chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Blindness
Clinical narrative: My mom went blind the day after she got the flu shot; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who went blind the day after she got the INFLUENZA VACCINE shot.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, expiry date was not reported) via unknown route in unknown administration site for Prophylaxis vaccine.  On an unknown date the patient went blind the day after she got the flu shot (blindness) (Latency: 1 day).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 24-Jan-2023: This case involves an unknown age female patient who went blind the day after she got the INFLUENZA VACCINE shot.The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Received 2 doses of Fluzone High-Dose Quadrivalent flu vaccine within 30 days with no reported adverse event; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received 2 doses of fluzone high-dose quadrivalent flu vaccine within 30 days with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization.  On 02-Nov-2022 the patient had a non-serious event of received 2 doses of fluzone high-dose quadrivalent flu vaccine within 30 days with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: given to a pregnant woman with no reported adverse event; Initial information received on 19-Jan-2023 regarding an unsolicited valid  non-serious case received from a health-care professional.  This case involves an unknown age female patient who was pregnant and got the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] vaccine during her pregnancy with no reported adverse event.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.   On an unknown date, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the pregnant woman was given diphtheria-2/tetanus/5 AC pertussis vaccine with no reported adverse event (exposure during pregnancy) (latency same day).  Relevant prenatal testing after exposure was not reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.  No additional information available
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Anti-Muellerian hormone level, Antinuclear antibody increased, Ectopic pregnancy, Infertility female, Laboratory test
Clinical narrative: Premature ovarian failure.  Pregnant at age 18 and had my son full-term, with no complications.  I have no infertility in my family. In my 20's I was diagnosed as POF while trying to get pregnant after this vaccine at age 24yr old when it came out. AMH level 0.28. Never able to get pregnant again and carry to term with fertility meds. Multiple ectopic pregnancies though. De quervain's diagnosis in the right wrist started in mid 30's and ANA level was always high.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause, Tenosynovitis stenosans
Clinical narrative: Premature ovarian failure.  Pregnant at age 18 and had my son full-term, with no complications.  I have no infertility in my family. In my 20's I was diagnosed as POF while trying to get pregnant after this vaccine at age 24yr old when it came out. AMH level 0.28. Never able to get pregnant again and carry to term with fertility meds. Multiple ectopic pregnancies though. De quervain's diagnosis in the right wrist started in mid 30's and ANA level was always high.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Feeling abnormal, Heart rate irregular, Hypotension, Injection site bruising
Clinical narrative: Pt described palpitations, irregular heartbeat, low blood pressure, fever, sore arm and sore armpit, swollen arm, bruise at injection site, swollen/hot/inflamed injection site.  Pt said she had the same reaction to her covid vaccinations too.  Told her to follow up with doctor and avoid getting the second dose for the shingles vaccine for now. Take a benadryl to rule out allergic reaction.  Pt went home quickly after getting the vaccine because she said she wasn't feeling good. Five days after getting the vaccine when she reported it to me, her arm was still bruised and red and swollen.  She had also picked up other medication that might have had to do with her low bp.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Pain in extremity, Palpitations
Clinical narrative: Pt described palpitations, irregular heartbeat, low blood pressure, fever, sore arm and sore armpit, swollen arm, bruise at injection site, swollen/hot/inflamed injection site.  Pt said she had the same reaction to her covid vaccinations too.  Told her to follow up with doctor and avoid getting the second dose for the shingles vaccine for now. Take a benadryl to rule out allergic reaction.  Pt went home quickly after getting the vaccine because she said she wasn't feeling good. Five days after getting the vaccine when she reported it to me, her arm was still bruised and red and swollen.  She had also picked up other medication that might have had to do with her low bp.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Pt described palpitations, irregular heartbeat, low blood pressure, fever, sore arm and sore armpit, swollen arm, bruise at injection site, swollen/hot/inflamed injection site.  Pt said she had the same reaction to her covid vaccinations too.  Told her to follow up with doctor and avoid getting the second dose for the shingles vaccine for now. Take a benadryl to rule out allergic reaction.  Pt went home quickly after getting the vaccine because she said she wasn't feeling good. Five days after getting the vaccine when she reported it to me, her arm was still bruised and red and swollen.  She had also picked up other medication that might have had to do with her low bp.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, UNK
Symptoms: Injection site rash, No reaction on previous exposure to drug, Rash, Skin lesion
Clinical narrative: Family had a bilingual staff member spoke with mom. Mom called HD on 1.23.23 & stated that daughter received vaccines listed above on 1.18.23 at HD & following day daughter had developed a rash on left upper arm that was distributed to part of body. Mom stated there were also some small lesions on the body. Per mom no additional symptoms were noted & no one in the home had any similar symptoms. Per mom started benadryl for 3 days in which "lesions" improved.  After stopping Benadryl, the "lesions" reappeared although smaller. Mom states rash is now resolving.   Patient has received previous vaccinations including 1st dose of MMR and previous doses of polio and DTaP without any type of reaction in past.  This was patient's first time receiving Kinrix.  Patient is without insurance and was not evaluated by doctor. Previously referred to social work on 1.18.23 & several low cost clinics in area were provided to mom for follow-up on day of call.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Abnormal menstrual clots, Amenorrhoea, Blood test normal, Cardiac disorder, Cyst
Clinical narrative: My period has been affected since receiving the first of the covid 19 vaccines. After the first  C-19 vaccine that I received, my period was affect/ altered and it was very heavy then reduced to spotting. After my last C-19 vaccine injection: the bivalent booster in 9/3/22, my period has now all together ceased. I no longer have periods. I experience the pain/ cramps/pms with no blood. After visiting my Gyno, ultra sound, in December 2022, my period in January 2023 was brown blood only when wiping and 2 small blood clots.  Also, when receiving the vary first vaccine for C-19 in 2021, after my 2nd shot, I believed that I was going to die. I did not call the ambulance. I sat at the edge of my bed and began bouncing up and down, praying, chanting, talking to God asking for help. It was my heart, it felt...not good. I called my sons regional center and told them I was going to bed, it was 5am. I was worried about my health I said as I am having an adverse reaction to the C-19 vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Premenstrual syndrome
Clinical narrative: My period has been affected since receiving the first of the covid 19 vaccines. After the first  C-19 vaccine that I received, my period was affect/ altered and it was very heavy then reduced to spotting. After my last C-19 vaccine injection: the bivalent booster in 9/3/22, my period has now all together ceased. I no longer have periods. I experience the pain/ cramps/pms with no blood. After visiting my Gyno, ultra sound, in December 2022, my period in January 2023 was brown blood only when wiping and 2 small blood clots.  Also, when receiving the vary first vaccine for C-19 in 2021, after my 2nd shot, I believed that I was going to die. I did not call the ambulance. I sat at the edge of my bed and began bouncing up and down, praying, chanting, talking to God asking for help. It was my heart, it felt...not good. I called my sons regional center and told them I was going to bed, it was 5am. I was worried about my health I said as I am having an adverse reaction to the C-19 vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Smear cervix normal, Ultrasound pelvis abnormal
Clinical narrative: My period has been affected since receiving the first of the covid 19 vaccines. After the first  C-19 vaccine that I received, my period was affect/ altered and it was very heavy then reduced to spotting. After my last C-19 vaccine injection: the bivalent booster in 9/3/22, my period has now all together ceased. I no longer have periods. I experience the pain/ cramps/pms with no blood. After visiting my Gyno, ultra sound, in December 2022, my period in January 2023 was brown blood only when wiping and 2 small blood clots.  Also, when receiving the vary first vaccine for C-19 in 2021, after my 2nd shot, I believed that I was going to die. I did not call the ambulance. I sat at the edge of my bed and began bouncing up and down, praying, chanting, talking to God asking for help. It was my heart, it felt...not good. I called my sons regional center and told them I was going to bed, it was 5am. I was worried about my health I said as I am having an adverse reaction to the C-19 vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Endoscopy, Feeling abnormal, Gastrointestinal disorder, Malaise
Clinical narrative: GONE FROM NORMAL TO NOT NORMAL/NOT LIKE BEFORE VACCINE; LOST ALMOST 50 POUNDS SINCE GETTING THE VACCINE GONE FROM 155 POUNDS TO 110 POUNDS; GASTROINTESTINAL SIDE EFFECTS; NOT BEEN WELL SINCE RECEIVING VACCINE; This spontaneous report received from a parent concerned a 28 year old male. The patient's weight was 110 kilograms, and height was 68 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 28 years old. No concomitant medications were reported. On OCT-2021, the patient experienced not been well since receiving vaccine. On NOV-2021, the patient experienced gastrointestinal side effects. On 2022, Laboratory data included: Computerised tomogram abdomen showed clean, Endoscopy showed clean, and Esophagram showed clean. On an unspecified date, the patient experienced gone from normal to not normal/not like before vaccine, and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds. Laboratory data (dates unspecified) included: Weight lost from 155 pounds to 110 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gastrointestinal side effects, and the outcome of not been well since receiving vaccine, gone from normal to not normal/not like before vaccine and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds was not reported. This report was non-serious. This case is a duplicate of 20230147196. This case, from the same reporter is linked to 20230145585, 20230146610, 20230146524 and 20230146842.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophagram, Weight, Weight decreased
Clinical narrative: GONE FROM NORMAL TO NOT NORMAL/NOT LIKE BEFORE VACCINE; LOST ALMOST 50 POUNDS SINCE GETTING THE VACCINE GONE FROM 155 POUNDS TO 110 POUNDS; GASTROINTESTINAL SIDE EFFECTS; NOT BEEN WELL SINCE RECEIVING VACCINE; This spontaneous report received from a parent concerned a 28 year old male. The patient's weight was 110 kilograms, and height was 68 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 28 years old. No concomitant medications were reported. On OCT-2021, the patient experienced not been well since receiving vaccine. On NOV-2021, the patient experienced gastrointestinal side effects. On 2022, Laboratory data included: Computerised tomogram abdomen showed clean, Endoscopy showed clean, and Esophagram showed clean. On an unspecified date, the patient experienced gone from normal to not normal/not like before vaccine, and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds. Laboratory data (dates unspecified) included: Weight lost from 155 pounds to 110 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gastrointestinal side effects, and the outcome of not been well since receiving vaccine, gone from normal to not normal/not like before vaccine and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds was not reported. This report was non-serious. This case is a duplicate of 20230147196. This case, from the same reporter is linked to 20230145585, 20230146610, 20230146524 and 20230146842.
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Diarrhoea, Weight, Weight decreased
Clinical narrative: LOST 30 POUNDS; DIARRHEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 19-OCT-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2022, the patient experienced diarrhea. On 19-JAN-2023, Laboratory data included: Colonoscopy Not reported. On an unspecified date, the patient experienced lost 30 pounds. Laboratory data (dates unspecified) included: Weight lost 30 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and lost 30 pounds was not reported. This report was non-serious. This case is a duplicate of 20230146524, 20230146842 and 20230146610. This case, from the same reporter is linked to 20230145473.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and med info agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "disease control had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 7th patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 29th patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13-Jul-2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 14th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received dose after its expiration date 13-Jul-2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 15th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13Jul2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022).    Concomitant medications were not reported.  Vial size was 5 ml. The vial did not undergo any temperature excursions. This case contains information for the 16th of 56 adult patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Eye irritation, Headache, Ocular hyperaemia, Pyrexia
Clinical narrative: Burning in eyes; redness in eyes; headaches; fever; upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of burning in eyes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning in eyes, eye red, headache, fever and upset stomach. On an unknown date, the outcome of the burning in eyes, eye red, headache, fever and upset stomach were unknown.   It was unknown if the reporter considered the burning in eyes, eye red, headache, fever and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient had experienced burning redness in eyes, headaches, fever, upset stomach. The follow-up could not be possible as no contact details were available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: She states she is not well; headache; dizziness; nausea; She said she did feel bad; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (in November 2020 received 1st dose).   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell, headache, dizziness, nausea and feeling bad. On an unknown date, the outcome of the feeling unwell, headache, dizziness, nausea and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell and feeling bad to be related to Shingrix. The reporter considered the headache, dizziness and nausea to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR008533   Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The reporter was the patient.  The patient had 2nd Shingrix shot in January 2021 and did not recall the exact date.  The patient did not had the lot number. The patient did not remember if it was in her left arm or right (though usually she gets vaccines in her left arm).  The patient did not look at the needle thus does not know if it was given intramuscularly.  The reporter said that she received paperwork which stated that you would feel bad for a couple days after receiving Shingrix.  The patient said that she did feel bad and she experienced headache, dizziness, and nausea, but it did not just last a couple days.  It continued to last and now two years later symptoms had not resolved.  The symptoms had lessened a little but they were still present.  The patient states that she was not well. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR008533:Same reporter
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test, SARS-CoV-2 test
Clinical narrative: infected twice with COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (infected twice with COVID) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included RA and Ex-smoker.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Dec-2022, the patient experienced COVID-19 (infected twice with COVID). At the time of the report, COVID-19 (infected twice with COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, Influenza virus test: Positive. In December 2022, SARS-CoV-2 test: Positive. In January 2023, Influenza virus test: Positive. In January 2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medications were reported. It was reported that patient had received one booster dose. Patient had been infected twice with COVID in the last 6 weeks. Once on 03-Dec-2022 and again on 07-Jan-2023. And both times patient went to an urgent care to get diagnosed because the Bionox test was negative. Both times the flu/Covid Test came back positive. Both times patient was prescribed the antiviral medication. Patient told this did not seem normal. And this last one, patient actually still could not breathe properly. Patient was breathing like patient had COPD. Patient got COVID 2 times in 1 month, patient do not go anywhere and tested negative with another test.   This case was linked to US-MODERNATX, INC.-MOD-2021-068675 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-068687 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068675:Husband case