chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to fatty products), Drug allergy (Allergic to antidepressant drugs (not all of them), anxiety and depression medications.), Drug allergy (Allergic to Novocaine), Allergy to antibiotic, Lactose intolerant, Caffeine allergy, Meat allergy (Allergic to pork products), Diabetes (No recent change in status such as improvement or worsening) since 2016, Blood pressure high (No recent change in status such as improvement or worsening) since 2019 and Arthritis. Concomitant products included CORTISONE for Arthritis, AMLODIPINE BESYLATE for Blood pressure high, CLONAZEPAM, LOSARTAN, PARACETAMOL (TYLENOL [PARACETAMOL]), CALCIUM, NICOTINAMIDE (VITAMIN B3), MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose). On 28-Oct-2021, ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose) had resolved.            The patient stated that they received a 3rd full dose of Moderna COVID-19 vaccine instead of a booster shot on 28-Oct-2021, but the patient was not an immunocompromised person. It was also reported that the patient was currently taking cortisone shots on their knees for arthritis every 3 months.  It was reported that the patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The Adverse events didn't cause patient to seek medical care and the patient had not experienced a similar event in the past. The adverse event outcome was reported as recovered and the symptoms had recovered.  The patient's height reported as 5 feet 3 inch.  Reportedly, no treatment was given for any of the symptoms after vaccination.   This case was linked to MOD-2022-484121, MOD-2022-484143 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial had been left ay room temperature for more than 24 hours; Vial was removed from the refrigerator at 8:12 AM 14 Feb 2022 and was administered on 15 Feb 2022 at 10:34 AM; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was removed from the refrigerator at 8:12 AM 14 Feb 2022 and was administered on 15 Feb 2022 at 10:34 AM) and PRODUCT STORAGE ERROR (Vial had been left ay room temperature for more than 24 hours) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 02-May-2021 and Pfizer on 24-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 15-Feb-2022 at 10:34 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022 at 10:34 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was removed from the refrigerator at 8:12 AM 14 Feb 2022 and was administered on 15 Feb 2022 at 10:34 AM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial had been left ay room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was removed from the refrigerator at 8:12 AM 14 Feb 2022 and was administered on 15 Feb 2022 at 10:34 AM) and PRODUCT STORAGE ERROR (Vial had been left ay room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  No additional doses and no events was reported. The vial was initially stored in the refrigerator on 10 FEB 2022. Vaccines were not returned to refrigerator once originally removed.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient mention that they have an AE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient mention that they have an AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient mention that they have an AE). At the time of the report, VACCINATION COMPLICATION (Patient mention that they have an AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow up received contain patient initials and route of administration of suspect drug was updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.; Room temperature for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 28-Mar-2021 and Pfizer vaccine on 19-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 15-Feb-2022 at 12:29 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No reported symptoms, no additional doses stated  by  the patient . Concomitant medications was not reported.  Treatment medications was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose three months after the first dose. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose three months after the first dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose three months after the first dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose three months after the first dose.) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-060921 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the booster dose 3 months after receiving the 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 005C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-483784.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Decreased appetite, Mouth haemorrhage, Pain
Clinical narrative: chest pain; starting bleeding from his mouth; rashes all over his body; body aches all over his body; lost appetite; Underweight; started losing strength all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 10:00 (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Premature baby" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 02Jul2021, outcome "not recovered", described as "chest pain"; MOUTH HAEMORRHAGE (non-serious) with onset 02Jul2021, outcome "not recovered", described as "starting bleeding from his mouth"; RASH (non-serious) with onset 02Jul2021, outcome "not recovered", described as "rashes all over his body"; PAIN (non-serious) with onset 02Jul2021, outcome "not recovered", described as "body aches all over his body"; DECREASED APPETITE (non-serious) with onset 02Jul2021, outcome "not recovered", described as "lost appetite"; UNDERWEIGHT (non-serious) with onset 02Jul2021, outcome "not recovered", described as "Underweight"; ASTHENIA (non-serious) with onset 02Jul2021, outcome "not recovered", described as "started losing strength all over his body". The events "chest pain", "starting bleeding from his mouth", "rashes all over his body", "body aches all over his body", "lost appetite", "underweight" and "started losing strength all over his body" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chest pain, mouth haemorrhage, rash, pain, decreased appetite, underweight, asthenia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Oct2021): 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.  Additional information: After receiving the Pfizer vaccine in 30Jun2021 after two days the patient started getting rashes all over his body, he then started losing strength all over his body, lost appetite, started bleeding from his mouth, body aches all over his body and chest pain. At first his reactions were stable but after a month they started getting worse day by day. Patient have no strength and very underweight. Patient did not had any other vaccine in four weeks. Patient did not have other medications in two weeks. If Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Patient did not have Known allergies.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Underweight
Clinical narrative: chest pain; starting bleeding from his mouth; rashes all over his body; body aches all over his body; lost appetite; Underweight; started losing strength all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 10:00 (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Premature baby" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 02Jul2021, outcome "not recovered", described as "chest pain"; MOUTH HAEMORRHAGE (non-serious) with onset 02Jul2021, outcome "not recovered", described as "starting bleeding from his mouth"; RASH (non-serious) with onset 02Jul2021, outcome "not recovered", described as "rashes all over his body"; PAIN (non-serious) with onset 02Jul2021, outcome "not recovered", described as "body aches all over his body"; DECREASED APPETITE (non-serious) with onset 02Jul2021, outcome "not recovered", described as "lost appetite"; UNDERWEIGHT (non-serious) with onset 02Jul2021, outcome "not recovered", described as "Underweight"; ASTHENIA (non-serious) with onset 02Jul2021, outcome "not recovered", described as "started losing strength all over his body". The events "chest pain", "starting bleeding from his mouth", "rashes all over his body", "body aches all over his body", "lost appetite", "underweight" and "started losing strength all over his body" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chest pain, mouth haemorrhage, rash, pain, decreased appetite, underweight, asthenia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Oct2021): 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.  Additional information: After receiving the Pfizer vaccine in 30Jun2021 after two days the patient started getting rashes all over his body, he then started losing strength all over his body, lost appetite, started bleeding from his mouth, body aches all over his body and chest pain. At first his reactions were stable but after a month they started getting worse day by day. Patient have no strength and very underweight. Patient did not had any other vaccine in four weeks. Patient did not have other medications in two weeks. If Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Patient did not have Known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Rashes; hives; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): LUS21-00448 .  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rashes"; URTICARIA (non-serious), outcome "unknown", described as "hives"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction".  Additional information: The patient has had allergic reaction to the vaccine, has suffered rashes and hives. No additional information can be provided at this time. This report will not be submitted to the FDA by another company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Oct2021): 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: Erythema, Vaccination site swelling
Clinical narrative: Only redness on shots one and two, very little swelling.; The injection site was very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scorpion bite" (unspecified if ongoing), notes: She took an anaphylactic reactoid to a scorpion bite about six months ago; "Type 1 Diabetic" (unspecified if ongoing); "TIAs" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Only redness on shots one and two, very little swelling."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "The injection site was very swollen".  Additional Information: She didn't take the hydrochloroquine for the use of covid-19.  She started it on 04Aug2021 arthritis. She actually did take it the day of the injection. I saw online that someone had a very similar reaction with someone that was taking hydro chloroquine  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211960 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Nose deformity, SARS-CoV-2 test
Clinical narrative: nose bleeds; sores in her nose that she describes as dried blood scabs; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 10Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; NOSE DEFORMITY (non-serious), outcome "unknown", described as "sores in her nose that she describes as dried blood scabs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer is the patient who had the Pfizer Covid Vaccine this year and has been having nose bleeds all summer. The other day she had to get on plane and so she had to take a COVID test where they stuck something in her nose, and it came back bloody. She said her nose has been bleeding all summer, she is 58 and has never had nose bleeds her whole life; but in the last months she has been getting nose bleeds and getting sores in her nose. The person said she did not want to alarm her, but she just thought caller should have that addressed; tell her doctor she had the Pfizer Covid Vaccine, inform the doctor that you're having this trouble. So caller called to ask if nose bleeds have been reported with Pfizer Covid Vaccine, if it's relative to the injection. she had to get on plane and so she had to take a COVID test where they stuck something in her nose, and it came back bloody  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Influenza, Rhinorrhoea
Clinical narrative: Flu symptoms; Cough; Runny nose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu symptoms"; COUGH (non-serious), outcome "unknown", described as "Cough"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Oct2021): 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: Epistaxis, Gait disturbance
Clinical narrative: it's hard for her to walk to go and get it; Terrible nosebleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (ongoing), notes: Stated it's going away because she is no longer eating grains. Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Past drug history included: Colloidal silver for Lyme disease, notes: She normally takes Colloidal silver, it cured her of Lyme disease. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer COVID Vaccine, Lot Number / Expiry Date: Unknown/Unknown, Route, Anatomical Location: Right Arm, Date: 26Aug2021), administration date: 26Aug2021, for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 18Sep2021 02:00, outcome "recovered" (18Sep2021 02:20), described as "Terrible nosebleed"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "it's hard for her to walk to go and get it". Therapeutic measures were not taken as a result of epistaxis.  Additional information: The patient did not receive Prior Vaccinations (within 4 weeks). Had no AEs following prior vaccinations. No additional Vaccines Administered on same Date of the Pfizer Suspect. Vaccination Facility Type: Pharmacy inside of the grocery store. The patient the first shot like three weeks ago, clarified to be 26Aug2021. Terrible Nosebleed- It started Saturday 2 AM. The patient got up with a drippy nose. Thought it was snot at first and it was not snot. The patient made it to the bathroom and stood over the sink and it poured out of nose. The nosebleed was for 20 minutes. It finally stopped. It was close to calling 911.  Had not had a nosebleed since she was a kid. The patient ended up staying up until about 4/5 AM and the nosebleed did not come back, but it scared the snot out of her. The patient did not visit Emergency Room/ Physician Office. The patient confirmed that does not had the lot/exp/NDC to provide from the first or second dose of the COVID Vaccine. She does not have the vaccination card with her. It's in her purse, it's hard for her to walk to go and get it.  The patient does not get sick. Does not take vaccines or anything. The patient normally takes Colloidal silver, it cured her of Lyme disease.  The patient has not had a cold or flu or anything. It keeps her from getting sick. Unable to clearly understand caller's statement due to distortion in the line.  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-202101236148 Same reporter/drug/event for different patients
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; fatigue; low grade fever; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 15:30 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic rhinitis (severe)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "possibly some IV contrast dyes" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 15:00 , vaccine location: Right arm), administration date: 28Aug2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Injection site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "fatigue"; PYREXIA (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced covid prior vaccination. Patient did not experienced covid tested post vaccination. Patient received medications within 2 weeks of vaccination. Patient received treatment as Acetaminophen 1000 mg for the fever.   Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Feeling abnormal, Pain
Clinical narrative: Red; Pain(sore to touch); Feels like a golf ball under my skin; Extremely uncomfortable; 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 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: ERYTHEMA (non-serious), outcome "unknown", described as "Red"; PAIN (non-serious), outcome "unknown", described as "Pain(sore to touch)"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels like a golf ball under my skin"; DISCOMFORT (non-serious), outcome "unknown", described as "Extremely uncomfortable". Additional information: The patient received second vaccination. Patient have had what they are calling COVID Arm for almost a week now. Red, circle, pain (sore to touch) and feels like a golf ball under skin. How much longer does this last. It was Extremely uncomfortable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "very bad allergic reaction". Additional information: The patient got a COVID-19 Pfizer shot and had a very bad allergic reaction to it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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: Abdominal distension, Dysmenorrhoea, Loss of personal independence in daily activities, Menstrual discomfort, Menstrual disorder
Clinical narrative: Immense difference in my menstrual cycle; Cramps/The cramps are to take the sunlight out of me; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; I have been bloated; Swollen; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free; 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 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 01Apr2021 09:00 (Lot number: EW0150) as dose 1, single and intramuscular, administered in arm, administration date 22Apr2021 10:00 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C, start date: Mar2021 (ongoing). The following information was reported: MENSTRUAL DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle"; DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Cramps/The cramps are to take the sunlight out of me"; PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to"; ABDOMINAL DISTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "I have been bloated"; SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen"; MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free".  Additional information: Since the patient got the Covid-19 Vaccine from this laboratory patient felt an immense difference in menstrual cycle. The patient has been bloated, swollen, and the cramps were to take the sunlight out of me. The level of pain has been so unbearable that the patient cannot live routine as used to. It started Apr2021, same month took the two dosages of the vaccine. Nothing in diet and routine has changed drastically to justify such change, and the cycle was light, regular, and almost pain-free. Relevant test: None. Anatomical location: Arm Vaccination facility type: Other. Prior vaccination: None. No AE prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Immense difference in my menstrual cycle; Cramps/The cramps are to take the sunlight out of me; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; I have been bloated; Swollen; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free; 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 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 01Apr2021 09:00 (Lot number: EW0150) as dose 1, single and intramuscular, administered in arm, administration date 22Apr2021 10:00 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C, start date: Mar2021 (ongoing). The following information was reported: MENSTRUAL DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle"; DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Cramps/The cramps are to take the sunlight out of me"; PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to"; ABDOMINAL DISTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "I have been bloated"; SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen"; MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free".  Additional information: Since the patient got the Covid-19 Vaccine from this laboratory patient felt an immense difference in menstrual cycle. The patient has been bloated, swollen, and the cramps were to take the sunlight out of me. The level of pain has been so unbearable that the patient cannot live routine as used to. It started Apr2021, same month took the two dosages of the vaccine. Nothing in diet and routine has changed drastically to justify such change, and the cycle was light, regular, and almost pain-free. Relevant test: None. Anatomical location: Arm Vaccination facility type: Other. Prior vaccination: None. No AE prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: experienced 2 hive marks on her left upper arm at the injection site; 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 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE URTICARIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "experienced 2 hive marks on her left upper arm at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: Fever; chills; arm soreness and heat; arm soreness and heat; hip pain; abdominal pain; severe headache; partial face numbness ( right side); muscle pain; dizziness; tired all the time and Extremely fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies", notes: known allergies: Keflex. The following information was reported: PYREXIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 15Sep2021, outcome "not recovered" and all described as "arm soreness and heat"; ARTHRALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "hip pain"; ABDOMINAL PAIN (non-serious) with onset 15Sep2021, outcome "not recovered", described as "abdominal pain"; HEADACHE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "severe headache"; HYPOAESTHESIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "partial face numbness ( right side)"; MYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "tired all the time and Extremely fatigued". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, feeling hot, arthralgia, abdominal pain, headache, hypoaesthesia, myalgia, dizziness, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Any other medications patient received within 2 weeks of vaccination reported as NA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Fever; chills; arm soreness and heat; arm soreness and heat; hip pain; abdominal pain; severe headache; partial face numbness ( right side); muscle pain; dizziness; tired all the time and Extremely fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies", notes: known allergies: Keflex. The following information was reported: PYREXIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 15Sep2021, outcome "not recovered" and all described as "arm soreness and heat"; ARTHRALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "hip pain"; ABDOMINAL PAIN (non-serious) with onset 15Sep2021, outcome "not recovered", described as "abdominal pain"; HEADACHE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "severe headache"; HYPOAESTHESIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "partial face numbness ( right side)"; MYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "tired all the time and Extremely fatigued". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, feeling hot, arthralgia, abdominal pain, headache, hypoaesthesia, myalgia, dizziness, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Any other medications patient received within 2 weeks of vaccination reported as NA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; arm soreness and heat; arm soreness and heat; hip pain; abdominal pain; severe headache; partial face numbness ( right side); muscle pain; dizziness; tired all the time and Extremely fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies", notes: known allergies: Keflex. The following information was reported: PYREXIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 15Sep2021, outcome "not recovered" and all described as "arm soreness and heat"; ARTHRALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "hip pain"; ABDOMINAL PAIN (non-serious) with onset 15Sep2021, outcome "not recovered", described as "abdominal pain"; HEADACHE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "severe headache"; HYPOAESTHESIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "partial face numbness ( right side)"; MYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 15Sep2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Sep2021, outcome "not recovered", described as "tired all the time and Extremely fatigued". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, feeling hot, arthralgia, abdominal pain, headache, hypoaesthesia, myalgia, dizziness, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Any other medications patient received within 2 weeks of vaccination reported as NA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Illness, Pyrexia
Clinical narrative: sick in bed for 4 days; Low grade temperature 101.5 fever; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Sep2021 12:30 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sick in bed for 4 days "; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Low grade temperature 101.5 fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Chills"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pyrexia, chills, headache.  Additional information- The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.