chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: COULD NOT DRIVE HOME; THREE DAYS SLEPT (NOT LIKE ME AT ALL); STOMACH WAS OFF; WAS DIZZY; SOME OF FINGERS WERE NOT FEELING RIGHT; HURTING FOOT/CONTINUES TO HURT FOOT/ TURNING IN FOOT; DO NOT HAVE THE STRENGTH; LEG GO NUMB/NUMB GOES UP ENTIRE LEG AND OTHER FOOT WAS STARTING; VERY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not drive home, three days slept (not like me at all), stomach was off, was dizzy, some of fingers were not feeling right, hurting foot/continues to hurt foot/ turning in foot, do not have the strength, leg go numb/numb goes up entire leg and other foot was starting, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired, could not drive home, three days slept (not like me at all), stomach was off, and was dizzy, had not recovered from leg go numb/numb goes up entire leg and other foot was starting, and the outcome of hurting foot/continues to hurt foot/ turning in foot, some of fingers were not feeling right and do not have the strength was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypersomnia, Hypoaesthesia, Impaired driving ability, Pain in extremity
Clinical narrative: COULD NOT DRIVE HOME; THREE DAYS SLEPT (NOT LIKE ME AT ALL); STOMACH WAS OFF; WAS DIZZY; SOME OF FINGERS WERE NOT FEELING RIGHT; HURTING FOOT/CONTINUES TO HURT FOOT/ TURNING IN FOOT; DO NOT HAVE THE STRENGTH; LEG GO NUMB/NUMB GOES UP ENTIRE LEG AND OTHER FOOT WAS STARTING; VERY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not drive home, three days slept (not like me at all), stomach was off, was dizzy, some of fingers were not feeling right, hurting foot/continues to hurt foot/ turning in foot, do not have the strength, leg go numb/numb goes up entire leg and other foot was starting, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired, could not drive home, three days slept (not like me at all), stomach was off, and was dizzy, had not recovered from leg go numb/numb goes up entire leg and other foot was starting, and the outcome of hurting foot/continues to hurt foot/ turning in foot, some of fingers were not feeling right and do not have the strength was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Asthma.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AEs reported.; Moderna COVID-19 Vaccine after more than 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No AEs reported.) in a 79-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No AEs reported.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No AEs reported.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported.   Healthcare professional reported that they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date. No AEs reported. Patient identifiers for patient number 11 are documented in this case.  No treatment details were reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who was diagnosed with flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for Flu (influenza immunization)  On an unknown date the patient diagnosed with a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Pt presented to the ED with complaints of a non-productive cough and shortness of breath for the last few days. She has been out of her inhalers and therefore has not been able to use them. The patient states it is hard for her to differentiate a COPD versus CHF exacerbation. She has been taking her Lasix daily as prescribed. The patient does not weight herself reguarly, but denies recent weight gain and her clothes feel the same. She denies leg swelling. The patient denies fever and chills. She denies congestion. The patient has intermittent chest pain that is not abnormal for her and occasionally takes Nitroglycerin for her chest pain. Cardio consulted. 11/16 BC sent 11/17 repeat COVID came back positive, she was started on decadron and Tessalon pearls.   Pt was seen and is not in apparent distress sometimes decline meds. Denies any current CP with intermittent exertional SOB. She was discharged in stable condition on 11/27/2021
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Ear pain, Injection site pain, Mastication disorder, Myalgia, Pain
Clinical narrative: A few hours after receiving the Covid 19 bivalent booster and addition to the Flu shot (which was administered into my right arm at the same pharmacy visit) I experienced pain I my right ear and lower jaw. The muscles of my jaw were sore and it was painful to chew on that side of my mouth for a few days and the ear on that side was painful for the first couple of days after the shots and remained tender and sensitive for about 4/5 days. There was no adverse effect on my hearing on that side but I could not chew or bite down on that side of my mouth without pain or sensitivity for almost a week. I am finally to the point where the ear and jaw on the right side of my face feel as though they are back to normal.
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain in jaw
Clinical narrative: A few hours after receiving the Covid 19 bivalent booster and addition to the Flu shot (which was administered into my right arm at the same pharmacy visit) I experienced pain I my right ear and lower jaw. The muscles of my jaw were sore and it was painful to chew on that side of my mouth for a few days and the ear on that side was painful for the first couple of days after the shots and remained tender and sensitive for about 4/5 days. There was no adverse effect on my hearing on that side but I could not chew or bite down on that side of my mouth without pain or sensitivity for almost a week. I am finally to the point where the ear and jaw on the right side of my face feel as though they are back to normal.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypertension, Muscle twitching, Tremor
Clinical narrative: twitching in different places (arms, face, thighs..) at first and then a trembling or twitching all over but inside my body . Also had sudden unexplained very high blood pressure readings and went to the cardiologist.  The highest reading was 235 over 110. Got on blood pressure meds.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Dizziness, Headache, Neuralgia
Clinical narrative: On the second day of vaccination, I felt minor dizzy on the morning with a little bit headache, but the symptom disappeared in the afternoon.  On the third and forth days after vaccination, I felt sore on both of my shoulders, especially on the right side, I can feel a nerve pulling from my shoulder to my rare side of my head causing headache occasionally, but the symptom disappeared after two and three days.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was exposed to temperatures out of the recommended range.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash/swelling/hives localized to left upper arm lasting approximately 2 weeks. States had same reaction to COVID vaccine previously
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash/swelling/hives localized to left upper arm lasting approximately 2 weeks. States had same reaction to COVID vaccine previously
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was exposed to temperatures out of the recommended range.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient claimed to have experienced a large area of redness, swelling and pain around the site of injection (right arm) but says it has now cleared. no other issues reported.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine was exposed to temperatures out of the recommended range.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient pointed to the area where we gave a shot and it is the correct area to give vaccine. Pt is saying he is still in pain and cannot lift his arm very well.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: A second series of Monovalent, Novavax Vaccine was administered and required only one. First dose 10/15/2022. Second dose not required 11/22/2022.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site mass, Weight bearing difficulty
Clinical narrative: 2 days after vaccines were given patient awoke unable to bear weight on left leg.  Mom called healthcare provider to inform that  he has been army crawling around the house for 2 days starting 2 days after getting his vaccines.  She can see a red lump on his leg from one of the vaccines but no streaking or sign of infection.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lymphocyte count decreased, Lymphopenia, Malaise
Clinical narrative: -flu like symptoms - body aches, fatigue, malise 1st day or so -Lymphocytopenia (absolute) 3/28/22 0.8 (normal) 12+/ 12/5/2022 1.1 15 (increased) -Monocytosis
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Monocyte count increased, Pain
Clinical narrative: -flu like symptoms - body aches, fatigue, malise 1st day or so -Lymphocytopenia (absolute) 3/28/22 0.8 (normal) 12+/ 12/5/2022 1.1 15 (increased) -Monocytosis
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Large are of erythema, warm, and induration left deltoid measuring up to 10 x 12 cm with associated pain and pruritus
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Hypertension, Nausea, Palpitations, Vomiting
Clinical narrative: 81 yo M with PMH of AFIB, OSA, anemia 2/2 CKD, CKD stage 3,  DM 2, macular degeneration age related, CAD (IDC 2016), COPD, PVO, OA,  H TN, HLD, and hx etoh abuse. Recieved COVID-19 bivalent booster (Moderna)  on 10/28/2022. Reports pain to shoulder that lasted 3 days (this is unclear as RN  had documented giving vaccine to buttocks - unable to clarify actual location of  administration). Reports n/v, "heart racing," and "HTN with SBP in 150s." Patient  self-reported all these sx and stated they started on the night of 10/28/2022 and  subsided on 11/01/2022.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired monovalent vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered).    Concomitant medication was not reported. Patient Did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment drug was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1 st dose was given on 09Nov2022 and the 2nd dose was given on 28Nov2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 st dose was given on 09Nov2022 and the 2nd dose was given on 28Nov2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 st dose was given on 09Nov2022 and the 2nd dose was given on 28Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 st dose was given on 09Nov2022 and the 2nd dose was given on 28Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 st dose was given on 09Nov2022 and the 2nd dose was given on 28Nov2022).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: 1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A; Welts; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Welts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 025C21A) for COVID-19 prophylaxis.     Patient had no parental vaccine exposure.  Concurrent medical conditions included Hypertension, Diabetes and High cholesterol. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), HYDROXYZINE and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced URTICARIA (Welts). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A). At the time of the report, URTICARIA (Welts) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient  started getting welts a week after the second dose,  the welts come and go. Patient was taking Zyrtec 2x a day, Hydroxyzine 75mg at bedtime and Singulair once a  day. It was reported that patient did labs for autoimmune disease and the rheumatologist does not think that it was autoimmune.  No treatment medications were provided.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: A second series of Monovalent, Novavax Vaccine was administered and required only one. First dose 10/15/2022. Second dose not required 11/22/2022.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Dizziness postural, Injection site pain, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Muscle & joint pain covering full body starting around 8 hours after shot and lasting about 40 hours.  Dizzy upon standing or movement of my head from side to side lasting 30 hours.  Stiffness swelling and pain in my left shoulder ( have had 2 surgeries on that shoulder) still somewhat going on.  Pain at the injection site.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia
Clinical narrative: Muscle & joint pain covering full body starting around 8 hours after shot and lasting about 40 hours.  Dizzy upon standing or movement of my head from side to side lasting 30 hours.  Stiffness swelling and pain in my left shoulder ( have had 2 surgeries on that shoulder) still somewhat going on.  Pain at the injection site.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received an adult dose of HEP A and not the pediatric dose, no adverse signs or symptoms that I am aware of.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received monovalent dose as above instead of bivalent dose. Patient had no adverse reactions
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/22/21, 5/20/21. Positive on 12/9/22.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Asthenia, Crying, Emotional distress, Feeling abnormal, Headache
Clinical narrative: Shortly after receiving vaccinations, pt. went to check out with her mom and stated that she felt "funny" and weak. She became pale and diaphoretic; nursing and her mother aided her to a patient room to lay down. She remained diaphoretic with mildly elevated heart rate. The patient was given Pedialyte and water and allowed to rest. Blood pressure and pulse ox were within appropriate range. Patient stated she felt numbness on her jaw, her legs were tingly, she had a HA and felt her head felt off. Pt was emotionally distressed and crying. Her neuro exam was appropriate, no sign of seizure. Heart rate returned to appropriate range. Pt was frequently reassessed.  All symptoms resolved by 45 mins later.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Neurological examination normal, Pallor
Clinical narrative: Shortly after receiving vaccinations, pt. went to check out with her mom and stated that she felt "funny" and weak. She became pale and diaphoretic; nursing and her mother aided her to a patient room to lay down. She remained diaphoretic with mildly elevated heart rate. The patient was given Pedialyte and water and allowed to rest. Blood pressure and pulse ox were within appropriate range. Patient stated she felt numbness on her jaw, her legs were tingly, she had a HA and felt her head felt off. Pt was emotionally distressed and crying. Her neuro exam was appropriate, no sign of seizure. Heart rate returned to appropriate range. Pt was frequently reassessed.  All symptoms resolved by 45 mins later.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Paraesthesia
Clinical narrative: Shortly after receiving vaccinations, pt. went to check out with her mom and stated that she felt "funny" and weak. She became pale and diaphoretic; nursing and her mother aided her to a patient room to lay down. She remained diaphoretic with mildly elevated heart rate. The patient was given Pedialyte and water and allowed to rest. Blood pressure and pulse ox were within appropriate range. Patient stated she felt numbness on her jaw, her legs were tingly, she had a HA and felt her head felt off. Pt was emotionally distressed and crying. Her neuro exam was appropriate, no sign of seizure. Heart rate returned to appropriate range. Pt was frequently reassessed.  All symptoms resolved by 45 mins later.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Headache, Infection
Clinical narrative: I had a breakthrough case of Covid with cough, nasal congestion, body aches, diarrhea, headache.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasal congestion, Pain, SARS-CoV-2 test positive
Clinical narrative: I had a breakthrough case of Covid with cough, nasal congestion, body aches, diarrhea, headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I started having a cough and low-grade fever that slowly became a high-grade fever and the cough continued. My husband tested positive the day before, so I decided to test once I got the low-grade fever. The test came back positive immediately, I contacted my doctor through the web portal, she prescribed PAXLOVID that I started immediately. The cough continued so the doctor prescribed two rounds of steroids to help me get rid of it. I am now feeling much better.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 11/7/2022. no adverse affect noted, agency informed and provided guidance to provide a redose at next visit.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Dizziness, Platelet count decreased, Pyrexia
Clinical narrative: 6 hours after shot - uncontrollable chills for 4 hours. 18 hours after shot vomiting. 24 hours after shot fever of 101.3. Dizziness and weakness for 5 days.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: 6 hours after shot - uncontrollable chills for 4 hours. 18 hours after shot vomiting. 24 hours after shot fever of 101.3. Dizziness and weakness for 5 days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Impaired work ability
Clinical narrative: Starting 06/07/2022, my whole family got sick. I knew right away it was COVID-19. I tested myself right away and it was a strong positive. I was out of work for about 5 days. I saw the doctor on video on day 4. I believe the symptoms lasted about 14 days but not 100% sure. I had very severe congestion and couldn't breathe through my nose for 4-5 days and intense headaches and body aches. Also, severe coughing.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Starting 06/07/2022, my whole family got sick. I knew right away it was COVID-19. I tested myself right away and it was a strong positive. I was out of work for about 5 days. I saw the doctor on video on day 4. I believe the symptoms lasted about 14 days but not 100% sure. I had very severe congestion and couldn't breathe through my nose for 4-5 days and intense headaches and body aches. Also, severe coughing.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer 3/18/21, 4/8/21, 12/3/21. Positive on 12/9/22
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer 3/18/21, 4/8/21, 12/3/21. Positive on 12/9/22
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer 6/28/21, 7/19/21, 1/22/22. Positive on 12/9/22
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 2/23/21, 3/16/21. Positive on 12/6/22
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Headache, Impaired work ability, Laboratory test normal
Clinical narrative: 1/25/2022 I have had headaches all my life. I had COVID in April of 2021. The head aches  became more severe and more often around 1/25/2022.  I had an appointment with my PCP. She prescribed amitriptyline. I had to cancel events and was unable to go to work. I also noted a light sensitivity and had issues with my eye site.  Around mid-September, I saw a Neurologist who prescribed Sumatriptan for the headaches, but it actually gave me rebound headaches and increased my headaches. A month into taking this medication,  September 29, 2022, I went to the ER because of this medication I was prescribed. I had more severe headaches for a week, vomiting, blurred vision, dizziness and light sensitivity. I went into the ER and they gave me a migraine cocktail, cannot remember the names. It ended the migraine and I went home. The next day I felt okay and back to normal. A few days later, I had another migraine, I took the Sumatriptan and began having the same symptoms as before. I stopped taking this medication in mid-October realizing this was causing adverse reactions.  I started taking Nortek in early October and noticed a rash, so I stopped taking this medication and now take Excedrin when I have a head ache.  I still will have vision issues and headaches, but feel I have recovered.  On December 5, I went to an Ophthamologist. I had a vision refraction test. My vision was good. She prescribed Betimol eye drops  and told me to get polorized sunglasses.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Migraine, Photophobia, Rash, Vision blurred
Clinical narrative: 1/25/2022 I have had headaches all my life. I had COVID in April of 2021. The head aches  became more severe and more often around 1/25/2022.  I had an appointment with my PCP. She prescribed amitriptyline. I had to cancel events and was unable to go to work. I also noted a light sensitivity and had issues with my eye site.  Around mid-September, I saw a Neurologist who prescribed Sumatriptan for the headaches, but it actually gave me rebound headaches and increased my headaches. A month into taking this medication,  September 29, 2022, I went to the ER because of this medication I was prescribed. I had more severe headaches for a week, vomiting, blurred vision, dizziness and light sensitivity. I went into the ER and they gave me a migraine cocktail, cannot remember the names. It ended the migraine and I went home. The next day I felt okay and back to normal. A few days later, I had another migraine, I took the Sumatriptan and began having the same symptoms as before. I stopped taking this medication in mid-October realizing this was causing adverse reactions.  I started taking Nortek in early October and noticed a rash, so I stopped taking this medication and now take Excedrin when I have a head ache.  I still will have vision issues and headaches, but feel I have recovered.  On December 5, I went to an Ophthamologist. I had a vision refraction test. My vision was good. She prescribed Betimol eye drops  and told me to get polorized sunglasses.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1/25/2022 I have had headaches all my life. I had COVID in April of 2021. The head aches  became more severe and more often around 1/25/2022.  I had an appointment with my PCP. She prescribed amitriptyline. I had to cancel events and was unable to go to work. I also noted a light sensitivity and had issues with my eye site.  Around mid-September, I saw a Neurologist who prescribed Sumatriptan for the headaches, but it actually gave me rebound headaches and increased my headaches. A month into taking this medication,  September 29, 2022, I went to the ER because of this medication I was prescribed. I had more severe headaches for a week, vomiting, blurred vision, dizziness and light sensitivity. I went into the ER and they gave me a migraine cocktail, cannot remember the names. It ended the migraine and I went home. The next day I felt okay and back to normal. A few days later, I had another migraine, I took the Sumatriptan and began having the same symptoms as before. I stopped taking this medication in mid-October realizing this was causing adverse reactions.  I started taking Nortek in early October and noticed a rash, so I stopped taking this medication and now take Excedrin when I have a head ache.  I still will have vision issues and headaches, but feel I have recovered.  On December 5, I went to an Ophthamologist. I had a vision refraction test. My vision was good. She prescribed Betimol eye drops  and told me to get polorized sunglasses.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER 100.8
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthritis, Lymphadenopathy, Malaise
Clinical narrative: Severe Left hip inflammation Swollen Lymph node in left arm pit slight feeling of sickness
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Extra dose administered, Headache, Pyrexia, Vomiting
Clinical narrative: Child received a 2nd dose of FluMist and should have only received one dose, due to age. No treatment. Spoke with child's mother , who stated child had a fever (parent did not know what temperature was), vomiting, stomach ache, and headache. She stated the symptoms resolved with in 4 -5 days. No other symptoms noted. Adverse event reported to the Department of Health.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received a 2nd dose of FluMist and should have only received 1 dose, due to age. No treatment. Spoke with child's mother, who stated her child did not have any signs or symptoms after adverse event. Adverse event reported.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Extra dose administered
Clinical narrative: Child received a 2nd dose of FluMist and should have only received 1 dose, due to age. No treatment. Spoke with child's father who stated child was coughing after adverse event, but symptoms have resolved. No other signs or symptoms noted. Reported adverse event.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid.  Received covid vaccine
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, who has received 5 COVID vaccines, began experiencing covid symptoms shortly after taking Bivalent Pfizer vaccine on 11/21/2022.  Pt is now hospitalized
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid.  Received Covid Vaccine
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: signficant left shoulder/upper arm erythema, induration, swelling and limited ROM starting after injection. Limited ROM is persisting
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Having issues with left arm. Now unable to lift arm above head. Having numbness from shoulder to fingers and fingers swelling.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  GSK/CDC guidelines no further vaccine necessary.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Urticaria
Clinical narrative: hives going on for 2 months now
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: No adverse event.  Per GSK/CDC guidelines no further vaccinations necessary.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back disorder, Blood immunoglobulin G, Computerised tomogram, General physical health deterioration
Clinical narrative: She got her vaccine, she did not have any issues.  By the end of the month she was driving and her knees were burning while she was driving back and did let up.  She then went to Dr. (Orthopedic surgeon) in April and he sent her to PT.  The knee began to buckle on her and he felt that it was a meniscal issue.  In the meantime her left breast went numb, her armpit went numb, and he put that on a back burner as he wanted her knee to be addressed.  On 7/16/21 she had a medial meniscal repair.  She went back to him as her knee was still buckling after the surgery, and he watched her walk and said that was her back.  She went to Dr. (orthopedic spine surgeon) and also to Dr. at Medical Center who gives injections in the back and did an MRI to look at her thoracic area, and found lesions on her back . She had a CT scan in 2017 and had nothing in her back at that time.   She went to an MS center and they decide that she has a virus that is causing her issue and they do not believe it's MS due to her age and the clean MRI that she had in 2017.  She had a Rotuxan infusion to slow the lesions down in her spine, 6 hours of infusion in June of 2022.  Now she is due to get one this coming Wednesday 12/14/22.  Her doctor told her to go to the Clinic who had the same symptoms as she had and she went to the Clinic.  They told her that they think it was MS.   This is all after the vaccine, and it's going to limit her from walking.  Her friend has lost her hair due to the vaccine.  Down at s Hospital.  The infusions are scaring her but she does not know what else to do.  MS care center at Hospital is where she has been seen.  She saw Dr. (neurologist).  She saw Medical Center who she went to first who did not think this was MS and needed to go where to go, Dr. at Medical Center Neurology.  They all tell her that COVID could cause the lesions, but she has never had COVID.  She did get her 1st booster on 12/30/21, Moderna, LOT#059H21A.  She retired in 2010 and was healthy and since March of 2021 getting the vaccine her health has been declining.  She is talk to the Clinic in January as to how this infusion is going to go for her, and she does not know what will happen again.  She said that Clinic and Pittsburgh can argue if it is MS or not.  The meds for MS are different than what they are treating her with.  She thinks they will probably do another MRI to keep a look at the lesions in her spine, and if they keep them inactive and does not have more then feels that they may not have to get the Retuxan.  She had bands in her spine to signify MS but she also had them in her blood which is unusual.  She also had 2 spinal taps and said that's when they said that she had gotten a virus which had caused the issues.  IgG bands.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of control of legs, Lumbar puncture, Magnetic resonance imaging spinal abnormal, Meniscus operation
Clinical narrative: She got her vaccine, she did not have any issues.  By the end of the month she was driving and her knees were burning while she was driving back and did let up.  She then went to Dr. (Orthopedic surgeon) in April and he sent her to PT.  The knee began to buckle on her and he felt that it was a meniscal issue.  In the meantime her left breast went numb, her armpit went numb, and he put that on a back burner as he wanted her knee to be addressed.  On 7/16/21 she had a medial meniscal repair.  She went back to him as her knee was still buckling after the surgery, and he watched her walk and said that was her back.  She went to Dr. (orthopedic spine surgeon) and also to Dr. at Medical Center who gives injections in the back and did an MRI to look at her thoracic area, and found lesions on her back . She had a CT scan in 2017 and had nothing in her back at that time.   She went to an MS center and they decide that she has a virus that is causing her issue and they do not believe it's MS due to her age and the clean MRI that she had in 2017.  She had a Rotuxan infusion to slow the lesions down in her spine, 6 hours of infusion in June of 2022.  Now she is due to get one this coming Wednesday 12/14/22.  Her doctor told her to go to the Clinic who had the same symptoms as she had and she went to the Clinic.  They told her that they think it was MS.   This is all after the vaccine, and it's going to limit her from walking.  Her friend has lost her hair due to the vaccine.  Down at s Hospital.  The infusions are scaring her but she does not know what else to do.  MS care center at Hospital is where she has been seen.  She saw Dr. (neurologist).  She saw Medical Center who she went to first who did not think this was MS and needed to go where to go, Dr. at Medical Center Neurology.  They all tell her that COVID could cause the lesions, but she has never had COVID.  She did get her 1st booster on 12/30/21, Moderna, LOT#059H21A.  She retired in 2010 and was healthy and since March of 2021 getting the vaccine her health has been declining.  She is talk to the Clinic in January as to how this infusion is going to go for her, and she does not know what will happen again.  She said that Clinic and Pittsburgh can argue if it is MS or not.  The meds for MS are different than what they are treating her with.  She thinks they will probably do another MRI to keep a look at the lesions in her spine, and if they keep them inactive and does not have more then feels that they may not have to get the Retuxan.  She had bands in her spine to signify MS but she also had them in her blood which is unusual.  She also had 2 spinal taps and said that's when they said that she had gotten a virus which had caused the issues.  IgG bands.