chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Miller Fisher syndrome, SARS-CoV-2 test, Vital capacity
Clinical narrative: Miller Fisher Syndrome; This is a literature report for the following literature source(s): (privacy)  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic painless vertical diplopia" (unspecified if ongoing); "inflammatory pseudotumor" (unspecified if ongoing); "painless paresthesiae of hands" (unspecified if ongoing); "severe gait ataxia" (unspecified if ongoing); "COVID-19 infection", start date: Feb2021 (unspecified if ongoing); "painless paresthesiae of feet" (unspecified if ongoing); "2 falls" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 15Jan2021, reaction(s): "COVID-19 infection". The following information was reported: MILLER FISHER SYNDROME (life threatening), outcome "recovering", described as "Miller Fisher Syndrome". The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) equivocal, 31 iv, (arup); csf protein: (unspecified date) 218 mg; csf white blood cell count: (unspecified date) 6, notes: cells/hpf; investigation: (unspecified date) was notable for limited movement of the right, notes: lateral rectus, right medial rectus, right inferior oblique, and left superior rectus with mixed diplopia in all directions of gaze; lumbar puncture: (unspecified date) showed albuminocytological dissociation with a csf, notes: protein of 218 mg and a CSF nucleated cell count of 6 cells/hpf; magnetic resonance imaging head: (unspecified date) unremarkable; magnetic resonance imaging neck: (unspecified date) unremarkable; sars-cov-2 test: (Feb2021) positive; (unspecified date) negative; vital capacity: (unspecified date) 1.1 L; (Feb2021) 1.8 L, notes: increase. Therapeutic measures were taken as a result of miller fisher syndrome.; Sender's Comments: As there is limited information in the case provided, the causal association between the event miller fisher syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: I now spot throughout my period; My period has now increased from 7 days to 12 days with cramping; My period has now increased from 7 days to 12 days with cramping; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2021 at 07:30 (Lot number: unknown) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy; "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Avacado; "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex; "Dust allergy" (unspecified if ongoing), notes: Known allergies: Dust; "Allergic to cats" (unspecified if ongoing), notes: Known allergies: Cats and "Vegetable allergy" (unspecified if ongoing), notes: Known allergies: Asparagus. There were no concomitant medications. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: right arm; Administration time: 14:00), administration date: 09Jan2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 01Apr2021 at 00:00, outcome "not recovered", described as "I now spot throughout my period"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 01Apr2021 at 00:00, outcome "not recovered", and all described as "My period has now increased from 7 days to 12 days with cramping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of intermenstrual bleeding, heavy menstrual bleeding and dysmenorrhoea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the COVID vaccine was taken her menstrual cycle had changed and she used a period calendar. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Headache, Lethargy
Clinical narrative: Severe burning on entire left side of body; Headache; Lethargy; Brain fog; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date an unknown date in Sep2021 (Lot number: unknown) at the age of 64 years as dose 1, single for COVID-19 immunisation. Relevant medical history included Fibromyalgia (unspecified if ongoing) and Allergy to intravenous contrast media (unspecified if ongoing). Concomitant medications were not reported. Past drug history included Tequin, reaction included Drug allergy, Known allergies Tequine; Nubaine, reaction included Drug allergy, Known allergies Nubane and Panadol, reaction included Drug allergy, Known allergies Ipanadol.  The following information was reported BURNING SENSATION (non-serious) with onset an unknown date in Sep2021, outcome recovered with sequelae (an unknown date in 2021); HEADACHE (non-serious) with onset an unknown date in Sep2021, outcome recovered with sequelae (an unknown date in 2021); LETHARGY (non-serious) with onset an unknown date in Sep2021, outcome recovered with sequelae (an unknown date in 2021); FEELING ABNORMAL (non-serious) with onset an unknown date in Sep2021, outcome recovered with sequelae (an unknown date in 2021). Therapeutic measures were not taken as a result of burning sensation, headache, lethargy, and feeling abnormal.  It was reported that the patient received bnt162b2 (BNT162B2) at 17:00. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy, Pyrexia
Clinical narrative: Chills; Fever; My left lymph nodes were swollen; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 at 11:15 (Lot number: FJ1611) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication included unspecified birth control medication. Past drug history included: Monosodium glutamate, reaction: "Reaction to monosodium glutamate", notes: Known allergies: MSG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0195; Anatomical location: Left arm), administration date: 02Jun2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0191; Anatomical location: Left arm), administration date: 23Jun2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 11:15, outcome "unknown", described as "Dose number 3"; CHILLS (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "My left lymph nodes were swollen". Therapeutic measures were not taken as a result of chills, pyrexia and lymphadenopathy. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. After 12 hours of receiving the vaccine booster, the patient had chills, a fever, and her left lymph nodes were swollen. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: drug ineffective; COVID-19; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4208727-00.  A 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "recovering", described as "drug ineffective"; COVID-19 (medically significant) with onset Dec2021, outcome "recovering", described as "COVID-19". The action taken for adalimumab was unknown. The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality as per reporter for the event(s) of COVID with bnt162b2 was possible. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: Deathly sick; Back ache; Vomiting; Nausea; Pain; Sweats; Feels cloudy; Weak and tired; Weak and tired; Pain in back on left side, cannot walk; This is a spontaneous report received from contactable reporter(s) (Other HCP: Registered Nurse) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Dec2021 12:30 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date Nov2021 (Batch/Lot number: unknown) as single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Deathly sick"; BACK PAIN (non-serious), outcome "unknown", described as "Back ache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweats"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels cloudy"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Weak and tired"; GAIT INABILITY (non-serious), outcome "unknown", described as "Pain in back on left side, cannot walk". Therapeutic measures were not taken as a result of illness, back pain, vomiting, nausea, pain, hyperhidrosis, feeling abnormal, asthenia, fatigue, gait inability. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Nausea, Pain, Vomiting
Clinical narrative: Deathly sick; Back ache; Vomiting; Nausea; Pain; Sweats; Feels cloudy; Weak and tired; Weak and tired; Pain in back on left side, cannot walk; This is a spontaneous report received from contactable reporter(s) (Other HCP: Registered Nurse) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Dec2021 12:30 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date Nov2021 (Batch/Lot number: unknown) as single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Deathly sick"; BACK PAIN (non-serious), outcome "unknown", described as "Back ache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweats"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels cloudy"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Weak and tired"; GAIT INABILITY (non-serious), outcome "unknown", described as "Pain in back on left side, cannot walk". Therapeutic measures were not taken as a result of illness, back pain, vomiting, nausea, pain, hyperhidrosis, feeling abnormal, asthenia, fatigue, gait inability. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Slight headache; Chills; 101.6 degree fever; Dose number 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 29Dec2021 at 12:30 (Lot number: FD7218) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: None; Known allergies: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EP7534; Administration location: Right arm), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Administration location: Right arm), administration date: 22Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 12:30, outcome "unknown", described as "Dose number 3"; HEADACHE (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (30Dec2021 at 08:15), described as "Slight headache"; CHILLS (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; PYREXIA (non-serious) with onset 30Dec2021 at 00:15, outcome "recovered" (an unknown date in Dec2021), described as "101.6 degree fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills and pyrexia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Commencing approximately 12 hours after receiving dose began having chills and slight headache and then within an hour had a 101.6-degree fever, the fever and chills lasted several hours and started to wane. The headache lasted 8 hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Failure per Pfizer / covid test result=Positive; Failure per Pfizer / covid test result=Positive; Booster; This is a spontaneous report received from 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 16Dec2021 15:45 (Lot number: Fd7218) at the age of 49 years as dose 3 (booster), single, administered in arm left, administration date 16Apr2021 15:45 (Lot number: Ep6955) at the age of 48 years as dose 2, single and administered in arm left, administration date 26Mar2021 16:00 (Lot number: Ep6955) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Steroids Allergy" (unspecified if ongoing), notes: Steroids. The patient's concomitant medications were not reported. No other vaccine was administered in four-weeks. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 15:45, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 12:30, outcome "not recovered" and all described as "Failure per Pfizer / covid test result=Positive". The event "failure per pfizer / covid test result=positive" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: covid test type post vaccination=Nasal Swab, covid test name post vaccination=Binax.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; have Pfizer vaccine and booster, and today test positive for covid; have Pfizer vaccine and booster, and today test positive for covid; This is a spontaneous report received from a contactable reporter from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: immunization, outcome unknown; drug ineffective, COVID-19 both with onset 31Dec2021, outcome unknown and both described as have Pfizer vaccine and booster, and today test positive for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy
Clinical narrative: dose number=3; Swollen lymph nodes and pain under arm; Swollen lymph nodes and pain under arm; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 at 08:45 (Lot number: 33130BA) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: CABERGOLINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8729, Route of Administration: Unspecified, Anatomical Location: Left arm), administration date: 07Apr2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0164, Route of Administration: Unspecified, Anatomical Location: Left arm.), administration date: 05May2021, when the patient was 35 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 08:45, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset an unknown date in Dec2021, outcome "not recovered", and all described as "Swollen lymph nodes and pain under arm". Therapeutic measures were not taken as a result of lymphadenopathy and axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: diagnosed with breast cancer on the same side she received the vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Dec2021 (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: BREAST CANCER (medically significant) with onset 2021, outcome "unknown", described as "diagnosed with breast cancer on the same side she received the vaccines". Clinical Information: Call transferred by (Withheld) from agency. According to agent,was a nurse and had some questions regarding the Pfizer BioNTech Covid-19 vaccine. Agent states that the caller got her 1st dose of the vaccine in Dec 2020 and her 2nd dose of the vaccine in Jan2021, where 6 months later she was diagnosed with breast cancer on the same side she received the vaccines. Agent states that the caller would like to know if breast cancer has been reported after receiving the vaccine and if it was contraindicated to receiving the booster since she lives in a specified state and they are mandating the booster. Caller states she had no history of breast cancer on either side of her family and she was nervous to receive the booster since she was uncertain if the breast cancer was related to the vaccine. Caller states she was a Nurse that works in hospital and deals with cancer patients Caller states one of her patients held off on getting the Covid-19 vaccine and tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer, which was why the caller was nervous about receiving the booster. Agent also states that she has an inquiry regarding her husband who also received the Pfizer BioNTech Covid-19 vaccines 3 days after her vaccine. Agent states her husband has had hives and a rash consistently for a year now and all of the medications including steroids and creams have not helped.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Breast Cancer and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My hair started to noticeably thin after the second shot. Is now much worse and is not stopping.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Nov2021 at 12:00 (Lot number: unknown) at the age of 63 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN), administration date: 22Oct2021, when the patient was 63 years old, for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "My hair started to noticeably thin after the second shot. Is now much worse and is not stopping". Therapeutic measures were not taken as a result of alopecia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: the arm I got the vaccine in the muscle pain disappeared; the arm I got the vaccine in the muscle pain disappeared; arm muscle hurts; 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 (005570). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single dose for covid-19 immunisation. Relevant medical history included: "Muscle pain" (unspecified if ongoing), notes: As of two weeks ago my muscles in the back of my thighs, buttock cause me so much pain I actually ordered a walker because I need more than a cane for this pain. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "the arm I got the vaccine in the muscle pain disappeared"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm muscle hurts".  Information about lot/batch number cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Nausea
Clinical narrative: Sore muscles in the lower back; Intense Headache; Cramping in the thighs, knees, calves, and feet; nausea/Light Nausea; 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 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 11:15 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "nausea/Light Nausea"; HEADACHE (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "Intense Headache"; MUSCLE SPASMS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "Cramping in the thighs, knees, calves, and feet"; MYALGIA (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Sore muscles in the lower back". Therapeutic measures were taken as a result of nausea, headache, muscle spasms, myalgia. Additional information: the light nausea was more like queasiness. The headache got so bad it was at a point where it hurt to even put her head on a pillow. She had had migraines, and this was worse. It was double what a migraine was. She couldn't even move her head it hurt so bad. The sore muscles was more in the lower back and may be due to being in bed for 3 days. The patient took ADVIL 200 mg at 400 mg 2-3 times during the events. The patient just bought the ADVIL and they were current, that she changed the ADVIL Into a bottle that was easier to open. Patient was due to go back in April and just wanted to know if she had to get the second vaccine or if she was covered enough with the first vaccine. She is worried she would experience these side effects again and does not want to go through that.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A 73-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 (Lot number: EN6201, Expiration Date: Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Medrol dose Pak, start date: 21Jan2021, stop date: 25Jan2021, for vertigo. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph nodes in my neck". Additional information: Patient stated that her 2nd dose is due tomorrow. She has swollen lymph nodes in her neck. How long does it take before it disappears? She heard people suggest they can take TYLENOL and drink lots of water after the 2nd shot and others say don't take anything some before or after, any information. Patient is thrilled to have the Pfizer shot. she just wanted to make sure this was not going to get worse with the 2nd shot. Fingers crossed she can do it tomorrow. It's wonderful you are there to answer these questions." No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; 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 male patient received bnt162b2 (BNT162B2), administered in arm, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included high anxiety (unspecified if ongoing); euphoria (unspecified if ongoing); sinuses (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included B12 shot. Vaccination history included Flu shot, for immunization. The following information was reported DIZZINESS (non-serious) with onset 08Mar2021, outcome unknown.  Consumer, stated his partner and himself received their first Pfizer Covid-19 vaccination on today, 08Mar2021. Caller stated his partner received a Band-Aid after receiving his injection, but he did not. Caller wanted to know if he needed to be concerned that the medication could leak out or that he got the full dose because he did not get a Band-Aid. Never had a shot, anywhere from Flu shot to a B12 shot, without given a Band-Aid. Patient was nervous about the vaccine. The paranoia comes in because the guy who administered the vaccine told him not to be nervous and then hands over the paperwork about the vaccine not being FDA approved. Stated he gets it because everything was rushed. He was grateful to have something. He thinks he was good. He felt a little bit dizzy earlier, but that could be sinuses. He feels fine. His arm doesn't even hurt. He kept his arm moving like he is told with the Flu shot.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: leg pain; Sleeping is difficult due to pain in calves; So Much Pain in Calves of Both Legs; Warmth in Calves; swelling in the calves of the legs; difficult to get on my feet to walk; Calves feel Hardened; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 11:00 (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure abnormal (ongoing); BENAZEPRIL taken for blood pressure abnormal (ongoing); CRESTOR taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (First vaccine dose, LOT: EN6201 Left Arm), administration date: 11Feb2021, for Covid-19 immunisation; Prevnar (No NDC, Prevnar Lot: PAA135492, No expiration. 0.5 dose, Left Arm.), administration date: Oct2020, reaction(s): "temperature", "red, hot, swollen down to elbow and hand", "red, hot, swollen down to elbow and hand", "effected her movement of her hand", "swelling in her left arm", "rash"; Prevnar (No NDC, Prevnar Lot: PAA135492, No expiration. 0.5 dose, Left Arm.), administration date: Oct2020, for chills; Infuenza vaccine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; PERIPHERAL SWELLING (non-serious) with onset 05Mar2021, outcome "not recovered", described as "swelling in the calves of the legs"; GAIT DISTURBANCE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "difficult to get on my feet to walk"; MUSCLE SPASMS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Calves feel Hardened"; INSOMNIA (non-serious) with onset 07Mar2021, outcome "not recovered", described as "Sleeping is difficult due to pain in calves"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "not recovered", described as "So Much Pain in Calves of Both Legs"; FEELING HOT (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Warmth in Calves". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, gait disturbance, muscle spasms, insomnia, pain in extremity, feeling hot.  Additional information: Treatment: No treatment; she states to be perfectly honest, she considered going to the Emergency Room that was how uncomfortable she was. She was very active and played pickleball a few days ago and never has leg problems of any kind. She clarifies that the pain was there if sitting or standing. Her calves feel hardened (firm), swollen and warm. She has been up and about and it has been painful before but not as bad as today and the swelling was acute today.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, White blood cell count
Clinical narrative: stated she had seasonal allergies, and after she received her COVID-19 Vaccine, her runny nose went away almost immediately and her sinuses cleared up; Experienced the "taste of the vaccine as the vaccine was being put in her arm (similar to an MRI contrast); Roof of my mouth went numb; 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 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 08:55 (Lot number: EN6205) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: she was diagnosed with COPD probably 10 years ago. She said she was on oxygen at one time, but has been off oxygen for about 5-6 years now.; "Pityriasis rubra pilaris" (ongoing), notes: She said she broke out in a Pityriasis Rubra Pilaris rash when she was in the hospital with a bleed out from ischemic colitis.; "Ischemic stroke" (unspecified if ongoing), notes: She said she broke out in a Pityriasis Rubra Pilaris rash when she was in the hospital with a bleed out from ischemic colitis.; "autoimmune disease" (unspecified if ongoing), notes: She said her autoimmune disease was genetic & only 2000 people had it.; "skin will peel" (unspecified if ongoing), notes: She said she had the Pityriasis Rubra Pilaris on her feet now & it looks like calluses. She said her skin keeps growing & growing & then will look OK & then her skin will peel & start the cycle all over.; "seasonal allergies" (unspecified if ongoing), notes: Reported she had seasonal allergies; "runny nose" (unspecified if ongoing), notes: Reported she had seasonal allergies, and the morning she received her COVID-19 Vaccine (05Mar2021) she had a runny nose. She said after she received her COVID-19 Vaccine, her runny nose went away almost immediately and her sinuses cleared up. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05Mar2021, outcome "unknown", described as "stated she had seasonal allergies, and after she received her COVID-19 Vaccine, her runny nose went away almost immediately and her sinuses cleared up"; TASTE DISORDER (non-serious) with onset 05Mar2021, outcome "recovered" (05Mar2021), described as "Experienced the "taste of the vaccine as the vaccine was being put in her arm (similar to an MRI contrast)"; HYPOAESTHESIA ORAL (non-serious) with onset 05Mar2021, outcome "recovered" (05Mar2021), described as "Roof of my mouth went numb". Relevant laboratory tests and procedures are available in the appropriate section.  Follow up (08Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that: Additional information regarding patient age, gender, medical history, Laboratory investigation, Batch/LOT number and adverse events were updated.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: vision was "not quite as sharp"; My arm was a tiny bit sore if I raise it above my head; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 19Feb2021 (Lot number: EL9266) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE [METHOTREXATE SODIUM]. Vaccination history included: Flu, for immunization, reaction(s): "arm was a tiny bit sore ". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 01Mar2021, outcome "unknown", described as "vision was "not quite as sharp""; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "My arm was a tiny bit sore if I raise it above my head". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient had a Pfizer vaccine on 19th of Feb2021 and had almost no reaction but her arm was a tiny bit sore if he raise it above her head. However, about 10 days later (on March 1st), she noticed her vision wasn't quite as sharp and she was wondering if this was one of the symptoms of the vaccine. No treatment was received for her arm as she don't have a complaint about her arm and it was no different from getting a flu shot.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: fatigue; sore throat; 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 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EM9810) at the age of 65 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, LOT: could be EL9261, LZ9261, LL9261), administration date: 10Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "sore throat"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Additional information: Caller wanted to know if it was normal to experience a sore throat and fatigue after the second dose of the vaccine. No investigation assessment was done. Caller wanted to know if these events could be related to the vaccine. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: a little sore arm; 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 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 13:40 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: She states she is allergic to penicillin and ACE inhibitors - has an anaphylactic reaction to both of those medications and additionally has allergies to various antibiotics. There were no concomitant medications. Vaccination history included: Bnt162b2 (she receive the first dose of the Covid-19 Vaccine 07Feb2021, First dose Lot: EL9262, Expiration unknown, Time the Vaccination Was Given: 07Feb2021 13:40), administration date: 07Feb2021, when the patient was 77 years old, for Covid-19 immunisation; Flu shot, for Immunization, reaction(s): "redness", "Swelling", "makes a hard lump in her arm"; Flu shot, for immunization, reaction(s): "hot to the touch". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On Jan2021, Covid-19 test Result: Negative. Caller said that she had a little bit of a sore arm and nothing else.  Any shot that she gets, whether in her arm or butt, she said that it swells, gets red, and hot. The caller said that with her Covid-19 Vaccines she got a little soreness and iced her arm in preparation thinking that she was going to have her usual reaction like she does with the flu shot, but she got nothing. Second dose lot number said that the Lot number for the second dose was written messy. She said that it looks like EN62N, but stated that the numbers are mixed together. She can not read the last 2 digits for the second dose lot. Description of Product Complaint: Description of complaint: Caller is a consumer that was calling about the Covid-19 vaccine and reported that she got the first and second injection and got the second one on 28Feb2021. Caller said that she had a little bit of a sore arm and nothing else. The caller said that when she reads about this, the reactions are showing the vaccine is making protection for her body. Does it mean that since she did not have any reactions did her body not make the antibodies anymore?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: rigors/chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "rigors/chills". It was unknown if therapeutic measures were taken as a result of chills. Additional information: The pharmacist reported that her husband experienced rigors/chills after the first dose of Pfizer COVID-19 vaccine, but tolerated the second dose without reaction. Other vaccine in four weeks was unknown. Other medications in two weeks was unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Allergies to medications, food, or other products was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.