chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot a year after 1st; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1 year ago prior to the receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received her 2nd dose of Shingrix vaccine about 1 year after receiving 1st dose of Shingrix vaccine. The patient stated that there was no other information available. The reporter did not consent to follow up. The reporter did not give permission to contact HCP. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 4 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was the patient's relative.  She stated that her relative never received his second dose of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site mass, Vaccination site pain, Vitreous floaters
Clinical narrative: INJECTION SITE REDNESS; SEEING SWIMMERS IN BOTH THE EYES; INJECTION SITE LUMP GETTING BIGGER (SINCE THE DAY PATIENT GOT VACCINE, SIZE OF HALF A DOLLAR AND GETTING BIGGER); STABBING PAIN/HURTS BAD AND TENDER AT THE SITE OF VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced seeing swimmers in both the eyes, injection site lump getting bigger (since the day patient got vaccine, size of half a dollar and getting bigger), and stabbing pain/hurts bad and tender at the site of vaccination. On 2022, the patient experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stabbing pain/hurts bad and tender at the site of vaccination, injection site lump getting bigger (since the day patient got vaccine, size of half a dollar and getting bigger), and injection site redness, and the outcome of seeing swimmers in both the eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20221101721.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: ACHING LIMBS; SEVERE RINGING IN EARS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced aching limbs, and severe ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe ringing in ears and aching limbs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via social media (Mbox Communication (Social Listening)) via a company representative concerned a female of unspecified age, race and ethnicity Initial information was processed with additional information received on 01-NOV-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported,1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The reporter reported, "I believe that every human being has the potential for negativity. Btw, Johnson and Johnson's Covid "vaccine" gave my mother a heart attack." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221107791.  Additional information was received from consumer via social media(Twitter) on 01-NOV-2022. It was determined that AER 20221107791 was a duplicate of this case. All relevant information regarding this case will be submitted under AER 20221107249.; Sender's Comments: V0: 20221107249- Heart attack. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from social media (Johnson and Johnson) via a parent concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for covid-19 prophylaxis.  Patient was not having any adverse events following vaccination with 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) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. Reported "Best Covid vaccine! My son and I Got our 1st and 2nd J&J vaccine and absolutely no issues! My son later got Covid and not even one symptoms appeared except a + test!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest
Clinical narrative: ARRESTED; This spontaneous report received from a consumer via a company representative via social media (J and J) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced arrested (Cardiopulmonary arrest). It was reported as "sounds exactly like what happened to my brother but my brother arrested and they couldn't recuscitate so he died". On an unspecified date, the patient died from arrested. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221108956-Arrested. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: ARRESTED
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Back pain, Menstruation irregular, Pain, Swelling
Clinical narrative: HAD A PERIOD IN JAN AND AUGUST 2022; BODY GOES THROUGH EXCRUCIATING, UNBEARABLE SWELLING THAT MAKES ME FEEL LIKE I AM GOING TO SUFFOCATE; UNGODLY AND EXCRUCIATING BACK PAIN; BODY IS IN HORRIBLE PAIN EVERY MONTH; DID NOT HAVE A PERIOD FROM MARCH 2021 TO JAN 2022; 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. The patient's pre-existing medical conditions included: Before the vaccine, the patient had normal monthly periods. She never cramped, nor ever had the extensive swelling throughout her body. She had very mild periods. 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 03-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced body is in horrible pain every month, and did not have a period from march 2021 to jan 2022. On 10-MAR-2021, the patient experienced body goes through excruciating, unbearable swelling that makes me feel like i am going to suffocate, and ungodly and excruciating back pain. On JAN-2022, the patient experienced had a period in jan and august 2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body goes through excruciating, unbearable swelling that makes me feel like i am going to suffocate, ungodly and excruciating back pain, body is in horrible pain every month, and did not have a period from march 2021 to jan 2022, and the outcome of had a period in jan and august 2022 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Dry mouth, Dysphagia, Lip swelling, Paraesthesia oral
Clinical narrative: ENTIRE MOUTH GOT SO DRY; COULD NOT SWALLOW; LIPS SWELLED; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; TONGUE STARTED TO TINGLING; This spontaneous report received from a patient via other manufacturer (Moderna) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose not reported, administered on an unspecified date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date, within 2 minutes of taking the shot, patient's tongue started to tingling, entire mouth got so dry and could not swallow (dose number in series 2). Patient waited for 45 minutes and went home. 2 hours later patient's lips swelled (dose number in series 2). Patient said they got a Kenalog shot from the doctor the next day and a Prednisone pill. The Kenalog helped with the dryness, the prednisone did not help stopping it. Treatment medications (dates unspecified) included: prednisone, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from entire mouth got so dry, and the outcome of tongue started to tingling, could not swallow, lips swelled and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Greater than 35 days between first two doses of the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Aug-2022, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported. It was reported pharmacist told that it was not true and patient was fully vaccinated and starts a new job on Monday 7NOV2022 where it was fully vaccinated.  Company Comment: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported in this case as interval between first two doses of the Moderna Covid-19 vaccine is greater than 35 days. Patient was found to be pregnant after the 1st dose of mRNA-1273 vaccine. No details of clinical course, lab reports or treatment received was available in the report. Outcome of events reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-669168 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported in this case as interval between first two doses of the Moderna Covid-19 vaccine is greater than 35 days. Patient was found to be pregnant after the 1st dose of mRNA-1273 vaccine. No details of clinical course, lab reports or treatment received was available in the report. Outcome of events reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-669168:dose 1 case
Sex: F
Vaccine: COVID19-2
Symptoms: Hypokinesia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot) in a female 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.    On an unknown date, 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 an unknown date, the patient experienced HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot). At the time of the report, HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient reported that vaccine messed up her arm bad, bad. Patient could not use her right arm ever since patient got the vaccine.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Covid didn't kill Grandma Pfizer and Moderna did; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Covid didn't kill Grandma Pfizer and Moderna did) in a female 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.    On an unknown date, 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experience the serious event of death, reported as "Covid didn't kill Grandma Pfizer and Moderna did".  The event occurred after the mRNA-1273.222 vaccine. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experience the serious event of death, reported as "Covid didn't kill Grandma Pfizer and Moderna did".  The event occurred after the mRNA-1273.222 vaccine. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Reported Cause(s) of Death: Covid didn't kill Grandma Pfizer and Moderna did
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mouth swelling, Oral pigmentation, Stomatitis, Swollen tongue, Tongue discolouration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp) and STOMATITIS (Sores in her mouth) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma, Dust allergy and Allergy NOS (General allergies).    On 10-Sep-2022, the patient received fifth 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-Sep-2022, the patient experienced MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.). At the time of the report, MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.) had resolved.              No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tongue polyp
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp) and STOMATITIS (Sores in her mouth) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma, Dust allergy and Allergy NOS (General allergies).    On 10-Sep-2022, the patient received fifth 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-Sep-2022, the patient experienced MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.). At the time of the report, MOUTH SWELLING (Her mouth got all swollen/ there was a lot of swelling), TONGUE DISCOLOURATION (Her tongue was white.), SWOLLEN TONGUE (Her tongue was all swollen / there was a lot of swelling/ a couple of places it seemed like her tongue had popped open/ the underpart of her tongue looked like she had a second tongue), TONGUE POLYP (There was a weird part of the underside of the tongue that looked like a skin tag or polyp), STOMATITIS (Sores in her mouth) and ORAL PIGMENTATION (Her mouth got all white.) had resolved.              No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 on 15-Dec-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of COVID-19 (Tested positive for COVID-19 on 15-Dec-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0b5P21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Patient had no chronic or long standing health conditions.  Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE from 10-Aug-2018 to an unknown date for GERD.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 9:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19 on 15-Dec-2021). At the time of the report, COVID-19 (Tested positive for COVID-19 on 15-Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received no other vaccines on the same day as that of Moderna vaccine.  No treatment information was provided.   This case was linked to MOD-2022-666044 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Patient received 100mcg first booster dose as she received a Janssen vaccine for her primary series, so vaccination provider told her that she needed the full strength booster.; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 100mcg first booster dose as she received a Janssen vaccine for her primary series, so vaccination provider told her that she needed the full strength booster.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002S21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Janssen (patient had a Janssen primary series). Past adverse reactions to the above products included No adverse reaction with Janssen.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 20-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 100mcg first booster dose as she received a Janssen vaccine for her primary series, so vaccination provider told her that she needed the full strength booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 100mcg first booster dose as she received a Janssen vaccine for her primary series, so vaccination provider told her that she needed the full strength booster.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The patient received her first Moderna booster dose on 20-Oct-2021but does not remember on which arm she received this monovalent Covid-19 vaccine.  The patient received a full 100mcg dose for her first booster dose. The vaccination provider told her that she needed the full-strength booster because she received the Janssen vaccine for her primary vaccine series. No treatment information was reported.   This case was linked to MOD-2022-669857, MOD-2022-669829 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a children vaccine instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B, 039A21A, 045B21A and 012H21B) for COVID-19 vaccination.     It was unknown if patient had ever tested or diagnosed for COVID-19. Patient had no medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. In the last 4 weeks,patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine).    Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (1st dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included Immunocompromised.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Hypothyroidism
Clinical narrative: Hypothyroid; This spontaneous case was reported by a medical assistant and describes the occurrence of HYPOTHYROIDISM (Hypothyroid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 06-Apr-2021 to an unknown date for Hypothyroidism.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (Intramuscular) 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOTHYROIDISM (Hypothyroid) (seriousness criterion medically significant). At the time of the report, HYPOTHYROIDISM (Hypothyroid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown  if the patient had acute illnesses at the time vaccination and up to one month before. Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced unexpected serious (medically significant) event of hypothyridism, which occurred 9 days after second dose of mRNA-1273. Vaccine. Patient started on LEVOTHYROXINE SODIUM 75 microgram once daily, At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-666042 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced unexpected serious (medically significant) event of hypothyridism, which occurred 9 days after second dose of mRNA-1273. Vaccine. Patient started on LEVOTHYROXINE SODIUM 75 microgram once daily, At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date), PRODUCT STORAGE ERROR (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Nov-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 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date), PRODUCT STORAGE ERROR (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date) and PRODUCT STORAGE ERROR (Received a dose of the Moderna Covid 19 vaccine bivalent after the 30-day use by date, after the refrigerated beyond use date).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date).    No Concomitant medications were provided. It was reported that 1 Patient received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date   Reporter does not had more information of the event at that time. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Patient had the Moderna vaccine and couldn't walk afterwards; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Patient had the Moderna vaccine and couldn't walk afterwards) in a female 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.    On an unknown date, 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 an unknown date, the patient experienced GAIT INABILITY (Patient had the Moderna vaccine and couldn't walk afterwards). At the time of the report, GAIT INABILITY (Patient had the Moderna vaccine and couldn't walk afterwards) outcome was unknown.            No concomitant medication information was provided. No treatment information was provided.   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Received only 1 dose of vaccine and didn't take second dose; Contracted covid 14 days after the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted covid 14 days after the vaccine) and PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Aug-2021, the patient experienced COVID-19 (Contracted covid 14 days after the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose). The patient was treated with Immunotherapy (Monoclonal Antibody) for COVID-19. At the time of the report, COVID-19 (Contracted covid 14 days after the vaccine) and PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient needed to skip the second dose of vaccine and wanted to get the newest vaccine due to the reason of COVID contraction after first vaccination. Patient was given monoclonal antibodies, so patient thought patient did not need second dose.  Adverse event did not caused patient to seek medical care.  Treatment included Monoclonal antibodies.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired bivalent booster beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 vaccination.     No Medical History information was reported.    In 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. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) 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 EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture).    Concomitant medication was not provided.  It was reported that the vial was initially stored in refrigerator on 03-Nov-2022 at about 3:30PM and doses administered to patients on 04-Nov-2022 at unknown time and 05-Nov-2022 at 3PM. The pharmacist reported that it was unsure, there were doses given from the same lot number on 03-Nov-2022, but was not sure if it was from the same vial.  The vial did not undergo any temperature excursions.  The vial was not exposed to room temperature. It was stored in the refrigerator after puncture. It was exposed to refrigerator temperature for about 24 hours, if the first puncture was 04-Nov-2022.  Treatment information was not provided.  The case contains information of patient 1 out of 2 patients.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Pain that went down arm to hand; pain that went into their chest; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain that went down arm to hand) and CHEST PAIN (pain that went into their chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 014M2DA and 032F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Enlargement heart (past medical history of an enlarged heart because of their asthma), Asthma (past medical history of an enlarged heart because of their asthma), Penicillin allergy, Allergy to animal (Cats) and Adhesive tape allergy (Surgical tape).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain that went down arm to hand) and CHEST PAIN (pain that went into their chest). At the time of the report, PAIN IN EXTREMITY (Pain that went down arm to hand) and CHEST PAIN (pain that went into their chest) outcome was unknown.            No concomitant medications were reported.  On 03-Dec-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  No treatment medications were reported.