chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that shingle shots were painful. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose Shingles vaccine and experienced shingles. The patient received second dose of Shingles vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in their system; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles in their system). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she was told by his or her physician that from the second dose he or she might get shingles in his or her system and that the reason he or she did not received second dose yet. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Went for the 2nd dose, they didn't have it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced product supply issue (Verbatim: Went for the 2nd dose, they didn't have it). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 15-MAR-2023 The patient had the first shingles shot years ago but every time he/she went for the second part of the first shot, they did not had it.  The patient stated that he/she guess to finally gave up and so far very fortunate. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 7 YO patient was administered Kinrix; Was supposed to receive IPOL and "something else"; Already received 5 of DTaP and 4 of IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   Previously administered products included DTaP (received 5 doses of DTaP) and IPV (4 years child received 4 doses of IPV).   On 16-FEB-2023, the patient received Kinrix. On 16-FEB-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 YO patient was administered Kinrix), wrong vaccine administered (Verbatim: Was supposed to receive IPOL and "something else") and inappropriate schedule of vaccine administered (Verbatim: Already received 5 of DTaP and 4 of IPV). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Mar-2023 The nurse reported that the 7 year old patient was administered a dose of Kinrix.  The nurse believes the patient was supposed to have received IPOL and something else but she was not sure.  The nurse reported that prior to the Kinrix dose, the patient had already received 5 doses of DTaP and 4 doses of IPV, however the fourth dose of IPV was given before the child was 4 years of age.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The 7 year old patient was administered a dose of Kinrix, which led to age at vaccine administration, wrong vaccine administered, inappropriate schedule of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with saline; Administered just the lyophilized portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo reconstituted with saline) and inappropriate dose of vaccine administered (Verbatim: Administered just the lyophilized portion). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Mar-2023 The nurse Practitioner reported that the patient received the lyophilized portion of Menveo and it was reconstituted with saline.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The healthcare professional could not pull up details during call; follow up ok via email in healthcare professional detail. The patient received the lyophilized portion of Menveo and it was reconstituted with saline, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 month old received kinrix inadvertently; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2LK4K, expiry date 09-NOV-2023) for prophylaxis.   On 16-JAN-2023, the patient received Kinrix. On 16-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 month old received kinrix inadvertently). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 The nurse reported that a patient received the kinrix vaccine inadvertently. The patient received Kinrix at the age of 6 months, which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Mass, Pruritus, Rash, Rash vesicular
Clinical narrative: big mass; extreme itching; extreme burning; Rash, has appearance of chickenpox/rash begins on left side of patient's neck and extends down their left shoulder and onto left, upper chest; Blistering in the form of one /blistery rash on chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 14-MAR-2023, the patient received the 1st dose of Shingrix (left arm) and PNEUMONIA VACCINE. On 15-MAR-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash, has appearance of chickenpox/rash begins on left side of patient's neck and extends down their left shoulder and onto left, upper chest) and blistery rash (Verbatim: Blistering in the form of one /blistery rash on chest). On an unknown date, the patient experienced mass (Verbatim: big mass), pruritus (Verbatim: extreme itching) and burning sensation (Verbatim: extreme burning). The outcome of the rash, blistery rash, mass, pruritus and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the rash, blistery rash, mass, pruritus and burning sensation to be related to Shingrix.     It was unknown if the company considered the rash, blistery rash, mass, pruritus and burning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAR-2023, 17-MAR-2023 and 28-MAR-2023 The reporter was husband of patient.  The patient received a pneumonia vaccine at the same time she received the first Shingrix vaccine in the left arm.. The patient woke the next morning to a blistery rash at over her chest and was in the form of one, big mass. The rash began on left side of patient's neck and extends down their left shoulder and onto left, upper chest.  The rash had appearance of chickenpox, except it was in a mass instead of spread out.  The rash had not resolved and she reported using HC 2.5% Cream to help with the extreme itching and burning. The reporter reported that her physician was out of the country and did not want to see another physician. The reporter reported wanting to let patient call in to report details of adverse event, all details provided by reporter was reported.  The reporter declined to report patient's demographics. 1 days after receiving PNEUMONIA VACCINE, the patient experienced rash, blistery rash. On an unknown date after receiving PNEUMONIA VACCINE, the patient experienced mass, pruritus and burning sensation. It was unknown if the reporter considered the rash, blistery rash, mass, pruritus and burning sensation to be related to PNEUMONIA VACCINE.  The reporter did not consent to follow-up. As per latest follow up, the event onset date was captured conservatively.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: two years and 9 months old received Kinrix; Got Kinrix as 3rd dose of Dtap series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: two years and 9 months old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Got Kinrix as 3rd dose of Dtap series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 A nurse reported that a two years and 9 months old patient received her third dose of Dtap series vaccination with a Kinrix dose, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: 31.8°F excursion and Vx administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On 16-MAR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: 31.8°F excursion and Vx administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 The reporter reported that the patient received dose of FluLaval (Quadrivalent) which had been in excursion where it reached the temperature of 31.8 degree Fahrenheit which was below freezing. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The FluLaval Quadrivalent vaccine temperature was exposed to 31.8 degree Fahrenheit, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023041462:Same reporter US-GSK-US2023041463:Same reporter
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Excursion of 31.8 degree fahrenheit and vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On 16-MAR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Excursion of 31.8 degree fahrenheit and vaccine administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 The reporter reported that the patient received dose of FluLaval (Quadrivalent) which had been in excursion where it reached the temperature of 31.8 degree fahrenheit which was below freezing. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The FluLaval Quadrivalent vaccine temperature was exposed to 31.8 degree fahrenheit, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023041460:Same reporter US-GSK-US2023041463:Same reporter
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: 31.8 degree F excursion and vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a infant female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: 31.8 degree F excursion and vaccine administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 The reporter called to inform that a dose of FluLaval QIV (Quadrivalent) was administered to a patient but such product had been in an excursion where it reached the temperature of 31.8 degree fahrenheit (below freezing).  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The FluLaval QIV (Quadrivalent) was administered to a patient but such product had been in an excursion where it reached the temperature of 31.8 degree fahrenheit (below freezing), which led to incorrect storage of vaccine. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023041460:Same reporter US-GSK-US2023041462:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: Sore Arm; Intramuscular formulation administered by other route; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Rubella Vaccine with an associated reaction of rubella antibody negative (had received 3 times in her past, and had negative Rubella titers after each vaccine.). Concurrent medical conditions included lipoma (on left shoulder.). Concomitant products included methotrexate and hydroxychloroquine (Plaquenil).   On 15-MAR-2023, the patient received the 2nd dose of Shingrix (intercostal, left deltoid). On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Intramuscular formulation administered by other route). On an unknown date, the patient experienced pain in arm (Verbatim: Sore Arm). The outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was the patient who reported that after she received her 2nd dose of Shingrix, she experienced a sore arm.  The patient also reported that the 2nd dose of Shingrix was administered about 2 inches down from a lipoma on her left shoulder (Current condition but was pre- existing the Shingrix Vaccine).  The patient also reported that she has received the Rubella Vaccine 3 times in her past, and had negative Rubella titers after each vaccine. She added that the 2nd time was 2 years after the 1st Rubella Vaccine, and the 3rd time was 4 years after the 2nd Rubella Vaccine, while she was pregnant (all pre - existing the Shingrix vaccine). The patient added that she was currently on Methotrexate and Plaquenil and asked if does that make a difference. The reporter consented to follow up. The patient was administered with Shingrix vaccine by intercostal route, which led to Intramuscular formulation administered by other route.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date 28-JUL-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2018) and Shingrix (2nd dose received on an unknown date in 2018).   On 07-OCT-2022, the patient received the 3rd dose of Shingrix. On 07-OCT-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 A pharmacist informed that a patient had received a 3rd dose of Shingrix, which led to extra dose administered. Originally the patient had finished the scheme back in 2018. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fear, Injection site haemorrhage, Muscle spasms, Wrong technique in product usage process
Clinical narrative: Severe muscle spasms in leg and chest; May have pricked a capillary; Bleeding at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF, expiry date 21-MAY-2024) for prophylaxis.   The patient's past medical history included surgery (multiple back surgeries including interbody fusion involving L4 + L5 and C3, C4, C5 and C6). Previously experienced adverse reactions included reaction to excipient (unable to tolerate "statin" medications, which are used to treat high cholesterol, due to muscle spasms/pain) and reaction to excipient (unable to tolerate injectable cholesterol lowering medications, such as Praluent). Concurrent medical conditions included cholesterol (the patient went to cardiologist due to (high) cholesterol) and spinal stenosis. Concomitant products included paracetamol (Tylenol).   On 22-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site) and wrong injection technique (Verbatim: May have pricked a capillary). On 23-MAR-2023 02:00, the patient experienced muscle spasm (Verbatim: Severe muscle spasms in leg and chest). The outcome of the injection site hemorrhage and muscle spasm were recovered/resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site hemorrhage and muscle spasm to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage and muscle spasm to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2023 The patient reported this case. On Wednesday 22nd March 2023 the patient received 1st dose of Shingrix. The patient noticed bleeding at the injection site and felt as though a capillary had been pierced by a needle. On Thursday 23rd March 2023 the patient experienced muscle spasms in the leg and chest. The patient experienced very severe muscles spasms and scared of might having a heart attack. The patient had received concomitant drugs Tylenol and Claritin. The spams resolved. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Dyskinesia, Muscle spasms, Musculoskeletal chest pain
Clinical narrative: Severe muscle spasms in leg and chest; May have pricked a capillary; Bleeding at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF, expiry date 21-MAY-2024) for prophylaxis.   The patient's past medical history included surgery (multiple back surgeries including interbody fusion involving L4 + L5 and C3, C4, C5 and C6). Previously experienced adverse reactions included reaction to excipient (unable to tolerate "statin" medications, which are used to treat high cholesterol, due to muscle spasms/pain) and reaction to excipient (unable to tolerate injectable cholesterol lowering medications, such as Praluent). Concurrent medical conditions included cholesterol (the patient went to cardiologist due to (high) cholesterol) and spinal stenosis. Concomitant products included paracetamol (Tylenol).   On 22-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site) and wrong injection technique (Verbatim: May have pricked a capillary). On 23-MAR-2023 02:00, the patient experienced muscle spasm (Verbatim: Severe muscle spasms in leg and chest). The outcome of the injection site hemorrhage and muscle spasm were recovered/resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site hemorrhage and muscle spasm to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage and muscle spasm to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2023 The patient reported this case. On Wednesday 22nd March 2023 the patient received 1st dose of Shingrix. The patient noticed bleeding at the injection site and felt as though a capillary had been pierced by a needle. On Thursday 23rd March 2023 the patient experienced muscle spasms in the leg and chest. The patient experienced very severe muscles spasms and scared of might having a heart attack. The patient had received concomitant drugs Tylenol and Claritin. The spams resolved. The reporter consented to follow up.
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.).    No concomitant information was reported. No treatment information was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius; No adverse event; Patient had been administered dose post excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius), POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AS7188B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: VAXIGRIP TETRA (Sanofi IIV4-Free, Lot number: UT7752NA, route of administration, intramuscular and vaccination site: left deltoid.) on 10-Jan-2023. Past adverse reactions to the above products included No adverse event with VAXIGRIP TETRA.    On 27-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 27-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius), POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion).    No concomitant drug information was provided. It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19. On 26-Jan-2023, the refrigerator door was open for 5 min and the temperature rose to 8.4 degrees Celsius. Patient had not experienced adverse reaction to the vaccine. Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716571 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716571:same reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 08-Jul-2022 and second dose on 16-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before/ any chronic or long-standing health conditions.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022).    It was unknown if patient ever been diagnosed with/ tested positive for COVID-19.  No treatment medication was provided.   This case was linked to MOD-2023-716921 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Inflammation, Migraine, Tenderness
Clinical narrative: tender spot a day or before inflamed; tender spot a day or before inflamed; Headaches/ Migraines; two flares during menstural cycle, on right buttock and left underarm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed), MIGRAINE (Headaches/ Migraines) and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Sulfonamide allergy (sulfer drugs) and Allergy to antibiotic. Concomitant products included ERYTHROMYCIN for an unknown indication.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF. On an unknown date, the patient experienced INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed), MIGRAINE (Headaches/ Migraines) and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm). At the time of the report, INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed) and MIGRAINE (Headaches/ Migraines) outcome was unknown and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm) was resolving.     It was reported that, on 29-Jan-2023, the patient experienced three new flares immediate after being without medication.  On unknown date event condition aggravated was recovered. For Pfizer, the reporter's causality for events Inflammation, condition aggravated, tenderness reported as reasonable possibility and for events migraine headache as not provided. For Humira, the reporter's causality for events migraine headache, Inflammation, tenderness, condition aggravated as not provided. No treatment medication was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got COVID after first shot of moderna; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got COVID after first shot of moderna) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 041C21A and 033K21) for COVID-19 prophylaxis.     Historical vaccine included FLU3Y+P administered on 21-Oct-2015 with lot number UI455AA, manufacturer was PMC and FLU QUAD PF on 09-Jan-2017 with lot number UI622AC, manufacturer was PMC. Previously administered products included for Product used for unknown indication: HEP B (AHBVB891DA) on 20-Jul-2010. Past adverse reactions to the above products included No adverse event with HEP B.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (I got COVID after first shot of moderna). At the time of the report, COVID-19 (I got COVID after first shot of moderna) outcome was unknown.            No concomitant product reported by the reporter.  Patient received FLU3Y+P vaccine on 21-Oct-2015; Batch number: UI455AA, FLU QUAD PF on 08-Jan-2017; Batch number: UI622AC, FLUCELVAX QUAD PF on 10-Mar-2022; Batch number: 308499, FLU QUAD PF on 17-Feb-2023; Batch number: AS2878B and PCV20 (PREVNAR 20) 0n 17-Nov-2022; Batch number: FL2935.   Patient received Pfizer as dose 4 with lot number GJ6739 in right arm on 17-Feb-2023, shortly after getting Pfizer vaccine patient threw up.   No treatment medication reported by reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C; No adverse event; Patients had been administered doses of the monovalent vaccine post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the monovalent vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    On 27-Jan-2023 at 6:55 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 27-Jan-2023 at 4:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the monovalent vaccine post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the monovalent vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the monovalent vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C).    Patient's race was reported as black. Dosage text for suspect product was reported as unknown.  It was reported that the monovalent vial which was stored in refrigerator went temperature excursion on 26-Jan-2023. The refrigerator door was left open for 5 minutes and the temperature went up to 8.4C. The doses had been used on patients from start of the excursion till 17-Feb-2023. No adverse event was reported by patients.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716594 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Patient details, vaccine details and narrative part updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716594: US-MODERNATX, INC.-MOD-2023-717419:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Thrombosis
Clinical narrative: thinking it's clotting in my legs, in my thighs; having things happening with me, in my body that are painful, within my heart area.; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (thinking it's clotting in my legs, in my thighs) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (thinking it's clotting in my legs, in my thighs) (seriousness criterion medically significant) and CHEST PAIN (having things happening with me, in my body that are painful, within my heart area.). At the time of the report, THROMBOSIS (thinking it's clotting in my legs, in my thighs) and CHEST PAIN (having things happening with me, in my body that are painful, within my heart area.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient called and said that he had received the vaccine in January and February of 2020 and that he has had "several changes in his body". He reported that he had a ton of issues. Patient having things happening with him. The patient was seeking advice on what to do. No treatment drug was reported.  Company comment.  This spontaneous case concerns an adult male patient (unknown age), with no medical history reported, who received two doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) AESI thrombosis. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient thought "it's clotting in my legs, in my thighs". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Patient got COVID after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID after getting the vaccine) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AFF166B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced COVID-19 (Patient got COVID after getting the vaccine). At the time of the report, COVID-19 (Patient got COVID after getting the vaccine) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had first shot were in //2021 and had every booster. Patient had small cough, mild cold and mild fever temperature.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717380:Husband case
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient mentioned that patient nurse friend also took the Moderna booster shot and also came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same.   No treatment medications were reported. Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Guillain-Barre syndrome, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). It was reported patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine, and that patient´s nurse friend also took the Moderna booster shot and came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same. The outcome of the event was reported as not recovered. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Inappropriate schedule of product administration
Clinical narrative: Guillain-Barre; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient mentioned that patient nurse friend also took the Moderna booster shot and also came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same.   No treatment medications were reported. Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Guillain-Barre syndrome, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). It was reported patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine, and that patient´s nurse friend also took the Moderna booster shot and came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same. The outcome of the event was reported as not recovered. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.