chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; diarrhea/Have the urge to go to the bathroom every hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 14:45 (Lot number: 30145BA) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Acid Reflux(GERD)" (unspecified if ongoing), notes: Acid Reflux(GERD). Concomitant medication(s) included: TYLENOL; PEPCID AC. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone". The following information was reported: NAUSEA (non-serious) with onset 20Oct2021 19:15, outcome "not recovered", described as "Nausea"; DIARRHOEA (non-serious) with onset 20Oct2021 19:15, outcome "not recovered", described as "diarrhea/Have the urge to go to the bathroom every hour". Therapeutic measures were not taken as a result of nausea, diarrhoea.  Additional information: Patient did not receive any vaccination within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: General malaise from booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "General malaise from booster shot".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 (Lot number: EN6203) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma, takes 2 eye drops for Glaucoma but does not know the names; "bee allergies" (unspecified if ongoing), notes: caller has a bee allergies and was desensitized years ago. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose:01, Anatomical location: right arm, lot number: EL9264), administration date: 06Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "tired".  Additional information: No additional vaccines administered on same date of the Pfizer Suspect. AE(s) did not require a visit to emergency room and physician office. No prior vaccinations within 4 weeks. AE(s) not following prior vaccinations. No relevant tests. It was reported that, patient was just tired after the first two shots. The caller clarifies and confirms that he was only tired after the second and third dose. After the second dose the caller was tired on 27Feb2021 but he recovered completely before receiving the third dose.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101410976 Same patient, same drug with different dose, different AE
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558).  A 40-year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunizations. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "little sick".  Description of complaint:  Patient got the vaccines in Sep2021, three weeks apart. With the first dose, patient did get a little sick and that was fine. Patient got a call from the pharmacy today stating the second dose batch was bad. The battery pack went down so the second shot was no good, it was bad. Pharmacy advised she can come in to redo the second COVID-19 Vaccine. In eight weeks, patient must get the booster.patient doesn't want to come in for another shot. Caller advised patient to get an antibody test.  Patient is a schoolteacher and in eight weeks must get the booster. Caller states this would be four COVID-19 Vaccine shots.  Caller states this would be four COVID-19 Vaccine shots. Caller declined to complete report. Full details.  Additional information: Caller states that withheld called her granddaughter who is a schoolteacher, saying her second dose was a bad batch, that the battery pack went down, and it was no good. Caller states withheld said she could come in and get an additional dose, but also her school is saying she needs a booster dose and that is 4 shots. Caller states she is not sure of the dates but in early Sep she got the second shot and was fine had a headache, some symptoms which was good it works. Caller states today she got a phone call from withheld saying the second shot was not good because the battery went out in the refrigerator and to come in for another shot. Caller states that withheld said it was 8 days of bad vaccines and that's a lot of people. Caller asks if she should wait and get an antibody test or wait and get a booster? Caller states she had it in Sep and they just figured it out today? She states it shouldn't have happened and they should've monitored it, what happens if she gets another dose?   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Nov2021) 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Oxygen saturation, Tenderness
Clinical narrative: tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Lot number: EL0142) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glucose intolerance" (ongoing); "Hyperlipidemia" (ongoing); "Hypothyroid" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: BIOTIN; CHOLECALCIFEROL; GINGER [ZINGIBER OFFICINALE]; LEVOTHYROXIN; METFORMIN; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; PREBIOTICS NOS;PROBIOTICS NOS. The following information was reported: TENDERNESS (non-serious), outcome "unknown", described as "tenderness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Nothing in her life has changed, medication, foods, nothing. She did have tenderness after the first injection, more than after the second or the booster. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: I had persistent cough and cold symptoms for the week after; I had persistent cough and cold symptoms for the week after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Sep2021 12:45 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Lot unknown reason: Not available/provided to reporter at the time of report completion, Vaccine Administration Time: 12:30 PM), administration date: 21Aug2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: COUGH (non-serious), NASOPHARYNGITIS (non-serious) all with onset 12Sep2021, outcome "recovered with sequelae" (2021) and all described as "I had persistent cough and cold symptoms for the week after". Therapeutic measures were not taken as a result of cough, nasopharyngitis.  Additional information:lot unknown reason=Not available/provided to reporter at the time of report completion.if other vaccine in fourweeks: No.other medications in two weeks: 25 mg metoprolol.ae resulted in: None of the above.if patient recovered: Recovered with lasting effects.if covid prior vaccination: No. if covid tested post vaccination: No.known allergies:No.other medical history: No.   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: Fatigue, Loss of personal independence in daily activities, Vision blurred
Clinical narrative: My eyes started to feel blurry after injection date/ reduced ability to see or read documents; Tiredness; unwanting to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Oct2021 19:00 (Lot number: 320308D) at the age of 31 years as dose 1, single and intramuscular, administered in arm left, administration date 09Nov2021 (Lot number: FH8028) as dose 2, single for covid-19 immunization. Relevant medical history included: "Schizophrenia diagnosed by doctor; but not confirmed or accepted by patient" (unspecified if ongoing), notes: Schizophrenia diagnosed by doctor; but not confirmed or accepted by, patient. There were no concomitant medications.The following information was reported: VISION BLURRED (non-serious) with onset 20Oct2021, outcome "recovered", described as "My eyes started to feel blurry after injection date/ reduced ability to see or read documents"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "Tiredness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "recovered" (2021), described as "unwanting to work". Therapeutic measures were not taken as a result of vision blurred.  Additional information: Patient did not take other vaccine in four weeks or other medications in two weeks.The patient did not test positive for COVID prior vaccination and post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Ocular discomfort
Clinical narrative: My eyes have been really dry lately. It has caused me to blink much harder; My eyes have been really dry lately. It has caused me to blink much harder; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 14:30 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRY EYE (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 11Oct2021 12:00, outcome "not recovered" and all described as "My eyes have been really dry lately. It has caused me to blink much harder". Therapeutic measures were taken as a result of dry eye, ocular discomfort.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual periods following two months. Early period first month after, then period for a day, then disappeared, then full period again 12 days later.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 15:00 (Lot number: EWO217) at the age of 14 years as dose 1, single and administered in arm left, administration date 18Aug2021 03:00 (Lot number: EWO185) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 11Aug2021 16:00, outcome "not recovered", described as "Irregular menstrual periods following two months. Early period first month after, then period for a day, then disappeared, then full period again 12 days later.". The event "irregular menstrual periods following two months. early period first month after, then period for a day, then disappeared, then full period again 12 days later." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: No other vaccine in four weeks, No Other medications in two weeks, No Covid prior vaccination, No Covid tested post vaccination, No known allergies, No Other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Sudden onset hot; chills; fever; headache; body aches; fatigue; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 17:30 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Adhesive, reaction(s): "Allergy". The following information was reported: FEELING HOT (non-serious) with onset 2021, outcome "not recovered", described as "Sudden onset hot"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of feeling hot, chills, pyrexia, headache, pain, fatigue, asthenia.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been COVID tested post vaccination as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Sudden onset hot; chills; fever; headache; body aches; fatigue; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 17:30 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Adhesive, reaction(s): "Allergy". The following information was reported: FEELING HOT (non-serious) with onset 2021, outcome "not recovered", described as "Sudden onset hot"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of feeling hot, chills, pyrexia, headache, pain, fatigue, asthenia.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been COVID tested post vaccination as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced peripheral swelling (arm swollen big/arms got real big), and musculoskeletal stiffness (arms got real big/really tight and hard), with outcome of unknown. Additional information: Patient stated, "My arm is swelling big. It is getting pretty big. It is my first dose and my arms got real big. It is really tight and hard." Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Back of brain got really hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101418174 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:30 (Lot number: FF8841) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE (ongoing); CBD OIL (ongoing). The following information was reported: FEELING HOT (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Back of brain got really hot".  Additional information: Prior Vaccinations (within 4 weeks) was none. Patient enquired about any deaths and also he want to know about fluid in the brain. Patient received response about the information pertaining to side effects in the head were headaches. She Referred to HCP. Patient enquired about second dose and she was worried about it that she was supposed to got on 03Nov.Patient also took Vitamins as Concomitant medication(s).  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Muscle contractions involuntary, Muscle twitching, Vaccination site pain
Clinical narrative: injection site (left arm) soreness; This symptom is a daily occurrence and gets worse when patient is at rest.; anxiety; Fasciculation; muscle twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Oct2021 09:15 (Lot number: EW0186) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: SETLAKIN taken for contraception. Past drug history included: Amoxicillin, reaction(s): "Rash"; Compazine, reaction(s): "dystonic"; Ambien, reaction(s): "paresthesia". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 13Oct2021, outcome "not recovered", described as "muscle twitching"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site (left arm) soreness"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "This symptom is a daily occurrence and gets worse when patient is at rest."; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Fasciculation". Therapeutic measures were taken as a result of anxiety.  Additional information: On 13Oct2021, she started to have muscle twitching (Fasciculation) in her left tricep. This happens randomly throughout the day especially at rest. This has been happening every day since with the severity varying from a few minutes once or twice during the day to frequently during the day causing issues especially at night with sleep. Patient have not seen a physician yet because she was hoping this may not be related to the vaccine but rather anxiety related to receiving the vaccine and a very busy work schedule onto of other things. In an attempt to try to remedy this, she had tried to increase my water intake along with magnesium and calcium levels. So far nothing has completely resolved the issue although she do find that by targeting that muscle group through weight lifting will alleviate the symptoms for a longer period of time. Prior vaccinations (within 4 weeks): None  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: just a sore arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 11:00 (Lot number: FD0809) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose lot number=EL9265, prev dose administration date=24Feb2021, prev dose administration time=10:00 AM, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 24Feb2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (prev dose lot number=EL1284, prev dose administration date=14Jan2021, prev dose administration time=10:00 AM , prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 14Jan2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "just a sore arm.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and patient was tested for COVID-19 post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: the site hurts if she touches it/she also has an itchy and a sore sensation; she had developed redness in the site of the injection that has the shape of an octagon,; she also has an itchy and a sore sensation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 18Oct2021 (Batch/Lot number: unknown) 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; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Oct2021, outcome "unknown", described as "the site hurts if she touches it/she also has an itchy and a sore sensation"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Oct2021, outcome "unknown", described as "she had developed redness in the site of the injection that has the shape of an octagon,"; VACCINATION SITE PRURITUS (non-serious) with onset 18Oct2021, outcome "unknown", described as "she also has an itchy and a sore sensation". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema, vaccination site pruritus.  Additional information: The patient received her booster dose of the Pfizer´s COVID-19 vaccine, she wanted to know if she should be concerned about her side effects or if these will go away. She received the dose 4 days ago (on Monday) since then she had developed redness in the site of the injection that has the shape of an octagon, she also had an itchy and a sore sensation, the site hurts if she touches it. Reporter declined to get transferred to the as she wanted to wait a couple of days to see how her side effects would evolve. Reporter mentioned that she had been using Hydrocortisone on the site of the injection but it had not worked.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulse abnormal, Vaccination site pain, Vaccination site swelling
Clinical narrative: Heart palpitations; pulse felt stronger on my wrist when I checked it. It was "pounding sort of".; Sore and swollen are where she had the injection; Sore and swollen are where she had the injection; 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 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 07Oct2021 (Batch/Lot number: unknown) 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: PALPITATIONS (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "Heart palpitations"; PULSE ABNORMAL (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "pulse felt stronger on my wrist when I checked it. It was "pounding sort of"."; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "Sore and swollen are where she had the injection". Therapeutic measures were not taken as a result of palpitations, pulse abnormal, vaccination site pain, vaccination site swelling.  Additional information: The caller stated she has had no symptoms yesterday and today. These side effects lasted 10-11 days. She didn't treat it; she took more deep breaths to try to relax about it. She said that she hadn't had them for the last two days, so she guesses it got better, but it took a while. She had concerns about getting the second dose. Caller was due for 2nd vaccine dose on 28Oct2021 and asked if other people had these symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Impaired work ability, Investigation, Pain in extremity
Clinical narrative: leg pain; balance problems; dizziness; hasn't been able to work in the past week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Sep2021 (Lot number: FE3592, Expiration Date: 10Oct2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, LOT: FC3184 and EXP: Oct2021, Anatomical location: left arm), administration date: 20Aug2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "leg pain"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "balance problems"; DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "dizziness"; IMPAIRED WORK ABILITY (non-serious) with onset 2021, outcome "not recovered", described as "hasn't been able to work in the past week". The events "leg pain", "balance problems", "dizziness" and "hasn't been able to work in the past week" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, balance disorder, dizziness.  Additional information: Since vaccination, she had leg pain, balance problems and dizziness. They went to ER, and they gave her medication, caller wasn't sure what it was and they wrote prescription to go by store pharmacy to pick up. The reporter said it was unknown what meds were given to her at the ER, which she went there on 15Oct2021. She has not gotten any better, patient hasn't been to work. She had already seen their HCP who said her symptoms were caused by the vaccine.  Caller wanted to know if these have been reported before, and how long to expect them to last.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic response unexpected
Clinical narrative: After both doses in spring she was no longer immunocompromised.; This is a spontaneous report received from a non-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) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; hydrocortisone acetate, neomycin sulfate, polymyxin b sulfate (CORTISPORIN) (Batch/Lot number: unknown). Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After both doses in spring she was no longer immunocompromised.". The action taken for hydrocortisone acetate, neomycin sulfate, polymyxin b sulfate was unknown.  Additional information: Talking about booster shot. Has always been considered immunocompromised. Took her and Dr along time to decided if caller should get covid vaccine. After both doses in spring she was no longer immunocompromised. Also had booster shot about week ago or so. Hasn't noticed anything about it in news but would like to know for those getting booster, wondering what level of protection they have after 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: Neurological symptom, Small fibre neuropathy
Clinical narrative: small fiber neuropathy; neurological condition; 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 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: chronic fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Oct2021 15:30 (Lot number: 301358A) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE, administration date 17Oct2021; LISINOPRIL AND HYDROCHLORTIAZIDE; METHYLPREDNISOLONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Oct2021 15:30, outcome "recovered" (2021), described as "chronic fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional Information: patient received within 2 weeks of vaccination: Lisinopril hctz 20/12.5mg and Methylprednisolone 4mg and  Patient reported that they experienced chronic fatigue post 48hrs of receiving COVID-19 booster. No covid prior vaccination and No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: insomnia; pain in the left arm; fatigue; general body pain and aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 10:00 (Lot number: FF841) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA, administration date 06Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "insomnia"; PAIN IN EXTREMITY (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "pain in the left arm"; FATIGUE (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "general body pain and aches". Therapeutic measures were not taken as a result of insomnia, pain in extremity, fatigue, pain. Additional information: Other vaccine 4weeks product Influenza, other vaccine 4weeks vaccine date 20Oct2021. No Covid prior vaccination, Covid not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 02:00 (Lot number: EW0217) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, No Events reported), administration date: 25Feb2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, No Events reported), administration date: 02Feb2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 21Oct2021 11:30, outcome "not recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional Information: Flu like symptoms includes headache, chills and achiness.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. No allergy reported. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination patient has not been tested for Covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Loss of personal independence in daily activities
Clinical narrative: sick; Patient couldn't drink; head hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-153964, 115262.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (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 (First Dose), administration date: Apr2021, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "sick"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Patient couldn't drink"; HEADACHE (non-serious) with onset May2021, outcome "recovered" (May2021), described as "head hurt so bad". Additional information:Patient got first shot in Apr and second shot in May for the Pfizer vaccine. Patient said that she was sick for a day after second dose. Patient couldn't drink, her head hurt so bad. This lasted for 24-48 hours, and then she was fine. Patient didn't have the vaccination card to provide full info on the shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: Have like loss of voice; Lost my voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF8841) 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: APHONIA (non-serious) with onset Oct2021, outcome "unknown", described as "Have like loss of voice; Lost my voice".  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Pain, Pain in extremity
Clinical narrative: body aches and pretty much both arms mostly in bilateral upper extremities/specifically like mid-day when it get worse and it started like wrist and elbow pain; body aches and pretty much both arms mostly in bilateral upper extremities/specifically like mid-day when it get worse and it started like wrist and elbow pain; body aches and pretty much both arms mostly in bilateral upper extremities/specifically like mid-day when it get worse and it started like wrist and elbow pain; body aches and pretty much both arms mostly in bilateral upper extremities/specifically like mid-day when it get worse and it started like wrist and elbow pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 31 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 27Sep2021 (Lot number: WM1247) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Guillain-Barre" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PROXIFEN 65. Vaccination history included: Bnt162b2 (Dose:01), administration date: 09Jan2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose:02), administration date: 30Jan2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "body aches and pretty much both arms mostly in bilateral upper extremities/specifically like mid-day when it get worse and it started like wrist and elbow pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain, arthralgia.  Additional Information:The patient stated that was no weakness, numbness, no pain going, just body aches. She was taking Ibuprofen as treatment medication. No prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This 46-year-old male consumer (patient) reported for himself that:  A 46 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration administered in arm left, administration date 15Oct2021 12:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Facility type vaccine; Pharmacy or Drug Store. The patient's relevant medical history was not reported. There were no concomitant medications. If other vaccine in four weeks: No, Other medications in two weeks: No. Past drug history included: Naproxen, reaction(s): "Drug allergies: Naproxen", notes: known allergies: Naprosen. The following information was reported: RASH  with onset 16Oct2021 12:00, outcome "not recovered", described as "Rash all over my body". The event "rash all over my body" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Most recent dose details: Product; COVID 19, Brand unknown; True, Brand name unknown=COVID19Vaccine, Lot unknown; True, Lot unknown reason; Not available/provided to reporter at the time of report completion, Dose number; 2.  Previous dose details: Prev dose product; COVID 19, Prev dose brand; unknown, Prev dose brand name unknown; COVID19 Vaccine, Prev dose lot unknown; True, Prev dose lot unknown reason; Not available/provided to reporter at the time of report completion. Prev dose administration date; 15Oct2021, Prev dose administration time; 12:00 PM, Prev dose number; 1, Prev dose vaccine location; Left arm.  Adverse event: Rash all over my body. No news or reports covering this as it seems you are ignoring patients. A simple internet search shows this isn't a rare occurrence amd doctors seem to act ignorant to the facts. Also seems like you don't want these reported as I'm struggling to get this reported with your forms. Adverse event start date: 16Oct2021, Adverse event start time: 12:00 PM, Adverse event country: (Privacy), Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Not recovered, If treatment ae: Yes, Ae treatment: Antihistamine amd steroid cream which was useless. If covid prior vaccination: No, If covid tested post vaccination: No, Other medical history: None. The lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts completed. No further information is expected.