chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Muscle spasms, Peripheral swelling
Clinical narrative: This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had past history of similar event. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swelling to right leg, spasms to right leg, and spasms to abdominal area. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling to right leg, spasms to right leg, and spasms to abdominal area. This report was non-serious. This report was associated with product quality complaint: 90000216050.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm soreness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I think I have COVID right now/COVID + possible after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination). At the time of the report, SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Company comment: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Suspected COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine was not reported, as event and vaccination dates are not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Suspected COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine was not reported, as event and vaccination dates are not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (After 3rd dose was sick for about 2 weeks) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 003B21A) for COVID-19 vaccination. Concomitant products included: Lisinopril; Atenolol; Oxycodone; Tizanidine; Multivitamin for Women; Baby Aspirin; Fish Oil; Cranberry Concentrate [Vaccinium Macrocarpon]) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (After 3rd dose was sick for about 2 weeks). At the time of the report, ILLNESS (After 3rd dose was sick for about 2 weeks) had resolved. No medical history was provided by the reporter. On 02 Dec 2021 patient received booster dose with the lot number 05 or 6 8H21A. No treatment information was provided. This case was linked to MOD-2022-470445 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.) and PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated). On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.). On 27-Jan-2022, PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated) had resolved. On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported. Reported time of administration of vaccine was 2.30pm - 4.30pm. Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2022: Follow up received contains significant information. Patient initials, Dose number, Event verbatim were updated.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that they administered 7 doses of an expired vial of Moderna COVID 19 Vaccine to 7 patients on 19 January 2022. The vial did not undergo any temperature excursions. It was reported that no adverse events were observed in any of the patients and no treatment was given to them. Patients were not under any concomitant or regular medication. The expiry date of vaccine was on 14 January 2022.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Underarm swollen/Is it normal for the arm you receive shot to swell under the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Underarm swollen/Is it normal for the arm you receive shot to swell under the arm) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Underarm swollen/Is it normal for the arm you receive shot to swell under the arm). At the time of the report, VACCINATION SITE SWELLING (Underarm swollen/Is it normal for the arm you receive shot to swell under the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: She was spotting for months on end; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (She was spotting for months on end) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (She was spotting for months on end). At the time of the report, INTERMENSTRUAL BLEEDING (She was spotting for months on end) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2022-471336 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Didn't get their period until 3 months after their vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (Didn't get their period until 3 months after their vaccine). At the time of the report, MENSTRUATION DELAYED (Didn't get their period until 3 months after their vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2022-471320 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Lethargy, Nausea, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose), NAUSEA (Nausea after 2nd dose) and ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .75 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose). On 01-Feb-2022, the patient experienced LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose) and NAUSEA (Nausea after 2nd dose). On 31-Jan-2022, ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose) had resolved. On 03-Feb-2022, LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose) and NAUSEA (Nausea after 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter stated that the patient received a 2nd dose of 0.75 ml instead of 0.5 ml on 31-Jan-2022. The next day on 01-Feb-2022, the patient reported that they had Nausea, Lethargy, and Pain on the injection Site and on 03-Feb-2022, the patient was fine. The reporter also stated that they already reported to VAERS. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: He had a rash all over his body and rash is on and off; allergic reaction to the booster half shot; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (He had a rash all over his body and rash is on and off) and ALLERGY TO VACCINE (allergic reaction to the booster half shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 028L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Dec-2021, the patient experienced RASH (He had a rash all over his body and rash is on and off) and ALLERGY TO VACCINE (allergic reaction to the booster half shot). At the time of the report, RASH (He had a rash all over his body and rash is on and off) had not resolved and ALLERGY TO VACCINE (allergic reaction to the booster half shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient took half of booster shot. The patient had a rash all over her body and rash wason and off. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: double dose of the booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (double dose of the booster shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In November 2021, the patient experienced ACCIDENTAL OVERDOSE (double dose of the booster shot). In November 2021, ACCIDENTAL OVERDOSE (double dose of the booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter enquired whether it was safe to get 4th booster.  No concomitant medications were reported. No treatment medications were provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Has breathing problems; has COPD; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Breathing difficult (Breathing problems).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD). At the time of the report, DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD) outcome was unknown.            No concomitant medication information was provided. No treatment information was provided.  It was reported that the patient was not told or made aware about the patient's medical history before or after the primary series and booster shot vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had a rash from the second vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (I had a rash from the second vaccine) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I had a rash from the second vaccine). At the time of the report, RASH (I had a rash from the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient had all three doses of Moderna. Patient never had any adverse reaction to anything.  No treatment details were provided.   This case was linked to MOD-2022-472019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow-up received include no new information.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a little bit of headache) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a little bit of headache). At the time of the report, HEADACHE (a little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided The caller also said his son and his son's wife also got Moderna, and they were happy with that. His son had a little bit of headache after that, but upon clarification, caller said that's nothing with the shot.   This case was linked to MOD-2022-472171 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin disorder, Swelling, Vaccination site discolouration
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 09:30 (Lot number: FD8448) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "completed chemotherapy 2 years ago" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Actually I received first dose of Pfizer vaccine on 18Mar2021, lot no EN6208 ), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Also 2nd dose on 08Apr2021 , lot no EWO150), administration date: 08Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Swelling"; ERYTHEMA (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Redness"; SKIN DISORDER (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "bubbling"; WOUND (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Wound"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "black spotty around the area of received arm of the 3rd dose vaccine"; PAIN (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Bad shore". The events "swelling", "redness", "bubbling", "wound", "black spotty around the area of received arm of the 3rd dose vaccine" and "bad shore" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of swelling, erythema, skin disorder, wound, vaccination site discolouration, pain. Additional information: No other vaccine in four weeks. Other medication in two weeks was tab ibuprofen 400mg/ aloe vera ointment. Patient had COVID-19 prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 09:30 (Lot number: FD8448) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "completed chemotherapy 2 years ago" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Actually I received first dose of Pfizer vaccine on 18Mar2021, lot no EN6208 ), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Also 2nd dose on 08Apr2021 , lot no EWO150), administration date: 08Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Swelling"; ERYTHEMA (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Redness"; SKIN DISORDER (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "bubbling"; WOUND (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Wound"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "black spotty around the area of received arm of the 3rd dose vaccine"; PAIN (non-serious) with onset 26Aug2021 22:30, outcome "not recovered", described as "Bad shore". The events "swelling", "redness", "bubbling", "wound", "black spotty around the area of received arm of the 3rd dose vaccine" and "bad shore" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of swelling, erythema, skin disorder, wound, vaccination site discolouration, pain. Additional information: No other vaccine in four weeks. Other medication in two weeks was tab ibuprofen 400mg/ aloe vera ointment. Patient had COVID-19 prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 12:30 (Lot number: FA6780) at the age of 36 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Currently breastfeeding" (unspecified if ongoing), notes: Currently breastfeeding. Concomitant medication(s) included: Tylenol; Motrin; Afrin [Oxymetazoline Hydrochloride]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0191, lot unknown=False, administration date=05Aug2021, administration time=08:30, dose number=1, vaccine location=Left arm), administration date: 05Aug2021, for Covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "Rigors"; PYREXIA (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "fever temperature max 100.4"; FATIGUE (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 26Aug2021 23:00, outcome "recovering", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, pain. Additional information: Facility type vaccine was Hospital. The patient did not have other vaccine in four weeks.  Patient did not have Covid-19 prior vaccination. Patient did not Covid tested post vaccination. The patient did not have known allergies. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Headache; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 17:30 (Lot number: Ew0187) at the age of 36 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 1, SINGLE , Product=COVID 19, Brand=Pfizer, Lot number=Ew0179, Administration date=30Jul2021, Administration time=04:45 PM, Vaccine location=Left arm, Dose number=1), when the patient was 36 years old, for Covid-19 immunisation. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), PAIN (non-serious), HEADACHE (non-serious), DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 25Aug2021 14:00, outcome "not recovered" and all described as "20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, dizziness, fatigue.  Additional information: Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient was not diagnosed with COVID-19 prior to and since the vaccination. Patient did not undergo COVID test post vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; 20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 17:30 (Lot number: Ew0187) at the age of 36 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 1, SINGLE , Product=COVID 19, Brand=Pfizer, Lot number=Ew0179, Administration date=30Jul2021, Administration time=04:45 PM, Vaccine location=Left arm, Dose number=1), when the patient was 36 years old, for Covid-19 immunisation. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), PAIN (non-serious), HEADACHE (non-serious), DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 25Aug2021 14:00, outcome "not recovered" and all described as "20 hours after injection fever of 101 degrees chills body aches lasting for 10 hours30 hours after injection headache dizziness fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, dizziness, fatigue.  Additional information: Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient was not diagnosed with COVID-19 prior to and since the vaccination. Patient did not undergo COVID test post vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Hypoaesthesia
Clinical narrative: my face feels numb, it's very red, it's very hot to touch and feels like burning; my face feels numb, it's very red, it's very hot to touch and feels like burning; my face feels numb, it's very red, it's very hot to touch and feels like burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3181) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Verbatim: Migraine. Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for migraine. The following information was reported: BURNING SENSATION (non-serious) with onset 26Aug2021 18:00, outcome "unknown", HYPOAESTHESIA (non-serious), ERYTHEMA (non-serious) all with onset 26Aug2021 18:00, outcome "not recovered" and all described as "my face feels numb, it's very red, it's very hot to touch and feels like burning".  Additional information: Migraine and I take Motrin for them and ADB and I take like Motrin and Ibuprofen (Further clarification unknown). Clinical course reported as I got my vaccine two days ago my first dose and today out of nowhere my face feels numb and its very red and it's very hot to touch, it's feels almost kind of like a burning when I do touch.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "CKD" (unspecified if ongoing); "hypokalemia" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: K Citrate; Aldactone [Spironolactone]. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Severe full body joint and muscle aches"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "have lessened in severity but limiting activities"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of arthralgia, loss of personal independence in daily activities, myalgia, fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Oct2021): New information received from a contactable other HCP included no new information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: I had a rash; my arm legs and chest were itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Aug2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 26Aug2021, outcome "unknown", described as "I had a rash"; PRURITUS (non-serious) with onset 26Aug2021, outcome "unknown", described as "my arm legs and chest were itchy". Therapeutic measures were not taken as a result of rash, pruritus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Patient was not tested for covid post vaccination.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Headache, Insomnia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: MALAISE (non-serious) with onset 30Jul2021, outcome "recovered" (01Aug2021), described as "Within 10 min of taking it I started feeling bad"; PYREXIA (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "fever"; CHILLS (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "sore throat"; HEADACHE (non-serious) with onset 31Jul2021, outcome "not recovered", described as "a low headache"; CONDITION AGGRAVATED (non-serious), INSOMNIA (non-serious) all with onset 31Jul2021, outcome "not recovered" and all described as "The headache never went away and got worse and worse until I was unable to sleep or anything else both times"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 31Jul2021, outcome "recovered" (02Aug2021) and all described as "pain down my arm and across my shoulder for the next 2 days". The events "within 10 min of taking it i started feeling bad", "fever", "chills", "sore throat", "a low headache", "the headache never went away and got worse and worse until i was unable to sleep or anything else both times", "pain down my arm and across my shoulder for the next 2 days", "pain down my arm and across my shoulder for the next 2 days" and "the headache never went away and got worse and worse until I was unable to sleep or anything else both times" were evaluated at the physician office visit. Therapeutic measures were taken as a result of malaise, pyrexia, chills, oropharyngeal pain, headache, condition aggravated, pain in extremity, arthralgia, insomnia. 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: Malaise, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: MALAISE (non-serious) with onset 30Jul2021, outcome "recovered" (01Aug2021), described as "Within 10 min of taking it I started feeling bad"; PYREXIA (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "fever"; CHILLS (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "sore throat"; HEADACHE (non-serious) with onset 31Jul2021, outcome "not recovered", described as "a low headache"; CONDITION AGGRAVATED (non-serious), INSOMNIA (non-serious) all with onset 31Jul2021, outcome "not recovered" and all described as "The headache never went away and got worse and worse until I was unable to sleep or anything else both times"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 31Jul2021, outcome "recovered" (02Aug2021) and all described as "pain down my arm and across my shoulder for the next 2 days". The events "within 10 min of taking it i started feeling bad", "fever", "chills", "sore throat", "a low headache", "the headache never went away and got worse and worse until i was unable to sleep or anything else both times", "pain down my arm and across my shoulder for the next 2 days", "pain down my arm and across my shoulder for the next 2 days" and "the headache never went away and got worse and worse until I was unable to sleep or anything else both times" were evaluated at the physician office visit. Therapeutic measures were taken as a result of malaise, pyrexia, chills, oropharyngeal pain, headache, condition aggravated, pain in extremity, arthralgia, insomnia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 15:00 (Lot number: RC3180) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Z-PAK. Vaccination history included: Bnt162b2 (product=COVID 19,  brand=Pfizer, lot number=FA7484, lot unknown=False, administration date=23Jul2021, administration time=03:00 PM, dose number=1), administration date: 23Jul2021, when the patient was 41 years old, for Covid-19 immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Shortness of Breath"; DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Unable to breath without coughing"; COUGH (non-serious) with onset 14Aug2021, outcome "recovering", described as "Cough"; PYREXIA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fatigue"; CHEST PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chest Pain". The events "shortness of breath", "unable to breath without coughing", "cough", "fever", "chills", "headache", "body aches", "fatigue" and "chest pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures included Covid-19 test negative on Jul2021. Therapeutic measures were taken as a result of dyspnoea, dyspnoea, cough, pyrexia, chills, headache, pain, fatigue, chest pain. No follow-up attempts are possible. No further information is expected. Follow-Up (07Sep2021): No new information was received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 15:00 (Lot number: RC3180) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Z-PAK. Vaccination history included: Bnt162b2 (product=COVID 19,  brand=Pfizer, lot number=FA7484, lot unknown=False, administration date=23Jul2021, administration time=03:00 PM, dose number=1), administration date: 23Jul2021, when the patient was 41 years old, for Covid-19 immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Shortness of Breath"; DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Unable to breath without coughing"; COUGH (non-serious) with onset 14Aug2021, outcome "recovering", described as "Cough"; PYREXIA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fatigue"; CHEST PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chest Pain". The events "shortness of breath", "unable to breath without coughing", "cough", "fever", "chills", "headache", "body aches", "fatigue" and "chest pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures included Covid-19 test negative on Jul2021. Therapeutic measures were taken as a result of dyspnoea, dyspnoea, cough, pyrexia, chills, headache, pain, fatigue, chest pain. No follow-up attempts are possible. No further information is expected. Follow-Up (07Sep2021): No new information was received.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Limb discomfort, Mass, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 69 year-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine), administered in arm (Lot number: FD8448) as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "my arm was sore; it is swollen"; MASS (non-serious), outcome "unknown", described as "swollen, hard to touch; it has got a hard lump in it, big hard lump"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I can not even lift my arm like up to my nose"; PAIN (non-serious), outcome "unknown", described as "But it is like even hard to touch". Relevant laboratory tests and procedures included Blood test on an unknown date. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 69 year-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine), administered in arm (Lot number: FD8448) as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "my arm was sore; it is swollen"; MASS (non-serious), outcome "unknown", described as "swollen, hard to touch; it has got a hard lump in it, big hard lump"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I can not even lift my arm like up to my nose"; PAIN (non-serious), outcome "unknown", described as "But it is like even hard to touch". Relevant laboratory tests and procedures included Blood test on an unknown date. No follow-up attempts are possible. No further information is expected.