chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in extremities; Onset was slow, but in mid May started to notice numbness / tingling in extremities.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 47-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 10:30 (Lot number: EP7533, Expiration Date: 31Jul2021) at the age of 47 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, Lot number: EN6208, Time: 10:30 AM, Anatomical location: Left arm, Route: Intramuscular Exp. date: 30Jun2021), administration date: 10Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 14Jun2021, outcome "not recovered", described as "numbness in extremities"; PARAESTHESIA (non-serious) with onset 17May2021, outcome "not recovered", described as "Onset was slow, but in mid-May started to notice numbness / tingling in extremities.". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any other medications within 2 weeks of vaccination. Relevant past drug history was none. The patient did not have any Known allergies. Family medical history relevant to AE(s) was no family history related to AE. Relevant tests were None. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported Event: Onset was slow, but in mid-May Date of start of reaction/event: 17May2021 started to notice numbness / tingling in extremities. Most noticeably in my fingers and toes at all temperatures. The sensation is ongoing and most recently affected this morning on my walk into the office and while typing this. Most noticeable when using my hands and feet (i.e., typing, walking, standing, etc.). Illness/AE: Numbness in extremities Onset date: 14Jun2021 Stop date: Ongoing, Pertinent details: Numbness/ tingling hands, fingers, toes. The event did not result in Prolonged Hospitalization Comments/Narrative: Physician recommended (withheld) to improve circulation. Filling effects claim on Pfizer site. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Reading disorder
Clinical narrative: Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.; Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 18:00 (Lot number: EW0177) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild hypertension" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ESCITALOPRAM; TOPIRAMATE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot  number=EW0168, lot  unknown=False, administration  date=15May2021, dose  number=1, vaccine  location=Left arm), administration date: 15May2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: APHASIA (non-serious), READING DISORDER (non-serious) all with onset 22Jun2021, outcome "not recovered" and all described as "Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.". Therapeutic measures were not taken as a result of aphasia, reading disorder.  Additional information: Patient didn't received any vaccination prior covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up 04Aug2021: Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: she was expecting her menstrual cycle, but is 4 days late.; 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 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 13:00 (Lot number: EW0198) at the age of 29 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 (Pfizer Covid 19 Vaccine: First Dose: 11Jun2021, LOT: EW0181, Expiry Date: Unknown, NDC: Unknown, Route, Anatomical Location: Not provided, No. of Previous Doses: one, Date: 11Jun2021, Age at Immunization if date not available: 29 years old), administration date: 11Jun2021, when the patient was 29 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 15Jul2021, outcome "not recovered", described as "she was expecting her menstrual cycle, but is 4 days late.".  Additional information: The patient states it was supposed to be around 15Jul2021, she usually had a 28 day cycle and now it seems to be 31 or something, The patient still waiting. Prior Vaccinations (within 4 weeks) patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Jul2021 22:40 (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), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible. No further information is expected.  Additional information: The reporter mentioned that there was no medical issue or symptoms. She just wanted to know which medication can she take if she would experience symptoms. The reporter was asking if she can take Tylenol or Aspirin for headache in the event that it may happen after having the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: my stomach is just killing me, I mean it is just upset; It just hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 14Jul2021, outcome "unknown", described as "my stomach is just killing me, I mean it is just upset"; ABDOMINAL PAIN UPPER (non-serious) with onset 14Jul2021, outcome "unknown", described as "It just hurts".  Additional information: Patient had the Pfizer shot the 14th and her stomach was just killing her, she meant it was just upset and wanted to know if that a side effect as she did not knew it that was because of the Pfizer shot or what her stomach truly upset on that day and it was been like 14, 15, 16, 17,18, 19, she meant 6 days and also stated "It just hurts, I don't know if it is you know something else is wrong with the stomach bile or it's a side effect from that."(Not further clarified). It was not clarified if lot number is FA6780 and expiration date is 14Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Salivary hypersecretion
Clinical narrative: feel a metallic taste on my tongue; my mouth is dry; when I start talking I produce a lot of saliva; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 18:00 (Batch/Lot number: unknown) at the age of 42 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: DYSGEUSIA (non-serious) with onset 14Jul2021 10:00, outcome "not recovered", described as "feel a metallic taste on my tongue"; DRY MOUTH (non-serious) with onset 14Jul2021 10:00, outcome "not recovered", described as "my mouth is dry"; SALIVARY HYPERSECRETION (non-serious) with onset 14Jul2021 10:00, outcome "not recovered", described as "when I start talking I produce a lot of saliva". Therapeutic measures were not taken as a result of dysgeusia, dry mouth, salivary hypersecretion.  Additional information: Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. The next day, after the vaccination, she started to feel a metallic taste on her tongue. Even when she licked her lips it was as if the metallic taste was also in them. As long as she did not talk, her mouth was dry, but when she started talking she produced a lot of saliva. Other medical history was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Streptococcus test
Clinical narrative: Strep throat; Sore throat; 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 parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (Lot number: EW0202) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 12Jul2021, outcome "recovering", described as "Strep throat"; OROPHARYNGEAL PAIN (non-serious) with onset 06Jul2021, outcome "recovering", described as "Sore throat". The events "strep throat" and "sore throat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal discomfort, oropharyngeal pain.  Additional information: Reporter was concerned because her 16 year old son was scheduled for his second dose of the Pfizer Covid 19 Vaccine tomorrow and was currently taking Amoxicillin for strep throat. Reporter was wondering if they should wait until he was recovered and done with the medication or go ahead and get the second dose of the vaccine tomorrow. Patient was taken to the clinic for a sore throat on 06Jul2021. His strep test was negative. He was given Claritin and took it for a week. Patient was taken back to the clinic for sore throat on 12Jul2021.His strep test was positive. He was placed on Amoxicillin 875mg twice a day, morning and night, for 10 days. Patient had no any Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swollen in her arm; 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 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 13:00 (Lot number: FW0181) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes swollen in her arm". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient had side effect after the first dose of the vaccine.  A 69 year old female patient who received her first dose of the Pfizer COVID-19 vaccine on 30Jun2021 and had lymphadenopathy in her arms. She was scheduled to receive her second dose of the vaccine today 21Jul2021. Caller wants to know if this side effect has been reported and what does it indicate. She had it probably 21 days ago, Her lymph nodes are swollen up in her arm. She was wondering if she should get it again and wants to know what does it indicate Started about 2 days after the shot and occurred probably in the evening. States that it went down. Took some garlic as treatment. States she was not taking any other Concomitant medications, just herbs and Hydrochlorothiazide. History of all previous immunization with the Pfizer vaccine considered as suspect were none, No Prior Vaccinations (within 4 weeks) or Additional Vaccines Administered on Same Date of the Pfizer Suspect, AE(s) following prior vaccinations: None, that she is aware of.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Paraesthesia, Tinnitus
Clinical narrative: Tingling in hands and feet; Tinnitus in left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jun2021 10:45 (Lot number: EW0202) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 30Jun2021, outcome "not recovered", described as "Tingling in hands and feet"; TINNITUS (non-serious) with onset 30Jun2021, outcome "not recovered", described as "Tinnitus in left ear". The events "tingling in hands and feet" and "tinnitus in left ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of paraesthesia, tinnitus.  Addition information: Facility type vaccine was pharmacy or drug store. Patient did not take other vaccine in four weeks and other medications in two weeks. Patient had COVID prior vaccination, patient did not test COVID post vaccination and known allergies was mentioned as none. Reporter stated that, Pfizer product did not have a casual effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes have not gone down, the glands in his neck have been swollen since April; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "not recovered", described as "lymph nodes have not gone down, the glands in his neck have been swollen since April". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: has issue with his face breaking out/with tunnels on face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Lot number: EL8982) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bitten by a dog when he was 5-6 years old" (unspecified if ongoing), notes: bitten by a dog when he was 5-6 years old; "he had growth on his forehead" (unspecified if ongoing), notes: he had growth on his forehead, it was a blemish and it was thicken up, 3/16th of inch and fell off".; "scar" (unspecified if ongoing), notes: he had a scar and it looked like they took a hotdog; "he had the E-coli" (unspecified if ongoing), notes: Clarified that he had the E-coli 10 years before the vaccine. There were no concomitant medications. The following information was reported: SKIN DISORDER (non-serious) with onset 08Apr2021, outcome "not recovered", described as "has issue with his face breaking out/with tunnels on face". Therapeutic measures were taken as a result of skin disorder.  Additional information: Patient stated that he put alcohol on it which brings round smaller things to the surface so they will fall off. Stated that he takes a washcloth and wipes it off. Stated that he had the Pfizer vaccine dated 13Feb2021 and the next one was 24Feb2021. Stated that his face started breaking out and he went to a dermatologist. Stated that he went to DO/Intern and he said no problem. Stated that his face was breaking out and he has tunnels on his face with stuff coming out. Stated that he has a tunnel on one end and the other end with a tail sticking out. Stated that before the tunnels that he took out something like an arrowhead like a triangle that was big on one end fine on other end and tail on it. Doctor said okay since they were not bleeding. Stated that he never had this problem. Stated. Stated that he put alcohol on it which brings round smaller things to the surface so they will fall off. Stated that he takes a washcloth and wipes it off.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node around the left side of his neck; 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 25 year-old male patient received bnt162b2 (BNT162B2), administration date 18Jul2021 (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, SINGLE; Lot number: Not provided), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19Jul2021, outcome "unknown", described as "swollen lymph node around the left side of his neck".  Additional information: The patient had the second dose of the Pfizer-BioNTech COVID-19 Vaccine this Sunday, and the next day he had a swollen lymph node around the left side of his neck. He described it as a "bubble on his neck". He was asking if there was any dietary restrictions or food that he can or cannot eat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: missed their menstrual cycle after their second shot of their COVID 19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  An adolescent female patient (not pregnant) 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 (First Dose), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "not recovered", described as "missed their menstrual cycle after their second shot of their COVID 19 vaccine.". It was unknown if therapeutic measures were taken as a result of menstrual disorder.  Additional information: Reporter reported that she had had three different adolescent females who missed their menstrual cycle after their second shot of their COVID 19 vaccine. Lot unknown reason was reported as not available/provided to reporter at the time of report completion. It was unknown if patient had COVID-19 prior to vaccination or patient was COVID tested post vaccination. It was unknown if patient received treatment for vaccination or not.  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930370 Same reporter/drug/AE, different patient;US-PFIZER INC-202100929375 Same reporter/drug/AE, different patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: after 8 days without a period/she had regular menses until her covid vaccine; Dose1 and Dose2 on 05Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: ER8727) as dose 2, single and administered in arm right, administration date 05Mar2021 17:45 (Lot number: EX6199) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergy: walnuts" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Toradol for drug allergy. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Mar2021, outcome "unknown", described as "Dose1 and Dose2 on 05Mar2021"; MENSTRUAL DISORDER (non-serious) with onset 28Apr2021, outcome "not recovered", described as "after 8 days without a period/she had regular menses until her covid vaccine". The event "after 8 days without a period/she had regular menses until her covid vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient took Prenatal vitamins as Other medications in two weeks. She was on her period at the time of second shot. Her period that began the following month lasted from 28Apr2021- 08Jun2021 after 8 days without a period, it began again on 17Jun2021 and is still currently going. No prior Covid vaccinations. Patient did not tested positive post vaccination. Patient told that she had regular menses until her covid vaccine. No other information, she was only seen 1 time in the office.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Hot flush, Pain, Panic attack
Clinical narrative: panic attacks; painful; depression; hot flashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jul2021 (Lot number: Fa6780) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing); "allergies: Yes, medications no foods" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose number 1, Lot number EW0181, Administration time 10:00 AM, Vaccine location Left arm , ), administration date: 13Jun2021, for Covid-19 Immunisation, reaction(s): "muscles and joints pain scale a nine", "pain all over my body", "muscles and joints pain scale a nine".  The following information was reported: PANIC ATTACK (non-serious), outcome "not recovered", described as "panic attacks"; PAIN (non-serious), outcome "not recovered", described as "painful"; DEPRESSION (non-serious), outcome "not recovered", described as "depression"; HOT FLUSH (non-serious), outcome "not recovered", described as "hot flashes". The events "panic attacks", "painful", "depression" and "hot flashes" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of panic attack, pain, depression, hot flush.  Additional information: Patient took second dose on 10Jul2021 and one week later she started to experience panic attacks and painful hot flashes and depression and patient's body was still experiencing pain all over. It was 21Jul2022 and patient was still experiencing all of these symptoms and they were all increasing. No report whether the patient took any other vaccine in four weeks. Patient had not been diagnose with Covid prior or post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Muscle tightness, Pain
Clinical narrative: whole body is sore; he could not even get up to go to work today/ His legs feel heavy and he couldn't go to work this morning; His muscles are all tightened up; His legs feel heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jul2021 18:00 (Lot number: EW0187) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart problem" (unspecified if ongoing); "stents in heart" (unspecified if ongoing); "chest pain " (unspecified if ongoing), notes: hospitalized . There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 21Jul2021, outcome "recovering", described as "whole body is sore"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "he could not even get up to go to work today/ His legs feel heavy and he couldn't go to work this morning"; MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "unknown", described as "His muscles are all tightened up"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "His legs feel heavy".  Additional information: Patient was hospitalized for chest pain with a history of heart disease and cardiac stents placed prior to hospitalization and vaccination. Patient was admitted for observation and cardiac work up. Patient received first dose of the Pfizer Covid 19 vaccine on 21Jul2021 before being discharged from the hospital and reporting that whole body was sore and muscles are tightening up. The patient have an doctor's appointment at morning but patient could not even get up to go to work. The report was not related to a study or programme. NDC number and expiry date were reported as unknown. The body soreness started about 10PM or 11:00PM on 21Jul2021. When he woke up this morning he could barely walk. He was supposed to be walking regularly. He wouldn't say that it hasn't improved. He was not sure about getting the second dose. They did stress test, drew lots of blood, and he stayed overnight.  The next morning when he was being discharged, he asked about the vaccine and they gave it to him.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Myalgia
Clinical narrative: 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), administered in arm left, administration date 14Apr2021 13:00 (Lot number: EW0150) at the age of 57 years as dose 2, single and administered in arm left, administration date 24Mar2021 15:00 (Lot number: EP7534) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; VITAMIN B12 [CYANOCOBALAMIN]; MAGNESIUM; COQ10 [UBIDECARENONE]; MULTIVIT [VITAMINS NOS]. Past drug history included: Cipro, reaction(s): "Allergies: Cipro". The following information was reported: MYALGIA (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "muscles hurt like never before/ leg muscles hurt"; FATIGUE (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "tired/ physically very tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, fatigue. Additional information: The patient had a vaccine on 23Mar2021. Approximately 12hrs her leg muscles hurt physically very tired. This has continued still have problem today some good day but still bad day. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discolouration
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68 year-old male patient received bnt162b2 (BNT162B2) at hospital, administered in arm right, administration date 30Mar2021 (Lot number: EN6208) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "disabled" (unspecified if ongoing), notes: Reporter type: Consumer stated, "No I am a disabled Veteran.". The patient took concomitant medications. Vaccination history included: Bnt162b2 (LOT# For First Shot: EN6199, Right arm both times, same spot."), administration date: 05Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 15Jul2021, outcome "not recovered", described as "Where I had the injection at is a small dark grey slash black spot"; PAIN IN EXTREMITY (non-serious) with onset 15Jul2021, outcome "not recovered", described as "Arm is sore like it was right after I got the shot". Therapeutic measures were not taken as a result of vaccination site discolouration, pain in extremity. Additional information : The patient had no other vaccination in 4 weeks prior to COVID 19 Vaccine. Also stated that he have labs and doctor's appointments all the time. Treatment- Consumer stated, "No, I am going to call my primary care tomorrow and notify about this. "Other Medical Condition- Consumer stated that he had got a lot of medical condition, he was 100% disabled. Would have to be on the phone for an hour if he tells about all his medical condition. About Concomitant medicine, Consumer stated that he takes like 25 prescriptions a day, would be another hour for that. Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: Headache; insomnia; Minimal arm pain for both doses; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2021 08:30 (Lot number: EL8982) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "recovered" (2021), described as "Minimal arm pain for both doses"; HEADACHE (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "Headache"; INSOMNIA (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "insomnia". Therapeutic measures were not taken as a result of pain in extremity, headache, insomnia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient also received second dose on 09Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling drunk, SARS-CoV-2 test
Clinical narrative: It is like her mind is still in the daydream; She is still a little out of it./This feeling was very strange; It was like she was drunk, and everything was moving slow; Dizziness; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100941075 (Pfizer).  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 09:29 (Lot number: EWO168) 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. The following information was reported: DIZZINESS (non-serious) with onset 23Jul2021 09:44, outcome "recovering", described as "Dizziness"; ASTHENIA (non-serious) with onset 23Jul2021, outcome "recovering", described as "Weakness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "It is like her mind is still in the daydream; She is still a little out of it./This feeling was very strange"; FEELING DRUNK (non-serious), outcome "unknown", described as "It was like she was drunk, and everything was moving slow". The event "dizziness" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Reporter reported that the symptoms seem to have stayed at a baseline now. She reports that after the event she was looking over the paper work that was given to get after the vaccine and it lists dizziness and weakness as severe side effects. She relayed that it doesn't say if it is severe dizziness and weakness or mild that is considered to be a severe side effect. She would like to know if she is going to be okay. She has no medical history. She has been allergic to fish since childhood. She takes no medications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness in my right leg/foot 8 weeks post vaccination; tingling and numbness in my right leg/foot 8 weeks post vaccination; 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 (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), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "tingling and numbness in my right leg/foot 8 weeks post vaccination".  Additional information: Patient got both doses of the vaccine. Patient was skinny with no medical history or circulating problems. She have noticed tingling and numbness in her right leg/foot 8 weeks post vaccination. E-transmitting AE. reporter refused to provide any demographics. The line got disconnected as she mentioned the side effects she had post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Consumer reported in response to Non-HCP follow-up letter sent in cross reference case.   A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 11:40 (Lot number: EW0161) at the age of 28 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for Allergies: hives, notes: Allergies: Amoxicillin, hives. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27May2021 (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: ILLNESS (non-serious), outcome "unknown", described as "she got sick".  Additional information: Patient was scheduled to take the 2nd dose last 18Jun however she got sick then she called the facility and they told her that she still has 45 days after the 1st dose to get the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: his body does not feel right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (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: MALAISE (non-serious) with onset Jul2021, outcome "unknown", described as "his body does not feel right". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness for a couple seconds and happen 10 to 15 times a day/LIght headedness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 09:30 (Lot number: ER8731) at the age of 38 years as dose 1, single and intramuscular, administered in arm left, administration date 13May2021 09:20 (Lot number: ELU0176) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Aspirin for Aspirin:Allergy. The following information was reported: DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (2021), described as "Dizziness for a couple seconds and happen 10 to 15 times a day/LIght headedness". The event "dizziness for a couple seconds and happen 10 to 15 times a day/light headedness" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of dizziness.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. Device date: 24Jul2021. AE term: 5-6 weeks. Treatment: The physician wanted to do more testing. Approximately 2 days after the 1st vaccine she experienced dizziness/light headedness for a few seconds - it happened 10-15 times a day. The dizziness / light-headedness stopped about 2 weeks after her second dose. She never had issues with either dizziness or light-headedness except when she received the vaccine. Honestly, she thought this side effect was actually worse than when she had covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Periods have been heavy and more frequent, with about 3 per month; Periods have been heavy and more frequent, with about 3 per month; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Mar2021 (Lot number: ER2613) at the age of 46 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 (Product: COVID 19, Brand: pfizer , Lot number: en6198  , Lot unknown: False, Administrator route: Intramuscular , Administration date: 04Mar2021 , Dose number:1, Vaccine location: Right arm), administration date: 04Mar2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), POLYMENORRHOEA (non-serious) all with onset 04Apr2021, outcome "not recovered" and all described as "Periods have been heavy and more frequent, with about 3 per month". Therapeutic measures were not taken as a result of heavy menstrual bleeding, polymenorrhoea.  Additional information: The patient had not covid prior vaccination. The patient had not tested covid post vaccination. The patient had no known allergies. Adverse event: Patient currently has IUD - prior to vaccination- periods light to non existent. Post vaccination- periods have been heavy and more frequent, with about 3 per month. No other vaccine in four weeks. Patient was tested covid positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia
Clinical narrative: Repeated hypoglycemic episodes beginning sitting in 30 minutes of shot continuing off and on for seven days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 17:30 (Lot number: ER8729) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypoglycaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: HYPOGLYCAEMIA (non-serious) with onset 09Jul2021 18:00, outcome "recovering", described as "Repeated hypoglycemic episodes beginning sitting in 30 minutes of shot continuing off and on for seven days.". Therapeutic measures were not taken as a result of hypoglycaemia.  Additional information: The patient did not received any other vaccine in four week and received Asea redox medication in two weeks. The patient doesn't have Covid prior to the vaccination and doesn't tested for Covid post vaccination. Facility where vaccine was administered Doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 19:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tenseness at injection site"; DIZZINESS (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "waves of faintness"; FATIGUE (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tiredness"; OROPHARYNGEAL PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "red sore throat"; RHINORRHOEA (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "runny/stuffy nose". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, dizziness, fatigue, oropharyngeal pain, rhinorrhoea. Additional information: Other medications in two weeks: multivitamin, meloxicam. No other vaccine was administered in four weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.