chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected counterfeit product, Vaccination site pain
Clinical narrative: POSSIBLE COUNTERFEIT PRODUCT; UNBEARABLE PAIN AT THE INJECTION SITE FOR THE FIRST 15 MINUTES POST-VACCINATION/ONGOING LINGERING PAIN AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 37 year 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: 212AZIA, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site. On an unspecified date, the patient experienced possible counterfeit product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site, and the outcome of possible counterfeit product was not reported. This report was non-serious. This case, involving the same patient is linked to 20211128020. This report was associated with a product quality complaint number 90000202127.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned an elderly female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose and start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: RINVOQ (upadacitinib) (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, after receiving vaccine the patient experienced rheumatoid arthritis flare up. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211135061-COVID-19 VACCINE AD26.COV2.S-Rheumatoid arthritis flare up. This event(s) is considered not related. 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: MEDICAL HISTORY
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 73 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS ON THE SCALP (STARTED ON THE LEFT SIDE OF THE SCALP AND IN DIFFERENT AREAS AND STRETCHED TO THE BACK OF THE SCALP, THE RIGHT SIDE OF THE SCALP NOT AS BAD AS THE LEFT SIDE); This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pain here and there, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced hair loss on the scalp (started on the left side of the scalp and in different areas and stretched to the back of the scalp, the right side of the scalp not as bad as the left side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair loss on the scalp (started on the left side of the scalp and in different areas and stretched to the back of the scalp, the right side of the scalp not as bad as the left side). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: A PUNCTURED VIAL LEFT IN REFRIGERATOR FOR MORE THAN 6 HOURS; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned multiple patients. 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: 211D21A expiry: 04-NOV-2022) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-NOV-2021, the patient experienced medication error. On an unspecified date, the patient experienced a punctured vial left in refrigerator for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and a punctured vial left in refrigerator for more than 6 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE FROM OPENED VIAL WAS ADMINISTERED PAST THE SIX HOUR USE BY TIME FOR OPENED VIALS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-NOV-2021, the patient experienced vaccine from opened vial was administered past the six hour use by time for opened vials. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine from opened vial was administered past the six hour use by time for opened vials was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES ALL OVER MY BODY THAT LASTED ABOUT 3 MONTHS; 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, 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 hives all over my body that lasted about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives all over my body that lasted about 3 months. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES AND PAINS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-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 aches and pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches and pains was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 71 year 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: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211136159.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dysphagia, Dyspnoea, Investigation
Clinical narrative: ORAL PROBLEMS; THROBBING PAIN IN THE RIGHT LOWER JAW GOES DOWN TO THE NECK; SHORTNESS OF BREATH; DIFFICULTY SWALLOWING; SWOLLEN TONGUE; EXTREME PAIN; WEAKNESS/SHE CAN BARELY STAND FOR 2 SECONDS; SWELLING UNDER THE TONGUE (GLANDS); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, difficulty swallowing, swollen tongue, extreme pain, weakness/she can barely stand for 2 seconds, and swelling under the tongue (glands). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and Investigation (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, weakness/she can barely stand for 2 seconds, difficulty swallowing, swollen tongue, extreme pain and swelling under the tongue (glands) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral disorder, Pain, Pain in jaw, Swollen tongue
Clinical narrative: ORAL PROBLEMS; THROBBING PAIN IN THE RIGHT LOWER JAW GOES DOWN TO THE NECK; SHORTNESS OF BREATH; DIFFICULTY SWALLOWING; SWOLLEN TONGUE; EXTREME PAIN; WEAKNESS/SHE CAN BARELY STAND FOR 2 SECONDS; SWELLING UNDER THE TONGUE (GLANDS); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, difficulty swallowing, swollen tongue, extreme pain, weakness/she can barely stand for 2 seconds, and swelling under the tongue (glands). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and Investigation (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, weakness/she can barely stand for 2 seconds, difficulty swallowing, swollen tongue, extreme pain and swelling under the tongue (glands) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: STILL FEEL AWFUL/HAD MY BUTT KICKED; 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 not reported, batch number: Unknown) dose was not reported, administered on 09-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 NOV-2021, the patient experienced still feel awful/had my butt kicked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still feel awful/had my butt kicked. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent by a Business partner (Pfizer Inc.) was received on 12-NOV-2021 and concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20211136270.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid neoplasm, Thyroidectomy
Clinical narrative: Papillary Thyroid Tumor,had 2 nodules measuring 0.2mm and 0.7mm; had a thyroid surgery on 19MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of THYROID NEOPLASM (Papillary Thyroid Tumor, had 2 nodules measuring 0.2mm and 0.7mm) and THYROIDECTOMY (had a thyroid surgery on 19MAR2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced THYROIDECTOMY (had a thyroid surgery on 19MAR2021). On an unknown date, the patient experienced THYROID NEOPLASM (Papillary Thyroid Tumor,had 2 nodules measuring 0.2mm and 0.7mm). At the time of the report, THYROID NEOPLASM (Papillary Thyroid Tumor,had 2 nodules measuring 0.2mm and 0.7mm) and THYROIDECTOMY (had a thyroid surgery on 19MAR2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called to inform that she had a partial thyroidectomy after her first dose of Moderna Covid-19 vaccination. Her first dose was on 19FEB2021, and second dose is 24MAR2021. Per patient her surgeon highly recommended to get the second dose of the vaccination. She was diagnosed with Papillary Thyroid Tumor, and had 2 nodules measuring 0.2mm and 0.7mm. Reports of doing well.  No concomitant was provided.  Treatment medication was not provided.  Company Comment: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history reported, who experienced non serious, unexpected events of Thyroid neoplasm and Thyroidectomy. The event Thyroid neoplasm occurred on an unknown date. Thyroidectomy occurred 1 month 1 day after the first dose of mRNA-1273 vaccine. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Upon internal review on 16-Nov-2021, Company comment was added in the case.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history reported, who experienced non serious, unexpected events of Thyroid neoplasm and Thyroidectomy. The event Thyroid neoplasm occurred on an unknown date. Thyroidectomy occurred 1 month 1 day after the first dose of mRNA-1273 vaccine. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: TIA; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-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 20-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) revealed a stroke which was a TIA..     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. Concomitant medications included diabetic medication, high blood pressure medication and heart disease medication.  Company Comment: This case concerns a 71-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of transient ischaemic attack. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up document contains updated patient demographics, suspect product details, events and narrative.; Sender's Comments: This case concerns a 71-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of transient ischaemic attack. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Dizziness, Erythema, Fatigue
Clinical narrative: hasn't taken second dose yet (more than 42 days following first dose); dizzy; my skin got very red in my arm; my neck was swollen with these lymph nodes; everything was sore leg, belly, breast; everything was sore leg, belly, breast; everything was sore leg, belly, breast; swollen lymph nodes; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast) and ABDOMINAL PAIN (everything was sore leg, belly, breast) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (dizzy). In April 2021, the patient experienced ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast) and FATIGUE (very tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)) and LYMPHADENOPATHY (swollen lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  It was stated that Patient felt dizzy right away after the first shot. Two to 3 days later, patient felt very tired and her skin got very red in the arm, her neck was swollen with these lymph nodes (swollen lymph nodes), and everything was sore (leg, belly, breast). It took a month and a half to have the swollen lymph nodes go away.  Patient had a reaction after the first shot, and she decided to postpone second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information include reporter phone number added, events start date added, event outcome updated and treatment medication added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Product dose omission issue, Swelling
Clinical narrative: hasn't taken second dose yet (more than 42 days following first dose); dizzy; my skin got very red in my arm; my neck was swollen with these lymph nodes; everything was sore leg, belly, breast; everything was sore leg, belly, breast; everything was sore leg, belly, breast; swollen lymph nodes; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast) and ABDOMINAL PAIN (everything was sore leg, belly, breast) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (dizzy). In April 2021, the patient experienced ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ERYTHEMA (my skin got very red in my arm), SWELLING (my neck was swollen with these lymph nodes), BREAST PAIN (everything was sore leg, belly, breast), ABDOMINAL PAIN (everything was sore leg, belly, breast), PAIN IN EXTREMITY (everything was sore leg, belly, breast) and FATIGUE (very tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (hasn't taken second dose yet (more than 42 days following first dose)) and LYMPHADENOPATHY (swollen lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  It was stated that Patient felt dizzy right away after the first shot. Two to 3 days later, patient felt very tired and her skin got very red in the arm, her neck was swollen with these lymph nodes (swollen lymph nodes), and everything was sore (leg, belly, breast). It took a month and a half to have the swollen lymph nodes go away.  Patient had a reaction after the first shot, and she decided to postpone second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information include reporter phone number added, events start date added, event outcome updated and treatment medication added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Noticed few small welts/Getting progressively worse throughout the day; Itchiness; condition worsened; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 09-Nov-2021 contains non significant information, based on previous report additional event of condition worsened were added. Narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past published expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry) had resolved.        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.  It was reported that no patients were immunocompromised and were vaccinated with the primary series over 6 months ago. The narrative stated that Moderna cannot guarantee patients received full protection against the Covid-19 virus on 29-OCT-2021.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: The follow up document was received and Dose 1 and 2 details was added.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: INTERCHANGE OF VACCINE PRODUCTS; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS) 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 INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS) had resolved. Not Provided          No treatment information was provided by the reporter. No Concomitant medicines were reported. Patient had taken Pfizer as one of the COVID-19 immunization doses and patient wanted to know what to take as booster dose  either Moderna or Pfizer .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Headache, Myalgia, Pain, Trigger finger
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (depressed feeling again), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071FZ1A, 027821A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Penicillin) and Food allergy (Chilli). Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (depressed feeling again), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache). The patient was treated with LORAZEPAM at a dose of .5 mg twice a day and DESVENLAFAXINE at a dose of 50 mg. At the time of the report, DEPRESSED MOOD (depressed feeling again) and TRIGGER FINGER (trigger finder which was better was all bent when I woke up) had not resolved and PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375495, MOD-2021-375488, MOD-2021-380319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: significant follow up Included- Concomitant Medicine, Treatment Medicine, Patient Demographis and medical History and also events are Updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depression, Fatigue, Headache, Trigger finger
Clinical narrative: Trigger finger; weepy/crying; sad feeling,Depressed, anxious; little achy,tired,slept all day; headache; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day), HEADACHE (headache) and TRIGGER FINGER (Trigger finger) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder, LORAZEPAM, VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and DESVENLAFAXINE BENZOATE for an unknown indication.   On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day), HEADACHE (headache) and TRIGGER FINGER (Trigger finger). At the time of the report, CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day) and HEADACHE (headache) outcome was unknown and TRIGGER FINGER (Trigger finger) had resolved.            No Treatment Information was provided by the reporter. Patient height 5ft 5 inch and weight 129 Patient had allergy to chilli. Patient went to a neurologist and had an electroencephalogram  Now patient seeking therapy and transcranial magnetic stimulation and breathwork to try to get this under control.   This case was linked to MOD-2021-375416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Patient details, allergy, Product details, concomitant medication added and event headache and Trigger finger added. On 09-Nov-2021: Non-Significant Follow up
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: the first day was horrible, it peaked; sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move; difficult to walk; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever) and CHILLS (chills, could not get warm, bone chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21 and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker, Kikuchi disease (Kikuchi's disorder) and Lumpectomy (breast cancer) (breast lumpectomy (microcalcification),). Concomitant products included CELECOXIB (CELEBREX) for Rheumatoid arthritis, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm). At the time of the report, FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medication contains birth control estradylla (0.25mg/0.035mg) and claritin daily 10mg. No treatment medication reported.   This case was linked to MOD-2021-377785, MOD-2021-377322 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: the first day was horrible, it peaked; sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move; difficult to walk; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever) and CHILLS (chills, could not get warm, bone chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21 and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker, Kikuchi disease (Kikuchi's disorder) and Lumpectomy (breast cancer) (breast lumpectomy (microcalcification),). Concomitant products included CELECOXIB (CELEBREX) for Rheumatoid arthritis, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm). At the time of the report, FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medication contains birth control estradylla (0.25mg/0.035mg) and claritin daily 10mg. No treatment medication reported.   This case was linked to MOD-2021-377785, MOD-2021-377322 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Arthralgia, Chills, Gait disturbance, Headache
Clinical narrative: she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml; sweating, wrenched in sweat; difficult to move; difficult to walk; sore arm; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031M20A and 001B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy (Breast lumpectomy (microcalcification)). Concurrent medical conditions included Smoker and Kikuchi disease. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) for Birth control, CELECOXIB (CELEBREX) for Rheumatoid arthritis, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml). In September 2021, the patient experienced HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and MYALGIA (body aches). On 02-Sep-2021, ACCIDENTAL OVERDOSE (she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml) had resolved. In September 2021, HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and MYALGIA (body aches) had resolved.            Concomitant medication claritin daily 10mg was reported. It was reported that the first day was horrible, it peaked, the second day was not so much, the third had started getting better. PATIENT went down for 48hs in bed.   This case was linked to MOD-2021-377778 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml; sweating, wrenched in sweat; difficult to move; difficult to walk; sore arm; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031M20A and 001B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy (Breast lumpectomy (microcalcification)). Concurrent medical conditions included Smoker and Kikuchi disease. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) for Birth control, CELECOXIB (CELEBREX) for Rheumatoid arthritis, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml). In September 2021, the patient experienced HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and MYALGIA (body aches). On 02-Sep-2021, ACCIDENTAL OVERDOSE (she and her parents got a 0.5ml dose on 02sep21 and then they know that the booster was 0.25ml) had resolved. In September 2021, HYPERHIDROSIS (sweating, wrenched in sweat), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and MYALGIA (body aches) had resolved.            Concomitant medication claritin daily 10mg was reported. It was reported that the first day was horrible, it peaked, the second day was not so much, the third had started getting better. PATIENT went down for 48hs in bed.   This case was linked to MOD-2021-377778 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.  Patient's year of birth was reported .