chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Patient was inadvertently administered PROQUAD on 1/18/2022 at the age of 14.; This spontaneous report was received from a medical assistant referring to a 14 years old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 07-DEC-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were not reported) for prophylaxis at another clinic.   On 18-JAN-2022, at the age of 14 years old, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength and route were not reported; 0.5 ml, lot # U002530, expiration date: 24-JUL-2022) for prophylaxis (product administered to patient of inappropriate age).         No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Had us down; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the 2nd shingles shot had him/her down for 12 hours and was fine at the time of reporting. This case has been linked to US2022AMR046621, reported by the same reporter. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046621:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles again now; No pain just itching in 3 places; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had them for almost a year).   On an unknown date, the patient received Shingrix. On an unknown date, 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had shingles for almost a year, he/she went to the doctor, had 2 different medications (unknown medication) which did not help. The patient got unknown shot when he/she was 50, discontinued that one. The patient had Shingrix shot 2 years before date of reporting and got shingles again then at the time of reporting, had no pain just itching in 3 places that were worse before. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine and still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient had Shingle vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: shot did sting a lot, arm hurt; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR046924  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and his/her arm hurt for several days after the vaccination. The patient stated that the shot did sting a lot. The follow-up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR046924; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046924:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: arm hurt, wasn't as bad; flu like symptoms; 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 Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date date, refer link  case US2022AMR046919).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR046919  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced pain in arm after receiving 2nd dose of Shingles vaccine, but was not bad as 1st dose. The patient did have flu like symptoms the next day. No other information was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046919:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash papular, Rash pruritic
Clinical narrative: shingles; Left side broke out in rash; raised rash; Itching; White raised areas, hives; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles, itchy rash, raised rash, pruritus, hives and pain. On an unknown date, the outcome of the shingles, itchy rash, raised rash, pruritus, hives and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, itchy rash, raised rash, pruritus, hives and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient went and took vaccine shot as patient doctors said. 3 days later patient left side broke out in rash and itching. The patients experienced white raised areas that turned into hives. The patient was fighting this for almost a month. The patient said very painful and nothing gives relief. The patient did not had shingles before. The reporter said before taking vaccine talked to your doctor and hoped he/she never go through this again.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: shingles; Left side broke out in rash; raised rash; Itching; White raised areas, hives; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles, itchy rash, raised rash, pruritus, hives and pain. On an unknown date, the outcome of the shingles, itchy rash, raised rash, pruritus, hives and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, itchy rash, raised rash, pruritus, hives and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient went and took vaccine shot as patient doctors said. 3 days later patient left side broke out in rash and itching. The patients experienced white raised areas that turned into hives. The patient was fighting this for almost a month. The patient said very painful and nothing gives relief. The patient did not had shingles before. The reporter said before taking vaccine talked to your doctor and hoped he/she never go through this again.
Sex: F
Vaccine: TDAP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Patient under 10 YO got Boostrix; This would have been dose 5 in the DTaP series; Patient under 10 YO got Boostrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Daptacel (received two doses of Daptacel), Daptacel (received two doses of Daptacel), Pentacel (received two doses of Pentacel) and Pentacel (received two doses of Pentacel).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The physician reported that under 10 year old patient received a dose of Boostrix, which led to inappropriate age at vaccine administration and accidental underdose. The physician clarified the patient had previously received two doses of Daptacel and two doses of Pentacel, so this inadvertently administered dose of Boostrix would have been dose 5 in the DTaP series, which led to wrong vaccine administered. No further details were shared during the call. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: MENB
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Bexsero instead of Engerix; 2 month old patient received bexsero; Received BEXSERO in left thigh; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) 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.   On 7th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration 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 reported were as follows: The 2 month old patient received Bexsero instead of Engerix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine was administered by experienced MA (medical Assistant). The patient received Bexsero in left thigh, which led to vaccine administered at inappropriate site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired drug used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported as follows: The registered nurse reported that, the patient might had received Kinrix dose after expiration date, which led to expired vaccine used. The reporter consented to follow up by email. This case was linked with US2022046882 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046882:Same reporter.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Pneumonia
Clinical narrative: This spontaneous report received from a parent concerned a 28 year old female of an unspecified 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, expiry: unknown) dose was not reported,1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, following day after vaccination the patient experienced fever and vomiting and couple of months after vaccination she experienced COVID-19 infection. The patient never felt better starting from the month of AUG-2021 to DEC-2021 which was coded as suspected Covid-19 infection and in the late DEC-2021, patient was hospitalized (date unspecified) for pneumonia and after 15 minutes of breathing treatment, patient could not see and the CT (computed tomography) scan was performed which was normal and following day MRI (Magnetic resonance imaging) showed a blood clog in her brain, and doctors told that she had a stroke. The patient can talk but had memory loss and peripheral vision issue. On an unspecified date, the patient experienced suspected clinical vaccination failure. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the memory loss, stroke, suspected Covid-19 infection, suspected clinical vaccination failure, pneumonia, fever and vomiting was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20220322057. Sender's Comments: 20220322480- Covid-19 vaccine ad26.cov2.s -PNEUMONIA, STROKE, SUSPECTED CLINICAL VACCINATION FAILURE. 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). Therefore, this event(s) is considered unassessable.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Vaccination failure, Vomiting
Clinical narrative: This spontaneous report received from a parent concerned a 28 year old female of an unspecified 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, expiry: unknown) dose was not reported,1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, following day after vaccination the patient experienced fever and vomiting and couple of months after vaccination she experienced COVID-19 infection. The patient never felt better starting from the month of AUG-2021 to DEC-2021 which was coded as suspected Covid-19 infection and in the late DEC-2021, patient was hospitalized (date unspecified) for pneumonia and after 15 minutes of breathing treatment, patient could not see and the CT (computed tomography) scan was performed which was normal and following day MRI (Magnetic resonance imaging) showed a blood clog in her brain, and doctors told that she had a stroke. The patient can talk but had memory loss and peripheral vision issue. On an unspecified date, the patient experienced suspected clinical vaccination failure. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the memory loss, stroke, suspected Covid-19 infection, suspected clinical vaccination failure, pneumonia, fever and vomiting was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20220322057. Sender's Comments: 20220322480- Covid-19 vaccine ad26.cov2.s -PNEUMONIA, STROKE, SUSPECTED CLINICAL VACCINATION FAILURE. 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). Therefore, this event(s) is considered unassessable.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; The vaccine was administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  It was reported that the first 9 patients received Moderna Covid-19 vaccine on 02 Mar 2022 past its 30 day beyond use date. Pharmacist didn't knew which dose patient received on which arm. The Pharmacist does not have any other adverse events or side effects to report.The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24 Jan 2022.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Diarrhoea, Dyspnoea
Clinical narrative: difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma; chest pain; chronic cough since receiving/ and is coughing; pain; diarrhea after the vaccine; chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma), PAIN (pain) and DIARRHOEA (diarrhea after the vaccine) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was asymptomatic. No treatment received and no hospitalization) on 31-Dec-2021. Concurrent medical conditions included Asthma.    On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced CHEST PAIN (chest pain). On 11-Mar-2022, the patient experienced DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma). In March 2022, the patient experienced COUGH (chronic cough since receiving/ and is coughing), PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue). In March 2022, PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not went to see a Physician about these symptoms so no cardiac work up was done. Patient was yet to receive a second dose of the Moderna Covid-19 vaccine. Patient did not had a history of Myocarditis/pericarditis.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma; chest pain; chronic cough since receiving/ and is coughing; pain; diarrhea after the vaccine; chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma), PAIN (pain) and DIARRHOEA (diarrhea after the vaccine) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was asymptomatic. No treatment received and no hospitalization) on 31-Dec-2021. Concurrent medical conditions included Asthma.    On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced CHEST PAIN (chest pain). On 11-Mar-2022, the patient experienced DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma). In March 2022, the patient experienced COUGH (chronic cough since receiving/ and is coughing), PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue). In March 2022, PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not went to see a Physician about these symptoms so no cardiac work up was done. Patient was yet to receive a second dose of the Moderna Covid-19 vaccine. Patient did not had a history of Myocarditis/pericarditis.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue, Product storage error
Clinical narrative: vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022; The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022; Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date), PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date), PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients. Lot Number 030H21B Expiration date 23MAR2022. The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022. Pharmacist did not know which dose the patient received the invalid dose on. The Pharmacist did not know which arm the patient received the Moderna Covid-19 vaccine in. The Pharmacist did not have any other adverse events or side effects to report.   No treatment medication was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Periarthritis
Clinical narrative: Frozen shoulder Physical therapy started 10/19; corticosteroid injection received 01/22
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Additional Details: Approx 7-10min after immunization pt complained of itching, redness on trunk/ neck. No difficulty breathing, MD called, pt went to urgent care after. Prednisone, famotidine and benadryl rx sent in.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Dizziness, Electric shock sensation
Clinical narrative: I was in perfect health prior to injections.   10/1/2021 - Drove to another state for 1st injection.  My dog was sitting in my lap the entire way.  Upon return, she would not lay in my lap and continues to not lay in my lap in the car or at home.   Same day about 3-4 hours later,  numbness in R hand and B LE leg feeling of  ?shaking? but not visibly.  Sudden increase swelling of R hand middle finger at metacarpals w/ pain at joint.  Continue to have pain and swelling in R middle finger with pain.  No pain or swelling prior to injection.  B LE ?shaking? continued into the night and continues to happen when sleeping and wakes me up w/ R>L in ?shaking?.  The shaking almost feels electrical w/ feet feeling like they?re hot.  I feel more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/1/2021  Pain at the injection site, heavy arm feeling, and dizziness for 20-30 minutes.   Immediate numbness in R hand after, and 20 min later, R forefoot and toes had numbness.   1 hour later, B LE feeling of ?shaking? increased and L foot numbness.   By evening, B LE ?shaking? feels increased than before w/  difficulty falling asleep and wakes me up w/ R>L in ?shaking?.  Still the shaking almost feels electrical w/ feet feeling like they?re hot.  I feel even more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/7/21 -  L sided chest pain (at heart) and tightness that lasted approximately 1 hour.  No medical treatment sought.  Rested and went away.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: I was in perfect health prior to injections.   10/1/2021 - Drove to another state for 1st injection.  My dog was sitting in my lap the entire way.  Upon return, she would not lay in my lap and continues to not lay in my lap in the car or at home.   Same day about 3-4 hours later,  numbness in R hand and B LE leg feeling of  ?shaking? but not visibly.  Sudden increase swelling of R hand middle finger at metacarpals w/ pain at joint.  Continue to have pain and swelling in R middle finger with pain.  No pain or swelling prior to injection.  B LE ?shaking? continued into the night and continues to happen when sleeping and wakes me up w/ R>L in ?shaking?.  The shaking almost feels electrical w/ feet feeling like they?re hot.  I feel more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/1/2021  Pain at the injection site, heavy arm feeling, and dizziness for 20-30 minutes.   Immediate numbness in R hand after, and 20 min later, R forefoot and toes had numbness.   1 hour later, B LE feeling of ?shaking? increased and L foot numbness.   By evening, B LE ?shaking? feels increased than before w/  difficulty falling asleep and wakes me up w/ R>L in ?shaking?.  Still the shaking almost feels electrical w/ feet feeling like they?re hot.  I feel even more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/7/21 -  L sided chest pain (at heart) and tightness that lasted approximately 1 hour.  No medical treatment sought.  Rested and went away.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Sleep disorder, Temperature intolerance, Tremor
Clinical narrative: I was in perfect health prior to injections.   10/1/2021 - Drove to another state for 1st injection.  My dog was sitting in my lap the entire way.  Upon return, she would not lay in my lap and continues to not lay in my lap in the car or at home.   Same day about 3-4 hours later,  numbness in R hand and B LE leg feeling of  ?shaking? but not visibly.  Sudden increase swelling of R hand middle finger at metacarpals w/ pain at joint.  Continue to have pain and swelling in R middle finger with pain.  No pain or swelling prior to injection.  B LE ?shaking? continued into the night and continues to happen when sleeping and wakes me up w/ R>L in ?shaking?.  The shaking almost feels electrical w/ feet feeling like they?re hot.  I feel more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/1/2021  Pain at the injection site, heavy arm feeling, and dizziness for 20-30 minutes.   Immediate numbness in R hand after, and 20 min later, R forefoot and toes had numbness.   1 hour later, B LE feeling of ?shaking? increased and L foot numbness.   By evening, B LE ?shaking? feels increased than before w/  difficulty falling asleep and wakes me up w/ R>L in ?shaking?.  Still the shaking almost feels electrical w/ feet feeling like they?re hot.  I feel even more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/7/21 -  L sided chest pain (at heart) and tightness that lasted approximately 1 hour.  No medical treatment sought.  Rested and went away.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS UNCONSIOUS FOR ABOUT 10 SECONDS, ONCE HE CAME TO HE WAS ALERT AND ORIENTED. EMT ARRIVED WITHIN 5 MINUTES. BP118/82 HEART RATE 62 PULSE 100
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, Ultrasound foetal abnormal
Clinical narrative: Estimated delivery day 10/10/22- miscarriage after vaccine
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Condition aggravated, Tinnitus
Clinical narrative: Tinnitus began a few days after booster vaccination. I had very minimal low-grade tinnitus prior, but after booster the ringing became very loud and remains so five months later.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Dysphagia, Dyspnoea, Swelling face, Throat irritation
Clinical narrative: Constant Hives, trouble breathing and swallowing, facial swelling, throat itching.  Steroid pack completed. Currently on Allegra 24hr and Pepcid in the AM, Zyrtec 24hr during PM. Benedryl for breakthrough reactions almost daily.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Constant Hives, trouble breathing and swallowing, facial swelling, throat itching.  Steroid pack completed. Currently on Allegra 24hr and Pepcid in the AM, Zyrtec 24hr during PM. Benedryl for breakthrough reactions almost daily.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: -PFIZER COVID 12 plus VACCINE, HE IS 9 YEARS OLD. -PARENT NOTIFIED -NO REACTIONS/ NO ADVERSE EVENTS
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: pain in neck radiating to arm
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: vaccinated pt admitted with covid infection
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Tinnitus, dizziness
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea
Clinical narrative: Acute hypoxemic respiratory failure, Shortness of breath, Covid 19
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bad tinnitus began within days of vaccine, remains constant today, over 7 months later
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance, Insomnia, Limb discomfort, Pain in extremity
Clinical narrative: Patient was vaccinated with booster Moderna on 3/4/22. Patient states no discomfort over the weekend but noticed discomfort on Monday 3/7/22 when walking to class. Patient reports having swollen, discolored, painful toes. Pain and discomfort from toes keeping patient up at night and making it difficult to walk. Patient states discomfort increased around 3/14/22.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Patient was vaccinated with booster Moderna on 3/4/22. Patient states no discomfort over the weekend but noticed discomfort on Monday 3/7/22 when walking to class. Patient reports having swollen, discolored, painful toes. Pain and discomfort from toes keeping patient up at night and making it difficult to walk. Patient states discomfort increased around 3/14/22.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Rash vesicular
Clinical narrative: Vesicular rash appearing about 24 hours after 3rd booster w/Pfizer. No similar reaction hx.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated patient tested positive for COVID-19 during inpatient admission.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anastomotic leak, C-reactive protein increased, COVID-19, Candida infection, Chest X-ray abnormal
Clinical narrative: 10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colectomy, Constipation, Cough, Culture wound positive, Dyspnoea
Clinical narrative: 10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Enterococcus test positive, Explorative laparotomy, Gram stain positive, Hypervolaemia, Ileostomy
Clinical narrative: 10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Postoperative wound infection, SARS-CoV-2 test positive, Small intestinal obstruction, Surgery
Clinical narrative: 10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Urinary tract infection, Vomiting, White blood cell count increased, Wound dehiscence
Clinical narrative: 10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Vaccinated pt admitted with covid infection