chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was vaccinated with the COVID 19 PFIZER Monovalent vaccine instead of the COVID 19 PFIZER Bivalent vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient received a flu shot on 09/19/22 and 12/10/22
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered the Monovalent dose instead of the Bivalent Dose as a Booster
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the COVID19 Monovalent dose instead of the COVID19 Bivalent dose as a booster. No signs of a reaction.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Quality of life decreased, Skin test positive, Urticaria
Clinical narrative: Approximately 2 weeks (about 11/12) after the booster I developed round hives on my wrists, ankles, tops of feet, waist area.  Also developed dermatagraphia (skin writting) at same time.  Treated with Claritin and Benadryl until I could get into the dermatologist a week later (about 11/18/22).  Diagnosed with dermatagraphia and treated with Xyzol.  Dermatagraphia is still present even with medication.  Quality of life has been greatly reduced.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: THE PRIMARY  COVID VACCIN SHOT WAS GIVEN TO THE PATIENT ONE DAY AFTER THE PATIENT GOT COVID VACCIN BOOSTER.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Joint range of motion decreased, Laboratory test, Pain, Pain in extremity
Clinical narrative: Patient stopped by the pharmacy stating that she will have to have surgery to correct her issue from Shingrix. Patient reports swelling, numbness, pain radiating down arm, decreased range of motion, worsening symptoms as time progresses since date of administration. Patient also stated taste disturbances and changes.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Taste disorder
Clinical narrative: Patient stopped by the pharmacy stating that she will have to have surgery to correct her issue from Shingrix. Patient reports swelling, numbness, pain radiating down arm, decreased range of motion, worsening symptoms as time progresses since date of administration. Patient also stated taste disturbances and changes.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Electromyogram, Magnetic resonance imaging, Musculoskeletal pain
Clinical narrative: After a week my right bicep deltoid area became sore and painful.   Saw the doctor on 2/2 /21 but never thought this was related to the vaccine. Pain radiates down arm, entire shoulder blade and rotator cuff. Burning sensation down right arm which has subsided a bit.  Still major pain, unable to treat with success
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, X-ray
Clinical narrative: After a week my right bicep deltoid area became sore and painful.   Saw the doctor on 2/2 /21 but never thought this was related to the vaccine. Pain radiates down arm, entire shoulder blade and rotator cuff. Burning sensation down right arm which has subsided a bit.  Still major pain, unable to treat with success
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Pruritus, Rash, Rash macular
Clinical narrative: Severe Rash, itchy and burn, blotch of redness  all over body.  Couldn?t sleep at night and it?s going on for over 3 weeks.  Took methyl Prednisolone  for last 10 days but allergies haven?t been improve.  Please help if you can!
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Arthralgia, Gait inability, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Pelvic pain, Walking aid user
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Ageusia, Anosmia, Arthralgia, Balance disorder, Body temperature increased
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Bronchitis, Choking, Constipation, Diarrhoea, Disturbance in attention
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Dyspnoea, Fall, Fatigue, Gait disturbance, Injection site discolouration
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Memory impairment, Myalgia, Paraesthesia, Pneumonia, Productive cough
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Pyrexia, Respiratory disorder, Skin exfoliation, Streptococcus test negative, Tunnel vision
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Walking aid user, Wheezing
Clinical narrative: Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cryotherapy, Skin lesion
Clinical narrative: Developed skin lesions behind my right ear, similar to keratosis. Will not heal!
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No  adverse reaction
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Corrective lens user, Eye inflammation, Vision blurred, Visual impairment
Clinical narrative: Patient needed new card made to show her doctors.  I asked if she had any boosters or just the primary series to make the replacement card.  She said just the primary series cause after the 2nd dose she had vision problems less then 30 days out.  On 5/23/21 she woke up with grey vision in the middle of her eye on the right side.  She said her peripheral vision was okay but the middle was blurry to the point that she couldn't see the stop sign when driving later that morning.  She did say her mother had vision problems also and feels that the shot may have exacerbated any vision problems to happen.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood lactic acid increased, Blood potassium decreased, Cardiac arrest, Cerebral disorder, Computerised tomogram abdomen abnormal
Clinical narrative: The Patient presented via EMS to the ED of local Hospital after cardiac arrest with ROSC on the 14th day after receiving her Covid booster shot.. Per report, pt had been feeling dizzy for a few days and was staying with family members, pt had a witnessed sudden collapse and CPR was initiated. EMS administered 3 rounds of Epi, gave Lidocaine and shocked x1 for Ventricular Tachycardia and ROSC was obtained. Pt was intubated in the field.  In the ED, pt was noted to be hypokalemic (1.3) and with elevated Lactate (13.3). CT Head is negative for acute findings. CT Chest PE, Abd and Pelvis prelim negative for PE, reports enterocolitis. Pt received Potassium repletion, Zosyn, Keppra, 1L NS bolus, calcium and magnesium, and started on Levophed and Propofol gtts.  Pt has been admitted to the ICU for further management.    Upon ICU arrival, Propofol was held for neuro assessment, pt is unresponsive to painful stimuli, pupils reactive, myoclonic jerks noted.  The patient did not improve (see below for EEG results) and was put on comfort care/hospice care starting on 2/4/2023. She was terminally extubated in the ICU on this date.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax normal, Dizziness, Electroconvulsive therapy, Electroencephalogram abnormal
Clinical narrative: The Patient presented via EMS to the ED of local Hospital after cardiac arrest with ROSC on the 14th day after receiving her Covid booster shot.. Per report, pt had been feeling dizzy for a few days and was staying with family members, pt had a witnessed sudden collapse and CPR was initiated. EMS administered 3 rounds of Epi, gave Lidocaine and shocked x1 for Ventricular Tachycardia and ROSC was obtained. Pt was intubated in the field.  In the ED, pt was noted to be hypokalemic (1.3) and with elevated Lactate (13.3). CT Head is negative for acute findings. CT Chest PE, Abd and Pelvis prelim negative for PE, reports enterocolitis. Pt received Potassium repletion, Zosyn, Keppra, 1L NS bolus, calcium and magnesium, and started on Levophed and Propofol gtts.  Pt has been admitted to the ICU for further management.    Upon ICU arrival, Propofol was held for neuro assessment, pt is unresponsive to painful stimuli, pupils reactive, myoclonic jerks noted.  The patient did not improve (see below for EEG results) and was put on comfort care/hospice care starting on 2/4/2023. She was terminally extubated in the ICU on this date.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Endotracheal intubation, Enterocolitis, Hypokalaemia, Intensive care, Myoclonus
Clinical narrative: The Patient presented via EMS to the ED of local Hospital after cardiac arrest with ROSC on the 14th day after receiving her Covid booster shot.. Per report, pt had been feeling dizzy for a few days and was staying with family members, pt had a witnessed sudden collapse and CPR was initiated. EMS administered 3 rounds of Epi, gave Lidocaine and shocked x1 for Ventricular Tachycardia and ROSC was obtained. Pt was intubated in the field.  In the ED, pt was noted to be hypokalemic (1.3) and with elevated Lactate (13.3). CT Head is negative for acute findings. CT Chest PE, Abd and Pelvis prelim negative for PE, reports enterocolitis. Pt received Potassium repletion, Zosyn, Keppra, 1L NS bolus, calcium and magnesium, and started on Levophed and Propofol gtts.  Pt has been admitted to the ICU for further management.    Upon ICU arrival, Propofol was held for neuro assessment, pt is unresponsive to painful stimuli, pupils reactive, myoclonic jerks noted.  The patient did not improve (see below for EEG results) and was put on comfort care/hospice care starting on 2/4/2023. She was terminally extubated in the ICU on this date.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Resuscitation, Syncope, Unresponsive to stimuli, Ventricular tachycardia
Clinical narrative: The Patient presented via EMS to the ED of local Hospital after cardiac arrest with ROSC on the 14th day after receiving her Covid booster shot.. Per report, pt had been feeling dizzy for a few days and was staying with family members, pt had a witnessed sudden collapse and CPR was initiated. EMS administered 3 rounds of Epi, gave Lidocaine and shocked x1 for Ventricular Tachycardia and ROSC was obtained. Pt was intubated in the field.  In the ED, pt was noted to be hypokalemic (1.3) and with elevated Lactate (13.3). CT Head is negative for acute findings. CT Chest PE, Abd and Pelvis prelim negative for PE, reports enterocolitis. Pt received Potassium repletion, Zosyn, Keppra, 1L NS bolus, calcium and magnesium, and started on Levophed and Propofol gtts.  Pt has been admitted to the ICU for further management.    Upon ICU arrival, Propofol was held for neuro assessment, pt is unresponsive to painful stimuli, pupils reactive, myoclonic jerks noted.  The patient did not improve (see below for EEG results) and was put on comfort care/hospice care starting on 2/4/2023. She was terminally extubated in the ICU on this date.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered on 01/07/2023 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30 days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted for re-administration of the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered on 01/07/2023 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30 days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted for re-administration of the vaccine.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccination administered on 2/4/23 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30-days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted to re-administer vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: PATIENT SAYS SHE GAVE BLOOD AT MD OFFICE THE SAME DAY AND DUE TO TINY VEINS, THEY TRIED IN RIGHT ARM AND THEN MOVED TO LEFT. SHE RECEIVED HER SHINGLES VACCINE IN THE RIGHT ARM AS WELL. SHE IS UNSURE AS TO WHETHER THE ATTEMPT AT THE BLOOD DRAW  OR THE VACCINE HAS CAUSED A "FLUTTERING" IN HER RIGHT ARM. SHE STATES IT IS ABOVE THE ELBOW, UNDER BOTTOM. SHE SAYS SHEWILL FOLLOW UP WITH HER MD.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Death, Endotracheal intubation
Clinical narrative: Unknown symptom onset; symptoms were fever, chills, myalgia, rhinorrhea, sore throat, headache, fatigue, and cough. Intubated at some point during hospitalization.  Person extubated while in hospice care and died on 2/24/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Unknown symptom onset; symptoms were fever, chills, myalgia, rhinorrhea, sore throat, headache, fatigue, and cough. Intubated at some point during hospitalization.  Person extubated while in hospice care and died on 2/24/2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Unknown symptom onset; symptoms were fever, chills, myalgia, rhinorrhea, sore throat, headache, fatigue, and cough. Intubated at some point during hospitalization.  Person extubated while in hospice care and died on 2/24/2022.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, Lacrimation increased, Malaise
Clinical narrative: 12/27/22 Started to feel sick. Tested positive for Covid (Binmax Now Covid kit) on 12/30/22. Symptoms: Coughing, watery eyes, runny nose, body ache, no energy. Called Primary care physician office but PCP doctor was on vacation and receptionist said there's nothing they can do. NOTE: I am two time cancer survivor, 65 yrs old and in high risk category. Since I was not feeling extremely sick I didn't go to the Emergency room (but my husband did go to the ER very sick). PCP came back from vacation on 1-9-23. We are passed 5 day period for Paxlovid so PCP advises NOT to take Paxlovid. To wait it out. Two days later on 1-11-23 I tested Negative for Covid (BinaxNow kit).
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: 12/27/22 Started to feel sick. Tested positive for Covid (Binmax Now Covid kit) on 12/30/22. Symptoms: Coughing, watery eyes, runny nose, body ache, no energy. Called Primary care physician office but PCP doctor was on vacation and receptionist said there's nothing they can do. NOTE: I am two time cancer survivor, 65 yrs old and in high risk category. Since I was not feeling extremely sick I didn't go to the Emergency room (but my husband did go to the ER very sick). PCP came back from vacation on 1-9-23. We are passed 5 day period for Paxlovid so PCP advises NOT to take Paxlovid. To wait it out. Two days later on 1-11-23 I tested Negative for Covid (BinaxNow kit).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My periods, starting in February 2022,  have been heavier, longer, and start earlier than prior to receiving my second dose of the vaccine. On average, periods now last two weeks since February 2022. My last period lasted 15 days, and I began my most recent period only 8 days after my previous one ended. I have not stopped bleeding profusely since January 28, and have decided to seek medical treatment once I'm able to reach my PCP on Monday, February 6, 2023, as I have been bleeding through tampons within an hour, and woke up February 3 and 4 in a pool of blood, after soaking through both a tampon, overnight pad, and the undergarments and joggers I wore to bed. I have never experienced menstrual bleeding to this extent and feel weak and lightheaded.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Product administered at inappropriate site
Clinical narrative: Grad intern gave IM vs Subq as recommended by manufacture
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: PATIENT RECEIVED MODERNA BIVALENT AT PHARMACY ON 1/28/23. ON 2/4/23 THE PATIENT CAME INTO THE CLINIC STATING HE RECEIVED THE WRONG VACCINATION FOR HIS PRIMARY SERIES. THE PATIENT STATES HE NEEDS TO BE FULLY VACCINATED FOR WORK. THE PATIENT WAS EDUCATED PER THE CDC RECOMMENDATIONS TO WAIT 8 WEEKS IN BETWEEN VACCINATIONS BEFORE RECEIVING THE PRIMARY SERIES DOSE. THE PATIENT DECLINED TO WAIT TO THE 8 WEEKS. HE OPTED TO RECEIVE THE 1ST DOSE OF THE PRIMARY SERIES TODAY WITH OUR MOBILE VACCINE CLINIC. ON  2/4/23 THE PATIENT RECEIVED MONOVALENT MODERNA.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Death, Pneumonia bacterial, SARS-CoV-2 test
Clinical narrative: CAUSE OF DEATH ON DEATH CERTIFICATE LISTED AS: ACUTE HYPOXIC RESPIRATORY FAILURE, SEPTIC SHOCK, BACTERIAL PNEUMONIA, COVID-19 PNEUMONIA
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Septic shock
Clinical narrative: CAUSE OF DEATH ON DEATH CERTIFICATE LISTED AS: ACUTE HYPOXIC RESPIRATORY FAILURE, SEPTIC SHOCK, BACTERIAL PNEUMONIA, COVID-19 PNEUMONIA
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Death
Clinical narrative: CAUSE OF DEATH LISTED ON DEATH CERTIFICATE: COVID PNEUMONIA, LUNG CARCINOMA
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Amino acid level normal, Blood culture negative, Computerised tomogram head normal, Culture urine negative, Electroencephalogram normal
Clinical narrative: Cluster of seizures lasting 1 - 1.5 hours, focal tonic seizures with fencer pose. Patient was taken to ER by EMS and given anti-seizure medication (Midazolam and Keppra). Patient was hospitalized after event. Patient discharged on Keppra.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging head normal, Partial seizures, Respiratory viral panel
Clinical narrative: Cluster of seizures lasting 1 - 1.5 hours, focal tonic seizures with fencer pose. Patient was taken to ER by EMS and given anti-seizure medication (Midazolam and Keppra). Patient was hospitalized after event. Patient discharged on Keppra.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Scan with contrast normal, Seizure cluster, Tonic convulsion, Urine organic acid test
Clinical narrative: Cluster of seizures lasting 1 - 1.5 hours, focal tonic seizures with fencer pose. Patient was taken to ER by EMS and given anti-seizure medication (Midazolam and Keppra). Patient was hospitalized after event. Patient discharged on Keppra.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Chest pain, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram spine, Coordination abnormal, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Inflammation, Migraine, Mobility decreased
Clinical narrative: Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Myalgia, Nervous system disorder, Neuralgia, Pain in extremity
Clinical narrative: Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Paraesthesia, Thunderclap headache, Vaccination site pain
Clinical narrative: Nervous system symptoms, thunder clap headaches, severe panic attacks, extreme fatigue, pain in chest, pain continues at vaccine site Left arm and right arm.  Numbness and tingling of extremities, face, arms.  Two episodes of  inability to move my Legs or get out of bed and stand due to agonizing pain to legs. Prescription for Lyrica shortly after for parasthesia and nerve pain.  Inflammatory symptoms to include joint pain, muscle pain, Migraine headaches.  Severe dizziness with racing heart beat, chest pain and inability to perform my job as a nurse  due to persistent brain fog, short term memory issues and lack of coordination.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspepsia, Exposure during pregnancy, Foetal heart rate abnormal
Clinical narrative: I found out I was pregnant via a Positive home Pregnancy test June 21, 2021. The pregnancy was also confirmed on June 26, 2021.  Starting July 10 thru July 14, 2021, I became sick with significant diarrhea, upset stomach, nausea, and heartburn. I did not have a fever, vomiting, head cold, headache, muscle aches, sore throat, not I had come in contact with anyone who was COVID+.  On July 26,  2021, I had my first ultrasound at which time my preganancy appeared  to be measuring two weeks earlier at 6 weeks, 4 days gestation, with the estimated delivery date 3.17.22.  According to the last menstrual period I had, I should have measured 9 weeks and 5 days, with estimated delivery date 2.24.22. On August 2, 2021, I had my Second ultrasound where it was discovered that there was no heartbeat and the decision to have a D&C was made, scheduled and performed on 8.6.2021 by OBGYN.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pregnancy test positive, Ultrasound foetal abnormal, Uterine dilation and curettage
Clinical narrative: I found out I was pregnant via a Positive home Pregnancy test June 21, 2021. The pregnancy was also confirmed on June 26, 2021.  Starting July 10 thru July 14, 2021, I became sick with significant diarrhea, upset stomach, nausea, and heartburn. I did not have a fever, vomiting, head cold, headache, muscle aches, sore throat, not I had come in contact with anyone who was COVID+.  On July 26,  2021, I had my first ultrasound at which time my preganancy appeared  to be measuring two weeks earlier at 6 weeks, 4 days gestation, with the estimated delivery date 3.17.22.  According to the last menstrual period I had, I should have measured 9 weeks and 5 days, with estimated delivery date 2.24.22. On August 2, 2021, I had my Second ultrasound where it was discovered that there was no heartbeat and the decision to have a D&C was made, scheduled and performed on 8.6.2021 by OBGYN.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swollen vaccine site, redness.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 069H21A) for COVID-19 prophylaxis.     Acute illness at the time of vaccination, chronic illness or if patient has ever been diagnosed with COVID-19 was unknown.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Significant follow up received. Route of administration and dose detail for 4th dose and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     It was if patient was diagnosed or tested positive with COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long standing health conditions.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13Jul2022 Date of administration of vaccine was -26Jul2022).    No concomitant product reported by reporter. It was reported that they inadvertently administered 51 doses of the monovalent vaccines of Lot number 004M21A, expiration date as 13-Jul-2022 and was administered on 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up contains significant information: Route and site of administration for suspect product added. Medical history details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin, X-ray
Clinical narrative: Physical Therapy August 1, 2022 till December 1, 2023. Orthopedica office.  First visit ex-rays and cortisone.  Second visit follow up.  Primary doctor prescribes Meloxicam.  Identifies the medical community cannot ex-ray soft tissue. Physical Therapy for four months.  No results.  Have new symtoms evolving.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain, X-ray limb
Clinical narrative: Physical Therapy August 1, 2022 till December 1, 2023. Orthopedica office.  First visit ex-rays and cortisone.  Second visit follow up.  Primary doctor prescribes Meloxicam.  Identifies the medical community cannot ex-ray soft tissue. Physical Therapy for four months.  No results.  Have new symtoms evolving.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin, X-ray
Clinical narrative: Immediate pain that has never subsided.  I have had shoulder muscle pain since the injection and exists today.  I can go to the point of injection on my are because pain and a lump navigates me there.  I have spent many hours at physical therapy now and visited an orthopediac sports doctor.  The sports doctor's solution to my injury was chortizone steroids.  Once the chortizone wore off the pain is still there.  My primary doctor tried to convince me that I must of injured my shoulder to cause the severity and length of the pain.  I thought through my doctor's declaration once I left his office.  I thought maybe the pain was not the shot but was prolonged in the spot due to another injury
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain, X-ray limb
Clinical narrative: Immediate pain that has never subsided.  I have had shoulder muscle pain since the injection and exists today.  I can go to the point of injection on my are because pain and a lump navigates me there.  I have spent many hours at physical therapy now and visited an orthopediac sports doctor.  The sports doctor's solution to my injury was chortizone steroids.  Once the chortizone wore off the pain is still there.  My primary doctor tried to convince me that I must of injured my shoulder to cause the severity and length of the pain.  I thought through my doctor's declaration once I left his office.  I thought maybe the pain was not the shot but was prolonged in the spot due to another injury
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Fatigue, Fear, Heart rate increased
Clinical narrative: Nausea,  Heart  Beat changes , high heart beats  tiredness, anxiety, depression and fear.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea,  Heart  Beat changes , high heart beats  tiredness, anxiety, depression and fear.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: On the 2nd day after the 4th Covid bivalent booster vaccine, my husband had a full syncope. It happened shortly after lunch. He passed out while standing on the kitchen counter to take his daily vitamins. He regained consciousness 30 sec after.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: wakeup in  night with very high BP 2 to 3 times in night
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Angina pectoris, Angina unstable, Obstructive sleep apnoea syndrome
Clinical narrative: wakeup in  night with very high BP 2 to 3 times in night
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever Body ache Sore and hot around where shot was given Chills
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests normal, Audiogram normal, Cerumen removal, Excessive cerumen production, Otoacoustic emissions test
Clinical narrative: Tinnitus - (ringing in the ear) started in left ear, then right ear. First six weeks it was intermittent, daily, but not all day. By six weeks post vaccine, the tinnitus was constant in both ears, worse in the left (higher pitched.) I saw a nurse practitioner in my PCP office, Nov 25, 2022 (first available appointment), minor ear wax noted in right ear on physical exam, and flushed easily with Ear Wax Removal  Drops (Carbamide peroxide 6.5%) at home. NP suggested audiology consult.  I made an appointment with the recommended audiologist, the soonest I could be seen was Dec. 16, 2022 at facility by Dr. She performed the follwoing tests: Pure Tone Threshold Air Only; Speech Audiometry, Tympanometry, and Comprehensive DPOAE. All results were "NORMAL, negative hearing loss." Diagnosis: bilateral tinnitus - no treatment available. Recommended white noise to distract the sound, and referred to ENT for further consult. I saw ENT Dr. on 2/3/2023 - first available appt- who briefly looked in both ears, and stated "nothing can be done for tinnitus, learn to live with it."
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Tinnitus, Tympanometry normal
Clinical narrative: Tinnitus - (ringing in the ear) started in left ear, then right ear. First six weeks it was intermittent, daily, but not all day. By six weeks post vaccine, the tinnitus was constant in both ears, worse in the left (higher pitched.) I saw a nurse practitioner in my PCP office, Nov 25, 2022 (first available appointment), minor ear wax noted in right ear on physical exam, and flushed easily with Ear Wax Removal  Drops (Carbamide peroxide 6.5%) at home. NP suggested audiology consult.  I made an appointment with the recommended audiologist, the soonest I could be seen was Dec. 16, 2022 at facility by Dr. She performed the follwoing tests: Pure Tone Threshold Air Only; Speech Audiometry, Tympanometry, and Comprehensive DPOAE. All results were "NORMAL, negative hearing loss." Diagnosis: bilateral tinnitus - no treatment available. Recommended white noise to distract the sound, and referred to ENT for further consult. I saw ENT Dr. on 2/3/2023 - first available appt- who briefly looked in both ears, and stated "nothing can be done for tinnitus, learn to live with it."
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Member was administered an expired vaccination. Vaccine expiration is 2022 NOV 03 @ proximatley 1000. Member notified by 1200.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Feeling abnormal, Lethargy, Nausea, Rash pruritic
Clinical narrative: chills, dry heaves, nausea, vomiting, uncontrollable body shaking while heaving.  Hard to describe feeling in head of being not in control of my body while heaving. Never experienced this feeling before.  Severe lethargy. Two days after vaccination I got  itchy rash under both upper arms. Worse on left than right side.  As I slowly recovered, brain fog set in at different times making it difficult to "think straight".
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Retching, Thinking abnormal, Tremor, Vomiting
Clinical narrative: chills, dry heaves, nausea, vomiting, uncontrollable body shaking while heaving.  Hard to describe feeling in head of being not in control of my body while heaving. Never experienced this feeling before.  Severe lethargy. Two days after vaccination I got  itchy rash under both upper arms. Worse on left than right side.  As I slowly recovered, brain fog set in at different times making it difficult to "think straight".
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok administered to 17 year old.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Super tired, severe headache, aches, super sore arm, nauseous
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit.