chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: 2 days after vaccinations I felt my hands getting heavy and numb, then symptoms increased to feeling numb in my hands (still present); got numbness in my face; 2 days after vaccinations I felt my hands getting heavy and numb, then symptoms increased to feeling numb in my hands (still present); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 16:00 (Lot number: ER8735) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MMR, administration date 30Mar2021; VARICELLA VACCINE, administration date 30Mar2021. The following information was reported: HYPOAESTHESIA (non-serious), LIMB DISCOMFORT (non-serious) all with onset 30Apr2021, outcome "not recovered" and all described as "2 days after vaccinations I felt my hands getting heavy and numb, then symptoms increased to feeling numb in my hands (still present)"; HYPOAESTHESIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "got numbness in my face". The events "2 days after vaccinations i felt my hands getting heavy and numb, then symptoms increased to feeling numb in my hands (still present)", "got numbness in my face" and "2 days after vaccinations i felt my hands getting heavy and numb, then symptoms increased to feeling numb in my hands (still present)" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, limb discomfort.  Additional information: No other medications in two weeks. No Covid prior Vaccination, nor tested post vaccination. No known allergies. No other medical history. Adverse event treatment with Advil.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Sick; Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: ILLNESS (non-serious), outcome "unknown", described as "Sick"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".   Additional information: Report 3 of 3. Report 3 is caller discussion her daughter's father. Caller stated that her daughter's dad had the vaccine, and was sick for several days with flu-like symptoms but no rash.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: A ball formed on her shoulder; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "A ball formed on her shoulder".   Additional information: Reporter said her sister in law's godmother, the lady that was her godmother was her family, it's her aunt, she had the same thing, she got the Pfizer COVID vaccine one, and a ball formed on her shoulder, in the same spot where the patient had hers, but her Godmother's went down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye infection, Headache, Musculoskeletal stiffness
Clinical narrative: Eye infection; stiff neck and headache; stiff neck and headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EP6955) 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: MUSCULOSKELETAL STIFFNESS (non-serious), HEADACHE (non-serious) all with onset Apr2021, outcome "recovered" (2021) and all described as "stiff neck and headache"; EYE INFECTION (non-serious), outcome "unknown", described as "Eye infection".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565358 same patient/reporter; different vaccine dose/AE
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness
Clinical narrative: Plus dizziness days and weeks after taking the shot.; I had every side effect listed on the CDC website; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 17:15 (Lot number: ER8737) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Azithromycin, reaction(s): "Drug allergy", notes: Known allergie- Azithromycin. The following information was reported: DIZZINESS (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Plus dizziness days and weeks after taking the shot."; ADVERSE EVENT (non-serious) with onset 09Apr2021, outcome "not recovered", described as "I had every side effect listed on the CDC website". The events "plus dizziness days and weeks after taking the shot." and "i had every side effect listed on the cdc website" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dizziness, adverse event.  Additional information: Facility where the most recent COVID-19 vaccine was administered was at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Patient took second dose of BNT162B2 on 24Apr2021 at 16:15 in left arm for covid-19 immunisation. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Headache, Migraine, Musculoskeletal stiffness, Vomiting
Clinical narrative: Stiff neck and headache; Stiff neck and headache; Migraine with vomitting for 10 hours; Migraine with vomitting for 10 hours/throwing up; Eye infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroiditis" (ongoing), notes: Verbatim: Hashimoto's disease, diagnosed 5 years ago; "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia, diagnosed about 15 years ago; "Arthritis" (ongoing), notes: Verbatim: Arthritis, diagnosed about 15 years ago. The patient's concomitant medications were not reported.The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "Stiff neck and headache"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraine with vomitting for 10 hours"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Migraine with vomitting for 10 hours/throwing up"; EYE INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Eye infection". Therapeutic measures were taken as a result of eye infection.  Additional information: Reporter states her husband and she got headache and really stiff necks on Day 1, eventually it went away, states it was gone in the morning when they woke up on Day 2, states on day three she ended up throwing up and had a migraine for 10 hours. Caller states on day four husband was fine and she felt good just a headache. Caller states they were supposed to get their second shot on 01May2021, and she got an eye infection in her left eye the day before, gave her a z pack, so she had to wait to get over the infection and had to get second shot, they got the second dose on 12May2021.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Product administered at inappropriate site, Underdose
Clinical narrative: arm pain; was not delivered in an optimal manner; she thinks the vaccine was given Sub-q versus IM./doesn't think it was placed in the muscle but that it was placed in the subcutaneous tissue; the caller doesn't think her daughter has gotten a full dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administration date 16May2021 (Batch/Lot number: unknown) at the age of 13 years 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: PAIN IN EXTREMITY (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "arm pain"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 16May2021, outcome "unknown", described as "was not delivered in an optimal manner"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 16May2021, outcome "unknown", described as "she thinks the vaccine was given Sub-q versus IM./doesn't think it was placed in the muscle but that it was placed in the subcutaneous tissue"; UNDERDOSE (non-serious) with onset 16May2021, outcome "unknown", described as "the caller doesn't think her daughter has gotten a full dose".  Additional information: Physician was calling about her 13.5 years old daughter who received the first dose of the Pfizer Covid 19 vaccine on Sunday 16May2021 and the caller stated that she believed that the vaccine her daughter received was not delivered in an optimal manner. She stated she had some arm pain that went to her hand but it resolved after a couple of days.  Her concerned was that she thought the vaccine was not delivered in an optimal manner by being placed too low and that the technique the vaccinator used was wrong.  She stated the vaccinator was pulling up on the muscle instead of pushing down and displacing the subcutaneous tissue. She said the supervisor of the vaccination site agrees it was placed too low.  The pharmacist thought it was at the very bottom of the muscle but thinks it might be capturing some of the muscle fibers. Caller stated her kids got the flu vaccines and they have never had issues before, between her and her mom and her kid they were all having issues, it was very frustrating. Caller stated but this issue was low. Caller asked was the lowness of delivery, it did not even get into the muscle at all, if it did not get into the muscle at all, what are the ramifications of that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 12-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0187), at the age of 12, in right arm, on May 17, 2021, at 16:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had vomiting, onset May 19, 2021, with outcome of recovering. Therapeutic measures were taken as a result of vomiting. Additional Information: No results in death. Not life-threatening. No prolonged hospitalization. Not disabling/incapacitating. No congenital anomaly/birth defect. No other medical history. Facility where the most recent COVID-19 vaccine administered: Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient treatment received for the adverse event included Zofran. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen; swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent (patient's mother) .  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 08:00 (Lot number: EW0185) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Allergic to Azithromycin; "Swollen lymph nodes" (unspecified if ongoing), notes: Diagnosed 5 year ago: Swollen lymph nodes all over his body. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: First, Lot number: EW0170), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 19May2021 08:00, outcome "unknown" and all described as "swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen".  Additional Information: NDC number and Expiry Date of Pfizer covid vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Therapeutic response unexpected
Clinical narrative: it made her feel incredibly good, took away her fatigue, her sinuses drained, was able to smell again and made her feel better.; she has had chronic pain on a daily basis, which is still there; 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 24Mar2021 (Lot number: ER2613) at the age of 59 years as unk unk, single and administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0169) as 2nd dose single for covid-19 immunisation. Relevant medical history included: "Samters Syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "it made her feel incredibly good, took away her fatigue, her sinuses drained, was able to smell again and made her feel better."; PAIN (non-serious), outcome "unknown", described as "she has had chronic pain on a daily basis, which is still there".  Description of Product Complaint: Description of complaint: Vaccine Supplemental Form completed in additional context. States she thinks the vaccine must have taken the inflammation down after the 1st dose of the vaccine and the sinus drainage she had after that 1st dose of the vaccine was so much and gobs and gobs of drainage; States the next day she could smell. States her 1st dose was administered on 24Mar2021 with lot ER2613 and her 2nd dose was administered three weeks and one day later and was administered on 15Apr2021 with lot EW0169; states the vaccine did not take away her headache and that really disappointed her and she has been dealing with headaches for 24 years. Has orthostatic headaches and never goes anywhere in the afternoon due to the pain increases as the day goes on; Caller states she takes pain medication for headaches, takes Tramadol 50mg 5-6 times per day and it is in an yellow pharmacy bottle  and she does not have the lot, expiry and NDC number to provide and began taking it in 2009-2010.States she takes Oxycodone 5mg up to four times per week and began taking it after she was changed to it and tried all different things to try to help with her pain levels and she does not know when she started the Oxycodone but there was about a year or two when she was on a Fentanyl patch in between that time; states she started the Oxycodone around the same time she started Tramadol; tried alternative pain medications that she used during those years and has no lots, expiry dates, NDC numbers or dosages to provide for the Fentanyl, other pain medications or alternative pain medications she tried. States the dosage amounts of the Fentanyl was changed to the higher dose because she got used to it; no further details provided.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain
Clinical narrative: severe pain; shaking chill; sick for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8735) at the age of 79 years 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: PAIN (non-serious), outcome "recovering", described as "severe pain"; CHILLS (non-serious), outcome "recovering", described as "shaking chill"; ILLNESS (non-serious), outcome "recovering", described as "sick for a week". Therapeutic measures were taken as a result of pain, chills, illness.  Additional information: No Concomitant Products. No other conditions. The patient was supposed to get the second dose on that week and was wondering if she should get it on 21May2021. Clarified that caller is referring to the Pfizer Covid 19 vaccine. On the paper given when she left, after the first shot, there was an immune thing mentioned. It was noted that she had something with her immune system that she caught a year ago, wondered if that had anything to do with anything. Has been a year and a half since something to do with her immune system. If it was, she shouldn't be getting the shot. For the record, she was a very healthy person except for colds and things like that, no serious illness or anything like that. Thought that it was important that she reported she was having severe pain to where she couldn't even function. She was having violent shaking chill and that basically sick for a week. She got the shot on Friday and called the doctor on Tuesday. Was incapacitated and was told to take Tylenol and things like that. It is getting a little better but is still not up to par. The patient was afraid to get the second. Does not know why they are asking all of these things.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Somnolence, Vomiting
Clinical narrative: vomiting "non stop/ she puked too; diarrhea; always sleeping/ sleeping a lot; not really eaten anything because when she does she vomit it back up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 10:00 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: verbatim: Diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: VOMITING (non-serious) with onset 18May2021, outcome "unknown", described as "vomiting "non stop/ she puked too"; DIARRHOEA (non-serious) with onset 18May2021, outcome "unknown", described as "diarrhea"; SOMNOLENCE (non-serious) with onset 18May2021, outcome "unknown", described as "always sleeping/ sleeping a lot"; FEELING ABNORMAL (non-serious) with onset 18May2021, outcome "unknown", described as "not really eaten anything because when she does she vomit it back up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, somnolence, feeling abnormal.  Additional Information: Reporter stated, "Orally, one in the morning and one in the afternoon. It is a tablet. After she got the Pfizer vaccine(Further not clarified hence captured as unspecified vaccine) and ever since she has been vomiting non stop and she's diabetic(Confirmed as other medical condition) as well. She is been like she is going high then she has been vomiting non stop and she is been sleeping a lot, she has not really eaten anything because when she does she vomit it back up and that's the another thing I want to ask if she can eat? What can she eat specifically like a soup or something on to keep her on, she's been drinking water and ginger. What? She vomited it back up. Reporter stated, "No, She hasn't just her Metformin the medication has been started for her diabetes." Still experiencing: Reporter stated, "No, no because she vomited four times yesterday then check her arm temperature it was fine and then we were actually driving in and on a highway she was vomiting again and we have to like park the car have it on."  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Muscle twitching, Tremor
Clinical narrative: tremors in her left shoulder and left arm.; laughing uncontrollably; her muscle got twitching; her left hand is shaking and little bit of tremors in the fingers; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 15 years 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: TREMOR (non-serious), outcome "unknown", described as "tremors in her left shoulder and left arm."; MOOD ALTERED (non-serious), outcome "unknown", described as "laughing uncontrollably"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "her muscle got twitching"; TREMOR (non-serious), outcome "unknown", described as "her left hand is shaking and little bit of tremors in the fingers".  Additional Information: Reporter stated, the patient 15 min after she received the dose, she began having tremors in her left shoulder and left arm little bit in the left-hand fingers. She was also laughing uncontrollably. This was the patient's 1st Pfizer vaccine dose and she received it about one hour ago. What treatment recommendations or suggestions do you have? Response: Spoke to the HCP from the attached document. Encouraged him to use his best clinical judgement. NDC number of COVID-19 Vaccine: Unknown. UPC number of COVID-19 Vaccine: Unknown. Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report. Expiry Date of COVID-19 Vaccine: Unknown. Reporter stated Alright, after the Vaccine her muscle got twitching her left hand that's where I gave her the shot in her left hand and her left hand is shaking and little bit of tremors in the fingers. So just wanted to report that you know so want to see if you had any suggestions or if you guys had any reporter who reported that or is that one of the side effects from the vaccine. Reporter was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM. When requested for probing, Reporter stated I would like to first speak to them. I have a patient here and I just want some advice and some guidelines first so we can take over the patient here. So I would have to call you back or I am not sure if I am able to call you back or not but we can do that a little bit later. But I do need to speak to somebody regarding this part. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Somnolence
Clinical narrative: Dizziness; slept the whole day; Headache; 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 63 year-old male patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Palpitations" (unspecified if ongoing), notes: He has palpitations; "Diabetes" (unspecified if ongoing), notes: He has sugar diabetes and a stent in in his heart; "Stent placement" (unspecified if ongoing), notes: He has sugar diabetes and a stent in in his heart. The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious) with onset 23Apr2021, outcome "recovered" (Apr2021), described as "Dizziness"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; SOMNOLENCE (non-serious) with onset 23Apr2021, outcome "recovered" (Apr2021), described as "slept the whole day". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large swelling to lymph nodes under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Apr2021 13:00 (Lot number: EP7534) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE taken for depression (ongoing). Past drug history included: Codine, reaction(s): "Drug allergy", notes: known_allergies: codine. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EP7534, Vaccination site: left Arm, Route: Intramuscular, Time: 13:00), administration date: 05Apr2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Apr2021, outcome "recovering", described as "Large swelling to lymph nodes under arm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Serious: No. Seriousness criteria reported as NO for included: Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect/Other medically important condition. Reported Event: Large swelling to lymph nodes under arm receiving the vaccination following second shot. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Codeine. Does Pfizer have permission to contact the reporter about this event: Yes. Does Pfizer have permission to contact your/the patient's healthcare provider about this report: No. 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 did not received any other medications within 2 weeks of vaccination: Fluoxetine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: her arm really  blew up after the first dose, states there was a firm bump at the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune anticardioid lipid" (ongoing). Concomitant medication(s) included: WARFARIN DEANOL. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "her arm really  blew up after the first dose, states there was a firm bump at the injection site.". Additional information: Caller states her arm really blew up after the first dose, states there was a firm bump at the injection site. The patient was taking concomitant product Warfarin for blood clots. Dosage text: 5mg 2 days a week and 7.5mg the other 5 days a week, tablets. No investigation assessment. Caller stated she got the second dose of the Pfizer Covid vaccine today, 19May2021, and while she was waiting for her 15 minutes, her vision became blurry, states they kept her there, caller states it was not going away, not sure what to do, had not heard of this before, wanted information about this symptom. Caller asks if she could be told how to treat it.   Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Just felt tired; Minor aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EN6201) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 10Feb2021, outcome "recovered", described as "Just felt tired"; PAIN (non-serious) with onset 10Feb2021, outcome "recovered", described as "Minor aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle twitching
Clinical narrative: sporadic muscle twitches all over my body; felt fatigue; headache; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0171) at the age of 47 years as dose number unknown, 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: MUSCLE TWITCHING (non-serious) with onset 12May2021, outcome "not recovered", described as "sporadic muscle twitches all over my body"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "felt fatigue"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache". The events "sporadic muscle twitches all over my body", "felt fatigue" and "headache" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of muscle twitching, fatigue, headache.  Additional information: No other vaccine was taken in four weeks. The patient did not have covid prior vaccination. Covid was not tested post vaccination. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His arm was sore by the end of the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 39 years 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: PAIN IN EXTREMITY (non-serious) with onset 27Apr2021, outcome "recovered" (2021), described as "His arm was sore by the end of the day".  Additional Information: First dose: Sore arm: Patient reported that he received the first dose of the Covid-19 vaccine almost 3 weeks ago to the day around 2:00 PM. He reported that his arm was sore by the end of the day and was sore for a couple of days before returning to normal. Vaccination Facility Type was Hospital. No Vaccine administered at Facility. No Emergency Room or Physician Office visit. No Prior Vaccinations (within 4 weeks), no AE(s) following prior vaccinations and no relevant tests reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Oligomenorrhoea, Oropharyngeal pain
Clinical narrative: A cyst occurred under the left chin; throat hurt; menstruation period became longer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 41 years 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: CYST (non-serious) with onset 12May2021, outcome "unknown", described as "A cyst occurred under the left chin"; OROPHARYNGEAL PAIN (non-serious) with onset 12May2021, outcome "unknown", described as "throat hurt"; OLIGOMENORRHOEA (non-serious) with onset 12May2021, outcome "unknown", described as "menstruation period became longer". Additional information: No treatment received. No covid prior vaccination and no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date, patient administered a full, undiluted COVID-19 vaccine, with outcome of unknown. The patient asked for medical advice. No follow-up attempts possible. Information about batch/lot  number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder
Clinical narrative: she developed diarrhea/viscous diarrhea; Patient can not eat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021583281 (Pfizer).  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 14May2021 (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: DIARRHOEA (non-serious) with onset 18May2021, outcome "not recovered", described as "she developed diarrhea/viscous diarrhea"; FEEDING DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Patient can not eat".  Additional information: Reporter states that patient had the covid vaccine on 14May2021. Patient went over to (vaccine facility name withheld), Facility and got the first dose of the covid vaccine. Since 18May2021, patient has had viscous diarrhea. Patient is still having diarrhea. Patient can not eat. Patient is having diarrhea four to six times a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Paraesthesia
Clinical narrative: She immediately felt pain from the left side of her beck down to her fingertips and has tingling at her fingertips; Has tingling at her fingertips; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 49 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 (1st Dose), for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "She immediately felt pain from the left side of her beck down to her fingertips and has tingling at her fingertips"; PARAESTHESIA (non-serious) with onset 19May2021, outcome "unknown", described as "Has tingling at her fingertips". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Paraesthesia, Sleep deficit
Clinical narrative: She immediately felt pain from the left side of her beck down to her fingertips and has tingling at her fingertips; Has tingling at her fingertips; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 49 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 (1st Dose), for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "She immediately felt pain from the left side of her beck down to her fingertips and has tingling at her fingertips"; PARAESTHESIA (non-serious) with onset 19May2021, outcome "unknown", described as "Has tingling at her fingertips". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Paraesthesia
Clinical narrative: Second dose: pain all the way down from her neck to her fingertips in her left hand; Second dose: did not sleep last night; Second dose: she is in pain; Second dose: fingers on her left hand are tingling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 16:28 (Lot number: EW0185) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "flu vaccine" (unspecified if ongoing), notes: she reports about 4 or 5 years ago she had a flu vaccine that caused her arm to swell. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/lot number: ER8735), administration date: 23Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: pain all the way down from her neck to her fingertips in her left hand"; SLEEP DEFICIT (non-serious) with onset 19May2021, outcome "unknown", described as "Second dose: did not sleep last night"; PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: she is in pain"; PARAESTHESIA (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: fingers on her left hand are tingling".  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient was not administered any additional vaccines on same date of the Pfizer suspect. There was no emergency room or no physician Office.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Paraesthesia, Sleep deficit
Clinical narrative: Second dose: pain all the way down from her neck to her fingertips in her left hand; Second dose: did not sleep last night; Second dose: she is in pain; Second dose: fingers on her left hand are tingling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 16:28 (Lot number: EW0185) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "flu vaccine" (unspecified if ongoing), notes: she reports about 4 or 5 years ago she had a flu vaccine that caused her arm to swell. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/lot number: ER8735), administration date: 23Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: pain all the way down from her neck to her fingertips in her left hand"; SLEEP DEFICIT (non-serious) with onset 19May2021, outcome "unknown", described as "Second dose: did not sleep last night"; PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: she is in pain"; PARAESTHESIA (non-serious) with onset 19May2021, outcome "not recovered", described as "Second dose: fingers on her left hand are tingling".  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient was not administered any additional vaccines on same date of the Pfizer suspect. There was no emergency room or no physician Office.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Caller is receiving an infusion for her asthma after receiving her 2nd shot of  Pfizer BioNTech Covid-19 Vaccine. The infusion may be an immunosuppressant; 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 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Caller is receiving an infusion for her asthma after receiving her 2nd shot of Pfizer BioNTech Covid-19 Vaccine. The infusion may be an immunosuppressant". Therapeutic measures were taken as a result of asthma.  Additional information: The patient wanted to know if the current infusion that she was taking for her asthma may lower the protection that she got from her 2 doses of Pfizer BioNTech Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Inappropriate schedule of product administration, Loss of proprioception
Clinical narrative: mild loss of proprioception in left hand; dissociation; administration_date:20May2021 10:00AM; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 10:00 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRYSELLE. Past drug history included: Hep b vaccine, reaction(s): "known allergies ", notes: known allergies: Hep B vaccine. Vaccination history included: Bnt162b2 (1st dose, administration date=06May2021,, administration time=09:30 AM,, vaccine location=Left arm}, adverse event: Dissociation for 30 minutes on first dose, which cleared up.), administration date: 06May2021, when the patient was 23 years old, for COVID-19 immunization , reaction(s): "Dissociation". The following information was reported: LOSS OF PROPRIOCEPTION (non-serious) with onset 20May2021 12:00, outcome "unknown", described as "mild loss of proprioception in left hand"; DISSOCIATION (non-serious) with onset 20May2021 12:00, outcome "unknown", described as "dissociation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20May2021 10:00, outcome "unknown", described as "administration date:20May2021 10:00AM". Therapeutic measures were not taken as a result of loss of proprioception, dissociation.  Additional Information: Covid prior vaccination was unknown and Covid not tested post vaccination. Reason why batch/lot is Unknown: Misplaced/discarded. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination:Cryselle Birth Control. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.