chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Incorrect route of product administration, Product preparation error
Clinical narrative: IM injection of Rotarix; received a dose diluted with sterile water; received a dose diluted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 6973H, expiry date 2nd April 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong route of administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The nurse reported that a female patient received Rotarix by intramuscular route which was diluted with sterile water, which led to wrong route of vaccination, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. Additional Supportive Information: This case was found to be duplicate of case US2022055949 reported by same reporter for same patient. Hence, present case would be kept as case of record and the US2022055949 would be deleted. All the future information corresponding to the case would be submitted to the case of record.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: it's been 9 months instead of 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st June 2021).   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: 29-Mar-2022 Reporter's Comments: Pharmacist enquired that a patient had a Shingrix vaccine and it's been 9 months instead of 6 months and patient wanted their second vaccine in the series, so could he/she get it or patient had to restart the whole series. The reporter consented to follow up with health care professional via postal. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administering Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: The reporter reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero instead of Menveo, which led to wrong vaccine administered. This is one of four cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056732:same reporter US-GLAXOSMITHKLINE-US2022056731:same reporter US-GLAXOSMITHKLINE-US2022056735:same reporter
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient recieved a Twinrix expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number 93KF5, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 28th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: The pharmacist reported that patient received a Twinrix expired dose by error. The reporter consented to follow up by email. Additional Supportive Information: On 28th March 2022, The patient received dose of Twinrix that was already got expired on 22nd February 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only got one Shingrix shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received four years before the date of reporting).   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: 28-MAR-2022 Reporter's Comment: The patient was positive that they only got one Shingrix shot four years ago. The reporter asked if in this situation GlaxoSmithKline restart the series or give the second dose as soon as possible. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. Attempted callback today (day of reporting) to HCP (Health Care Professional) to gathered more information but had to leave voicemail for callback.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME.; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Two weeks after taking vaccine, on an unspecified date the patient started having problems and ended up with Guillain Barre syndrome. Patient almost did not survive. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220359620-Covid-19 vaccine ad26.cov2.s- Guillain Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Headache, SARS-CoV-2 test, Vision blurred
Clinical narrative: MEMORY LOSS/ SHORT TERM MEMORY LOSS; BLURRED VISION; HEADACHES; This spontaneous report received from a patient concerned of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical conditions included: tested negative for covid (prior to the vaccine). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total administered on DEC-2020 for prophylactic vaccination. The patient had sharp memory began to get fuzzy a few months later, noticed could remember everything prior to the vaccine and everything within the last two months, but everything in between was a blur following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient additionally 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 was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced memory loss/ short term memory loss, blurred vision, and headaches. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The patient memory loss was to the extent that many times patient cannot remember patient had taken medication or to the extent or even had to put alarms in phone to remember to pick up kids from school. This was like being 45 and having Alzheimer's Disease. The memory loss had been noticed by friends, family, and co-workers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory loss/ short term memory loss, and the outcome of blurred vision and headaches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220361891.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Magnetic resonance imaging, Neuralgia, Thrombosis
Clinical narrative: ANAPHYLACTIC REACTION; BLOOD CLOTS; NERVE PAIN IN LEGS AND FEET; This spontaneous report received from a health care professional (retired pediatrician) concerned a 40 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no prior related complaints before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced an anaphylactic reaction and was admitted to the hospital (date unspecified) and was possibly readmitted afterwards. The number of days of hospitalization was not reported and it was unknown if the patient was discharged from the hospital. The reporter was speculating that the patient may have also experienced blood clots. The patient had then begun experiencing nerve pain in legs and feet, and had visited the doctor/healthcare professional office. The magnetic resonance imaging (MRI) and other studies were performed with no outcome. The patient had lost work for a month or two due to the side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, had not recovered from nerve pain in legs and feet, and the outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220361972-COVID-19 VACCINE AD26.COV2.S-anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related. 20220361972-COVID-19 VACCINE AD26.COV2.S-blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LITTLE TO NO SIDE EFFECTS; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little to no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little to no side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220361763.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON ARM; This spontaneous report received from a consumer concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: wheel chair user, and home bound. 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 date not reported) dose was not reported, 01 in total was administered, start therapy date was not reported for prophylactic vaccination. On an unspecified date, the patient had few marks on her arm (dose number in series 1). The outcome of  few marks on her arm was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 30-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash on arm (dose number in series 2). The reporter reported that when she visited a week and a half later the she told her that she has the rash on her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220363110.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Feeling abnormal, Inappropriate schedule of product administration, Influenza, Off label use
Clinical narrative: COLON INFLAMMATION; FEELING ABNORMAL/FEELS BLAH; FLU/FLU LIKE SYMPTOMS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 27 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received 2 doses of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered on 01-APR-2021, and dose was not reported, 1 in total administered on 01-SEP-2021 for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) (citrate free) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Concomitant medications included elasomeran (Moderna covid-19 vaccine) for prophylactic vaccination. On an unspecified date, the patient experienced entire colon was inflamed. The patient was in the hospital for four days and went to the emergency room. She found that her entire colon was inflamed. She had both COVID-19 vaccination. Second day felt like she had flu, and the third day feeling abnormal/felt blah. Flu shot caused flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not reported. The outcome of the colon inflammation, feeling abnormal/feels blah, flu/flu like symptoms, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220362454. covid-19 vaccine ad26.cov2.s - colon inflammation. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. (CROHN'S). Therefore, this event(s) is considered not related.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: MARKS ON ARMS; This spontaneous report received from a consumer concerned an 8 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced marks on arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of marks on arms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220362290.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK FOR ABOUT A WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for about a week. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered for prophylactic vaccination. No adverse events were reported following vaccination. (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s booster (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster, the patient experienced pain (Dose number in series 2). Treatment medications included: Naproxen sodium for pain but was not effective per patient. The patient had enquired about the administration of the Tylenol chewable tablet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: history of pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: REACTION TO COVID BOOSTER SHOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced reaction to covid booster shot (Dose number in series 2). The doctor told patient to take Benadryl. The reporter made medical enquiry for dose of children Benadryl Dye-Free. The patient visited physician office for the same event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction to covid booster shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a hard lump in arms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a hard lump in arms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: MUSCULAR PAIN ON LOWER LEG; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, cholesterol, and hypertension, and other pre-existing medical conditions included: Patient was taking unspecified blood pressure and cholesterol medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced muscular pain on lower leg, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscular pain on lower leg was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Inappropriate schedule of product administration, Lymphadenopathy, Memory impairment, Off label use
Clinical narrative: MEMORY PROBLEMS; CLOGGED EARS; SWOLLEN AND PAINFUL LYMPH GLANDS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, and dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced memory problems, clogged ears, swollen and painful lymph glands, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory problems, clogged ears, and swollen and painful lymph glands, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eyelid rash, Pain in extremity, Rash
Clinical narrative: RASH ON EYELIDS; ARM SORENESS; RASH ON STOMACH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. Cov2. S (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. Cov2.s  (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in NOV-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm soreness for several days and for that the patient took Motrin, after 2 to 3 days of taking Motrin the patient developed rash on eyelids, and rash on stomach (all events in dose number series 2). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and the outcome of rash on eyelids and rash on stomach was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist administered 100mcg instead of 50mcg as his booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 039K20-2A, 040A21A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Become pain free from the arthritic pain after getting the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Become pain free from the arthritic pain after getting the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Arthritic pains.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Become pain free from the arthritic pain after getting the Moderna Covid-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Become pain free from the arthritic pain after getting the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.  Patient stated that she had read an article which says that there are patients who become pain free from the arthritic pain after getting the Moderna Covid-19 vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 03Bc21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jun-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have allergies to medications, food and other products. Patient did not have chronic or long standing health conditions. No concomitant medications were reported. No treatment information was reported.  Company Comment: This spontaneous case concerns a 21-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred approximately 6 and a half months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test done on 13-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-504787 (Patient Link).; Sender's Comments: This spontaneous case concerns a 21-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred approximately 6 and a half months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test done on 13-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: headache; left arm hurt; tired/wiped out for a week; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week). At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   The patient reported of being tired, wiped out for a week.  No treatment details were reported.   This case was linked to MOD-2022-526422, MOD-2022-526424, MOD-2022-526426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up information contain non significant information-reporter's details updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site soreness for 2 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025120-2A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness for 2 days). In February 2021, VACCINATION SITE PAIN (injection site soreness for 2 days) had resolved. Concomitant drugs were not reported. Treatment details were not given. This case was linked to MOD-2022-526433, MOD-2022-526483 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: trouble walking several meters without being out of breath; extreme pain on the other leg; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble walking several meters without being out of breath) and PAIN IN EXTREMITY (extreme pain on the other leg) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble walking several meters without being out of breath) and PAIN IN EXTREMITY (extreme pain on the other leg). At the time of the report, DYSPNOEA (trouble walking several meters without being out of breath) had not resolved and PAIN IN EXTREMITY (extreme pain on the other leg) had resolved.            No concomitant medications were reported.   Patient stated that after the first dose he experienced extreme lateralized pain on one side of his body, particularly his leg. Upon second dose patient experienced extreme pain on the other leg and the pain lasted for 2 days. Now, the patient has trouble walking several meters without being out of breath. Treatment information was not provided.   This case was linked to MOD-2022-526516 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) outcome was unknown.        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.  Reporter stated that the vial was initially stored in the refrigerator on 23-Mar-2022. And the vial did not undergo any temperature excursions. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Very bad night sweats after receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Very bad night sweats after receiving the booster dose) 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 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 NIGHT SWEATS (Very bad night sweats after receiving the booster dose). At the time of the report, NIGHT SWEATS (Very bad night sweats after receiving the booster dose) was resolving.            No concomitant medication were reported.   Patient received the booster dose on January 2022 or beginning of February 2022, the reporter did not remember the precise date. Patient started having very bad night sweats after receiving the booster dose. Patient explained that they have gotten better, but were still ongoing.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-526693 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medications was reported. No treatment information was reported.   This case was linked to MOD-2022-526778, MOD-2022-526822, MOD-2022-526823 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: sore injection site left arm.; Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm.) and EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 014F21A, 031B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.). On 26-Mar-2022, the patient experienced VACCINATION SITE PAIN (sore injection site left arm.). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm.) and EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-526778, MOD-2022-526820, MOD-2022-526822 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary series from Johnson and Johnson) on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy.    On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as 66 inches. No concomitant medications were reported. The patient had not received any other vaccines prior to Moderna vaccine. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. The patient did not have any symptoms and did not seek medical care. No treatment medications were reported.   This case was linked to MOD-2022-526971 (Patient Link).