chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Thought she was going to faint; Took Tylenol felt "really bad"/Still a little bad; could not do anything that day; Headache; Body aches; Stomach ache; she was sick with a fever; Skin was warm/Fever; skin was warm; She felt chilly; Body weakness/ little weak; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for product used for unknown indication.   The patient's past medical history included shingles (shingles outbreak in (around August 2021)- painful rash) and painful rash. Concurrent medical conditions included post herpetic neuralgia (post-herpetic neuralgia (PHN)- intermittent).   On 13th April 2022 15:00, the patient received the 1st dose of Shingrix. In April 2022, the patient started Tylenol at an unknown dose and frequency. On 14th April 2022, 1 days after receiving Shingrix, the patient experienced activities of daily living impaired and feeling bad. In April 2022, the patient experienced sickness, fever, skin warm, chilliness, weakness generalized, headache, general body pain and stomach pain. On 15th April 2022, the patient experienced felt faint. The action taken with Tylenol was unknown. On an unknown date, the outcome of the sickness, chilliness, weakness generalized, general body pain and stomach pain were recovered/resolved and the outcome of the fever, skin warm, activities of daily living impaired, headache, feeling bad and felt faint were unknown.   It was unknown if the reporter considered the sickness, headache and feeling bad to be related to Shingrix. The reporter considered the fever, skin warm, chilliness, weakness generalized, activities of daily living impaired, general body pain, stomach pain and felt faint to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: The case was reported by the patient.  The patient did not have the lot number or expiration date of the injection but did provide the contact information for the pharmacy where she received the shot. The patient had the shot around 3:00 in the afternoon and felt fine until around midnight/early in the morning and then she thought that, something was wrong with her.  The patient did not take her temperature but felt like she was sick with a fever, her skin was warm and she felt chilly.  She had to use an electric blanket (to keep warm). She also experienced body weakness, headache, body aches and stomach ache. She took Tylenol.  She felt really bad on 14th April 2022 and could not do anything that day.  On 15th April 2022, she felt better but she was still a little weak, still a little bad. She felt like she thought that, she was going to faint.  After receiving Tylenol, the patient experienced activities of daily living impaired, feeling bad and felt faint. It was unknown if the reporter considered the activities of daily living impaired, feeling bad and felt faint to be related to Tylenol. The reporter consented to follow up.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 7 year old female patient received a dose; Patient's 4th dose of DTAP in the schedule.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 1st, 2nd and 3rd dose on an unknown date).   On 22nd April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 22nd April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too long. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comments: A physician assistant reported that a 7 year old female patient received a dose of Infanrix. It was the patient's 4th dose of DTAP in the schedule. The reporter consented to follow up. Additional Supportive Information: The 7 year old patient received 4th dose of Infanrix, which led to inappropriate age at vaccine administration and lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st dose on 2019 not received her 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The case was reported by the patient. The patient stated that, she was scheduled to receive her first Nucala injection in about a week.  The patient did not receive her second dose of the Shingrix vaccine. The reporter provided permission to contact healthcare professional but disconnected call before any details could be obtained. No additional details were provided by the patient. The reporter consented to follow up. Additional Supportive Information: The patient did not receive her second dose of the Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: received adult dose instead of pediatric; received adult dose instead of pediatric; This case was reported by a pharmacist and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult use of a child product. On an unknown date, the outcome of the overdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The case was reported by patient's parent. The patient received ENGERIX-B VACCINE adult dose instead of the pediatric dose. The reporter would like to know what she should do. The reporter did not have expiry date of vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received adult dose instead of the pediatric dose which led to overdose and adult use of a child product.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash erythematous
Clinical narrative: Rash is red; Rash is very itchy; Burns, Still has burning pain; Is painful, Still has burning pain; Still has the itching; Suspected vaccination failure/Both doses in 2018, now experiencing a mild case; Experiencing a mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In April 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced red rash, itchy rash, burning sensation, pain burning and pruritus. The patient was treated with aloe barbadensis (Aloe Vera) and lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, itchy rash, burning sensation, pain burning and pruritus were not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the red rash, itchy rash, burning sensation, pain burning and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 26-Apr-2022 and 28-Apr-2022 Reporter's comment: The caller was the patient. The caller reported that she received both doses of Shingrix in 2018 and was believing that they were experiencing a mild case of shingles. In April 2022, the shingles episode began approximately 10 days ago.   The caller reported that she had a rash the covers the left side of the thoracic area down to the umbilicus and wraps around to the left side of the back, left shoulder and in the left ear.  The rash was red, very itchy, burns, and was painful.  The caller reported that she was using Lidocaine and real aloe very to reduce symptoms. The caller reported had appointments with a dermatologist and their general practitioner for the day of reporting, to confirm the diagnosis. Consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Vaccination failure
Clinical narrative: Rash is red; Rash is very itchy; Burns, Still has burning pain; Is painful, Still has burning pain; Still has the itching; Suspected vaccination failure/Both doses in 2018, now experiencing a mild case; Experiencing a mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In April 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced red rash, itchy rash, burning sensation, pain burning and pruritus. The patient was treated with aloe barbadensis (Aloe Vera) and lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, itchy rash, burning sensation, pain burning and pruritus were not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the red rash, itchy rash, burning sensation, pain burning and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 26-Apr-2022 and 28-Apr-2022 Reporter's comment: The caller was the patient. The caller reported that she received both doses of Shingrix in 2018 and was believing that they were experiencing a mild case of shingles. In April 2022, the shingles episode began approximately 10 days ago.   The caller reported that she had a rash the covers the left side of the thoracic area down to the umbilicus and wraps around to the left side of the back, left shoulder and in the left ear.  The rash was red, very itchy, burns, and was painful.  The caller reported that she was using Lidocaine and real aloe very to reduce symptoms. The caller reported had appointments with a dermatologist and their general practitioner for the day of reporting, to confirm the diagnosis. Consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: PEDIATRIC dose of ENGERIX B was given to an adult; PEDIATRIC dose of ENGERIX B was given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number J7H4d, expiry date 23rd March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th December 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 20th December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The adult patient received a pediatric dose of Engerix B in right deltoid. Additional Supportive Information: The adult patient received a pediatric dose of Engerix B, which led to adult use of a child product and underdose.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Flu like symptoms; Arm pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm and headache. On an unknown date, the outcome of the influenza-like symptoms, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient's wife reported the case. The reporter stated that, the patient had flu-like symptoms, arm pain, and a headache after receiving his Shingrix vaccine. No further information was provided. The reporter did not give consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a consumer 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: ADMINISTERED TO A 14 YEARS OLD; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 31-JAN-2022 for prophylactic vaccination. Age at time of vaccination 14 years old. No concomitant medications were reported.  On 31-JAN-2022, the patient experienced administered to a 14 years old, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered to a 14 years old and off label use was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients. Number of doses/vials: 22 The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions. In Apr-2022, patient received second booster dose which was expired on 27-Mar-2022. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information. On 28-Apr-2022: Follow-up received included significant information wherein reporter, patient, suspect information updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 016B21A, 016C21A and 027H21B) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Pre-diabetes, Osteoporosis and Osteopenia. Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg). At the time of the report, ARTHRITIS (aggravated her arthritis,severe swelling in the joints,knee swelled,can't use the left leg) outcome was unknown.            Patient take healthy diet. Patient reported that she did not take any medication and had to ice it.  Company comment: This case concerns a 55-year-old female patient, with reported relevant medical history of Rheumatoid Arthritis, who experienced, unexpected, non-serious, AESI of Arthritis (reported as Aggravated her Arthritis), the same day after receiving mRNA-1273 vaccine as a second booster dose. It was reported that the patient had swelling of joints, was not able to use her left leg, and had to ice it. The outcome of the event was unknown. The patient's relevant history of Rheumatoid Arthritis remains to be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This case concerns a 55-year-old female patient, with reported relevant medical history of Rheumatoid Arthritis, who experienced, unexpected, non-serious, AESI of Arthritis (reported as Aggravated her Arthritis), the same day after receiving mRNA-1273 vaccine as a second booster dose. It was reported that the patient had swelling of joints, was not able to use her left leg, and had to ice it. The outcome of the event was unknown. The patient's relevant history of Rheumatoid Arthritis remains to be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Had covid after the first 2 doses of moderna vaccine; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046E21A) for COVID-19 vaccination.     It was reported that the patient has no allergies.  Concomitant products included SERTRALINE for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         Birth control was also reported as concomitant medication. No treatment medication was reported. Company comment:This spontaneous case concerns a 28 year old female with no reported medical history, who experienced the unexpected, non-serious ADR of COVID-19. The event occurred approximately 7 months after receiving a dose of mRNA1273 as second dose of COVID-19 vaccine. This was supported by the positive SARS-COV-2 Antibody test. The patient received both the doses of primary vaccination series from Moderna within 28 days from each other. The clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28 year old female with no reported medical history, who experienced the unexpected, non-serious ADR of COVID-19. The event occurred approximately 7 months after receiving a dose of mRNA1273 as second dose of COVID-19 vaccine. This was supported by the positive SARS-COV-2 Antibody test. The patient received both the doses of primary vaccination series from Moderna within 28 days from each other. The clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 23-Nov-2021 and administered on 26-Apr-2022 12 hours post puncture; Expired dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 23-Nov-2021 and administered on 26-Apr-2022 12 hours post puncture) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 4:30 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022 at 4:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 23-Nov-2021 and administered on 26-Apr-2022 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 23-Nov-2021 and administered on 26-Apr-2022 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 23 Nov 2021 estimate. It was unknown when vial was first punctured. On 26 Apr 2022 4:30 PM the vaccine was administered. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The vial was expired and sitting in box for 4.5 months. About 4.5 months the vial was exposed to room temperature range (8° to 25°C, 46° to 77°F). No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored Moderna vaccine in their refrigerator and administered past the BUD date; BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Vaccination site rash, Vaccination site swelling
Clinical narrative: Macular rash right arm Injection Site after second shot; Swelling right arm Injection Site after second shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) and VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Immune disorder (NOS). Concurrent medical conditions included ANA (Positive) since 1988.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) and VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot). The patient was treated with IBUPROFEN at a dose of 100 milligram. On 23-Mar-2021, VACCINATION SITE RASH (Macular rash right arm Injection Site after second shot) had resolved. On 23-Apr-2021, VACCINATION SITE SWELLING (Swelling right arm Injection Site after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal and normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician prescribed an EpiPen for the 2nd dose.  The patient used cold compress as treatment.   This case was linked to MOD-2022-551364, MOD-2022-551605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Follow up included Laboratory.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Fatigue, Vaccination site rash
Clinical narrative: A little Fluidy Macular Rash left arm Injection Site after booster; really tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster) and FATIGUE (really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36D21A, 040A21A and 03120A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS) (Positive ANA since 1988 and very immune reactive).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (really tired). On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster). The patient was treated with IBUPROFEN at a dose of 100 milligram. In October 2021, VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster) had resolved. At the time of the report, FATIGUE (really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) abnormal and abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient had a little Fluidy Macular rash on the left arm injection site. Thee patient took Pediatric Ibuprofen 100mg and used Ice on the area. Finally after 2-3 days it resolved.  Patient used Ice on the area where had a little fluidly macular rash on the left arm injection site. . Patient believed patient could had myocarditis or pericarditis and that unusual things were happening.  On Nov/Dec patient was really tired when patient  "was not usually" tired and patient  "never though about the time frame of the Eco's related to the booster dose".   This case was linked to MOD-2022-551364, MOD-2022-551599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Follow-up received, contains new events of tiredness added, laboratory test added and narrative updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after having the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after having the vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Jul-2021 The patient died on 17-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  Reporter was not the only one with this issues, (liver discomfort) that he had family members, and people in his social networks that had the same issue after the second dose of the Moderna COVID-19 vaccine.   No treatment medications was reported.  Company Comment: This spontaneous case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred approximately 6 months after receiving an unspecified dose of the mRNA-1273 vaccine. The reporter stated that his father died after having the vaccine. No further details were provided. It was reported that the patient expired on 17Jul2021 and the cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-551786 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred approximately 6 months after receiving an unspecified dose of the mRNA-1273 vaccine. The reporter stated that his father died after having the vaccine. No further details were provided. It was reported that the patient expired on 17Jul2021 and the cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored greater than 12 hours post-puncture; 3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 11:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 11:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 22 Apr 2022 Date and time vial was first punctured on  22 Apr 2022 at 9:55 AM. The vial stored post puncture in  Refrigerator. The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C/46° to 77°F): 1.5-hours on  26 Apr 2022. No concomitant medication were provided No treatment details were provided Product used   This case was linked to MOD-2022-551983, MOD-2022-551989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow up received: Added suspect details, event onset date  and updated narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: After getting the 2nd dose of the vaccine she "blacked out"; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment-:This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected event of loss of consciousness after a second dose of mRNA-1273 vaccine was administered. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-551327 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected event of loss of consciousness after a second dose of mRNA-1273 vaccine was administered. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: patient experienced headache for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (patient experienced headache for 24 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder. Concurrent medical conditions included Diabetes since 1993, Drug allergy and Allergy to chemicals. Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN DETEMIR (LEVEMIR), GLIPIZIDE, METOPROLOL, LOSARTAN, FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (patient experienced headache for 24 hours). The patient was treated with GABAPENTIN at a dose of 100 microgram three times a day. On 05-Feb-2021, HEADACHE (patient experienced headache for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient has no COVID + test or diagnosis. It was reported that no recent change in status such as improvement or worsening.  It was reported that other no vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #). .   This case was linked to MOD-2022-552505, MOD-2022-552517 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Musculoskeletal chest pain
Clinical narrative: Soreness on ribs; Strained or something/Not pain but like I've been hit on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058M21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and POTASSIUM CHLORIDE for an unknown indication.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side) had not resolved.            Concomitant medication also included heart blood thinner. Patient did not receive other vaccine within 1 month prior to Moderna vaccine. Treatment details was not reported by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: skin hurt to the touch; soreness in the left arm; a low-grade fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had visited emergency room for observation and was given IV fluids.) in December 2020. Previously administered products included for Product used for unknown indication: J and J COVID-19 vaccine (J and J COVID-19 vaccine, 1st Dose and Left Deltoid) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 vaccine. Concurrent medical conditions included Immune system disorder NOS (Patient reported that her immune system was not that best.), Allergy to antibiotic (Amoxicillin), Penicillin allergy, Allergy to antibiotic (Erythromycin), Drug allergy (Codeine), Drug allergy (Darvocet), Allergy to antibiotic (Doxycycline), Latex allergy and Exercise induced asthma (It started in her late 20's. No change in the condition was reported. Patient stated that the condition was doing pretty good.).    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Dec-2021, the patient experienced PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Dec-2021, Body temperature: low grade fever Low grade fever.         Concomitant medication included Pro-Air Inhaler as needed for exercised induced asthma.  It was reported that the adverse events lasted for a day and a half and then resolved.   This case was linked to MOD-2022-552553 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: skin hurt to the touch; soreness in the left arm; a low-grade fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had visited emergency room for observation and was given IV fluids.) in December 2020. Previously administered products included for Product used for unknown indication: J and J COVID-19 vaccine (J and J COVID-19 vaccine, 1st Dose and Left Deltoid) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 vaccine. Concurrent medical conditions included Immune system disorder NOS (Patient reported that her immune system was not that best.), Allergy to antibiotic (Amoxicillin), Penicillin allergy, Allergy to antibiotic (Erythromycin), Drug allergy (Codeine), Drug allergy (Darvocet), Allergy to antibiotic (Doxycycline), Latex allergy and Exercise induced asthma (It started in her late 20's. No change in the condition was reported. Patient stated that the condition was doing pretty good.).    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Dec-2021, the patient experienced PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (skin hurt to the touch), PAIN IN EXTREMITY (soreness in the left arm), PYREXIA (a low-grade fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Dec-2021, Body temperature: low grade fever Low grade fever.         Concomitant medication included Pro-Air Inhaler as needed for exercised induced asthma.  It was reported that the adverse events lasted for a day and a half and then resolved.   This case was linked to MOD-2022-552553 (Patient Link).