chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Losing a lot of hair.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:00 (Lot number: EN6208) at the age of 61 years as dose 1, single, administered in arm left, administration date 08Apr2021 10:00 (Lot number: EW0153) as dose 2, single and administered in arm left, administration date 31Aug2021 09:15 (Lot number: FC3183) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Losing a lot of hair.". Therapeutic measures were not taken as a result of alopecia.  Additional information: Patient prior to vaccination, was the patient diagnosed with COVID-19: No. Patient since the vaccination, has the patient been tested for COVID-19:No. Patient known allergies: no. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: After covid shot my hand swelled up and is numb; After covid shot my hand swelled up and is numb; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Oct2021 17:00 (Lot number: FH8027) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP/Diabetes/Stroke; "DIABETES" (unspecified if ongoing), notes: Other medical history: HBP/Diabetes/Stroke; "stroke", start date: 2018 (unspecified if ongoing), notes: I had a stroke in 2018, Other medical history: HBP/Diabetes/Stroke; "it affected my right arm and hand", start date: 2018 (unspecified if ongoing), notes: I had a stroke in 2018 and it affected my right arm and hand. In which my right hand was slowly recovering. The patient took concomitant medications. Past drug history included: Asprin, reaction(s): "Allergy: Aspirin", notes: Known allergies: Asprin.  The following information was reported: PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 22Oct2021, outcome "not recovered" and all described as "After covid shot my hand swelled up and is numb". Therapeutic measures were not taken as a result of peripheral swelling, hypoaesthesia.  Additional information: Patient didnt affect with covid prior vaccination and not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EP7533) at the age of 44 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Alport Syndrome" (unspecified if ongoing), notes: Other medical history: Alport Syndrome, Anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: Alport Syndrome, Anxiety; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: LAMICTAL; TRAZODONE; EFFEXOR; FISH OIL; VIT D [VITAMIN D NOS]. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "the injection site was sore, red, and swollen". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site pain, injection site erythema, vaccination site swelling.  Additional Information: If other vaccine in four weeks was reported as yes. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Hyperhidrosis, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Skin burning sensation started in arms at 2 weeks; electric shocks in left foot; cold lower legs; sweating on torso; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg; buzzing in hands; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: FC3180) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing); "Occasional hives" (unspecified if ongoing); "Premature atrial contraction" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE HCL; CLARITIN ALLERGIC. Past drug history included: Toradol, reaction(s): "known allergies". The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "electric shocks in left foot"; PERIPHERAL COLDNESS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "cold lower legs"; HYPERHIDROSIS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "sweating on torso"; TINNITUS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks"; HYPOAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg"; PARAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "buzzing in hands"; SKIN BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "Skin burning sensation started in arms at 2 weeks". The events "electric shocks in left foot", "cold lower legs", "sweating on torso", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg", "buzzing in hands" and "skin burning sensation started in arms at 2 weeks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia.  Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Tinnitus
Clinical narrative: Skin burning sensation started in arms at 2 weeks; electric shocks in left foot; cold lower legs; sweating on torso; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg; buzzing in hands; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: FC3180) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing); "Occasional hives" (unspecified if ongoing); "Premature atrial contraction" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE HCL; CLARITIN ALLERGIC. Past drug history included: Toradol, reaction(s): "known allergies". The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "electric shocks in left foot"; PERIPHERAL COLDNESS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "cold lower legs"; HYPERHIDROSIS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "sweating on torso"; TINNITUS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks"; HYPOAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg"; PARAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "buzzing in hands"; SKIN BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "Skin burning sensation started in arms at 2 weeks". The events "electric shocks in left foot", "cold lower legs", "sweating on torso", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg", "buzzing in hands" and "skin burning sensation started in arms at 2 weeks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia.  Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I had the booster the other day and it basically knocked me out.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I had the booster the other day and it basically knocked me out.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: sore arm; achy; not feeling well (flu like); not feeling well (flu like); swollen arm; no appetite; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PAIN (non-serious), outcome "unknown", described as "achy"; INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "not feeling well (flu like)"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; achy; not feeling well (flu like); not feeling well (flu like); swollen arm; no appetite; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PAIN (non-serious), outcome "unknown", described as "achy"; INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "not feeling well (flu like)"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Vomiting
Clinical narrative: Tired; Upset stomach; Dizzy spells; Threw up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 13:00 (Lot number: FH82521) at the age of 79 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: 1, Lot-EM9810), administration date: 02Feb2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot-ENG198), administration date: 23Feb2021, when the patient was 78 years old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 25Oct2021, outcome "recovered" (Oct2021), described as "Dizzy spells"; VOMITING (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Threw up"; FATIGUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "Tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Oct2021, outcome "unknown", described as "Upset stomach".  Additional information: Patient, reporting on the Pfizer Covid booster that she got on Monday and wanted to report an events after getting the product. It was explained that she waited for 15 minutes and then left, about 5-10 minutes after that she starting having dizzy spells. On Tuesday this was really bad. That night she threw up. The dizzy spells and throwing up are gone now but now she was tired. This started yesterday and today. She also had an upset stomach Tuesday night. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunisation. The patient experienced vomiting (threw-up) and headache, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on back, side of torso, under breasts, on head and some on face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 11:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single and administered in arm right, administration date 19Oct2021 (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included: "thryoid disease" (unspecified if ongoing); "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEVOTHYROXINE. The following information was reported: URTICARIA (non-serious) with onset 22Oct2021 16:00, outcome "recovering", described as "hives on back, side of torso, under breasts, on head and some on face". Therapeutic measures were not taken as a result of urticaria. Prior to vaccination,the patient was not diagnosed with covid 19 and since the vaccination,the patient has not been tested for covid19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (01Dec2021)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.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: injection site pain; Swollen lymph node in arm pit/swollen lymph node (left arm pit); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 17:00 (Lot number: F63527) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: PAROXETINE taken for anxiety, start date: 2003 (ongoing); BUPROPION taken for anxiety, start date: 2005 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 10 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot number: ER8734), administration date: 29Mar2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Time: 10 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot number: ER8731), administration date: 26Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Flu (Dose 1 on left arm.), administration date: 30Sep2021. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Oct2021, outcome "recovered", described as "injection site pain"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "recovered" (31Oct2021), described as "Swollen lymph node in arm pit/swollen lymph node (left arm pit)". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy.  Additional information: Booster dose due to high risk of frequent institutional or occupation exposure to coronavirus (and at risk for serious COVID-19 complications). Event took place after use of product. Injection site pain and swollen lymph nodes (left arm pit) manifested (approximately equal) 36 hours after injection. Injection site pain resolved after 24 hours and swollen lymph nodes resolved after (approximately equal) 3 days. Vaccination facility type was pharmacy or drug store. The patient had Flu shot Prior Covid-19 vaccinations within 4 weeks. Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts are possible. No further information is expected.  Follow-up (15Nov2021): New information received from a contactable consumer. This consumer (patient) reported in response to non-hcp letter sent which included that: Patient initials, Patient age at time of vaccination: 41 Years, Vaccination details, RMH, event details.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Family history included: "lupus" (unspecified if ongoing), notes: my sister has lupus; "Covid" (unspecified if ongoing), notes: My daughter and grand daughter got Covid; "taste issues" (ongoing), notes: they are still having taste issues; "memory problems" (unspecified if ongoing), notes: memory problems, it was a nasty little disease. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The first week of January, patient received the 1st dose, and she was fine other than a sore arm.  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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Fatigue; Headache; aches all over; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 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: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "aches all over"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: a little swelling in the arm; her arm was a little sore afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single and administered in arm right, administration date 15Apr2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: 2018 (ongoing); "Mitral valve replacement", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "a little swelling in the arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was a little sore afterwards".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: woke up with a swollen lymph node in the axilla; some mild pain in the left arm (site of injection); There's only 1 palpable site. It is not very tender, but does induce mild pain; I am unable to lift heavy objects with my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization; Bnt162b2 (Second Dose), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Oct2021, outcome "unknown", described as "some mild pain in the left arm (site of injection)"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "unknown", described as "woke up with a swollen lymph node in the axilla"; LYMPH NODE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "There's only 1 palpable site. It is not very tender, but does induce mild pain"; LIMB DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "I am unable to lift heavy objects with my left arm".  Additional information: I meant I didn't have any major issue except some mild pain in the left arm. The lymphadenopathy was not observed until yesterday morning (28th Thursday morning). It seems the lymph node swelled up overnight on the 27th. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numb lips; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) 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: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numb lips".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore at test site; 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 female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 15:00 (Lot number: EL3249) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "many cancers" (unspecified if ongoing), notes: Illness/ AE: Many cancers; "Marrow (illegible) disease", start date: 2012 (ongoing), notes: illness/AE: marrow (illegible disease); "Chronic UTI", start date: 1970 (unspecified if ongoing), notes: illness/AE: chronic UTI, Stop date: Now Under control. Concomitant medication(s) included: BROVANA; AZITHROMYCIN; PULMICORT; DILTIAZEM HCL A; ESTRADIOL; FLONASE ALLERGY RELIEF; HYDRODIURIL; LIDOCAINE 5% EXTRA; COZAAR; HIPREX [METHENAMINE HIPPURATE]; SINGULAIR; THYROID; NYSTATIN; PREDNISONE; PREVIDENT; RESTASIS MULTIDOSE; SODIUM CHLORIDE; TIOTROPIUM; KENALOG [TRIAMCINOLONE ACETONIDE]; CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; ADVIL [IBUPROFEN] taken for pain, inflammation; MOTRIN [IBUPROFEN] taken for pain, inflammation; KY taken for nasal dryness; LOPERAMIDE HCL FLX taken for diarrhoea; LUTEIN ZEAXANTHIN; MULTI VITAMINS & MINERALS; RETAINE FLAX; VIT C; FOSAMAX taken for osteoporosis. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore at test site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2nd shot moderately sore at test site plus upper arm sore after 8 hrs. 3rd shot same, but entire arm sore and stiff-especially stiff, took ibuprofen 14 hrs later and that solved the problem site was reddish for a couple of days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Migraine, Pain
Clinical narrative: horrible migraine headache; chills; fever; body aches; fatigue; could not get out of bed; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 01), administration date: 30Dec2020, for COVID-19 immunization, reaction(s): "tired", "fatigued"; Bnt162b2 (DOSE 02), for COVID-19 immunization, reaction(s): "chills", "Fatigue", "could not get out of bed", "horrible migraine headache", "body aches", "fever". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "horrible migraine headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "could not get out of bed". Therapeutic measures were taken as a result of pyrexia.  Additional Information: After first dose on 30Dec she was tired and fatigued. After the second dose, 12 hours post dose she had a horrible migraine headache, chills, fever, body aches, fatigue and could not get out of bed. Took Advil and Tylenol-neither helped. This lasted 36 hours. After the booster on 06Oct. 24 hours post dose she developed the same symptoms as after the second dose. This lasted for 24 hours then felt better for 12 hours then felt horrible again for 24 more hours. She reports no other health issues. She says she is otherwise healthy and reports nothing .Event took place after use of product.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101478504 same patient/drug, different event and dose;US-PFIZER_INC-202101478505 same patient/drug, different event and dose
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: horrible migraine headache; chills; fever; body aches; fatigue; could not get out of bed; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 01), administration date: 30Dec2020, for COVID-19 immunization, reaction(s): "tired", "fatigued"; Bnt162b2 (DOSE 02), for COVID-19 immunization, reaction(s): "chills", "Fatigue", "could not get out of bed", "horrible migraine headache", "body aches", "fever". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "horrible migraine headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "could not get out of bed". Therapeutic measures were taken as a result of pyrexia.  Additional Information: After first dose on 30Dec she was tired and fatigued. After the second dose, 12 hours post dose she had a horrible migraine headache, chills, fever, body aches, fatigue and could not get out of bed. Took Advil and Tylenol-neither helped. This lasted 36 hours. After the booster on 06Oct. 24 hours post dose she developed the same symptoms as after the second dose. This lasted for 24 hours then felt better for 12 hours then felt horrible again for 24 more hours. She reports no other health issues. She says she is otherwise healthy and reports nothing .Event took place after use of product.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101478504 same patient/drug, different event and dose;US-PFIZER_INC-202101478505 same patient/drug, different event and dose
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: my arm is still, is that like red, pink, in a radius area, pre large area; and it''s still sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd), for covid-19 immunization; Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "my arm is still, is that like red, pink, in a radius area, pre large area"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "and it''s still sore.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Decreased appetite, Hyperhidrosis, Migraine
Clinical narrative: worst migraine; body aches; chills; worst migraine/today he got another migraine/last night it hurt so bad could barely open his eyes; sweating; no appetite/having a hard time keeping stuff down/can't eat/appetite is diminished; he lost 10 pounds; 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-202101482270 (pfizer).  A 27 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tested positive for Covid" (unspecified if ongoing), notes: he tested positive for Covid a while back before the vaccine. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 20Oct2021, outcome "unknown", described as "worst migraine/today he got another migraine/last night it hurt so bad could barely open his eyes"; PAIN (non-serious) with onset 21Oct2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 21Oct2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweating"; DECREASED APPETITE (non-serious) with onset Oct2021, outcome "unknown", described as "no appetite/having a hard time keeping stuff down/can't eat/appetite is diminished"; WEIGHT DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "he lost 10 pounds"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "worst migraine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that ever since last week, nothing sounds good to him. his appetite is diminished. Reporter also stated that "from last week, he lost 10 pounds. Reporter also stated that patient was having chills though his temperature feels normal and he gets goosebumps. Reporter asked if appetite loss was reported side effect with the Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Weight, Weight decreased
Clinical narrative: worst migraine; body aches; chills; worst migraine/today he got another migraine/last night it hurt so bad could barely open his eyes; sweating; no appetite/having a hard time keeping stuff down/can't eat/appetite is diminished; he lost 10 pounds; 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-202101482270 (pfizer).  A 27 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tested positive for Covid" (unspecified if ongoing), notes: he tested positive for Covid a while back before the vaccine. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 20Oct2021, outcome "unknown", described as "worst migraine/today he got another migraine/last night it hurt so bad could barely open his eyes"; PAIN (non-serious) with onset 21Oct2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 21Oct2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweating"; DECREASED APPETITE (non-serious) with onset Oct2021, outcome "unknown", described as "no appetite/having a hard time keeping stuff down/can't eat/appetite is diminished"; WEIGHT DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "he lost 10 pounds"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "worst migraine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that ever since last week, nothing sounds good to him. his appetite is diminished. Reporter also stated that "from last week, he lost 10 pounds. Reporter also stated that patient was having chills though his temperature feels normal and he gets goosebumps. Reporter asked if appetite loss was reported side effect with the Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: period cramps; 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), intramuscular, administered in arm right, administration date 01Feb2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: Dec2020 (unspecified if ongoing), notes: removal of ovarian Cyst and Endometriosis; "Allergic to Shrimp" (unspecified if ongoing), notes: May be allergic to shrimp; still getting tested.; "Unknown Ptential Virus Not COVID", start date: 10Mar2021, stop date: 10Mar2021, notes: significant Vomiting , Diarrhea hospitalized But not admitted; "Endometriosis and Fibroids", start date: Nov2016 (unspecified if ongoing), notes: Removal of uterine fibroid and Endometriosis. Concomitant medication(s) included: KYLEENA taken for uterine leiomyoma, start date: Aug2018 (ongoing); TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, site: Right upper arm, Route: Intramuscular), administration date: 11Jan2021, when the patient was 32 years old, for COVID-19 Immunization. The following information was reported: DYSMENORRHOEA (non-serious) with onset 01Feb2021, outcome "not recovered", described as "period cramps". Therapeutic measures were not taken as a result of dysmenorrhoea.  Additional information: Patient have endometriosis. Patient not sure if that was related to this, but wanted to report an event so your team may study this side effect (or just explain to me why it happens because I'm curious). Obviously patient still got third injection so it didn't deter me, but patient have gotten severe period cramps within an hour after the second and third dose. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101480028 similar report from same reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: either the first or second dose of the Covid vaccine she had chills; Was achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2021 (Lot number: EN5318) at the age of 73 years as dose 1, single and administration date 03Mar2021 (Lot number: TN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "high cholesterol" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; OLMESARTAN taken for hypertension; ATORVASTATIN taken for blood cholesterol increased. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "either the first or second dose of the Covid vaccine she had chills"; PAIN (non-serious), outcome "recovered", described as "Was achy".  Additional info:Patient received Booster Dose on 27Oct2021 and experienced vomiting and diarrhoea but she noticed her pulse has been very high all day. Caller states she didn't realize it if it was elevated yesterday.  No follow-up attempts are possible. No further information is expected.  Follow-up (08Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Right arm sore and can''t lift her arm up, after booster.; has been having arm soreness in the site of injection or left arm until today; Her left arm feels okay now and is a bit swollen.; 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-202101482847 (Pfizer).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Right arm sore and can''t lift her arm up, after booster."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "has been having arm soreness in the site of injection or left arm until today"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her left arm feels okay now and is a bit swollen.". Therapeutic measures were taken as a result of pain in extremity. Additional information: Patient had the first two vaccines with no problems. Patient taken Tylenol for treatment which makes her sleepy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101482793 (Pfizer).  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (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: CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "Chills".  Additional Information: Caller was talking to her sister and they had both Pfizer COVID19 shots. Caller stated she had no problems, but her sister had the second shot 7 months ago and was still complaining of having chills. Her family doctor doesn't know anything. Reporter just wonders if that was normal. Her sister was upset about it and was not getting satisfaction from her family doctor. Is it normal she asked? Usually, they say that side effects just last a few days then are gone but her sister was still complaining that out of the blue she still gets chills. Her sister doesn't want to get booster. The reporter getting her booster shot. Caller was trying to find out if it was normal or something she should be concerned about. Caller asks if she should be concerned or attempt to take the booster if she is still having chills. She turned 75 in Sep, but the chills started when she was 74 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.