptom; Extreme vertigo; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6204, Expiration Date: unknown), via an unspecified route of administration on right arm on 15Mar2021 10:00 AM at single dose for Covid-19 immunization.The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9267, Expiration Date: unknown), via an unspecified route of administration, on right arm on 22Feb2021 9:00 AM at single dose for Covid-19 immunization. Patient medical history included Multiple Sclerosis. No Allergies to medications, food, or other products was reported. Concomitant medications included other medications were received in two weeks. On 16Mar2021 at 03:00 AM patient experienced Extreme vertigo and aches in her bones concentrated in her hips and lower back. It also triggered a relapse of Multiple Sclerosis symptom as and she had significant difficulty walking. The pain has continued for days. She had been taking high doses of Aleve for days for the pain. Facility type vaccine: Pharmacy or Drug Store. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to vaccination, the patient was not diagnosed with COVID-19. The outcome of event was not recovered. .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Gait disturbance, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my right calf; Had difficulty just walking; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in left arm on 12Feb2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart (as reported) and known allergies to penicillin. There concomitant medications were not reported. On 15Feb2021 18:30 the patient experienced two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf, had difficulty just walking. It was reported that two nights after receiving the vaccine, she suffered shortness of breath and pain in her right calf. She tried to relax the next day, but had difficulty just walking. She went to a walk in medical facility. They sent her to the ER. After testing they found that she had two blood clots in her right calf that travelled up to my lungs. The event two blood clots in my right calf that travelled up to my lungs was considered as serious (hospitalization) and other event were considered as serious (hospitalization). The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included blood test on 15Feb2021 with showed two blood clots in my right calf that travelled up to my lungs and sars-cov-2 test with negative results on Feb2021.Therapeutic measures were taken as a result of two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf and had difficulty just walking. AE treatment included blood thinner. The outcome of the events was recovering. No other vaccine was given to patient in four weeks and two weeks. No Covid prior vaccination. If Covid tested post vaccination: Yes. Patient was covid tested post vaccination in Feb2021 with negative results. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Facility type vaccine was Public Health Clinic facility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my right calf; Had difficulty just walking; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in left arm on 12Feb2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart (as reported) and known allergies to penicillin. There concomitant medications were not reported. On 15Feb2021 18:30 the patient experienced two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf, had difficulty just walking. It was reported that two nights after receiving the vaccine, she suffered shortness of breath and pain in her right calf. She tried to relax the next day, but had difficulty just walking. She went to a walk in medical facility. They sent her to the ER. After testing they found that she had two blood clots in her right calf that travelled up to my lungs. The event two blood clots in my right calf that travelled up to my lungs was considered as serious (hospitalization) and other event were considered as serious (hospitalization). The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included blood test on 15Feb2021 with showed two blood clots in my right calf that travelled up to my lungs and sars-cov-2 test with negative results on Feb2021.Therapeutic measures were taken as a result of two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf and had difficulty just walking. AE treatment included blood thinner. The outcome of the events was recovering. No other vaccine was given to patient in four weeks and two weeks. No Covid prior vaccination. If Covid tested post vaccination: Yes. Patient was covid tested post vaccination in Feb2021 with negative results. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Facility type vaccine was Public Health Clinic facility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she unknowingly had Covid infection/tested positive for Covid/chills, headache and coughing; she unknowingly had Covid infection/tested positive for Covid/chills, headache and coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine on an unknown date, but she unknowingly had Covid infection on an unknown date. On the second day, she had chills, headache and coughing, and her symptoms got worst on the third day. They took her to urgent care and it turned out it was not related to the vaccine, she tested positive for Covid (date unspecified) and they gave her a Bam infusion. She was recovered now, she tested negative on an unknown date, but reporter wanted to know if patient can get the second dose, that patient have scheduled for 26Mar2021. The outcome of the event was recovered on an unspecified date.   Information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Upper limb fracture
Clinical narrative: broke my arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unknown date at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not on any concomitant medications. On 13Mar2021, she broke her arm pretty severely. Treatment for event reported as HCP who treated her arm (as reported). The patient was due for her next dose on Monday (22Mar2021). It was not known whether the patient was hospitalized for broken arm. Outcome of the event of broke arm was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Loss of consciousness, Syncope, Tachycardia
Clinical narrative: like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events.   Information on the lot/ batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events.   Information on the lot/ batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope episode; Lightheaded; This is a spontaneous report from a non-contactable nurse. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscularly on 19Mar2021 at 13:00 (01:00 PM) (Batch/Lot Number: ep6955) at the age of 58-years-old as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. There was no other vaccine in four weeks. The patient's medical history and patient's concomitant medications were not reported. The patient experienced lightheaded/syncope episode on 19Mar2021 at 13:15 (01:15 PM). The events resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The patient had no COVID prior to vaccination and has not been tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event syncope episode cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Respiratory arrest, Throat irritation, Throat tightness
Clinical narrative: her throat itches; she could not breath; her pressure raised to 230; throat started to close; This is a spontaneous report from a contactable consumer (patient's husband). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 56-year-old, via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband commented that both of them got the first dose of the Pfizer covid vaccine on 07Mar2021 and some minutes later, the patient started having a reaction that she had to be taken into the ER with an ambulance: her throat started to close, she could not breath and her pressure raised to 230. Until today, she has not fully recovered, and they have been getting in and out of the ER, in fact they just arrived home from there. Physicians only prescribed antiallergy medications and the patient was still having the same problem and her throat itches on an unspecified date. The physicians they have consulted have contradictive opinions about how she should do: one recommended her not to get the second dose while another recommended her to get started again on the series. The husband wants to know what they can do about this. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Dry skin, Lip swelling, Rash pruritic, SARS-CoV-2 test
Clinical narrative: On the right hand between the thumb and the index finger there were itchy bumps under the skin/Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up; Lips were swollen; Right nipple was irritated and the skin around it dried up; This is a spontaneous report from a non-contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 27Feb2021 16:00 (Batch/Lot number was not reported) at single dose (at the age of 63 years old) for COVID-19 immunisation.  Medical history included hypertension, hyperlipidaemia, retinal tears and known allergies: Penicillin. Concomitant medications included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid (BABY ASPIRIN), all taken for an unspecified indication.  The patient previously took NIASPAN and experienced known allergies.  At 19:30 pm on the day of the vaccination, on the right hand between the thumb and the index finger there were itchy bumps under the skin. Patient assumed it was insect bite. Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up. Patient started taking OTC Benadryl and Claritin on 4-5 days after consultation with PCP. However, reaction continued and the lips were swollen as well. Patient was prescribed steroids 4mg tapering blister pack by a separate physician since the rash had progressed to the chest. Right nipple was irritated and the skin around it dried up. Patient went to a dermatologist on 10Mar2020 and got a biopsy. Condition has not improved. The patient underwent blood test on Mar2021 for COVID and the result was negative. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Herpes zoster, Neck pain, Pyrexia
Clinical narrative: They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; Headache; Sore neck; Chills; slight fever; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Mar2021 at 13:00 (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient's medical history included Known allergies: Penicillin. The patient's concomitant medications were not reported. On 19Mar2021 at 03:00, the patient experienced headache, sore neck, chills, slight fever. Friday evening, the patient noticed hives. The patient went to the emergency room (ER) Saturday morning at 3 AM, to be sure hives were not concerning. They diagnosed the hives as shingles (which the patient never had before) and provided anti-viral prescription, Valtrex 1000 mg 3 times per day for 7 days. The outcome of the events was recovering. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; Headache; Sore neck; Chills; slight fever; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Mar2021 at 13:00 (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient's medical history included Known allergies: Penicillin. The patient's concomitant medications were not reported. On 19Mar2021 at 03:00, the patient experienced headache, sore neck, chills, slight fever. Friday evening, the patient noticed hives. The patient went to the emergency room (ER) Saturday morning at 3 AM, to be sure hives were not concerning. They diagnosed the hives as shingles (which the patient never had before) and provided anti-viral prescription, Valtrex 1000 mg 3 times per day for 7 days. The outcome of the events was recovering. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: Through a CT scan, the doctor determined I had Acute Appendicitis; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 16:30 (Lot Number: EN6199) as single dose for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history was none, no known allergies. The patient didn't have COVID prior to vaccination. Concomitant medications in two weeks included metoprolol succinate, propafenone and sertraline, all taken for an unspecified indication, start and stop date were not reported. There were no other vaccine in four weeks. Patient received his first dose on 12Mar2021. He started getting abdominal pains on the morning of 14Mar2021 02:00 AM. On 15Mar2021 he started having severe diarrhea. By 16Mar2021 the severe diarrhea continued which was nothing but water. On 17Mar2021 he went to the emergency room at (Name) .Through a CT scan, the doctor determined he had Acute Appendicitis. On the night of 17Mar2021 he had his appendix removed. The event resulted in hospitalization for 2 days. COVID test post vaccination included Nasal Swab on 17Mar2021 with negative result. The outcome of the event was recovering.  Follow-Up (01Apr2021): Follow-up attempts are completed. No further information is expected.