chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema of eyelid, Eye pruritus, Flushing, Ocular hyperaemia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EYE PRURITUS (Eyes became extremely itchy), OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01721A) for COVID-19 vaccination.  Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Graves' disease, Bee sting hypersensitivity and Allergy to wool. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from May 2012 to an unknown date for an unknown indication. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE PRURITUS (Eyes became extremely itchy). On 25-Apr-2022, the patient experienced OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed). On 30-Apr-2022, EYE PRURITUS (Eyes became extremely itchy), OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On the second day of taking Paxlovid (after 4 doses), patient's eyes became extremely itchy. Patient took a shower in the morning of the third day and eyes became very red, as did the eyelids; patient's cheeks were flushed. Patient continued taking the full dose of Paxlovid for the third day. Patient's provider and patient decided not to continue for days 4 and 5. Device Date was reported as 27May2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired vaccine beyond the 30 day refrigerator shelf life; Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that 6 patients received expired Moderna COVID-19 vaccine, from 05 May 2022 through 23 May 2022. 3 patients received first booster, 1 patient received a second booster, 2 patients received 2nd primary dose. 1 patient received on 05-May-2022, 1 patient on 06-May, 1 patient on 18-May, 2 patients on 19-May, and 1 patient on 23-May-2022. On 30-Mar-2021 the vial was initially stored in the refrigerator and was administered to the patient on 06-May-2022. The vial did not undergo any temperature excursion.  No treatment medication reported.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Reporter stated that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. Nurse confirmed that vaccine was administered to 7 patients on 2 different days. Number of doses/vials:2 No adverse event reported. No treatment medication details was reported. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated  date of administration: 2May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Reporter stated that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. Nurse confirmed that vaccine was administered to 7 patients on 2 different days. Number of doses/vials:2 No adverse event reported. No treatment medication details was reported. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022. This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergy.  Concurrent medical conditions included Blood pressure high.    On 06-Apr-2022 at 4:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported. The Device Date :02-Jun-2022.  Company Comment: This spontaneous case reported by a patient concerns a 63-year-old male patient, with no relevant medical history, who experienced unexpected, non-serious Covid19, around 1 month and 3 weeks after receiving a third dose of mRNA-1273.  He was treated with a 5-day course of Nirmatrelvir/Ritonariv (Paxlovid) and tested negative for Covid19 the next day.  However, around 3 days later he started to have Covid19 symptoms and tested positive for Covid19 again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case reported by a patient concerns a 63-year-old male patient, with no relevant medical history, who experienced unexpected, non-serious Covid19, around 1 month and 3 weeks after receiving a third dose of mRNA-1273.  He was treated with a 5-day course of Nirmatrelvir/Ritonariv (Paxlovid) and tested negative for Covid19 the next day.  However, around 3 days later he started to have Covid19 symptoms and tested positive for Covid19 again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 1 patient received doses from vial that went to 6.6 F; 1 patient received doses from vial that went to 6.6 F/ freezer excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion) and POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion). On 01-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion) and POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Freezer excursion was reported, and the data log said it happened on 12-May 2022. There was a loss of power close to midnight.  Maximum temperatures reached was 6.6 F with the excursion duration of 5 minutes. Vials were moved from freezer to refrigerator on 31-May-2022 and were stored in fridge, quarantined in a separate bag. Vaccine was still frozen upon visual inspection on 16-May-2022. Proposed desired use by date was reported as 03-Jun-2022 and 09-Jun-2022 to 10-Jun-2022. 8 vials were impacted in the excursion, three were used, there were 5 left. Remaining 5 vials were not punctured with no previous excursions.  It was also reported that patient received Spikevax on 01-Jun-2022. The vial was initially stored in the refrigerator on 31-May-2022 and the vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, SARS-CoV-2 test
Clinical narrative: He said her first pregnancy was terminated around the same time frame and for similar medical reasons; This is a spontaneous report received from a contactable reporter (Pharmacist). A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 21 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bnt162b2 for COVID-19 immunization, notes: Dose 1. The following information was reported: ABORTION INDUCED (medically significant), outcome "unknown", described as "He said her first pregnancy was terminated around the same time frame and for similar medical reasons". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed with Covid. Additional information: The Caller/Pharmacist has a patient who is pregnant of 21 weeks, and she has been diagnosed with Covid.  He confirmed that the patient received vaccines before being diagnosed with Covid and had severe side effects from Covid. He said her first pregnancy was terminated around the same time frame and for similar medical reasons.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, termination of pregnancy is considered an intercurrent medical condition associated with mentioned 'similar medical reasons' and unrelated to BNT162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had positive Covid test; had positive Covid test; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; TAMSULOSIN; TADALAFIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovering" and all described as "had positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Patient had negative Covid tests/ had positive Covid test; positive, notes: Patient had negative Covid tests/ had positive Covid test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had negative Covid tests, felt better, then on 21May began to feel cough, headache, and had positive Covid test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case   dose 1 Pfizer 5/5/21 EW0175 dose 2 Pfizer 5/26/21 EW0183
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Blood test normal, Computerised tomogram normal, Crying
Clinical narrative: Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeding disorder, Feeling abnormal, Gait disturbance
Clinical narrative: Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site pain, Lethargy, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Screaming, Somnolence, Tenderness, Weight decreased
Clinical narrative: Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: , Additional Details: Patient was experiencing tingling down both her legs
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: , Additional Details: pt states large area of redness refused to come to store to show pharmacist pt states area seemed hot to touch tender and swollen
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood test abnormal, Dizziness, Hypertension, Nervousness
Clinical narrative: , Additional Details: about 5-10mins after recieving the vaccine pt complained of back pain/dizzy,fainting. sat her down gave water. she was very nervous. no site/neck,shouolder pain but back pain of the same side. she called husband. after staying for 15 mins she felt better to leave but had gone to urgent care.called in pm to follow up around 7pm. she was  better. they did blood work at uc. bp was high and blood work showed a MI from past few months. nothing new. she said she was okay now. no pain or dizzy
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: , Additional Details: about 5-10mins after recieving the vaccine pt complained of back pain/dizzy,fainting. sat her down gave water. she was very nervous. no site/neck,shouolder pain but back pain of the same side. she called husband. after staying for 15 mins she felt better to leave but had gone to urgent care.called in pm to follow up around 7pm. she was  better. they did blood work at uc. bp was high and blood work showed a MI from past few months. nothing new. she said she was okay now. no pain or dizzy
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Dysmenorrhoea, Flatulence, Gastrointestinal pain
Clinical narrative: Bad gas pains- 1 week Menses arrived 9 days earlier than expected- heavier flow, much more painful After that, 2 days of migraines Followed by perpetual nausea(even with ZOFRAN), diarrhea- unable to remain hydrated Ended up going to the ER to get fluids, more meds
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Laboratory test normal, Menstruation irregular, Migraine, Nausea
Clinical narrative: Bad gas pains- 1 week Menses arrived 9 days earlier than expected- heavier flow, much more painful After that, 2 days of migraines Followed by perpetual nausea(even with ZOFRAN), diarrhea- unable to remain hydrated Ended up going to the ER to get fluids, more meds
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: THE VACCINE GIVEN WAS STORED IN THE REFRIDGERATOR PAST THE 10 WEEK TIME FRAME
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE THAT WAS GIVEN WAS IN THE REFRIDGERATOR PAST THE 10 WEEK VIABILITY TIME
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: The patient received the vaccines on 6/3/22 around 1PM; parents reported about 24 hours later, his right thigh began to turn red and warm with swelling. He was seen in PCP office 6/6/22 with similar symptoms. Patient denied pain.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE THAT WAS GIVEN WAS IN THE REFRIDGERATOR PAST THE 10 WEEK VIABILITY TIME
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site haemorrhage
Clinical narrative: Has a large ecchymotic area on Right upper arm at vaccine site.  No loss of function. Mild discomfort relieved with Advil and Tylenol. Denies numbness and tingling.  States she will call her PCP if gets worse.  Area is 5inches by 5 inches.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE THAT WAS GIVEN WAS IN THE REFRIDGERATOR PAST THE 10 WEEK VIABILITY PERIOD
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: Severe flu like symptoms to include fever, body aches, diarrhea, profuse sweating, and vertigo approximately 12 hours after administration through 48 hours.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe flu like symptoms to include fever, body aches, diarrhea, profuse sweating, and vertigo approximately 12 hours after administration through 48 hours.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Somnolence
Clinical narrative: Per patient's mother, patient could not breathe-needed an inhaler, 103 fever, puking, whole body aches, massive headache, and slept for 5 hours straight.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Per patient's mother, patient could not breathe-needed an inhaler, 103 fever, puking, whole body aches, massive headache, and slept for 5 hours straight.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Echocardiogram, Electromyogram, Gait disturbance
Clinical narrative: Prior to receiving the Moderna shots, I had pin and needle sensations in extremities from catching Covid 19 in January 2021.  By middle of February 2021 tested negative.  After receiving the 2nd moderna vaccine around 8 weeks later started having stomach issues, pin and needle feeling in extremities became stronger, weakness in legs when starting to walk.  A week later started experiencing severe lower back pain and mild neck pain. By end of  September 2021 I had developed vertigo and internal vibrations...
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intervertebral disc protrusion, Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Muscular weakness, Neck pain
Clinical narrative: Prior to receiving the Moderna shots, I had pin and needle sensations in extremities from catching Covid 19 in January 2021.  By middle of February 2021 tested negative.  After receiving the 2nd moderna vaccine around 8 weeks later started having stomach issues, pin and needle feeling in extremities became stronger, weakness in legs when starting to walk.  A week later started experiencing severe lower back pain and mild neck pain. By end of  September 2021 I had developed vertigo and internal vibrations...
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Quantitative sudomotor axon reflex test, Spinal X-ray, Ultrasound Doppler, Vertigo
Clinical narrative: Prior to receiving the Moderna shots, I had pin and needle sensations in extremities from catching Covid 19 in January 2021.  By middle of February 2021 tested negative.  After receiving the 2nd moderna vaccine around 8 weeks later started having stomach issues, pin and needle feeling in extremities became stronger, weakness in legs when starting to walk.  A week later started experiencing severe lower back pain and mild neck pain. By end of  September 2021 I had developed vertigo and internal vibrations...
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vibratory sense increased, X-ray limb
Clinical narrative: Prior to receiving the Moderna shots, I had pin and needle sensations in extremities from catching Covid 19 in January 2021.  By middle of February 2021 tested negative.  After receiving the 2nd moderna vaccine around 8 weeks later started having stomach issues, pin and needle feeling in extremities became stronger, weakness in legs when starting to walk.  A week later started experiencing severe lower back pain and mild neck pain. By end of  September 2021 I had developed vertigo and internal vibrations...
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Janssen vaccine in 2021 with angioedema reaction- severity high.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had stated she was eligible for her 2nd booster shot and had forgotten that she got one in april. Vaccine was given at improper interval.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Fatigue, Headache, Hepatic enzyme abnormal
Clinical narrative: Covid symptoms started on 05/26/22 and I tested positive for 05/28/22. It was like a mild flu with congestion, fatigue, no real sore throat per se, and I completely lost my sense of smell. I tested myself every day and today 06/07/22 is the first day I tested negative. I was testing positive from 05/28-06/07. The only lingering symptom is that I am tired. The week before Covid, I had probably one of the worse flu-like viruses I've had and that lasted for 3 weeks. I had really bad headaches and I went in for that and had blood work done and my liver enzymes were way off. I was testing negative for Covid with rapid and pcr tests. I have read since then that you can test negative for covid and that your immune system is fighting the virus but you will experience symptoms of Covid. 05/01-05/28 I had a really bad virus. I had three rounds of blood work and they still want me to come back in a week or so.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Malaise, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Covid symptoms started on 05/26/22 and I tested positive for 05/28/22. It was like a mild flu with congestion, fatigue, no real sore throat per se, and I completely lost my sense of smell. I tested myself every day and today 06/07/22 is the first day I tested negative. I was testing positive from 05/28-06/07. The only lingering symptom is that I am tired. The week before Covid, I had probably one of the worse flu-like viruses I've had and that lasted for 3 weeks. I had really bad headaches and I went in for that and had blood work done and my liver enzymes were way off. I was testing negative for Covid with rapid and pcr tests. I have read since then that you can test negative for covid and that your immune system is fighting the virus but you will experience symptoms of Covid. 05/01-05/28 I had a really bad virus. I had three rounds of blood work and they still want me to come back in a week or so.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Feeling abnormal, Pain
Clinical narrative: I woke and was feeling really bad, dry cough, fever, whole body aches, chills, runny nose. I went to the emergency room where I was tested for COVID-19, that came back positive. The emergency room doctor gave me monoclonal antibody therapy while I was there in the emergency room and told me to take Tylenol for any pain, discomfort and fever once I left yesterday. I do feel better than I did yesterday.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I woke and was feeling really bad, dry cough, fever, whole body aches, chills, runny nose. I went to the emergency room where I was tested for COVID-19, that came back positive. The emergency room doctor gave me monoclonal antibody therapy while I was there in the emergency room and told me to take Tylenol for any pain, discomfort and fever once I left yesterday. I do feel better than I did yesterday.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given RotaTeq oral vaccine at 9m, when it ages out at 8m.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia, Skin lesion
Clinical narrative: One month before the vaccine, I had a case of shingles and it was a relatively non trivial case and it wasn't just mild, it really set me back. I had fever and the skin lesions and it went away with prednisone. I thought it was over but 2 days after the first shot I broke out again pretty badly and it went back down and I thought it was over. It lasted for 2 weeks but it didn't completely go away.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness, Myalgia, Palpitations, Pyrexia
Clinical narrative: 5/31 Pt given 1.8mg of vaccine instead of 0.3mg.  This was the 2nd booster dose  The next night, pt reported fever (101F), palpitations, flu-like symptoms  6/6 pt reports fever and muscle ache are improving
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test normal, Computerised tomogram, Confusional state, Extra dose administered
Clinical narrative: 04/21/2022 I received my fourth dose of the Covid vaccine within a few hours I started having amnesia and confusion. I went to the hospital the same day and was admitted for 24 hr. observation. It was confirmed that I had memory loss and confusion. Five days later I went to my doc and did blood test. Nothing was found, symptoms lasted approx. 2-3 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: 04/21/2022 I received my fourth dose of the Covid vaccine within a few hours I started having amnesia and confusion. I went to the hospital the same day and was admitted for 24 hr. observation. It was confirmed that I had memory loss and confusion. Five days later I went to my doc and did blood test. Nothing was found, symptoms lasted approx. 2-3 weeks.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone marrow oedema, Inflammatory marker test, Joint swelling, Magnetic resonance imaging abnormal
Clinical narrative: 04/04/2022 I woke up and had foot and ankle pain when I walked. I had swelling. All continued to get worse through the month and would get very swollen at the end of the day. I have worn a wrap, brace and a boot. I had an MRI 2 weeks ago. I had gone through PT and it made it worse. I was diagnosed with Diffuse Bone Marrow Edema. The majority of it is in talon navicular. The back of the ankle also has this. I have been prescribed a prescription brace to wear. I am unable to get it until 6/22/2022.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray abnormal
Clinical narrative: 04/04/2022 I woke up and had foot and ankle pain when I walked. I had swelling. All continued to get worse through the month and would get very swollen at the end of the day. I have worn a wrap, brace and a boot. I had an MRI 2 weeks ago. I had gone through PT and it made it worse. I was diagnosed with Diffuse Bone Marrow Edema. The majority of it is in talon navicular. The back of the ankle also has this. I have been prescribed a prescription brace to wear. I am unable to get it until 6/22/2022.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: 2 days after shot I broke out again with shingles and the doctor stated he never seen a case of shingles hang like this. It lasted about 2 weeks but I do still have it. I was going to urgent care and my doctor and they were shooting me up with prednisone and I was pretty involved in seeing my PCP during that time.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Hospitalized with pneumonia. Treated with O2 high flow, remdesivir, dexamethasone,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Back pain, Biopsy liver abnormal, Blood glucose increased, Bone densitometry
Clinical narrative: In March 2022, after tiredness, back pain and brown urine, hospitalized for three days with high liver counts (over 1000) and it took two weeks and a liver biopsy to diagnose with autoimmune hepatitis.  Was put on Prednisone and liver counts have gone down but now have increased BP and now being treated for not only the Autoimmune Hepatitis but Hypertension as well.  Will have to have a total cardiac workup to see exactly what is going on and who knows how long I will have to stay on the Prednisone.  Both of these organs, heart and liver, I never had problems with before and I am attributing to the COVID vaccine.