chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Continuous itching; I have a rash to my neck and chest and both Arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms). At the time of the report, PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.   No treatment information was provided.   Reportedly, a provider realized that they had been treating Moderna vaccine as though it had preservative. A preliminary spreadsheet (with the affected doses administered, with the lot numbers and time from vial opening) was sent.   The patient in question received the vaccine that was punctured 11 days earlier.; Sender's Comments: This is a case of Expired product administered (Expired vaccine used) for this patient of an unknown gender. Reportedly, the patient received the vaccine that was punctured 11 days before administration which is considered to be Expired product administered. No adverse events were reported at this moment. The company causality for this event is as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after use by date; 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Medical history was not provided.    On 24-Sep-2021 at 1:30 PM, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter No treatment information provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia, Off label use, Vaccination site warmth
Clinical narrative: warmth at injection site; I slept longer then normally I do; soreness; Received 3rd dose being not immunocompromised; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site), HYPERSOMNIA (I slept longer then normally I do), OFF LABEL USE (Received 3rd dose being not immunocompromised) and MYALGIA (soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 013M20A and 23M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced OFF LABEL USE (Received 3rd dose being not immunocompromised). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), HYPERSOMNIA (I slept longer then normally I do) and MYALGIA (soreness). On 25-Sep-2021, OFF LABEL USE (Received 3rd dose being not immunocompromised) had resolved. At the time of the report, VACCINATION SITE WARMTH (warmth at injection site), HYPERSOMNIA (I slept longer then normally I do) and MYALGIA (soreness) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Patient reported that she was not immunocompromised however she was given third shot. Patient does not recall the site of administration for doses 1 and 2.   This case was linked to MOD-2021-333240, MOD-2021-333346 (Patient Link).; Sender's Comments: This case concerns a  70-year-old, male patient with no relevant medical history, who received the third dose of Moderna COVID-19 Vaccine, however, the patient was not immunocompromised, therefore, it is considered to be Off label use. The patient experienced the unexpected events of vaccination site warmth and hypersomnia, as well as the expected event of myalgia. The events occurred after the third dose of Moderna COVD-19 Vaccine, however, the temporal relationship was unknown as the start date of the events was not provided. The rechallenge was not applicable, since the patient received the third dose of the vaccine and no additional doses will be given. The company causality for Off label use is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. Vaccine was administered 8 days after first puncture of vial. No treatment was provided.  This is a case of expired product administered for this 81 year-old, male patient with no relevant medical history, with no associated adverse events. The expired product administered occurred on the same day after the dose of mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received and it contains no significant information. Sender's Comments: This is a case of expired product administered for this 81 year-old, male patient with no relevant medical history, with no associated adverse events. The expired product administered occurred on the same day after the dose of mRNA-1273 vaccine. It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine administered 10 days after 1st punctured. No concomitant medication information was reported. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information. Sender's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 037C21A with no reported AEs. Causality for the medication error is not applicable.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered 15 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: Her platelet count began dropping right after receiving the Moderna Covid-19 vaccine, & it continues to drop.; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Her platelet count began dropping right after receiving the Moderna Covid-19 vaccine, & it continues to drop.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dialysis (She has been on dialysis since May 2021.) since September 2021.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced THROMBOCYTOPENIA (Her platelet count began dropping right after receiving the Moderna Covid-19 vaccine, & it continues to drop.) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Her platelet count began dropping right after receiving the Moderna Covid-19 vaccine, & it continues to drop.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Platelet count: 328 (normal) normal. On 15-Sep-2021, Platelet count: 119 (Low) low. On 21-Sep-2021, Platelet count: 85 (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided, No Treatment drug information was provided,; Sender's Comments: This case concerns a female patient of unknown age with relevant concurrent medical conditions of Dialysis since May 2021, who experienced non-serious unexpected event of platelet count decreased. The event occurred approximately 2 days after the first dose of mRNA-1273. The rechallenge was unknown, since at the time of report no information about second dose is available. Concurrent medical conditions of Dialysis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 deaths after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (3 deaths after the second dose of the Moderna vaccine) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Treatment medications were not reported.  This case concerns a unspecified patient with no reported medical history experienced serious events of death after unspecified  days after the second dose of Spikevax. The event's causality considered possible by reporter. Patient experienced AEs after second dose and no information about the first dose is available rechallenge is not applicable . The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-334634, MOD-2021-334642 (Patient Link).; Sender's Comments: This case concerns a unspecified patient with no reported medical history experienced serious events of death after unspecified  days after the second dose of Spikevax. The event's causality considered possible by reporter. Patient experienced AEs after second dose and no information about the first dose is available rechallenge is not applicable .The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 deaths after the second dose of the Moderna vaccine; 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 DEATH (3 deaths after the second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant products were not provided.    Treatment medication were not reported.  Further information has been requested.  This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected serious event of death (reported as 3 deaths after the second dose of the Moderna vaccine). The event occurred at an unknown day after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given (due to the outcome). The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-334634, MOD-2021-334640 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected serious event of death (reported as 3 deaths after the second dose of the Moderna vaccine). The event occurred at an unknown day after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given (due to the outcome). The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia
Clinical narrative: Sharp chest pains like needles in upper chest area lasting 15-60 sec's each two days in a row,  1 week after vaccine.  Since then periodic tingling sensations in chest in upper chest and side.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Runny nose and congestion on July 30, 2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest tube insertion, Computerised tomogram thorax
Clinical narrative: Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability.  Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Deep vein thrombosis, Dyspnoea, Endotracheal intubation
Clinical narrative: Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability.  Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Extubation, Infection, Lung opacity, Pneumonia, Pneumothorax
Clinical narrative: Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability.  Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pupil fixed, Renal cyst, SARS-CoV-2 test positive, Scan with contrast abnormal, Septic shock
Clinical narrative: Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability.  Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin
Clinical narrative: Pregnant at the time of vaccination. Miscarriage occurred 20 days after vaccination at around 5 weeks along.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, CSF glucose increased, CSF protein increased, Computerised tomogram head normal, Full blood count
Clinical narrative: syncope, then hours later, generalized tonic clonic seizure. followed by altered mental status, fever 102.6
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Laboratory test, Mental status changes, Metabolic function test, Pyrexia
Clinical narrative: syncope, then hours later, generalized tonic clonic seizure. followed by altered mental status, fever 102.6
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope, then hours later, generalized tonic clonic seizure. followed by altered mental status, fever 102.6
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: Patient reported left arm stiffness day after administration and her arm locked up. Later in the day at night she reported a stiff neck in addition to locked arm. The next day she developed a rash on her back, neck, hairline to front of her shoulder blade and down her legs.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: no additional AE; inadvertent administration via intramuscular route; This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-SEP-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) lot# T035411 has been verified to be a valid lot number, expiration date 14-APR-2022, 0.5 milliliter, inadvertently administered intramuscularly as opposed to the recommended subcutaneous route (incorrect route of product administration) (formulation, and anatomical location were not reported) for prophylaxis. No other adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Insomnia, Pain in extremity
Clinical narrative: sore arm/ hurts; Not feeling good; large red area/ still very red; difficult time sleeping; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Influenza vaccine (received on an unknown date).   On 23rd September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm, feeling bad, localized erythema and difficulty sleeping. On an unknown date, the outcome of the pain in arm, localized erythema and difficulty sleeping were not recovered/not resolved and the outcome of the feeling bad was recovering/resolving.   It was unknown if the reporter considered the pain in arm, feeling bad, localized erythema and difficulty sleeping to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported the case. The age at vaccination was not reported. The patient got shingles vaccine in right arm , the day before reporting date. The patient had gotten the flu shot on that side also and stated that never was given chance to get the shingles vaccine on right arm. The patient's arm hurt really bad and there was a large red area, hope the redness and pain go away. The patient reported some side effects like not feeling good and very sore arm and was better in the morning of reporting date. The patient had a difficult time sleeping because he/she sleep 90 percent of the time on left side The patient agreed that the vaccine hurts after several days and had still very red than getting shingles. The follow-up would not possible as contact information was not available. The patient would go back in a few months for second one.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling hot, Headache, Pain
Clinical narrative: Dizzy; feeling Weak; Headache; feeling Hot; felt "like a truck had hit; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR205215).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, less than a day after receiving Shingrix, the patient experienced dizziness, weakness, headache, feeling hot and pain. On an unknown date, the outcome of the dizziness, weakness, headache, feeling hot and pain were unknown.   It was unknown if the reporter considered the dizziness, weakness, headache, feeling hot and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for himself. The age at vaccination was not reported. Information regarding the vaccine was not collected (lot/expiration, dose, route, or site of administration). The patient received his second dose of the Shingrix vaccine and experienced being hot, having a headache, feeling weak and dizzy. he described his symptoms that he felt "like a truck had hit him". The reporter did not consent to follow up. The reporter did not give consent to contact doctor or provide date of birth.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205215:Same patient, AE with 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Dizzy; feeling Weak; Headache; feeling Hot; felt "like a truck had hit; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR205215).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, less than a day after receiving Shingrix, the patient experienced dizziness, weakness, headache, feeling hot and pain. On an unknown date, the outcome of the dizziness, weakness, headache, feeling hot and pain were unknown.   It was unknown if the reporter considered the dizziness, weakness, headache, feeling hot and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for himself. The age at vaccination was not reported. Information regarding the vaccine was not collected (lot/expiration, dose, route, or site of administration). The patient received his second dose of the Shingrix vaccine and experienced being hot, having a headache, feeling weak and dizzy. he described his symptoms that he felt "like a truck had hit him". The reporter did not consent to follow up. The reporter did not give consent to contact doctor or provide date of birth.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205215:Same patient, AE with 1st dose
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Fall, Fear
Clinical narrative: PASSED OUT; CONVULSIONS; BLOOD PRESSURE CRASHED TO 78/50; IRREGULAR HEART ACTIVITY; LIGHT-HEADED; FELL OUT OF CHAIR; CAN'T SLEEP; LIVING IN FEAR; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnic origin. 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, 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was waiting in the seating area with reporter's wife when he felt light-headed, passed out, and fell out of the chair. Reporter's wife helped him back to his chair wherein he again passed out for the second time and went into convulsions. During this time the nurses called 911 and he was transported by ambulance to the hospital where he was admitted to emergency room (ER). The doctor had ordered electrocardiogram (EKG) and head computed tomography (CT) of the patient which was normal. The blood pressure of the patient had crashed to 78/50 mmHg and even after two bags of intravenous (IV) fluid the blood pressure was not above 100/70 mmHg. After remaining in the ER for the remainder of the day the patients blood pressure (BP) leveled off (normal) and he was released that evening. The attending physician recommended that the patient not receive a follow up or booster vaccine in the future.  The patient continued to have irregular heart activity and was seeing an internal medicine doctor near his college. It was reported that the patient had been in the hospital twice in his life, the day he was born and the day he had received the johnson and johnson vaccine. The patient was living in fear and struggling with classes as he could not sleep due to heart irregularities and was placed on beta blockers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure crashed to 78/50, had not recovered from irregular heart activity, and can't sleep, and the outcome of light-headed, passed out, fell out of chair, convulsions and living in fear was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211000598-COVID-19 VACCINE AD26.COV2.S-Passed out, Convulsions, Blood pressure crashed to 78/50. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Insomnia, Loss of consciousness, Seizure
Clinical narrative: PASSED OUT; CONVULSIONS; BLOOD PRESSURE CRASHED TO 78/50; IRREGULAR HEART ACTIVITY; LIGHT-HEADED; FELL OUT OF CHAIR; CAN'T SLEEP; LIVING IN FEAR; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnic origin. 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, 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was waiting in the seating area with reporter's wife when he felt light-headed, passed out, and fell out of the chair. Reporter's wife helped him back to his chair wherein he again passed out for the second time and went into convulsions. During this time the nurses called 911 and he was transported by ambulance to the hospital where he was admitted to emergency room (ER). The doctor had ordered electrocardiogram (EKG) and head computed tomography (CT) of the patient which was normal. The blood pressure of the patient had crashed to 78/50 mmHg and even after two bags of intravenous (IV) fluid the blood pressure was not above 100/70 mmHg. After remaining in the ER for the remainder of the day the patients blood pressure (BP) leveled off (normal) and he was released that evening. The attending physician recommended that the patient not receive a follow up or booster vaccine in the future.  The patient continued to have irregular heart activity and was seeing an internal medicine doctor near his college. It was reported that the patient had been in the hospital twice in his life, the day he was born and the day he had received the johnson and johnson vaccine. The patient was living in fear and struggling with classes as he could not sleep due to heart irregularities and was placed on beta blockers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure crashed to 78/50, had not recovered from irregular heart activity, and can't sleep, and the outcome of light-headed, passed out, fell out of chair, convulsions and living in fear was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211000598-COVID-19 VACCINE AD26.COV2.S-Passed out, Convulsions, Blood pressure crashed to 78/50. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Vaccination site pain
Clinical narrative: Not immunocompromised; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains Initiative.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Urinary tract infection
Clinical narrative: Mild urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Mild urinary tract infection) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced URINARY TRACT INFECTION (Mild urinary tract infection) (seriousness criterion hospitalization). At the time of the report, URINARY TRACT INFECTION (Mild urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood glucose: low (Low) Low blood sugar (Below 50).     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 were reported. No treatment information was provided by the reporter.  Reporter stated that on 19-SEP-2021 patient was taken to the emergency room and found out that patient had mild urinary tract infection and a dirty diaper.  Company Comment: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dyspnoea, Palpitations
Clinical narrative: palpitations; can't breath properly; Patient was crying; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (can't breath properly) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016c21a and 036c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PALPITATIONS (palpitations) (seriousness criteria hospitalization and medically significant), DYSPNOEA (can't breath properly) (seriousness criteria hospitalization and medically significant) and CRYING (Patient was crying). The patient was hospitalized on sometime in September 2021 due to DYSPNOEA and PALPITATIONS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of in the hospital. At the time of the report, PALPITATIONS (palpitations), DYSPNOEA (can't breath properly) and CRYING (Patient was crying) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment - This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine went through excursion in freezer twice and administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.  She actually called last Thursday to cancel this inquiry. Her pharmacist on duty and she had a miscommunication. The sensor, to her understanding was not in correct position and was not collecting the data of the vaccine temperature. She was originally under the impression that the freezer had not been closed for the entire day.  She had called in last Wednesday about a possible excursion, but  called back Thursday to cancel it when she spoke more to her pharmacist that was on duty the day in question and learned that what she thought had happened did not happen. So sorry for the confusion.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non Significant Follow up received and checked medication error On 28-Sep-2021: Non Significant follow up received and appended
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise). At the time of the report, CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise) had not resolved.            No concomitant medication provided.  No treatment medication provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) in a 56-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell). At the time of the report, MALAISE (feeling unwell) outcome was unknown. Not Provided          No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-330232 (Patient Link).