chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenitis
Clinical narrative: Developed  lymph nodes that were inflamed in the  neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) and HEADACHE (Headache). At the time of the report, LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.   It was reported that patient was scared and did not receive the second dose.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Got a pain in left arm; got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Got a pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 29-Jan-2021. Past adverse reactions to the above products included Allergic reaction with Pfizer.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Got a pain in left arm). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Got a pain in left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Insomnia, Nervousness, Urinary incontinence, Weight decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Water started coming out, and she wet the bed), WEIGHT DECREASED (Felt was losing weight), FEEDING DISORDER (Could not eat/did not have any appeal to eating), NERVOUSNESS (Nervous wreck, She is afraid this vaccine is going to kill me) and INSOMNIA (Trouble going to sleep, and sometimes has difficulty staying asleep) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced NERVOUSNESS (Nervous wreck, She is afraid this vaccine is going to kill me). On 10-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY INCONTINENCE (Water started coming out, and she wet the bed). On 13-Jan-2022, the patient experienced WEIGHT DECREASED (Felt was losing weight) and FEEDING DISORDER (Could not eat/did not have any appeal to eating). In January 2022, the patient experienced INSOMNIA (Trouble going to sleep, and sometimes has difficulty staying asleep). The patient was treated with HONEY for Adverse event, at an unspecified dose and frequency and CITRUS LIMON ESSENTIAL OIL (LEMON) for Adverse event, at an unspecified dose and frequency. At the time of the report, URINARY INCONTINENCE (Water started coming out, and she wet the bed), WEIGHT DECREASED (Felt was losing weight), FEEDING DISORDER (Could not eat/did not have any appeal to eating), NERVOUSNESS (Nervous wreck, She is afraid this vaccine is going to kill me) and INSOMNIA (Trouble going to sleep, and sometimes has difficulty staying asleep) outcome was unknown. Patient was shivering while waiting for the booster dose and was very nervous, although patient was also waiting outside in the cold. Patient was afraid that vaccine was going to kill her. Patient regularly see a kidney doctor and heart doctor. No relevant concomitant medications were reported. Treatment information included patient consumed tea which helps her to go sleep. This case was linked to MOD-2022-461735 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 2nd Covid Vaccination reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (2nd Covid Vaccination reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021 at 5:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (2nd Covid Vaccination reaction). On 11-Mar-2021, VACCINATION COMPLICATION (2nd Covid Vaccination reaction) had resolved.            No concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2022-453316 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: hurt my shoulder,affected my shoulder; little bit of  headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 016MZ0A and 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache). The patient was treated with IBUPROFEN on 25-Jan-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2022-461490 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (if he moves his arms afterwards, he has overall less pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (if he moves his arms afterwards, he has overall less pain). At the time of the report, PAIN IN EXTREMITY (if he moves his arms afterwards, he has overall less pain) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications reported. No treatment reported. This case was linked to MOD-2022-461467 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received 0.25 ml as the third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as the third dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. 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 ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as the third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as the third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Bleeding time prolonged, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding). At the time of the report, MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant product were reported. No treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vein discolouration
Clinical narrative: hands turned blood red; ein on top of knuckle middle digit, bubbled up and turned bluish red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (treated in the past for Hyperthyroidism). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red). At the time of the report, ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2022-461617, MOD-2022-461618 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Face turned blood red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face turned blood red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (Treated in the past). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Face turned blood red). On 04-Mar-2021, ERYTHEMA (Face turned blood red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported Concomitant medication Ciclopirox was used under breast and toes. Batch number for suspect product was reported as 025A2(illegible 7 or 9) It was reported that after vaccination, patient was kept on observation for 15 minutes, her face turned red after she went back home which lasted for a minute tops.   This case was linked to MOD-2022-461572, MOD-2022-461618, MOD-2022-461295 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Sinusitis
Clinical narrative: lower back and up to shoulder were killing me/hurting/Back pain; shoulder were killing me; Chills; Started coughing, coughed and cough and it wouldn't let up; Sinus were just draining; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Started coughing, coughed and cough and it wouldn't let up), SINUSITIS (Sinus were just draining), BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain), ARTHRALGIA (shoulder were killing me) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (being treated in the past for hyperthyroidism). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COUGH (Started coughing, coughed and cough and it wouldn't let up), SINUSITIS (Sinus were just draining) and CHILLS (Chills). On 24-Jan-2022, the patient experienced BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain) and ARTHRALGIA (shoulder were killing me). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of Tylenol around 10pm. and Bed rest (Laid down got some relief) for Back pain. At the time of the report, COUGH (Started coughing, coughed and cough and it wouldn't let up) had not resolved, SINUSITIS (Sinus were just draining) and ARTHRALGIA (shoulder were killing me) outcome was unknown and BACK PAIN (lower back and up to shoulder were killing me/hurting/Back pain) and CHILLS (Chills) was resolving.            Sinus were just draining went through a whole box of Kleenex.   This case was linked to MOD-2022-461617, MOD-2022-461572 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a FULL Moderna Booster (NOT 1/2); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received a FULL Moderna Booster (NOT 1/2)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (received a FULL Moderna Booster (NOT 1/2)). On 08-Sep-2021, ACCIDENTAL OVERDOSE (received a FULL Moderna Booster (NOT 1/2)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over; Red hives on my back, slightly raised, and very itchy; Very itchy/red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over), RASH ERYTHEMATOUS (Very itchy/red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over) and PRURITUS (Red hives on my back, slightly raised, and very itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced URTICARIA (Red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over) and PRURITUS (Red hives on my back, slightly raised, and very itchy). In 2021, the patient experienced RASH ERYTHEMATOUS (Very itchy/red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over), RASH ERYTHEMATOUS (Very itchy/red hives on my back, slightly raised, and very itchy , all over my back, thighs, arms, waist, armpits, neck, all over) and PRURITUS (Red hives on my back, slightly raised, and very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Patient reported hives after 4 to 5 days later after vaccination and it raised slightly and itchy it spreads all over on back, thighs, arms, waist, armpits, neck, all over. It takes 7 months to go away and no medicines taken by patient to treat. Doctor advised patient to take Zyrtec or Benadryl for itching. Patient taken second dose of vaccine on 17 May and still having hives and taking one Zyrtec a day and antihistamines.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Illness
Clinical narrative: had diarrhea after the booster and continue to have it now; very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs) and DIARRHOEA (had diarrhea after the booster and continue to have it now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (J and J vaccine) in March 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs). On an unknown date, the patient experienced DIARRHOEA (had diarrhea after the booster and continue to have it now). In November 2021, ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs) had resolved. At the time of the report, DIARRHOEA (had diarrhea after the booster and continue to have it now) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine given to patient below 18 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old). On 25-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered 25 Jan 2021 morning and patient did not experienced any adverse events.  No concomitant medications were reported.  No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication. On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose). On 25-Jan-2022, ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided. HCP states that yesterday an immunocompromised patient that was supposed to be given the 3rd dose was instead administered the booster dose 0.25 ml. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up information received added patient initials.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Have several side effects / Symptoms after booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Have several side effects / Symptoms after booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced VACCINATION COMPLICATION (Have several side effects / Symptoms after booster). At the time of the report, VACCINATION COMPLICATION (Have several side effects / Symptoms after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided. Patient received the booster on Monday morning.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Vaccination complication
Clinical narrative: side effects- side effects after 5 days; bleed out your nose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose). At the time of the report, VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient stated that its been five days since the booster.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture). On 20-Jan-2022 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Moderna COVID-19 vaccine was administered 12 to 15 hours beyond the expiration date. Date the vial was initially stored in the refrigerator was on 23 Dec 2021. Concomitant drugs were not reported. Treatment details were not given. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow-up information received contains reporter details and updated narrative.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Is it still safe and does the vaccine work 2 weeks after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: second dose >35 days after first dose; fatigue; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 25-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose). On 25-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) had resolved. At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Patient's concomitant medication include- thyroid tablet.  No any treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Caller was a Pharmacist who stated that they administered the booster dose of the Moderna COVID19 vaccine from a vial that was less than 24 hours expired.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. Did the vial undergo any temperature excursions: No. This case was linked to MOD-2022-461874 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-NMDA antibody, Feeling abnormal, Impaired work ability, Psychotic disorder
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Diabetes and Thyroid disorder NOS. Concomitant products included LOSARTAN POTASSIUM (COZAAR) and HYDROCHLOROTHIAZIDE for Blood pressure management, METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store). The patient was treated with QUETIAPINE FUMARATE (SEROQUEL) at a dose of 1 dosage form and RISPERIDONE (RISPERDAL) at a dose of 1 dosage form. At the time of the report, PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Anti-NMDA antibody: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 23-AUG-2021 she was taken to Emergency room by her family. She was not suicidal and did not have a family history of any psychosis related issues or trauma. She had never been on any anti psychotics before this.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Congestion/ Stopped up nose; Coughing; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (Congestion/ Stopped up nose) and COUGH (Coughing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced NASAL CONGESTION (Congestion/ Stopped up nose) and COUGH (Coughing). At the time of the report, NASAL CONGESTION (Congestion/ Stopped up nose) and COUGH (Coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 vaccine were given past the expiration date) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 vaccine were given past the expiration date). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 vaccine were given past the expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided. This case was linked to MOD-2022-461859 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-461858, MOD-2022-461877 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm shoulder deltoid muscle./sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 040A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm) outcome was unknown.            No Concomitant product use was reported.  The patient received their Moderna Covid-19 booster dose on 28-Aug-2021 and complained of a sore left arm shoulder deltoid muscle.  No treatment information was provided.   This case was linked to MOD-2022-461876, MOD-2022-461858 (Patient Link).   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received a booster shot instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received a booster shot instead of full dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Received a booster shot instead of full dose). On 03-Nov-2021, UNDERDOSE (Received a booster shot instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment medications were not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received booster instead of third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of third dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 031A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer since 2010.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of third dose). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (Received booster instead of third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea
Clinical narrative: lot of mucus after the Moderna Covid-19 vaccine; developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson vaccine (The patient developed a severe blood clot in her eye and a severe rash on her neck. Rash went down her arms to her elbow and the rash lasted for several months.) in March 2021 and Johnson vaccine (The patient developed a severe blood clot in her eye and a severe rash on her neck. Rash went down her arms to her elbow and the rash lasted for several months.) in March 2021. Past adverse reactions to the above products included Clot blood with Johnson vaccine; and Rash with Johnson vaccine.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.). The patient was treated with CORTISONE at an unspecified dose and frequency and CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.) outcome was unknown.            No Concomitant medication was reported. treatment medication liquids, ointments,  antihistamine.   Patient says that she is in her sixties. The patient went to a Dermatologist and started to get better. Sleeping was difficult.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter had stated that the vial did not undergone any temperature excursions and the vial was initially stored in the refrigerator on 28 Dec 2021. No Concomitant information was reported. No Treatment information was reported.