chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes under her arms".  Additional information: Patient had her booster shot on Thursday last week, 30Sep2021, she heard about the symptoms of swollen lymph nodes, she asked if this was something to be alert about as she has swollen lymph nodes under her arms.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Pain
Clinical narrative: body aches/ Pains; sick; Not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches/ Pains"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "Not feeling good".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Having some side effects from the second dose; I have given it a week and a half almost and I am getting a little weary about it; The initial case was missing the following minimum criteria: [AE for BNT162B2]. Upon receipt of follow-up information of 05Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FF2587) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Lot FC3183 (manufacturer unknown)), for covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Having some side effects from the second dose; I have given it a week and a half almost and I am getting a little weary about it".  Additional information: It was stated that, patient was calling because she had been having some side effects from the second dose (clarification unknown) and she thought it would go away but it was not going away. Consumer stated, well, she was really concerned about what it was doing to her body (further clarification was unknown).  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "didn't feel good after the Covid booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: sick; not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient 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 (Dose 1, Unknown date), for Covid-19 immunization, reaction(s): "sick", "Not feeling good", "body aches/ Pains". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "not feeling good".  Additional information: the day after the covid vaccine patient was sick and it happened patient have had all 3 shots of Pfizer. After the first shot patient was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot patient just felt terrible the next day patient got the third booster and the next day patient threw up patient was nauseous when patient woke up and a / the day after the covid vaccine patient was sick and it happened patient have had all three shots of pfizer after the first shot patient was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot i just felt terrible the next day patient got the third booster / and the next day I threw up patient was nauseous when patient woke up and a nauseous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vomiting
Clinical narrative: i just felt terrible the next day i got the third booster; I got the third booster and the next day I threw up I was nauseous; I got the third booster and the next day I threw up I was nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (First Dose), for Covid-19 immunization, reaction(s): "body aches"; Bnt162b2 (Second Dose), for Covid-19 immunization, reaction(s): "sick", "not feeling good". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "i just felt terrible the next day i got the third booster"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2021, outcome "unknown" and all described as "I got the third booster and the next day I threw up I was nauseous".  Additional information: The day after the covid vaccine Patient was sick and it happened that she had all three shots of Pfizer after the first shot she was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot she just felt terrible the next day she got the third booster and the next day she threw up and was nauseous when she woke up she was nauseous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: representative; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 44 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: MALAISE (non-serious) with onset 05Oct2021 15:09, outcome "unknown", described as "representative". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I am still having a pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 (Lot number: FF2587) at the age of 50 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am still having a pain.". Therapeutic measures were taken as a result of pain.  Additional Information: Treatment: Consumer stated, "For the Vaccine, I mean the diabetic or the Vaccine problem? Just Tylenol."  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Myalgia, Pain in extremity, Vaccination site swelling
Clinical narrative: swelling on the injection site; Muscle pain; arm pain; Joint pain; Redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 16Aug2021, when the patient was 72 years old, for covid 19 immunization, reaction(s): "no side effects". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling on the injection site"; MYALGIA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "unknown", described as "arm pain"; ARTHRALGIA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Joint pain"; ERYTHEMA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Redness". Therapeutic measures were taken as a result of vaccination site swelling, myalgia, pain in extremity, arthralgia, erythema.  Additional information: Consumer stated, "That I get any medication afterwards. No, I did not get no medication just the injection (Further Clarification Unknown)."  Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine; muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 09:30 (Lot number: EW0217) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose dose number was1, Dose vaccine location on Right arm), administration date: 21Jan2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose dose number was 2, dose vaccine location on Right arm), administration date: 11Feb2021, when the patient was 58 years old, for Covid-19 immunization; Flu shot (other vaccine 4weeks product was flu shot, other vaccine 4weeks vaccine date was23Sep2021, other vaccine 4weeks vaccine location on right arm), administration date: 23Sep2021, when the patient was 59 years old. The following information was reported: MYALGIA (non-serious), FATIGUE (non-serious) all with onset 04Oct2021 16:00, outcome "recovering" and all described as "muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine". Therapeutic measures were not taken as a result of myalgia, fatigue.  Additional information: If covid no prior vaccination and no covid tested post vaccination. No allergies and no medical history.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Right ear Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2021 17:00 (Lot number: EL9269) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Prev dose product=COVID 19, Prev dose brand= Pfizer, Prev dose lot unknown=False, Prev dose lot number= EL0142, Prev dose administration date: 14Jan2021, Prev dose administration time=05:00 PM, Prev dose vaccine location=Right arm, Prev dose dose number=1), administration date: 14Jan2021, when the patient was 54 years old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 06Feb2021, outcome "not recovered", described as "Right ear Tinnitus". The event "right ear tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: The event was treated with Antibiotics and steroids. Facility type vaccine was Hospital. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient did not have Covid prior vaccination and did not Covid tested post vaccination. The patient did not have known allergies. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Vertigo
Clinical narrative: I've had vertigo at random times ever since.; At time of injection there was an immediate tingling sensation throughout the entire lining between my skull and brain that lasted a few seconds; 30 seconds later the room seemed to be swaying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 07Aug2021 10:00 (Lot number: FA7484) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; IRON; ZINC; CALCIUM; POTASSIUM. Past drug history included: Known allergies: penicillin, reaction(s): "Allergy", notes: known allergies: penicillin. The following information was reported: VERTIGO (non-serious) with onset 07Aug2021 10:00, outcome "not recovered", described as "I've had vertigo at random times ever since."; PARAESTHESIA (non-serious) with onset 07Aug2021 10:00, outcome "recovered" (07Aug2021), described as "At time of injection there was an immediate tingling sensation throughout the entire lining between my skull and brain that lasted a few seconds"; DIZZINESS (non-serious) with onset 07Aug2021 10:00, outcome "not recovered", described as "30 seconds later the room seemed to be swaying". Therapeutic measures were not taken as a result of vertigo, paraesthesia, dizziness.  Additional information: Facility where the most recent COVID-19 vaccine was administered Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At time of injection there was an immediate tingling sensation throughout the entire lining between my skull and brain that lasted a few seconds. 30 seconds later the room seemed to be swaying. That lasted a few seconds. However, I've had vertigo at random times ever since. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Relevant Tests: Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Hyperhidrosis, Migraine, Pain in extremity, Vision blurred
Clinical narrative: Heavy Sweating; migraines through out the day and night.; Dry mouth; blurry vision; left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 04Oct2021 11:00 (Lot number: 301458A) at the age of 45 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: HYPERHIDROSIS (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "Heavy Sweating"; MIGRAINE (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "migraines through out the day and night."; DRY MOUTH (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "Dry mouth"; VISION BLURRED (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "blurry vision"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2021 17:00, outcome "recovered" (06Oct2021), described as "left arm soreness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any 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 was not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hypoacusis, Magnetic resonance imaging, Tinnitus
Clinical narrative: 2nd dose: Hearing problems and tinnitus in left ear; 2nd dose: Hearing problems and tinnitus in left ear; concerning to him; high pitched ringing in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FC3183) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BC [ACETYLSALICYLIC ACID;CAFFEINE] taken for headache. Vaccination history included: Bnt162b2 (1st Dose, at around 6pm in Left arm. Lot: FD8448, Expiry/NDC: Unknown), administration date: 13Sep2021, for Covid-19 immunisation, reaction(s): "tinnitus in left ear", "tinnitus in left ear"; Bnt162b2 (1st Dose, at around 6pm in Left arm. Lot: FD8448, Expiry/NDC: Unknown), administration date: 26Aug2021, for Covid-19 immunisation.  The following information was reported: HYPOACUSIS (non-serious), TINNITUS (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "2nd dose: Hearing problems and tinnitus in left ear"; ANXIETY (non-serious) with onset 27Sep2021, outcome "not recovered", described as "concerning to him"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "high pitched ringing in both ears". The events "2nd dose: hearing problems and tinnitus in left ear", "2nd dose: hearing problems and tinnitus in left ear" and "high pitched ringing in both ears" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Hypoaesthesia, Intraocular pressure test
Clinical narrative: left eye started getting numb, the eyelid and then down her face to the top lip, about 1/3 of the mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2021 (Lot number: EC1283) at the age of 78 years as dose number unknown for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Onset date unknown other diagnosed while she was in her 60s.; "Corneal dystrophy", start date: 2007 (ongoing), notes: Chronic condition, probably hereditary; "Allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); ATORVASTATIN taken for hypertension (ongoing). The following information was reported: HYPOAESTHESIA (non-serious) with onset 22Jan2021, outcome "recovered" (22Jan2021), described as "left eye started getting numb, the eyelid and then down her face to the top lip, about 1/3 of the mouth". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 10:00 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HPB, SVT, Hypothyroidism (all treated)" (unspecified if ongoing), notes: Treated; "HPB, SVT, Hypothyroidism (all treated)" (unspecified if ongoing), notes: Treated. Concomitant medication(s) included: FLECAINIDE ACETATE; LISINOPRIL; SYNTHROID. Past drug history included: Anesthesia, reaction(s): "Allergy", notes: no, other than nausea reactions to anesthesia. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Flecainide acetate , lisinopril, synthroid were the medications received within 2 weeks of vaccination. She was not tested positive for COVID prior to vaccination and was not tested positive post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: eyesight problems. Her vision went blurry; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A female patient 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 (took both doses of the Pfizer vaccine about 3-4 months ago), for Covid-19 immunisation. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "eyesight problems. Her vision went blurry".  Additional information: Reporter provided In a qualitative interview, the respondent reported that they knew someone (sister of a friend) who took both doses of the Pfizer vaccine about 3-4 months ago and a couple of weeks after the second dose, she developed eyesight problems. Her vision went blurry and she went to her doctor and had still currently experiencing problems with her eyesight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 10:00 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HPB" (unspecified if ongoing), notes: Hepato-Pancreato-Biliar  (all treated); "Supraventricular tachycardia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE ACETATE; LISINOPRIL; SYNTHROID. Past drug history included: Anesthesia, reaction(s): "Allergy", notes: no, other than nausea reactions to anesthesia. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Arm Left, 10:00 AM), administration date: 10Feb2021, for Covid-19 immunisation, reaction(s): "Fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Arm Left, 10:00 AM), administration date: 10Feb2021, for COVID-19 immunisation, reaction(s): "sore in arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Feeling abnormal, Pain
Clinical narrative: states it feels like a "gas pocket"; nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout; she was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (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: ABDOMINAL PAIN (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout"; PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (Oct2021), described as "she was sore"; FEELING ABNORMAL (non-serious), outcome "recovered" (Oct2021), described as "states it feels like a "gas pocket"". Therapeutic measures were taken as a result of feeling abnormal.  Additional Information: Caller states she received the Pfizer COVID-19 vaccine last Wednesday and on Thursday she was sore. On Saturday, she started having a nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout. She has had the pain since then , and states it feels like a "gas pocket". She has put a waist trainer belt.  She does not have fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: states it feels like a "gas pocket"; nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout; she was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (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: ABDOMINAL PAIN (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout"; PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (Oct2021), described as "she was sore"; FEELING ABNORMAL (non-serious), outcome "recovered" (Oct2021), described as "states it feels like a "gas pocket"". Therapeutic measures were taken as a result of feeling abnormal.  Additional Information: Caller states she received the Pfizer COVID-19 vaccine last Wednesday and on Thursday she was sore. On Saturday, she started having a nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout. She has had the pain since then , and states it feels like a "gas pocket". She has put a waist trainer belt.  She does not have fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Feeling abnormal, Pain
Clinical narrative: Aching pain in the back in my back lower, left side; just achy just annoying achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 (Lot number: 301358A) at the age of 59 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: BACK PAIN (non-serious) with onset 30Sep2021, outcome "unknown", described as "Aching pain in the back in my back lower, left side; just achy just annoying achy". Therapeutic measures were not taken as a result of back pain.  Additional information included: The patient took the Pfizer the First dosage on Wednesday day of last week. patient was aching on Thursday and then since Monday she had this annoying Aching pain in the back in her back lower left side since she got the vaccine done. It's just achy just annoying achy, ligament.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: Aching pain in the back in my back lower, left side; just achy just annoying achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 (Lot number: 301358A) at the age of 59 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: BACK PAIN (non-serious) with onset 30Sep2021, outcome "unknown", described as "Aching pain in the back in my back lower, left side; just achy just annoying achy". Therapeutic measures were not taken as a result of back pain.  Additional information included: The patient took the Pfizer the First dosage on Wednesday day of last week. patient was aching on Thursday and then since Monday she had this annoying Aching pain in the back in her back lower left side since she got the vaccine done. It's just achy just annoying achy, ligament.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling, Vomiting
Clinical narrative: My left foot starts swelling; I am going to throw up holding the phone; I am getting sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FC3183) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemia; "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. Concomitant medication(s) included: CARVEDILOL; FUROSEMIDE. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: FD8448), administration date: 30Aug2021, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My left foot starts swelling"; VOMITING (non-serious), outcome "unknown", described as "I am going to throw up holding the phone"; ILLNESS (non-serious), outcome "unknown", described as "I am getting sick".  Additional information: Consumer stated, "Well, she called her pharmacist because she got her second COVID shot (BioNTech COVID-19 Vaccine) two weeks ago today and about six days ago her left foot starts swelling and she said that some people's wrist and ankles are swollen (Further clarification was unknown, hence split case was not made) to give you all a call because she didn't know how long it lasted. She didn't know how long it lasted or if she should go to the doctor but it's pretty swollen, have you heard of this?" What was the expiration date getting a do with? she does not see the expiration date on the card it was got the two dates. She got it on August 30th (30Aug2021) and September 20th (20Sep2021)." She does not see expiration date, she sees it says next to the date it has RA1987 she don't know what that means and then it has a number of the dose Pfizer FD8448, was that what you are looking for that? That was for 8/20 and then 9/20 was FC3183.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea, Physical examination
Clinical narrative: My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period; My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 11:45 (Lot number: Ff2588) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "3 c sections" (unspecified if ongoing), notes: 3 c sections and a tubal ligation. No other medical problems. other medical history: None.; "tubal ligation" (unspecified if ongoing). There were no concomitant medications. The following information was reported: OLIGOMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 20Sep2021, outcome "not recovered" and all described as "My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period". The event "my menstrual cycle has not stopped. i received my shot 16sep2021. my period was due 17sep2021 it came 20sep2021 to this date 06oct2021 i still have a period" and "my menstrual cycle has not stopped. i received my shot 16sep2021. my period was due 17sep2021 it came 20sep2021 to this date 06oct2021 i still have a period" was 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 oligomenorrhoea, menstrual disorder.  Additional information: No any other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Dysmenorrhoea, Eye disorder, Headache
Clinical narrative: I have been having cramps in my stomach like; menstrual cramp or something; I have been having bloated in the stomach; I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye; From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00; Headache; 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), administration date 04Oct2021 (Lot number: 30155BA) at the age of 60 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 (1st dose, Lot 30135BA), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I have been having cramps in my stomach like"; DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramp or something"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "I have been having bloated in the stomach"; PHOTOPSIA (non-serious), outcome "unknown", described as "I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye"; EYE DISORDER (non-serious), outcome "unknown", described as "From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: The patient got the second shot on yesterday and she was having cramps in her stomach like and menstrual cramp or something and then having bloated in the stomach and seeing a flashing blue and white light flashing, very bright as she drive down the hallway she could see light up in the front of the car and backseat of the car (further not clarified). This ways of flashing light and then when she went into bed last night, she turned all the light off to walk upstairs and this light was so bright it kept coming from her right side of the eye like may be from back of the head to the front of the right eye and it feels freaking today. So she got the shot yesterday 1:00, maybe 01:30 and noticed the flicking of the light starting now after 8:00 and it's feels 6:00 now (not clarified). Patient had headache. Patient stated can somebody talk to her from medical representative or something because her Doctor had no idea what to tell.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: I have been having cramps in my stomach like; menstrual cramp or something; I have been having bloated in the stomach; I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye; From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00; Headache; 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), administration date 04Oct2021 (Lot number: 30155BA) at the age of 60 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 (1st dose, Lot 30135BA), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I have been having cramps in my stomach like"; DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramp or something"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "I have been having bloated in the stomach"; PHOTOPSIA (non-serious), outcome "unknown", described as "I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye"; EYE DISORDER (non-serious), outcome "unknown", described as "From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: The patient got the second shot on yesterday and she was having cramps in her stomach like and menstrual cramp or something and then having bloated in the stomach and seeing a flashing blue and white light flashing, very bright as she drive down the hallway she could see light up in the front of the car and backseat of the car (further not clarified). This ways of flashing light and then when she went into bed last night, she turned all the light off to walk upstairs and this light was so bright it kept coming from her right side of the eye like may be from back of the head to the front of the right eye and it feels freaking today. So she got the shot yesterday 1:00, maybe 01:30 and noticed the flicking of the light starting now after 8:00 and it's feels 6:00 now (not clarified). Patient had headache. Patient stated can somebody talk to her from medical representative or something because her Doctor had no idea what to tell.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature; she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature; His arm is a little sore this morning but he feels good; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A 21 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 05Oct2021 18:15 (Lot number: FC3182, Expiration Date: 31Jan2022) at the age of 21 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2021 18:15, outcome "unknown" and all described as "she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "His arm is a little sore this morning but he feels good".  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: vomiting; nausea; felt sick the next day; 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 28Sep2021 (Lot number: FC3182) at the age of 60 years as booster, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (1st Dose, Lot #  E1123 or E11283, Right arm), administration date: 23Jan2021, for Covid-19 immunization, reaction(s): "arm pain", "sick the next day", "body ache", "feeling like I had the flu"; Bnt162b2 (2nd dose, Lot# E11283, Right arm), administration date: 13Feb2021, for Covid-19 immunization, reaction(s): "feeling like I could have the flu", "sick the next day", "sore arm", "nausea", "body ache". The following information was reported: VOMITING (non-serious) with onset 29Sep2021, outcome "unknown", described as "vomiting"; ILLNESS (non-serious) with onset 28Sep2021, outcome "unknown", described as "felt sick the next day"; NAUSEA (non-serious) with onset 29Sep2021, outcome "unknown", described as "nausea".  Additional information: Consumer stated, she got the 'third' here so with the day, the three day (Not Clarified). Consumer stated, she was a (Privacy). She was a (Privacy)(Hence captured as Consumer or other non health professional). Other Medication included Thyroid medication. Levothyroxine (Further not appropriately clarified hence not captured).Dose of Levothyroxine: 150 mcg. Side effects: Consumer stated, for the first shot 23Jan21 just sick the next day 'meaning' body ache, feeling like she had the flu, arm pain and the same with the second shot 13Feb21. Just sick the next day and then sore arm, painful arm, nausea, body ache feeling like she could have the flu and then the other one 28Sep21 just felt sick the next day nausea, vomiting that was it.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gingival pain, Gingival swelling, Headache, Nausea
Clinical narrative: Gums swelling and pain-mostly above and behind upper two front teeth; Gums swelling and pain-mostly above and behind upper two front teeth; dizziness; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 11:00 (Lot number: 301308A) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; MUCINEX D; FLONASE [FLUTICASONE PROPIONATE]; EFFEXOR. Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=301308A,, prev_dose_lot_unknown=False,, prev_dose_administration_date=14Sep2021prev_dose_administration_time=12:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Right, arm}]), administration date: 14Sep2021, when the patient was 45 years old, for Covid-19 immunization; Influenza ([{other_vaccine_4weeks_product=Infl, uenza,, other_vaccine_4weeks_vaccine_date, =21Sep2021,, other_vaccine_4weeks__vaccine_loca, tion=Lt Arm}]), administration date: 21Sep2021, when the patient was 45 years old. The following information was reported: GINGIVAL SWELLING (non-serious), GINGIVAL PAIN (non-serious) all with onset 05Oct2021 14:00, outcome "not recovered" and all described as "Gums swelling and pain-mostly above and behind upper two front teeth"; DIZZINESS (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "dizziness"; NAUSEA (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of gingival swelling, gingival pain, dizziness, nausea, headache.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: Yes. other vaccine 4weeks details: other vaccine 4weeks product=Influenza, other vaccine 4weeks vaccine date=21Sep2021, other vaccine 4weeks vaccine location=Lt Arm, other medications in two weeks: Effexor, Flonase, Mucinex D, Probiotics  No follow-up attempts are possible. No further information is expected.