chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Swollen tongue
Clinical narrative: her tongue was swollen; swollen lymph glands; Initial information regarding an unsolicited valid non-serious case was received from consumer via Medical Information (Reference number- 00746458) and transmitted to Sanofi on 30-Aug-2021.  This case involves a 60-year-old female patient who experienced her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
Sex: M
Vaccine: IPV
Symptoms: Contusion, Product storage error, Vaccination complication
Clinical narrative: Red bruise for quite awhile; Vaccine exposed at 54.5 degree Fahrenheit and was out of range for 1 hour; Initial information regarding an unsolicited valid non-serious case was received from consumer via Agency (Reference number- 00748555) and transmitted to Sanofi on 31-Aug-2021.   This case involves a six-month-old male patient who experienced red bruise for quite awhile (contusion) and reported vaccine exposed at 54.5-degree Fahrenheit and was out of range for 1 hour (product storage error) while receiving IPV (VERO) [IPOL].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE for prophylactic vaccination.  On 26-Jul-2021, the patient received a (total, once) dose of suspect IPV (VERO) [lot number and expiry date not reported] via unknown route in the left thigh for prophylactic vaccination.  On 26-Jul-2021, the patient developed non-serious red bruise for quite awhile (contusion) and reported vaccine exposed at 54.5-degree Fahrenheit and was out of range for 1 hour (product storage error) on the same day following the administration of IPV (VERO).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel was administered / no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Medical Information (Reference number- 00748845)  This case is linked to 00748869 (same reporter).  This case involves a three-year-old female patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.  On 06-Aug-2021, the patient received a fourth dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5643AA and expiry date: 17-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse reports that expired DAPTACEL was administered to 2 patients. Nurse asks if there are any recommendations for when expired DAPTACEL is administered."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA290302:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL vaccine was given with no reported adverse event; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age and gender patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 29-Jul-2021, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number-UJ349AA, expiry date-22-Jun-2022) via an unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported that, "Caller stated that a 2-month-old patient was given the Ipol and dtap portion of product and not the Acthib. Caller wanted to know if the ActHIB can be given separately. She also wanted to know if there was any concerns of not given the product with Act-Hib".  It was a case of actual medication error due to expired vaccine used (latency-same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: some vaccine left in the vial and that he hadn't received all of it/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-Sep-2021 from a Physician via Agency (Reference number- 00750478) and transmitted to Sanofi on 01-Sep-2021.  This case involves a one-year-old male patient who reported some vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] left in the vial and that he hadn't received all of it with no reported adverse event (Underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications VARICELLA ZOSTER VACCINE LIVE (OKA) (VARICELLA BIKEN) for prophylactic vaccination, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination and PNEUMOCOCCAL VACCINE (PNEUMOCIN [PNEUMOCOCCAL VACCINE]) for prophylactic vaccination.  On 13-Aug-2021, the patient received a 0.5 ml (total) [1X(Once)] dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ464AB and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported, "That her son received a PENTACEL vaccination on 13AUG2021 and was contacted 13 days later and informed that the vaccine was expired. Caller states that she called back to confirm that product was expired and that she was told that the product was not expired. At this time, she was told that there was still some vaccine left in the vial and that he hadn't received all of it but that the product was not expired. Caller states that she has the lot number and would like to determine the expiration date. Caller also asked about the need to revaccinate her son if the product was expired or if he did not receive all of it. "  It was case of an actual medication error due to vaccine underdose (latency was on the same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 41.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site bruising
Clinical narrative: Bruising at the injection site; This spontaneous case was received on 27-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01760) and concerned 41-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 26-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose: 0.5 ml and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported. It was administered by the site nurse in the on-site clinic.  On 27-Aug-2021 in the morning, one day after receiving Flucelvax Quadrivalent, while getting ready for work the patient realized there was bruising at the injection site. He was not experiencing any other issues.   At the time of initial reporting on 27-Aug-2021, the patient had not recovered from the event of 'vaccination site bruising'.  The reporter did not provide causality assessment.   The reporter assessed the case non-serious.  Company comment: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.; Sender's Comments: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other AE reported; received the second dose of GARDASIL 9 on 30-JUL-2021/received the third dose of GARDASIL 9 on 12-AUG-2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 30-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.    On 12-AUG-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T028583, expiration date 04-MAR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, which was given too soon after the second dose (inappropriate schedule of product administration). No other adverse event was reported. No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This case was reported by a consumer via media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. A patient got shingles shot and less than a week later she had a stroke.  The reporter showed her an article warning of risk of strokes. When the patient confronted, the physician admitted the risk which he had not mentioned to her. But he said there was no way to prove the stroke was from the shot.  The reporter said that the patient said could you blame for wondering. No contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo has not resolved; This case was reported by a consumer and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received Shingrix (intramuscular). On 20th August 2021, 2 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee for a friend. The age at vaccination was not reported. The patient's DOB  (date of birth) was unknown by the reporter. The patient received the dose of Shingrix in unknown arm and 2 days after the vaccination the patient experienced vertigo. The reporter and patient gave permission to be contact by GlaxoSmithKline. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced incorrect product storage. On 02-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm
Clinical narrative: ABDOMINAL ANEURYSM; This spontaneous report received from a patient via a company representative concerned a 30 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not had any drug abuse, or illicit drug usage. The patient did not had any drug consumption and did not had any histories of anything related to this. Patient was healthy women. The Patient did exercise often. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose,1 total, 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 abdominal aneurysm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal aneurysm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210907837-covid-19 vaccine ad26.cov2.s-abdominal aneurysm. This event(s) is considered unassessable. 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).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 63 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: unknown) dose was not reported, frequency time 1 total administered at left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient had done blood test for antibodies which was found to be negative (confirmed immunological vaccination failure). She had no side effects from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000192172.; Sender's Comments: V0: 20210907895-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccination failure. 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: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAY-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 got the corona virus after the vaccine and the only reason patient know was because patient thought that patient caught the sniffles from patient's grandchild (suspected covid-19 infection). Patient's symptoms had been mild 102 fever for one night then feeling normal most of the day until 16:00. Patient did get tired early. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 fever. Patient was 7 days in and patient feels that patient has been 95 % back to normal but not taste. Lost taste on day 4. Patient had zero initial side effects after vaccination, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192284; Sender's Comments: V0: 20210908721-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: DIFFICULTY BREATHING; HEADACHES (NOT THAT BAD); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic back pain, non-alcohol user, cigarette smoker, liver problem, chronic obstructive pulmonary disease (copd), and sulfa allergy, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced headaches (not that bad). On 04-SEP-2021, the patient experienced difficulty breathing. The action taken with covid-19 vaccine was not applicable. The outcome of the difficulty breathing and headaches (not that bad) was not reported. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination complication
Clinical narrative: battle between Antibodies in patient body and vaccine antibody; Mini-COVID for 24 hours; This spontaneous case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   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. In 2021, the patient experienced VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody). On an unknown date, the patient experienced SUSPECTED COVID-19 (Mini-COVID for 24 hours). At the time of the report, SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP described as vaccination reaction as a modified reaction of COVID-19. Concomitant medications were not provided. Treatment medication was not provided.   This case was linked to MOD-2021-294336 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Non-significant follow up information included patient demographic details. On 30-Aug-2021: Vaccination reaction Event added
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain; First dose on 14-MAY-2021/ patient didn't receive the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain). At the time of the report, PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) had not resolved and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Patient  saw a hematologist, the pain in her arm and leg was so great she thought it was thrombosis, but it was not. She is still has a lot of pain. On 29-Sep-2021 she has an appointment with a new GP since hers did not help her and said she should return in 6 months, she is also trying to see a neurologist.  she did not receive the 2nd dose.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SERTRALINE, ATORVASTATIN, OLANZAPINE, CLONIDINE HYDROCHLORIDE (CLONIDINE [CLONIDINE HYDROCHLORIDE]) and CARVEDILOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). The patient was treated with ECONAZOLE NITRATE (ECONAZOLE [ECONAZOLE NITRATE]) (topical) for Rash, at an unspecified dose and frequency and FLUOCINONIDE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication also included supplements.  The patient received second dose of the vaccine in mid February.   This case was linked to MOD-2021-294486 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: arm was sore, similar as previous vaccination; minimum swelling; soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness). At the time of the report, PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was  not provided.   This case was linked to MOD-2021-294360 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tremor
Clinical narrative: shaking for 24 hours; a terrible fever for 24 hours; very tired for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient says he had Covid on Christmas 2020 for 2 days , It was mild.) on 25-Dec-2020.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours). At the time of the report, TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided treatment information was not provided   This case was linked to MOD-2021-294606 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: reaction to it was a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, 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 experienced VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) outcome was unknown.            Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-294926, MOD-2021-294965 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body Aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  No side effects were reported with the first dose of the vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Myalgia, Pyrexia
Clinical narrative: Nose bleed; Chills; Body aches; Fever; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Nose bleed), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). On 24-Aug-2021, the patient experienced EPISTAXIS (Nose bleed). At the time of the report, EPISTAXIS (Nose bleed) had resolved and CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication were not reported.   No treatment medication were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: FU received on 24-AUG-2021 contains No new information
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medication details were not provided by the reporter.  On 05 Aug 2021, patient received antibodies treatment. He is due for the second dose of the vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Excruciating pain; Muscle weakness; Excruciating pain started on her neck; Excruciating pain in back/excruciating pain in multiple spots in her back; Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers; It is so bad she can barely move; Excruciating pain in shoulder; Muscle pain/muscle burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back) and PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (High blood pressure), Genital tract inflammation (GTI) and Pain. Concomitant products included LABETALOL for Hypertension.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning). At the time of the report, PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included patient was on antibiotic for GTI and on medication for the pain.  It was stated that since the following Monday 16-Aug-2021 or Tuesday 17-Aug-2021 (patient did not remember which day) she has been experiencing excruciating pain, muscle pain and burning and weakness, starting on her neck, shoulder, then her back (multiple spots in her back), legs, hands and fingers. On a scale from 1 to 10 (where 10 was the worst pain a person could feel) she would describe her pain as a 12. It was so bad she could barely move and it was not getting any better.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Excruciating pain; Muscle weakness; Excruciating pain started on her neck; Excruciating pain in back/excruciating pain in multiple spots in her back; Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers; It is so bad she can barely move; Excruciating pain in shoulder; Muscle pain/muscle burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back) and PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (High blood pressure), Genital tract inflammation (GTI) and Pain. Concomitant products included LABETALOL for Hypertension.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning). At the time of the report, PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included patient was on antibiotic for GTI and on medication for the pain.  It was stated that since the following Monday 16-Aug-2021 or Tuesday 17-Aug-2021 (patient did not remember which day) she has been experiencing excruciating pain, muscle pain and burning and weakness, starting on her neck, shoulder, then her back (multiple spots in her back), legs, hands and fingers. On a scale from 1 to 10 (where 10 was the worst pain a person could feel) she would describe her pain as a 12. It was so bad she could barely move and it was not getting any better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: legs were hurting as if she had restless leg syndrome; legs were hurting as if she had restless leg syndrome; could not get out of bed; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Concomitant medications were provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and MELOXICAM for Adverse event, at a dose of 15 milligram. At the time of the report, last episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-295607, MOD-2021-295431 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: my knees swell incredibly; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (my knees swell incredibly) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Seasonal allergy and Shellfish allergy. Concomitant products included LISINOPRIL for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced JOINT SWELLING (my knees swell incredibly). The patient was treated with PREDNISONE at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (my knees swell incredibly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-295813 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased, Panic attack, Tachycardia
Clinical narrative: kind of panicking; The heart is elevated, but not a whole lot; Thought that it was anxiety; felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again), HEART RATE INCREASED (The heart is elevated, but not a whole lot), ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), MAGNESIUM, ZINC and NICOTINIC ACID (B3 NIACIN) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and ANXIETY (Thought that it was anxiety). On 24-Aug-2021, the patient experienced HEART RATE INCREASED (The heart is elevated, but not a whole lot). On 25-Aug-2021, the patient experienced PANIC ATTACK (kind of panicking). At the time of the report, TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and HEART RATE INCREASED (The heart is elevated, but not a whole lot) had not resolved and ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) the heart is elevated, but not a whole lot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Women's multivitamins. No treatment details were reported.  It was stated that she has a Whoop band that tracks the heart rate during exercise and every time she felt like her heartbeat was elevated. She was planning on going to the doctor today