chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 3 episodes of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. The patient was treated with medication unknown (Topical Cream). On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received his first dose of Shingrix in unknown arm, no lot number or expiration date was known.  Since then, he had 3 episodes of Shingles.  He was treated by his healthcare professional with medication and topical cream.  He asked if he should get the second dose of vaccine.  The reporter was provided medical disclaimer and referred to healthcare professional.  The reporter was offered number to Medical Information for healthcare professional to follow up. The reporter did not consent to follow up and declined to provide healthcare professional contact information. The case US2021AMR240066, US2021AMR240065 were deleted and all the information were merged in US2021239183 in one cases because different episodes from the same adverse event occurred after the same dose administered. Note: Same preferred term was kept only once.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR240065:Same reporter. US-GLAXOSMITHKLINE-US2021AMR240066:Same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eye pain, Headache, Injection site pain, Ocular hyperaemia
Clinical narrative: Right eye pain; Redness of right eye; Pain at injection site; Headache; rash on her chest became worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash. Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 BOOSTER).   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th November 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and rash aggravated. On 22nd November 2021, the patient experienced eye pain and eye red. On an unknown date, the outcome of the injection site pain, rash aggravated, eye pain and eye red were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the injection site pain, headache, rash aggravated, eye pain and eye red to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received Moderna Covid-19 Booster vaccine on 20th September 2021. The patient states that she had a rash on her chest that had started prior to receiving the vaccine.  The health care professional administering Shingrix told her that since it was not painful it could not be shingles.  After the administration she had pain at the injection site, headache and the rash on her chest became worse.  The patient started experiencing pain and redness of her right eye. The patient consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Right eye pain; Redness of right eye; Pain at injection site; Headache; rash on her chest became worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash. Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 BOOSTER).   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th November 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and rash aggravated. On 22nd November 2021, the patient experienced eye pain and eye red. On an unknown date, the outcome of the injection site pain, rash aggravated, eye pain and eye red were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the injection site pain, headache, rash aggravated, eye pain and eye red to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received Moderna Covid-19 Booster vaccine on 20th September 2021. The patient states that she had a rash on her chest that had started prior to receiving the vaccine.  The health care professional administering Shingrix told her that since it was not painful it could not be shingles.  After the administration she had pain at the injection site, headache and the rash on her chest became worse.  The patient started experiencing pain and redness of her right eye. The patient consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Product availability issue
Clinical narrative: No Bexsero doses available; This case was reported by a consumer and described the occurrence of product availability issue in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 10th August 2021, by Intramuscular route).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The age at vaccination was not applicable for this report. The reporter called to schedule the second dose, they advised they did not have any additional doses available as they had just thrown out the remaining vaccines which were not expired.The reporter tried to find other pharmacies with Bexsero but has not had luck and  asked if there was any way to locate Bexsero nearby. The patient did not receive 2nd dose of Bexsero due to availability issue, which led to product availability issue. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 3 year old; Was the 3rd dose in series for Dtap; received kinrix in Lt. Vastus Lateralis; 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 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site 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 patient received Kinrix in Lt. Vastus Lateralis, which led to vaccine administered at inappropriate site. The Kinrix was administered to a 3 year old and this was their 3rd dose in series for Dtap, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. No reactions reported. The reporter consented to follow up.
Age: 12.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 12YO patient vaccinated with Pediarix; vaccinated with Pediarix instead of Boostrix; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 12-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 24th November 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Other health professional reported a 12 year patient was vaccinated with Pediarix instead of Boostrix which led to wrong vaccine administration and inappropriate age at vaccine administration. The reporter didn't feel comfortable giving patient's personal information. The reporter did not give consent to follow up because she does not believe it was necessary.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient had no history of chronic illness.  The patient received his first vaccination (series 1) with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) on an unspecified date as prophylactic vaccination. The batch number was not reported and has been requested. The patient received his booster dose (series 2) with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) administered to his left arm on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced chills and cough and on 12-NOV-2021 he lost his sense of smell. A COVID-19 home test kit was positive for COVID-19 antigen on 12-NOV-2021 and a PCR COVID-19 test performed on 13-NOV-2021 was positive for confirmed COVID-19 infection. Confirmed clinical vaccination failure criteria was met for the series 1 vaccination. The patient was recovering from chills and cough but had not recovered from loss of smell.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not recovered. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint, and reference number requested.; Sender's Comments: V0; 20211136590-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative 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 his initial vaccination (series 1) with Janssen covid-19 vaccine ad26.cov2.s (manufacturer was not specified) (suspension for injection, route of administration not specified) on an unspecified date for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not specified)  booster dose (series 2) on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications were not reported. On an unspecified date, whilst waiting for 15 minutes of observation following his booster vaccination, he experienced a stroke.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211137111-covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: TWO DOSES OF THE JANSSEN VACCINE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 two doses of the janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two doses of the janssen vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 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 experienced blood clot after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211156823-COVID-19 VACCINE AD26.COV2.S-Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM STILL HURTS AND FELT LIKE THE NEEDLE STILL IN THERE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 arm still hurts and felt like the needle still in there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts and felt like the needle still in there. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Tenderness
Clinical narrative: FLU-LIKE SYMPTOMS; TENDERNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 flu-like symptoms, and tenderness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and tenderness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: VACCINE GAVE BACK PROBLEMS; 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 (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 vaccine gave back problems. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine give back problems was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: INTENSE ARM PAIN IN OPPOSITE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced intense arm pain in opposite arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of intense arm pain in opposite arm was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Headache, Heart rate, Hypertension
Clinical narrative: high blood pressure; tachycardia; Messed up heart and rest of her life; Inability to work; severe body ache; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work) and MYALGIA (severe body ache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain, Diabetes since 2010, Tachycardia since June 2021, Blood pressure high since June 2021 and Latex allergy. Concomitant products included DICLOFENAC and TIZANIDINE for Back pain, METFORMIN, PRAVASTATIN, MELOXICAM, LOSARTAN and PROPRANOLOL for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachycardia) had not resolved and CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood pressure measurement: high (High) blood pressure was really high. In 2021, Heart rate: high (High) pulse was extremely high.         No specific Treatment medication was reported.  Event Tachycardia and high blood pressure started on 06-2021 month unknown.   This case was linked to MOD-2021-393192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contain no significant information. On 19-Nov-2021: Follow-up added patient information, lab data, medical history, concomitant drugs and events added.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: high blood pressure; tachycardia; Messed up heart and rest of her life; Inability to work; severe body ache; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work) and MYALGIA (severe body ache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain, Diabetes since 2010, Tachycardia since June 2021, Blood pressure high since June 2021 and Latex allergy. Concomitant products included DICLOFENAC and TIZANIDINE for Back pain, METFORMIN, PRAVASTATIN, MELOXICAM, LOSARTAN and PROPRANOLOL for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachycardia) had not resolved and CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood pressure measurement: high (High) blood pressure was really high. In 2021, Heart rate: high (High) pulse was extremely high.         No specific Treatment medication was reported.  Event Tachycardia and high blood pressure started on 06-2021 month unknown.   This case was linked to MOD-2021-393192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contain no significant information. On 19-Nov-2021: Follow-up added patient information, lab data, medical history, concomitant drugs and events added.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: high blood pressure; tachycardia; Messed up heart and rest of her life; Inability to work; severe body ache; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work) and MYALGIA (severe body ache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain, Diabetes since 2010, Tachycardia since June 2021, Blood pressure high since June 2021 and Latex allergy. Concomitant products included DICLOFENAC and TIZANIDINE for Back pain, METFORMIN, PRAVASTATIN, MELOXICAM, LOSARTAN and PROPRANOLOL for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachycardia) had not resolved and CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood pressure measurement: high (High) blood pressure was really high. In 2021, Heart rate: high (High) pulse was extremely high.         No specific Treatment medication was reported.  Event Tachycardia and high blood pressure started on 06-2021 month unknown.   This case was linked to MOD-2021-393192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contain no significant information. On 19-Nov-2021: Follow-up added patient information, lab data, medical history, concomitant drugs and events added.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling). At the time of the report, PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  Reporter stated that the provider had no temperature monitoring equipment, data loggers and was not labeling vials appropriately. She noted that there were multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling. During the inspection, she observed the provider remove a vial from the freezer and started shaking the vaccine very hard to get them to thaw more quickly instead waiting the appropriate time. She indicated that a few hundred patients have received vaccines from this provider. No information was available on the patient involved, dates of administration, storage or any relevant information The reporter could not get temperature information as the vaccine provider was not keeping temperatures or logs.  According to reporter, number of patients affected was 68  Lot numbers for the Moderna vaccine include 939905, 038C21A, 021C21A, and 023C21A.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received on 18-Nov-2021 has lot no and patient effected details updated in I narrative. On 19-Nov-2021: Follow-up attached contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Everyone she talks to that had reactions from the booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster). At the time of the report, VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-388496, MOD-2021-394964.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: No new information added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  It was reported that patient received third shot of Moderna COVID  vaccine, the six month booster.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Added reporter details, start date of suspect product and batch number. On 22-Nov-2021: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in his left arm pit that worsened overnight; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight) outcome was unknown.     No concomitant medications information was reported.  No treatment medications were provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  It was reported that patient would be seeing his primary care physician on 17-Nov-2021   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Symptom recurrence
Clinical narrative: Grand mal seizure; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) and SYMPTOM RECURRENCE (Condition aggravated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Grand mal seizure. Concomitant products included LEVETIRACETAM (KEPPRA XR) for Grand mal seizure.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criteria hospitalization and medically significant) and SYMPTOM RECURRENCE (Condition aggravated) (seriousness criteria hospitalization and medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) and SYMPTOM RECURRENCE (Condition aggravated) outcome was unknown.            No Treatment medication was provided. Patient was on anti-seizure medication Keppra still he got his first seizure. While on COVID-19 Patient had daily seizure and he took 9 months of cognitive therapy for the same. Doctor advised him not to take COVID vaccine due to his current condition.  Company comment: This is a spontaneous case concerning a male patient of unknown age with relevant medical history of grand mal seizure, who experienced the unexpected, serious, AESI event of grand mal seizure and unexpected, serious event of symptom recurrence. The events grand mal seizure and symptom recurrence occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of grand mal seizure remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with relevant medical history of grand mal seizure, who experienced the unexpected, serious, AESI event of grand mal seizure and unexpected, serious event of symptom recurrence. The events grand mal seizure and symptom recurrence occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of grand mal seizure remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased, Malaise
Clinical narrative: Difficulty breathing / Still currently feeling shortness of breath; Chest Pain; Feeling unwell for several days; Arm Pain; Injection site redness- left arm; After the shot vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain) and VACCINATION SITE ERYTHEMA (Injection site redness- left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting). On 13-Nov-2021, DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Heart rate increased: increased (High) fast heart beat.         No relevant concomitant medications reported.  No treatment information was provided.  Patient had no history of COVID-19 and  Myocarditis/pericarditis.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vomiting
Clinical narrative: Difficulty breathing / Still currently feeling shortness of breath; Chest Pain; Feeling unwell for several days; Arm Pain; Injection site redness- left arm; After the shot vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain) and VACCINATION SITE ERYTHEMA (Injection site redness- left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting). On 13-Nov-2021, DYSPNOEA (Difficulty breathing / Still currently feeling shortness of breath), CHEST PAIN (Chest Pain), MALAISE (Feeling unwell for several days), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Injection site redness- left arm) and VOMITING (After the shot vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Heart rate increased: increased (High) fast heart beat.         No relevant concomitant medications reported.  No treatment information was provided.  Patient had no history of COVID-19 and  Myocarditis/pericarditis.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hearing problem/hearing problem happened after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037A21B) for COVID-19 vaccination.     Previously administered products included for an unreported indication: QUADRIVALENT INFLUENZA VACCINE (quadrivalent flu vaccine) in October 2021.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine). The patient was treated with PREDNISONE for Adverse event, at a dose of 20 mg; PREDNISONE for Adverse event, at a dose of 60 mg and PREDNISONE for Adverse event, at a dose of 40 mg. At the time of the report, HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine) outcome was unknown.            Patient stated that he had hearing problem after receiving the moderna vaccine. No concomitant medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Feeling abnormal, Nerve injury, Vaccination site pain
Clinical narrative: nerve zings that feels like a battery is being hooked to his arm; feels like electrocution makes him jump up crazy; Might be nerve damage; Sore arm/Hurt/now getting nerve zings; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 001B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (nerve zings that feels like a battery is being hooked to his arm), ELECTRIC SHOCK SENSATION (feels like electrocution makes him jump up crazy), NERVE INJURY (Might be nerve damage) and VACCINATION SITE PAIN (Sore arm/Hurt/now getting nerve zings) outcome was unknown.            No concomitant medications were reported. The patient stated that it was not swollen and mentioned that he had no issues with the shot in the past.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Erythema, Feeling hot, Peripheral coldness
Clinical narrative: at night woke up to go to the bathroom and almost felt; They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack; face is a little bit red; fells hot, forehead is warm; their hand are frizzing cold.; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm) and PERIPHERAL COLDNESS (their hand are frizzing cold.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included METFORMIN, VALSARTAN, ALLOPURINOL, APIXABAN (ELIQUIS), AMLODIPINE, ATORVASTATIN, METOPROLOL and DULAGLUTIDE (TRULICITY) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm), PERIPHERAL COLDNESS (their hand are frizzing cold.) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm), PERIPHERAL COLDNESS (their hand are frizzing cold.) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took blood pressure medications