chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Hypoaesthesia, Pain
Clinical narrative: I cannot even walk; weakness/I'm so weak; pain; numbness all over her body which had gotten worse day by day.; very tired; tingling all over her body; 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 46-year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 01Jun2021 (Lot number: EW0181) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose: Lot number: EW0182), administration date: 04May2021, when the patient was 46 years old, for covid-19 immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "I cannot even walk"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness/I'm so weak"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness all over her body which had gotten worse day by day"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "tingling all over her body". The events "i cannot even walk", "weakness/i'm so weak", "pain", "numbness all over her body which had gotten worse day by day.", "very tired" and "tingling all over her body" were evaluated at the physician office visit.  Additional information: It was reported that patient got one dose in left arm and one in the right arm, unsure which dose in which arm. Investigation assessment was not provided. The patient also stated that she had been to the doctors, everything was normal, cannot give her any medication they do not see anything wrong. Stated that she was just getting worse, reports weakness, pain, numbness and tingling all over her body, from her head to all over, states she has just been staying home, does not go take a walk, just getting worse, unable to work or walk really at this point. Patient stated she has been to the doctors, everything was normal, cannot give her any medication as they did not see anything wrong.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I cannot even walk; weakness/I'm so weak; pain; numbness all over her body which had gotten worse day by day.; very tired; tingling all over her body; 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 46-year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 01Jun2021 (Lot number: EW0181) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose: Lot number: EW0182), administration date: 04May2021, when the patient was 46 years old, for covid-19 immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "I cannot even walk"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness/I'm so weak"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness all over her body which had gotten worse day by day"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "tingling all over her body". The events "i cannot even walk", "weakness/i'm so weak", "pain", "numbness all over her body which had gotten worse day by day.", "very tired" and "tingling all over her body" were evaluated at the physician office visit.  Additional information: It was reported that patient got one dose in left arm and one in the right arm, unsure which dose in which arm. Investigation assessment was not provided. The patient also stated that she had been to the doctors, everything was normal, cannot give her any medication they do not see anything wrong. Stated that she was just getting worse, reports weakness, pain, numbness and tingling all over her body, from her head to all over, states she has just been staying home, does not go take a walk, just getting worse, unable to work or walk really at this point. Patient stated she has been to the doctors, everything was normal, cannot give her any medication as they did not see anything wrong.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient; Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient; nausea; dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Oct2021 16:00 (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing), notes: Verbatim: Generalized anxiety disorder; "Migraine" (unspecified if ongoing), notes: Verbatim: Migraine. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 26Oct2021 16:00, outcome "unknown" and all described as "Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient"; NAUSEA (non-serious) with onset 26Oct2021, outcome "recovered" (26Oct2021), described as "nausea"; DIZZINESS (non-serious) with onset 26Oct2021, outcome "recovered" (26Oct2021), described as "dizziness".  Additional information: The reporter stated that 12-year-old male patient received vaccine which was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient, the vaccine was mixed, and it was out for over 6 hours. The vaccine was actually out for 7 hours instead. The vaccine was expired at 3PM and instead was given at 4PM. Caller states that the vaccine was diluted and was in the vial stored at room temperature for 7 hours and then administered to a patient. Caller asks if the patient needs to be revaccinated or for any recommendations or monitoring. No investigation assessment. The patient did complain of dizziness and nausea at the 15-minute mark, and there were no other reactions. Caller clarified that this event happened today and this was the first dose for the patient. The dizziness and nausea resolved, both only lasted for about a couple of minutes. The patient has no drug allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Investigation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 78 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Atrophic" (unspecified if ongoing), notes: Verbatim: Atrophic now it's prostate and like other things that has come with him older; "Prostate" (unspecified if ongoing), notes: Verbatim: Prostate, now it's prostate and like other things that has come with him older. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "With the first one he got sick". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: problem with her knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EW0164) as dose 2, single and administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "rheumatoid" (unspecified if ongoing); "Lupus" (unspecified if ongoing), notes: SLE Lupus (not clarified). The patient's concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious) with onset 2021, outcome "unknown", described as "problem with her knees".  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: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US243524.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-101921-24788 (RA). A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Verbatim: She is Immunocompromised; "chronic fatigue syndrome" (unspecified if ongoing), notes: Verbatim: chronic fatigue syndrome; "Myalgic Encephalomyelitis" (unspecified if ongoing), notes: Verbatim: Myalgic Encephalomyelitis; "Chronic lyme" (unspecified if ongoing), notes: Verbatim: Chronic lyme; "Brain injury" (unspecified if ongoing), notes: Verbatim: Brain injury from birth; "Allergy to horse dander" (unspecified if ongoing), notes: Verbatim: Allergic to Augmentin and horse dander. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Allergy: Augmentin", notes: Verbatim: Allergic to Augmentin. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel unwell"; VOMITING (non-serious), outcome "unknown", described as "vomit". Additional information: As per Consumer # age 48 female reports using Cetaphil Gentle Cleansing Bar lot 20014.5 oz. size (part of 3 pack) beginning on 17Oct2021 She has ringworm-  it had stopped itching 15Oct2021 and was getting smaller. The rash is getting worse since 18Oct2021 after she had used the product. The rash expanded in size and is more itchy. She has not used the soap directly on the rash. She also noted on 16Oct2021. she had the 3rd Pfizer vaccine. She has a headache today, 19Oct2021 but she believes it is from the vaccine as the second vaccine made her vomit and feel unwell. She discontinued the product for now (last use 18Oct2021) until she speaks to her dermatologist. The events are ongoing. Concomitant products include Nystatin cream since 11Oct2021 Ketoconazole Shampoo since 12Oct2021 and Ketoconazole 2% cream since 12Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: HIV antibody, HIV test, HIV test positive, Polymerase chain reaction
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 09:30 (Lot number: EP7534) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "known allergies: fish protein" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 27Feb2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: HIV TEST POSITIVE (non-serious) with onset 25Aug2021, outcome "unknown", described as "I screened HIV positive and PCR negative. I had no HIV exposures, other illnesses, or vaccine except the Pfizer Covid vaccine"; HIV ANTIBODY (non-serious) with onset 25Aug2021, outcome "unknown", described as "It's possible the Covid vaccine Kick-started my vaccine-derived HIV antibody production". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of HIV test positive, HIV antibody. Additional information: Reporter was in a HIV vaccine study 2002-2006. It was a Merck vaccine that used an adenovirus vector with an HIV gag protein (I think). Due to the vaccine induced antibody, I would screen positive on some HIV screening tests, but always confirmed negative with PCR. About 4 years ago, I found out I no longer had detectable HIV antibodies so I began regularly donating   blood to the Red Cross. My last donation was 29Dec2020 and I did not screen HIV positive. I attempted to donate again on 25Aug2021, but I screened HIV positive and PCR negative. I had no HIV exposures, other illnesses, or vaccines except the Pfizer Covid vaccine between donations. I thought this might be of interest to your researchers. It's possible the Covid vaccine kick-started my vaccine derived HIV antibody production. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not receive any treatment before medical attention. Patient did not had Covid prior vaccination. patient was not tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Ventricular extrasystoles
Clinical narrative: chest pain; increase in PVC's; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown", described as "increase in PVC's".  Additional information: Subject: Patient Assistance. Customer Verbatim: Patient had over 10 days of chest pain and an increase in PVCs after receiving the first dose of Pfizer COVID-19 vaccination. Patient reached out to healthcare provider before pursuing the 2nd dose, to advise patient. He consulted with a cardiologist, and it was recommended that patient seek further testing (EKG, echocardiogram) before receiving 2nd dose. Patient was self-insured. Patient was inquiring if there were any funds or grants available (through Pfizer or other companies) to help off-set the costs of these tests.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Illness, Influenza like illness
Clinical narrative: 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 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: FALL (non-serious), outcome "unknown", described as "I feel like I am going to fall over"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Equilibrium is off, my balance is"; ILLNESS (non-serious), outcome "unknown", described as "sick"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Additional information: The patient's equilibrium was off, balance was, the patient felt like the patient was going to fall over. The second dose got the patient very sick, with flu like symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Feeling really achy; Kind of like the flu; 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), administration date 26Oct2021 10:00 (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), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "recovering", described as "Feeling really achy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Oct2021, outcome "recovering", described as "Kind of like the flu". Therapeutic measures were taken as a result of pain, influenza like illness.  Additional information: The patient received the COVID Booster shot yesterday around 10 a.m. and woke up this morning feeling really achy, kind of like the flu. The patient took some Aleve this morning and it was subsiding.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Eczema, SARS-CoV-2 test
Clinical narrative: Eczema; contact dermatitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol; "hearing loss" (unspecified if ongoing), notes: Other medical history: hearing loss; "eczema" (unspecified if ongoing), notes: Other medical history: eczema. Concomitant medication(s) included: CRESTOR; OMEGA 3 [FISH OIL]; VITAMIN D [COLECALCIFEROL]; TRANEXAMIC ACID. The following information was reported: ECZEMA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Eczema"; DERMATITIS CONTACT (non-serious) with onset 09Mar2021, outcome "not recovered", described as "contact dermatitis". The events "eczema" and "contact dermatitis" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, dermatitis contact.   Additional information: Eczema and contact dermatitis that was under control flared up approx 2-3 days after 1st shot. Got it cleared up and flared up again after 2nd shot. Still cant get it under control since then. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event with Creams to treat skin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies: Methyldibromo Glutaronitrile.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: complained of a left sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "complained of a left sore arm".  Additional Information: Reported stated that she wanted to report that after the Covid booster (third shot) that her husband complained of a left sore arm. Reporter seriousness for complained of a left sore arm was unspecified.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: experiencing neurological adverse events after receiving the booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "experiencing neurological adverse events after receiving the booster dose".  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: Fall, Gait disturbance
Clinical narrative: every time she took it she stayed whole night where she can''t walk; would fall to the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient 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 (1st dose, single), for Covid-19 immunization; Bnt162b2 (2nd dose, single), for Covid-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "every time she took it she stayed whole night where she can''t walk"; FALL (non-serious), outcome "unknown", described as "would fall to the floor".  Additional Information: Consumer said, she took three times the Pfizer COVID-19 vaccine, and called today because every time she took it she stayed whole night where she can't walk and would fall to the floor, she can't walk for 7-8 hours, she can't walk three times, so she wants to know if this is a problem from her or the vaccine. Report related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (03Dec2021): 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: U
Vaccine: COVID19
Symptoms: Fatigue, Hangover, Headache, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: HANGOVER (non-serious) with onset 2021, outcome "unknown", described as "24 hour hangover like symptoms"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Culture urine, Magnetic resonance imaging, Osteoarthritis
Clinical narrative: Ongoing worsening (Multiple Yes) Osteoarthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Feb2021 14:00 (Lot number: EN6201) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib", start date: 01Jan2006 (ongoing). Family history included: "Heart diseases" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date Jan2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Route of administration: Intramuscular, Vaccine Administration Time: 15:00, Lot number: EL9264), administration date: 29Jan2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Ongoing worsening (Multiple Yes) Osteoarthritis". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Prior vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient was not tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: sore arm; Body aches; exhausted; This is a spontaneous report received from a contactable reporter(s) (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 29Oct2021 18:30 (Batch/Lot number: unknown) at the age of 35 years as dose 2 (initial pfizer dose), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 29Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "known allergies : Adhesive" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies". Vaccination history included: J&j (Dose Number: 1, Batch/Lot No: Unknown. Obscured by other product labelling,Location of injection: Arm Left,Vaccine Administration Time: 02:00 PM), administration date: 09Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "sore arm"; PAIN (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 30Oct2021 07:00, outcome "recovering", described as "exhausted". Therapeutic measures were not taken as a result of pain in extremity, pain, fatigue.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 10:15 (Lot number: 320308D) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed 6-7 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no=1 at 18:30 , Lot FF2589,, Injected in left arm in the muscle), administration date: 01Oct2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "recovering", described as "Hair loss".  Additional Information: Warm transfer from (Name withheld), Support, 159558 She has a consumer on the line who just received Series from Pfizer in Oct2021 and since then has noticed hair loss.Patient confirmed information above. She works in the medical field, but is not a healthcare professional. She received her first dose on 01Oct2021, which was a Friday, and by Monday or Tuesday, she realized her hair was coming out quite a bit and for the next 2-3 weeks, she was losing a lot of hair.She never had a hair problem before.It did not dawn on her until she talked to a friend last night.It was embarrassing and she looked it up online and saw articles where a few patients had hair loss with it. Since she noticed it at first, over 2-3 weeks, it was more and more, but now it has slowed down a bit.She thought that it was due to getting the shot and it does lower your immune and didn't know if that were it. She did look at the vaccine before he gave it to her, even though she is not a nurse. The second dose of the Pfizer COVID vaccine was last Saturday.By then, she had considerably less hair on her head.She provided lot 320308D, Expiration unknown. Date was 23Oct2021, and it was injected in right arm in the muscle. She got it for her job and she wants to travel and have no restrictions for travel. She did not wish to provide her primary care doctor's name or contact details. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Any AE(s) require a visit to Emergency Room and Physician Office reported as No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as none. Patient's Medical History (including any illness at time of vaccination) reported as None or Unknown Family Medical History Relevant to AE(s) and Relevant Tests reported as None.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Pain, Tinnitus
Clinical narrative: Lot of pains all over my body; Light headedness; dizziness; Ringing in my ears; When I lay down, I get like these head rushes, it is almost like an electrical current going through my brain, it is very weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years 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 (non-serious), outcome "unknown", described as "Lot of pains all over my body"; DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; TINNITUS (non-serious), outcome "unknown", described as "Ringing in my ears"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "When I lay down, I get like these head rushes, it is almost like an electrical current going through my brain, it is very weird".  Additional Information:Consumer stated that she would have been 59, sorry 58 (years) (hence, captured in tab). Patient experienced side effects actually ever since she got the Pfizer shot, they have kind of lightened up from what they were in beginning, so it had gotten better. Patient also reported that in the very beginning she was getting like a lot of pains all over the body. The worst of it was just experiencing light headedness and dizziness and also ringing in ears. Also stated when she lay down to try to go to sleep, when she started kind of relaxing, got head rushes, it was almost like an electrical current going through her brain, it was very weird and never experienced that before. Consumer was informed that she can reach to Pfizer. Further probing could not be done as the consumer was unwilling to share any further information, hence limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "the caller's body is severely sensitive" (unspecified if ongoing), notes: Verbatim: the caller's body is severely sensitive; "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for blood pressure abnormal; IBUPROFEN. The following information was reported: MALAISE (non-serious), outcome "recovering", described as "didn't feel great after the first dose". Additional information: Pfizer Covid vaccine: didn't feel great after the first dose - Related. Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Illness
Clinical narrative: He has felt ill with muscle aches/feeling lousy with muscle aches; Flu-like symptoms; Nausea; Weakness; Dizziness; Fatigue; he is pretty sick; Feeling lousy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Oct2021 (Lot number: FH8020) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Disease", start date: 2002 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot Number: EL3249), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot Number: EN9581), administration date: 09Mar2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Thought he had just caught a bug"; Flu vaccine, administration date: 2021. The following information was reported: MYALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "He has felt ill with muscle aches/feeling lousy with muscle aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Flu-like symptoms"; NAUSEA (non-serious) with onset Oct2021, outcome "not recovered", described as "Nausea"; ASTHENIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Weakness"; DIZZINESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset Oct2021, outcome "not recovered", described as "Fatigue"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "he is pretty sick"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling lousy". The events "he has felt ill with muscle aches/feeling lousy with muscle aches", "flu-like symptoms", "nausea", "weakness", "dizziness", "fatigue", "he is pretty sick" and "feeling lousy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.   Additional information:  Caller stated States he is not sure what to think. He just got the booster on 14Oct2021 and the same thing that happened with his second dose of the vaccine happened again. States when he first got the third vaccine, he was fine the first couple of days. That Sunday he felt ill. Since then, he has been feeling lousy with muscle aches, flu, and nausea.  States this has been ongoing since then. Confirmed that some of the patient's similar symptoms were reported such as fatigue and muscle aches.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: He has felt ill with muscle aches/feeling lousy with muscle aches; Flu-like symptoms; Nausea; Weakness; Dizziness; Fatigue; he is pretty sick; Feeling lousy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Oct2021 (Lot number: FH8020) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Disease", start date: 2002 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot Number: EL3249), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot Number: EN9581), administration date: 09Mar2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Thought he had just caught a bug"; Flu vaccine, administration date: 2021. The following information was reported: MYALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "He has felt ill with muscle aches/feeling lousy with muscle aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Flu-like symptoms"; NAUSEA (non-serious) with onset Oct2021, outcome "not recovered", described as "Nausea"; ASTHENIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Weakness"; DIZZINESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset Oct2021, outcome "not recovered", described as "Fatigue"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "he is pretty sick"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling lousy". The events "he has felt ill with muscle aches/feeling lousy with muscle aches", "flu-like symptoms", "nausea", "weakness", "dizziness", "fatigue", "he is pretty sick" and "feeling lousy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.   Additional information:  Caller stated States he is not sure what to think. He just got the booster on 14Oct2021 and the same thing that happened with his second dose of the vaccine happened again. States when he first got the third vaccine, he was fine the first couple of days. That Sunday he felt ill. Since then, he has been feeling lousy with muscle aches, flu, and nausea.  States this has been ongoing since then. Confirmed that some of the patient's similar symptoms were reported such as fatigue and muscle aches.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Food poisoning
Clinical narrative: Experienced diarrhea after believed food poisoning; Experienced diarrhea after believed food poisoning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: they did have covid prior to being vaccinated, just as a note.; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high BP" (unspecified if ongoing); "scoliosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot number: UNKNOWN.), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), FOOD POISONING (non-serious) all with onset 2021, outcome "recovered" and all described as "Experienced diarrhea after believed food poisoning".  The reporter considered "experienced diarrhea after believed food poisoning" not related to bnt162b2.  Additional information: The patient was fully vaccinated and got a second shot several months ago. They waited the allotted time before vaccination and two doses vaccinated summer 2021. Precise vaccination date, Jun2021 reporter believed was the 2nd dose.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event and the suspect BNT162B2 can 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Feb2021 (Lot number: EN6201) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (ongoing), notes: Verbatim: AFib. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 23Jan2021, when the patient was 83 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache".  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Malaise
Clinical narrative: inflammed lymph node under arm of injection site; general malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization.  The following information was reported: LYMPHADENITIS (non-serious) with onset 31Oct2021, outcome "recovered", described as "inflammed lymph node under arm of injection site"; MALAISE (non-serious) with onset 31Oct2021, outcome "recovered", described as "general malaise". Therapeutic measures were not taken as a result of lymphadenitis, malaise.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Feeling abnormal
Clinical narrative: she was really tired; unwell for a few hours; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), 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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was really tired"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "unwell for a few hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported after second dose when she was really tired and did not feel good for about 6 hours after the second dose. The patient did not receive prior vaccination with in 4 weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (06Dec2021): 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.