chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: extreme swelling at injection site; extreme tenderness at injection site; was real tired; This is a spontaneous report received from 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 16Feb2021 12:00 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing). The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 17Feb2021, outcome "recovered" (19Feb2021), described as "extreme swelling at injection site"; VACCINATION SITE PAIN (non-serious) with onset 17Feb2021, outcome "recovered" (19Feb2021), described as "extreme tenderness at injection site"; FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered" (19Mar2021), described as "was real tired".  Additional information: Patient reported that while reporting on son, Reporter adds that she had Covid in Nov 2020. The report not related to a study or programme History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Investigation assessment reported as no. Her arm was so tender she did not even want her clothes to touch it. She applied ice and that helped. She received the second dose 12Mar2021. Patient does not know if she kept the vaccine card or if she threw it away. Additional vaccines administered on same date of the pfizer suspect reported as none. Prior Vaccinations (within 4 weeks) reported as none. The patient was not visited to emergency room and physician office. Family Medical History Relevant to AE(s) reported as none. Relevant tests reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Taste disorder
Clinical narrative: Got my first Pfizer vaccine and ever since I got it, I have like a bad taste; I just have cold and stuff; 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) (Lot number: ER8736) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: TASTE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Got my first Pfizer vaccine and ever since I got it, I have like a bad taste"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "I just have cold and stuff".  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Inner ear disorder, Tinnitus
Clinical narrative: inner ear issues; Ringing of the ears; stuffiness; I feel I don't hear as well in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 09:30 (Lot number: ER8737) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal outdoor allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ALEVE. Vaccination history included: Bnt162b2 (product = COVID 19, brand = Pfizer,, lot number = ER8737,, lot unknown = False,, administration date = 02Apr2021,, administration time = 10:15 AM,, dose number = 1,, vaccine location = Left arm), administration date: 02Apr2021, when the patient was 55 years old, for Covid-19 Immunisation. The following information was reported: INNER EAR DISORDER (non-serious) with onset 24Apr2021, outcome "not recovered", described as "inner ear issues"; TINNITUS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ringing of the ears"; EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "stuffiness"; HYPOACUSIS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "I feel I don't hear as well in my left ear". Therapeutic measures were not taken as a result of inner ear disorder, tinnitus, ear discomfort, hypoacusis. Additional information: Adverse event: Patient was on her 5th consistent day after vaccination with inner ear issues. Ringing of the ears, stuffiness. She felt she don't hear as well in her left ear. other vaccine same date details: other vaccine same date vaccine date: 23Apr2021. If other vaccine in four weeks: No. Other medications in two weeks: Rosuvstatin (cholesterol), Aleve. If Covid prior vaccination: No. If Covid tested post vaccination: No.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Saliva analysis
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 13:30 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: PROBIOTICS. Past drug history included: Morphine, reaction(s): "allergies"; Clarithromycin, reaction(s): "allergies". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination: OTC allergy medicine and vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021500137 same patient and reporter, different dose and event
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test, Sinus headache
Clinical narrative: immediate arm pain; Severe sinus headache; Tired; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 13:30 (Lot number: EN6205) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS. Past drug history included: Morphine for Drug Allergies: morphine; Clarithromycin for Drug Allergies: Clarithromycin. Vaccination history included: Bnt162b2 (lot number EL9266, le, administration date 10Mar2021, administration time 02:30 PM, vaccine location Left arm]), administration date: 10Mar2021, for COVID-19 immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered", described as "immediate arm pain"; SINUS HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered", described as "Severe sinus headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, sinus headache, fatigue.  Additional information: The patient did not have COVID 19 prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021500107 same patient and reporter, different dose and event
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Her daughter is experiencing headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 29Apr2021, outcome "unknown", described as "Her daughter is experiencing headache". Therapeutic measures were taken as a result of headache.  Additional information: Patient got the second dose yesterday which was the 28April2021 and now was experiencing headache and she wants to know if she can provide Tylenol for her daughter's headache, that's the reason for the call. Reporter stated, Yes, is that okay if I give her Tylenol over the counter medicine. I just gave her some Tylenol (Treatment), so hopefully she will be better. Reporter stated, regarding lot number It is EWO169, that O could be zero, I can't tell.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Have reaction on bottom right side of leg; have swelling at leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: ER8731) at the age of 37 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: PERIPHERAL SWELLING (non-serious) with onset 29Apr2021, outcome "unknown", described as "Have reaction on bottom right side of leg; have swelling at leg". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Patient received his second dose of Pfizer at around 1 o'clock close to 2 today (29Apr2021) and went home. About three hours later at 5 o'clock, patient had a reaction on bottom right side of his leg. He was asking if this was because of the shot as he had swelling at leg.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue
Clinical narrative: autoimmune disease to flare up; tire/run down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: Ew0151) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hashimito" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: en6207, Administration time: 02:00 P.M., Dose 1, Single, Vaccine location: Left arm), administration date: Mar2021, when the patient was 42 years old, for Covid-19 immunization.The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 12Apr2021, outcome "not recovered", described as "autoimmune disease to flare up"; FATIGUE (non-serious) with onset 12Apr2021, outcome "not recovered", described as "tire/run down". It was unknown if therapeutic measures were taken as a result of condition aggravated, fatigue.  Additional information: Facility type vaccine was reported as Other. The patient had not received other vaccine in four weeks prior vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. Since vaccination the patient was not test for Covid-19. The patient though it caused her autoimmune disease to flare up. She had hashimoto. She felt tired 24 hours after the shot and woke up the next day fine but now the last almost 20 days she felt so run down and required more sleep and could do less. So she though it causes her autoimmune to flare. She mentioned she would going to consult her endo.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; splitting headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 14:15 (Lot number: EW0162) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic fatigue" (unspecified if ongoing); "insilun resistance" (unspecified if ongoing); "peanut" (unspecified if ongoing), notes: known allergies: peanuts; "known allergies: chocolate" (unspecified if ongoing), notes: known allergies: chocolate. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1,, Lot number: ER8727,, Administration time: 02:30 PM,, Vaccine location: Left arm), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "extremely exhausted", "tummy upset", "general malaise", "extremely aggitated". The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "tired"; HEADACHE (non-serious), outcome "recovering", described as "splitting headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: Other vaccine in four weeks was reported as no and Other medications in two weeks was reported as Trazadone. Covid prior vaccination and covid tested post vaccination was reported as no. After the first vaccine, she was extremely exhausted for about two weeks after the vaccine with tummy upset and general malaise. she was also extremely agitated and needed to be left alone so as not to offend others. After the second vaccine (Dose 2 administration time; 02:15 AM), she had a splitting headache everyday for 18 days. Today was the 19th day and she have a slight headache today. she've also been sleeping 9 hours per night and she have been tired and not able to do anything, but she was not as exhausted as with the first dose. She have been unwell for over a month now because of the vaccine and never want to get another one. Adverse event start date: 20Mar2021. Adverse event start time: 06:00 PM.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, SARS-CoV-2 test, Sciatica
Clinical narrative: small episode of sciatica; nerve pain in left leg, similar to sciatic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. The following information was reported: SCIATICA (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "small episode of sciatica"; NEURALGIA (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "nerve pain in left leg, similar to sciatic". The events "small episode of sciatica" and "nerve pain in left leg, similar to sciatic" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information :The patient had not received any other vaccine within 4 weeks. Within 2 weeks of vaccination patient received Vyvanse. If-covid prior vaccination reported as Yes, If-covid test-post-vaccination was reported as yes. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Was really tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 08:00 (Lot number: ER8727) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung carcinoma cell type unspecified stage IV" (ongoing), notes: Verbatim: Lung cancer stage IV; "Recently broken collar bone", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: Recently broken collar bone; "Heart attack", start date: Oct2020 (unspecified if ongoing), notes: Verbatim: Heart attack. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (AE(s) following prior vaccinations: One time, yes, caller had severe allergic reaction to got flu shot and something else can't remember. Very severe reactions to these, years ago.), for immunization, reaction(s): "Severe allergic reaction". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "Was really tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a consumer reporting she received both doses of the Pfizer Covid Vaccine. Received first dose and then like three weeks later received second dose and then got Covid and ended up in the hospital. Caller remembers her first night in the hospital hearing on the local news that the second dose for caller was given at the facility and the dosage wasn't right where caller received second dose. Caller heard on the news a nurse messed up on the dosage from like 0810 to 0840 in the morning and that happened to be the time when the caller received her second dose Pfizer Covid Vaccine. Caller was curious if she was one of those people. Caller was diagnosed with Covid the same day the caller received the second dose Pfizer Covid Vaccine, 07Apr2021. Caller reports she was really tired. This began the end of March. Caller was still tired but it was getting better. Caller states it had improved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, SARS-CoV-2 test
Clinical narrative: Insomnia / trouble sleeping; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old 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: INSOMNIA (non-serious), outcome "unknown", described as "Insomnia / trouble sleeping"; HEADACHE (non-serious), outcome "recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "I have some question. I know the common side effects of covid. I am calling in regards to mother. My mother got the covid vaccine (Capture as verbatim). Is anybody reported any side effects like insomnia? That is my question. Even it is like small or rare or because my mom never had insomnia. After she took the first covid vaccine and she is been having like ongoing headache that was go away and trouble sleeping. So I am trying you know she went to go tested and she doesn't have covid. Her doctor doesn't understand why she has onset of insomnia happening. So our last step is to call you guys or may be we are hoping that somebody has reported you know some minor."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: After first vaccine, experienced extreme tiredness; was also drowsy for the next 2 days; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High triglycerides" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE; FISH OIL. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "After first vaccine, experienced extreme tiredness"; SOMNOLENCE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "was also drowsy for the next 2 days". Therapeutic measures were not taken as a result of fatigue, somnolence.  Additional information: After first vaccine, patient experienced extreme tiredness and slept for 2 hours, was also drowsy for the next 2 days. After second vaccine, injection site became swollen, hard and red for 3 days; had a flush of chills; and was extremely tired every day for about 3 days after that. All symptoms have resolved at this point. The vaccine was only referred to as the "Pfizer" vaccine, so I'm assuming there is only one Pfizer vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient took multivitamins as other medications. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021501800 (same reporter/drug/AE, different patients). 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: FATIGUE (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Has fatigue and a headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Has fatigue and a headache; Has fatigue and a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021501798 (same reporter/drug/AE, different patients.).  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: FATIGUE (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Has fatigue and a headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 18:30 (Lot number: EN6201) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Tetanus vaccine, for Immunization, reaction(s): "headache", "swollen arm", "rashness"; Flu vaccine, for Immunization; Pneumonia vaccine, for Immunization, reaction(s): "Headache", "Swollen arm", "Rash". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501874 same patient/drug, different vaccine dose/AE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Headache
Clinical narrative: I had a slight headache.; I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing it's just the pain comes and goes and it's very irritating .; It's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so it's very uncomfortable.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 40 years 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: HEADACHE (non-serious) with onset 28Apr2021, outcome "not recovered", described as "I had a slight headache."; ABDOMINAL PAIN (non-serious) with onset 28Apr2021, outcome "not recovered", described as "I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing it's just the pain comes and goes and it's very irritating ."; ABDOMINAL DISCOMFORT (non-serious) with onset 28Apr2021, outcome "not recovered", described as "It's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so it's very uncomfortable.". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated I had my vaccine. My first vaccine on Tuesday and I had a slight headache. I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing but it's just the pain that comes and goes and it's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so. It's very uncomfortable. I just took Tylenol yesterday because I had headache. Scheduled vaccination date for second dose: consumer stated: 18May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain
Clinical narrative: diarrhea; body aches; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EP7534, Expiration Date: 30Jun2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: diagnosed 25 years ago. There were no concomitant medications. Vaccination history included: Flu shot (when she was in her 20s), reaction(s): "she gets sick from it". The following information was reported: PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "body aches"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "nausea"; HEADACHE (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "headache"; DIARRHOEA (non-serious) with onset 19Mar2021, outcome "recovered" (Mar2021), described as "diarrhea".  Additional information: Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine(s) were none. Additional vaccines administered on same date of the pfizer suspect were none. Time the Vaccination was Given: 10:00-10:15. Other Products: No. The patient stated she had severe nausea, headache, diarrhea. She was down a week. The patient also stated she had body aches. She stated it all started immediately and after each one kept happening. The patient verifies all symptoms after first dose started the same day except the diarrhea, that started the following day. The patient verifies all the symptoms began 18 MAR 2021 and the diarrhea began 19Mar2021. The patient stated the symptoms: severe nausea, headache, diarrhea, body aches, all ended 25Mar2021 or 26Mar2021 and she did recover completely from them.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain". Additional information: Patient received his 1st shot on 28Apr2021 and experienced arm pain after the 1st dose. Patient would like to reschedule his appointment from 18May2021 to 21May2021.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: Right arm still hurts from shot; Blurienest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE, Lot number: Not reported, Vaccination Time: 10:00), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2021, outcome "not recovered", described as "Right arm still hurts from shot"; VISION BLURRED (non-serious) with onset 28Apr2021, outcome "recovered" (29Apr2021), described ".  Additional information: Right Arm still hurts From shot - - as gone Away after one day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vitreous floaters
Clinical narrative: headaches; floaters in her eyes; limp nodes swollen; 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 parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters in her eyes"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "limp nodes swollen". The events "headaches", "floaters in her eyes" and "limp nodes swollen" were evaluated at the physician office visit.  Additional information: Reporter stated her daughter had both vaccines and was having terrible side effects. She was having headaches, floaters in her eyes, limp nodes swollen. She has been to an eye doctor and now is waiting to get a c-scan. The reporter said she will never get the vaccine because it was nothing but poison being put into human race. She wants to know if there is an antidote for all these side effects. Relayed number to PMI, read ISI transferred to PMI queue due to long hold time. Any medical questions addressed by this program forwarded/reffered to medical information reported as yes.  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: Pain, Pain in extremity
Clinical narrative: After second dose left heel hurts; pain throughout the body; 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), administered in arm left, administration date 29Mar2021 11:00 (Lot number: ER8733) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SYNTHROID; LIOTHYRONIN; CYCLOBENZAPRIN. Vaccination history included: Bnt162b2 (Terrible itch and rash in butt, Lot #EN6205, 11 AM, Left arm), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunisation, reaction(s): "Itch", "Rash". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021 23:00, outcome "recovered" (30Mar2021), described as "After second dose left heel hurts"; PAIN (non-serious) with onset 29Mar2021 23:00, outcome "recovered" (30Mar2021), described as "pain throughout the body". Additional information: the patient did not take any other vaccine in four weeks. After second dose left heel hurted and it was still not better. The patient had neither problem before this. The patient did get pain throughout the body 12 hours after the second dose that went away the next day. The patient had no COVID prior vaccination and was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486656 same pt/drug, diff events from diff dose
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site".  Additional information: The report was not related to a study or programme. NDC number, expiry date, investigation assessment were not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Pain in extremity
Clinical narrative: pain on the left side of the stomach; pain in the left leg; dizzy; feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "pain on the left side of the stomach"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in the left leg"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: He had chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 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: CHILLS (non-serious), outcome "unknown", described as "He had chills".  Additional information: Patient stated that after 1st vaccine he had chills for 2 days. He went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot was the only thing different from his regular routine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site discomfort, Vaccination site erythema, Vaccination site nodule
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 05:00 (Lot number: EW0162) at the age of 52 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT taken for depression; OMEPRAZOLE; SYNTHROID. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "Injection site turned very hard and warm to touch"; VACCINATION SITE NODULE (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "not recovered" and all described as "Around the injection site was a lump, it was hard, it was not fire red but red"; PAIN (non-serious) with onset May2021, outcome "recovering", described as "Did hurt"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Aches at vaccination site"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "I was very tired". Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site nodule. Additional information: Reporter got the 1st dose of the Pfizer vaccine on Thursday, 29Apr2021 5 o'clock. Everything went well until Friday. Saturday she felt tired and the injection site turned very hard and warm to touch. She did not know if it was a local reaction but she called because she did not know what to do. She had already put a cold and hot compress and it still ached and still hard. She was hoping to get some suggestion. It was 10-15 minutes for any reaction so fine, Friday she felt fine, Saturday she was very tired but what developed around the injection site was a lump and it was hard, it was red not fire red but red it was warm to touch and it hurt, She had applied cold compresses, She had applied warm compresses and it was still that way, it did hurt but she haven't had much pain today because she had an ice. Haven't really used it much. She had called to see if there was any other recommendation of something else she could try. Anatomical site of administration was reported as "Left upper arm". Lab tests were reported as "Not in the 2021, in 2020". RA number, UPC number and Expiry date of Covid-19 vaccine was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 05:00 (Lot number: EW0162) at the age of 52 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT taken for depression; OMEPRAZOLE; SYNTHROID. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "Injection site turned very hard and warm to touch"; VACCINATION SITE NODULE (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "not recovered" and all described as "Around the injection site was a lump, it was hard, it was not fire red but red"; PAIN (non-serious) with onset May2021, outcome "recovering", described as "Did hurt"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Aches at vaccination site"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "I was very tired". Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site nodule. Additional information: Reporter got the 1st dose of the Pfizer vaccine on Thursday, 29Apr2021 5 o'clock. Everything went well until Friday. Saturday she felt tired and the injection site turned very hard and warm to touch. She did not know if it was a local reaction but she called because she did not know what to do. She had already put a cold and hot compress and it still ached and still hard. She was hoping to get some suggestion. It was 10-15 minutes for any reaction so fine, Friday she felt fine, Saturday she was very tired but what developed around the injection site was a lump and it was hard, it was red not fire red but red it was warm to touch and it hurt, She had applied cold compresses, She had applied warm compresses and it was still that way, it did hurt but she haven't had much pain today because she had an ice. Haven't really used it much. She had called to see if there was any other recommendation of something else she could try. Anatomical site of administration was reported as "Left upper arm". Lab tests were reported as "Not in the 2021, in 2020". RA number, UPC number and Expiry date of Covid-19 vaccine was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Disease recurrence, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: The top of my breast to the bottom of my stomach feels like that; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast).; my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb); body aches; bad 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 34 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 34 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing), notes: Verbatim: migraines. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2021, outcome "recovering", described as "bad headache"; HYPOAESTHESIA ORAL (non-serious) with onset 20May2021, outcome "not recovered", described as "my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb)"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "The top of my breast to the bottom of my stomach feels like that"; HYPOAESTHESIA (non-serious), ABDOMINAL PAIN (non-serious), outcome "unknown" and all described as "There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast)."; PAIN (non-serious) with onset 10May2021, outcome "recovering", described as "body aches".  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain
Clinical narrative: The top of my breast to the bottom of my stomach feels like that; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast).; my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb); body aches; bad 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 34 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 34 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing), notes: Verbatim: migraines. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2021, outcome "recovering", described as "bad headache"; HYPOAESTHESIA ORAL (non-serious) with onset 20May2021, outcome "not recovered", described as "my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb)"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "The top of my breast to the bottom of my stomach feels like that"; HYPOAESTHESIA (non-serious), ABDOMINAL PAIN (non-serious), outcome "unknown" and all described as "There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast)."; PAIN (non-serious) with onset 10May2021, outcome "recovering", described as "body aches".  No follow-up attempts are possible. No further information is expected.