chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: foggy vision/black and looked smoky.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 06Apr2021 11:00 (Lot number: EP6955) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Really high eye pressure", start date: 2008 (ongoing). Concomitant medication(s) included: LATANOPROST taken for intracranial pressure increased. Past drug history included: Xalatan. The following information was reported: VISION BLURRED (non-serious) with onset 06Apr2021, outcome "not recovered", described as "foggy vision/black and looked smoky."  Additional information: First dose: foggy vision: The caller received the first dose, could see ahead further in the distance a fog. The caller states in the further distance was kind of black and looked smoky. Caller clarifies this occurred after receiving the first dose Adult Pfizer Covid 19 Vaccine. The caller states caller's vision got foggy. The caller told his wife things looked foggy and when caller drives, caller can see further in the distance like black, kind of like smoke and if caller was wearing sunglasses. The caller used Xalatan eye drops and the caller switched to Latanoprost a couple of months ago or switched a year or so ago. The caller clarifies the caller was taking Xalatan a year ago and was not using Xalatan two weeks prior to receiving the Adult Pfizer Covid 19 Vaccine. The caller was taking Latanoprost when the caller received the Adult Pfizer Covid 19 Vaccine. The caller states Xalatan and Latanoprost are the same eye drop. The caller was taking the minimum dose of Latanoprost 0.1 of 0.5, really low. The caller does not know the units on the dose provided. No further information provided. No, additional vaccines administered on same date of the Pfizer suspect. No, the caller had never taken any vaccines but the Adult Pfizer Covid Vaccine, he was not sure about when caller was little. No, AE prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Lot number: FL8095) at the age of 8 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: FK5618, NDC and Expiry Dates for the patient's vaccines are unknown), administration date: 09Dec2021, when the patient was 8 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Headache".  Additional Information: Caller states that she was calling about the shot that her 8 year old son got the second dose of yesterday. States that her son had a headache now and she wants to know if he can take Tylenol. Caller denies any other medication, medical conditions, labs, testing, or treatments for her son relevant to these events. No There were no other products, patient history and investigation assessment  No follow-up attempts are possible. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: I am so nauseous; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jul2021 (Lot number: SA6780) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Loose stools" (unspecified if ongoing). Concomitant medication(s) included: NAMZARIC; CREON; TAMSULOSIN; SEROQUEL. Vaccination history included: Covid-19 vaccine (Dose no: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "I am so nauseous"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of nausea, dizziness. Additional information: Patient consumed 14th bottle of Pepto-Bismol As patient was so nauseous, dizzy ever since getting the vaccine." patient taken 2 tablespoons, for every 4 hours and it doesn't help .Expiry Date of Pepto-Bismol was 20Aug2023.  No follow-up attempts are possible. No further information is expected.  Follow-Up (13Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my arm swelled up; my arm swelled up and hurts in it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my arm swelled up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm swelled up and hurts in it".  Additional information: Caller stated he/she had that Covid-19 (vaccine) on his/her arm, his/her arm swelled up and hurts in it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: maybe just sore arm, that was it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 (Lot number: EN6200, Expiration Date: 30Jun2021) as dose 2, single and administered in arm right, administration date 01Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "maybe just sore arm, that was it".  Additional information: With the first two vaccine shots, she was fine and had no reaction, maybe just sore arm, that was it. First time speaking with Pfizer's Safety Department in regards to her experience.she had all three vaccines in right arm because she had an implant in her left arm and she didn't know how it would interact. Patient did not require visit to Emergency Room for any AE  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Biopsy, Lichen planopilaris
Clinical narrative: maybe just sore arm, that was it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 (Lot number: EN6200, Expiration Date: 30Jun2021) as dose 2, single and administered in arm right, administration date 01Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "maybe just sore arm, that was it".  Additional information: With the first two vaccine shots, she was fine and had no reaction, maybe just sore arm, that was it. First time speaking with Pfizer's Safety Department in regards to her experience.she had all three vaccines in right arm because she had an implant in her left arm and she didn't know how it would interact. Patient did not require visit to Emergency Room for any AE  Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema infected, Herpes dermatitis, Skin disorder
Clinical narrative: first one had herpes like outbreak on chest; it was like an infected Eczema Hepatica Skin Disorder; it was like an infected Eczema Hepatica Skin Disorder; 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 91 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL9266) at the age of 90 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (ongoing); "Lung Condition" (ongoing); "Eczema" (ongoing). The patient took concomitant medications. The following information was reported: HERPES DERMATITIS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "first one had herpes like outbreak on chest"; ECZEMA INFECTED (non-serious), SKIN DISORDER (non-serious) all with onset Feb2021, outcome "recovered" (2021) and all described as "it was like an infected Eczema Hepatica Skin Disorder". Therapeutic measures were taken as a result of herpes dermatitis, eczema infected.  Additional information: Patient had received all 3 doses of Pfizer covid 19 vaccine: second dose on 13Mar2021, lot: EX6208 and booster dose on 15Nov2021, lot: FH8027. First one had herpes like outbreak on chest, went away with witch hazel and alcohol. Patient states with the first dose, she had a  herpes outbreak on her chest. Also her states it was like an infected eczema hepatica skin disorder. It started a few days after the dose and it lasted for a couple of weeks and she got rid of it by treating it with different things like alcohol and witch hazel.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33025BD) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: Reporter stated she was a healthy 67-year-old with no problems, no diabetes and no cancer and no high blood pressure and had nothing of that nature and stated she had bronchitis which was diagnosed twenty years ago prior to her getting the Pfizer Covid vaccine and the spelling of bronchistis was captured as stated by the reporter as she was unsure of the spelling of that. Reporter stated she was not a sick person and was very well and had been on the job for 35 years. Stated she can't get an appointment with the people at the hospital where she took the Pfizer Covid vaccine and stated her headache began when she took the vaccine on 30Dec2021, and it was ongoing and the same and she had never had headaches. Stated she began no new medication and was taking the same medications she always took and her headache was strange and she had the headache all last week until now and takes Tylenol enough and the dosage of that was 600mg and she took it when she came home on 30Dec2021 and had the headache and took the Tylenol and the only thing was that when she took the Pfizer Covid vaccine she had not eaten all day long and never gets headaches if she did not eat; stated she had no lot, expiry date to provide for the Tylenol. No other products and investigation assessment reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: after the second dose she experienced body malaise, she was tired, and did not want to do anything; after the second dose she experienced body malaise, she was tired, and did not want to do anything; she did not feel like her self/ She just felt like something was not right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (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), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "after the second dose she experienced body malaise, she was tired, and did not want to do anything"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she did not feel like her self/ She just felt like something was not right".  Additional information: She was calling to check to see if she waited too long for the booster. She wanted to know if it was okay to get the booster now. She was scheduled to get it 06Jan2022. She clarified and said she just said she did not feel like herself. She wants us to know it's not her fault she waited this long for the booster. She went to try and get the booster the same time she had the flu shot, but the doctor told her to wait.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Overdose, Product administration error
Clinical narrative: Received undiluted doses; received undiluted doses; Depression with Anxiety; Depression with Anxiety; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Other HCP) from medical information team.  A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid right, administration date 05Jan2022 10:58 (Lot number: FF2587) at the age of 36 years as dose 1, 0.3 ml single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE), administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; HYDROXYZINE; MIRTAZAPINE; RISPERIDONE. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 05Jan2022, outcome "unknown", described as "Received undiluted doses"; OVERDOSE (non-serious) with onset 05Jan2022, outcome "unknown", described as "received undiluted doses"; DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 05Jan2022, outcome "not recovered" and all described as "Depression with Anxiety".  Additional information: Prior vaccinations (within 4 weeks), relevant tests and specific relevant test for thromboembolic events with thrombocytopenia were reported as none. It was reported that the patient received undiluted dose. Preparation and administration is where the event occurred. Vaccine was not diluted with NaCl 0.9 percent. Nurse Forgot to dilute the vaccine. No clinical consequences were noted after the vaccine. Patient was not hospitalized. No follow up treatment was needed. No adverse effects. Patient was informed about the error.  Follow-up (23Feb2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter sent to another pharmacist. Updated information included: New reporter in reporter slider 3 and 4, added new events (Depression with Anxiety) updated narrative.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: First and Second Dose: Soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and administration date 24Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious), outcome "recovered", described as "First and Second Dose: Soreness".  Additional information: The AE required Physician Office. Additional vaccines administered on same date of the Pfizer suspect and prior vaccinations (within 4 weeks) were none.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: having menstrual periods; precramping a little bit.; 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 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: EWD162) at the age of 66 years as dose 2, single and administered in arm left, administration date 16Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "having menstrual periods"; DYSMENORRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "precramping a little bit.".  Additional information: Patient was administered covid vaccine. After the first vaccine she had no changes. After the second dose of the covid vaccine, three weeks after, started getting a period and the normal kinds of things that go along like precramping a little bit. She had about 5 days of it and then it went away. About 30 days later she got another period, then after that it went the same way as the previous period. After that second period, she had a about 5 months before she just got the booster on 17Dec2021. She started a period three days ago.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: rigors; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "rigors"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue".  Additional information: Patient received 1st dose of Pfizer Vaccine in the 1st Quarter of 2021. Patient experienced rigors, headache and fatigue for 4 hours, then adverse events subsided. Patient received 2nd dose of the Pfizer Vaccine and experienced injection site pain. Patient is male and over 50.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult male 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), administration date: 2021, for COVID-19 Immunization, reaction(s): "rigors", "headache"; Bnt162b2 (Dose 1), administration date: 2021, for fatigue.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Patient is male and over 50. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Decreased appetite, Fall, Malaise, Memory impairment
Clinical narrative: Swelling left arm; Urinated on herself; Fell up the stairs; Did not eat for 2 days; Stayed in bed for 2 days; Caller states she did not recognize her family.; feeling sick; after the first dose; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Lot number: FH8020) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux; "Covid", start date: Sep2021 (unspecified if ongoing), notes: had got Delta virus last Sep and whole month of Oct Further clarification Unknown.; "dealt and held in hospital whole month", start date: 2021 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "feeling sick; after the first dose"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever"; SWELLING (non-serious), outcome "unknown", described as "Swelling left arm"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "Urinated on herself"; FALL (non-serious), outcome "unknown", described as "Fell up the stairs"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Did not eat for 2 days"; BEDRIDDEN (non-serious), outcome "unknown", described as "Stayed in bed for 2 days"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Caller states she did not recognize her family.". Therapeutic measures were taken as a result of malaise, pyrexia.  Additional information: Patient said that she took the Pfizer Covid-19 Vaccine yesterday and she felt sick after the taken the Pfizer Covid-19 Vaccine, first dose."  Consumer stated, "she got her first dose. She had Covid in Sep but didn't get hospitalized until Oct she dealt and held in hospital whole month (history). They give in her arm. Patient was on acid regimen (further not clarified), Nitro (further not clarified). Patient had acid reflex. Patient take lot of medication and told them whatever medication she was on." Patient had an accident and broke her ankle. Patient also stated that, she fell up the stairs but did not break her ankle. Patient scheduled to get her second dose on 26Jan2022. She stated, she got her first vaccine on 05Jan2022, and the next day, she urinated on herself, and then fell up the stairs. Caller stated she did not eat for 2 days and stayed in bed for 2 days. She did not recognize her family. Caller stated, her appointment for her second vaccine is 26Jan2022, and she does not drive. Also mentioned that, had got Delta virus last Sep and whole month of Oct (Further clarification Unknown). The report was related to a study or programme.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Urinary incontinence
Clinical narrative: Swelling left arm; Urinated on herself; Fell up the stairs; Did not eat for 2 days; Stayed in bed for 2 days; Caller states she did not recognize her family.; feeling sick; after the first dose; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Lot number: FH8020) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux; "Covid", start date: Sep2021 (unspecified if ongoing), notes: had got Delta virus last Sep and whole month of Oct Further clarification Unknown.; "dealt and held in hospital whole month", start date: 2021 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "feeling sick; after the first dose"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever"; SWELLING (non-serious), outcome "unknown", described as "Swelling left arm"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "Urinated on herself"; FALL (non-serious), outcome "unknown", described as "Fell up the stairs"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Did not eat for 2 days"; BEDRIDDEN (non-serious), outcome "unknown", described as "Stayed in bed for 2 days"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Caller states she did not recognize her family.". Therapeutic measures were taken as a result of malaise, pyrexia.  Additional information: Patient said that she took the Pfizer Covid-19 Vaccine yesterday and she felt sick after the taken the Pfizer Covid-19 Vaccine, first dose."  Consumer stated, "she got her first dose. She had Covid in Sep but didn't get hospitalized until Oct she dealt and held in hospital whole month (history). They give in her arm. Patient was on acid regimen (further not clarified), Nitro (further not clarified). Patient had acid reflex. Patient take lot of medication and told them whatever medication she was on." Patient had an accident and broke her ankle. Patient also stated that, she fell up the stairs but did not break her ankle. Patient scheduled to get her second dose on 26Jan2022. She stated, she got her first vaccine on 05Jan2022, and the next day, she urinated on herself, and then fell up the stairs. Caller stated she did not eat for 2 days and stayed in bed for 2 days. She did not recognize her family. Caller stated, her appointment for her second vaccine is 26Jan2022, and she does not drive. Also mentioned that, had got Delta virus last Sep and whole month of Oct (Further clarification Unknown). The report was related to a study or programme.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: lymph glands in my left arm pit are very enlarged and very painful to touch; lymph glands in my left arm pit are very enlarged and very painful to touch.; running a fever of 100.1 to 101 for the past three days; extreme body aches/ left area is terribly sore; chills; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 13:45 (Lot number: FD7218) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; SULFASALAZINE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "lymph glands in my left arm pit are very enlarged and very painful to touch"; LYMPH NODE PAIN (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "lymph glands in my left arm pit are very enlarged and very painful to touch."; PYREXIA (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "running a fever of 100.1 to 101 for the past three days"; PAIN (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "extreme body aches/ left area is terribly sore"; CHILLS (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, pyrexia, pain, chills.  Additional Information: No other vaccine was taken in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient's left area was terribly sore but what was most concerning was that the lymph glands in her left arm pit were very enlarged and very painful to touch. She had been running a fever of 100.1 to 101 for the past three days. She had extreme body aches and chills.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lymph glands in my left arm pit are very enlarged and very painful to touch; lymph glands in my left arm pit are very enlarged and very painful to touch.; running a fever of 100.1 to 101 for the past three days; extreme body aches/ left area is terribly sore; chills; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 13:45 (Lot number: FD7218) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; SULFASALAZINE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "lymph glands in my left arm pit are very enlarged and very painful to touch"; LYMPH NODE PAIN (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "lymph glands in my left arm pit are very enlarged and very painful to touch."; PYREXIA (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "running a fever of 100.1 to 101 for the past three days"; PAIN (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "extreme body aches/ left area is terribly sore"; CHILLS (non-serious) with onset 04Jan2022 21:30, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, pyrexia, pain, chills.  Additional Information: No other vaccine was taken in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient's left area was terribly sore but what was most concerning was that the lymph glands in her left arm pit were very enlarged and very painful to touch. She had been running a fever of 100.1 to 101 for the past three days. She had extreme body aches and chills.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Diplopia, Dizziness, Pruritus
Clinical narrative: Tightness in chest; occasional double vision; light-headed; very low energy; itchy skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 13:00 (Lot number: 330308D) at the age of 55 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 (Dose 1, Lot number= 33030Bd, Administration time= 03:30 PM, Vaccine location= Right arm), administration date: 14Dec2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 06Jan2022, outcome "unknown", described as "Tightness in chest"; DIPLOPIA (non-serious) with onset 06Jan2022, outcome "unknown", described as "occasional double vision"; DIZZINESS (non-serious) with onset 06Jan2022, outcome "unknown", described as "light-headed"; ASTHENIA (non-serious) with onset 06Jan2022, outcome "unknown", described as "very low energy"; PRURITUS (non-serious) with onset 06Jan2022, outcome "unknown", described as "itchy skin". The events "tightness in chest", "occasional double vision", "light-headed", "very low energy" and "itchy skin" were evaluated at the physician office visit.  Additional information: The patient did receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: swelling in his arm pit/swollen lymph node; swelling in his arm pit and pain; Nausea; Headache; did not feel well; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200028767.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 13May2021 (Lot number: EW0162) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tourette's disorder" (unspecified if ongoing), notes: diagnosed when he was 5 or 6 years old. There were no concomitant medications. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; MALAISE (non-serious), outcome "recovered", described as "did not feel well"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling in his arm pit/swollen lymph node"; AXILLARY PAIN (non-serious), outcome "unknown", described as "swelling in his arm pit and pain". Clinical course: Patient experienced some headache, nausea and did not feel well for about 5 hours. Then he was fine. He did have swelling in his arm pit and pain with first dose. A lot of pain was really bad and could feel a swollen lymph node after his first dose. On 03jun2021, the patient second dose of Pfizer covid-19 vaccine and on 06Jan2022, the patient received third dose of booster.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Migraine, Pyrexia
Clinical narrative: Extreme pain in joints; chills; fever; migraine; swollen lymph nodes in underarm and groin; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 15:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "Allergies: Walnuts" (unspecified if ongoing); "Allergies: latex" (unspecified if ongoing); "Allergies: Bees" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SINGULAIR; NASONEX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Extreme pain in joints"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "fever"; MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "swollen lymph nodes in underarm and groin". Therapeutic measures were not taken as a result of arthralgia, chills, pyrexia, migraine, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient did not test positive for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: she had soreness in her arm; Strong shaking for probably like 30 minutes; 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. Other Case identifier(s): US-PFIZER INC-202200035131 (Pfizer).  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: 33025BD) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Strong shaking for probably like 30 minutes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had soreness in her arm". Therapeutic measures were not taken as a result of tremor.  Additional information: Patient had no other products, had no patient history and had no investigation assessment, consumer stated, she was calling because she received the first dose of the Pfizer vaccine yesterday and last night, she started having just like some really strong, like shaking, it wasn't chills but it was like really strong shaking for probably like 30 minutes. Had been seeing before, side effect to that something serious enough she should not get the next one, had no treatment. Had no prior vaccination (within 4 weeks), she reported feeling fine at first, then about 12 hours later, her body started shaking, and she couldn't stop. It lasted for about 30 minutes. When asked if it was similar to chills, she stated that she would compare it to something similar she experienced after giving birth. She also stated she had soreness in her arm. Also informed about timing as Monday to Friday, 08:00 to 21:00, est.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration, Vaccination site swelling
Clinical narrative: my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 070H21H) as dose 1, single for covid-19 immunisation. Relevant medical history included: "infected and had a severe lung problem" (unspecified if ongoing); "two type of pneumonia" (unspecified if ongoing); "lung surgery right before COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "my right arm is it is just it is swelling at injection site; arm swelled up and turn purple".  Additional Information: It was reported that the patient was concern about what happened after she had her booster shot and her son first shot. They thought they had the same thing that happened with little bit odd on both of them. It was also due to the fact that she had the lung surgery right before COVID, and she meant, she had been in a breakout and had her surgery and lung was constantly spasm, the further clarification was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036095 Same patient and drug, different event separated in time;US-PFIZER INC-202200036495 Same reporter, same drug, different patient
Sex: M
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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: he was immunocompromised and have diabetes; "diabetes" (unspecified if ongoing), notes: he was immunocompromised and have diabetes. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: left eye is constantly twitching; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FL0007) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "left eye is constantly twitching"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasm". Therapeutic measures were not taken as a result of muscle twitching, muscle spasms.  Additional information: Reporter stated, "I am first of all I am not sure whether to call this number. Actually, what happened to that I had a concern about what happened after, I had my booster shot and my son first shot. We think we had the same thing that happened which was little bit odd on both of us." When asked if you both had the shot: Reporter stated, "Yes, I have been fully vaccinated with the first booster and my son had his first shot."  When asked want to anything about it: Reporter stated, "Is this normal to all of this sudden like your left eye is constantly twitching or had like muscle spasm in your body." Reporter stated, "It was also due to the fact that I had the lung surgery right before COVID (Intent Medical history) and I mean, I have been in a breakout and I had my surgery and my lung is constantly spasm (Further clarification unknown, hence Ae captured as conservatively). So, I am kind of concerned about that." Reporter was informed about Pfizer Medical information department and was provided with the Number as (Withheld) (Option 3) and was informed about the timings as 8 AM-8 PM Monday To Friday (EST). Expiration Date: Reporter stated, "It doesn't have an expiration date." Other medical condition: Reporter stated, "No he does not." Other Medications: Reporter stated, "No." Lab test: Reporter stated, "No." Treatment: Reporter stated, "No, he did not." Vaccination Facility type: Reporter stated, "It was the pharmacy." Prior Vaccination (Within Four week) Reporter stated, "No, I did not." When probed for any further help: Reporter  further stated, "No, that was just it, I was just wonder if this is one normal to have like that muscle spasm you know in your body and because your eye or same eye your both of your eye constantly twitching and it has still not stopped. It was his on the (incomplete sentence) and my was like 12Dec2021 his first one when he got the vaccine, the 11th had their second dose (Further clarification unknown) and I will called his pediatrician to double check and I am waiting to call my doctor just to double check."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036315 Same reporter, same drug, different patient;US-PFIZER INC-202200036095 Same product and event, different patient
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Swelling
Clinical narrative: has a very big swelling in his left armpit area; the size of the inflammation/is very big.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 11:30 (Lot number: 331308A) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot Number / Expiry Date: EP7533, Unknown expiry, Route, Anatomical Location: Left arm), administration date: 05Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 02, Lot Number / Expiry Date: EW0173, Aug2021, Route, Anatomical Location: Left arm), administration date: 03May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 10Jan2022, outcome "not recovered", described as "has a very big swelling in his left armpit area"; INFLAMMATION (non-serious) with onset 10Jan2022, outcome "not recovered", described as "the size of the inflammation/is very big.". The event "has a very big swelling in his left armpit area" was evaluated at the physician office visit. Additional information: The reporter reported on behalf of her husband. She wanted to report that he got his vaccine on 08Jan2022, Saturday, and on 10Jan2022 he has a very big swelling in his left armpit area. States that he got the shot in his left arm. She states that they have consulted with their medical center and the healthcare provider told them it was normal but adviced to call us and report. He went to the medical center and they said to call Pfizer and that they are unable to do anything and it wasn't normal but they don't know what to do. he went to the Medical Center and they gave him 2 days off of work. There was no information regarding the size of the inflammation in the reports. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). prior to the first administration date of the suspect vaccine no list of other vaccinations within four weeks. No AE(s) following prior vaccinations.  Follow-up attempts are completed. No further information is expected.