chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: experiencing body pains after the first dose; she was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose1, 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 "unknown", described as "experiencing body pains after the first dose"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: The patient was experiencing body pains after the first dose. She was sick and had the body pain from being sick, needs to know if she should reschedule her second dose. She also clarifies that her body pains did not occur after her first dose. She just got sick this past weekend after she had her first dose about 3 weeks ago. So this is her second dose she will be getting three weeks after the first dose. Her body pains were not a result of her first COVID vaccine, it was from being sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Had a root canal between first and second dose Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 25Apr2021 11:00 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Flu shot for immunization, reaction(s): "Muscle pain". The following information was reported: TOOTH DISORDER (non-serious) with onset 04May2021, outcome "unknown", described as "Had a root canal between first and second dose Vaccine". Therapeutic measures were taken as a result of tooth disorder.  Additional information: The patient had root canal treatment on 04May2021. During the root canal treatment he received a Novocain injection and Ativan pills. The patient later received second dose of bnt162b2 (BNT162B2), administration date 09May2021 at 11:00 as dose 2, single for covid-19 immunisation. Prior Vaccinations (within 4 weeks) were none.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue; Chills; Headache; Arm Soreness; Dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 11:45 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Sinus" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy; "Allergy" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=Mar/2021, dose number=1, administration time=11:45 AM, dose number=1, vaccine location=Left arm), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunisation, reaction(s): "Chills", "Fatigue", "Headache", "Arm Soreness". The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious), outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious), outcome "recovered" (2021), described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "Arm Soreness"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "Dizzy". Therapeutic measures were not taken as a result of fatigue, chills, headache, pain in extremity, dizziness. 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: Chemical burn of skin, Headache, Sunburn
Clinical narrative: Chemical burn on the arm; Burn like mark at the band aid site like a sunburn; Light headache; 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. Other Case identifier(s): US-PFIZER INC-2021535873 (Pfizer).  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 13:00 (Lot number: EW0176) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEMICAL BURN OF SKIN (non-serious), outcome "unknown", described as "Chemical burn on the arm"; SUNBURN (non-serious), outcome "not recovered", described as "Burn like mark at the band aid site like a sunburn"; HEADACHE (non-serious) with onset 02May2021, outcome "unknown", described as "Light headache".  Additional Information: The caller denies being sick at the time of vaccination. Patient says there is a band aid mark where she got the shot is still on her arm and it is like a burn, not a rash. The patient described the mark on her arm as a burn like a sunburn. She said it was like when a sunburn leaves a mark and it was in the exact shape of the band aid. She said it looked like a tattoo. When asked for a start date she said she got her shot on 30APR2021 and it was a couple days later when she realized the mark was still on her arm. She said she thought did she not scrub her arm good enough. She said it looks like part of her skin. She said there has been no change since she noticed it and that she noticed it at midday. She said she experienced other things like a light headache and she thought those things were normal based on what she was seeing on the CDC website and pfizer website. She said the burn was the only thing that had no information on it at all. She said she noticed the headache on Sunday then had daily headaches for about 3 days. No Emergency Room visit, Physician Office. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): None.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder, Overdose
Clinical narrative: Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021; Missed menstrual cycle; Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) at the age of 29 years as dose 1, single and administration date 28Mar2021 (Lot number: EW0164) 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: MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Missed menstrual cycle"; OVERDOSE (non-serious) with onset 28Mar2021, outcome "unknown", INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021". Therapeutic measures were not taken as a result of menstrual disorder, overdose, inappropriate schedule of product administration.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient did not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Device Date:10May2021  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 16:00 (Lot number: EW0167) at the age of 32 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Known allergies: Soy, pollen, tree nuts, stone fruit" (unspecified if ongoing); "Known allergies: Soy, pollen, tree nuts, stone fruit" (unspecified if ongoing). Concomitant medication(s) included: Prozac; Nutrafol; Multivitamins [Vitamins NOS]; St John's Wort. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: EW0161, lot unknown: False, administration date: 14Apr2021, administration time: 04:00 PM, dose number: 1, vaccine location: Right arm. 1st dose felt a metallic taste in mouth), administration date: 14Apr2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "taste disorder". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "2nd shot had sour arm"; HEADACHE (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "slight headache"; PAIN (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "slight body ache"; DIZZINESS (non-serious) with onset 06May2021 23:45, outcome "recovered", described as "Very dizzy". Therapeutic measures were not taken as a result of pain in extremity, headache, pain, dizziness. Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine was taken in four weeks. The patient was very dizzy on the second day of 2nd dose of shot but went away after an hour or two. There was no Covid-19 prior vaccination. Covid-19 was not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Speech disorder
Clinical narrative: When I try to stand up I get like a real bad headache; Talking like this with low speech, like real slow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08May2021 (Lot number: EW0175) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1, ER8731 - Lot number), administration date: 17Apr2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "When I try to stand up I get like a real bad headache"; SPEECH DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Talking like this with low speech, like real slow".  Additional Information: Consumer stated, "I have the second dose given to me Saturday and I am having like I don't know this is a side effect when I try to stand up I get like a real bad headache and am talking like this with low speech, like real slow is that normal, Consumer was informed about role of Pfizer Drug Safety department. Consumer was informed about the Pfizer Medical Information Department and provided with the number as and was requested to select option 3, timings as 8am to 8pm Monday to Friday and 9am to 3pm Saturday and Sunday as per EST. Consumer stated, "Is this the side effect do you usually feel like this?" Consumer was informed again about Pfizer Medical Information Department. Consumer further stated, "So, what am I talking to you about then, Consumer was informed about filing safety report. Consumer stated, "It was a bad experience. Just this second shot was very, it was I don't think, it's anything wrong with the shot. I just think it is having an effect on me. Consumer added, "That's all I have to say. You said you are a pharmacist right, Consumer was informed we do not have that information. "Okay, well then I can talk with them tomorrow." Consumer was unwilling to provide further details. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Dizziness, Fatigue, Influenza
Clinical narrative: overall general malaise; extreme fatigue; lightheaded; extremely cold feet; severe flu symptoms; aches & pains; nausea; constipation; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabectic" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "HBP" (unspecified if ongoing); "HCholesterol" (unspecified if ongoing); "Sleep Apenea" (unspecified if ongoing); "Lumbar Stenosis" (unspecified if ongoing). Concomitant medication(s) included: LASIX [FUROSEMIDE]; METOPROLOL; GLIPIZIDE; ZYRTEC; LEXAPRO. Past drug history included: Lisinopril for known allergy, notes: Lisinopril. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EN6207, administration date=23Mar2021, administration time=10:30 AM, dose number=01, vaccine location=Left arm), administration date: 23Mar2021, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "severe flu symptoms"; PAIN (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "aches & pains"; NAUSEA (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "nausea"; CONSTIPATION (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "constipation"; DIARRHOEA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "lightheaded"; PERIPHERAL COLDNESS (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "extremely cold feet"; MALAISE (non-serious), outcome "not recovered", described as "overall general malaise"; FATIGUE (non-serious) with onset 16Apr2021 06:00, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of influenza, pain, nausea, constipation, diarrhoea, dizziness, peripheral coldness, malaise, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Peripheral coldness
Clinical narrative: overall general malaise; extreme fatigue; lightheaded; extremely cold feet; severe flu symptoms; aches & pains; nausea; constipation; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabectic" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "HBP" (unspecified if ongoing); "HCholesterol" (unspecified if ongoing); "Sleep Apenea" (unspecified if ongoing); "Lumbar Stenosis" (unspecified if ongoing). Concomitant medication(s) included: LASIX [FUROSEMIDE]; METOPROLOL; GLIPIZIDE; ZYRTEC; LEXAPRO. Past drug history included: Lisinopril for known allergy, notes: Lisinopril. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EN6207, administration date=23Mar2021, administration time=10:30 AM, dose number=01, vaccine location=Left arm), administration date: 23Mar2021, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "severe flu symptoms"; PAIN (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "aches & pains"; NAUSEA (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "nausea"; CONSTIPATION (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "constipation"; DIARRHOEA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "lightheaded"; PERIPHERAL COLDNESS (non-serious) with onset 14Apr2021 06:00, outcome "not recovered", described as "extremely cold feet"; MALAISE (non-serious), outcome "not recovered", described as "overall general malaise"; FATIGUE (non-serious) with onset 16Apr2021 06:00, outcome "not recovered", described as "extreme fatigue". Therapeutic measures were not taken as a result of influenza, pain, nausea, constipation, diarrhoea, dizziness, peripheral coldness, malaise, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; 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 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms". No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: ''I'' have felt dizzy ever since; On day 3 after the second vaccine, ''I'' woke up with the room spinning; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 10:00 (Lot number: EN6250) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. Past drug history included: Parafon forte for Muscle relaxant, reaction(s): "Hives", notes: Known allergies: Parafon forte (old muscle relaxant). Hives. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6200, Anatomical site: Left arm), administration date: 23Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious) with onset 19Mar2021 07:00, outcome "recovered" (21Mar2021), described as "On day 3 after the second vaccine, ''I'' woke up with the room spinning"; DIZZINESS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "''I'' have felt dizzy ever since". The events "on day 3 after the second vaccine, ''i'' woke up with the room spinning" and "''i'' have felt dizzy ever since" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, dizziness.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Steroid as the treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore/arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Lot number: EW0169) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm was sore/arm soreness".  Additional information: It was reported that she had no side effects from the second shot. She wondered if she really got it. Her arm was sore with the first vaccine, that was it. No fever or chills.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for one day after 1st vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0158) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm for one day after 1st vaccination". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient received second vaccination on 04May2021. Sore arm for one day after 1st vaccination. No known allergies. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: terrible, terrible dizziness;  has started little by little/dizzy in the head when getting up and feeling very weak; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, solution for injection) (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: DIZZINESS (non-serious), outcome "unknown", described as "terrible, terrible dizziness;  has started little by little/dizzy in the head when getting up and feeling very weak"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". Additional information: States she got the Pfizer Covid-19 injection about 2 weeks ago and is due for the second one next week, but she has been having these terrible, terrible dizziness and some weakness. Having dizziness in her head and didn't feel anything after she had had it, she was fine. Now this has started little by little and she doesn't understand why. When she is getting up she is so dizzy in the head and feeling very weak and just so dizzy. Wanted to know if it's possible to have side effects later on or do they only happen right after getting the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pretty significant pain in my both of my lower legs like it almost feels like shin splint on top of the leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (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: Bnt162b2 (Dose number: 01), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Pretty significant pain in my both of my lower legs like it almost feels like shin splint on top of the leg".  Additional information: The patient got second dose of the vaccine on Wednesday and was having some pretty significant pain in my both of lower legs like it almost feels like shin splint on top of the leg and was unclear if something should be done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injections site, 1st dose; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis in her knees" (unspecified if ongoing), notes: Diagnosed about 5 years ago. Concomitant medication(s) included: ALEVE taken for headache.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injections site, 1st dose".  Additional Information: Patient did not received Prior Vaccinations within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available):  No, she has had vaccines before but, she is not sure if they were Pfizer. Caller reports she takes some times when she gets headaches but, other that medication, nothing else. The headaches are not related to the vaccine per the caller. 1st dose NDC, Lot and Expiration: EW0150; patient got it in the left arm. A friend of the callers husband said anecdotally, that the patient should get the injections in the opposite arms.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; 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 received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: ER873U) at the age of 63 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: FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Tired".  Additional Information: Patient had her last COVID Pfizer shot on 31Apr and she is very tired. She was asking if it was normal to be so tired. Start date of event was reported as about a week after.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: diarrhea; reoccurring extreme fatigue; some body ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Bnt162b2 (Dose 1), for Covid-19 immunisation, reaction(s): "some fatigue ", "Headache", "swelling in my arm ". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "reoccurring extreme fatigue"; PAIN (non-serious), outcome "unknown", described as "some body ache"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The patient stated, "I just got the vaccine, the second dose. Sometime in, I think it was last week on Thursday. So, I that was a second dose, that was the last dose I needed for the Pfizer vaccine and I know this that I have been experiencing diarrhea and reoccurring extreme fatigue and some body ache and chills and I was just wondering about the common side effects that uses have reported." After second dose, you know I was experiencing some weird symptoms. I was not experiencing fever or seizure anything like this and I was just shocked and how they escalated."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Morbid thoughts
Clinical narrative: 'Bad thoughts' (further not clarified); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09May2021 (Lot number: EW0176) 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 on 18Apr2021.), administration date: 18Apr2021, for COVID-19 Immunization. The following information was reported: MORBID THOUGHTS (non-serious) with onset 09May2021, outcome "unknown", described as "'Bad thoughts' (further not clarified)". Therapeutic measures were not taken as a result of morbid thoughts.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain".  Additional information:  Patient had a side effect. Patient had already spoke to patient forget her name but patient told her I was having leg pain. Patient had the Pfizer vaccine. Consumer confirmed it was the Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Impaired driving ability, Pain in extremity, Tinnitus
Clinical narrative: Could not drive; Laying down made symptoms worse; Tinnitus; Dull headache; Severe vertigo; Sore arm; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 16:30 (Batch/Lot number: unknown) at the age of 48 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: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Sore arm"; VERTIGO (non-serious) with onset 27Apr2021 05:00, outcome "recovering", described as "Severe vertigo"; IMPAIRED DRIVING ABILITY (non-serious), outcome "not recovered", described as "Could not drive"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Laying down made symptoms worse"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus"; HEADACHE (non-serious), outcome "not recovered", described as "Dull headache". Therapeutic measures were taken as a result of pain in extremity, vertigo, tinnitus, headache.  Additional information: The patient did not receive any other vaccine in four weeks and did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The seriousness of the events was reported as non-serious. The patient had not taken any medications other than an occasional aspirin or ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Could not drive; Laying down made symptoms worse; Tinnitus; Dull headache; Severe vertigo; Sore arm; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 16:30 (Batch/Lot number: unknown) at the age of 48 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: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Sore arm"; VERTIGO (non-serious) with onset 27Apr2021 05:00, outcome "recovering", described as "Severe vertigo"; IMPAIRED DRIVING ABILITY (non-serious), outcome "not recovered", described as "Could not drive"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Laying down made symptoms worse"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus"; HEADACHE (non-serious), outcome "not recovered", described as "Dull headache". Therapeutic measures were taken as a result of pain in extremity, vertigo, tinnitus, headache.  Additional information: The patient did not receive any other vaccine in four weeks and did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The seriousness of the events was reported as non-serious. The patient had not taken any medications other than an occasional aspirin or ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-087789 (Moderna).  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: NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information : Reporter stated she received her first Moderna vaccine and was fine. Reporter stated her boyfriend received the second Moderna vaccine on 24Apr2021 and could not get out of bed, felt like did not sleep, totally wiped out and totally exhausted. Reporter stated her friend had the second Moderna vaccine and she was totally exhausted. Reporter stated her friend (withheld) received the second Moderna vaccine and is prone to migraine had migraines and a rash and her husband had a rash too. Reporter stated her Dermatologist received both Moderna vaccines and did not feel well. Reporter stated her friend (withheld) received the Pfizer vaccine and had nausea. Reporter stated she regretted getting the Moderna vaccine and was not going to get the second Moderna vaccine. Patient asked is the Moderna vaccine going to get FDA approval. Reporter asked did I receive the Moderna vaccine. Patient asked how effective is the Moderna vaccine after one dose. Reporter asked can she receive the Pfizer vaccine for her second dose. Reporter asked is there any information on a Moderna vaccine booster. Reporter asked what is MRNA. Reporter asked how long the Moderna vaccine last. Reporter asked what happens if I don't get second Moderna vaccine. Reporter asked will i develop something five years from know form the Moderna vaccine. Reporter declined consent for any contact information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain, Vaccination site reaction
Clinical narrative: Experienced a severe pain I believe it's on the injection site which is her arm; Area where I got the shot is little bit sensitive and painful; Area where I got the shot is little bit sensitive and painful; Pain is like different, it's more like in the muscle I would say like in the internal side of the arm as opposed to external; When I stretch my arm like fully it hurt a lot of it, it feels like different then like the pain when you just got the shot; 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 25 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: EW0175) at the age of 25 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), outcome "unknown", described as "Experienced a severe pain I believe it's on the injection site which is her arm"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Area where I got the shot is little bit sensitive and painful"; MYALGIA (non-serious) with onset 06May2021, outcome "unknown", described as "Pain is like different, it's more like in the muscle I would say like in the internal side of the arm as opposed to external"; PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "When I stretch my arm like fully it hurt a lot of it, it feels like different then like the pain when you just got the shot".  Additional information: The patient reported that she was not experiencing severe pain it was just some kind of discomfort she would more describe it like that. It was like very mild pain in the arm. It was also reported that she thought that was weird and the pain kind of went away and then some kind of new pain appeared after. So the patient was wondering if there were people who were experiencing this or she did not know what she would be recommended.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Pain in extremity, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: arm pain at injection site; arm pain at injection site; 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 female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 17:30 (Lot number: EL3247) at the age of 74 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: She had shingles prior when she was 42; "She assumes she must have had COVID /antibodies present in May 2020, when she was tested", start date: May2020 (unspecified if ongoing); "chicken pox" (unspecified if ongoing), notes: She had the chicken pox when she was young; "she needs a magnifying glass/She always has her glasses to read with" (unspecified if ongoing); "she had slight mitral regurgitation", start date: Apr2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 15Jan2021, outcome "recovered" (Jan2021) and all described as "arm pain at injection site". The patient underwent the following laboratory tests and procedures: cardiac stress test: (Apr2019) she had slight mitral regurgitation; sars-cov-2 antibody test: (May2020) antibodies present in may 2020, when she was teste. Additional information: Patient had no other medical conditions. She was healthy at the time of the report. No family medical history. She started shrinking before she got the vaccine. It was years before. She assumed she must have had COVID and did not know, she had the antibodies present in May 2020, when she was tested. When looking up an address, she stated she needs a magnifying glass.  She needed this before the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other vaccines administered on same date of the Pfizer vaccination. No relevant tests were performed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 65-year-old 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness in left arm; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PE" (unspecified if ongoing), notes: Other medical history: PE, Sarcoidosis; "Sarcoidosis" (unspecified if ongoing), notes: Other medical history: PE, Sarcoidosis. The patient took concomitant medications. Past drug history included: Codine, reaction(s): "Known allergies: codine", notes: Known allergies: codine. The following information was reported: HEADACHE (non-serious) with onset 14Apr2021 14:30, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "soreness in left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  Additional Information: Facility type vaccine: Public Health Clinic/Veterans Administration facility. Other medication in two weeks as dietary supplements. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received dietary supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Small rash on the arm he received the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Small rash on the arm he received the shot".  Additional information: Caller received 1st Pfizer vaccine and had a small rash on the arm he received the shot. Received the 2nd vaccine and broke out into a rash all over his body. Caller stated he was speaking with a woman who said she will call him back, he attempted to get his information to transfer him to speak with a medical professional he said he will wait for the call back because he had a lot on his calendar. Caller disconnected. This Medical information team reported that this is to confirm that we are unable to proceed with the inquiry. There are no contact details nor medical information question to be addressed. Follow up (10May2021): This is a follow up spontaneous from a Pfizer sponsored program. A non-contactable male consumer (patient) reported for himself that: No clinical information received. Follow up (11May2021): This is a follow up spontaneous report from a medical information team. This Medical information team reported No clinical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site swelling
Clinical narrative: She is experiencing itchiness and a swollen injection site; She is experiencing itchiness and a swollen injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a regulatory authority Support (159558). 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: PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset May2021, outcome "unknown" and all described as "She is experiencing itchiness and a swollen injection site".  Additional information: Caller got the first dose of the vaccine on 30Apr2021, and the second dose is scheduled on 21May2021 (correct dosing schedule). Caller said that 10 days after the first dose she experienced itchiness and a swollen injection site, and she was asking if the first or second dose has extended relief.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.