chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: A lot of brain fog; Dizziness; Joint pain; Trouble sleeping; Confusion; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Age: 63 Years), when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Joint pain", "Dizziness", "Brain fog", "Headache". The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "A lot of brain fog"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "Dizziness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "Joint pain"; INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Trouble sleeping"; CONFUSIONAL STATE (non-serious) with onset Feb2021, outcome "unknown", described as "Confusion"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "Fatigue".  Additional information: The patient received his 3rd (Booster) dose of Pfizer Coronavirus vaccines on 31Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: I am no longer testing positive for antibodies; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 07Mar2021 11:30 AM(Batch/Lot number: EN6205 ) as dose number 1, single for covid-19 immunisation and administration date 26Mar2021 11:45 AM(Batch/Lot number: EP6955 ) as dose number 2,, single for covid-19 immunisation   The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST NEGATIVE (non-serious) with onset 18Aug2021, outcome "unknown", described as "I am no longer testing positive for antibodies". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (12Oct2021): This is a follow-up spontaneous report from a contactable Nurse. This 54-year-old Nurse reported in response to Non-HCP letter sent which included that: Patient details, Batch/LOT number were updated  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia, Visual impairment
Clinical narrative: Light perception seemed to be diminished to 50% one day after vaccine/Visual; felt chills; slight fever; headache; general feeling of malaise/I also felt general malaise for two days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 16:45 (Lot number: FF8839) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, Single , Batch/Lot No: EJI685, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 29Dec2020, when the patient was 48 years old, for COVID-19 immunisation; Bnt162b2 (Dose 2, Single , Batch/Lot No: ELI283, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 19Jan2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "Light perception seemed to be diminished to 50% one day after vaccine/Visual"; CHILLS (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "felt chills"; PYREXIA (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "slight fever"; HEADACHE (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "headache"; MALAISE (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "general feeling of malaise/I also felt general malaise for two days.". Therapeutic measures were not taken as a result of visual impairment, chills, pyrexia, headache, malaise.  Additional information:  the patient reported After vaccination in the evening of same day Light perception seemed to be diminished to 50% one day after vaccine. Additionally, felt chills, slight fever, headache and general feeling of malaise.Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  Follow-up (27Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non HCP letter sent that included:  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: arm swollen; itchy; painful arm at the site of injection; feeling tired; I would say its like bad but it is irritating; I felt like I am sick; 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 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Oct2021 (Lot number: EW0178) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "arm swollen"; PRURITUS (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "itchy"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "painful arm at the site of injection"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling tired"; SKIN IRRITATION (non-serious) with onset Oct2021, outcome "unknown", described as "I would say its like bad but it is irritating"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "I felt like I am sick". Therapeutic measures were not taken as a result of peripheral swelling, pruritus, vaccination site pain, fatigue, skin irritation, illness.  Additional information: This female consumer reports receiving her very first injection of the Pfizer covid-19 vaccine yesterday and she was experiencing swollen, itchy, and painful arm at the site of injection. She was also feeling tired.  Follow-up (25Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 33-year-old female consumer reported for herself that: She received her very first injection of the Pfizer covid-19 vaccine yesterday and at the site of injection on her arm, she was experiencing swelling, itchiness and pain. She said that its hurts and also she mention that she was felling tired. Concomitant medication included: Nebulizer. Event started like last night around 10'o clock, she got shot yesterday. Its her first and she felt like she was sick. She said its like bad but it was irritating. Treatment for adverse event was not received as she didn't know what to take.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm swollen; itchy; painful arm at the site of injection; feeling tired; I would say its like bad but it is irritating; I felt like I am sick; 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 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Oct2021 (Lot number: EW0178) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "arm swollen"; PRURITUS (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "itchy"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "painful arm at the site of injection"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling tired"; SKIN IRRITATION (non-serious) with onset Oct2021, outcome "unknown", described as "I would say its like bad but it is irritating"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "I felt like I am sick". Therapeutic measures were not taken as a result of peripheral swelling, pruritus, vaccination site pain, fatigue, skin irritation, illness.  Additional information: This female consumer reports receiving her very first injection of the Pfizer covid-19 vaccine yesterday and she was experiencing swollen, itchy, and painful arm at the site of injection. She was also feeling tired.  Follow-up (25Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 33-year-old female consumer reported for herself that: She received her very first injection of the Pfizer covid-19 vaccine yesterday and at the site of injection on her arm, she was experiencing swelling, itchiness and pain. She said that its hurts and also she mention that she was felling tired. Concomitant medication included: Nebulizer. Event started like last night around 10'o clock, she got shot yesterday. Its her first and she felt like she was sick. She said its like bad but it was irritating. Treatment for adverse event was not received as she didn't know what to take.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Headache, Tinnitus
Clinical narrative: tinnitus-right ear/constant, buzz pulsating sound; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: ej1685) as dose 1, single for covid-19 immunisation. Relevant medical history included: "OA" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; MYRBETRIQ; VITAMIN D3; B12 [CYANOCOBALAMIN]. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "tinnitus-right ear/constant, buzz pulsating sound"; HEADACHE (non-serious), outcome "not recovered", described as "Headache". The events "tinnitus-right ear/constant, buzz pulsating sound" and "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 tinnitus, headache.  Additional information: Patient had no Covid prior vaccination and no known allergies, patient had no tested covid post vaccination. Adverse event: tinnitus-right ear, constant, buzz pulsating sound. Noticed right after the first injection alone with a headache-no other issues at that time. AE treatment included ENT referral-CT scan-Audiotory exam.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021513935 Same patient/Vaccine, different event, different vaccine shot
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 16:45 (Lot number: ER8731) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: required hospitalization and mainly affected my left lung. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Little soreness". Therapeutic measures were not taken as a result of pain.  Additional Information: It's been a little over 24 hours since patient second dose. The day of the vaccination (yesterday, May5th) patient didn't experience anything; patient was actually really surprised at how little soreness felt, in comparison to the first dose. However, today patient experienced what could best describe as the typical signs that a heavy cold is fixing to knock out in the coming days. patient had ongoing moderate body aches, internal fever, a slight headache, and, what seems unusual, slight chest pain. Patient feel it specifically on left side, almost as if over the heart. There's also a slight intermittent ache in left armpit. But specifically to the chest pain, patient mainly feel it upon exhaling deeply. No other symptoms thus far to report at this time. Patient did not receive any vaccine within four weeks prior to covid vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash papular
Clinical narrative: red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit; red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit; it is kind of hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: ER8737) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date Oct2021. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: RASH PAPULAR (non-serious), ERYTHEMA (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "red, it is big of a like a ''shape of the holler'' and it is kind of hot and it is little raised up a little bit"; FEELING HOT (non-serious) with onset Oct2021, outcome "not recovered", described as "it is kind of hot".  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Muscle spasms
Clinical narrative: I had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. I continued to cramp and bleed for 2 more weeks. I also; I had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. I continued to cramp and bleed for 2 more weeks. I also; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 09:15 (Lot number: EN8733) at the age of 35 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: MUSCLE SPASMS (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 30Mar2021 10:00, outcome "recovered with sequelae" and all described as "I had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. I continued to cramp and bleed for 2 more weeks. I also". The event "i had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. i continued to cramp and bleed for 2 more weeks. i also" and "i had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. i continued to cramp and bleed for 2 more weeks. i also" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle spasms, intermenstrual bleeding. Additional information: I had break through bleeding and cramping within 24 hours of 1 dose which lead to heavy bleeding for the next 4 weeks up to the time of dose 2. I continued to cramp and bleed for 2 more weeks. I also became extremely ill-fever of 102, diarrhea and vomiting for 48 hours after second dose. I continue to have breakthrough bleeding randomly between menstrual cycles and I'm having much worse menstrual cycle side effects examples debilitating cramps nausea And diarrhea that I did not have prior to being vaccinated with Pfizer COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101449356 similar report from same reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: When she had first two Pfizer COVID vaccine shots in Feb2021, it was just an itchy arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2021 (Lot number: EL8982, Expiration Date: Mar2021) at the age of 75 years as dose 1, single and administered in arm left, administration date 10Feb2021 (Lot number: EN5318, Expiration Date: May2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "upper respiratory nasal drip" (unspecified if ongoing), notes: Over the last 5 years, she has developed the upper respiratory nasal drip; "irregular heart beat" (unspecified if ongoing), notes: Why was the patient taking Concomitant Products Amlodipine (Verbatim): irregular heart beat. Family history included: "Diabetes", start date: 1995 (ongoing), notes: Mother had diabetes and it seems to run in family. Concomitant medication(s) included: HUMALOG BASAL taken for diabetes mellitus; METFORMIN [METFORMIN HYDROCHLORIDE] taken for diabetes mellitus; PRAVASTATIN taken for blood pressure measurement; AMLODIPINE taken for heart rate irregular; EZETIMIBE taken for blood pressure measurement; ASPIRIN [ACETYLSALICYLIC ACID]; LOSARTAN taken for hypertension. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "When she had first two Pfizer COVID vaccine shots in Feb2021, it was just an itchy arm.".  Additional information: Received call from consumer who provided her middle initial. She had her Booster shot of the Pfizer Covid vaccine last Wednesday, 20Oct2021. She had the two previous ones in February and then space and got another one. He had no effects from the others at all except an itchy arm.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Tremor, Vertigo
Clinical narrative: Vertigo; Trembling; Upper body rash/ I had a reaction like a rash that last for three days in my upper body; Fever; Chills; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Lot number: EN6201) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: It's been ten years since, I had cancer treatment; "Vertigo" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (DOSE: 1, Batch/lot number: EL8982), administration date: 30Jan2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 20Feb2021, outcome "recovered" (23Feb2021), described as "Upper body rash/ I had a reaction like a rash that last for three days in my upper body"; PYREXIA (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "Fever"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Chills"; TREMOR (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "Trembling"; VERTIGO (non-serious) with onset Mar2021, outcome "unknown", described as "Vertigo". Therapeutic measures were taken as a result of rash, pyrexia, chills, tremor, vertigo.  Additional information: She have had 2 doses of the Pfizer BTC Vaccine and with the 2nd dose the patient reported she had an upper body rash that lasted more than 3 days, fever that lasted 6 hours with chills. She asked Should she pre medicate, for the rash before she gets her Pfizer BTC vaccine booster dose? The patient stated she always pre medicates before she has any scans that involve iodine contrast. Therapeutic measures were taken as a result of events with Panadol.   No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The initial case was missing the following minimum criteria. Upon receipt of follow-up information on [22Nov2021], this case now contains all required information to be considered valid.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 07Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient age at time of vaccination: 8. Vaccination facility type: Workplace clinic. Vaccine administered at a facility: No. Prior vaccination: Unknown. Concomitant drugs: Unknown. Patient medical history: Unknown. Relevant tests: Unknown. Specific Relevant tests: Unknown. Seriousness Criteria: Not serious.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test, Stomatitis, Taste disorder, Wound secretion
Clinical narrative: I got large mouth sores that were oozing; I got large mouth sores that were oozing; my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad; my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 08:30 (Lot number: EM9810) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing); "drug allergy" (unspecified if ongoing); "Lichen Planus" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; OMEPRAZOLE; PROGESTERONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: E9265, Location of injection: Arm Right), administration date: 04Feb2021, when the patient was 65 years old, for Covid-19 immunization.  The following information was reported: STOMATITIS (non-serious), WOUND SECRETION (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "I got large mouth sores that were oozing"; PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of stomatitis, wound secretion, parosmia, taste disorder.  Additional information: there is no hospitalization prolongation. The patient received booster dose on 17Nov2021 at 15:45 (Batch/lot number: 330268D, age at the time of vaccination: 66-year-old) administered in arm left for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamin D within 2 weeks of vaccination. 2 weeks after second dose, patient got large mouth sores that were oozing.  6 weeks after second dose, sense of smell and taste went bad, could taste and smell but everything tasted and smelled bad. She was tested both times for COVID and both tests were negative, so she assume it had to do with the vaccine. She have had Lichen Planus and I heard that could make her susceptible to these side effects. It was now 7 months later, and still have problems with taste and smell. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: FC3180) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Aug2021, outcome "recovered" (2021), described as "extremely tired". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient had no adverse reaction after first shot, besides being extremely tired for 2-3 days after getting it.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: he is covered in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (COMIRNATY) (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 1), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "he is covered in hives".  Additional information: The patient received vaccination probably like about 4 O'clock at his primary care office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Antibody test abnormal, Drug interaction, SARS-CoV-2 antibody test
Clinical narrative: did not develop any (COVID-19) antibodies at all; Zydelig and Biontech COVID-19 vaccination interaction; did not develop any (COVID-19) antibodies at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-0560094.  A 66 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation, prophylaxis; idelalisib (ZYDELIG) (Batch/Lot number: unknown) for chronic lymphocytic leukaemia. Relevant medical history included: "Chronic lymphocytic leukaemia" (ongoing), notes: Notes: Previously was a test person for Idelalisib. The patient's concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown" and all described as "did not develop any (COVID-19) antibodies at all"; DRUG INTERACTION (non-serious), outcome "unknown", described as "Zydelig and Biontech COVID-19 vaccination interaction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the patient's SARS CoV-2 antibody test was negative. This case manufacturer control number 2021-0560094.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: pain in the underarm the same night she got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization.  The following information was reported: AXILLARY PAIN (non-serious) with onset 14Dec2021, outcome "unknown", described as "pain in the underarm the same night she got the shot".  Additional Information: Clinical Trials Experience Local and Systemic Adverse Reactions Solicited in the Study In participants 16 through 55 years of age after receiving Dose 2, the mean duration of pain at the injection site was 2.5 days and for swelling 2.1 days.  Booster Dose In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose included lymphadenopathy. Revised: 09Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Chills; he doesn't feel well; he has a pain the most and we are worries that pain that he got in his chest, Muscle ache; Fever; he has a pain the most and we are worries that pain that he got in his chest, Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "he doesn't feel well"; MYALGIA (non-serious), CHEST PAIN (non-serious), outcome "unknown" and all described as "he has a pain the most and we are worries that pain that he got in his chest, Muscle ache"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (14Jan2022): This is a spontaneous follow up report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included that: Updated Information included: Primary Reporter's information.  The lot number for the vaccine , BNT162B2 was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vitreous floaters
Clinical narrative: Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater; Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater; This is a spontaneous report received from a 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 19Apr2021 12:00 (Lot number: ER8737) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: Verbatim: I have lupus. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6204, Administration time: 12:00 PM,, Vaccine location: Left arm,), administration date: 25Mar2021, when the patient was 56 years old, for Covid-19 immunisation, reaction(s): "floaters in my right eye", "i had a tear in my retina". The following information was reported: VITREOUS FLOATERS (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater". The event "then i got my second vaccine 19apr2021 and by that afternoon dark black larger floater" and "then i got my second vaccine 19apr2021 and by that afternoon dark black larger floater" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vitreous floaters, condition aggravated.  Clinical Course: The patient did not taken other vaccine in four weeks. The patient got second vaccine 19Apr2021 and by that afternoon dark black larger floater returned and wish she would of never got the vaccine retina could of detached. She was worried, she had another tear, lupus and got it to save her life but regret getting looked up clinical trials after this happened and saw it happened to very few people. She was taken treatment of Emergency laser eye surgery.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: I woke in the night with the urge to evacuate my bowels. It was diarreha (twice during the night; I also vomited once during the night.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FENOFIBRATE. Vaccination history included: Bnt162b2 (Batch/lot number: ER8732, Date of start of drug  31Mar2021, Anatomical Location :Arm Right), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "I woke in the night with the urge to evacuate my bowels. It was diarreha (twice during the night"; VOMITING (non-serious), outcome "recovered", described as "I also vomited once during the night.".  Additional information: Within 16 hours of receiving second dose, i woke in the night with the urge to evacuate my bowels. It was diarreha (twice during night, once early morning). I also vomited once during the night. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Hyperhidrosis, Pain, Therapeutic response unexpected
Clinical narrative: sweating it hurt so bad; sweating it hurt so bad; he would notice it and stats it did not hurt but was an "awkward feeling", but today reports even more of an improvement. He states "it's gone."; That night the caller couldn't get that tooth ache pain; 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 male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation; paracetamol (TYLENOL) (Batch/Lot number: unknown) for toothache. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN taken for toothache. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 24Apr2021, outcome "recovered" (25Apr2021), described as "That night the caller couldn't get that tooth ache pain"; PAIN (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "sweating it hurt so bad"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 25Apr2021, outcome "unknown", described as "he would notice it and stats it did not hurt but was an "awkward feeling", but today reports even more of an improvement. He states "it's gone."".  Additional information: Patient reported that he had a toothache on the right side of this mouth since last July that he had been treating with Ibuprofen 400mg twice daily and reports that initially after taking the second dose of the vaccine, no matter what he took medication wise, the toothache pain would not go away. However, he stated that the next day and every day he had not had to take anything for the toothache and reported that it's "almost as if it has disappeared." He also reported that yesterday if he were to touch it, he would notice it and stated it did not hurt but was an "awkward feeling", but today reported even more of an improvement. He stated "it's gone." He mentioned that he had no negative side effects with the vaccine and offered to had blood work done if Pfizer was interested in his case. On Saturday, 24Apr2021, the patient received the second dose of the Pfizer covid vaccine. That night the patient couldn't get that tooth ache pain to stop, he was sweating it hurt so bad. The patient took Ibuprofen and Tylenol and it didn't help with the pain. Every day after that incident, the patients tooth ache had been gone. Prior to this event the patient couldn't bite down or drink cold water on the right side of his mouth where the tooth ache was. Every day he was experiencing the tooth ache pain prior to this event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: soreness & aching in her arm of injection site; arm and muscle is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 63 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: VACCINATION SITE PAIN (non-serious) with onset 30Apr2021, outcome "unknown", described as "soreness & aching in her arm of injection site"; MYALGIA (non-serious) with onset 30Apr2021, outcome "unknown", described as "arm and muscle is sore".  Additional Information: It was reported that patient got her first dose on 30APR2021 and scheduled to get the second dose on 21May. She experienced arm and muscle was sore on the injection site. She wanted to know if she can use Salonpas with Lidocaine. She mentioned that its not an adverse reaction and that its just a little muscle sore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Nightmare, Pain in extremity
Clinical narrative: headaches/Waking up with really bad headaches; her head feels like a water balloon that weighs 50 pounds. She struggles to take her head off the pillow.; nightmares; Her left arm was sore; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scleroderma" (unspecified if ongoing), notes: Verbatim: Scleroderma. Family history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "headaches/Waking up with really bad headaches"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "her head feels like a water balloon that weighs 50 pounds. She struggles to take her head off the pillow."; NIGHTMARE (non-serious) with onset 2021, outcome "not recovered", described as "nightmares"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Her left arm was sore".   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vitreous floaters
Clinical narrative: floaters on the eye; headache; swelling of the lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters on the eye"; HEADACHE (non-serious), outcome "unknown", described as "headache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph node".  Additional information: Reporter mentioned that PFIZER should develop an antidote to the poison (referring to the PFIZER-BIONTECH COVID-19 VACCINE) that we are administering to many people. She would not recommend getting the vaccine from Pfizer. Also, she was asking why Pfizer is keeping on pumping this poison to everybody and that the Emergency Use Authorization (EUA). Reporter had a daughter who finished the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE and had experienced side effects such as that of floaters on the eye, headache and swelling of the lymph node. She would like to know if there is any available information in regards the side effect experienced specifically that of the development of floaters in the eye amongst her daughters age group (for teenagers). She mentioned that she know that both headaches and swelling of lymph nodes are commonly reported. Also, gave contact information by CDC as stated on the FAQ-COVID-19 Vaccine - CDC vaccination registry V-safe (adverse effects, pregnancy, lactation, other comorbidities).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: First dose: flu-like symptoms; temperature was 102-103 degrees, His temperature would probably lower to 100 degrees at times and then go back; he received the first dose of the COVID vaccine on 25Mar2021, and confirms starting on 04Apr2021 he started to feel bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EP6955) at the age of 33 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: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Apr2021, outcome "recovered" (07Apr2021), described as "First dose: flu-like symptoms"; PYREXIA (non-serious) with onset 04Apr2021, outcome "recovered" (07Apr2021), described as "temperature was 102-103 degrees, His temperature would probably lower to 100 degrees at times and then go back"; FEELING ABNORMAL (non-serious) with onset 04Apr2021, outcome "recovered" (07Apr2021), described as "he received the first dose of the COVID vaccine on 25Mar2021, and confirms starting on 04Apr2021 he started to feel bad".  Additional information: After the 1st shot, the patient experienced a 3-day adverse reaction that started about 10 days after the first vaccine. No additional vaccine was administered on same date of the Pfizer suspect. The events did not result in emergency room or physician office. The Patient believes he was running a consistent temperature of around 102-103 degrees.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: mild fatigue; mild arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, 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: FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "mild fatigue"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "mild arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.