chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Regulatory authority consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Medical facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: On 7-24-2022, I had a sore throat. The following morning I had the sniffles. On 7-26, I used a home COVID-19 test with negative results. On 7-27, I tested positive with a home COVID-19 test. I contacted my primary care physician on 7-27 thru their internet portal. She responded back on 7-29 thru the portal and told me to take aspirin or TYLENOL for fever (don't know if I ever had one) and drink a lot of non caffeinated fluids. She did not order any medications or tests. I tested negative on 8-6-2022 with a home COVID-19 test. I am reporting a breakthrough case of COVID-19.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Medical facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough; COVID-19 (Pfizer) 1; 86 Years 8 Months 02/26/2021; Pfizer; EN6201; COVID-19 (Pfizer) 2 86 Years 9 Months; 03/19/2021; Pfizer; EN6198; COVID-19 (Pfizer; 3; 87 Years 4 Month; 10/14/2021; Pfizer FF2590
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: On Friday mother of pt brought her in to get her first covid vaccine, I did not double check the age and accidently gave the 5-11 pfizer dose for peds. When i vaccinated pt she did not have any reaction to vaccine GH
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain
Clinical narrative: Severe chest pains. Heart strain.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: He had a fever and possibly a sore throat. The only treatment was TYLENOL and MOTRIN to manage the fever. He had a fever all of 08/08/2022 and most of 08/09/2022. He has not had a fever today. He tested negative for COVID-19, Flu and Strep. Doctors just thought maybe he caught something viral from somewhere. He has been going to daycare recently (first time ever) so we feel like it may be mostly related to that.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Brain cancer metastatic, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted for metastatic cancer to the brain and acute respiratory failure with hypoxia on 8/3. Pt was not tested for COVID on admission. She was tested on 8/9 due to placement and was found to be positive.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received the Jynnoes Vaccine via incorrect route, IM instead of SQ.  Left arm was swollen, red, and painful at injection site upon waking on 8/9 around 0520.  Took ibuprofen, used an Ice-Pack on 8/9 with some relieve.  Left arm is still swollen and tender at injection site.  Upon doing some research, found out I received the vaccine incorrectly.  Should have been SQ or TD.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Gait disturbance, Headache, Pyrexia
Clinical narrative: Fourth dose in Pfizer series. I developed an extremely high fever. 105 degrees. Excruciating headache and had a very difficult time walking. This was the evening of the 8/8/22 (vaccination date). I was extremely cold. Eventually able to bring the fever down to 103.8 Fever and chills through the night. Fever and headache on the 9th. Again able to eventually bring the fever to 103 on the evening of the ninth. Fever abated the morning of the 10th.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated 2 doses
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 16.0
Sex: M
Vaccine: COVID19, HEPA, HPV9, IPV, TDAP
Symptoms: Bacteraemia, Condition aggravated, Epilepsy, Feeling cold, Headache
Clinical narrative: 8/7/2022- Assitant to the family calling for acute constant severe fever (101.5 currently), headache and intermittent seizures "every night" since pt received immunizations (TDAP, Polio, Covid-19, Hep A and HPV) at Health Dept on 7/29. Per pt's father pt "feeling cold and shaky". Pt is awake and alert per pt's father. Pt has hx of seizures but from symptoms reported by pt's family the number of seizures pt has been having has increased since pt received the 5 immunizations. PT reached out to pt's neurologist on 8/5 r/t reported seizures and neurologist recommended increasing pt's Keppra medication to 750 mg BID per note in pt's chart. Per note in pt's chart neurologist staff were not able to reach pt's family to inform them of the increase in medication dosage. Pt's family denies receiving message regarding increasing pt's Keppra medication dose.   Symptoms started 7/29.   Pertinent negatives include: No chest pain. No breathing difficulty. No cyanosis. No diarrhea. No vomiting. No cough. No known exposure to Covid-19. No symptoms of dehydration, still urinating with normal frequency.  Patient unknown.   Patient presented to Hospital on 8/7/22 and is currently admitted (as of 8/10/22) for;  Hospital Problem List   Epilepsy, unspecified, not intractable, without status epilepticus  Left lower lobe pneumonia  Sepsis due to pneumonia  Fever in pediatric patient   Hyponatremia   Leukocytosis   Hypotension   Bacteremia due to Gram-positive bacteria
Age: 16.0
Sex: M
Vaccine: COVID19, HEPA, HPV9, IPV, TDAP
Symptoms: Hypotension, Nervousness, Pneumonia, Pyrexia, Seizure
Clinical narrative: 8/7/2022- Assitant to the family calling for acute constant severe fever (101.5 currently), headache and intermittent seizures "every night" since pt received immunizations (TDAP, Polio, Covid-19, Hep A and HPV) at Health Dept on 7/29. Per pt's father pt "feeling cold and shaky". Pt is awake and alert per pt's father. Pt has hx of seizures but from symptoms reported by pt's family the number of seizures pt has been having has increased since pt received the 5 immunizations. PT reached out to pt's neurologist on 8/5 r/t reported seizures and neurologist recommended increasing pt's Keppra medication to 750 mg BID per note in pt's chart. Per note in pt's chart neurologist staff were not able to reach pt's family to inform them of the increase in medication dosage. Pt's family denies receiving message regarding increasing pt's Keppra medication dose.   Symptoms started 7/29.   Pertinent negatives include: No chest pain. No breathing difficulty. No cyanosis. No diarrhea. No vomiting. No cough. No known exposure to Covid-19. No symptoms of dehydration, still urinating with normal frequency.  Patient unknown.   Patient presented to Hospital on 8/7/22 and is currently admitted (as of 8/10/22) for;  Hospital Problem List   Epilepsy, unspecified, not intractable, without status epilepticus  Left lower lobe pneumonia  Sepsis due to pneumonia  Fever in pediatric patient   Hyponatremia   Leukocytosis   Hypotension   Bacteremia due to Gram-positive bacteria
Age: 16.0
Sex: M
Vaccine: COVID19, HEPA, HPV9, IPV, TDAP
Symptoms: Sepsis
Clinical narrative: 8/7/2022- Assitant to the family calling for acute constant severe fever (101.5 currently), headache and intermittent seizures "every night" since pt received immunizations (TDAP, Polio, Covid-19, Hep A and HPV) at Health Dept on 7/29. Per pt's father pt "feeling cold and shaky". Pt is awake and alert per pt's father. Pt has hx of seizures but from symptoms reported by pt's family the number of seizures pt has been having has increased since pt received the 5 immunizations. PT reached out to pt's neurologist on 8/5 r/t reported seizures and neurologist recommended increasing pt's Keppra medication to 750 mg BID per note in pt's chart. Per note in pt's chart neurologist staff were not able to reach pt's family to inform them of the increase in medication dosage. Pt's family denies receiving message regarding increasing pt's Keppra medication dose.   Symptoms started 7/29.   Pertinent negatives include: No chest pain. No breathing difficulty. No cyanosis. No diarrhea. No vomiting. No cough. No known exposure to Covid-19. No symptoms of dehydration, still urinating with normal frequency.  Patient unknown.   Patient presented to Hospital on 8/7/22 and is currently admitted (as of 8/10/22) for;  Hospital Problem List   Epilepsy, unspecified, not intractable, without status epilepticus  Left lower lobe pneumonia  Sepsis due to pneumonia  Fever in pediatric patient   Hyponatremia   Leukocytosis   Hypotension   Bacteremia due to Gram-positive bacteria
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 16.0
Sex: F
Vaccine: COVID19, MNQ
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: Mother asked for Pfizer vaccine however Moderna was inadvertently administered. Both mother and patient were advised of the error immediately after vaccination was given. The correct dose of Moderna was given to the patient and she had no adverse reactions.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest pain, Electrocardiogram normal, Feeling hot
Clinical narrative: Starting on 07/28/2022, I started having a lot of body aches all over and chest pain. My back was throbbing at one point. I had some nausea and threw up once. I also had a fever which lasted for a full week. Thursday, Friday, and Saturday, the fever was over 100 degrees. On Thursday, it got up to 102. Sunday and Monday, it was between 99.5 and 100.5. I saw my PCP on Tuesday and my temperature was still elevated to 99 degrees and they said that they could feel the heat radiating off me. My temperature is normally around 97.7 degrees. My doctor did not prescribe anything or do a COVID-19 test. They advised that I treat with Advil and Tylenol and call back if things worsened. My fever finally broke on Thursday and got back down to 98 degrees.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Starting on 07/28/2022, I started having a lot of body aches all over and chest pain. My back was throbbing at one point. I had some nausea and threw up once. I also had a fever which lasted for a full week. Thursday, Friday, and Saturday, the fever was over 100 degrees. On Thursday, it got up to 102. Sunday and Monday, it was between 99.5 and 100.5. I saw my PCP on Tuesday and my temperature was still elevated to 99 degrees and they said that they could feel the heat radiating off me. My temperature is normally around 97.7 degrees. My doctor did not prescribe anything or do a COVID-19 test. They advised that I treat with Advil and Tylenol and call back if things worsened. My fever finally broke on Thursday and got back down to 98 degrees.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine administered, no adverse event immediately following administration, patient monitored for 15 minutes
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Stiff neck, chills, fever, headache, body aches, painful injection site, nausea
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Stiff neck, chills, fever, headache, body aches, painful injection site, nausea
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram normal, Bell's palsy, Magnetic resonance imaging normal
Clinical narrative: Bell's Palsy starting on 6/19.  No significant change in  activities of daily life.  Continued to work.   Normal MRI and MRA on 6/25.  Significant improvement in symptoms by 7/3.  Minor symptoms which are not concerning now.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: First booster dose. Received 0.2ml instead of 0.3ml of Pfizer
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site mass
Clinical narrative: Sometime within the few following days after vaccination, I remarked a painless, marble-sized lump under the skin, approximate to the injection site. Feels similar to a fatty deposit. Pharmacist indicated that at least one other patient had reported a similar finding. Nearly two weeks after the injection, the lump remains and seems to be the same size.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events  or treatment needed
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Giant cell arteritis, Headache, Inflammatory marker increased
Clinical narrative: 8/1/2022 - 8/2/2022 (21 hours)  Hospital   This is a 75-year-old female presenting to the emergency department for headache. Vital significant tachycardia otherwise afebrile not hypoxic or hypertensive. On exam, patient is uncomfortable appearing.  She has tenderness to palpation of the bilateral temporal regions.  She is otherwise neuro intact.  No numbness tingling or weakness in the upper lower extremities.  Cranial nerves are intact. Differential diagnosis includes was not limited to migraine, tension headache, temporal arteritis.  Low suspicion subarachnoid hemorrhage, as the pain is been ongoing for 2 days, is not the worst headache she has ever had in her life and has no other neuro symptoms. Based on bitemporal location of headache with tenderness to palpation, I do have concern for temporal arteritis and laboratory work is obtained.  Patient is given a migraine cocktail. After migraine cocktail, patient still continues to have pain.  She does have elevated inflammatory markers with an ESR of 65 concerning for possible temporal arteritis.  I spoke with Neurology who will evaluate the patient at bedside. After neurology evaluation, they agree with possible temporal arteritis.  They recommended admission to Medicine.  Screening COVID is obtained, and does appear to be positive.  Patient admitted for further observation and discharged 8/2/22 stable
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Red blood cell sedimentation rate increased, SARS-CoV-2 test positive, Subarachnoid haemorrhage
Clinical narrative: 8/1/2022 - 8/2/2022 (21 hours)  Hospital   This is a 75-year-old female presenting to the emergency department for headache. Vital significant tachycardia otherwise afebrile not hypoxic or hypertensive. On exam, patient is uncomfortable appearing.  She has tenderness to palpation of the bilateral temporal regions.  She is otherwise neuro intact.  No numbness tingling or weakness in the upper lower extremities.  Cranial nerves are intact. Differential diagnosis includes was not limited to migraine, tension headache, temporal arteritis.  Low suspicion subarachnoid hemorrhage, as the pain is been ongoing for 2 days, is not the worst headache she has ever had in her life and has no other neuro symptoms. Based on bitemporal location of headache with tenderness to palpation, I do have concern for temporal arteritis and laboratory work is obtained.  Patient is given a migraine cocktail. After migraine cocktail, patient still continues to have pain.  She does have elevated inflammatory markers with an ESR of 65 concerning for possible temporal arteritis.  I spoke with Neurology who will evaluate the patient at bedside. After neurology evaluation, they agree with possible temporal arteritis.  They recommended admission to Medicine.  Screening COVID is obtained, and does appear to be positive.  Patient admitted for further observation and discharged 8/2/22 stable
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tenderness, Tension headache
Clinical narrative: 8/1/2022 - 8/2/2022 (21 hours)  Hospital   This is a 75-year-old female presenting to the emergency department for headache. Vital significant tachycardia otherwise afebrile not hypoxic or hypertensive. On exam, patient is uncomfortable appearing.  She has tenderness to palpation of the bilateral temporal regions.  She is otherwise neuro intact.  No numbness tingling or weakness in the upper lower extremities.  Cranial nerves are intact. Differential diagnosis includes was not limited to migraine, tension headache, temporal arteritis.  Low suspicion subarachnoid hemorrhage, as the pain is been ongoing for 2 days, is not the worst headache she has ever had in her life and has no other neuro symptoms. Based on bitemporal location of headache with tenderness to palpation, I do have concern for temporal arteritis and laboratory work is obtained.  Patient is given a migraine cocktail. After migraine cocktail, patient still continues to have pain.  She does have elevated inflammatory markers with an ESR of 65 concerning for possible temporal arteritis.  I spoke with Neurology who will evaluate the patient at bedside. After neurology evaluation, they agree with possible temporal arteritis.  They recommended admission to Medicine.  Screening COVID is obtained, and does appear to be positive.  Patient admitted for further observation and discharged 8/2/22 stable
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the   Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.   Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Electrocardiogram
Clinical narrative: hearet issues; blasion
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Roseola, Viral infection
Clinical narrative: Fever developed the night of the vaccine and continues for three days. On the third day after the vaccine, the fever stopped and a rash appeared. Clinically this is consistent with a viral infection (roseola) and likely not related to vaccine.   However, given temporal relationship to vaccine administration, report made
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Second booster dose. Given 0.2ml instead of 0.3ml
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone decreased, Blood thyroid stimulating hormone increased, Fatigue, Pain, Red blood cell count decreased
Clinical narrative: Generalized pain, fatigue, weight gain,
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Therapeutic product ineffective, Weight increased, White blood cell count decreased
Clinical narrative: Generalized pain, fatigue, weight gain,
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.  Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Second booster dose. Given 0.2ml instead of 0.3ml
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, COVID-19, Confusional state, Fall
Clinical narrative: Brought to ED by family due to confusion, weakness and frequent falls. Tested positive for covid on admission. Treatment includes anticoagulation, and monitoring.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Brought to ED by family due to confusion, weakness and frequent falls. Tested positive for covid on admission. Treatment includes anticoagulation, and monitoring.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Second booster. Given 0.2ml instead of 0.3ml
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Second Booster. Given 0.2ml instead of 0.3ml
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Second booster. Given 0.2ml instead of 0.3ml
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: At 11:25 pt stated " I feel dizzy and would like to lay down". Laid pt down and placed cold pack on him. 11:27 BP: 120/80 P:86 R:20 O2 Sat 96. At 11:36 pt stated he felt better nurse had pt stay an additional 15 mins before he left the site.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Mobility decreased, Myalgia, Pain
Clinical narrative: The next morning after my dose 3 when I woke up I was experiencing a significant amount of joint and muscle pain all over.  I stayed in bed  and took some Aleve. I contacted my doctor the following evening because the pain and discomfort continued the following day. By the the third day it was still present but was diminishing.  I think by the end of the third day it was completely gone.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested COVID + and required hospitalization after receiving 2 vaccines and two booster.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dizziness, Laboratory test, Vomiting
Clinical narrative: Sx of dizziness and vomiting. Treatment includes IV fluid resuscitation, labs, cardiac monitoring.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Diffuse, red, itchy rash x  1 week, starting 1 week after vaccination
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: First booster. Given 0.2ml instead of 0.3ml
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was given the vaccine on 8/9/22 @ 1513 and then again (same lot and arm) on 8/10/22 @ 1142 accidentally.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Accidental 5th Pfizer booster shot administered. No adverse effect noted.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond use date of  07/29/2022 (30 day freezer to fridge dating). Patient contacted and has no signs or symptoms and will contact MD regarding re-vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated with 2 Pfizer doses.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: She developed a fever to 101 on Friday August 5th. Fever returned on 8/6/2022, last fever was on the evening of 8/6/2022. Resolved with motrin and tylenol. Two episodes of emesis one am on 8/6 and another in the middle of the night on 8/7/22. Went to pediatric urgent care 8/6/22. Afebrile, no abnormal findings, flu and covid negative. Doctor believed it be a virus and that it would resolve with rest, fluids, tylenol.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient had a swollen arm which was warm not located by injection site
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: Starting 07/20/2022, I had symptoms. I did the at-home COVID-19 test the same day which was positive. I called the clinic that day and they scheduled me for the monoclonal antibody infusion the next day. After this I came home and went to bed early, and upon waking up on 07/22/2022, I felt much better. I have been feeling better progressively since then. I am still experiencing some "brain fog" to this day.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Peripheral swelling, X-ray
Clinical narrative: Severe back pain and left foot swelling  Took Motrin and got x-rays but resolved in 24 hours
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Procedural pain
Clinical narrative: The patient experienced knee pain, on an area next to previous injury
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. consulted with the  Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site bruising, Injection site mass, Injection site swelling
Clinical narrative: Growing lump and bruise at injection site; continuing more than 9 days after injection
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented with shortness of breath and tested + for Covid. Treated with Remdesivir and dexametasone. Once stable pt discharged home.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Hyperhidrosis, Hypersomnia
Clinical narrative: She got her vaccine, she was fine until about late afternoon and by dinner she was so cold she was frozen, cold all over, aching, definite pain at the site of the injection.  She went to bed at 8:00 and at 12:00 she got up to use the bathroom, and was unbelievably weak and nauseated and she was completely diaphoretic from her top of her head to her toes and then fainted right next to the bed.  Her husband tried to get her up, she got up and fainted again.  Finally he got her back into bed, and usually they are up at 5:30 to 6:00 AM as they walk 3-4 miles a day, and she got up at 8:00 Am and still didn't feel real great, but feeling pretty decent now.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Syncope
Clinical narrative: She got her vaccine, she was fine until about late afternoon and by dinner she was so cold she was frozen, cold all over, aching, definite pain at the site of the injection.  She went to bed at 8:00 and at 12:00 she got up to use the bathroom, and was unbelievably weak and nauseated and she was completely diaphoretic from her top of her head to her toes and then fainted right next to the bed.  Her husband tried to get her up, she got up and fainted again.  Finally he got her back into bed, and usually they are up at 5:30 to 6:00 AM as they walk 3-4 miles a day, and she got up at 8:00 Am and still didn't feel real great, but feeling pretty decent now.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: They came out like hives. I was itching with red bumps and patches. The itching was like it was bubbling underneath the skin. I waited a while and finally went to urgent care and got prednisone at the end of May. It suppressed but it came back as soon as the medication was completed. I saw an allergist on July 21, and I saw a dermatologist in June. I still get them. They do not come every day  but they do pop up here and there.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Detoxification, Nausea, Tremor
Clinical narrative: Asymptomatic, nausea, tremors, here for detox.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: undiluted vaccine
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Herpes zoster, Nausea
Clinical narrative: 7/06/2022-07/13/2022 I had off and on chills,no fever, nausea and severe pain in right hip area and lower back. 7/11/2022 I felt a cluster of bumps on my right lower back. By 07/13/2022 in the evening they covered my lower right back, right hip, groin, upper right leg and right side of stomach. Called primary on 7/14/2022, she wasn't available but saw another doctor in the practice for in office appt at 3 pm. After describing my syptoms she diagosed me with shingles. She prescribed an 5 day course of antiviral medication. Rash lessoned as the weeks went on but the nerve pain is still there 4 weeks later. At the time I saw that doctor I did not connect the COVID booster to shingles, but after doing some research and and talking to friends and one person who had COVID in June and got shingles also, I reported my diagnosis to VSafe, who asked me to fill out this form. I did not include the doctors name who diagnosed me because we didn't talk at the time about any connection to my COVID booster 2 months prior to my outbreak. If you need her name, let me know.