chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Muscle strain, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep last night), MUSCLE STRAIN (feels as if she pulled a muscle), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches) and MASS (Bump/lump) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported.On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MUSCLE STRAIN (feels as if she pulled a muscle), PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) and ARTHRALGIA (hurting on the same side on the back of the shoulder). On 17-Jan-2022, the patient experienced INSOMNIA (couldn't sleep last night), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever) and MYALGIA (Had body aches but it's more on the left side). On 18-Jan-2022, the patient experienced BONE PAIN (collarbone on the left side, it was a lot of pain.), MASS (Bump/lump) and BACK PAIN (has pain in the front and the back). At the time of the report, INSOMNIA (couldn't sleep last night), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever), ARTHRALGIA (hurting on the same side on the back of the shoulder) and MYALGIA (Had body aches but it's more on the left side) outcome was unknown and MUSCLE STRAIN (feels as if she pulled a muscle), MASS (Bump/lump), BACK PAIN (has pain in the front and the back) and PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) had not resolved. No Concomitant product use was reported. The patient stated they received the Moderna booster on 17-Jan-2022 and had headache, fever, aches, and especially pain on the side that they put the shot. The patient couldn't sleep last night. The patient had body aches, but it was more on the left side. Reportedly, on 18-Jan-2022 by the collarbone on the left side, it was a lot of pain. The patient touched it, and there was a bump. It was a lump, and it was hurting. If the patient pressed the lump, it hurts. Also, it was hurting on the same side on the back of the shoulder. The patient reported that it was hurting all this top part. The patient had pain in the front and the back, and the patient felt as if the patient pulled a muscle.No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep last night), MUSCLE STRAIN (feels as if she pulled a muscle), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches) and MASS (Bump/lump) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported.On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MUSCLE STRAIN (feels as if she pulled a muscle), PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) and ARTHRALGIA (hurting on the same side on the back of the shoulder). On 17-Jan-2022, the patient experienced INSOMNIA (couldn't sleep last night), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever) and MYALGIA (Had body aches but it's more on the left side). On 18-Jan-2022, the patient experienced BONE PAIN (collarbone on the left side, it was a lot of pain.), MASS (Bump/lump) and BACK PAIN (has pain in the front and the back). At the time of the report, INSOMNIA (couldn't sleep last night), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever), ARTHRALGIA (hurting on the same side on the back of the shoulder) and MYALGIA (Had body aches but it's more on the left side) outcome was unknown and MUSCLE STRAIN (feels as if she pulled a muscle), MASS (Bump/lump), BACK PAIN (has pain in the front and the back) and PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) had not resolved. No Concomitant product use was reported. The patient stated they received the Moderna booster on 17-Jan-2022 and had headache, fever, aches, and especially pain on the side that they put the shot. The patient couldn't sleep last night. The patient had body aches, but it was more on the left side. Reportedly, on 18-Jan-2022 by the collarbone on the left side, it was a lot of pain. The patient touched it, and there was a bump. It was a lump, and it was hurting. If the patient pressed the lump, it hurts. Also, it was hurting on the same side on the back of the shoulder. The patient reported that it was hurting all this top part. The patient had pain in the front and the back, and the patient felt as if the patient pulled a muscle.No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature). At the time of the report, PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: moderna covid-19 doses administered past manufacturers expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) 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 EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.2 F) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 013M208) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PYREXIA (fever of 99.2 F). At the time of the report, PYREXIA (fever of 99.2 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 99.2 (High) fever of 99.2 F.         No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: Had a fall after booster; If he tried to stand up he would fall, after booster; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Had a fall after booster) and ASTHENIA (If he tried to stand up he would fall, after booster) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F210, 002B21A and 013A71A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced FALL (Had a fall after booster). 23-Oct-2021, the patient experienced ASTHENIA (If he tried to stand up he would fall, after booster). On 24-Oct-2021, FALL (Had a fall after booster) and ASTHENIA (If he tried to stand up he would fall, after booster) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever of 99.9; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (fever of 99.9) and CHILLS (chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 013M208) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, 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 PYREXIA (fever of 99.9) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Jan-2022 for Chills and Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 99.9) outcome was unknown and CHILLS (chills) had resolved.            No concomitant products were reported.  The patient had little chills but it went away. She took a couple of Tylenol yesterday (18 Jan 2022) and on 19 Jan 2022 morning.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F210, 002B21A and 013A71A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster). On 30-Oct-2021, BALANCE DISORDER (Equilibrium problems after booster/Reaction continued on & off for 1 week, after booster) had resolved. No Concomitant medications were provided. No treatment medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site rash
Clinical narrative: More of a rash going on below the injection site; Began noticing her left arm being itchy and it was fevered & warm; Began noticing her left arm being itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Began noticing her left arm being itchy), VACCINATION SITE RASH (More of a rash going on below the injection site) and PYREXIA (Began noticing her left arm being itchy and it was fevered & warm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 053C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, the patient experienced PRURITUS (Began noticing her left arm being itchy) and PYREXIA (Began noticing her left arm being itchy and it was fevered & warm). On 18-Jan-2022, the patient experienced VACCINATION SITE RASH (More of a rash going on below the injection site). At the time of the report, PRURITUS (Began noticing her left arm being itchy), VACCINATION SITE RASH (More of a rash going on below the injection site) and PYREXIA (Began noticing her left arm being itchy and it was fevered & warm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick last week; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I was sick last week) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick last week). At the time of the report, ILLNESS (I was sick last week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. patient Reported Just got booster and Had shots 2&2 in March 2021. Patient reported that was sick last week. Home test done and tested negative.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pruritus, Pyrexia
Clinical narrative: General body aches; Chills; Headaches; Fever; General itching; Itching on the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills) and HEADACHE (Headaches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site arm). On 17-Feb-2021 at 2:00 PM, the patient experienced PRURITUS (General itching), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever). In February 2021, PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient received injection at the hospital and the hospital kept her there for an hour after second Moderna Covid-19 vaccine because of the itching.  Patient went to bed at 6pm on 17 Feb 2021 at when she woke up it was all over. No side effects.   This case was linked to MOD-2022-455172, MOD-2022-455193 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: General body aches; Chills; Headaches; Fever; General itching; Itching on the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills) and HEADACHE (Headaches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site arm). On 17-Feb-2021 at 2:00 PM, the patient experienced PRURITUS (General itching), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever). In February 2021, PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient received injection at the hospital and the hospital kept her there for an hour after second Moderna Covid-19 vaccine because of the itching.  Patient went to bed at 6pm on 17 Feb 2021 at when she woke up it was all over. No side effects.   This case was linked to MOD-2022-455172, MOD-2022-455193 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was sore for two days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was sore for two days.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 024M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore for two days.). In November 2021, VACCINATION SITE PAIN (injection site was sore for two days.) had resolved.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2022-455192, MOD-2022-455172 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd shot 6 weeks & 4 days after first shot/first shot on 16 Aug and 2nd shot on 24 sep; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd shot 6 weeks & 4 days after first shot/first shot on 16 Aug and 2nd shot on 24 sep) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 053C21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd shot 6 weeks & 4 days after first shot/first shot on 16 Aug and 2nd shot on 24 sep). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd shot 6 weeks & 4 days after first shot/first shot on 16 Aug and 2nd shot on 24 sep) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2022-455222 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Physician). A-75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Feb2021 10:40 (Lot number: EL3247) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coronary atherosclerosis" (unspecified if ongoing); "Atrial Fibrillation" (unspecified if ongoing); "Renal cell Carcinoma" (unspecified if ongoing), notes: Partial nephrectomy (06Jan2021). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Time: 10:40 AM, Anatomical location: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 26Jan2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "Right hand pain/swelling", "Right hand pain/swelling", "Rt arm weakness". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 10:00, outcome "recovered" (27Feb2021), described as "Headache". Therapeutic measures were not taken as a result of headache.No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Urinary tract infection
Clinical narrative: She has continual UTI; 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). The reporter is the patient.  A female patient in her 70's received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 2021, outcome "not recovered", described as "She has continual UTI". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received both doses of the Pfizer-BioNTech Covid-19 Vaccine 7 and a half months ago. She said her husband, who previously had covid 10 months ago, also received both doses and his antibodies was around 20. After both immunizations, she said she was told to wait for a period of time for the vaccine to begin to work fully in their bodies. With that, she wants to know how long it takes for the booster dose to take its effect in the body. She wants to know if the future Pfizer booster doses would also take the same time to be effective in the body compared to the booster dose that is available now. Consumer also mentioned that she is disabled, and has medical issues. She said she is currently taking medications. She said she has continual UTI that she had been trying to treat but it's not working. She also mentioned that she is in contact with a hematologist. She said she can't even get herself a glass of water. Responded from the attached, CONS-booster dose (v13.0) and CONS-when does the vaccine start protecting me against covid-19 (v5.0).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Gait disturbance
Clinical narrative: Severe, debilitating lower back pain 10/10 level pain  OTC pain meds provide zero relief  Barely able to walk Began less than 12 hours after vaccination  3 days later, pain level is still 10/10
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatitis B virus vaccine (unspecified) on 10-AUG-2012, 21-SEP-2012 and 24-APR-2013 separately; This spontaneous report was received from a lawyer referring to a 64 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 10-AUG-2012, 21-SEP-2012 and 24-APR-2013, the patient received hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis separately (inappropriate schedule of product administration).      The case was split from a legal case referring the same patient.; Sender's Comments:  US-009507513-1812USA003429:
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2022, the patient received the 2nd dose of Shingrix. On 16th January 2022, 1 days after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. On the day of reporting, the patient had a fever of 101.8 degree F and a bad headache The patient asked that how he/she treated it. The follow-up would not possible as no contact details were available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was not reported and height was 172.72 centimeters. The patient's past medical history included: Covid-19, and concurrent conditions included: non smoker, alcohol use of 1 to 2 glasses per week, and hypothyroid, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse at the time of vaccination. She was not ill at the time of vaccination. She had no adverse event after any previous vaccination(s). No history of allergy to vaccine, drug, or food. No pre-existing acute illness 30 days prior to vaccination. 30 days prior to vaccination no history of hospitalization. She was not pregnant at the time of vaccination and not was breastfeeding. 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 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included thyroid for hypothyroid. On 14-JAN-2022, the patient experienced Covid positive 4.5 months after Janssen vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid positive 4.5 months after Janssen vaccine was not reported. This report was non-serious. Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a consumer concerned a male of unspecified age. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: BAD STOMACH PAIN; 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 was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad stomach pain was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: stinging sensation; itching; raging case of hives of back and chest; getting an eruption; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging sensation), PRURITUS (itching), URTICARIA (raging case of hives of back and chest) and RASH (getting an eruption) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (stinging sensation), PRURITUS (itching), URTICARIA (raging case of hives of back and chest) and RASH (getting an eruption). At the time of the report, PAIN (stinging sensation), PRURITUS (itching), URTICARIA (raging case of hives of back and chest) and RASH (getting an eruption) was resolving.            The patient has no medical conditions and had no concomitant medications.  Patient visited a medical doctor and a dermatologist, and was prescribed an antihistamine and a steroid pack The symptoms are starting to resolve after taking an antihistamine (either Zyrtec or Claritin). The booster was given somewhere right before Christmas.   This case was linked to MOD-2022-454200, MOD-2022-455291 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Hypersensitivity, Skin burning sensation, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent), URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 045B21A) for COVID-19 vaccination. No Medical History information was reported.On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-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 SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent), URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent) had not resolved and URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction) outcome was unknown. No concomitant medications were reported. Patient had other OTC medications for treatment.Two weeks after  the booster patient started to experience what he believe to be some sort of allergic reaction. Patient was  affected by these symptoms for roughly 50% of the day and at night the burning sensation gets worse. During the day it was  not so bad but during the night it was bad. On 13 Jan 2021,patient went to specialist and did some sort of scratch test.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Was supposed to received a 3rd full dose but received only half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose). In November 2021, ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. No treatment drugs were reported. Pharmacist stated there were no adverse event to report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills after her first vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills after her first vaccine.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills after her first vaccine.). At the time of the report, CHILLS (chills after her first vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The medical history was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-068335 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Follow up  contains no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 018F21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021 at 2:41 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Jan-2022 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022). On 04-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 23-Nov-2021 and second dose received on 4-Jan-2022) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Saliva Test. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications was provided by the reporter. No treatment information was provided by  the reporter. Reportedly, there was no adverse reaction observed. This case was linked to MOD-2021-403089 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cataract, Cataract operation (Left Eye cataract surgery), Surgery (Afib ablation) and Hysterectomy. Concurrent medical conditions included AFib, Hashimoto's disease, Hypothyroidism (Hypothyroid), ADHD and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), PREDNISONE, LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, APIXABAN (ELIQUIS), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), VENLAFAXINE HYDROCHLORIDE (VENLAFAXIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and BUSPIRONE for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Injection site reaction; injection site on her upper arm is red, itchy, big and round; injection site on her upper arm is red,itchy, big and round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Patient had not applied anything on the site of reaction. Patient never had a reaction to the flu vaccine. Patient was scared to proceed.  Second dose due on 11 Feb 2022.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 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 OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were reported.  No treatment were reported.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child age 12 received 1st Moderna dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child age 12 received 1st Moderna dose) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child age 12 received 1st Moderna dose). On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child age 12 received 1st Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.  The HCP stated that the child did not experience any side effects after receiving the first dose to his knowledge. It was also reported that the child has not yet received a second COVID-19 dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Fatal panic attack before taking  the vaccine shot
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Skin warm, Swelling, Tenderness
Clinical narrative: I woke up with a thickness/swelling upper left chest/arm, underarm and around to my back. The area is tender and hot to the touch. Feels like swollen lymph nodes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after use limitation expiration date.