chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after each dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included RA.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   On an unknown date, patient took second dose and received third dose on 25Sep2021.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-350754, MOD-2021-350755 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain in extremity
Clinical narrative: Sick; Body Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02FB21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm). On 10-Apr-2021, ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Somnolence, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling; Red; feels slightly warm to the touch compared to the other arm/slightly warm to touch; kind of tender to the touch/Tender; the feeling of wanting to go back into bed and sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep   ) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 013M20A and 035C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU on 15-Oct-2021.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep   ). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep   ) outcome was unknown.            No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-356400.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Significant follow-up : AE added On 18-Oct-2021: Significant Follow Up Appended; Mailbox Contains Pictures to describe the event
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Joint pains in both the shoulders and progressing to the hips; Pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Radical prostatectomy on 04-Oct-2004. Concurrent medical conditions included Bee sting, Drug allergy (Meloxicam and carry a epipen) and Prostate cancer since 14-Aug-2004.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 02-Aug-2021, the patient experienced ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) had not resolved.            No relevant concomitant medications were reported..   The patient had unbearable pain. He applied rubs which do not help and packs occasionally Patient had an appointment on 1st of July and he has been using salonpas on shoulders which lessens the soreness and also bio freeze on the hip areas to relieve the stiffness .   This case was linked to MOD-2021-359083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 Oct 2021 . Added patients demographics , past medical conditions, information regarding suspect product and outcome of events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: she didn't realize they were given the booster before it was "approved".; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Sepsis.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced OFF LABEL USE (she didn't realize they were given the booster before it was "approved".). On 30-Aug-2021, OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) had resolved.            No Concomitant medications were reported. No Treatment medications were reported. reoporter said she took the flu shot  and so far so good.   This case was linked to MOD-2021-355780 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 oct 2021,mentioning  patient has taken flu shot
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site coldness
Clinical narrative: second vaccine felt cold when it was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (second vaccine felt cold when it was given) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE COLDNESS (second vaccine felt cold when it was given). At the time of the report, VACCINATION SITE COLDNESS (second vaccine felt cold when it was given) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient toll the flu vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received on 20 oct 2021 relevant information updated in the I narrative.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: other people had situations that required treatment; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (other people had situations that required treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other people had situations that required treatment). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (other people had situations that required treatment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-355659.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received- Patient, product and reporter HP details added,
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.   This case was linked to MOD-2021-355943, MOD-2021-355908 (Patient Link).
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Heart rate
Clinical narrative: Back pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (Back pain) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated. On an unknown date, Heart rate: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medical information were reported. No Treatment informations were reported.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU VACCINE VII) (Intramuscular) at an unspecified dose. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs  were provided. No treatment drugs are provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received and updated patient demographics and flu vaccine were added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Soreness at the injection site; Sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle). On 22-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Second dose was taken by the patient on 23-Feb-2021.  No concomitant medications was reported.  No treatment drug details was reported.  patient didn't report any adverse reaction to the shots. There was only mild sorness in her left arm at the injection site that went away after a couple of days. No other side effects were noted. she will now waiting to qualify for the booster.   This case was linked to MOD-2021-355997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received on 21-Oct-2021 contains no new information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer COVID19 Vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 18-Sep-2021.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Reporter information, contact details were Updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Fatigue, Pruritus
Clinical narrative: after he had the first dose, he had like a burst of energy/He came home and had tons of energy; little itchy on his stomach; the next day he just crashed/was tired/exhausted/Felt completely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Hypertension, Migraine, Hypokalemic periodic paralysis (it's a condition that causes extreme muscle weakness, he probably had it since a kid, sometimes they call it dead sleep,he has liquid potassium and liquid magnesium in his hand, and when he feels it coming, he can feel his muscles weak, and he would mix that with juice and then feel better, and then take it again after an hour) and Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for Asthma, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY XR) for Diabetes, LOSARTAN for Hypertension, ROSUVASTATIN CALCIUM (CRESTOR) for Lipids, ALPRAZOLAM, TADALAFIL (CIALIS), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR), DULAGLUTIDE (TRULICITY), OMEPRAZOLE, METOPROLOL TARTRATE, FINASTERIDE, ZOPICLONE and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted). At the time of the report, ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. Reporter provided concomitant Metoprolol tartrate  indication for Heart.  As the patient is suffering from hypokalemic periodic paralysis, he  states that  is the reason why he can't take certain medications anymore: azythromycin , prednisone triggers the condition   This case was linked to MOD-2021-356037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non-significant Follow-up
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccinated on day 46 with second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs were provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site joint pain
Clinical narrative: left shoulder where the vaccine was put in his shoulder has been sore; Patient was in bed; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:30 (at the age of 90-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; EL9265, expiration date was 31May2021), via an unspecified route of administration, in Arm Left on 31Jan2021 at dose 1, single for covid-19 immunization. The patient probably had a little sensation on the vaccination day but left shoulder pain started the next day after the second shot and has not gotten better, has not gotten worse on 22Feb2021. Patient was in bed. Caller stated the left shoulder where the vaccine was put in patient's shoulder has been sore and tried a hot water bottle, it did not help. The most recent vaccine was administered at the Forum, it was a big round building. Patient got no other vaccines the same day. The events not resulted in Emergency Room and Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. They do not have a primary care physician. Patient goes to a heart specialist and if they have a certain thing they go to a specialist for that. Caller asked if shoulder pain after the vaccine has been reported by other people. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Postmenopausal haemorrhage
Clinical narrative: says it is spotting like period blood; first dose, there was blood in the urine/second dose, there was blood in her urine again; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6208), dose 1, single and on 30Mar2021 (lot number: ER8734), dose 2, single; both via an unspecified route of administration at the age of 79-year-old for COVID-19 immunisation. Medical history included menopause. The patient's concomitant medications were not reported. In Mar2021, 3 days later the vaccination, the patient went to pee and there was blood in the urine. The patient went to the doctor and they checked her urine and there was blood and they said they did not know where the blood was coming from. The patient took an anti-biotic cephalexin (Keflex) 500 mg for 10 days. The bleeding stopped 3 days later after she started the treatment medication. The patient stated there was no more bleeding when she peed for 10 days. Then the patient took the second vaccine around 10:00 in the morning and a couple hours later (about 02:00) she went to pee and there was blood in the urine again. It was kind of suspicious she has never bled since menopause at like 40, she has never bled all these years it was kind of strange she just wanted to tell about her experience. The patient stated she called her gynecologist on 31Mar2021 and she was going to go take a test at 01:45 and see what they say at the hospital. She said it was spotting like period blood and she said it was persisting on 31Mar2021 about the same as on 30Mar2021. The patient further stated, when she peed this morning, a lot of blood came out. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366596 Pfizer
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Chills; Fever; Not feeling well; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), via an unspecified route of administration in the right arm on 25Mar2021 at 00:30 (at the age of 52-year-old), as DOSE 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Medical history included thyroid Thyroid cancer but had no allergies to any medicines, food or other products. Concomitant medications included influenza virus vaccine(flu). On unknown date, the patient experienced pain in the arm. On day 4, 29Mar2021, the patient experienced chills, fever and was not feeling well in the whole body. The patient had received no treatment for the clinical events. The clinical outcome of the events pain in arm was recovered on an unknown date; chills, fever and not feeling well was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated country added in patient tab; updated relevant Med History and narrative tab per source provided; updated vaccination Facility Type and Vaccination Facility Country; updated Onset Date/Time for events updated Leading and final sentence.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disorientation, Pelvic pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: extreme pelvic pain; 101 fever; felt mentally disoriented; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included shoulder replacement (I'm 70 and I've had shoulder replacement about a year ago and still recovering from that). Concomitant medications were not reported.  It was reported that patient received her first dose of Pfizer's COVID vaccine on 22Mar2021. She was fine until 6 days later on 28Mar2021, she stated she had 101 fever, and felt mentally disoriented but she managed to get in for a COVID test the next day on Monday, and it was negative. By Easter Sunday, she had extreme pelvic pain, so she went into a walk-in clinic and got treated for that. Just today, my symptoms are letting up. She is 70 and she have  had shoulder replacement about a year ago and still recovering from that. Patient is concerned if she should get the second dose. Patient was asking if there may be more symptoms on the second dose. Patient also asking if surgery causes you to be immunocompromised. The patient underwent lab tests and procedures which included fever (body temperature): 101 on an unspecified date, COVID test (sars-cov-2 test): negative on an unspecified date. Therapeutic measures were taken as a result of extreme pelvic pain. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Lymphadenopathy, Oropharyngeal pain, Pharyngeal mass
Clinical narrative: usual chills; Swollen lymph nodes same side as vaccine in neck and throat; feeling of lump in throat; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; strep throat.; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ED753Y) via an unspecified route of administration, administered in the right arm on 24Mar2021(age at the time of vaccination was 59-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Osteoarthritis, gastritis, coiled and stented aneurysm and Tetracycline allergy. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 25Mar2021 besides the usual chills 24 hours later. Swollen lymph nodes same side as vaccine in neck and throat. Constant feeling of lump in throat and dull pain from lower throat all along up to inner ear. Lymph node under neck reduced but still lump in throat feeling and dull ache up to inner ear at end of week 2. Getting next shot in 5 days. Doctor prescribed antibiotics to rule out strep throat. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event resulted in treatment with antibiotics. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: usual chills; Swollen lymph nodes same side as vaccine in neck and throat; feeling of lump in throat; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; strep throat.; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ED753Y) via an unspecified route of administration, administered in the right arm on 24Mar2021(age at the time of vaccination was 59-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Osteoarthritis, gastritis, coiled and stented aneurysm and Tetracycline allergy. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 25Mar2021 besides the usual chills 24 hours later. Swollen lymph nodes same side as vaccine in neck and throat. Constant feeling of lump in throat and dull pain from lower throat all along up to inner ear. Lymph node under neck reduced but still lump in throat feeling and dull ache up to inner ear at end of week 2. Getting next shot in 5 days. Doctor prescribed antibiotics to rule out strep throat. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event resulted in treatment with antibiotics. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Developed generalized pruritic uricaritc rash; Developed generalized pruritic uricaritc rash; This is a spontaneous report from a contactable consumer (patient). A male patient (Age: 80; Unit: unknown) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE  , solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced developed generalized pruritic uricaritc rash on an unspecified date. The patient received two doses of vaccine. Developed generalized pruritic uricaritc rash and dermatologist put him on prednisone- relived the itching temporality. Once off prednisone the rash has returned. The patient has another dermatologist appointment today. The patient wanted to know if this side effects has been reported. Therapeutic measures were taken because of developed generalized pruritic uricaritc rash with prednisone. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature abnormal, Chills, Feeling abnormal
Clinical narrative: Headache; Chills; had a temperature; Weakness; body aches; Joint pain; feeling miserable; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 06Apr2021 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) (age at vaccination 57 years) as 0.3 mg, single for covid-19 immunisation. Medical history included allergies and covid-19. Historical vaccine included BNT162B2 as first dose received on 15Mar2021 (lot EN6206, expiration date 30Jun2021). Concomitant medication included sinus pills for allergies. On 06Apr2021 20:00, the patient experienced headache, chills, had a temperature, weakness, body aches, joint pain and feeling miserable. The patient had covid before and he wanted to make sure he didn't get it anymore. The patient had the second dose of his vaccine yesterday 06Apr2021 and he has been feeling some side effects from the vaccination. Early in the day after the vaccine the patient was feeling fine. At 8:00 pm that night the patient had a headache, chills, a temperature, weakness in his body, joint pain, and feeling miserable. The patient wanted to know what he can take for these symptoms. The outcome of the events was resolving and feeling miserable was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Chills; had a temperature; Weakness; body aches; Joint pain; feeling miserable; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 06Apr2021 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) (age at vaccination 57 years) as 0.3 mg, single for covid-19 immunisation. Medical history included allergies and covid-19. Historical vaccine included BNT162B2 as first dose received on 15Mar2021 (lot EN6206, expiration date 30Jun2021). Concomitant medication included sinus pills for allergies. On 06Apr2021 20:00, the patient experienced headache, chills, had a temperature, weakness, body aches, joint pain and feeling miserable. The patient had covid before and he wanted to make sure he didn't get it anymore. The patient had the second dose of his vaccine yesterday 06Apr2021 and he has been feeling some side effects from the vaccination. Early in the day after the vaccine the patient was feeling fine. At 8:00 pm that night the patient had a headache, chills, a temperature, weakness in his body, joint pain, and feeling miserable. The patient wanted to know what he can take for these symptoms. The outcome of the events was resolving and feeling miserable was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: less smell; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as Dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced less smell and taste after receiving the first dose of the COVID vaccine on 31Mar2021. The outcome of the event was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site joint movement impairment, Wrong product administered
Clinical narrative: Dizziness; Can hardly raise my arm where the shot was given; First dose which I received was Moderna and on April 3rd I received the Pfizer; Dosage was mixed; I got two different shots, I got, the first one was the Moderna and second one wat the Pfizer one; This is a spontaneous report received from a contactable consumer (patient reported for himself/herself). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration on 03Apr2021 as dose 2 (initial Pfizer dose), single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness can hardly raise my arm where the shot was given, first dose which i received was moderna and on April 3rd i received the Pfizer; dosage was mixed; i got two different shots, i got, the first one was the moderna and second one wat the Pfizer one on an unspecified date. Consumer stated, "I am calling because Saturday I received the second dosage, the first dose which I received was March the 6th which was Moderna (further clarified hence captured as COVID shot). And Saturday on April 3rd I received the Pfizer (further clarified hence captured as COVID shot), not realizing that it was the Pfizer. So, I am calling about, I am having the side effects as in the dizziness and can hardly raise my arm where the shot was given. And I am concerned because the dosage was mixed, so I wanted to know, they did a report on place where they gave the shot, but I did not receive the report and I want to know if they had reported it to you or not.' Consumer stated, 'Yes, because the First shot it was the Moderna, so I got two different shots, I got, the first one was the Moderna and second one wat the Pfizer one. So, I want to know, I just got off the phone with my primary care doctor and they said to go to emergency room, but I wanted to know what other side effects will happen to me taking the first dose of each one and do I need to take the second dose of the Moderna or the second dose of the Pfizer". The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: headaches; nausea; fever; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, post COVID 19 vaccine dose 2, the patient experienced headaches, nausea, fever (101 degrees F+). It was reported that event took place after use of product. The patient underwent lab tests and procedures which included fever: 101+ Fahrenheit on an unspecified date. The outcome of events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: an allergic reaction it was not a severe; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 11Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had an allergic reaction it was not a severe but when the patient returned on 01Apr2021 to get the second vaccine, the patient was told that could not receive it as the patient had a reaction to the first vaccine. The patient explained to them that it was not severe, they said that did not matter and the patient need to take the second vaccine in a hospital setting so they would not give second vaccine. They referred this to doctor's office, the patient's doctor's office did agree, they said it probably good to administer it in hospital setting, however they referred the patient to the local health department. The patient contacted the health department they said we won't approve that you need to be in a hospital setting so now I am here back and forth. The patient asked that do I really need to a hospital to have the second vaccine done, I am running out of time right now. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: It made me drowsy; I itch all over; itchy; This is a spontaneous report from a contactable consumer or other non hcp (Patient).A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiration date: not reported) via an unspecified route of administration on 06Apr2021 (at the age of 45-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included naproxen sodium (NAPROXEN SODIUM) taken 220 mg twice a day. On 06Apr2021, patient experienced i itch all over, on an unspecified date, it made me drowsy. Patient did not receive any treatment. It was reported that second shot of vaccine was scheduled on 27Apr2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: after I got the Second injection the first injection was in the first of the month last month and the last injection was on the 26th and I got injected in the opposite arm and that broke up in rash; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6202), via an unspecified route of administration, administered in Arm Right on 26Feb2021 (at the age of 77-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol (METOPROLOL) one tablet a day, 50mg, orally taken for hypertension from (for 5 years) an unspecified start date and ongoing; amlodipine (AMLODIPINE) 2.5mg, one tablet a day, orally taken for hypertension, start and stop date were not reported. On an unspecified date the patient experienced after i got the second injection the first injection was in the first of the month last month and the last injection was on the 26th and i got injected in the opposite arm and that broke up in rash. The outcome of event unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I had a kind of an allergic reaction to it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a kind of an allergic reaction to it. Outcome of the event was unknown.  No follow-up attempts are needed. Information about Lot/Batch number cannot be requested.