chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Magnetic resonance imaging
Clinical narrative: First dose: Little chemical taste; First dose: Tired; This is a spontaneous report from a contactable consumer(patient).  A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 (at the age of 68-year-old) and received second dose of BNT162B2 administered in Arm Left on 15Jun2021 14:00 (lot: EW0186) as single dose for covid-19 immunisation. Medical history included thyroid disorder from 1999 and ongoing. Concomitant medication(s) included latanoprost (LATANOPROST) Ongoing taken for Thyroid condition, levothyroxine sodium (TIROSINT) taken for thyroid disorder from 1999 and ongoing. On 15Jun2021 20:00 she had headache decided to take some Tylenol and it never went away, it just took the edge off. She took 500mg Tylenol and it did not work (Lot: LJA101, expiration date: Jun2021). At midnight and the whole night, she had a pressure in her head. Arm soreness, felt dehydrated, blood pressure elevated. Patient stated that she had a slight fever in the morning. Her temperature was usually 95 or 96, and if it goes a little higher, her temperature was about 98 on 16Jun2021 and experienced Heart racing and palpitations. She had a little chemical taste in her mouth for like a half hour after getting the first shot. It was strange and then passed. She was recovered completely from her symptoms after the first dose. The patient underwent lab tests and procedures which included magnetic resonance imaging: MRI no contrast on 14Jun2021.The patient had not recovered from Headache, Little fever, recovered from little chemical taste in her mouth, tired on27May2021 and outcome was unknown for remaining events.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion
Clinical narrative: Worsening stuffy nose; Tiredness; Experienced coughing/Dry cough; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration to her right arm on 03Jun2021 15:00 (Batch/Lot number: EW0181, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. Age at vaccination was 12-year-old. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 via an unspecified route of administration to her right arm on 23May2021 (at the age of 12-years) (Batch/Lot number: EW0182) as single dose for Covid-19 immunization and no reaction was reported on previous exposure to vaccine. Mother called on behalf of her daughter who took the second dose of the Pfizer COVID 19 vaccine last 13Jun2021 and experienced coughing on the same day when she took the vaccine. Tiredness on the next day but it already went away. Worsening stuffy nose and cough was persisting. Asking if these were normal side effects of the vaccine or her daughter needs to see a doctor. Potential duplicate AE Report E transmit. No zip code provided. First dose was given last 30May2021. Patient would turn 13-year. Stuffy nose and persisting cough were not listed as side effects of the vaccine. Side effect dry cough on 13Jun2021, tiredness on 14Jun2021 and stuffy nose on 15Jun2021. Stuffy nose was reported as worsened. Her daughter had her second dose on Sunday. Her daughter was almost 13-year-old. After the vaccine she started coughing. The next day she was tired. Now she was coughing with a stuffy nose. She stated that her daughter had no fever. Referred to HCP. Caller stated it was a dry cough that started the evening of the vaccine. States it was persisting. Regarding stuffy nose, caller stated it started yesterday and was worse today. Tired, states it was only an issue for the patient the day after the vaccine. Reporter seriousness for events was unspecified. Caller denied any medications, medical conditions, labs, testing or treatments for the patient relevant to the events. Outcome of the event tired was recovered on 14Jun2021, whereas other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eosinophil count, Eosinophil count increased, Inappropriate schedule of product administration
Clinical narrative: had both doses of the Pfizer COVID-19 vaccine in March.; Eosinophil is 670 which is 3x more; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 09Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had both doses of the Pfizer COVID-19 vaccine in March. He said that he has testing himself for several years and his eosinophil level was always around 200 and after the vaccine, his eosinophil is 670 which is 3x more. Caller wanted to know whether the vaccine was causing this problem or there had been reports of this experience with the vaccine. The patient was suggested to consult with her physician as there was no information regarding elevated eosinophil count after being vaccinated. The outcome of the events was unknown  Follow up(16Jun2021): Follow up information was received from the same contactable consumer included: non- significant information.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Vaccination site pain
Clinical narrative: lymph node; top of her arm where she got the shot was still sore; her underarm was very painful/ pain in her underarm.; This is a spontaneous report from a contactable consumer (reported for herself). A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181), via an unspecified route of administration on 14Jun2021 (at the age of 32-years-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171), first dose via an unspecified route of administration on 08May2021 (at the age of 32-years-old) for covid-19 immunisation. On an unspecified date, the patient experienced lymph node and on 15Jun2021, the patient experienced pain in her underarm and it was a very painful sharp pain, and it started hurting. The reporter stated that, she got the second vaccine on Monday, so a couple of days ago, and the top of her arm where she got the shot was still sore and also under her arm like near her armpit so opposite of where she got the shot like her underarm was very painful and it started hurting yesterday on Tuesday. reporter stated the pain was not a sore pain it was a sharp pain. The reporter wanted to know has anyone else reported this before or should she go to the doctor. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: aching; dizziness; Headache; This is a spontaneous report from a contactable pharmacist. A 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Jun2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history included vertigo. The patient's concomitant medications were not reported. On an unspecified date, patient experienced aching, dizziness and headache. As per report it was reported that, patient took the second Pfizer shot on yester-day (15Jun2021). Patient did not had a lots of symptoms that bothered her after first dose. But with the second shot, patient had aching and headache for which she took Tylenol as a relief to what she was experiencing. Then she was told that she should not take Tylenol. She said that, she did not know that. She got the fact sheet for the first one, but no fact sheet for the second shot. She was told not to take anything after she took the shot, but was told that after she took the Tylenol. It did not say anything about not taking pain medicine. She reported that, other people told her they took Tylenol. She was aching and a little dizzy. Patient took Tylenol as a treatment for events. The outcome of the events reported as unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Fibromyalgia, Influenza like illness, Oropharyngeal pain
Clinical narrative: fatigue; runny rose; coughing; sore throat; "flu like" for 6 days; phlegm in lungs; pain in body; overly sensitive; fibromyalgia; This is a spontaneous report from a contactable consumer (himself).   A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 01Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported first dose of confirmed Pfizer Covid 19 vaccine on 01June2021. He reported on 10Jun2021 he experienced runny rose, coughing, sore throat, "flu like" for 6 days, fatigue, phlegm in lungs, pain in body. Caller reported that these are his first flu-like symptoms in 30 years. Symptoms began on June 10th and symptoms are still current. He stated next dose: 28 June 2021. he reports that he has fibromyalgia and that he is overly sensitive, and everything is tripled in pain on unspecified date. Can I get second dose of Pfizer Covid 19 vaccine if I am still having these symptoms. On 10JUN2021, symptoms of runny nose, phlegm in the lungs, pain in the body and fatigue hit the caller. It has been 6 days and the symptoms have sort of plateaued off. The outcome of the events was reported as recovering.  Information about lot/batch number is available. Follow-up attempts are needed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Productive cough, Rhinorrhoea, Sensitive skin
Clinical narrative: fatigue; runny rose; coughing; sore throat; "flu like" for 6 days; phlegm in lungs; pain in body; overly sensitive; fibromyalgia; This is a spontaneous report from a contactable consumer (himself).   A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 01Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported first dose of confirmed Pfizer Covid 19 vaccine on 01June2021. He reported on 10Jun2021 he experienced runny rose, coughing, sore throat, "flu like" for 6 days, fatigue, phlegm in lungs, pain in body. Caller reported that these are his first flu-like symptoms in 30 years. Symptoms began on June 10th and symptoms are still current. He stated next dose: 28 June 2021. he reports that he has fibromyalgia and that he is overly sensitive, and everything is tripled in pain on unspecified date. Can I get second dose of Pfizer Covid 19 vaccine if I am still having these symptoms. On 10JUN2021, symptoms of runny nose, phlegm in the lungs, pain in the body and fatigue hit the caller. It has been 6 days and the symptoms have sort of plateaued off. The outcome of the events was reported as recovering.  Information about lot/batch number is available. Follow-up attempts are needed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Depressed mood, Fatigue, Fear, Fibromyalgia
Clinical narrative: fatigue; runny rose; coughing; sore throat; "flu like" for 6 days; phlegm in lungs; pain in body; overly sensitive; fibromyalgia; This is a spontaneous report from a contactable consumer (himself).   A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 01Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported first dose of confirmed Pfizer Covid 19 vaccine on 01June2021. He reported on 10Jun2021 he experienced runny rose, coughing, sore throat, "flu like" for 6 days, fatigue, phlegm in lungs, pain in body. Caller reported that these are his first flu-like symptoms in 30 years. Symptoms began on June 10th and symptoms are still current. He stated next dose: 28 June 2021. he reports that he has fibromyalgia and that he is overly sensitive, and everything is tripled in pain on unspecified date. Can I get second dose of Pfizer Covid 19 vaccine if I am still having these symptoms. On 10JUN2021, symptoms of runny nose, phlegm in the lungs, pain in the body and fatigue hit the caller. It has been 6 days and the symptoms have sort of plateaued off. The outcome of the events was reported as recovering.  Information about lot/batch number is available. Follow-up attempts are needed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Productive cough, Rhinorrhoea
Clinical narrative: fatigue; runny rose; coughing; sore throat; "flu like" for 6 days; phlegm in lungs; pain in body; overly sensitive; fibromyalgia; This is a spontaneous report from a contactable consumer (himself).   A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 01Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported first dose of confirmed Pfizer Covid 19 vaccine on 01June2021. He reported on 10Jun2021 he experienced runny rose, coughing, sore throat, "flu like" for 6 days, fatigue, phlegm in lungs, pain in body. Caller reported that these are his first flu-like symptoms in 30 years. Symptoms began on June 10th and symptoms are still current. He stated next dose: 28 June 2021. he reports that he has fibromyalgia and that he is overly sensitive, and everything is tripled in pain on unspecified date. Can I get second dose of Pfizer Covid 19 vaccine if I am still having these symptoms. On 10JUN2021, symptoms of runny nose, phlegm in the lungs, pain in the body and fatigue hit the caller. It has been 6 days and the symptoms have sort of plateaued off. The outcome of the events was reported as recovering.  Information about lot/batch number is available. Follow-up attempts are needed.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Fibromyalgia, Influenza like illness, Oropharyngeal pain
Clinical narrative: coughing up phlegm; I am afraid to if they doesn't go away; I have Fibromyalgia which is pain; Runny nose; Fatigue; I a little depressed; the aches in bones, in muscles; the aches in bones, in muscles; This is a spontaneous report from a contactable consumer (patient). A 73-years-old unknown gender patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on 01Jun2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia (ongoing) and spinal stenosis (ongoing). Concomitant medication was not reported. Patient was pretty healthy and don't have any flu or cancer or anything. On unspecified date, patient had coughing up phlegm and have fibromyalgia which pain. On 10Jun2021, patient had runny nose, the aches in bones, in muscles, fatigue and a little depressed. Patient wants to know how long this was to supposed to happen, mean was it couple of days, weeks or going with the pain whole month and should get the second shot if still have the symptoms. Patient stated that hopefully the symptoms go away in a week if they go, don't want to go for the second shot you know what I mean to I am afraid to if they doesn't go away. I have fibromyalgia which is pain, and if patient have just flu body overreacts, it hurts extra, that's part of fibro, just amplification of what all problem have and that's why patient was concerned. Treatment received was acetylsalicylic acid (ASPIRIN) about 500 mg every 4 hours, alternate to know whether in 4 hours as per range, patient just alternate and took just over the counter pain pills for back and other vitamins. Patient was health freak and don't like the sick. Patient don't have anything else so surprised as body was acting this way and cut out all herbs making sure that not doing anything to effect body and it was not going a way. Reporter seriousness for coughing up phlegm, fatigue, runny nose and a little depressed was unspecified. The outcome of all event was unknown.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Productive cough, Rhinorrhoea, Sensitive skin
Clinical narrative: coughing up phlegm; I am afraid to if they doesn't go away; I have Fibromyalgia which is pain; Runny nose; Fatigue; I a little depressed; the aches in bones, in muscles; the aches in bones, in muscles; This is a spontaneous report from a contactable consumer (patient). A 73-years-old unknown gender patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on 01Jun2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia (ongoing) and spinal stenosis (ongoing). Concomitant medication was not reported. Patient was pretty healthy and don't have any flu or cancer or anything. On unspecified date, patient had coughing up phlegm and have fibromyalgia which pain. On 10Jun2021, patient had runny nose, the aches in bones, in muscles, fatigue and a little depressed. Patient wants to know how long this was to supposed to happen, mean was it couple of days, weeks or going with the pain whole month and should get the second shot if still have the symptoms. Patient stated that hopefully the symptoms go away in a week if they go, don't want to go for the second shot you know what I mean to I am afraid to if they doesn't go away. I have fibromyalgia which is pain, and if patient have just flu body overreacts, it hurts extra, that's part of fibro, just amplification of what all problem have and that's why patient was concerned. Treatment received was acetylsalicylic acid (ASPIRIN) about 500 mg every 4 hours, alternate to know whether in 4 hours as per range, patient just alternate and took just over the counter pain pills for back and other vitamins. Patient was health freak and don't like the sick. Patient don't have anything else so surprised as body was acting this way and cut out all herbs making sure that not doing anything to effect body and it was not going a way. Reporter seriousness for coughing up phlegm, fatigue, runny nose and a little depressed was unspecified. The outcome of all event was unknown.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Depressed mood, Fatigue, Fear, Fibromyalgia
Clinical narrative: coughing up phlegm; I am afraid to if they doesn't go away; I have Fibromyalgia which is pain; Runny nose; Fatigue; I a little depressed; the aches in bones, in muscles; the aches in bones, in muscles; This is a spontaneous report from a contactable consumer (patient). A 73-years-old unknown gender patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on 01Jun2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia (ongoing) and spinal stenosis (ongoing). Concomitant medication was not reported. Patient was pretty healthy and don't have any flu or cancer or anything. On unspecified date, patient had coughing up phlegm and have fibromyalgia which pain. On 10Jun2021, patient had runny nose, the aches in bones, in muscles, fatigue and a little depressed. Patient wants to know how long this was to supposed to happen, mean was it couple of days, weeks or going with the pain whole month and should get the second shot if still have the symptoms. Patient stated that hopefully the symptoms go away in a week if they go, don't want to go for the second shot you know what I mean to I am afraid to if they doesn't go away. I have fibromyalgia which is pain, and if patient have just flu body overreacts, it hurts extra, that's part of fibro, just amplification of what all problem have and that's why patient was concerned. Treatment received was acetylsalicylic acid (ASPIRIN) about 500 mg every 4 hours, alternate to know whether in 4 hours as per range, patient just alternate and took just over the counter pain pills for back and other vitamins. Patient was health freak and don't like the sick. Patient don't have anything else so surprised as body was acting this way and cut out all herbs making sure that not doing anything to effect body and it was not going a way. Reporter seriousness for coughing up phlegm, fatigue, runny nose and a little depressed was unspecified. The outcome of all event was unknown.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Productive cough, Rhinorrhoea
Clinical narrative: coughing up phlegm; I am afraid to if they doesn't go away; I have Fibromyalgia which is pain; Runny nose; Fatigue; I a little depressed; the aches in bones, in muscles; the aches in bones, in muscles; This is a spontaneous report from a contactable consumer (patient). A 73-years-old unknown gender patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on 01Jun2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia (ongoing) and spinal stenosis (ongoing). Concomitant medication was not reported. Patient was pretty healthy and don't have any flu or cancer or anything. On unspecified date, patient had coughing up phlegm and have fibromyalgia which pain. On 10Jun2021, patient had runny nose, the aches in bones, in muscles, fatigue and a little depressed. Patient wants to know how long this was to supposed to happen, mean was it couple of days, weeks or going with the pain whole month and should get the second shot if still have the symptoms. Patient stated that hopefully the symptoms go away in a week if they go, don't want to go for the second shot you know what I mean to I am afraid to if they doesn't go away. I have fibromyalgia which is pain, and if patient have just flu body overreacts, it hurts extra, that's part of fibro, just amplification of what all problem have and that's why patient was concerned. Treatment received was acetylsalicylic acid (ASPIRIN) about 500 mg every 4 hours, alternate to know whether in 4 hours as per range, patient just alternate and took just over the counter pain pills for back and other vitamins. Patient was health freak and don't like the sick. Patient don't have anything else so surprised as body was acting this way and cut out all herbs making sure that not doing anything to effect body and it was not going a way. Reporter seriousness for coughing up phlegm, fatigue, runny nose and a little depressed was unspecified. The outcome of all event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Incorrect dose administered
Clinical narrative: out for the count this weekend; the one who administered the vaccine must have dripped or dropped some of the contents of the syringe, was reporting in case of dosage, and he suspected some of it spilled; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Caller stated that getting the second shot today of the Pfizer Biontech COVID-19 vaccine and reports the one who administered the vaccine must have dripped or dropped some of the contents of the syringe, was reporting in case of dosage, and he suspected some of it spilled. Caller declined to complete report on his wife at this time, says he will see if he gets sick, says lets keep that separate. Caller states his wife received the same Pfizer vaccine. The patient experienced out for the count this weekend on an unspecified date. The outcome of event was unknown.    Information about batch/lot number has been requested. Further information was expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Exostosis, Insomnia, Magnetic resonance imaging, Pain, X-ray
Clinical narrative: Bone spurs; Cannot sleep at night; pain that goes from her shoulder to her elbow/pain from shoulder to elbow; This is a Spontaneous case report received via Pfizer Sponsored Program from a Contactable Consumer (Patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: N 6199, Expiry Date: unknown), via an unspecified route of administration on 18Mar2021 administered in upper right arm as single dose for covid-19 immunisation. Medical history included heart alternation from an unknown date and unknown if ongoing. The patient takes regular (unspecified) medicines for her heart condition. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EN6201), via an unspecified route of administration on 25Feb2021 administered in upper right arm as single dose for COVID-19 immunisation. Caller stated she has had both doses of the Pfizer covid 19 vaccine. Caller stated the second dose is suspected dose for her AE. Caller stated she has a pain that goes from her shoulder to her elbow on Apr2021. It is a kind of pain that feels like her arm will fall off. She doesn't know if it's from vaccine or from other things. Pain has improved a little bit, but she can still feel it. Caller does not know if maybe there is a pinched nerve in her neck maybe it worked its way down to her arm. She just wants to rule things out. She has never had this problem before that she can remember. The patient experienced bone spurs on unspecified date, and Caller cannot sleep at night on unspecified date. Caller states her sister wanted her to call in and find out in order to rule something out. Just to make sure that the pain doesn't have anything to do with the vaccine. Pain from shoulder to elbow: Event start was in April, but she is not really sure. Pain has improved a little bit, but she can still feel it and she has a hard time sleeping at night, she switches sides back and forth. The patient underwent lab tests and procedures which included magnetic resonance imaging on neck on May2021; result: bone spurs, X-ray on May2021 result bone spurs. Therapeutic measures were taken with pain reliever and it kind of helped at first, but she can still feel it. The outcome of the event "The patient experienced bone spurs", "cannot sleep at night" was "unknown" and for event "pain that goes from her shoulder to her elbow/pain from shoulder to elbow" was "not recovered".
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Balance disorder, Dry mouth, Fatigue
Clinical narrative: arm soreness; really tired; slight fever; cold/flu like symptoms; achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits; like lymph nodes are swollen; drowsy; dry mouth; doesnt feel like herself; her equilibrium off; cold/flu like symptoms; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 14Jun2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unspecified date in Jun2021, the patient experienced arm soreness, really tired, slight fever, cold/flu like symptoms, achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits, feels like lymph nodes are swollen, drowsy, her equilibrium off, she does not feel like herself, she was in so much pain she does not feel safe to drive, and has dry mouth/cotton mouth. Clinical course of the events was reported as follows: Caller received the first dose this past Monday the 14Jun2021. She did report several adverse events. She was very shocked that she has had all of these adverse reactions after the first dose because she had been told that most people did not have an issue with the first dose. She reported she was in so much pain she does not feel safe to drive and have other people experienced these side effects. It started yesterday afternoon when it was in her system for about 24hrs. It got worsened this morning when she woke up at 6. She slept most of the morning away. She got up at 6 and got up every hour after that. She felt better after She took Tylenol and Alee, put on some cream, and was using a heating pad. The outcome of all events was unknown. No PQC involved.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Malaise, Nasopharyngitis, Neck pain
Clinical narrative: arm soreness; really tired; slight fever; cold/flu like symptoms; achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits; like lymph nodes are swollen; drowsy; dry mouth; doesnt feel like herself; her equilibrium off; cold/flu like symptoms; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 14Jun2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unspecified date in Jun2021, the patient experienced arm soreness, really tired, slight fever, cold/flu like symptoms, achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits, feels like lymph nodes are swollen, drowsy, her equilibrium off, she does not feel like herself, she was in so much pain she does not feel safe to drive, and has dry mouth/cotton mouth. Clinical course of the events was reported as follows: Caller received the first dose this past Monday the 14Jun2021. She did report several adverse events. She was very shocked that she has had all of these adverse reactions after the first dose because she had been told that most people did not have an issue with the first dose. She reported she was in so much pain she does not feel safe to drive and have other people experienced these side effects. It started yesterday afternoon when it was in her system for about 24hrs. It got worsened this morning when she woke up at 6. She slept most of the morning away. She got up at 6 and got up every hour after that. She felt better after She took Tylenol and Alee, put on some cream, and was using a heating pad. The outcome of all events was unknown. No PQC involved.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: arm soreness; really tired; slight fever; cold/flu like symptoms; achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits; like lymph nodes are swollen; drowsy; dry mouth; doesnt feel like herself; her equilibrium off; cold/flu like symptoms; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 14Jun2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unspecified date in Jun2021, the patient experienced arm soreness, really tired, slight fever, cold/flu like symptoms, achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits, feels like lymph nodes are swollen, drowsy, her equilibrium off, she does not feel like herself, she was in so much pain she does not feel safe to drive, and has dry mouth/cotton mouth. Clinical course of the events was reported as follows: Caller received the first dose this past Monday the 14Jun2021. She did report several adverse events. She was very shocked that she has had all of these adverse reactions after the first dose because she had been told that most people did not have an issue with the first dose. She reported she was in so much pain she does not feel safe to drive and have other people experienced these side effects. It started yesterday afternoon when it was in her system for about 24hrs. It got worsened this morning when she woke up at 6. She slept most of the morning away. She got up at 6 and got up every hour after that. She felt better after She took Tylenol and Alee, put on some cream, and was using a heating pad. The outcome of all events was unknown. No PQC involved.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysphemia, Laboratory test, Memory impairment
Clinical narrative: stuttering 2 weeks after receiving the second dose; or inability to understand what a person is saying; This is a spontaneous report from a contactable consumer (Patient's wife). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunization. On an unspecified date the patient experienced stuttering 2 weeks after receiving the second dose, or inability to understand what a person is saying. The patient underwent lab tests and procedures which resulted normal- all test have come back normal. The outcome of events was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain to injection site arm; sore arm; This is a Spontaneous report from a Pfizer sponsored program. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Left arm on 15Jun2021 at 16:00 (at the age of 68-year-old) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EW0178), via an unspecified route of administration on 24May2021 administered in upper left arm as single dose for COVID-19 immunisation. The patient experience pain to injection site arm. The caller is asking if the Ibuprofen she took will interfere with the Pfizer Covid Vaccine. The CDC Committee has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine). These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. The caller states the sore arm began 2 hours after the caller received the second dose Pfizer Covid Vaccine on 15Jun2021.The caller states she still has the sore arm. Therapeutic measures were taken with ibuprofen (Product strength and count size dispensed :200mg each tablet, count size 500, Lot: O8E2445A, Expiration: May2022, UPC: 9661962159). The outcome of event was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported (patient) that a 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: un EWO185) via an unspecified route of administration on 25May2021 14:48 (age at vaccination 49years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The clinical outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716077 similar report from same reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joints are very sore and achy/Joints really hurt after second dose; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Jun2021 (at the age of 78-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included lung cancer (she was diagnosed with lung cancer about a year ago and was still in treatment). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization and was ok. The patient stated that she received the second dose of the Pfizer BioNTech Covid-19 vaccine on 13Jun2021. On an unspecified date, the patient experienced joints are very sore and achy. She had an effect from the second dose. She did not know what to take and wanted to ask Pfizer what she could take. The patient stated that now her joints are very sore and achy. The patient stated that her HCP referred her to Pfizer to see what she can take for joint soreness. The patient asked what she can take for soreness in her joints. The patient stated that first one was ok, and with the second one, her joints really hurt. The patient declined to receive any further information over the phone regarding her side effects in relation to the Pfizer Covid-19 vaccine. Referred to healthcare professional for further guidance. The outcome of the event was unknown.  Information on the lot/batch, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Nausea, Vomiting
Clinical narrative: nausea and vomiting; nausea and vomiting; couldn't stand up; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0105), dose 1 via an unspecified route of administration, administered in right arm on 12May2021 as single dose to prevent the Covid 19 virus. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 02Jun2021 as single dose to prevent the Covid 19 virus. Patients medical history was not reported. Concomitant medication included vitamins from an unspecific date to an unspecified date. No additional vaccines administered on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations was not available. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have any illness at the time of vaccination. No AEs following prior vaccinations. Additional Vaccines administered on same date of the Pfizer suspect was reported as none. After receiving the first dose of the COVID-19 vaccine two weeks passed and then patient started having nausea and could not stand up because patient threw up everything patient had eaten on an unknown date in 2021. She received the first dose of the Covid 19 vaccine last month and two weeks passed and she started having nausea and vomiting, she could not stand up because she threw up everything she had eaten on an unspecified date. She stated she has had nausea for the past 2 or 3 days and yesterday it was very strong. Patient stated she wanted to know if she could take Pepto Bismol for nausea after the vaccine as she already took it. She asked if after two weeks it was possible to still have side effects, and asked if she could start taking her vitamins and drinking alcohol again. Investigation Assessment was reported as no. Right now, about two weeks had passed since she received the second Covid 19 vaccine. Exactly two weeks and she was feeling a lot of nausea and she felt like she wanted to throw up. She had not thrown up but she had taken Pepto Bismol. She was asking if it was ok to take Pepto Bismol. She was asking if this is related to the Covid 19 vaccine. She also had itchiness around her whole body especially her back. She had avoided all tests and medications except for the Pepto Bismol that she took yesterday, 15Jun2021. Adverse events (AEs) did not require a visit to: Emergency Room, Physician Office. Relevant Tests was reported as none. Therapeutic measures were taken as a result of nausea and vomiting. The outcome of the events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain in the legs; This is a spontaneous report received from a contactable consumer (patient).  A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date in May2021 (at the age of 46 years), as a single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunisation. On an unspecified  date, the patient stated that she received her second dose of the vaccine 3 weeks ago and is still experiencing joint pain in the legs. At the time of reporting, the outcome of the event were reported as not recovered.  Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate increased, Illness, Nausea
Clinical narrative: sick; a elevated heart beat; sick; Nausea; Vomiting; Fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient) from a Pfizer Call Center. A 36-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EW0153; Expiration Date: 20Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 28Apr2021 15:00 as 1st dose, single (at the age of 36-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no prior Vaccinations within 4 weeks. After vaccination on 28Apr2021, patient was sick and had a elevated heart rate since then, it is not as bad as it was but it is still higher than normal levels. and also had nausea, vomiting, fatigue, and dizziness; these events were gone three days later. On 19May2021, patient was scheduled to receive her second dose, but missed it as she was feeling sick again. Patient had a visit to Physician Office. Patient reported she had lab work since then but does not specify type or results. No Investigation Assessment. Patient was recovering from elevated heart beat, the outcome of feeling sick was unknown and recovered from rest of the events on 01May2021.  Follow-up actions are needed. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sick; a elevated heart beat; sick; Nausea; Vomiting; Fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient) from a Pfizer Call Center. A 36-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EW0153; Expiration Date: 20Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 28Apr2021 15:00 as 1st dose, single (at the age of 36-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no prior Vaccinations within 4 weeks. After vaccination on 28Apr2021, patient was sick and had a elevated heart rate since then, it is not as bad as it was but it is still higher than normal levels. and also had nausea, vomiting, fatigue, and dizziness; these events were gone three days later. On 19May2021, patient was scheduled to receive her second dose, but missed it as she was feeling sick again. Patient had a visit to Physician Office. Patient reported she had lab work since then but does not specify type or results. No Investigation Assessment. Patient was recovering from elevated heart beat, the outcome of feeling sick was unknown and recovered from rest of the events on 01May2021.  Follow-up actions are needed. Further information has been requested.