chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: upper lip is swollen; prickly feeling; inflammation to the pre-existing areas of eczema on her arms and neck; arm pain at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, eczema, hypothyroidism, anxiety and anaphylaxis (after beta blocker). Concomitant products included clonazepam and levothyroxine sodium (Synthroid).   On 21st March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 24th March 2022, the patient experienced pricking skin sensation and inflammation localized. On 25th March 2022, the patient experienced lip swelling. The patient was treated with benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site swelling was recovered/resolved and the outcome of the pricking skin sensation and lip swelling were not recovered/not resolved and the outcome of the inflammation localized was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, pricking skin sensation, inflammation localized and lip swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's comment: The patient self reported the case. On the day of Shingrix dose, the patient had arm pain and swelling at the injection site. On 24th March 2022 at 8pm, 3 days after Shingrix dose,the patient developed a prickly feeling and further described this feeling as inflammation to the pre-existing areas of eczema on arms and neck. On the day of reporting, 4 days after Shingrix administration, half of her upper lip was swollen. The injection site pain had decreased over the past four days and was mild now. She treated the prickly feeling and lip swelling with oral Benadryl. On the day of reporting patient was having appointment with her doctor.  The reporter consented to follow up with physician but declined to provide doctor's name or contact information at this time as she wanted to speak with him first. The reporter consented to follow up by email but declined to provide email.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, SARS-CoV-2 test
Clinical narrative: DRY COUGH; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 06-SEP-2021) dose was not reported, 1 total, administered on 23-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient received non-company suspect vaccine Moderna (Spikevax, elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination.  On 21-MAR-2022, the patient had symptoms of headache and dry cough, both symptoms still lingered but did not seem to be getting worse (Dose number in series 2). On 24-MAR-2022, the patient tested negative for Binax rapid test (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from headache, and dry cough. This report was non-serious. This case, involving the same patient is linked to 20220357912. This case, from the same reporter is linked to 20220354365.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Nail disorder, Oedema peripheral, Thrombosis
Clinical narrative: BLOOD CLOT TO THE BIG TOE; FOOT WAS GETTING INFECTED/BOTH TOES FOOT WERE RED; SWELLING OF TOES/GOT VERY HARD/BOTH TOES IN BAD SHAPE; NAIL REMOVED, FLESH CUT OFF WITH THE NAIL; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot to the big toe. It was reported that on 25-MAR-2022, patient visited hospital and seen a foot doctor and other doctors, both her toes were in bad shape, nail removed, flesh cut off with the nail and toe was swelled up (got very hard). Doctors performed surgery on her blood clot on her toe a couple of weeks ago. The foot doctors did not know what it was. They took out the blood clot. Patient's mother reported that patient's other toes were also red, they had not done any surgery on that one. Both toes on the other foot were red. The other foot was getting infected. Patient's mother was unable to determine which foot was originally affected and was seeking medical advice.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot to the big toe, foot was getting infected/both toes foot were red, swelling of toes/got very hard/both toes in bad shape, and nail removed, flesh cut off with the nail. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220355692-Covid-19 vaccine ad26.cov2.s- blood clot to the big toe.The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pyrexia
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had fever (Dose number in series 2). Patient thought patient purchased the wrong Tylenol brand. Patient had Tylenol Cold & Flu Severe. Patient had Covid-19 shots and end up having fever. Patient thought this was a wrong Tylenol. Patient did not have a cold or flu, It was just the after effects of the Covid Shot (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little red rash or hives or something inside right thigh under the skin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little red rash or hives or something inside right thigh under the skin was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anger, Cardiac flutter, Dyspnoea, Extrasystoles, Flatulence
Clinical narrative: This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little red rash or hives or something inside right thigh under the skin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little red rash or hives or something inside right thigh under the skin was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Muscle spasms, Palpitations, Rash, Rash erythematous
Clinical narrative: This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little red rash or hives or something inside right thigh under the skin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little red rash or hives or something inside right thigh under the skin was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LITTLE TO NO SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced little to no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little to no side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220362145.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: TERRIBLE THING IN THE KNEECAP; This spontaneous report received from a patient concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported,1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 24-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-OCT-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had no pain in the arm but experienced terrible thing in the kneecap (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible thing in the kneecap was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Somnolence
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease. The patient was previously received with Covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was on blood thinner. On an unspecified date, the patient had been so sick and wanted to sleep all the time. The patient also experienced diarrhea real bad (all events in dose number series 2). Patient did not know that patient can take Imodium or not because patient took blood thinner and had heart disease. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the so sick, want to sleep all the time and diarrhea real bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARMS WERE SORE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-OCT-2021, the patient experienced arms were sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms were sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Expired product administered, Feeding disorder, Headache, Off label use
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: Covid-19, and concurrent conditions included: allergies (a little bit of allergies), and other pre-existing medical conditions included: Patient was completely fine before the vaccine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used, and off label use. On an unspecified date, the patient experienced tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, and really bad headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really bad headache, tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, expired vaccine used and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Purulence, Tonsillar hypertrophy, Vomiting
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: Covid-19, and concurrent conditions included: allergies (a little bit of allergies), and other pre-existing medical conditions included: Patient was completely fine before the vaccine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used, and off label use. On an unspecified date, the patient experienced tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, and really bad headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really bad headache, tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, expired vaccine used and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALLING OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Vomiting
Clinical narrative: FOOD LODGING ON THE THROAT AND CAUSES TROUBLE BREATHING; THROWING UP AFTER EATING ANY TYPE OF FOOD; COUGH; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use (1 glass on the weekends), and non-smoker, and other pre-existing medical conditions included: The patient had no relevant medical history and no known allergies. 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 18-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-OCT-2021, the patient experienced cough. On 01-NOV-2021, the patient experienced food lodging on the throat and causes trouble breathing, and throwing up after eating any type of food. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, throwing up after eating any type of food, and food lodging on the throat and causes trouble breathing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. No adverse events reported after primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient received JNJ booster dose 14 days earlier than on-label interval after JNJ primary dose (off label use, and inappropriate schedule of vaccine administered) (dose number in series 2). Reporter stated that the event occurred 4 to 5 months ago in a long-term care facility. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Alopecia, Autoimmune disorder
Clinical narrative: TWO DIFFERENT AUTOIMMUNE DISORDERS; LOST ALL HAIR ON THE BODY; ADVERSE EVENTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no family history of either autoimmune disease. The patient work in military and have regular exercises. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, almost immediately after vaccination the patient began to have problems. The patient was diagnosed with two different autoimmune disorders and the patient was now taking medication daily and told for rest of his life. Additionally the patient had lost all hair on the body and paying to have treatments to hopefully bring it back but it was expensive for him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two different autoimmune disorders, lost all hair on the body and adverse events was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220362785-COVID-19 VACCINE AD26.COV2.S- Two different autoimmune disorders The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure; This spontaneous serious safety report with reference number 2022SA063571 was received by a partner on 23-FEB-2022 and forwarded to Agency on 24-FEB-2022 from a health care professional.  A 9 month and 24 days old patient, with unknown medical history of seizures, had been vaccinated with the 3rd dose of Vaxelis on unknown date for prophylaxis.  The following concomitant vaccinations were reported: Pneumococcal 13 valent vaccine  On the same date as Vaxelis vaccination, within 4 hours after vaccination the patient developed seizures.  At time of this report, the outcome of the event was unknown.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of seizure.  Further information is expected.  For reference purposes only case is linked to MCM-003180 (same reporter).   Company comment:  Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous serious safety report with reference number 2022SA063571 was received by a partner on 23-FEB-2022 and forwarded to Agency on 24-FEB-2022 from a health care professional.  A 2 month and 22 days old patient, with unknown medical history, had been vaccinated with the 1st dose of Vaxelis on an unknown date for prophylaxis.  The following concomitant vaccinations were reported: Pneumococcal 13 valent vaccine.  On the same date as Vaxelis vaccination, within 4 hours after vaccination the patient developed seizures.  At time of this report, the outcome of the event was unknown.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of seizure.  Further information is expected.  For reference purposes only case is linked to MCM-003179 (same reporter).  COMPANY COMMENT: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Age: 0.25
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 3-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Allergy to Penicillin. Baby was conceived through IVF, Low AMH is the culprit for infertilitiy.  The mother's past medical history included Alcohol use (Mother was taking 1-2 drinks, 3 times per week) on 22-Jun-2020 and Subfertility (Baby was conceived through IVF, Low AMH is culprit of infertility).    No Medical History information was reported.    On 03-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was in June 2020 and the estimated date of delivery was 12-Apr-2021. On 03-Mar-2021, the infant was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 02-Apr-2021, which was reported as Premature. For neonate 1, the birth weight was 2551 grams (5lbs 10oz) with an APGAR score of 1 and 5 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. Baby was measuring small- labeled as IUGR.  Water broke and chose to do a C-section. Live Preterm birth =37 weeks gestation. No other fetal/infant abnormalities identified on delivery or one month post-partum. On 03-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) was unknown.       No concomitant and  treatment medications  were reported. Weekly NST's test was normal.  Weekly ultrasounds with MFM was normal.  No Perinatal complications for the infant. No identified infant abnormalities at 1-month post-partum.   This case was linked to MOD-2021-051792 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding Mother received Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-257990 (Parent-Child Link). See case MOD-2021-257990 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days; administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial was initially stored in the refrigerator on 15-Feb-2022 at 5:15 pm and patient was administered with vaccine that had been stored in the refrigerator for 34 days.  No patient had reported any adverse events so far.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received, contains reporter details, patient information and dose information was added and event verbatim was updated. On 26-Mar-2022: Follow-up received contains no new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed clots after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed clots after her booster dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed clots after her booster dose) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Developed clots after her booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient developed clots after booster dose and was ordered Aspirin for the blood clots. Company comment: This spontaneous case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis. The date of onset of the event and date of administration of third dose of mRNA-1273 were not specified, hence latency could not be assessed. There was no information provided on the previous two doses of mRNA-1273. The patient was treated with Aspirin for the blood clot at an unspecified dose and frequency. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-522801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up received included reporter's contact details.; Sender's Comments: This spontaneous case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis. The date of onset of the event and date of administration of third dose of mRNA-1273 were not specified, hence latency could not be assessed. There was no information provided on the previous two doses of mRNA-1273. The patient was treated with Aspirin for the blood clot at an unspecified dose and frequency. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 28 days since first dose,She still has not received the second dose, she is waiting to get it.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 28 days since first dose,She still has not received the second dose, she is waiting to get it.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 10-Dec-2021.    In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 28 days since first dose,She still has not received the second dose, she is waiting to get it.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 28 days since first dose,She still has not received the second dose, she is waiting to get it.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant products were reported.  Patient received their first dose of the vaccine in February 2022. She still has not received the second dose, she is waiting to get it.  No treatment drugs were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Felt like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like the flu) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 INFLUENZA LIKE ILLNESS (Felt like the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like the flu) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer on 20-Jan-2021, Pfizer on 19-Feb-2021 and Flu shot (Patient got Flu shot two week prior). Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer and Pfizer. Concurrent medical conditions included Hypertension. Concomitant products included FINASTERIDE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea). At the time of the report, DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea) was resolving. The concomitant medications included Cholesterol medication and blood pressure medication. Patient was going to see doctor on the 28-Mar-2022. No treatment medications reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Date the vial was initially stored in the refrigerator was 25-Mar-2022, 8:00am  The vial did not undergo any temperature excursions.  No treatment information provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Extra dose administered, Pain in extremity
Clinical narrative: Severe pain in legs; severe pain in back; could not get out of bed; Patient received Fourth Dose in 14-Mar-2022; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back), ASTHENIA (could not get out of bed), CHILLS (chills) and EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045B21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022). In March 2022, the patient experienced CHILLS (chills). On 15-Mar-2022 at 2:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back) and ASTHENIA (could not get out of bed). In March 2022, CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back) and ASTHENIA (could not get out of bed) had resolved and EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022) outcome was unknown.            No Concomitant product use was reported.  The patient was reporting adverse event from their 4th Moderna Covid-19 dose and explained that week after their 4th dose after initial chill in the middle of night at 2:30 AM the patient started to experience severe pain in their back and both legs. The patient said that it was tremendous pain, and it made the patient unable to get out of bed. Reportedly, the patient said that they fully recovered within 24 hours. No other adverse events were reported. The patient also stated that they did not need to visit their primary care doctor and said the patient's reactions was from the shot.   The patient was unable to verify booster versus full dose.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered out a vial that experienced excursion for 4 hours; Doses administered out a vial that experienced excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 001J21-2A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  It was reported that 3 doses were administered out a vial which experienced excursion for 4 hours. The vials were returned to stable refrigerator temperature after 4 hours.   No treatment information provided   This case was linked to MOD-2022-525790, MOD-2022-525791 (Patient Link).