chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Influenza like illness, Spinal pain, Vaccination site pain
Clinical narrative: Flank and spinal pain; Flank and spinal pain; Sore at the shot location site; She experienced 24 hours of flu like symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine 3 weeks ago. On an unspecified date, the patient had flank and spinal pain that lasted two days after the first dose. She also was sore at the shot location site. After vaccination, she also experienced 24 hours of flu like symptoms and spent a day laying on her couch. Outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Slight pain in deltoid muscle when lifting left arm.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EN 5318, expiration date unknown), via an unspecified route of administration on the left arm at the age of 34 years old on 28Jan2021 at 10:45 at a single dose for COVID-19 immunisation in the workplace clinic. Patient has no medical history reported. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight pain in deltoid muscle when lifting left arm on 28Jan2021. No treatment was received in response to the event. The patient assessed the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervous system disorder, Orthostatic hypotension
Clinical narrative: Orthostatic hypotension; neurological sequalae; foggy brain; This is a spontaneous report from contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender (age within 30-49 years old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), 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 patient experienced orthostatic hypotension, neurological sequalae, and foggy brain on unspecified date which were post 10-day administration. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash/The rash occurred on 90% of the patient's body.; This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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.  It was reported that a patient was treated (treatment not reported) because of severe rash which occurred in a patient within 24 hours of receipt of the vaccine. The rash occurred on 90% of the patient's body. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 27Jan2021 at 14:30 at a single dose on right arm for COVID-19 immunisation. Medical history included polycystic ovaries (Polycystic Ovarian Syndrome) from an unknown date and unknown if ongoing. Concomitant medications included metformin, spironolactone, buspirone and ethinylestradiol, levonorgestrel (CAMRESE). The patient experienced sore arm and tiredness on 27Jan2021 at 15:00. Treatment received for the adverse event was reported as No. Outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Osteoarthritis
Clinical narrative: stabbing pain in base joint of left thumb; Right knee has osteoarthritis; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 15:00 (Lot number: E29262) via an unspecified route of administration in the right arm at single dose for COVID-19 immunization. The patient's medical history includes Left thumb normally has some arthritis pain and 3-weeks since repair of bleeding ulcer unknown if ongoing from an unknown date. The patient had no had no allergies to medications, food, or other products. The patients concomitant medications included sucralfate, pantoprazole, ferrous sulfate and bifidobacterium nos, lactobacillus acidophilus, lactobacillus paracasei, streptococcus thermophilus (RISAQUAD). The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patients left thumb normally has some arthritis pain, but within 2-hours of vaccination, experienced stabbing pain in base joint of left thumb, when grasping objects. Lasted intermittently for 6-hours, then subsided. Right knee has osteoarthritis, with some pain when walking, but was not affected. The events were assessed as non-serious by the reporter. The patient did not received treatment for the event. The outcome of the event was recovered on 28Jan2021 23:00.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Irregular sleep wake rhythm disorder, Sleep disorder
Clinical narrative: abnormal sleep patterns; sleep problems/Sleep is worse after the covid vaccine; sleep problems/Sleep is worse after the covid vaccine; This is a spontaneous report from a contactable healthcare professionals. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 23Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included depression anxiety and ongoing sleep problems. There were no concomitant medications. It was reported that the patient got the first dose and had abnormal sleep patterns on an unspecified date. It was reported that the patient was concerned that the Pfizer vaccine may contain something that could damage her brain and make it so she can't sleep. She stated she has existing issues with sleep so she is unsure if the vaccine has affected her sleep or not. She just wants to know if there is something in it that could affect her sleep. Added that she was able to fall asleep that night and then woke up in the middle of the night but that is not unusual. Added she has problems with sleep anyway and she is wondering if there is anything in the vaccine that could interfere with her sleep or could cause you to not be able to sleep. It was reported that the patient's sleep is worse after the COVID vaccine. She wanted to know if it is because of the vaccine. She is scheduled for the next dose on 13Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: the caller experience some headaches; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. This consumer reported similar events for two patients. This is 1st of two reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history were not reported. Concomitant medications included paracetamol (TYLENOL) for  arthritis. The patient received 1st shot of the covid19 vaccine last Saturday. He asked if it is fine to take Tylenol after the shot because the patient and his wife experience some headaches in Jan2021. He explained that he takes Tylenol for his arthritis in accordance to his doctor's instructions. He was never told to discontinue the Tylenol before taking the COVID-19 vaccine. After the shot, he continued taking the Tylenol as well because he had some headaches from what he believes were the side effects of the vaccine. He was told by some people that it was not good to take Tylenol after the COVID-19 vaccine, that it impacts the efficacy of the vaccine and asked if this was true and if he should stop taking the Tylenol. Therapeutic measures were taken as a result of headache. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092405 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program . This consumer reported the same events for two patients. This is the second of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took 6-8 pills of TYLENOL after receiving the vaccine because she was having a headache on Jan2021. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092403 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: I get cluster headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient himself) reported that a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, lot/batch number were not reported), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced cluster headaches on an unspecified date and was taking a medicine (Triptans). The outcome of event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Got an ear infection last week; This is a spontaneous report from a Pfizer sponsored program, . A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration and date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received the first shot already on an unknown date. She got an ear infection last week (in 2021) and was inquiring if she can get a second shot while taking antibiotics for ear infection. Outcome of the event was not recovered.   Information on the LOT/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: little drowsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid-19 vaccine. Medical history and concomitant medications were not reported. The patient slept really good. It was reported that he got a little drowsy after being vaccinated on an unspecified date. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body height decreased, Hypersensitivity, Rash maculo-papular, Skin swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 89-years-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (by injection once to left arm) on 22Jan2021 COVID-19 immunization since patient was in an independent facility with 238 residents. The patient had no relevant medical history. There were no concomitant medications. She said she got her first COVID-19 Vaccine dose on a Friday. She said she had no pain in her arm after receiving the first COVID-19 Vaccine, but then on 26Jan2021 she noticed about 8 hives right at her waist line. She asked if the hives were a reaction to the COVID-19 Vaccine. She said her skin was red and puffy in 8 different places on her waistline. She said her skin on her waistline looks like what happens when being allergic to something. She said she lives in an independent living community, and the COVID-19 Vaccine was provided to the residents in a group setting. She said no COVID-19 Vaccine immunization cards were provided at the time of vaccination. Patient reported "you know when the person gets hives, you get blisters, red blisters and now they are getting worse" and asked if that was a side effect from the vaccine." She was fine for a couple days, then noticed, and she doesn't know if this is a side effect or not, the waistline, she has about 5, states "you know when a person gets hives in the skin, it is raised and red? Is that a side effect?" States she shrunk (onset date not reported). There was a doctor there she would see her week and would show her, she will be giving her a physical. Patient would try to get physical therapy there. She further stated it looks like hives, she was looking now, she has 8 hives, they were the same color, and it was also itchy. She was not given a vaccine card. She was brought into a dining room, one area aside, there was a nurse, and applications already filled out, she has no idea what her number was, but after the injection she was put in another room, and sat for 15 minutes, to make sure no reaction, and there wasn't, she had no pain in arm, she felt well, but this showed up. She has to go back in 3 weeks for second injection. No investigation assessment was performed. The outcome of shrunk was unknown and not recovered (ongoing) for the other events. Information about Batch/Lot number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 89-years-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (by injection once to left arm) on 22Jan2021 COVID-19 immunization since patient was in an independent facility with 238 residents. The patient had no relevant medical history. There were no concomitant medications. She said she got her first COVID-19 Vaccine dose on a Friday. She said she had no pain in her arm after receiving the first COVID-19 Vaccine, but then on 26Jan2021 she noticed about 8 hives right at her waist line. She asked if the hives were a reaction to the COVID-19 Vaccine. She said her skin was red and puffy in 8 different places on her waistline. She said her skin on her waistline looks like what happens when being allergic to something. She said she lives in an independent living community, and the COVID-19 Vaccine was provided to the residents in a group setting. She said no COVID-19 Vaccine immunization cards were provided at the time of vaccination. Patient reported "you know when the person gets hives, you get blisters, red blisters and now they are getting worse" and asked if that was a side effect from the vaccine." She was fine for a couple days, then noticed, and she doesn't know if this is a side effect or not, the waistline, she has about 5, states "you know when a person gets hives in the skin, it is raised and red? Is that a side effect?" States she shrunk (onset date not reported). There was a doctor there she would see her week and would show her, she will be giving her a physical. Patient would try to get physical therapy there. She further stated it looks like hives, she was looking now, she has 8 hives, they were the same color, and it was also itchy. She was not given a vaccine card. She was brought into a dining room, one area aside, there was a nurse, and applications already filled out, she has no idea what her number was, but after the injection she was put in another room, and sat for 15 minutes, to make sure no reaction, and there wasn't, she had no pain in arm, she felt well, but this showed up. She has to go back in 3 weeks for second injection. No investigation assessment was performed. The outcome of shrunk was unknown and not recovered (ongoing) for the other events. Information about Batch/Lot number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Hyperthermia, Pain
Clinical narrative: always feels achy; hyperthermia (high temperature: 101.2 degrees Fahrenheit); headaches; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 25Jan2021 at a single dose on the left arm to not get Covid. The patient's medical history included joint disorder (reported as: for his hip). Concomitant medication included ongoing paracetamol (TYLENOL, lot number: SMA051, expiry date: Aug2024) for his hip. Patient reported that his son tested positive of Covid-19. On 25Jan2021, patient received the first dose of vaccine and experienced hyperthermia (high temperature: 101.2 degrees Fahrenheit) and headaches on 27Jan2021. Patient also stated that he always feels achy on an unspecified date. Patient wanted to know if being around his son who has tested positive would have an effect to his vaccine. The patient underwent lab tests and procedures which included body temperature: 101.2 degrees Fahrenheit on 27Jan2021 down to 99.8 degrees Fahrenheit on an unspecified date. The outcome of the event hyperthermia (high temperature: 101.2 degrees Fahrenheit) was recovering; headaches was not recovered while the other event was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: always feels achy; hyperthermia (high temperature: 101.2 degrees Fahrenheit); headaches; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 25Jan2021 at a single dose on the left arm to not get Covid. The patient's medical history included joint disorder (reported as: for his hip). Concomitant medication included ongoing paracetamol (TYLENOL, lot number: SMA051, expiry date: Aug2024) for his hip. Patient reported that his son tested positive of Covid-19. On 25Jan2021, patient received the first dose of vaccine and experienced hyperthermia (high temperature: 101.2 degrees Fahrenheit) and headaches on 27Jan2021. Patient also stated that he always feels achy on an unspecified date. Patient wanted to know if being around his son who has tested positive would have an effect to his vaccine. The patient underwent lab tests and procedures which included body temperature: 101.2 degrees Fahrenheit on 27Jan2021 down to 99.8 degrees Fahrenheit on an unspecified date. The outcome of the event hyperthermia (high temperature: 101.2 degrees Fahrenheit) was recovering; headaches was not recovered while the other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Sinus headache
Clinical narrative: sinus headache; pollen allergy; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable consumer (reporting for herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on an unspecified date at single dose, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date after getting first dose on a morning, patient experienced pollen allergy and a sinus headache and was asking if it was okay to take ADVIL and Ibuprofen. The outcome of the events was recovered.   No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: she has been seeing some blood when she blows her nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), 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. Patient verbally reported that she has been seeing some blood when she blows her nose. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling okay; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking how to register/sign up with V-safe. She doesn't know how to use a smartphone. At the end of the call, while transferring to the Consumer Fact sheet, the patient said she is not feeling okay then call got disconnected. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 antibody test
Clinical narrative: she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via the Pfizer-sponsored program. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at single dose, for covid-19 immunization. Medical history included covid-19 - the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her. Concomitant medications were not reported. The patient had the first shot yesterday 26Jan2021 and she's not feeling well on Jan2021. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient did not have any reaction except for a very mild soreness at the injection site on an unspecified date. The patient wanted to known if is there any correlation to the minimal reaction and effectiveness. Does that have any correlation to the effectiveness of the vaccine for him. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111577 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Pain, Pyrexia
Clinical narrative: Body aches; Low grade fever; Chills; Swollen upper lip; This is a spontaneous report from a non-contactable Physician via the Pfizer-sponsored program.  A patient of unspecified age and gender receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician reported that 13 hour after vaccination, the patient developed body aches, low grade fever, chills, and swollen upper lip, on an unspecified date. The patient took Tylenol for the body aches, low grade fever, chills, and swollen upper lip. The clinical outcome of body aches, low grade fever, chills, was recovered. The outcome of and swollen upper lip was not revered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling hot, Palpitations
Clinical narrative: heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control
Clinical narrative: blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM) ongoing since an unknown date and thyroid cancer excised on an unknown date. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. It took a week to 10 days for her insulin requirement to come close to baseline after the first vaccine dose. The outcome of the event blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event "blood sugars have been out of control in the range of 400-500's" in this insulin-dependent diabetes mellitus patient 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: medical history of arthritis treated with cortisone; medical history of arthritis treated with cortisone; Rash on her face/rash on the cheek; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included ongoing arthritis in her knee (for 7-8 years) and blood pressure high but so far so good. Concomitant medication included cortisone for arthritis in her knee. The patient previously had cortisone shot for arthritis and experienced rash on her face. On 14Jan2021, patient got the first vaccine dose and had rash on her face/rash on the cheek. Her next one is due 04Feb2021. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her left arm, via an unspecified route of administration on 12Jan2021 17:45 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen. Historical vaccine included on 22Dec2020 (first dose) and experienced Bilateral lower extremity numbness, Tingling and Foot pain. It was reported that the patient had tingling sensation bilateral upper extremities on 12Jan2021 18:00. Continues to present day. PCP following prescribed gabapentin. The outcome of the event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza
Clinical narrative: Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination.   No follow up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination.   No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Multiple nodules in the right side of the neck, around 1 cm; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 (at the age of 40years) at single dose for Covid-19 immunization. The patient's medical history was not reported; no known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple nodules in the right side of the neck, around 1 cm on 15Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My wife took the COVID-19 vaccine at the same time than me and had mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient's husband). 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 were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.It was reported that the patient had mild soreness at the injection site on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021099121 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: twinge of pain when she had the shot and that was it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she did not have any symptoms after the injection. The patient just had a twinge of pain when she had the shot and that was it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Slight pain at the injection site; muscle and joint aches (mostly in shoulders and  back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Pulled his band aid there was a little blood; This is a spontaneous report from a contactable consumer (wife of patient). An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her husband had his first dose today but at a different location and when he pulled his band aid there was a little blood. This was his first dose and it was given in his left upper arm. Outcome of event was unknown.  Information about Lot/ Batch has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; Extremely itchy; This is a spontaneous report from a contactable other health professional. A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at 10:30 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included modafinil. On 24Jan2021 at 12:00, the patient experienced diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared. Started next day. So far lasting for 4 days. Extremely itchy. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain in extremity
Clinical narrative: After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.  Information about batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received  ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination.  Information on the lot/batch number has been requested.