chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; recently got 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 male patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EN6208) 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: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Sore throat"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "recently got sick".  Additional Information: The events started about 4 or 5 days before the day of report. Because of the events, the patient cannot attend his second dose. He was not feeling healthy to get it so was asking for rescheduling the second dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 22 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "She doesn't want to eat."; HEADACHE (non-serious), outcome "unknown", described as "Headache". Additional Information: The reporter was asking if those were common side effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Gout and all symptoms have stopped; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Gout and all symptoms have stopped".  Additional information: Patient received both doses (second dose on 12Apr2021), reports that Gout and all symptoms have stopped since first dose and was very grateful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: Diarrhoea; Fatigue; muscular pain; 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 (PFIZER-BIONTECH COVID-19 VACCINE, 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: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhoea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MYALGIA (non-serious), outcome "unknown", described as "muscular pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER8727) at the age of 26 years as dose 1 single for covid-19 immunisation. Relevant medical history included: "Allergy-Zithromax" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (2021), described as "Soreness at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered:Other. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Hormonal Birth Control within 2 weeks of vaccination.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nodule, Tenderness
Clinical narrative: small nodule above my clavical on the left side; swollen lymph node; tenderness; tired after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0158) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (dose 1), administration date: 25Mar2021, for Covid-19 Immunization, reaction(s): "tired". The following information was reported: NODULE (non-serious) with onset 14Apr2021, outcome "unknown", described as "small nodule above my clavical on the left side"; LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "not recovered", described as "swollen lymph node"; TENDERNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "tenderness"; FATIGUE (non-serious) with onset 14Apr2021, outcome "not recovered", described as "tired after second dose".  Additional information: The patient received her second dose at 1040 yesterday.  Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. She got tired today at 1230.  That was the primary symptom the first day after the first dose also.  It was not so much that she couldn't function, she was just tired. She laid down and thought why is her neck sore?  She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot.  It's not worse or better. History of all previous immunization with the Pfizer vaccine considered as suspect was None.  Additional Vaccines Administered on same date of the Pfizer suspect was reported as no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision in her right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:30 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE, LOT:EN6206), administration date: 06Mar2021, for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 31Mar2021, outcome "not recovered", described as "blurred vision in her right eye".  Additional Information: Second dose of the Pfizer-BioNtech Covid-19 vaccine two weeks ago, a few hours after she received the injection she experienced blurred vision in her right eye and is still experiencing it.  States she had the vaccine in the morning and by night her eye was blurry and bothering her. Caller states it is still the same blurriness as it was two weeks ago. Prior Vaccinations (within 4 weeks): Patient has received both doses of the Pfizer Covid Vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: I have been feeling a little tired and weak; may be some body aches; I have been feeling a little tired and weak; may be some body aches; I have been feeling a little tired and weak; may be some body aches; 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 28Mar2021 (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: FATIGUE (non-serious), ASTHENIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I have been feeling a little tired and weak; may be some body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Bad pain from forearm to her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Bad pain from forearm to her hand".  Additional information: It was reported that, the patient received second dose of the Pfizer covid vaccine 3 weeks ago on 19Mar and since then she had been having until today really bad pain from forearm to her hand. The patient wanted to report it and know what can she do about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, General physical health deterioration
Clinical narrative: I have a lingering and its getting worse, total fatigue; I feel half dead, in another week  I wont be able to get out of bed and I have no other health problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (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:1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I have a lingering and its getting worse, total fatigue"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "I feel half dead, in another week  I wont be able to get out of bed and I have no other health problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nauseous; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "dizzy" (unspecified if ongoing). Family history included: "cancer" (unspecified if ongoing), notes: Husband had pfizer vaccine had cancer a few years ago. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 31Mar2021, outcome "unknown", described as "nauseous"; DIZZINESS (non-serious) with onset 31Mar2021, outcome "unknown", described as "dizzy". The events "nauseous" and "dizzy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, dizziness.  Additional information: PQC was not  present. Patient received Pfizer-Biontech Covid19 vaccine 27Mar2021. Four days later she started to feel dizzy and nauseous and those symptoms have continued. She reports that she felt dizzy, sometimes, before having her vaccine, but that its worse now. She mentioned that her family doctor put her on baby aspirin and TUMS to treat these symptoms. The following day (5th day) better. Even until now, sometimes feel dizzy, more dizzy than normal.  Before the vaccine she would feel dizzy sometimes. She read in her husband's paperwork that dizziness means she had a severe reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a stronger leg pain when she sat down or laid down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Leg pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "had a stronger leg pain when she sat down or laid down".  Additional information: It was reported that for a little less than two years patient had been experiencing leg pain,  and after she received the first dose of the vaccine , that night and the day after she had a stronger leg pain when she sat down or laid down. Caller would like to know if she should get the second dose of the vaccine because she's been hearing about people dying from blood clots with the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental paraesthesia, Hypoaesthesia teeth, Toothache
Clinical narrative: experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DENTAL PARAESTHESIA (non-serious), TOOTHACHE (non-serious), HYPOAESTHESIA TEETH (non-serious), outcome "recovered" and all described as "experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day".  Additional information: The patient reported that she experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Pain in extremity
Clinical narrative: Hot and cold; sore arm; chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (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: FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "Hot and cold"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  Additional information: The patient is scheduled to get the second one on 19Apr2021. She added she has to travel the day following the injection and asked if she should receive the second dose earlier than scheduled. Caller explained she had a "sore arm" and "fatigue" after getting the first dose, and she "doesn't remember anything major" after that. She said 2 weeks after the shot she then felt "hot and cold" and had "chills". Caller asked: is feeling hot and cold and getting chills 2 weeks after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine related to the vaccine. Responded per attachments. Used section "Safety: Adverse Reactions or Side Effects" of the VR-Consumer Inquiry Management (Off-Label or No Info). Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose- Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population " from the Full EUA PI, LAB-1457-7.0 revised: 6Apr2021. "Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter" from CONS -How long side effects last final.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Stomatitis
Clinical narrative: Sore throat; Mouth sores; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: EP6955) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EP6955, Anatomical Location: Arm Left , Dose Number:1, administration time: 04:00 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09Apr2021 09:00, outcome "recovering", described as "Sore throat"; STOMATITIS (non-serious) with onset 09Apr2021 09:00, outcome "recovering", described as "Mouth sores". The events "sore throat" and "mouth sores" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, stomatitis.  Additional Information: Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Valtrex, Dexamethasone, Flonase was the treatment received for the events.Prior to vaccination the patient was not dignosed with COVID-19. Since the vaccination the patient has been tested for COVID-19.Test Name: Nasal Swab Date: 13Apr2021 Result: Negative.       No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache 1st day post vaccination, moderate headache 2nd day post vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 14:15 (Lot number: ew0161) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertriglyceridemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "degenerated discs" (unspecified if ongoing); "known allergies: whey" (unspecified if ongoing); "known allergies: pineapple, banana" (unspecified if ongoing); "known allergies: asparagus" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SUDAFED 12 HOUR; FENOFIBRIC ACID. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin: rash as infant"; Ondansetron, reaction(s): "Known allergies: ondansetron: facial swelling"; Ondansetron, reaction(s): "Known allergies: ondansetron: digestive issues"; Ondansetron, reaction(s): "Known allergies: ondansetron: stuffy nose"; Ondansetron, reaction(s): "Known allergies: ondansetron: migraine". The following information was reported: HEADACHE (non-serious) with onset 13Apr2021, outcome "unknown", described as "Severe headache 1st day post vaccination, moderate headache 2nd day post vaccination.". Therapeutic measures were not taken as a result of headache.  Additional Information: The patient reported that, first day she did not work, second day reduced work hours. Prior vaccination she never had Covid and post vaccination she was not tested for Covid.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eating disorder, Illness, Retching
Clinical narrative: She is enviably ill and she cannot keep even a sip of water down; she cannot even eat; Dry heaves; Diarrhea; She is enviably ill and she cannot keep even a sip of water down; she cannot even eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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: EATING DISORDER (non-serious), ILLNESS (non-serious) all with onset Apr2021, outcome "unknown" and all described as "She is enviably ill and she cannot keep even a sip of water down; she cannot even eat"; RETCHING (non-serious) with onset Apr2021, outcome "unknown", described as "Dry heaves"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: sore arm; Light headedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 42 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: DIZZINESS (non-serious) with onset 02Apr2021, outcome "recovered" (02Apr2021), described as "Light headedness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Caller is patient's wife. Caller states patient husband got Pfizer COVID-19 on 02Apr2021 and was light headed on the day of the immunization but only lasted for a couple of hours. Caller states patient also experienced a sore arm, and she is not sure how long it lasted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 16:15 (Lot number: ER2613) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin", notes: known allergies Amoxicillin. The following information was reported: MYALGIA (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered" (20Mar2021), described as "tiredness".  Additional Information: The patient did not take other vaccine in four weeks and other medications in two weeks prior COIVD-19 Vaccination. The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3. The second shot caused me to become loopy and lightheaded on day 1, 2, and 3 and whole-body muscle soreness on day 2 and a serious migraine and nausea on day 3 as well as tiredness and lightheadedness on day 4. The second one also caused my armpits to swell up really bad on day 2 and I am on day 5 after it and my left armpit is still swollen and sore. I started having a light cough on day 4 and still persists on day 5. Patient had no Covid-19 prior and post vaccination. Facility type vaccine was a facility.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nipple disorder, Paranasal sinus discomfort
Clinical narrative: Some kind of sinus pressure in my head; Tip of my nipples are kind of injured or kind of unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EW0150) 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: PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Some kind of sinus pressure in my head"; NIPPLE DISORDER (non-serious), outcome "unknown", described as "Tip of my nipples are kind of injured or kind of unwell".  Additional Information: Consumer stated, I got the vaccine on Tuesday 06Apr2021, the first one since then I was having some kind of sinus pressure in my head. And my nipples, tip of my nipples are kind of injured or kind of unwell I am saying. I donot know if this something serious that I should stop getting the second one or I donot know. When probed for date of birth and age, consumer stated, Oh God all the information, yes, its 40 I was 40. Consumer stated, Yeah with the symptoms do I, my second dose was scheduled for 27, 27Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with dose #1 for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 07:45 (Lot number: EN6207) at the age of 73 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 19Mar2021 07:45, outcome "recovered" (Mar2021), described as "Sore arm with dose #1 for a couple of days". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen arm". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  Additional information: 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: 1st shot hot spot red swelling at injection area.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 13:15 (Lot number: ER5732) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asma high blood pressure" (unspecified if ongoing), notes: Asma high blood pressure; "Asma high blood pressure" (unspecified if ongoing), notes: Asma high blood pressure; "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "1st shot hot spot red swelling at injection area.".  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Investigation, Migraine
Clinical narrative: sinus migraine; a lingering headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6199) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOPIRAMATE; ADVIL [IBUPROFEN]. Past drug history included: Motrin, reaction(s): "known allergies: Motrin". Vaccination history included: Bnt162b2 (Dose 1, Lot number=EN6201, Administration time=02:15 PM, Vaccine Location=Right arm), administration date: 17Feb2021, when the patient was 58 old, for Covid-19 immunisation. The following information was reported: MIGRAINE (non-serious), outcome "recovered", described as "sinus migraine"; HEADACHE (non-serious), outcome "recovered", described as "a lingering headache". The events "sinus migraine" and "a lingering headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 24 hours after first dose I was teaching online and got a sudden pain in my chest that quickly intensified. I was in severe pain and had my husband take me to the EMT station a few doors down from my home. The pain began to radiate down my sides and into my stomach. The EMT did an EKG and determined it was not a heart attack and helped me calm down. I was then in panic mode. The chest pains lasted the rest of the night off and on but less intense. I also had a painful sinus infection feeling/migraine for 3 days with a lingering headache for 2 more days. My second vaccine left me with the same sinus migraine but only for 1 day with a lingering headache for 3 days. No chest pains with second dose. Doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. The treatment medications inculded Imetrix, lots of fluids and lots of sleep.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bedridden, Fatigue, Headache, Lymphadenopathy
Clinical narrative: I got large swollen lymph nodes in my right armpit; They hurt alot to have my arms down/I still have that pain on day 3 after the shot; headache; muscle pain; extreme fatigue; laid in bed all day; nausea; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 14:45 (Lot number: EP7533) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot number=ER8727, administration time=02:30 PM, vaccine location=Left arm, dose number=1), administration date: 20Mar2021, when the patient was 42 years old, for Covid-19 immunisation, reaction(s): "First shot I got a large red circle around the injection sight", "It hurt", "itchy", "It got hard". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "I got large swollen lymph nodes in my right armpit"; AXILLARY PAIN (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "They hurt alot to have my arms down/I still have that pain on day 3 after the shot"; HEADACHE (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "muscle pain"; FATIGUE (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "extreme fatigue"; BEDRIDDEN (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "laid in bed all day"; NAUSEA (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, myalgia, fatigue, bedridden, nausea, pain in extremity. Additional information: Patient got first shot and got a large red circle around the injection site. It got hard and went away in a week. It also got itchy. After second shot she got large swollen lymph nodes in her right armpit. They hurt a lot to keep her arms down. She still have pain on third day after the shot. She also had a headache, muscle pain, extreme fatigue (laid in bed all day), nausea, arm pain within hours of receiving the shot on Saturday. She had not received any other vaccine in four weeks. She is under concomitant medications in two weeks which include prescribed and OTC. She was not tested positive for COVID prior to vaccination and was not tested positive post vaccination. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: I got large swollen lymph nodes in my right armpit; They hurt alot to have my arms down/I still have that pain on day 3 after the shot; headache; muscle pain; extreme fatigue; laid in bed all day; nausea; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 14:45 (Lot number: EP7533) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot number=ER8727, administration time=02:30 PM, vaccine location=Left arm, dose number=1), administration date: 20Mar2021, when the patient was 42 years old, for Covid-19 immunisation, reaction(s): "First shot I got a large red circle around the injection sight", "It hurt", "itchy", "It got hard". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "I got large swollen lymph nodes in my right armpit"; AXILLARY PAIN (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "They hurt alot to have my arms down/I still have that pain on day 3 after the shot"; HEADACHE (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "muscle pain"; FATIGUE (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "extreme fatigue"; BEDRIDDEN (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "laid in bed all day"; NAUSEA (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset 10Apr2021 18:00, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, myalgia, fatigue, bedridden, nausea, pain in extremity. Additional information: Patient got first shot and got a large red circle around the injection site. It got hard and went away in a week. It also got itchy. After second shot she got large swollen lymph nodes in her right armpit. They hurt a lot to keep her arms down. She still have pain on third day after the shot. She also had a headache, muscle pain, extreme fatigue (laid in bed all day), nausea, arm pain within hours of receiving the shot on Saturday. She had not received any other vaccine in four weeks. She is under concomitant medications in two weeks which include prescribed and OTC. She was not tested positive for COVID prior to vaccination and was not tested positive post vaccination. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Delayed 2nd dose later took after 4 weeks and no symptoms but sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto's but Thyroid was in rage during a this event. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number- EN6206, administration time-10:00, vaccine location: Left arm), administration date: 08Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Face numbness", "Feeling of blood moving in arms/legs with cold sensation", "SOB", "Events of low blood sugar (not diabetic)", "Dizziness", "Clammy feet", "Very scary", "Thyroid was in rage during this event". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Delayed 2nd dose later took after 4 weeks and no symptoms but sore arm". The event "delayed 2nd dose later took after 4 weeks and no symptoms but sore arm" was evaluated at the physician office visit and emergency room visit.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not COVID prior vaccination. The patient had no COVID teste post vaccination. The patient reported that delayed 2nd dose later took after 4 weeks and no symptoms but sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021415529 similar report from same reporter
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Head discomfort, Headache
Clinical narrative: after the second dose apart from other moderate symptoms like chills; head ache; pressure in the ears & back of the head; pressure in the ears & back of the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 12:30 (Lot number: ER8729) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergy: Sulpha Drugs" (unspecified if ongoing), notes: Known Allergy: Sulpha Drugs; "Diabetes" (unspecified if ongoing), notes: Diabetes. Concomitant medication(s) included: METFORMIN; LEVEMIR. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: ER8727, lot unknown: False, administration date: 19Mar2021, administration time: 12:30 PM, vaccine location: Left arm, dose number: 1), administration date: 19Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "after the second dose apart from other moderate symptoms like chills"; HEADACHE (non-serious) with onset 11Apr2021, outcome "not recovered", described as "head ache"; HEAD DISCOMFORT (non-serious), EAR DISCOMFORT (non-serious) all with onset 11Apr2021, outcome "not recovered" and all described as "pressure in the ears & back of the head". The event "after the second dose apart from other moderate symptoms like chills" was evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, headache, head discomfort, ear discomfort.  Additional information: AE treatment over the counter pain medication. The patient receive other medications within 2 weeks of vaccination included metformin and levemir. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Fatigue, Heart rate, Heart rate increased
Clinical narrative: fatigue; high blood sugar; high heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (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, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high blood sugar"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "high heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymphadenopathy
Clinical narrative: Dizzy; Felt like something popped up in my head; Lymph node was swollen; 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) (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) with onset 02Apr2021, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 02Apr2021, outcome "unknown", described as "Felt like something popped up in my head"; LYMPHADENOPATHY (non-serious) with onset 02Apr2021, outcome "unknown", described as "Lymph node was swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: vomiting; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (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: VOMITING (non-serious), outcome "unknown", described as "vomiting"; ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: the reporter mentioned that the patient (husband) had his first Pfizer shot 8 days ago and he got really sick and vomiting, and asked if that is related to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.