chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed practitioner nurse concerning to a 12 month old male patient with dermatitis. On 15-OCT-2015, the patient was vaccinated with dose 1 of MMR II (Lot No. K026366, exp. 15-DEC-2016), 0.5 ml, subcutaneous. Concomitant therapies included hydrocortisone (manufacturer unknown). On 30-OCT-2015, the patient developed a rash at the injection site. The patient sought medical attention and was seen at the office on 05-NOV-2015 but no treatment was given. No laboratory test were performed. No intervention to prevent serious criteria was made. No cancer, disability, hospitalization nor life threatening were reported. The outcome of injection site rash was not reported. Relationship between rash at the injection site and therapy with MMR II was not reported. Additional information has been requested.
The patient developed left wrist swelling, pain, warmth one week after getting the Moderna COVID vaccine. It is in the same arm in which she got the vaccine. She tried tylenol but it didn't help. I applied Voltaren gel to the wrist and that helped the pain. I advised if it worsens for her to return. She will monitor the wrist for signs of infection however at this time we will treat for arthritis flare.
No adverse effects; The patient, who is an adult, was inadvertently administered one dose of the pediatric VAQTA; This spontaneous report was received from a medical assistant concerning an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 26-JUL-2019, the patient was inadvertently administered one dose of the pediatric hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R034339, expiration date 23-NOV-2019 for prophylaxis (frequency and route of administration were not reported) (product administered to patient of inappropriate age).     No adverse effects were reported.
Patient had 2 vaccines in each arm, right arm was very painful throughout the evening, later became red and swollen.  She took ibuprofen for pain and alternated cold and heat on it.  Day three she called her physician who prescribed Tylenol 3 for pain.
the patient did not have any symptoms fro receiving an expired VAQTA dose; expired VAQTA administered; This spontaneous report was received from a doctor of osteopathy and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 23-NOV-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T017179, expiration date 26-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No adverse event was reported.  The reporter inquired was there any danger to the patient.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA009083:
pt recv vax 9OCT95 & in the month following vax pt has been experiencing numbness & tingling of the entire arm which has not resolved as of the reporting date;pt has not undergone evaluation by MD;
flu like symptoms; headaches; swollen lymph nodes; fever of 100.2F; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced flu like symptoms, headaches, swollen lymph nodes, fever of 100.2f. Reporter, male, aged 69, received vaccine last Wednesday. Friday, he had a PET scan. Friday and Saturday, he developed flu like symptoms. He developed headaches, swollen lymph nodes and a fever of 100.2F. He has been having symptoms for 9 days. Is this normal. The patient underwent lab tests and procedures which included fever: 100.2 fahrenheit on an unspecified date in Feb2021, PET scan: unknown results on 05Feb2021. Outcome of the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up (03Apr2021): Follow-up attempts are completed. No further information is expected.
104.3 fever, diarrhea, confusion, headaches that are still persistent to today, shakiness in the hands and legs, blurriness in the vision still to today,
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 07-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). On 06-Feb-2022 at 11:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient received booster dose.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 08-JAN-2015, the patient was vaccinated with improperly stored VAQTA (strength: 25/0.5(unit unspecified), lot # K005323 with expiration date of 10-FEB-2017; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/26/21 lot# Ew0176;  Pfizer 5/17/21 lot# EW0183
I received the vaccine yesterday at 5 pm. This morning starting at 8 am I had muscle aches, chills, and a headache. I took my temperature around 1 pm today and had a fever of 100.8. Throughout today, my headache has gotten progressively worse. The pain is sharp at the base of my head and radiates down my spine. I cannot put my chin to my chest without excruciating pain. I have had migraines before and this does not feel the same. This headache is more localized in the back of my head and spine. I also have had COVID19 before at the beginning of July 2020 from which the only symptom I had was a loss of smell which returned 2 weeks after my positive COVID test.
Localized reaction.   Area of about 4 inches wide by 2 inches tall, warm to the touch, redness, hardened
dose received 3; Pain at the injection was unable to lift arm; was unable to lift arm; Headache; Low grade fever; Chills; Cough; "feels like the flu"; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Nov2021, as a single dose for COVID-19 immunisation. It was unknown if patient had any medical history or known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, both as single dose for COVID-19 immunisation. On 10Nov2021, the patient experienced pain at the injection and was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at the injection was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Narrative: 75yo male pt with the following problem list: E87.6 Hypokalemia (SCT 43339004) I13.10 Renal failure (SCT 42399005) E83.42 Primary hypomagnesemia (SCT 80710001) J43.8 Pulmonary emphysema (SCT 87433001) M54.5 Backache (SCT 161891005) I50.40 Congestive hear failure (SCT 42343007) N52.9 History of male erectile disorder (SCT 429031006) H90.0 Hearing loss (SCT 15188001) 356.9 Unspecified idiopathic peripheral neuropathy (ICD-9-CM 356.9) 443.9 Intermittent Claudication (ICD-9CM 443.9) E11.9 Diabetes mellitus (SCT 73211009) R80.0 Proteinuria (SCT 29738008) D64.9 Anemia (SCT 21737000) 719.41 Pain in joint involving shoulder region (ICD-9-CM 719.41) 782.1 Rash (ICD-9-CM 782.1) V67.9 Unspecified Follow-Up Examination (ICD-9-CM V65.9) I10. Hypertension (SCT 38341003) E78.2 Hyperlipidemia (SCT 5582204) I10. Hypertension (SCT 110483000) 794.31 Nonspecific abnormal electrocardiogram (ECG) (EKG) (ICD-9-CM 794.31) 600.00 Hypertrophy (Benign) of Prostate without Urinary obstruction (ICD-9-CM 600.00) K21.9 Gastroesophageal reflux disease (SCT 235595009) Patient self-presented to Emergency Facility Emergency Notification Intake Date Presenting to the Facility: 1/5/2022 Care Hospital: Chief complaint: Shortness of Breath Primary Diagnosis: Patient Admitted? Yes of Admission: ER Date/Time of Admission: 1/5/2022 Admitting Diagnosis: Acute hypoxic respiratory failure per health prtal-remains inpatient- Transferred to ICU 1/8/2022 for worsening respiratory and mental status; Continue aggressive oxygen supplementation, Continue antibiotics, Await pathology from bronc Continue Precedex. Pt expired 1/13/2022 @1344 of note pt had another ER visit on  12/10/2021 to same facility as above for Chief complaint: Unspecified complication of genitourinary prosthetic device AND previous to this, another ER visit on 12/8/21 to same facility for urinary retention. Pt had received covid vaccines on 4/1/21 & 4/22/21. Likely this death is not related to covid vaccines.
Pain in both knees (right knee more so). L, began about 2 hours after shot and continues. No pain in any other joints.
Patient did not report adverse event.  He was inadvertently given 9 doses of IPOL instead of 1.
I had a flu shot (Flaud Quadrivalent Influenza Vaccine For - Type A&B Surfa - 0.5 ml) on 10.02.20 from the Pharmacy.  About 4 minutes after the shot I experienced very sudden debilitating pain in my lower back.  I could not walk and only remained standing because I could lean on a shopping cart.  Without that I would have fallen to the floor.  That condition only lasted a couple minutes and I was able to walk again. I?m not sure what would have happened if I had been driving at the time.  This shot also caused a one degree temperature rise and much higher than normal pain from my thumbs (Arthritis) and even more so my shoulder (Crystals).
1/18/05 this is to report an apparent reaction to flu vaccination received 12/02/2004 at city hall, after that date left town and still away. Approx 5-6 days after the shot, I developed very severe pains in upper extremities, in forearm and tricep muscles, joints, and esp shoulder joints on both sides. Never had anything like that before and was tennis player, exerciser to present. Was not able to lift arms above shoulder level for weeks. Still some tenderness, but gradually cleared after 3 weeks went to orthopedic surgeon for exam. He first thought had rotator cuff injury, but pain was both shoulders, worse left side of injection. He took x-ray which showed normal joint. Then he diagnosed bursitis which recommended ibuprofen or cortisone injection. I took ibu 6 days then stopped in order to avoid medications when possible. Gradual improvement since, and will soon resume gym workouts. Only possible other factor, is that I had general malaise for one week before injection low grade, that I attributed to some kind of infection, probably throat. I'm ending this to be of assistance to your evaluations; will be interested if others had any problems - thank you.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 12:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 12:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 76.54.   Concomitant products were not provided.  On 28-MAR-2021, Excursion time was reported at 10:00 AM with  temperature as 35 degrees Fahrenheit, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on 27-MAR-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-APR-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Symptom's started the day after vaccine. She c/o: Right shoulder pain and difficulty moving her right arm. She was seen in office by Dr. and prescribed: Naproxen - 500 mg - BID - for 7 days. Dx: acute pain of right shoulder.
higher part of his arm and then tapered down the arm. It feels like he has been punched in the arm; arm pain and pain at the injection site.; arm pain and pain at the injection site.It is now spreading to the underside of his arm and towards his chest.; arm pain; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm on May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  In May2021, the patient experienced higher part of his arm and then tapered down the arm. it feels like he has been punched in the arm, arm pain and pain at the injection site, arm pain and pain at the injection site.it is now spreading to the underside of his arm and towards his chest and arm pain. The patient underwent lab tests and procedures which included pain assessment: it is not 10 out of 10 pain. It was reported that the patient received the vaccine a week ago.  He was okay for the first 2-4 days.  About four and half days in, he started experiencing arm pain and pain at the injection site. It was at the higher part of his arm and then tapered down the arm. It felt like he has been punched in the arm.  It is now spreading to the underside of his arm and towards his chest. It seem to be getting worse, not better.  He spoke with his pharmacist and doctor who said it was not normal. The patient asked if the events were reported and if it was unusual as the events started few days later. He asked if he can take Tylenol. He reported first 3-4 days, 4.5 days in experiencing pain in arm, injection site into arm, higher side and taper to lower side and now all on underside of arm towards chest. the same arm that vaccine. Felt like he's been punched in the arm. Outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt reports loss of taste and smell after receiving dose #1 of Pfizer mRNA vaccine
Patient began to feel dizzy with a scratchy throat, felt better when she laid down. No significant medical hx
A little bruise at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 5 days after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient experienced "a little bruise" at the injection site five days after receiving Shingrix. The healthcare professional was in a hurry and could not share more information. The reporter did not give permission to follow up.
Woke up with fever; Chills; Headache; Body aches; Sever pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix. On 10th March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 11th March 2022, the patient experienced fever, chills, headache and general body pain. On an unknown date, the outcome of the injection site pain, fever, chills, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, headache and general body pain to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. On the day before the reporting the patient received Shingrix. The patient reported sever pain at injection site. One day after receiving Shingrix, the patient woke up with fever, chills, headache and body aches.  The patient refused to give any other details. The patient was referred to healthcare professional who spoke per Shingrix FAQ but the patient abruptly hung up and ended call. The patient did not consent to follow-up.  The report was filed with limited information
Day 8 post vaccine developed raised red rash at injection site. Warm to touch. Day 9 and 10 rash still present, Day 11 rash with itching.