chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, SARS-CoV-2 antibody test
Clinical narrative: Delayed rash on arms & legs; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EN6201) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]; VITAMIN B-12; VITAMIN D NOS; MELATONIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Vaccine location: Left arm), administration date: 25Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Delayed rash on arms & legs"; FATIGUE (non-serious) with onset 16Jul2021, outcome "not recovered", described as "severe fatigue". The events "delayed rash on arms & legs" and "severe fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, fatigue.  Additional information: Other vaccine in four weeks: No. Other medication in two weeks: Advil, vitamin b-12, d, melatonin. The patient experienced Delayed rash on arms & legs, severe fatigue 6 months after 2nd dose. Her daughter also had delayed rash reaction. The worst of the rash lasted a month. Still experiencing small areas of rash on arms. She still was experiencing terrible fatigue and saw a naturopathic doctor. Adverse event start date: 16Jul2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not recover. Treatment was taken for the AE which included Supplements/homeopathic remedies. No Covid prior vaccination.  Follow-up attempts were completed. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrointestinal disorder, Headache, Insomnia, Pyrexia
Clinical narrative: headache; intestinal burning; restlessness; rash; fever; the feeling of sunburnt skin; the feeling of sunburnt skin; Chills; loss of sleep; Restless legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 15:00 (Lot number: FC3180) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: EW0196, Depression onset date: 22Jul2021., Recovered), administration date: 20Jul2021, for Covid-19 Immunization, reaction(s): "Depression", "Anxiety", "Dispair". The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 10Aug2021, outcome "recovered", described as "Restless legs"; SKIN DISCOMFORT (non-serious), SUNBURN (non-serious) all with onset 11Aug2021, outcome "recovered" and all described as "the feeling of sunburnt skin"; RASH (non-serious) with onset 12Aug2021, outcome "recovered", described as "rash"; PYREXIA (non-serious) with onset 11Aug2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 15Aug2021, outcome "recovered", described as "headache"; CHILLS (non-serious) with onset 11Aug2021, outcome "recovered", described as "Chills"; INSOMNIA (non-serious) with onset 10Aug2021, outcome "recovered", described as "loss of sleep"; GASTROINTESTINAL DISORDER (non-serious) with onset 12Aug2021, outcome "recovered", described as "intestinal burning"; RESTLESSNESS (non-serious) with onset 12Aug2021, outcome "recovered", described as "restlessness". The events "restless legs", "the feeling of sunburnt skin", "the feeling of sunburnt skin", "rash", "fever" and "headache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, sunburn, rash, pyrexia, headache, chills, insomnia, gastrointestinal disorder, restlessness.  Additional Information: The patient not pregnant. The patient was not other vaccine in four weeks. The patient had not covid tested post vaccination. No known allergies reported. vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Restless legs syndrome, Restlessness, Skin discomfort, Sunburn
Clinical narrative: headache; intestinal burning; restlessness; rash; fever; the feeling of sunburnt skin; the feeling of sunburnt skin; Chills; loss of sleep; Restless legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 15:00 (Lot number: FC3180) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: EW0196, Depression onset date: 22Jul2021., Recovered), administration date: 20Jul2021, for Covid-19 Immunization, reaction(s): "Depression", "Anxiety", "Dispair". The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 10Aug2021, outcome "recovered", described as "Restless legs"; SKIN DISCOMFORT (non-serious), SUNBURN (non-serious) all with onset 11Aug2021, outcome "recovered" and all described as "the feeling of sunburnt skin"; RASH (non-serious) with onset 12Aug2021, outcome "recovered", described as "rash"; PYREXIA (non-serious) with onset 11Aug2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 15Aug2021, outcome "recovered", described as "headache"; CHILLS (non-serious) with onset 11Aug2021, outcome "recovered", described as "Chills"; INSOMNIA (non-serious) with onset 10Aug2021, outcome "recovered", described as "loss of sleep"; GASTROINTESTINAL DISORDER (non-serious) with onset 12Aug2021, outcome "recovered", described as "intestinal burning"; RESTLESSNESS (non-serious) with onset 12Aug2021, outcome "recovered", described as "restlessness". The events "restless legs", "the feeling of sunburnt skin", "the feeling of sunburnt skin", "rash", "fever" and "headache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, sunburn, rash, pyrexia, headache, chills, insomnia, gastrointestinal disorder, restlessness.  Additional Information: The patient not pregnant. The patient was not other vaccine in four weeks. The patient had not covid tested post vaccination. No known allergies reported. vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Palpitations, Swelling face
Clinical narrative: her face, well more specifically her eyes, on the next morning had swelled and they have been swollen; her face, well more specifically her eyes, on the next morning had swelled and they have been swollen; racing heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3181) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 24Aug2021, outcome "recovered" (24Aug2021), described as "racing heartbeat"; SWELLING FACE (non-serious), EYE SWELLING (non-serious) all with onset 25Aug2021, outcome "recovering" and all described as "her face, well more specifically her eyes, on the next morning had swelled and they have been swollen". Therapeutic measures were taken as a result of palpitations, swelling face, eye swelling.  Clinical Course: She went to her doctor and he gave her steroids and she took the course and it still has not gone down.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Throat irritation
Clinical narrative: Coughing with tickles in the throat; Coughing with tickles in the throat; They think allergic, now this is the third week.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3181) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot: FA7484), administration date: 06Aug2021, for COVID-19 immunization.  The following information was reported: COUGH (non-serious) with onset 29Aug2021, outcome "not recovered", THROAT IRRITATION (non-serious) with onset 29Aug2021, outcome "unknown" and all described as "Coughing with tickles in the throat"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "They think allergic, now this is the third week.". The events "coughing with tickles in the throat", "coughing with tickles in the throat" and "they think allergic, now this is the third week." were evaluated at the physician office visit. Therapeutic measures were taken as a result of cough, throat irritation, hypersensitivity.  Additional information: The reporter called behalf of his daughter Second dose 27Aug2021, next Sunday she started coughing, with tickles in the throat. Wanted to know if this is because of the vaccine or something else. Still has the cough currently. She's better but she's still coughing. She already has medicines. Trying to recall which ones, reporter can't recall which ones. Has already seen HCP. They think allergic, now this is the third week. Just wanted to see if this is an adverse event of the vaccine. She claimed tickle in throat made her cough. Two days after vaccine started coughing, third week. Now I will wait. I just want to be sure it's not the vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Muscle spasms, Nausea
Clinical narrative: had 100.4F fever; feeling nauseous; cramping in her legs; chills/chills really bad; joint pain; injection site hurting really bad/site were it was given was hurting really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 10:00 (Lot number: 30130BA) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1:  lot number: EW0179.), administration date: 02Aug2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "cramping in her legs"; CHILLS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "chills/chills really bad"; ARTHRALGIA (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "joint pain"; VACCINATION SITE PAIN (non-serious) with onset 13Sep2021, outcome "not recovered", described as "injection site hurting really bad/site were it was given was hurting really bad"; PYREXIA (non-serious) with onset 14Sep2021 07:00, outcome "unknown", described as "had 100.4F fever"; NAUSEA (non-serious) with onset 14Sep2021 07:00, outcome "not recovered", described as "feeling nauseous". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course:She had the second injection yesterday. She got up during the night with chills really bad, cramping in her legs, and joint pain. The site were it was given was hurting really bad. She has a 100.4 fever and was nauseous. She wanted to know is it normal or something she should be seen for. Joint pain had improved and was a little better. When she got up she started getting nauseous. She didn't notice it before that. It was ongoing. Site were it was given was hurting really bad,it was ongoing and persisting since it feels the same. When she woke up she realized she felt warm and took her temperature.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: had 100.4F fever; feeling nauseous; cramping in her legs; chills/chills really bad; joint pain; injection site hurting really bad/site were it was given was hurting really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 10:00 (Lot number: 30130BA) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1:  lot number: EW0179.), administration date: 02Aug2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "cramping in her legs"; CHILLS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "chills/chills really bad"; ARTHRALGIA (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "joint pain"; VACCINATION SITE PAIN (non-serious) with onset 13Sep2021, outcome "not recovered", described as "injection site hurting really bad/site were it was given was hurting really bad"; PYREXIA (non-serious) with onset 14Sep2021 07:00, outcome "unknown", described as "had 100.4F fever"; NAUSEA (non-serious) with onset 14Sep2021 07:00, outcome "not recovered", described as "feeling nauseous". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course:She had the second injection yesterday. She got up during the night with chills really bad, cramping in her legs, and joint pain. The site were it was given was hurting really bad. She has a 100.4 fever and was nauseous. She wanted to know is it normal or something she should be seen for. Joint pain had improved and was a little better. When she got up she started getting nauseous. She didn't notice it before that. It was ongoing. Site were it was given was hurting really bad,it was ongoing and persisting since it feels the same. When she woke up she realized she felt warm and took her temperature.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Shots were 13 weeks apart and we are 10 days away from the second shot; Headache; Fever; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Shots were 13 weeks apart and we are 10 days away from the second shot"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache".  Additional Information: Reporter stated, "Reporter just had a question, reporter mom and reporter both received, both of the shots for the Pfizer vaccine (not clarified), the shots were 13 weeks apart and we are 10 days away from the second shot. Reporter mom was having symptoms of headache, fever and muscle ache. So, reporter was just calling to see if that was a normal reaction 10 days out of the second shot. She was having symptoms for two days now." (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab checked-Yes). Reporter was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. In response to further probing for safety report, reporter stated, " just talked to somebody and gave them all of reporter age and medical and everything, reporter just did that (not clarified further). reporter will try that number again." (further clarification unknown if reporter called in Pfizer Drug Safety earlier, hence report type captured as initial report. Further probing could not be done as reporter was unwilling to further answer the questions and hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 10:00 (Lot number: EW0171, Expiration Date: 31Aug2021) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset Aug2021, outcome "recovered" (28Aug2021), described as "hives"; RASH (non-serious) with onset Aug2021, outcome "recovered" (28Aug2021), described as "Rash". Therapeutic measures were taken as a result of urticaria, rash.  Additional Information: Calling about Pfizer COVID-19 Vaccine. States that she works in dietary at the hospital. One of the nurses told her she should call. When she first got the vaccine 2-3 weeks ago, she broke out in hives really bad about 2 days later. She got her shot on a Wednesday, then Thursday or Friday she broke out in hives. States that she kept forgetting to call. She gets the 2nd dose tomorrow. Treatment: She just put ice on it at home. States that she still needs to call her primary care doctor and let him know what happened. She broke out on her arms, legs and thighs. Asked, when getting in contact with her primary care doctor will someone contact her first or let her know and make an appointment with her.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Progesterone
Clinical narrative: "Effects my fertility". "I must start progesterone one day after ovulation to avoid spotting in luteal phase"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 11:00 (Lot number: EL9267, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Luteal Phase defect", start date: Aug2019 (ongoing), notes: Monthly Since August 2019. There were no concomitant medications. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset Feb2021, outcome "not recovered", described as ""Effects my fertility". "I must start progesterone one day after ovulation to avoid spotting in luteal phase"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of intermenstrual bleeding.  Additional Information: It was reported that the vaccination facility type was at school/student health clinic. Prior vaccination was reported as none. From Aug2019 to Feb2021 patient had started spotting. One week after ovulation so she takes progesterone to allow her body to successfully conceive a baby starting. Starting from Feb2021 to present, patient started spotting the day after ovulation making it impossible to Conceive w/o progesterone. There was a positive co-ordination to her vaccine dates and needing to start progesterone much sooner than before to avoid mid-cycle Spotting during entire Luteal Phase. It appears the vaccine further imbalanced my hormone levels. Progesterone test was conducted 6 days after ovulation. Seriousness criteria was reported as effects my fertility.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101005236 same patient and drug, different dose
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint stiffness, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and sore lymph nodes in neck; Swollen and sore lymph nodes in neck; sore and stiff joints including shoulder joints and fingers; very sore and stiff joints including shoulder joints and fingers.; I believe to what arthritis would feel like; fingers and shoulder joints continue to ache; fingers and shoulder joints continue to ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 13:30 (Lot number: Fd8448) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "Swollen and sore lymph nodes in neck"; ARTHRALGIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "sore and stiff joints including shoulder joints and fingers"; JOINT STIFFNESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "very sore and stiff joints including shoulder joints and fingers."; ARTHRITIS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "I believe to what arthritis would feel like"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "fingers and shoulder joints continue to ache". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, arthralgia, joint stiffness, arthritis, pain in extremity, arthralgia. Additional information: No other vaccine in four weeks. Other medications in two weeks: Levothyroxine 50 mcg. Swollen and sore lymph nodes in neck both sides for at least 2 weeks and very sore and stiff joints including shoulder joints and fingers. The patient have never had any signs of arthritis, but this would be similar the patient believe to what arthritis would feel like. Lymph nodes have subsided, but fingers and shoulder joints continue to ache. No covid prior vaccination. Did not get covid tested post vaccination. Known allergies and other medical history reported as not applicable.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Swollen and sore lymph nodes in neck; Swollen and sore lymph nodes in neck; sore and stiff joints including shoulder joints and fingers; very sore and stiff joints including shoulder joints and fingers.; I believe to what arthritis would feel like; fingers and shoulder joints continue to ache; fingers and shoulder joints continue to ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 13:30 (Lot number: Fd8448) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "Swollen and sore lymph nodes in neck"; ARTHRALGIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "sore and stiff joints including shoulder joints and fingers"; JOINT STIFFNESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "very sore and stiff joints including shoulder joints and fingers."; ARTHRITIS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "I believe to what arthritis would feel like"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "fingers and shoulder joints continue to ache". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, arthralgia, joint stiffness, arthritis, pain in extremity, arthralgia. Additional information: No other vaccine in four weeks. Other medications in two weeks: Levothyroxine 50 mcg. Swollen and sore lymph nodes in neck both sides for at least 2 weeks and very sore and stiff joints including shoulder joints and fingers. The patient have never had any signs of arthritis, but this would be similar the patient believe to what arthritis would feel like. Lymph nodes have subsided, but fingers and shoulder joints continue to ache. No covid prior vaccination. Did not get covid tested post vaccination. Known allergies and other medical history reported as not applicable.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Fatigue, Heart rate
Clinical narrative: chest pain; shortness of breath; rapid heartbeat and pulse; not feeling well; felt anxious; very tired; left arm hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 16:00 (Lot number: FC3183) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 14Sep2021, outcome "not recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "shortness of breath"; HEART RATE INCREASED (non-serious) with onset 14Sep2021, outcome "not recovered", described as "rapid heartbeat and pulse"; ANXIETY (non-serious) with onset 13Sep2021, outcome "unknown", described as "felt anxious"; MALAISE (non-serious) with onset 14Sep2021, outcome "unknown", described as "not feeling well"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "unknown", described as "left arm hurt"; FATIGUE (non-serious) with onset 11Sep2021, outcome "unknown", described as "very tired". The events "chest pain", "shortness of breath", "rapid heartbeat and pulse", "felt anxious", "not feeling well", "left arm hurt" and "very tired" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reports that on Friday her daughter was ok except her left arm hurt. On Saturday and Sunday her daughter was very tired. She was tired yesterday, 13Sep2021 as well and her daughter felt anxious. The caller let her daughter stay home from school yesterday, Monday, 13Sep2021. She told her daughter it had been over 48 hours, everything should be alright. Her daughter returned to school today and the school nurse called around 1:00PM and told the caller the daughter is not looking or feeling well.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Pain in extremity
Clinical narrative: chest pain; shortness of breath; rapid heartbeat and pulse; not feeling well; felt anxious; very tired; left arm hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 16:00 (Lot number: FC3183) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 14Sep2021, outcome "not recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "shortness of breath"; HEART RATE INCREASED (non-serious) with onset 14Sep2021, outcome "not recovered", described as "rapid heartbeat and pulse"; ANXIETY (non-serious) with onset 13Sep2021, outcome "unknown", described as "felt anxious"; MALAISE (non-serious) with onset 14Sep2021, outcome "unknown", described as "not feeling well"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "unknown", described as "left arm hurt"; FATIGUE (non-serious) with onset 11Sep2021, outcome "unknown", described as "very tired". The events "chest pain", "shortness of breath", "rapid heartbeat and pulse", "felt anxious", "not feeling well", "left arm hurt" and "very tired" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reports that on Friday her daughter was ok except her left arm hurt. On Saturday and Sunday her daughter was very tired. She was tired yesterday, 13Sep2021 as well and her daughter felt anxious. The caller let her daughter stay home from school yesterday, Monday, 13Sep2021. She told her daughter it had been over 48 hours, everything should be alright. Her daughter returned to school today and the school nurse called around 1:00PM and told the caller the daughter is not looking or feeling well.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20May2021 19:20 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 20May2021 21:00, outcome "recovered" (2021), described as "Bloody nose". Therapeutic measures were not taken as a result of epistaxis. Additional information: The patient's prior vaccinations were none. The patient's relevant tests were none. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Illness, Oropharyngeal pain, Pain
Clinical narrative: itching on lower arms with red bumps was reported as worsened; tired; a little sore throat on right side; achy; sick a couple of days before; little red bumps starting to travel up her arms; after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FA7485) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 2003 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2003. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA6780), for Covid-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset Aug2021, outcome "not recovered", described as "little red bumps starting to travel up her arms"; PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "itching on lower arms with red bumps was reported as worsened"; FATIGUE (non-serious), outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a little sore throat on right side"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sick a couple of days before"; PAIN (non-serious), outcome "unknown", described as "achy".  Additional information: Patient stated she wanted to call, she got the Pfizer Covid vaccine on 21Aug2021 and after the second one, about a week after, she has developed itching on just her lower arm, both of them, has somewhat little red bumps and was hoping it would all disappear but appears to be traveling up the arm, was sick a couple of days before, states she was achy, tired, had a little sore throat on right side, stated there were no fever and no breathing issues. Exact dates unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: itching on lower arms with red bumps was reported as worsened; tired; a little sore throat on right side; achy; sick a couple of days before; little red bumps starting to travel up her arms; after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FA7485) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 2003 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2003. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA6780), for Covid-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset Aug2021, outcome "not recovered", described as "little red bumps starting to travel up her arms"; PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "itching on lower arms with red bumps was reported as worsened"; FATIGUE (non-serious), outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a little sore throat on right side"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sick a couple of days before"; PAIN (non-serious), outcome "unknown", described as "achy".  Additional information: Patient stated she wanted to call, she got the Pfizer Covid vaccine on 21Aug2021 and after the second one, about a week after, she has developed itching on just her lower arm, both of them, has somewhat little red bumps and was hoping it would all disappear but appears to be traveling up the arm, was sick a couple of days before, states she was achy, tired, had a little sore throat on right side, stated there were no fever and no breathing issues. Exact dates unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: red bumps on her fingers and her hands and at the bottom of her feet; rashes on top of her head; top of her head looks like a carpet burn, that is how rash looks; her hands or her feet hurt on touch; her hands or her feet hurt on touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "red bumps on her fingers and her hands and at the bottom of her feet"; RASH (non-serious), outcome "unknown", described as "rashes on top of her head; top of her head looks like a carpet burn, that is how rash looks"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "her hands or her feet hurt on touch".  Additional information: Reporter stated, calling on behalf of fiancé. Reporter's fiancé got a vaccination of Pfizer (clarified as Pfizer COVID 19 Vaccine) 4 days ago. 2 days ago she started getting basically looks like red bumps on her fingers and her hands and at the bottom of her feet and then she also started getting like this rashes on top of her head so, reporter just want to see if you know anything about that and what she can do about it cause basically her hands or her feet hurt on touch now and then the top of her head looks like a carpet burn, that's how the rash looks. Reporter further stated, they have the LOT number if you need it, it was 'FL' OR 'FC' 3183. Looks like a 'FL' the way they have wrote it on it looks like a F' and 'C' 3183, it was FC3183.''  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Inflammation, Lip swelling, Product use issue
Clinical narrative: allergic reaction; Lips swollen; hands, wrist had bumps; other vaccine same date vaccine date 21May2021; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21May2021 (Lot number: EW0179) at the age of 16 years as dose 2, single and administered in arm right, administration date 21May2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIP SWELLING (non-serious) with onset 22May2021, outcome "recovered with sequelae", described as "Lips swollen"; INFLAMMATION (non-serious) with onset 22May2021, outcome "recovered with sequelae", described as "hands, wrist had bumps"; HYPERSENSITIVITY (non-serious) with onset 12Jun2021 15:00, outcome "recovered with sequelae", described as "allergic reaction"; PRODUCT USE ISSUE (non-serious) with onset 21May2021, outcome "unknown", described as "other vaccine same date vaccine date 21May2021"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21May2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "lips swollen", "hands, wrist had bumps", "allergic reaction", "other vaccine same date vaccine date 21may2021" and "inappropriate schedule of vaccine administered" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lip swelling, inflammation, hypersensitivity.  Additional information: Patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that Next day after getting vaccine, the patient experienced Lips swollen, hands, wrist had bumps. After taking him to the ER he took Benadryl everyday since 12Jun2021 because he got the allergic reaction, he was advice by doctor because if he got a steroid shot it would defeat the purpose of the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Dysmenorrhoea, Menstrual disorder
Clinical narrative: My monthly period is coming more often bleeding is heavy ,clotting and cramps; My monthly period is coming more often bleeding is heavy ,clotting and cramps; My monthly period is coming more often bleeding is heavy ,clotting and cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 09:00 (Lot number: EW0183) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product COVID 19, brand Pfizer, lot number EW0167, lot unknown False, administration date 29Apr2021, administration time 09:00 AM, dose number 1, vaccine location Left arm.), administration date: 29Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious), COAGULOPATHY (non-serious), DYSMENORRHOEA (non-serious) all with onset 01Jul2021 03:00, outcome "not recovered" and all described as "My monthly period is coming more often bleeding is heavy ,clotting and cramps". Therapeutic measures were not taken as a result of menstrual disorder, coagulopathy, dysmenorrhoea.  Additional Information: The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered:  Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Events reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal disorder, Inflammation, Lactose tolerance test
Clinical narrative: Digestive issues; inflamation; diahrrea; abdominal pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Lot number: EW0177) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D; FISH OIL. Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0176, vaccine location: Left arm), administration date: 01Jul2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Gastric pain". The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Digestive issues"; INFLAMMATION (non-serious) with onset 20Aug2021, outcome "not recovered", described as "inflamation"; DIARRHOEA (non-serious) with onset 20Aug2021, outcome "not recovered", described as "diahrrea"; ABDOMINAL PAIN (non-serious) with onset 20Aug2021, outcome "not recovered", described as "abdominal pain". The events "digestive issues", "inflamation", "diahrrea" and "abdominal pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastrointestinal disorder, inflammation, diarrhoea, abdominal pain.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received following medication within 2 weeks of vaccination as Multivitamin, vitamin D, fish oil. The adverse event result in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The healthcare professional considered the suspect vaccine had a no causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Although the attending Physician has assessed as events as no causal effect from BNT162B2,Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.