chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature fluctuation, Chills, Fatigue, Headache
Clinical narrative: She is tired; she has been sneezing; injection site is extremely painful; Chills; mild headache; muscle and joint pain; muscle and joint pain; temperature went up to 98.8; Cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 86-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN5138, Expire Date: Unknown) intramuscularly in arm left on 08Feb2021 at 09:20 as single dose for COVID-19 immunization. Medical history included ongoing diabetes, thyroid disorder. She was diagnosed for diabetes for about 30 years ago. Concomitant medications included unspecified thyroid pill, furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication and ongoing metformin (METFORMIN) 500mg tablet by mouth three times a day taken for diabetes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient stated the injection site was extremely painful. She had not put on a cold pack. She had the chills so bad. She was letting it hurt. She was tired. She had a mild headache and still has one, its not bad. She had muscle and joint pain. She had a slight fever. She came down with a cold on the same day she had the vaccine, she had been sneezing and had the whole thing with a cold. She does not think the cold had anything to do with the shot. The patient underwent lab tests and procedures which included body temperature fluctuation: 98.8 on 08Feb2021. Her normal temperature is 96.2, and her temperature went up to 98.8, her temp is starting to go down. She was scheduled for second dose on 01Mar2021. The outcome of the events injection site is extremely painful, muscle and joint pain, temperature went up to 98.8 were reported as recovering/resolving and other events chills, cold was reported as not recovered/not resolved and mild headache was reported as recovered/resolved on Feb2021. The outcome events sneezing and fatigue were unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pyrexia, Sneezing, Vaccination site pain
Clinical narrative: She is tired; she has been sneezing; injection site is extremely painful; Chills; mild headache; muscle and joint pain; muscle and joint pain; temperature went up to 98.8; Cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 86-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN5138, Expire Date: Unknown) intramuscularly in arm left on 08Feb2021 at 09:20 as single dose for COVID-19 immunization. Medical history included ongoing diabetes, thyroid disorder. She was diagnosed for diabetes for about 30 years ago. Concomitant medications included unspecified thyroid pill, furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication and ongoing metformin (METFORMIN) 500mg tablet by mouth three times a day taken for diabetes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient stated the injection site was extremely painful. She had not put on a cold pack. She had the chills so bad. She was letting it hurt. She was tired. She had a mild headache and still has one, its not bad. She had muscle and joint pain. She had a slight fever. She came down with a cold on the same day she had the vaccine, she had been sneezing and had the whole thing with a cold. She does not think the cold had anything to do with the shot. The patient underwent lab tests and procedures which included body temperature fluctuation: 98.8 on 08Feb2021. Her normal temperature is 96.2, and her temperature went up to 98.8, her temp is starting to go down. She was scheduled for second dose on 01Mar2021. The outcome of the events injection site is extremely painful, muscle and joint pain, temperature went up to 98.8 were reported as recovering/resolving and other events chills, cold was reported as not recovered/not resolved and mild headache was reported as recovered/resolved on Feb2021. The outcome events sneezing and fatigue were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Vaccination site pain
Clinical narrative: jaw tenderness; soreness on her arm; This is a spontaneous report from a contactable nurse. This female nurse (patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/Expiry date: Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 10Feb2021. The patient's medical history and concomitant medications were not reported. On 10Feb2021, she had only soreness on her arm where she got the vaccine and on 11Feb2021 (reported as now this morning), she is having jaw tenderness when she opens her mouth. She says she would like to know if this is a known side effect or something else. She says that it is slight, so it could be something else. Investigation Assessment was Not Provided. The clinical outcome for the events was unknown.   No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After second vaccination, an intermittent "squeezing" full head headache (each lasting around 2-3 seconds) starting; This is a spontaneous report from a contactable pharmacist. The 46-year-old male patient received bnt162b2 (COMIRNATY) solution for injection, dose 2 (Batch/Lot Number: EL3249) on 22Jan2021, at 09:30 AM, and dose 1 (Batch/Lot Number: EK9231) on 02Jan2021 at 10:00 AM via an Intramuscular route of administration in right arm as a single dose for covid-19 immunisation. The medical history and concomitant medication were not reported. Patient reported on 22Jan2021 at 01:15 PM after 1st vaccination, mild intermittent headache that subsided after 24 hours. And after second vaccination, a intermittent squeezing full head headache (each lasting around 2-3 seconds) starting 2 hours post vaccination. It seemed to subside after 2 weeks and now has returned. Patient took other medications in two weeks once time. Patient received treatment drug as Ibuprofen. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Patient did not have any known allergies. The outcome of event was Not recovered.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body temperature, Fatigue, Pyrexia, Somnolence
Clinical narrative: fever/My dad reached up to a 103; My dad was sleepy and tired after he got the shot yesterday in the morning; My dad was sleepy and tired after he got the shot yesterday in the morning; This is a spontaneous report from a contactable consumer via Medical information team. An 83-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. reporter (daughter) stated, "I am calling for my mom and dad, both of them received the second Pfizer shot yesterday and they both have the same age, they both (birth year withheld) born. They both had fever just last night like this early morning. My dad reached up to a 103. My dad was sleepy and tired after he got the shot yesterday in the morning. He was sleepy and then in the evening he starts getting fever on 13Feb2021. They took tylenol for it. The patient underwent lab tests and procedures which included height: 5'5, 5'3 as well, temperatures: 103 and Weight: about 200 lbs on an unspecified date in 2021. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: fever/My dad reached up to a 103; My dad was sleepy and tired after he got the shot yesterday in the morning; My dad was sleepy and tired after he got the shot yesterday in the morning; This is a spontaneous report from a contactable consumer via Medical information team. An 83-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. reporter (daughter) stated, "I am calling for my mom and dad, both of them received the second Pfizer shot yesterday and they both have the same age, they both (birth year withheld) born. They both had fever just last night like this early morning. My dad reached up to a 103. My dad was sleepy and tired after he got the shot yesterday in the morning. He was sleepy and then in the evening he starts getting fever on 13Feb2021. They took tylenol for it. The patient underwent lab tests and procedures which included height: 5'5, 5'3 as well, temperatures: 103 and Weight: about 200 lbs on an unspecified date in 2021. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Swelling in left armpit lymph node.Swelling and water retention in surrounding area; 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, expiry date was unknown) via an unknown route in the left arm on 14Feb2021, at 07:45 AM, (at the age of 42 years) as a single dose for COVID-19 immunisation. Patient did not have medical history. The patient had no allergies. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC) and chondroitin (within 2 weeks of the vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262, expiry date was unknown) via an unknown route in the left arm on 28Jan2021 at 05:00 PM (at the age of 41 years) as a single dose for COVID-19 immunization. On 02Feb2021, the patient had covid test (covid test type post vaccination: Nasal Swab) and result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021 at 04:00 AM the patient experienced swelling in left armpit lymph node, swelling and water retention in surrounding area. Patient did not receive any treatment for the adverse event. 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021 to patient, which is Inappropriate schedule of vaccine administered. The outcome of the event swelling in left armpit lymph node, swelling and water retention in surrounding area was recovering.  Information about batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Chills, Headache, Malaise
Clinical narrative: chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL8952) (at the age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included azilsartan kamedoxomil (EDARBI) and torsemide (MANUFACTURER UNKNOWN) both taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (COMIRNATY), dose 1, administered in Arm left (Batch/Lot number: EK9231) (at the age of 72-years-old) for covid-19 immunisation and experienced malaise, nausea, no appetite and throwing up bile. On 03Feb2021, the patient experienced chills, fever, malaise, headache. The events not resulted in emergency room/physician office. The outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL8952) (at the age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included azilsartan kamedoxomil (EDARBI) and torsemide (MANUFACTURER UNKNOWN) both taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (COMIRNATY), dose 1, administered in Arm left (Batch/Lot number: EK9231) (at the age of 72-years-old) for covid-19 immunisation and experienced malaise, nausea, no appetite and throwing up bile. On 03Feb2021, the patient experienced chills, fever, malaise, headache. The events not resulted in emergency room/physician office. The outcome of events was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong soreness at the injection site (left arm); feeling chills; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm left on 16Feb2021 09:00 (Batch/Lot Number: EN 5318) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medication included desvenlafaxine succinate (PRISTIQ) 50 mg ER taken for an unspecified indication, from an unknown start date (two weeks prior to vaccination). The patient previously received BNT162B2 (Batch/Lot Number: EN 5318) dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 12:00 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the day when patient received second dose on 16Feb2021 at 21:00, he felt strong soreness at the injection site (left arm) and began feeling chills by the time he went to bed (12 hours after receiving the vaccine), but no other symptoms. On the following day (17Feb2021) when he woke up, he experienced a multitude of symptoms, including headache, sore muscles throughout my body, alternating sense of hot/cold, and general fatigue. These symptoms continued most of the day but began to subside by that evening. No treatment was given for the events. The outcome of the events was recovered on 18Feb2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong soreness at the injection site (left arm); feeling chills; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm left on 16Feb2021 09:00 (Batch/Lot Number: EN 5318) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medication included desvenlafaxine succinate (PRISTIQ) 50 mg ER taken for an unspecified indication, from an unknown start date (two weeks prior to vaccination). The patient previously received BNT162B2 (Batch/Lot Number: EN 5318) dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 12:00 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the day when patient received second dose on 16Feb2021 at 21:00, he felt strong soreness at the injection site (left arm) and began feeling chills by the time he went to bed (12 hours after receiving the vaccine), but no other symptoms. On the following day (17Feb2021) when he woke up, he experienced a multitude of symptoms, including headache, sore muscles throughout my body, alternating sense of hot/cold, and general fatigue. These symptoms continued most of the day but began to subside by that evening. No treatment was given for the events. The outcome of the events was recovered on 18Feb2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021.  The patient was recovering from all the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Pyrexia
Clinical narrative: chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021.  The patient was recovering from all the events.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site erythema, Vaccination site mass
Clinical narrative: Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Sudden low back pain; stiffness; This is a spontaneous report from a contactable consumer. The consumer reported similar events for two patients, this is the 2nd of 2 reports. A female patient of an unspecified age received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the same vaccine for covid-19 immunization on an unspecified date. The patient experienced sudden low back pain and stiffness on an unspecified date a few hours after receiving her second vaccination. The outcome of the events was unknown.   No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154727 same  drug/reporter, different patient/event
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Urticaria
Clinical narrative: total body hives, fatigue; total body hives, fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el9266), via an unspecified route of administration on right arm on 10Feb2021 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia and covid-19 prior vaccination. No known allergies to medications, food, or other products. Patient received unspecified other medications within 2 weeks of vaccination. The patient experienced total body hives and fatigue on 12Feb2021 08:00 AM. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated with antihistamine. The patient recovered from both the events on an unspecified date in 2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 in the left arm on 14Feb2021 (Batch/Lot number EN6201) as a SINGE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient did not do a test Covid post vaccination. The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. On 14Feb2021 after the first dose of the vaccine, the patient experienced soreness of the injection arm. Outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: N6201) via an unspecified route of administration in Left arm on 14Feb2021 17:00 as single dose for COVID-19 immunization (66-year age at Vaccination). The patient medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer and experienced dizziness on 15Feb2021 6:15 am at the gym, the patient had to stop and drink water. The patient doesn't see that listed unless a side effect of severe allergic reactions. She is wondering if this is a side effect. On an unspecified date in 2021 she lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy. She has a friend who is a nurse who said her fellow nurse had her first dose of the vaccine and had dizziness as well. She doesn't have that nurses information but will pass on that she should call in and report as well. Outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Orthostatic hypotension
Clinical narrative: dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: N6201) via an unspecified route of administration in Left arm on 14Feb2021 17:00 as single dose for COVID-19 immunization (66-year age at Vaccination). The patient medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer and experienced dizziness on 15Feb2021 6:15 am at the gym, the patient had to stop and drink water. The patient doesn't see that listed unless a side effect of severe allergic reactions. She is wondering if this is a side effect. On an unspecified date in 2021 she lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy. She has a friend who is a nurse who said her fellow nurse had her first dose of the vaccine and had dizziness as well. She doesn't have that nurses information but will pass on that she should call in and report as well. Outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, hot, and itchy; This is a spontaneous report from a contactable consumer(patient).A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none.Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,lot number EM9810) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation, anatomical location was left upper arm muscle. There were no concomitant medications.Patient was took second dose of vaccine on 09Feb2021 and on 12feb2021, night her ears were real hot, she had no other symptoms at all with the vaccine, no headache or fever, her ears were red, hot, and itchy, welts on face are still there and itchy, and her neck, and on 15feb2021, she has 2 spots on two fingers, they have itchy spots on them, little bump on each one. She wondered if this was related to it, it was 3 days after the vaccine, that it started. She was not sure this was an experienced, she was curious to know if it was a side effect. Family medical history relevant to AE was none. she has taken some Benadryl. The outcome of the event was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body height, Rash
Clinical narrative: arm was a little sore; Little rash, red dots on inside of bicep; This is a spontaneous report from a contactable consumer(Patient).  A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1via an unspecified route of administration, administered in Arm Left on 25Jan2021 16:35 as single dose for covid-19 immunisation. Medical history included mitral valve prolapse. The patient's concomitant medications were not reported. Had Pneumonia shot and yearly Flu shot. Had no reaction. Has no NDC/Lot/Exp to provide for Pneumonia and Flu shot. On 25Jan2021 in evening patient had a little rash on inside part of bicep. There were little red dots. It itched for a while. Next day was gone. Stated he was shrinking and provided height as 5 feet 11 inches. First time the dots were there it itched a little bit, next morning it was gone. Had no reaction to COVID-19 Vaccine. Had no fever, nothing else. Next day his arm was a little sore. Patient clarified rash and red dots occurred on both arms. Patient thought rash and red dots were something else like detergent or he didn't rinse soap off in the shower. his doctor didn't seem to think it was anything serious. No prior vaccinations within 4 weeks. Had a family medical history of diabetes runs in family, but most other people had that in their eighties and nineties.The outcome of the event little rash on inside part of bicep, little red dots was recovered on 26Jan2021 and for other it was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Pain, Somnolence, Vaccination site pain
Clinical narrative: 1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea
Clinical narrative: chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6198), via an unspecified route of administration in left arm on 22Feb2021 15:15 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills, sweats, and nausea. The outcome of the events was reported as recovered on an unspecified date.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report received from a contactable consumer. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL 3247) via an unspecified route of administration in left arm on 22Feb2021 12:00 at single dose for COVID-19 immunization. Patient medical history included ADHD and Depression. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), multivitamin, fish oil and ademetionine (SAM-E). On 23Feb2021 05:30 patient experienced with Injection site soreness. Patient did not receive any treatment. Outcome of event was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough; This is a spontaneous report from a contactable other Hcp (patient herself). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EK5730) via intramuscular in Left Arm on 26Jan2021 as single dose and second dose via an unspecified route of administration on 18Feb2021 09:00 (Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included Hypothyroid. Concomitant medications included levothyroxine and liothyronine. On 26Jan2021, he patient experienced dry cough for about five days after first dose of vaccine. On 18Feb2021 at around 9 am, second dose was given and again she started dry cough late that night and it was persisting through today. Patient did not receive any treatment. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph node swollen; lower in arm only pain around shot area; Chills; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 06Feb2021 in right arm at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 for Covid-19 immunization and experienced very bad arm pain on injection arm, tiredness/fatigue, mild headache, chills, and feeling unwell. It was reported that patient experienced lower in arm only pain around shot area, lymph node swollen and sore still today and chills all in Feb2021. No treatment received for adverse events. The outcome of lymphadenopathy was not recovered, vaccination site pain was unknown, chills was recovered in Feb2021.  Information about Lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her husband experienced only some sore arm.; This is a spontaneous report from a contactable consumer (wife). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021) via unknown route of administration in right arm on 13Feb2021 as single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that the patient experienced only some sore arm on 14Feb2021. The outcome of event was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: Flushing in my face, in my cheeks and the redness; Flushing in my face, in my cheeks and the redness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 15Feb2021 09:30 as single dose for COVID-19 immunisation. Medical history included fibromyalgia, migraine and ongoing asthma. Concomitant medications included duloxetine at 50mg, amitriptyline at 50mg, topiramate at 150mg and fluticasone propionate (FLOVENT) for asthma with a dosage regimen of 2 Sprays one in morning and one in the evening. It was reported that Yesterday patient went to get the shot (clarified as Covid-19 Vaccine Pfizer, 1st shot) in about 9:30 in the morning and know that patient listed all the side effects, you can go ahead and get from it and the only thing that patient experienced shortly after it was flushing in face, in cheeks and the redness in Feb2021 and I still do have that today. For treatment patient stated, "No, I took a tiny bit of Benadryl this morning, since the, if it would help like lessen the redness but it seems like it lightly helped it because I woke up this morning and I was like oh my god I am still red, it seems like lightly helped." The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female non-pregnant patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly in the left arm on 17Feb2021 11:00 (Lot Number: EL9266) at single dose for Covid-19 immunization. Medical history included asthma, mitral valve prolapses, gastroenteritis and leiomyoma. (Two weeks after receiving BNT162B2) the patient's concomitant medications included Calcium, Vitamin D3, Cranberry capsules and Turmeric. The past medications included Penicillin, Vancomycin, Levaquin, Ceftin and experienced known allergies to Penicillin, Vancomycin, Levaquin, Ceftin. Prior vaccination with BNT162B2 the patient had not experienced any covid symptoms. The patient reported that she was not on any other vaccine till four weeks after receiving BNT162B2. No Covid test were conducted post BNT162B2 vaccination. On 17Feb2021 19:00, the patient experienced mild pain at injection site, slight headache, mild fatigue. At the time of report, the outcome of the events mild pain at injection site, slight headache and mild fatigue was recovered on an unspecified date of 2021. The patient had not taken any treatment medications for the experienced events.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in lymph node area under left arm and sensitive to touch.; This is a spontaneous report from a contactable other HCP (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration in left arm on15Feb2021, at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included IGA Nephropathy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included atorvastatin, losartan and aspirin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302), via an unspecified route of administration in left arm on 25Jan2021, at 09:15 for COVID-19 immunisation. On 16Feb2021 at 05:00, the patient experienced swelling in lymph node area under left arm and sensitive to touch. The patient treatment details for the event was unknown. The outcome of the event swelling in lymph node area under left arm and sensitive to touch was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea
Clinical narrative: menstrual bleeding occurred after receiving the shot, this was early for the cycle; menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days.; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration, on 17Feb2021 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included multivitamin, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took Tetracycline and experienced allergy. On 17Feb2021, at 11:00 the patient experienced menstrual bleeding after receiving the shot, this was early for the cycle and lasted 2-3 days. The patient did not receive any treatment for the event menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days. The outcome of the event was recovered on an unknown date in Feb2021 while for other event menstrual bleeding occurred after receiving the shot, this was early for the cycle (Irregular menstruation) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Hot flush, Nausea
Clinical narrative: Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 18:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, endometriosis, GERD (gastrooesophageal reflux disease). Known allergies were none. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) received in two weeks for birth control. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 27Jan2021 at 18:00 as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has not tested for COVID post vaccination. The patient experienced bad headache, stomach ache, chills, hot flashes, aches all over, fever, nausea on 18Feb2021 at 06:00 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment medication for the adverse events. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 18:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, endometriosis, GERD (gastrooesophageal reflux disease). Known allergies were none. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) received in two weeks for birth control. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 27Jan2021 at 18:00 as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has not tested for COVID post vaccination. The patient experienced bad headache, stomach ache, chills, hot flashes, aches all over, fever, nausea on 18Feb2021 at 06:00 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment medication for the adverse events. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Experiencing moderate fatigue; This is a spontaneous report based on information received by Pfizer (Pfizer colleague). A contactable consumer reported that a patient of an unspecified Gender and age received second dose BNT162b2 (Comirnaty, Formulation: Solution for injection), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and Concomitant medication were not reported. Historical vaccine included BNT162b2 (Comirnaty) for Covid-19 immunisation. On an unspecified date, patient reported that they were experiencing moderate fatigue (tiredness) after their 2nd COVID vaccination (Pfizer/BioNTech). Outcome for event was unknown.  Information about lot/ batch number has been requested.