chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Menstrual disorder, Palpitations
Clinical narrative: have not gotten my period; heart palpitate; my tongue went numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FF8839) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "anemia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin". The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "have not gotten my period"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitate"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "my tongue went numb". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Facility type vaccine: Pharmacy or Drug Store, Other medications in two weeks: only vitamins: D, Multi, After the first dose, she felt her heart palpitate but it went away quickly. Then her tongue went numb. She was checked out by an RN who said she was ok. She also had not gotten her period since the vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101372458 same patient and drug, different AE and dose
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Lot number: EN6203) as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hip arthroplasty" (unspecified if ongoing), notes: Verbatim: Hip replacement about 12 years ago. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: NDC number was not reported. Investigation Assessment was not reported. She did not have problems.  No additional vaccines administered on same date of the pfizer Suspect. Emergency room visit and physician office visit was not required. No relevant tests reported.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, SARS-CoV-2 test, Tinnitus
Clinical narrative: fatigue; brain fog; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 27Mar2021 (Lot number: ER8734) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; WARFARIN. Past drug history included: Known allergies: vancomyacin, reaction(s): "Allergy", notes: known allergies: vancomyacin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "brain fog"; TINNITUS (non-serious) with onset 12Apr2021, outcome "recovered with sequelae", described as "tinnitus". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, feeling abnormal, tinnitus.  Additional information: No other vaccine in four weeks. Other medications in two weeks: antacid. Event treatment included medication. No covid prior to vaccination. Patient was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Inflammation at injection site that is increasing in size as of day 2; It is painful/hot to touch and mildly itchy.; It is painful/hot to touch and mildly itchy.; It is painful/hot to touch and mildly itchy.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Oct2021 (Lot number: FE3590) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 07Oct2021; TRIPTAN [OXITRIPTAN]; NAPROXEN; BIOTIN; VITAMIN D [VITAMIN D NOS]; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Bacitraicin, reaction(s): "Known allergies: Bacitraicin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201), administration date: 21Feb2021, when the patient was 40 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262), administration date: 31Jan2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 12Oct2021, outcome "recovering", described as "Inflammation at injection site that is increasing in size as of day 2"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 12Oct2021, outcome "recovering" and all described as "It is painful/hot to touch and mildly itchy.". Therapeutic measures were not taken as a result of vaccination site inflammation, vaccination site pain, vaccination site warmth, vaccination site pruritus.  Additional information: Patient received other vaccine in four weeks. Inflammation at injection site that is increasing in size as of day 2. It is painful/hot to touch and mildly itchy. No covid prior vaccination. Patient did not tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Caller stated that he had never had anxiety before in his life until all of this covid stuff.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Caller stated that he had never had anxiety before in his life until all of this covid stuff.". Additional information: Caller stated that he was fully vaccinated with the Pfizer Biontech covid 19 vaccine series back in February. Caller reported he was now 8 months plus 5 days out and was seeking information regarding the booster shot and its efficacy since the recommendation was to get the booster dose 6 months later. Caller stated that he had never had anxiety before in his life until all of this covid stuff. Caller was fully vaccinated with both doses in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Formication, Insomnia, Skin irritation
Clinical narrative: I can't sleep it feels like something is under my skin or like I am having chills, the Tylenol is not touching it; Chills; it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all; it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: 30135BA) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep it feels like something is under my skin or like I am having chills, the Tylenol is not touching it"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FORMICATION (non-serious), SKIN IRRITATION (non-serious), outcome "unknown" and all described as "it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all". Therapeutic measures were taken as a result of insomnia, chills.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: slight icnrease in pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: FLUARIX QUADRIVALENT; METOPROLOL SUCCINATE; B COMPLEX [VITAMIN B COMPLEX]. Past drug history included: Lisinopril, reaction(s): "Allergy: Lisinopril"; Motrin, reaction(s): "Allergies: MOTRIN"; Diltiazem, reaction(s): "Allergies: DILTIAZEM". The following information was reported: PAIN (non-serious), outcome "unknown", described as "slight icnrease in pain".  Additional information: Patients wife Withheld completed the assessment for her husband has missed 3 days of medication and has had a slight increase in pain. 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: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: extreme tiredness; she can't get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (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: FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness"; ASTHENIA (non-serious), outcome "unknown", described as "she can't get out of bed".  Additional information: Patient Stated that since the booster she had been late for work 9 times and on weekends she can't get out of bed and she has to to get to work. Caller stated it's terrible. Phone answered by the consumer who provided the mailing address.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test negative
Clinical narrative: Not adverse just soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 15:15 (Lot number: FD0809) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEXA [CELECOXIB]; ADDERALL. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: Er8736, Anatomical location: Left Arm, Vaccine Administration Time: 12:00 PM), administration date: 16May2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, single, Batch/Lot No: Ew968, Anatomical location: Left Arm, Vaccine Administration Time: 12:00 PM), administration date: 13Jun2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Oct2021 10:00, outcome "recovering", described as "Not adverse just soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received Celexa, adderall within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The vaccine was administered at Public Health Clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101374795 similar report from same reporter
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: irregular periods; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER: 1), administration date: Apr2021, when the patient was 21 years old, for COVID-19 Immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular periods".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Blepharospasm, Nausea, Occupational exposure to product
Clinical narrative: my right eye started twitching; agitated; nauseated; accidental spraying of the Pfizer Covid vaccine into her right eye; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 24Sep2021, outcome "unknown", described as "accidental spraying of the Pfizer Covid vaccine into her right eye"; BLEPHAROSPASM (non-serious) with onset 03Oct2021, outcome "unknown", described as "my right eye started twitching"; AGITATION (non-serious) with onset 03Oct2021, outcome "unknown", described as "agitated"; NAUSEA (non-serious) with onset 03Oct2021, outcome "unknown", described as "nauseated". The events "accidental spraying of the pfizer covid vaccine into her right eye", "my right eye started twitching", "agitated" and "nauseated" were evaluated at the physician office visit. Therapeutic measures were taken as a result of occupational exposure to product, blepharospasm, agitation, nausea.  Additional information: It was reported that, on 24Sep2021, she had just finished vaccinating a patient, she pulled out the needle and as she was priming it, she felt a spray in her right eye, but continued doing her work. 2 hours later when she got home she thought about it, and felt maybe she should have said something. 8 days after this happened her right eye started twitching, and agitated, and sometimes she feel nauseated. Her doctors said it may be just stress from work. Rinsed thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: her niece is "icy cold on the inside."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient 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 NUMBER: 1, his niece had the COVID 19 vaccine), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER: 2, his niece had the COVID 19 vaccine), for COVID-19 Immunization. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "her niece is "icy cold on the inside."".  Additional information: Caller was a consumer who was calling for her niece who got the booster dose of the Pfizer Biontech COVID19 vaccine yesterday. Caller said her niece was "icy cold on the inside." Caller was asking for any information available on this and if they should go to the doctor. She needed to talk to someone to see what they should do. She doesn't want to do a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: chills; Felt hot and cold; sweating one time; 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 85 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Oct2021 (Lot number: 30155BA) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "chills"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Felt hot and cold"; HYPERHIDROSIS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "sweating one time".  Additional information: No family medical history relevant to adverse events. History: The caller took lots of medications but declined to provide that information. The patient was taking Pfizer Covid vaccine as she decided to get it. Vaccine was administered at (Privacy) Facility. Had the Pfizer shot last Friday (in the morning) and wanted to know how long the side effects would last. She wanted to know if chills was an adverse event after getting the Pfizer BioNtech Covid-19 Vaccine and wanted to know how long it would usually lasts. On the evening of 09Oct2021, she experienced chills (felt hot and cold, sweating one time and chills on another time). The caller got cold and then she got hot, she had chills and then she got hot. The caller was not running a temperature. She asked whether that was normal. Caller stated that she still experienced that. No investigation assessment. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site swelling, Nodule
Clinical narrative: swelling and Nodules in all locations she was treated in Jul; nodules in her chin area; everywhere she had treatment she had bumps/ Nodules in all locations she was treated in Jul; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): GL-090821-21582.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: INJECTION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling and Nodules in all locations she was treated in Jul"; NODULE (non-serious) with onset 2021, outcome "unknown", described as "nodules in her chin area"; INJECTION SITE NODULE (non-serious) with onset 2021, outcome "unknown", described as "everywhere she had treatment she had bumps/ Nodules in all locations she was treated in Jul". The events "swelling and nodules in all locations she was treated in Jul", "nodules in her chin area" and "everywhere she had treatment she had bumps/ nodules in all locations she was treated in Jul" were evaluated at the physician office visit. Therapeutic measures were taken as a result of injection site swelling, nodule, injection site nodule.  Additional Information: It was stated that, the caller had a patient that was treated by her practice many times over the years. She was treated in Jul by her PA with all these syringes in one treatment. The patient called on 31Aug and stated everywhere she had treatment she had bumps. When she came in to the office we saw nodules in chin area only. We treated with some medication at that visit. The patient came back this weekend and had swelling and Nodules in all locations she was treated in Jul. Note the patient did have the Pfizer vaccine earlier in the year and the product she was treated with in Jul.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: We both of us very fatigue; Little nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 06Oct2021, outcome "not recovered", described as "We both of us very fatigue"; NAUSEA (non-serious) with onset 06Oct2021, outcome "recovered" (Oct2021), described as "Little nauseated".  Follow-up (25Oct2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity which included that: Any additional information: Phone Out 11:26 AM EST, 1st attempt by phone to non-HCP to obtain mailing information. Phone answered by the consumer who provided his mailing address. Consumer questionnaire forwarded to reporting mailbox Consumer's mailing address is: withheld  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101376484 same reporter/product, different patient / event.
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Frequent bowel movements, Headache, Nausea
Clinical narrative: Headache; Nausea; Multiple bowel movements not diarrhea type form; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS VACCINE), administered in arm right, administration date 11Oct2021 (Batch/Lot number: unknown) as unk unk, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single, Lot number: EN6198), administration date: 02Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Single, Batch/lot number: ER2613, Dosage text: Unknown dosage injection left arm), administration date: 23Mar2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "Headache", "Nausea", "Diarrhea", "Vomiting", "Backache". The following information was reported: HEADACHE (non-serious) with onset 11Oct2021, outcome "recovered" (12Oct2021), described as "Headache"; NAUSEA (non-serious) with onset 11Oct2021, outcome "recovered" (14Oct2021), described as "Nausea"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 11Oct2021, outcome "recovered" (12Oct2021), described as "Multiple bowel movements not diarrhea type form". Therapeutic measures were taken as a result of headache.  Additional Information- Reporter Stated that she had the first Pfizer vaccine with no side effects. Stated that with the second one and the booster that she had many side effects. Stated that the second one side effects lasted one day and third one three days. Stated that she was better now. Stated that a local newspaper article stated that Pfizer is looking to give the vaccine to ages 5-11. Stated that after reading it she thought her dad who is 91 years old and had no side effects. Stated that he was a lot heavier than her. Stated that she is 67 years old and only 5 foot and does not even weigh 100 pounds. Stated that if they did not think of fact that different there are weights of people that she would not have reacted if given a lesser dose like children. Stated that getting sick for one day versus Covid was okay. Clarified that this was for the Pfizer Covid vaccine. Stated that she got the flu shot on the same day as her booster. Stated that she has gotten the flu shot for many years so she knows that her symptoms were not from the flu shot. Later clarified that it all of this was for the Pfizer BioNTech. Reporter Stated that she took Tylenol for the headache with the third dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: headache; nausea; diarrhea; vomiting; backache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot Number: EN6198), administration date: 02Mar2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "no side effects". The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "headache"; NAUSEA (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "vomiting"; BACK PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "backache".  Additional information: Patient report not related to a study or programme. Patient not had any investigation assessment. Stated that a local newspaper article stated that Pfizer is looking to give the vaccine to ages 5-11. Stated that after reading it she thought her dad who is 91 years old and had no side effects. Stated that he is a lot heavier than her. Stated that she is 67 years old and only 5 foot and does not even weigh 100 pounds. Stated that if they did not think of fact that different there are weights of people that she would not have reacted if given a lesser dose like children. Stated that getting sick for one day versus Covid is okay. Stated that when one is sick that they do not think about this is better than Covid. Stated that they should think about how much a person weighs instead of the dosage. Stated that she wrote down all the symptoms she had second and third time. Stated that maybe other people her size are having a hard time should be given a lesser dose. Stated that children will be given 1/3 of dose and she should have to. Stated her husband got Moderna and had no reaction but weighs more than she does maybe 175. Clarified that this is for the Pfizer Covid vaccine. Stated that she got the flu shot on the same day as her booster. Stated that she has gotten the flu shot for many years so she knows that her symptoms were not from the flu shot. Later clarified that it all of this was for the Pfizer BioNTech.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Electrocardiogram
Clinical narrative: abnormal heart on my left side (enlarge heart); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FN5318) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hermia ( stomach ) - fiber tissue on uterus" (unspecified if ongoing), notes: Hermia ( stomach ) - fiber tissue on, uterus. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, dose product:COVID 19, Pfizer, administration time:16:00, Lot number: 30135BA, location: Left arm), when the patient was 58 years old, for Covid-19 Immunization; Bnt162b2 (dose number: 2, product: COVID 19, Pfizer, lot number: EN5318, location: Left arm), when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 04Oct2021 14:30, outcome "not recovered", described as "abnormal heart on my left side (enlarge heart)". The event "abnormal heart on my left side (enlarge heart)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cardiomegaly.  Additional information: Patient had no history of heart disease, nor high blood pressure and had no red meat in 17 years pretty much strike diet, he was concern if this condition is caused from the vaccine. Facility type vaccine: Pharmacy or Drug Store, No other vaccine and medication was taken in four weeks. Patient was not tested for covid prior and after vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Nausea, Pain
Clinical narrative: little bit of nausea; Feeling of Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 15:00 (Lot number: FF2590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1st, Start Date: 26Jan2021, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: EL3247), administration date: 26Jan2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose:2nd, Start date: 16Feb2021, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: EN5318), administration date: 16Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 13Oct2021 06:30, outcome "recovered" (Oct2021), described as "little bit of nausea"; PAIN (non-serious) with onset 13Oct2021 05:30, outcome "recovered" (Oct2021), described as "Feeling of Aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: could hardly walk and she is having problem walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "could hardly walk and she is having problem walking".  Additional information: Reporter stated, my wife had the COVID shot couple of days ago and she has got bad problems yesterday and today she could hardly walk and she is having problem walking but is, has less then listed so, I am just wondering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: swollen lymph nodes; Muscle pain; chills; injection site pain; stiffness; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 10:30 (Lot number: 30145BA) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "swollen lymph nodes"; MYALGIA (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "Muscle pain"; CHILLS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "injection site pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "stiffness"; MALAISE (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "feeling unwell". Therapeutic measures were not taken as a result of lymphadenopathy, myalgia, chills, vaccination site pain, musculoskeletal stiffness, malaise.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: swollen lymph nodes; Muscle pain; chills; injection site pain; stiffness; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 10:30 (Lot number: 30145BA) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "swollen lymph nodes"; MYALGIA (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "Muscle pain"; CHILLS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "injection site pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "stiffness"; MALAISE (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "feeling unwell". Therapeutic measures were not taken as a result of lymphadenopathy, myalgia, chills, vaccination site pain, musculoskeletal stiffness, malaise.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: After the booster shot she felt better, even better than she had in several years; After the booster shot she felt better, even better than she had in several years; 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 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 11Oct2021 13:30 (Lot number: FC3181) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Myasthenia Gravis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number EL9265), administration date: 27Jan2021, when the patient was 75 years old, for Covid-19 Immunisation, reaction(s): "had all kinds of infection with head and lung", "always running a low grade fever"; Bnt162b2 (Dose 2, lot number EN6198), administration date: 24Feb2021, when the patient was 75 years old, for Covid-19 Immunisation, reaction(s): "down again", "had low grade fever again". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious) all with onset Oct2021, outcome "unknown" and all described as "After the booster shot she felt better, even better than she had in several years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination Facility Type: Pharmacy/Drug Store. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. AEs did not require a visit to Emergency Room or Physician Office.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: all had styes after Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HORDEOLUM (non-serious), outcome "unknown", described as "all had styes after Pfizer vaccine".  Additional information: Clinical course reported as the patient and his wife reported to the physician that the patient's sister, and her son (sister and sister's son styes as bad as patient's eyes or worse); and patient's daughter (stye not as bad), all had styes after Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375744 same reporter, drug and event, different patient;US-PFIZER INC-202101375858 same reporter, drug and event, different patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Movement disorder, Musculoskeletal discomfort, Pain
Clinical narrative: aching all over/ I have a lot of pain, lots of pain; I can hardly move my neck and it goes across my shoulder to the top; I can hardly move my neck and it goes across my shoulder to the top; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 (Lot number: 3-1358A) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Restless legs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Lot number: EL3246; Anatomical site of administration: Left), administration date: 01Feb2021, when the patient was 76 years old, for COVID-19 immunization; Bnt162b2 (Dose 2; Lot number: EL9262; Anatomical site of administration: Left), administration date: 22Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "aching all over/ I have a lot of pain, lots of pain"; MUSCULOSKELETAL DISCOMFORT (non-serious), MOVEMENT DISORDER (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "I can hardly move my neck and it goes across my shoulder to the top". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, musculoskeletal discomfort, movement disorder.  Additional information: The patient called to report side effects from the booster he had yesterday. He was aching all over and can hardly move his neck and it goes across shoulder to the top and all just he has a lot of pain, lots of pain. Patient takes unspecified medications for restless legs. Weight reported as 281 (Further Clarification Unknown). He underwent lab test couple of weeks ago (reported as of the blood whatever that is, they run all the test). No prior vaccination. Expiry Date of COVID 19 Vaccine was Unknown. Reporter seriousness for events was unspecified.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: a little swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (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: VACCINATION SITE SWELLING (non-serious) with onset 02Jul2021, outcome "recovering", described as "a little swelling at injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red swollen rash around injection site; Red swollen rash around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 10:00 (Lot number: Ff2589) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing), notes: Chronic cough; "Opiods after surgery" (unspecified if ongoing), notes: Opiods after surgery. Concomitant medication(s) included: NYQUIL. Past drug history included: Opiods after surgery, reaction(s): "Allergy", notes: Opiods after surgery. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 14Mar2021, when the patient was 67 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. No others on this dste but COVID vaccination, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 12Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 13Oct2021, outcome "not recovered" and all described as "Red swollen rash around injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site rash, vaccination site swelling.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications NyQuil within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient had tested for COVID-19 since vaccination. The patient was not received treatment for the adverse events.  No follow-up attempts are possible. No further information is expected.  Follow-Up (20Oct2021): Follow-up attempts are completed. No further information is expected.