chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Functional gastrointestinal disorder
Clinical narrative: This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath / difficulty in breathing, difficulty in bowel function, difficulty with bladder control, chest pain, dizziness, muscle aches, headache, nausea, and weakness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath / difficulty in breathing, difficulty in bowel function, chest pain, muscle aches, headache, dizziness, nausea, weakness, and difficulty with bladder control. This report was non-serious. Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Urinary incontinence
Clinical narrative: This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath / difficulty in breathing, difficulty in bowel function, difficulty with bladder control, chest pain, dizziness, muscle aches, headache, nausea, and weakness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath / difficulty in breathing, difficulty in bowel function, chest pain, muscle aches, headache, dizziness, nausea, weakness, and difficulty with bladder control. This report was non-serious. Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhoids
Clinical narrative: HEMORRHOIDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hemorrhoids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhoids was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: GETTING SORES; PAINS IN LEGS; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced getting sores, pains in legs, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains in legs, headaches and getting sores was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Chest discomfort, Chills, Dizziness, Fatigue
Clinical narrative: This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight was 135 pounds, and height was 66 inches. The patient's past medical history included: born premature, and many complications/surgeries early in life, and concurrent conditions included: bee stings allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 18-JUN-2022) dose was not reported, administered on 10-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced moody/agitated/short tempered than normal. On 11-MAR-2022, the patient experienced nausea, vomiting, and tiredness. On 12-MAR-2022, the patient experienced lower throat-lower chest tightness/discomfort for breathing, pale in color, dizziness, super achy, hot/cold/chills/cold sweats, off and on headaches, and ears ringing/weird sounding. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower throat-lower chest tightness/discomfort for breathing, and ears ringing/weird sounding, and the outcome of nausea, hot/cold/chills/cold sweats, pale in color, moody/agitated/short tempered than normal, off and on headaches, dizziness, super achy, vomiting and tiredness was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pallor, Tinnitus
Clinical narrative: This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight was 135 pounds, and height was 66 inches. The patient's past medical history included: born premature, and many complications/surgeries early in life, and concurrent conditions included: bee stings allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 18-JUN-2022) dose was not reported, administered on 10-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced moody/agitated/short tempered than normal. On 11-MAR-2022, the patient experienced nausea, vomiting, and tiredness. On 12-MAR-2022, the patient experienced lower throat-lower chest tightness/discomfort for breathing, pale in color, dizziness, super achy, hot/cold/chills/cold sweats, off and on headaches, and ears ringing/weird sounding. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower throat-lower chest tightness/discomfort for breathing, and ears ringing/weird sounding, and the outcome of nausea, hot/cold/chills/cold sweats, pale in color, moody/agitated/short tempered than normal, off and on headaches, dizziness, super achy, vomiting and tiredness was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight was 135 pounds, and height was 66 inches. The patient's past medical history included: born premature, and many complications/surgeries early in life, and concurrent conditions included: bee stings allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 18-JUN-2022) dose was not reported, administered on 10-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced moody/agitated/short tempered than normal. On 11-MAR-2022, the patient experienced nausea, vomiting, and tiredness. On 12-MAR-2022, the patient experienced lower throat-lower chest tightness/discomfort for breathing, pale in color, dizziness, super achy, hot/cold/chills/cold sweats, off and on headaches, and ears ringing/weird sounding. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower throat-lower chest tightness/discomfort for breathing, and ears ringing/weird sounding, and the outcome of nausea, hot/cold/chills/cold sweats, pale in color, moody/agitated/short tempered than normal, off and on headaches, dizziness, super achy, vomiting and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Tendon disorder
Clinical narrative: TENDON EXTENDED THAT WENT DOWN FROM ARM TO ELBOW, EXTENDING ACROSS LEFT BREAST; SWOLLEN LYMPH NODES; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-JUN-2021, the patient experienced tendon extended that went down from arm to elbow, extending across left breast, and swollen lymph nodes. Laboratory data (dates unspecified) included: Mammogram (NR: not provided) Abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tendon extended that went down from arm to elbow, extending across left breast, and swollen lymph nodes. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site reaction
Clinical narrative: Pins/needles in left hand/fingers and foot/toes starting 8/24/21; experience some numbness in left hand and foot PLUS constant pins/needles in left hand and foot which varies in degree througout the day; Soreness at injection site after about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 10:45 (Lot number: Unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lifelong Migraines" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: Breast Cancer in 2009 and 2014. There were no concomitant medications. Past drug history included: Known allergy: none known. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Soreness at injection site after about 12 hours"; PARAESTHESIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Pins/needles in left hand/fingers and foot/toes starting 8/24/21"; HYPOAESTHESIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "experience some numbness in left hand and foot PLUS constant pins/needles in left hand and foot which varies in degree througout the day". The events "soreness at injection site after about 12 hours", "pins/needles in left hand/fingers and foot/toes starting 8/24/21" and "experience some numbness in left hand and foot plus constant pins/needles in left hand and foot which varies in degree throughout the day" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site reaction, paraesthesia, hypoaesthesia.  Additional information: 21Aug2021 - Soreness at injection site after about 12 hours, as expected. Resolved within a couple of days. Pins/needles in left hand/fingers and foot/toes starting 24Aug2021. Seemed to improve on 29Aug2021, but returned in full and progressively worse since 31Aug2021. She now experiences some numbness in left hand and foot, constant pins/needles in left hand and foot which varies in degree throughout the day. The patient was administered vaccine in a pharmacy. The patient did not receive other vaccine in four weeks nor other medication in 2 weeks. The patient did not have covid prior vaccination nor was tested post vaccination. The patient had no known allergies.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: skin allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 04Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "polycystic kidneys" (unspecified if ongoing), notes: I have polycystic kidneys, is that considered immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "skin allergy".  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Productive cough, SARS-CoV-2 test
Clinical narrative: now I am losing my voice.; I have a cough filled with mucus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 11:30 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, product = COVID 19,, lot unknown = True,, lot unknown  reason = Unable to locate or read the details, vaccine location = Left arm), for COVID-19 Immunization. The following information was reported: APHONIA (non-serious) with onset 22Apr2021, outcome "not recovered", described as "now I am losing my voice."; PRODUCTIVE COUGH (non-serious) with onset 22Apr2021, outcome "not recovered", described as "I have a cough filled with mucus". The events "now i am losing my voice." and "i have a cough filled with mucus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of aphonia, productive cough.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with Covid 19. No known allergies and Other medical history reported for the patient.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscular weakness, Off label use, Product use in unapproved indication
Clinical narrative: Diarrhea; fatigue; muscle weakness; Fever; breastfeeding toddler (13 months); breastfeeding toddler (13 months); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 15:30 (Lot number: Unknown) at the age of 31 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: OFF LABEL USE (non-serious), PRODUCT USE IN UNAPPROVED INDICATION (non-serious) all with onset 21Sep2021, outcome "unknown" and all described as "breastfeeding toddler (13 months)"; DIARRHOEA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Diarrhea"; FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021, outcome "unknown", described as "muscle weakness"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of diarrhoea, fatigue, muscular weakness, pyrexia.  Additional information: No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; fatigue; muscle weakness; Fever; breastfeeding toddler (13 months); breastfeeding toddler (13 months); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 15:30 (Lot number: Unknown) at the age of 31 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: OFF LABEL USE (non-serious), PRODUCT USE IN UNAPPROVED INDICATION (non-serious) all with onset 21Sep2021, outcome "unknown" and all described as "breastfeeding toddler (13 months)"; DIARRHOEA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Diarrhea"; FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021, outcome "unknown", described as "muscle weakness"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of diarrhoea, fatigue, muscular weakness, pyrexia.  Additional information: No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: CHILLS (non-serious), outcome "unknown", described as "chills"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: This consumer reported in response to Non-HCP telephonic activity in cross-referenced case that included Phone-Out 11:12 AM: 2nd attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Consumer did not want to provide mailing address but agree to provide e-mail address instead. She also stated in all three shot she had chills and fever, but with covid booster shot she had a rash like hives for a week and a half.  Follow-up attempts completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: chills; pain where the shot was; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 28Jan2021 (Batch/Lot number: unknown) at the age of 65 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: FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 29Jan2021, outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 28Jan2021, outcome "unknown", described as "pain where the shot was".  Additional information: It is unknown if patient received any other vaccines within 4weeks prior to the first administration date of the suspect vaccine. It is unknown for patient medical history including illness at the time of vaccination. Patient family medical history not provided and unknown for relevant tests.  Follow-up attempts completed. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Vaccination site swelling
Clinical narrative: Had swelling at the injection site, considerable swelling about two and half to three inch; Very sore to touch; Itching in her whole arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 93 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 93 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Second dose), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Had swelling at the injection site, considerable swelling about two and half to three inch"; PAIN OF SKIN (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Very sore to touch"; PRURITUS (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Itching in her whole arm". Therapeutic measures were taken as a result of vaccination site swelling, pain of skin, pruritus.  Additional Information: She had swelling at the injection site, considerable swelling about two and half to three inch, very sore to the touch and she is having itching in her whole arm and it's still persisting today like I said she got the shot early on 01Oct2021 and it's still persisting the day.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: one had a pain in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "one had a pain in the arm".  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: she developed little tiny red bumps like little fire ant bites and they kinda went away.; 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. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune deficiency/tolerance" (unspecified if ongoing); "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "she developed little tiny red bumps like little fire ant bites and they kinda went away.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pain in extremity
Clinical narrative: my arm is still hurting; its hurting so bad; instead of getting better it got worst; today this is the worst it ever felt ever instead of getting better it got worst; Today its hurting like I just got the shot, its hurting so bad, I can't lift my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jun2021 (Lot number: Unknown, Batch number: EW0161) at the age of 47 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Batch ER8733), administration date: 15May2021. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm is still hurting; its hurting so bad; instead of getting better it got worst"; MALAISE (non-serious), outcome "unknown", described as "today this is the worst it ever felt ever instead of getting better it got worst"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Today its hurting like I just got the shot, its hurting so bad, I can't lift my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient reported that that after his shot, second dosage, she got it in June and his arm was still hurting. She reported that she got both vaccine on her left arm. The patient reported that the lot number ER83, she guessed its 33 it was got 2 upon here. She got 2, 33 she thought that's a 3 because it was straighten out now and the 2nd one was L is lot and EW0161 and the first one might be ER8733, it was either 38 or 33. The reported that she got both vaccine on her left arm. The patient reported that a pharmacist give the 1st time and the soldier give the 2nd time. The patient reported that no, and today this was the worst it ever felt ever instead of getting better it got worst. The patient reported that no, she just took a vaccine in the other arm, she thought it was September. Pneumonia, it was the flu shot. No flu but she didn't get in that arm.  Follow-up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: ''I'' have had a chronic headache; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Aug2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 17Sep2021, the patient experienced chronic headache since the day after her last dose. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event chronic headache since the day after her last dose was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (12Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Head problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Head problems".  Additional information: After filing a report on himself, caller stated that he is not the only only at work that is having a problem after receiving the vaccine. States, one guy is having head problems, and he got the Pfizer vaccine too. Caller declined to complete the report for his co-worker stating that he does not even know the dates that the guy got his vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more; With the second one maybe a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more"; FATIGUE (non-serious), outcome "unknown", described as "With the second one maybe a little tired".  Additional information: The patient maybe had a sore arm for 2 days, 3 days max with the second one. With the first one there was nothing to report. With the second one maybe a little tired and arm hurt a little more. The patient had the last shot on 16Mar so it was waning.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101324789 Same patient and drug, different event separated in time
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: felt sick the next day; body ache; sore arm/painful arm; feeling like I could have the flu; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid medication" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder. Vaccination history included: Bnt162b2 (First dose, Lot: E11283 , E1123 or E11283., Anatomical site of administration: Right arm), administration date: 23Jan2021, for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt sick the next day"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/painful arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling like I could have the flu"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: Investigation Assessment: No. Laboratory Test and Treatment for Adverse Event reporter stated as None.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Stopped bleeding; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 17:00 (Lot number: FF3590) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number= EC3184, administration date=13Sep2021,, administration time=04:45 PM  , dose number=1, vaccine location=Left arm), administration date: 13Sep2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "Started menstrual bleeding". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stopped bleeding". Therapeutic measures were not taken as a result of menstrual disorder.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: Armpit, on the site of the injection, after two days, it start to swell; Armpit is swelling; Armpit is swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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 (Dose1, Single), for Covid-19 immunization; Bnt162b2 (Dose2, Single), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Armpit, on the site of the injection, after two days, it start to swell; Armpit is swelling"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Armpit is swelling".  Additional Information: Consumer stated, "I have a concern about the Covid-19, the booster shot. I just have a question about the side effect because I took the booster shot on Monday and my armpit, on the site of the injection, after two days, it starts to swell. So, the armpit is swelling and 'just little bit of that swelling'. So, the patient just wanted to know are these adverse events are normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Illness
Clinical narrative: I got sick from it; I had reactions (voice distorted); 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "MS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 29Sep2021, outcome "unknown", described as "I got sick from it"; DYSPHONIA (non-serious) with onset 29Sep2021, outcome "unknown", described as "I had reactions (voice distorted)". Therapeutic measures were taken as a result of illness, dysphonia.  Additional information: Consumer stated, It says Pfizer 3013OHC. Its kind a hard to read if tell you the truth, may be its 301508 something. It's very hard to read.  Follow-up attempts completed. No further information is expected.The lot/batch number is not available despite the follow-up attempts made.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: have sharp pains and cramping in my abdomen lasting up to about 30 minutes and then it stops; I didn't menstruate until 03Aug2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 17:00 (Lot number: ER8731) at the age of 20 years as dose 1, single and administered in arm right, administration date 24Jun2021 18:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DYSMENORRHOEA (non-serious) with onset 01Jun2021, outcome "unknown", described as "have sharp pains and cramping in my abdomen lasting up to about 30 minutes and then it stops"; MENSTRUATION DELAYED (non-serious) with onset 01Jun2021, outcome "unknown", described as "I didn't menstruate until 03Aug2021.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation delayed.  Additional information: The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination. It was reported as unknown about known allergies. Facility type vaccine was other. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks were none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Suppressed lactation
Clinical narrative: I am not even getting 3 ounces every 12 hours and my breast are not full and have not felt full in over a day; I am breastfeeding. I was pumping a minimum of 25-30 ounces a day to feed my baby, and if I didnt pump every 4 hours I would feel very full and hard on my breasts. 2 days after receiving the first do; I am breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: OFF LABEL USE (non-serious) with onset 05Oct2021, outcome "unknown", described as "I am breastfeeding. I was pumping a minimum of 25-30 ounces a day to feed my baby, and if I didnt pump every 4 hours I would feel very full and hard on my breasts. 2 days after receiving the first do"; PRODUCT USE ISSUE (non-serious) with onset 05Oct2021, outcome "unknown", described as "I am breastfeeding"; SUPPRESSED LACTATION (non-serious) with onset 07Oct2021, outcome "not recovered", described as "I am not even getting 3 ounces every 12 hours and my breast are not full and have not felt full in over a day". Therapeutic measures were not taken as a result of suppressed lactation.  Additional Information: Patient previous pumping a minimum of 25-30 ounces a day to feed her baby, and if she didn't pump every 4 hours she would feel very full and hard on her breasts. On 07Oct2021 at 00:00, 2 days after receiving the first dose, patient was not even getting 3 ounces every 12 hours and her breast were not full and have not felt full in over a day. Patient had to buy formula for baby in order to feed the baby. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications included unspecified pre-natal (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101488763 baby case
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Started with fevers 24 hours after vaccine administration; max temp 105.2 degrees Fahrenheit; Still experiencing fevers 4 days post vaccine administration
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Withdrawal syndrome
Clinical narrative: Rashes; Blisters on arm; Body mimicked symptoms of med withdrawal; Chronic itching problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: RASH (non-serious), outcome "unknown", described as "Rashes"; BLISTER (non-serious), outcome "unknown", described as "Blisters on arm"; WITHDRAWAL SYNDROME (non-serious), outcome "unknown", described as "Body mimicked symptoms of med withdrawal"; PRURITUS (non-serious), outcome "unknown", described as "Chronic itching problem". Therapeutic measures were taken as a result of rash, blister, withdrawal syndrome, pruritus.  Additional information: Patient stated after taking Covid Vaccine she was having a lot of rashes, blisters on arm, and body mimicked symptoms of med withdrawal and extremely patient went to dermatologist and urgent care for treatment and was given Nedrol and Medrol dose patch & Atarax. Patient stated constant she has chronic itching problem. Patient stated she gets contact dermatologist rashes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction; the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (1st dose), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "the chills and little shaking, you know cause I know somebody that took the second shot and they have the same reaction".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (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: HEADACHE (non-serious), outcome "recovered", described as "mild headache"; CHILLS (non-serious), outcome "recovered", described as "chills". Additional information: With the 2nd dose she had mild headache and chills. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Dyspnoea; Fatigue; Pharyngeal Inflammation; Infusion Site Pain; Pain; Infusion Site Bruising; Chills; Asthenia; Feeling Hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil sodium (REMODULIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil (TREPROSTINIL) (Batch/Lot number: unknown) for pulmonary arterial hypertension; warfarin (WARFARIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; macitentan (MACITENTAN) (Batch/Lot number: unknown) for pulmonary arterial hypertension. The patient's relevant medical history was not reported. Concomitant medication(s) included: SILDENAFIL CITRATE. The following information was reported: DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnoea"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PHARYNGEAL INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Pharyngeal Inflammation"; INFUSION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Pain"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain"; INFUSION SITE BRUISING (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Bruising"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Asthenia"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "Feeling Hot". The action taken for macitentan, treprostinil sodium, treprostinil, warfarin and macitentan was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.