chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Oropharyngeal pain, Paraesthesia, Respiratory tract congestion
Clinical narrative: Difficult to breathe; Sore throat; Congestion; super congested and found it difficult to breathe; She was cold; Tingling in her fingers; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 08Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the vaccine on Friday (08Jan2021) at 3:00 PM and an hour or two later, she was cold and had tingling in her fingers. Everything got better. On Saturday (09Jan2021), the patient had sore throat and congestion. On Sunday (10Jan2021), the patient was super congested and found it difficult to breathe. That could have been because of congestion. Today (11Jan2021), the patient was still congested. The patient is not sure if that is a vaccine side effect or if she should get tested for coronavirus. The main thing is the congestion. All the other has resolved. The patient worked in the hospital and was not sure if she should get tested. The patient had not recovered from "Congestion; super congested and found it difficult to breathe". The patient recovered from the other events in Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperaesthesia
Clinical narrative: sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Burning sensation, Chills, Erythema
Clinical narrative: red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; She feels like her skin is burning; right side of face started feeling numb and tingling; right side of face started feeling numb and tingling; Chills; low grade fever; Fatigue; back and body aches; normal body aches/back and body aches; Nausea; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. The first vaccine BNT162B2 she received on 18Dec2020. She didn't have any side effects to it. It's lot number was  EH9899. Caller just wanted to report her adverse reaction to the COVID 19 vaccine. She got it for work. She got her second vaccine on Thursday. The first vaccine was fine. That Friday she was sick. On 07Jan2021, the patient experienced low grade fever, fatigue, back and body aches, nausea. On 08Jan2021, the patient experienced chills, and normal body aches. On 10Jan2021, the patient experienced right side of face started feeling numb and tingling. This started around her jaw line at 8 o'clock. Then it worked up her face. It was only on the right side. She then monitored it. She went to bed. She woke up at 4 am, and she felt like her face was on fire on an unspecified date. It was tingly. Her face was bright red and blotchy on both sides of her face. She took Benadryl, and put cold compresses on her face. This morning, both sides of her face were very red, hot, and blotchy. She feels like her skin is burning. She feels like she had a burn on her face.It is very odd. There were a couple of days between her reaction and when it started. It has worsened. This morning for work she couldn't put her video on. The outcome of the event low grade fever, back aches, nausea, was recovered on 08Jan2021, fatigue, normal body aches/body aches, chills was recovered on 09Jan2021, the outcome of the events right side of face started feeling numb and tingling was not recovered, while unknown for the other events. Treatment was received for the events "Her face was bright red and blotchy on both sides of her face.", She feels like her skin is burning.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Hypoaesthesia, Nausea
Clinical narrative: red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; She feels like her skin is burning; right side of face started feeling numb and tingling; right side of face started feeling numb and tingling; Chills; low grade fever; Fatigue; back and body aches; normal body aches/back and body aches; Nausea; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. The first vaccine BNT162B2 she received on 18Dec2020. She didn't have any side effects to it. It's lot number was  EH9899. Caller just wanted to report her adverse reaction to the COVID 19 vaccine. She got it for work. She got her second vaccine on Thursday. The first vaccine was fine. That Friday she was sick. On 07Jan2021, the patient experienced low grade fever, fatigue, back and body aches, nausea. On 08Jan2021, the patient experienced chills, and normal body aches. On 10Jan2021, the patient experienced right side of face started feeling numb and tingling. This started around her jaw line at 8 o'clock. Then it worked up her face. It was only on the right side. She then monitored it. She went to bed. She woke up at 4 am, and she felt like her face was on fire on an unspecified date. It was tingly. Her face was bright red and blotchy on both sides of her face. She took Benadryl, and put cold compresses on her face. This morning, both sides of her face were very red, hot, and blotchy. She feels like her skin is burning. She feels like she had a burn on her face.It is very odd. There were a couple of days between her reaction and when it started. It has worsened. This morning for work she couldn't put her video on. The outcome of the event low grade fever, back aches, nausea, was recovered on 08Jan2021, fatigue, normal body aches/body aches, chills was recovered on 09Jan2021, the outcome of the events right side of face started feeling numb and tingling was not recovered, while unknown for the other events. Treatment was received for the events "Her face was bright red and blotchy on both sides of her face.", She feels like her skin is burning.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Rash macular
Clinical narrative: red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; She feels like her skin is burning; right side of face started feeling numb and tingling; right side of face started feeling numb and tingling; Chills; low grade fever; Fatigue; back and body aches; normal body aches/back and body aches; Nausea; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. The first vaccine BNT162B2 she received on 18Dec2020. She didn't have any side effects to it. It's lot number was  EH9899. Caller just wanted to report her adverse reaction to the COVID 19 vaccine. She got it for work. She got her second vaccine on Thursday. The first vaccine was fine. That Friday she was sick. On 07Jan2021, the patient experienced low grade fever, fatigue, back and body aches, nausea. On 08Jan2021, the patient experienced chills, and normal body aches. On 10Jan2021, the patient experienced right side of face started feeling numb and tingling. This started around her jaw line at 8 o'clock. Then it worked up her face. It was only on the right side. She then monitored it. She went to bed. She woke up at 4 am, and she felt like her face was on fire on an unspecified date. It was tingly. Her face was bright red and blotchy on both sides of her face. She took Benadryl, and put cold compresses on her face. This morning, both sides of her face were very red, hot, and blotchy. She feels like her skin is burning. She feels like she had a burn on her face.It is very odd. There were a couple of days between her reaction and when it started. It has worsened. This morning for work she couldn't put her video on. The outcome of the event low grade fever, back aches, nausea, was recovered on 08Jan2021, fatigue, normal body aches/body aches, chills was recovered on 09Jan2021, the outcome of the events right side of face started feeling numb and tingling was not recovered, while unknown for the other events. Treatment was received for the events "Her face was bright red and blotchy on both sides of her face.", She feels like her skin is burning.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Sore arm; swollen/tender lymph nodes in armpit of injection arm; swollen/tender lymph nodes in armpit of injection arm; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular left arm on 10Jan2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included melatonin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient took the 1st dose (lot number: EL4284) on intramuscular left arm on 23Dec2020 10:15. The patient experienced sore arm, swollen/tender lymph nodes in armpit of injection arm, headache, chills, fatigue on 10Jan2021 19:30. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; swollen/tender lymph nodes in armpit of injection arm; swollen/tender lymph nodes in armpit of injection arm; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular left arm on 10Jan2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included melatonin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient took the 1st dose (lot number: EL4284) on intramuscular left arm on 23Dec2020 10:15. The patient experienced sore arm, swollen/tender lymph nodes in armpit of injection arm, headache, chills, fatigue on 10Jan2021 19:30. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: nasal congestion/ nose is stopped up; Fever; body ache; Headache; Muscle soreness; Chills; tired; This is a spontaneous report from a  contactable consumer reporting for herself.   A 59-years-old female patient  received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) , via an unspecified route of administration on  08Jan2021 11:00 at single dose  for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The first dose of the vaccine was given on an unknown date. The patient experienced chills  on 08Jan2021 23:00 with outcome of recovering , fever  on 09Jan2021 with outcome of recovered , body ache  on 09Jan2021 with outcome of recovering , headache  on 09Jan2021 with outcome of recovered , muscle soreness on 09Jan2021 with outcome of recovering , tired  on 08Jan2021 with outcome of recovering , nasal congestion/ nose is stopped up  on an unspecified date with outcome of recovered.  Paracetamol (TYLENOL) was taken as a result of chills.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: nasal congestion/ nose is stopped up; Fever; body ache; Headache; Muscle soreness; Chills; tired; This is a spontaneous report from a  contactable consumer reporting for herself.   A 59-years-old female patient  received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) , via an unspecified route of administration on  08Jan2021 11:00 at single dose  for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The first dose of the vaccine was given on an unknown date. The patient experienced chills  on 08Jan2021 23:00 with outcome of recovering , fever  on 09Jan2021 with outcome of recovered , body ache  on 09Jan2021 with outcome of recovering , headache  on 09Jan2021 with outcome of recovered , muscle soreness on 09Jan2021 with outcome of recovering , tired  on 08Jan2021 with outcome of recovering , nasal congestion/ nose is stopped up  on an unspecified date with outcome of recovered.  Paracetamol (TYLENOL) was taken as a result of chills.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Fatigue, Headache
Clinical narrative: she thinks she lost an inch; mild headache; tired, feeling wiped out; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date unknown), intramuscular on the left upper arm on 08Jan2021 at 14:15 to 14:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications, no additional vaccines administered on the same date of BNT162B2 and there were no prior vaccinations within 4 weeks. The patient previously received flu vaccine and experienced a slight reaction to the flu vaccine, she does not recall when she had it. She got it in the supermarket (she was told one vaccine was super and one flu vaccine was regular, and she had the super vaccine and she thinks that is why she had the side effects). She does not know the name of the flu vaccine or have lot number to provide. The patient was calling about the COVID vaccine that she received a couple of days ago. She received the first dose on Friday, 08Jan2021. She wanted to call and report the side effects. She had a mild headache and was tired. She started feeling tired on Saturday, reported that she felt wiped out. It was reported that the events headache and feeling tired both started on Saturday (09Jan2021). It was also reported that she is about 5'1", she thinks she lost an inch, and that her headache is going away - it was not a major headache, not a migraine. She also took Tylenol as treatment. Her tiredness went away about 48 hours later, and confirmed she recovered completely as of that day. She was alarmed at first and she was wondering where the headache was coming from. She read the paperwork she received, and it is listed as a side effect. She was told that there may be some soreness when she went in to get the vaccine. The event tired, feeling wiped out resolved on 11Jan2021 while the mild headache was resolving and the outcome of the event she thinks she lost an inch was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy
Clinical narrative: Fatigue; Extremely swollen lymph nodes in neck on side of injection; Joint pain; This is a spontaneous report from a contactable nurse (reported for self). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 15:00 at a single dose in the left arm for Covid-19 immunization. The patient's medical history was not reported. The patient had no Covid prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications.  The patient had no other vaccine in four weeks and no other medications in two weeks. On 07Jan2021, patient experienced fatigue, extremely swollen lymph nodes in neck on side of injection, and joint pain. The patient did not receive treatment in response to the events reported. The patient was not tested for COVID post vaccination. The events fatigue, extremely swollen lymph nodes in neck on side of injection, and joint pain were reported as not recovered.   Information regarding lot/batch number of the product has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Fatigue, Heart rate
Clinical narrative: Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Joint stiffness, Malaise, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Chills, Pyrexia
Clinical narrative: Fever; Chills; Joint pain; Strange dreams; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID vaccine and as Coronavirus Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that he has a student who verbally informed that he was unable to attend class on 19Jan2021 because of his concern of the adverse events from the first vaccine. It was reported that he should take second dose on or around 19Jan2021. The patient experienced fever, chills, joint pain and strange dreams on an unspecified date. He does not have any other information except the list of adverse events that he is experiencing. The outcome of the events was unknown.   The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache/ He can't get rid of the headache and he has taken all sorts of Tylenol; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients. This is the first of 2 reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient took the Pfizer COVID at (Hospital name) on 10Jan2021 and experienced a headache and has been taking Tylenol since yesterday. It was so bad that he went to sleep at 7 and he was still in bed. The patient can't get rid of the headache and he has taken all sorts of Tylenol. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026399 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 10Jan2021 at a single dose for COVID-19 immunization. The patient's medical history concomitant medications were not reported. The patient took the Pfizer COVID at (Hospital name) on 10Jan2021 and experienced a headache immediately and that went away. The outcome of the event was recovered on 10Jan2021.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026386 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sinus congestion, Vaccination site pain
Clinical narrative: Bot fatigue and nasal/sinus congestion 2 days post-inoculation; Bot fatigue and nasal/sinus congestion 2 days post-inoculation; Soreness at injection site; This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 08Jan2021 at single dose for COVID-19 immunization.  Medical history included allergies: shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included spironolactone (ALDACTONE), dextrin (BENEFIBER), folic acid, atorvastatin (LIPITOR), famotidine (PEPCID), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC), estradiol (VIVELLE). The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration on the left arm on 19Dec2020 for COVID-19 immunization. The patient experienced soreness at injection site on 08Jan2021, bot fatigue and nasal/sinus congestion 2 days post-inoculation on 10Jan2021. The patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Deafness unilateral, Fear, Hypoacusis
Clinical narrative: Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0140) on 18Dec2020 at single dose in the left deltoid for COVID-19 immunization.Medical history included ongoing anaemia. There were no concomitant medications. On 06Jan2021 at 16:00 the patient experienced hearing loss, serious as medically significant. Patient had no problems with her ears before hand. On 06Jan2021 around 4 PM, she was just walking in the store, with no loud music or anything, and all of a sudden her hearing in her left ear went lost and muffled. On 07Jan2021 she went to the Otolaryngologist (ENT doctor) to get her ears checked. They said no it looked perfectly fine. They did an audiogram and hearing test on 07Jan2021 and there was a 20% hearing loss. She had no idea what it was from. She took no other medications. She had anemia but that was it. She was wondering if hearing loss has been reported with the vaccine either in the studies or recently. She researched it, and with the COVID virus itself, back in Jul2020 and Oct2020, people reported hearing loss. So she went and had a COVID test in Jan2021 and it was negative. Patient stated it was very scary and weird. Event treatment included high dose oral steroids to see if it can be treated and the ENT doctor was also giving her steroid shots in the ear. She was due to see him again in Jan2021. The outcome of the event Hearing loss was not recovered.  Patient also clarified that she did continue with her second dose of the vaccine on 08Jan2021. She had asked the ENT doctor his opinions on still getting the second dose, and he recommended it. The second dose of the vaccine was given on 08Jan2021 (lot EL3302, EXP: May2021) at single dose in the left deltoid for COVID-19 immunization.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0140) on 18Dec2020 at single dose in the left deltoid for COVID-19 immunization.Medical history included ongoing anaemia. There were no concomitant medications. On 06Jan2021 at 16:00 the patient experienced hearing loss, serious as medically significant. Patient had no problems with her ears before hand. On 06Jan2021 around 4 PM, she was just walking in the store, with no loud music or anything, and all of a sudden her hearing in her left ear went lost and muffled. On 07Jan2021 she went to the Otolaryngologist (ENT doctor) to get her ears checked. They said no it looked perfectly fine. They did an audiogram and hearing test on 07Jan2021 and there was a 20% hearing loss. She had no idea what it was from. She took no other medications. She had anemia but that was it. She was wondering if hearing loss has been reported with the vaccine either in the studies or recently. She researched it, and with the COVID virus itself, back in Jul2020 and Oct2020, people reported hearing loss. So she went and had a COVID test in Jan2021 and it was negative. Patient stated it was very scary and weird. Event treatment included high dose oral steroids to see if it can be treated and the ENT doctor was also giving her steroid shots in the ear. She was due to see him again in Jan2021. The outcome of the event Hearing loss was not recovered.  Patient also clarified that she did continue with her second dose of the vaccine on 08Jan2021. She had asked the ENT doctor his opinions on still getting the second dose, and he recommended it. The second dose of the vaccine was given on 08Jan2021 (lot EL3302, EXP: May2021) at single dose in the left deltoid for COVID-19 immunization.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the third (3rd) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got vaccinated for the Covid-19 Vaccine but tested positive after that; got vaccinated for the Covid-19 Vaccine but tested positive after that; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that someone she knew who got vaccinated for the Covid-19 Vaccine but tested positive after that. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: Chills; body aches; Massive right axillary adenopathy (10cm); headache; This is a spontaneous report from a contactable physician reporting for himself. A 62-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in the right arm, on 07Jan2021 at 04:00 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Previously, on 21Dec2020 at 05:00 PM, the patient received the 1st dose of bnt162b2, intramuscular in right arm. The patient experienced chills, body aches, massive right axillary adenopathy (10cm), headache all on 08Jan2021 at 04:00 AM with outcome of recovering. The events required physician office visit. The patient was not tested for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in jaw
Clinical narrative: Jaw ache/pain - unable to sleep due to it; Jaw ache/pain - unable to sleep due to it; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686) in a hospital, via an unspecified route of administration at the left arm on 08Jan2021 at 11:00 AM at single dose for COVID-19 immunization. The patient's medical history included birth control. No other medical history and has no known drug allergies. The patient had no COVID prior to vaccination. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) birth control pills. The patient experienced jaw ache/pain - unable to sleep due to it on 10Jan2021 at 18:00 (06:00 PM) and these were not relived by Advil. The patient has not been tested for COVID post-vaccination. The clinical outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow up attempts are possible. No further information is expected.