chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Absence of menstrual period. I have always been on a regular cycle.; This is a spontaneous report received from a 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 14Sep2021 15:45 (Lot number: 301308A) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Absence of menstrual period. I have always been on a regular cycle.". Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: Dose received: 2, product: COVID 19, brand: Pfizer, brand unknown: False, lot number: 301388A, lot unknown: False, administration date: 05Oct2021, administration time: 16:45 PM, dose number: 2, vaccine location: Left arm.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Insomnia, Limb discomfort, Neck pain
Clinical narrative: Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Can feel where the needle went into her arm; She can't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical location: Right arm), for COVID-19 Immunization. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Constant pain from the left side of her neck, crook of neck, to her elbow on the side she got the vaccine, feels paralyzing"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Constant pain from the left side of her neck, crook of neck, to her elbow on the side she got the vaccine, feels paralyzing"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Can feel where the needle went into her arm"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "She can't sleep". Therapeutic measures were taken as a result of neck pain, arthralgia.  Additional information: She got her last vaccination on 11Sep2021 and she has had constant pain from the left side of her neck, crook of neck, to her elbow on the same side she got the vaccination. She has tried heat, Tylenol and cold and nothing helps. Tylenol was not effective and she took 500mg pills, sometimes up to 4 pills a day. She got the Tylenol packets from the gas station.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Pain in muscles; Aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06Jan2021 (Lot number: EL3246) 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 (1st dose on the 19Dec, Lot#: EJ1685), administration date: 19Dec2020, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Jan2021, outcome "unknown", described as "Pain in muscles"; PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Aches".  Additional information: Nurse was stated, "Let me just tell you, I was a Nurse (hence captured as reporter type) and I got my first Vaccine on the 19Dec and one of the reasons I wanted to do this is to show people that this is a good thing and all that. And a part of that is my responsibility to report any side effects. So, why I am calling you is I got my booster shot on 07Sep and it was (incomplete sentence), the second shot that I had, I had it on 06Jan. It wasn't anything not to be expected pain in muscles, aches and bla-bla-bla. But the third one about 5 hours after I got it. So, that is 07Sep, my arm really hurt, my hand and I actually missed two days of work. I was in a lot of joint pain and muscle pain and all of that and I would have missed 3 days of work. But I just did not want to lose my co-workers. I needed (incomplete sentence), I am training somebody and I have to be there, so I never miss work. So, the thing is like that my joints still are very painful. But especially my left (incomplete sentence) I had the booster on my left deltoid and I can't even hold things, it's like I do not have Arthritis. But this must be how Arthritis feels. So, I cannot hold even simple things, like I cannot hold a bag with my left hand, you know my hands, my thumbs, my fingers, my wrist it feels like somebody beat my hands with a hammer and my knees hurt. Now I am not saying that my knees do not hurt anyway, but 'they hurt a lot' my ankles feels like, all my joints and I was hoping that this would go away but it hasn't. So, I am just telling you that. So, when I started reading online, I am reading online about the incidents of side effects and how long they last and what all you can expect and are not what you can expect (voice not clear) report it. So, I was reporting this to you not that I expect you to do anything about it because can't. I actually was going to see my Primary Care and I was not sure what they can do about it, really nothing. I was not interested in taking any steroids or anything."  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Off label use, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 (Lot number: Fc3184) at the age of 32 years as dose 2, single for Covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 07Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: Metoprolol; Metformin; Pantoprazole; Norethindrone Acetate. Vaccination history included: Bnt162b2 (Dose number: 1, product: COVID 19, Brand: Pfizer, Lot number: FC3183, Administration date: 16Sep2021, Administration time: 10:30 AM, Vaccine location: Left arm), administration date: 16Sep2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine - Influenza 070ct2021"; MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious) all with onset 07Oct2021 12:00, outcome "recovering" and all described as "Very painful Stiff neck on left side"; NAUSEA (non-serious) with onset 07Oct2021 12:00, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of musculoskeletal stiffness, neck pain, nausea. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Tenderness
Clinical narrative: Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 10:45 (Lot number: EW0175) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 22Sep2021; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 08:45 AM), administration date: 21Dec2020, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Right, Vaccine Administration Time: 08:45 AM), administration date: 11Jan2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: TENDERNESS (non-serious), PERIPHERAL SWELLING (non-serious), LIMB DISCOMFORT (non-serious) all with onset 09Oct2021 02:15, outcome "not recovered" and all described as "Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.". Therapeutic measures were not taken as a result of tenderness, peripheral swelling, limb discomfort.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular, Polymenorrhoea
Clinical narrative: Irregular cycle my period came 10 days early and very painful; Irregular cycle my period came 10 days early and very painful; Irregular cycle my period came 10 days early and very painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Sep2021 (Lot number: EW0172) at the age of 47 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 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= ER8737, prev dose lot unknown=False, administrator route=Intramuscular, prev dose administration date=30Aug2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 30Aug2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious), POLYMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious) all with onset 11Oct2021, outcome "unknown" and all described as "Irregular cycle my period came 10 days early and very painful". It was unknown if therapeutic measures were taken as a result of menstruation irregular, polymenorrhoea, dysmenorrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymph node pain, Lymphadenopathy, Myalgia, Pain
Clinical narrative: visibly swollen, painful lymphnode under armpit of left arm; visibly swollen, painful lymphnode under armpit of left arm; achy; diarrhea; soar arm, muscle; soar arm, muscle; possible lymphoma pain under arm; This is a spontaneous report received from a 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 left, administration date 10Oct2021 12:30 (Lot number: FE3590) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Antiphosolipid syndrome" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergy: Latex sensitivity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; WELLBUTRIN. Past drug history included: Known allergies= cephalosporins, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6208, prev dose lot unknown=False, prev dose administration date=20Mar2021 , prev dose administration date=11:30 AM, prev dose dose number=2 , prev dose vaccine location=Left arm), administration date: 20Mar2021, when the patient was 47 years old, for covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6198, prev dose lot unknown=False, prev dose administration date=27Feb2021 , prev dose administration time=12:30 PM, prev dose dose number=1 , prev dose vaccine location=Left arm), administration date: 27Feb2021, when the patient was 47 years old, for covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "achy"; DIARRHOEA (non-serious) with onset 10Oct2021, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 10Oct2021, outcome "not recovered" and all described as "soar arm, muscle"; LYMPH NODE PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "possible lymphoma pain under arm"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "visibly swollen, painful lymphnode under armpit of left arm". Therapeutic measures were not taken as a result of pain, diarrhoea, pain in extremity, myalgia, lymph node pain, lymphadenopathy, lymph node pain.  Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. Patient was not received treatment for AE.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: visibly swollen, painful lymphnode under armpit of left arm; visibly swollen, painful lymphnode under armpit of left arm; achy; diarrhea; soar arm, muscle; soar arm, muscle; possible lymphoma pain under arm; This is a spontaneous report received from a 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 left, administration date 10Oct2021 12:30 (Lot number: FE3590) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Antiphosolipid syndrome" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergy: Latex sensitivity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; WELLBUTRIN. Past drug history included: Known allergies= cephalosporins, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6208, prev dose lot unknown=False, prev dose administration date=20Mar2021 , prev dose administration date=11:30 AM, prev dose dose number=2 , prev dose vaccine location=Left arm), administration date: 20Mar2021, when the patient was 47 years old, for covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6198, prev dose lot unknown=False, prev dose administration date=27Feb2021 , prev dose administration time=12:30 PM, prev dose dose number=1 , prev dose vaccine location=Left arm), administration date: 27Feb2021, when the patient was 47 years old, for covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "achy"; DIARRHOEA (non-serious) with onset 10Oct2021, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 10Oct2021, outcome "not recovered" and all described as "soar arm, muscle"; LYMPH NODE PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "possible lymphoma pain under arm"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "visibly swollen, painful lymphnode under armpit of left arm". Therapeutic measures were not taken as a result of pain, diarrhoea, pain in extremity, myalgia, lymph node pain, lymphadenopathy, lymph node pain.  Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. Patient was not received treatment for AE.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen and painful lymph nodes in armpit; Swollen and painful lymph nodes in armpit; Redness around injection site with slight swelling; Redness around injection site with slight swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 14:15 (Lot number: FF8841) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), subcutaneous, administered in arm right, administration date 08Oct2021 (Lot number: 308435). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EP6955, Anatomical site of injection: Right arm, Route of administration: Intramuscular, prev dose administration date=24Mar2021), administration date: 24Mar2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EL3248, Anatomical site of injection: Right arm, Route of administration: Intramuscular, Prev Dose Administration Date: 04Mar2021), administration date: 04Mar2021, when the patient was 33 years old, for covid-19 immunization. The following information was reported: Lymphadenopathy(non-serious), Lymph node pain(non-serious) all with onset 09Oct2021, outcome "recovered" (11Oct2021) and all described as "Swollen and painful lymph nodes in armpit"; Vaccination site swelling(non-serious) with onset 09Oct2021, outcome "recovering", Vaccination site erythema(non-serious) with onset 09Oct2021, outcome "recovered" (11Oct2021) and all described as "Redness around injection site with slight swelling". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, vaccination site swelling, vaccination site erythema.  Follow-Up (22Oct2021): Follow-up attempts are completed. No further information is expected.  Follow-up (29Nov2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non- HCP letter follow-up activity that includes: Update information: Patient tab: Co suspect added,Event tab: Event outcome & date of recovery updated.  Additional information: Booster dose due to high risk of frequent intuitional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).Prior vaccinations:Manufacturer: SEQIRUS  No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Pain, X-ray
Clinical narrative: L hip bursitis; Pain in my hip; If she tries to walk then that is when it hurts; 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 93 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Oct2021 13:30 (Lot number: 301250A) at the age of 93 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hip replacement" (unspecified if ongoing), notes: One hip replacement was about 10 years ago and the other one was about a year ago, Pertinent Details : Bilateral hip replacements; "Chronic leukocytosis" (ongoing), notes: Illness/AE: Chronic leukocytosis, Stop Date : Ongoing; "Hypothyroidism" (ongoing), notes: Illness/AE: Hypothyroidism, Stop Date : Ongoing; "Hypertension" (ongoing), notes: Illness/AE: Hypertension/Hyperlipidemia, Stop Date : Ongoing; "Hyperlipidemia" (ongoing), notes: Illness/AE: Hypertension/Hyperlipidemia, Stop Date : Ongoing. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose number: 1, Date/Time: 26Jan2021, Time : 11:30AM, Anatomical Site of Injection : Left deltoid, Route of Administration: Intramuscular, Batch/Lot number : EL8982), administration date: 26Jan2021, when the patient was 92 years old, for COVID-19 immunization; Bnt162b2 (Dose number: 2, Date/Time: 16Feb2021, Time : 11:30, Anatomical Site of Injection : Left deltoid, Route of Administration: Intramuscular, Batch/Lot number : EM9810), administration date: 16Feb2021, when the patient was 92 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "Pain in my hip"; PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "If she tries to walk then that is when it hurts"; BURSITIS (non-serious), outcome "unknown", described as "L hip bursitis". The event "pain in my hip" was 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 arthralgia. Additional information: Treatment of adverse event with Steroid shot Tylenol arthritis No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; The caller explains that she has nothing to report other than being tired for about a week after the previous shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 10:30 (Lot number: EN5318) at the age of 61 years as dose 1, single and administered in arm left, administration date 14Feb2021 08:30 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (not ongoing), notes: Verbatim: Osteoarthritis, had for 5 years, done around 2005; "Metal in spine" (unspecified if ongoing), notes: Verbatim: metal in spine; "Metal in both ankles", start date: 2014 (unspecified if ongoing), notes: Verbatim: metal in both ankles, done 2014, she broke both ankles at the same time. There were no concomitant medications. Vaccination history included: Zoster vaccine (Zoster vaccine, the old shingles shot, it was give at her primary care/ this was about 2 years ago.), administration date: 01Jul2018.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Feb2021 08:30, outcome "unknown", described as "inappropriate schedule of vaccine administered"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "The caller explains that she has nothing to report other than being tired for about a week after the previous shots.".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101351823 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 73-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6202), intramuscularly, in left arm, on Mar 29, 2021, at 13:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6204), in left arm, on Mar 8, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient had vaccination site pain (lingering injection site pain/at the injection site it is still very sore and sensitive), onset 2021, with outcome of not recovered. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue, Headache, Insomnia
Clinical narrative: Difficulty sleeping for 3 days; Temperature; Headache; Pain at injection site; Tiredness for 2 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 02Oct2021, outcome "recovered" (05Oct2021), described as "Difficulty sleeping for 3 days"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 02Oct2021, outcome "recovering", described as "Temperature"; HEADACHE (non-serious) with onset 02Oct2021, outcome "recovering", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2021, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "Tiredness for 2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, body temperature abnormal, headache, vaccination site pain, fatigue.   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Oct2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Difficulty sleeping for 3 days; Temperature; Headache; Pain at injection site; Tiredness for 2 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 02Oct2021, outcome "recovered" (05Oct2021), described as "Difficulty sleeping for 3 days"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 02Oct2021, outcome "recovering", described as "Temperature"; HEADACHE (non-serious) with onset 02Oct2021, outcome "recovering", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2021, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "Tiredness for 2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, body temperature abnormal, headache, vaccination site pain, fatigue.   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Oct2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Pain, Product use issue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 14:30 (Lot number: FF2587, Expiration Date: 30Dec2021) at the age of 61 years as dose 3 (booster), 0.3 ml single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose-1, Manufacturer: Pfizer, Lot: Either EN6208 or FN6208, providing from patient record card, EXP: Unknown, Received in left arm), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Eyes started burning a lot", "Sore arm"; Bnt162b2 (dose-2, LOT: EP7533, Dose: Unknown , Received in left arm), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Arm was more sore than the first dose", "Had mild eye burning"; Shingles (Vaccine Name: Shingles, Lot Number: Unknown, Date: 03Sep2021, Second dose schedule for: 03Nov2021), administration date: 03Sep2021; Flu. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "States that he would bet his house on it that it did not go into muscle"; PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "he says that he didn't have soreness really, just a little when he laid on his left side/ Didn't feel a big amount of pain after administration, was just a tap on the arm". The patient underwent the following laboratory tests and procedures: allergy test: normal, notes: Had testing and allergist said it was ok. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel sick; 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 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), outcome "not recovered", described as "feel sick".  Additional Information: It was reported that, she felt fine before she got the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt a little funny after getting vaccine; 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 male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for Covid-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt a little funny after getting vaccine".   Additional information: The patient wanted to know if he really received new Comirnaty and if it was actually FDA approved. Said his DR said new Comirnaty vaccine was not fully approved just the license was approved and it's not even available. Started arguing about him having a medical team on hand and know nothing. Also mentioned his DR wants him to have an EKG just to make sure everything ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very sore arm".  Additional information: Event took place after use of the product.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at the injection site; injection site swelling; injection site redness or swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: ff259oh) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "pain at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 08Oct2021, outcome "unknown", described as "injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Oct2021, outcome "unknown", described as "injection site redness or swollen". Additional event: Complete user utterance for AE: immediated pain at the injection site, followed by injection site swelling, followed by injection site rednessinjection site pain, injection site swelling, injection site redness or swollen   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Swelling of left armpit underneath injection site; Arm feels very heavy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 13:00 (Lot number: FF 2587) at the age of 17 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: PERIPHERAL SWELLING (non-serious) with onset 10Oct2021 18:00, outcome "unknown", described as "Swelling of left armpit underneath injection site"; LIMB DISCOMFORT (non-serious) with onset 10Oct2021 18:00, outcome "unknown", described as "Arm feels very heavy". Therapeutic measures were not taken as a result of peripheral swelling, limb discomfort. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 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.  A 55 year-old female patient received bnt162b2 (COMIRNATY) (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: ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cold with sore throat; Cold with sore throat; Runny nose; It "might just be allergies";  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 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), OROPHARYNGEAL PAIN (non-serious), outcome "unknown" and all described as "Cold with sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "It "might just be allergies"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness traumatic, Ear discomfort, Hypoacusis, Pain
Clinical narrative: pain; clogging sound on her right ear/ it sounds clogged.; She can hear but not well; she notes it is like she has a lot of noise in her ear.; clogging sound on her right ear/ it sounds clogged.; it has gotten worse; 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 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Jun2021 18:00 (Lot number: EW0177) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose- 19May2021, give about 6pm in the right arm, Lot- ER8736), administration date: 19May2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Jun2021, outcome "recovering" and all described as "clogging sound on her right ear/ it sounds clogged."; HYPOACUSIS (non-serious) with onset Jun2021, outcome "recovering", described as "She can hear but not well"; DEAFNESS TRAUMATIC (non-serious) with onset Jun2021, outcome "recovering", described as "she notes it is like she has a lot of noise in her ear."; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "recovering", described as "it has gotten worse". Therapeutic measures were not taken as a result of pain, ear discomfort, hypoacusis, deafness traumatic, condition aggravated, tinnitus.  Additional Information: Caller reporting on receiving the Covid 19 vaccine and who explains that all of a sudden her right ear, she is having difficulty with it but doesn't know how to describe it. It sounds like she is going under a tunnel or on an airplane, like her ear is popping and like she needs to put her finger in ear to clear it, it sounds clogged. This didn't start until the second dose and she has never experienced anything like this before. She has a doctor's appointment at the end of the month but is calling because that is a long time away. It is scaring her, she she going to lose her hearing. She can hear but not well. Have we heard of this happening before. She is looking for recommendations. When describing the event she notes it is like she has a lot of noise in her ear. It is starting to hurt, this is just the right ear. The noise is not really a static sound but like water and ringing. it is hard to describe. She thought she might have gotten water in it from the shower but it has gotten worse. The event - it was very mild in Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: pain; clogging sound on her right ear/ it sounds clogged.; She can hear but not well; she notes it is like she has a lot of noise in her ear.; clogging sound on her right ear/ it sounds clogged.; it has gotten worse; 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 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Jun2021 18:00 (Lot number: EW0177) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose- 19May2021, give about 6pm in the right arm, Lot- ER8736), administration date: 19May2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Jun2021, outcome "recovering" and all described as "clogging sound on her right ear/ it sounds clogged."; HYPOACUSIS (non-serious) with onset Jun2021, outcome "recovering", described as "She can hear but not well"; DEAFNESS TRAUMATIC (non-serious) with onset Jun2021, outcome "recovering", described as "she notes it is like she has a lot of noise in her ear."; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "recovering", described as "it has gotten worse". Therapeutic measures were not taken as a result of pain, ear discomfort, hypoacusis, deafness traumatic, condition aggravated, tinnitus.  Additional Information: Caller reporting on receiving the Covid 19 vaccine and who explains that all of a sudden her right ear, she is having difficulty with it but doesn't know how to describe it. It sounds like she is going under a tunnel or on an airplane, like her ear is popping and like she needs to put her finger in ear to clear it, it sounds clogged. This didn't start until the second dose and she has never experienced anything like this before. She has a doctor's appointment at the end of the month but is calling because that is a long time away. It is scaring her, she she going to lose her hearing. She can hear but not well. Have we heard of this happening before. She is looking for recommendations. When describing the event she notes it is like she has a lot of noise in her ear. It is starting to hurt, this is just the right ear. The noise is not really a static sound but like water and ringing. it is hard to describe. She thought she might have gotten water in it from the shower but it has gotten worse. The event - it was very mild in Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Nothing other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 23Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Nothing other than a sore arm".  Additional information: Patients first 2 Covid shots did not react like third dose, and she was on the same medications and had the same medical problems. Prior Vaccinations (within 4 weeks) was none. she did not want to go to the ER and possibly expose herself to Covid unless it is necessary.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: prolonged site soreness; swelling of lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, She does not know the date of her first, second, or booster dose and does not have lot, ndc, or expiration date to provide for the doses), for COVID-19 immunization; Bnt162b2 (second dose, She does not know the date of her first, second, or booster dose and does not have lot, ndc, or expiration date to provide for the doses), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Sep2021, outcome "unknown", described as "prolonged site soreness"; LYMPHADENOPATHY (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling of lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy.  Follow-up (12Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts 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.