chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Dry mouth, Fatigue
Clinical narrative: dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache,  extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hunger, Hyperhidrosis, Hypoaesthesia
Clinical narrative: dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache,  extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Insomnia, Joint swelling, Lacrimation increased, Lethargy
Clinical narrative: dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache,  extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Rash erythematous, Urticaria
Clinical narrative: dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache,  extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: positive COVID-19 test with symptom; positive COVID-19 test with symptom; This is a spontaneous report from a contactable consumer (patient's daughter) reported that a 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at age of 95-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, Alzheimer's disease, depression and blood clot. Concomitant medications included amlodipine taken for high blood pressure from an unspecified date; apixaban (ELIQUIS) taken as blood thinner from an unspecified date; donepezil hcl taken for Alzheimer's disease from an unspecified date; memantine taken for Alzheimer's disease from an unspecified date; escitalopram oxalate (LEXAPRO) taken for depression from an unspecified date; folic acid taken for an unspecified indication from an unspecified date. The reporter was actually calling how to schedule for the second dose since her mother tested positive second week after getting the first dose (Apr2021) and currently she still didn't have the second dose of shot. It also reported about 2 weeks after she got the first vaccine, she got COVID. She just had a fever for couple of days that was it, the reporter asked when she got the second vaccine. No treatment received for the event. No lab work other than COVID that was positive in Apr2021. The outcome of the events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Oropharyngeal discomfort, Tinnitus, Weight
Clinical narrative: problem with her throat; Ears were ringing; turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her; felt an intense heat in her chest and throat; This is a spontaneous report from a contactable registered nurse (the patient's mother). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 10May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: reflux, "weird allergy" that had popped up before and caused Steven Johnson Syndrome (further clarification unknown). Concomitant medication included an unspecified reflux medicine. The patient daughter received the first dose of the Pfizer BioNtech COVID-19 vaccine yesterday (10May2021), and she had a problem with her throat (May2021). She took diphenhydramine hydrochloride (BENADRYL), and it was resolved after an hour (treatment). The patient's mother also specified that the patient felt an intense heat in her chest and throat, and her ears were ringing (both May2021). The patient turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her (May2021). At the vaccination site, they were able to put an ice bag on her neck and on her chest, and it resolved afterward, after an hour, so ice was applied for an hour as well. The symptoms resolved at the time over there (at the center where the vaccine was given), and they gave her BENADRYL. The patient's weight was maybe in the 150 range. The outcome of the events was resolved in May2021.  Information on Lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: dizziness and felt woozy almost all days; When I lay down I do get the spins and stuff; Nauseous; This is a spontaneous report from a contactable consumer (patient). This 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. The patient denied having any medical condition and confirmed not taking any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. On 14Apr2021, the patient experienced dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous. The clinical course of the events was as follows: The patient reported, "I have been having dizziness and mild nausea since my second vaccine and I have got my vaccine on the 13Apr2021 and I have started on 14Apr2021 the day after the vaccine and it's been like a whole month already that I have been feeling like that dizzy and nauseous when I wake up in the morning and when I lay down I do get the spins and stuff, and then during the day as I work and stuff, I have to look up the stuff I get woozy. I have been taking Dramamine 25 mg tablet." The patient also mentioned that she cannot set an appointment at her doctor's office since they don't have appointments for 2 months. She is just calling to get a recommendation on which medication she can take and what she can do. The clinical outcome of the events, dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Fatigue, Pruritus
Clinical narrative: Exhaustion; Red itchy arm; Red itchy arm; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-Sponsored Patient Support Program. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6201), via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (had a reaction to a lot of things in life), headaches since she was about 12 years old, supraventricular tachycardia, cardiac loop which died, normally had abnormally low blood pressure her whole life (normally 98 would be high and 58-60 as the bottom number would be normal). Concomitant medications were not reported. On 12Mar2021, the patient experienced red itchy arm. After the vaccination, she was told to sit in the sitting area because she had an unspecified underlying condition and had a reaction to a lot of things in life, just allergies basically. The patient's arm was red. Within a couple minutes and all of a sudden, she had streaks down it and it started getting very itchy. The red, itchy arm lasted about half an hour. On 13Mar2021, the patient experienced heavy duty exhaustion for a week - she thought she was just tired from stress. The clinical outcome of "red itchy arm" was resolved on 12Mar2021, of exhaustion was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539682 same patient, different dose number and event
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Sensation of foreign body
Clinical narrative: Acid reflux reaction; like something is coming out it is like something is blocking her throat; Acid reflux reaction; like something is coming out it is like something is blocking her throat; This is a spontaneous report from a contactable consumer (reporter's wife) from a Pfizer sponsored program.  A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10May2021 (Lot Number: ER8735) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation.  The patient experienced "acid reflux reaction; like something is coming out it is like something is blocking her throat" on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer.     A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  (age at vaccination 53 years).  Medical history included , lower limb fracture on an unknown date. Tetanus vaccine taken because of broken leg.  The patient's concomitant medications were not reported.  The patient experienced hives on 02May2021 with outcome of not recovered.  The reported event was considered an Important Medical Event. The event was treated with diphenhydramine (BENADRYL)  tablet and cream.  Course of the event. The patient  reported he got the first Covid shot on 08Apr2021 and everything was fine until about a week ago. He started breaking out in hives and going through Benadryl. States nothing in his life has changed, no change in detergent or what he eats, the only thing different was him getting the shot. Is due for the other one and is concerned if he should get the other one with him having the hives. Will this go away or will he get more hives with the second one. Has been taking Benadryl tablets and the hives go away but within 6 hours they come back and he has been using a Benadryl anti-itch cream so that he is not over doing the tablets. Has been through at least 7-8 tubes of cream in the last week or so. The patient also clarified he is actually using a generic Benadryl, its called generic healthcare allergy relief tablets. Has been taking 2 tablets every 8 hours for the last 7-9 days and when the hives come back he uses the Benadryl cream, it has diphenhydramine as active ingredient the same as Benadryl. As soon as the pills wear off he uses the cream.    Information on the Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Kidney infection, Pyrexia
Clinical narrative: kidney infection; fever as high as 103 F; This is a spontaneous report based on the information received by Pfizer   (Reference ID: NVSC2021US100597). A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported she experienced fever as high as 103 F and was admitted to the hospital on 30Apr2021. Patient stated she was discharged on 03May2021. Patient noted that while admitted to the hospital she was found to have a kidney infection, and also stated that she received the COVID-19 vaccine 1 week prior to start of fever. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Heart rate increased, Hypoaesthesia
Clinical narrative: my heart rate went to 168 BPM; chest pains; numbness is face and arms; numbness is face and arms; shortness of breath; elevated blood pressure; Numbness and tingling in my arms and legs; Numbness and tingling in my arms and legs; At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported " I received my first Pfizer shot on06May2021. Immediately after the shot I began feeling symptoms, my heart rate went to 168 beats per minute (BPM), I had chest pains, numbness is face and arms, shortness of breath, elevated blood pressure. I was taken via Fire Rescue to the hospital where I was later admitted. Now that I am out of the hospital I am experiences a new set of symptoms. Numbness and tingling in my arms and legs. At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!".  The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder due to a general medical condition
Clinical narrative: my heart rate went to 168 BPM; chest pains; numbness is face and arms; numbness is face and arms; shortness of breath; elevated blood pressure; Numbness and tingling in my arms and legs; Numbness and tingling in my arms and legs; At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported " I received my first Pfizer shot on06May2021. Immediately after the shot I began feeling symptoms, my heart rate went to 168 beats per minute (BPM), I had chest pains, numbness is face and arms, shortness of breath, elevated blood pressure. I was taken via Fire Rescue to the hospital where I was later admitted. Now that I am out of the hospital I am experiences a new set of symptoms. Numbness and tingling in my arms and legs. At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!".  The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as 1single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fever (non-serious) on 10May2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; Nausea; Malaise; Chills; Fever; Fatigue; Myalgia; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (at the age of 23-year-old) (Lot Number: 204A21A) as single dose (unknown if first or second dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myalgia on 10Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 15 hours), malaise on 11Apr2021 with outcome of recovering, chills on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 2 hours), fever on 11Apr2021 with outcome of recovering and fatigue on 11Apr2021 with outcome of not recovered. The events were considered as non-serious. The patient underwent lab tests and procedures which included body temperature: fever, temperature not measured on an unspecified date.    No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Malaise; Chills; Fever; Fatigue; Myalgia; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (at the age of 23-year-old) (Lot Number: 204A21A) as single dose (unknown if first or second dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myalgia on 10Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 15 hours), malaise on 11Apr2021 with outcome of recovering, chills on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 2 hours), fever on 11Apr2021 with outcome of recovering and fatigue on 11Apr2021 with outcome of not recovered. The events were considered as non-serious. The patient underwent lab tests and procedures which included body temperature: fever, temperature not measured on an unspecified date.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation
Clinical narrative: experienced the event of atrial; This is a solicited report from a specialty pharmacy based on information received by Pfizer. A contactable other HCP reported that a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (IH TYVASO, delivered by Tyvaso Inhalation Device (TD-300/A)) oral from 06Mar2015 (Lot Number: 2101911; Expiration Date: 31Oct2021) and ongoing at 60-120 ug (10-20 breaths) 4x/day for pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension. Concomitant medication included warfarin. The patient got second coronavirus disease (COVID) shot and then went into atrial fibrillation about seven day later, so they were unsure if that had anything to do with vaccine or not. But, she would be going to get an ablation done on 17May2021. She had no issues with her breathing, no chest pain or other side effects. She had a history of atrial fibrillation a while ago. The action taken in response to the event for treprostinil sodium was unknown. The outcome of event was unknown. The reporter did not provide causality for the event of atrial fibrillation.  Senders Comment: The company has assessed the serious adverse event of atrial fibrillation as not related to IH treprostinil and TD-300/A device. The event was likely due to complications of secondary pulmonary arterial hypertension. Underlying medical condition which led to secondary pulmonary arterial hypertension also likely contributed.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information expected.; Sender's Comments: The association between the event atrial fibrillation with BNT162b2 can not be completely excluded based on the temporal relationship. The pre-existing pulmonary arterial hypertension may have been contributory as well.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Erythema, Headache, Hypersensitivity, Pain in extremity
Clinical narrative: It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: My whole stomach is covered in hives; Rash; This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration on 07May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included propranolol taken for an unspecified indication, start and stop date were not reported. On May2021, the patient had rash and her whole stomach was covered in hives. The patient stated that she had never had hives in her whole life. Pharmacist stated that, I don't think I should get the second shot if I am covered in hives. So I will call them tomorrow and let them know about the hive, then the rash and see if I should not get the second shot then. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in their ears; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer covid 19 vaccine and three days later got ringing in their ears and it went away. The patient recovered from the event on unspecified date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Body temperature, Headache, Pyrexia, Vision blurred
Clinical narrative: Could not see out of it for a little; Head was pounding; Eyes were clouding up again in right eye; She also had temperature of 103; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and had no reaction. Patient received Covid shot and first injection she had no reaction but with second one her head was pounding, eyes were clouding up again in right eye and could not see out of it for a little. She also had temperature of 103 F. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a non-contactable consumer received from Pfizer-sponsored program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction to the vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Laboratory test, Wrong product administered
Clinical narrative: The caller received the first dose of the Pfizer Covid vaccine on 20Apr2021. The second dose was on 11May2021, but on her vaccination card sticker says Jansen; Her blood pressure is low, not qualified low, but it runs like 96/69; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Apr2021 (Batch/Lot Number: EW0153; Expiration Date: Jul2021, 42-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history included endometriosis from 1997 to ongoing. Patient has endometriosis and is suspected to have it right now. Has had it her whole life and had 4 surgeries, the first in 1997. The patient's concomitant medications were not reported. The patient experienced the caller received the first dose of the Pfizer covid vaccine on 20Apr2021. the second dose was on 11May2021, but on her vaccination card sticker says Jansen  and her blood pressure is low, not qualified low, but it runs like 96/69 on 2021. Patient had labs yesterday and everything was normal and Her blood pressure is low, not qualified low, but it runs like 96/69 in 2021. Reporter also stated that She just noticed today that she was given the Johnson & Johnson for the second dose. She called the pharmacy who told her they have no way of knowing if they messed up the sticker. She would like the second shot but now has the first shot of Johnson & Johnson. She has had zero symptoms. She did not have any symptoms with the first dose. Everyone she knows that had Pfizer had no symptoms. The sticker has Jansen 0.5ml listed in this spot.The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown.  No follow-up attempts are needed. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown.  No follow-up attempts are needed. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown.  No follow-up attempts are needed. No further information is expected
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in calves worse on left side then right; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0176), via an unspecified route of administration in left arm on 11May2021 13:30 (at the age of 34-year-old) at first, single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. Prior to vaccination, the patient did not have other vaccinations within four weeks prior, did not have other vaccinations on the same date. On 13May2021, the patient reported that he started with pain in calves worse on left side then right. It felt like they were sore, like he was working out. But he had just been sitting at his desk and doing nothing. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Haemoglobin decreased, Haemorrhage, Lethargy, White blood cell count
Clinical narrative: Bleeding starts 1 day after dose given; large blood in urine output at night; increased lethargy; WBC and Hgb drop; WBC and Hgb drop; This is a spontaneous report from a contactable consumer (the patient). The consumer reported similar events for herself with two doses. This is the second of two reports. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included PNH anemia since 2006 and known allergies: Latex, sulfamethoxazole trimethoprim (BACTRIM). The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications (received within 2 weeks of vaccination) included iron, cyanocobalamin (VITAMIN B12) and one a day women vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8732) via an unspecified route of administration in left arm on 26Mar2021 10:15 AM at age of 53-year-old for COVID-19 immunisation. Minor side effects after first dose but did have some spotting blood in urine at night. Told MD and was told to proceed with dose 2. After second dose on 22Apr2021 23:00, large blood in urine output at night and increased lethargy. Bleeding starts 1 day after dose given. Lasted less than 1 week but white blood cell (WBC) and haemoglobin (Hgb) decreased/drop (22Apr2021). The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529122 same patient/drug, similar AE, different dose of vaccine