chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 477Z7, expiry date 7th December 2021) for prophylaxis.   On 11th March 2022, the patient received the 2nd dose of Shingrix. On 11th March 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The case was reported by Medical Assistant. The reporter stated that, the patient was administered expired dose of Shingrix, which led to expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: HEP, HEPA, HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient got an extra dose of Havrix; Patient got an extra dose of Engerix-B and Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (completed primary series in 2018) and Havrix (completed primary series in 2018).   On 10th March 2022, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 4th dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Additional details were provided as follows: The case was reported by Registered Nurse. The reporter stated that, she administered an extra dose of Engerix-B and Havrix to a patient, which led to extra dose administered. The reporter consented to follow up via email. Note: 3rd dose of Havrix was also considered as suspect as only 2 doses are considered in the primary schedule (a single dose and a booster dose). This case is linked with US2022045527, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022045527:Same reporter
Age: 74.0
Sex: M
Vaccine: HEP, HEPA, HEPA
Symptoms: Extra dose administered
Clinical narrative: administered an extra dose; Patient got an extra dose of Engerix-B and Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (completed the primary series in 2018) and Havrix (completed the primary series in 2018).   On 10th March 2022, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 4th dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by Registered Nurse. The reporter stated that, she administered an extra dose of Engerix-B and Havrix to a patient, which led to extra dose administered. The reporter consented to follow up via email. Note: 3rd dose of Havrix was also considered as suspect as only 2 doses are considered in the primary schedule (a single dose and a booster dose). This case is linked with US2022045525, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022045525:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Grip strength decreased, Mass, Nodule, Osteoarthritis
Clinical narrative: PSORIATIC ARTHRITIS AGGRAVATED, INFLAMMATION, SKIN BREAKOUT; SINUS INFECTION; HAND OSTEOARTHRITIS; NODULE ON FINGER; MASS; ERYTHEMA OF EXTREMITIES, RED HANDS; GRIP STRENGTH DECREASED; THROAT INFECTION; This spontaneous report received from a patient via other company (Abbvie) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total administered on 20-MAR-2021 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: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis aggravated, inflammation, skin breakout, sinus infection, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, grip strength decreased, and throat infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from sinus infection, and throat infection, and had not recovered from psoriatic arthritis aggravated, inflammation, skin breakout, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, and grip strength decreased. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220320480-covid-19 vaccine ad26.cov2.s- Psoriatic arthritis aggravated.The event(s) has a unknown/unclear  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.This event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Psoriatic arthropathy, Sinusitis
Clinical narrative: PSORIATIC ARTHRITIS AGGRAVATED, INFLAMMATION, SKIN BREAKOUT; SINUS INFECTION; HAND OSTEOARTHRITIS; NODULE ON FINGER; MASS; ERYTHEMA OF EXTREMITIES, RED HANDS; GRIP STRENGTH DECREASED; THROAT INFECTION; This spontaneous report received from a patient via other company (Abbvie) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total administered on 20-MAR-2021 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: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis aggravated, inflammation, skin breakout, sinus infection, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, grip strength decreased, and throat infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from sinus infection, and throat infection, and had not recovered from psoriatic arthritis aggravated, inflammation, skin breakout, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, and grip strength decreased. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220320480-covid-19 vaccine ad26.cov2.s- Psoriatic arthritis aggravated.The event(s) has a unknown/unclear  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.This event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass, Muscular weakness, Vaccination site pain, Vertigo
Clinical narrative: EXTREME VERTIGO; HARD SPOT AT INJECTION SITE; ARM WAS WEAK; INJECTION SITE PAINFUL 10 MONTHS LATER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced extreme vertigo, arm was weak, hard spot at injection site, and injection site painful 10 months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme vertigo, and the outcome of arm was weak, injection site painful 10 months later and hard spot at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that the patient had to have heart surgery after taking the vaccine and it was also started by the reporter that, "I just had a friend who just had to have heart surgery after taking that stupid shot that not was really even affective all took the shots were the one getting the virus an yaw got sued mega million dollars cause the shot an your talcum powder". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart surgery was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000221486. Sender's Comments: V0 20220325588-COVID-19 VACCINE AD26.COV2.S-heart surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: This solicited report received from a consumer. Analysis to support the Real time signal evaluation in response to ongoing routine PV monitoring "PRIVATE" concerned a 27 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 received J &J vaccine 2 weeks prior presenting to emergency department. Three days prior the patient noticed petechiae on legs and followed up with primary care physician and referred to hematologist after platelets were drawn and were less than 1000. Hematology department again redraw and was 2000. Hematology then send to emergency department and requested starting IVIG (Intravenous immunoglobulin) and to be admitted. Received IVIG (Intravenous immunoglobulin). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute idiopathic thrombocytopenic purpura was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s, and acute idiopathic thrombocytopenic purpura as related. The company causality between Covid-19 vaccine ad26.cov2.s, and acute idiopathic thrombocytopenic purpura as related This report was serious (Other Medically Important Condition). Sender's Comments: V0-20220326336-Covid-19 vaccine ad26.cov2.s- Acute idiopathic thrombocytopenic purpura. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer via a company representative via social media (JNJ Corporate) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with Covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died due to unspecified cause of death (dose number in series 2). The reporter stated that, "My ex and his brother both died from getting the J&J booster". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220327356. Sender's Comments: V0: 20220327268-covid-19 vaccine ad26.cov2.s-death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20220316156.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS/BAD COLD TYPE SYMPTOMS/FEVERISH/HEADACHE/SICKNESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient went to the hospital because he felt like he had a bad cold. He was quarantined for 12 days. He was tested (Q-tip up the nose) positive, but he felt he was misdiagnosed. Symptoms of Covid went away 2 days into quarantine. He was at a party in close contact with a number of friends and none of them got Covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 20-DEC-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient experienced flu like symptoms/bad cold type symptoms/feverish/headache/sickness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Felt like a temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms/bad cold type symptoms/feverish/headache/sickness on 19-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: RECEIVED 6 JOHNSON AND JOHNSON COVID-19 VACCINES; OFF LABEL USE; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced received 6 johnson and johnson covid-19 vaccines, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 6 Johnson and Johnson covid-19 vaccines and off label use was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 49 year old male of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 18-DEC-2021) dose was not reported, 1 total, administered at left arm on 07-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 08-JUL-2022) dose was not reported, 1 total, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient took Binax now at home test Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) and tested positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20220331195.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was 1.5 weeks pregnant at the time of vaccination and had a perfectly healthy full-term baby 9 months later. Patient had no reactions or side effects from the vaccine. The patient was gravida 1, para 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a live birth. The patient gave birth to a baby of unspecified sex. Birth outcome was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astra Zeneca Vaccine on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with Astra Zeneca Vaccine.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary Series of Moderna Vaccine received after  patient received a different Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-507124 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Two hours after the shot the patient patient had overall body chills that stayed with her for several hours.; Right arm injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Two hours after the shot the patient patient had overall body chills that stayed with her for several hours.) and VACCINATION SITE PAIN (Right arm injection site was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Two hours after the shot the patient patient had overall body chills that stayed with her for several hours.). 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Right arm injection site was sore). On 02-Feb-2021, CHILLS (Two hours after the shot the patient patient had overall body chills that stayed with her for several hours.) had resolved. At the time of the report, VACCINATION SITE PAIN (Right arm injection site was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-507441 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up received contains non-significant information: Date of administration of first dose was amended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: overall body chills that stayed with her for several hours.; Right arm injection site was sore.; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (overall body chills that stayed with her for several hours.) and VACCINATION SITE PAIN (Right arm injection site was sore.) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 013M20A, 012M20A and 939906) for an unknown indication.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (overall body chills that stayed with her for several hours.) and VACCINATION SITE PAIN (Right arm injection site was sore.). At the time of the report, CHILLS (overall body chills that stayed with her for several hours.) had resolved and VACCINATION SITE PAIN (Right arm injection site was sore.) outcome was unknown.            Concomitant and treatment medication was not reported. The patient reports no adverse events or side effects after the Moderna COVID-19 booster dose.   This case was linked to MOD-2022-507429 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills all over his body lasting for several hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills all over his body lasting for several hours) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills all over his body lasting for several hours). On 02-Mar-2021, CHILLS (chills all over his body lasting for several hours) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown. The patient received the Moderna COVID-19 vaccine on 22-Nov-2021 with lot number 939906 with no expiration date. The patient received the booster dose in his right arm shoulder deltoid muscle as an intramuscular injection. The patient reported no adverse event.   This case was linked to MOD-2022-507456 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2022: Follow up received included the corrected year as 2021 instead of 2022 in the mail
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: My daughter got the Moderna vaccination & she still got Omicron.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.). At the time of the report, COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient had unknown allergies. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Company Comment: This spontaneous case concerns a female patient of unknown age, with unknown medical history, who experienced the unexpected non-serious AESI of COVID-19, Omicron variant. The event occurred unknown number of days after receiving a dose of mRNA-1273 vaccine, dose number unknown. As reported, patient had a COVID positive test or diagnosis at an unknown date. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with unknown medical history, who experienced the unexpected non-serious AESI of COVID-19, Omicron variant. The event occurred unknown number of days after receiving a dose of mRNA-1273 vaccine, dose number unknown. As reported, patient had a COVID positive test or diagnosis at an unknown date. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Paraesthesia
Clinical narrative: after 2nd dose, I got tingling a week later/experiencing tingling of her left foot, closer to the little toe and running on the left side of the foot; after 2nd dose, I got numbness a week later/experiencing numbness of her left foot, closer to the little toe and running on the left side of the foot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (after 2nd dose, I got tingling a week later/experiencing tingling of her left foot, closer to the little toe and running on the left side of the foot) and HYPOAESTHESIA (after 2nd dose, I got numbness a week later/experiencing numbness of her left foot, closer to the little toe and running on the left side of the foot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa medictaions). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Sep-2021, the patient experienced PARAESTHESIA (after 2nd dose, I got tingling a week later/experiencing tingling of her left foot, closer to the little toe and running on the left side of the foot) and HYPOAESTHESIA (after 2nd dose, I got numbness a week later/experiencing numbness of her left foot, closer to the little toe and running on the left side of the foot). At the time of the report, PARAESTHESIA (after 2nd dose, I got tingling a week later/experiencing tingling of her left foot, closer to the little toe and running on the left side of the foot) and HYPOAESTHESIA (after 2nd dose, I got numbness a week later/experiencing numbness of her left foot, closer to the little toe and running on the left side of the foot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Electromyogram: insignificant insignificant.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she did not experience numbness and tingling right away with the second  dose. However, she received  those symptoms a week later. She said that the symptoms had been on and off since OCT2021 and she still had them in her left foot. Even while on the call, she was experiencing numbness and tingling of her left foot, closer to the little toe and running on the left side of the foot. No Treatment information was reported.   This case was linked to MOD-2022-507583 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: daughter got killed from the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (daughter got killed from the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Reporter stated that patient got killed from the Moderna vaccine.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death after administration of an unspecified dose of the Moderna mRNA-1273 vaccine on an unspecified date. The reporter stated that her 'entire world is destroyed my daughter got killed from the Moderna vaccine'. The patient passed away on an unspecified date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death after administration of an unspecified dose of the Moderna mRNA-1273 vaccine on an unspecified date. The reporter stated that her 'entire world is destroyed my daughter got killed from the Moderna vaccine'. The patient passed away on an unspecified date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during breast feeding
Clinical narrative: COVID Infection about 6 months after 2nd shot; Breastfeeding when received the second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID Infection about 6 months after 2nd shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (She delivered a healthy (9 months) baby on 18APR2021) on 18-Apr-2021.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot). In December 2021, the patient experienced COVID-19 (COVID Infection about 6 months after 2nd shot). In May 2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot) had resolved. At the time of the report, COVID-19 (COVID Infection about 6 months after 2nd shot) outcome was unknown.            No concomitant medication reported. No treatment medication reported.  It was reported that the patient was not hospitalized because of infection.  COMPANY COMMENT : This maternal exposure during pregnancy case reported by the spontaneous concerns a 39-year-old female patient, with medical history of Pregnancy (She delivered a healthy 9 months baby) on 18APR2021, who experienced the unexpected non serious event of covid- 19, which occurred 6 months after second dose of mRNA-1273 vaccine. Maternal exposure during breast feeding also reported.was not added as no proper start date of 1st dose was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-508309, MOD-2022-508349 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This maternal exposure during pregnancy case reported by the spontaneous concerns a 39-year-old female patient, with medical history of Pregnancy (She delivered a healthy 9 months baby) on 18APR2021, who experienced the unexpected non serious  event of covid- 19, which occurred 6 months after second dose of mRNA-1273 vaccine. Maternal exposure during breast feeding also reported. was not added as no proper start date of 1st dose was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator 26 Jan 2022,and administered on 03 March 2022.; 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26 Jan 2022,and administered on 03 March 2022.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26 Jan 2022,and administered on 03 March 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26 Jan 2022,and administered on 03 March 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The vial was initially stored in the refrigerator on 26 Jan 2022. No treatment medication were reported.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients received a Moderna vaccine past the 30 day use by date; Patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (Patients received a Moderna vaccine past the 30 day use by date) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a Moderna vaccine past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients received a Moderna vaccine past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (Patients received a Moderna vaccine past the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. On 26-Jan-2022 vial was stored in refrigerator Reporter stated not sure the temperature excursion was happened or not Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator 26-Jan-2022; 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 26-Jan-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 26-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 26-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Elevated Heart rate/ Heart rate high; Dizziness; First dose janssen and second dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (Dose1 with Batch no as 1805022 reported and Action taken was given as Not applicable.). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine). At the time of the report, HEART RATE INCREASED (Elevated Heart rate/ Heart rate high), DIZZINESS (Dizziness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose janssen and second dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (High) Elevated.         No concomitant medications reported  It was unknown if any adverse reactions took place after Dose 1.  No Treatment medications reported