chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in left arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:30 as dose 4 (booster), single (Lot number: GJ6742) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS; "Cervical Focal Dystonia" (unspecified if ongoing), notes: Cervical Focal Dystonia; "Diverticulosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "covid" (unspecified if ongoing), notes: if covid prior vaccination reported as yes. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; TIZANIDINE; LEVOTHYROXIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: known allergies: Codeine; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "Soreness in left arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. if covid tested post vaccination reported as no.
Vaccinated Wed 9/3. On Sat 9/6 noticed arm hurt to touch - not sore otherwise. On Sun 9/7, arm was hot and red around injection site - No fever - called H.D. and Dr - was free to take Motrin or Tylenol and use cool compress. If not better in a few days gets worse to call us:
Phone call made by pt, she c/o (L) deltoid tender to touch after vaccine admin. On 11/8/07 pt c/o nausea and headache.
Employee had Varicella Zoster vaccination on 3/16/22 in Employee Health at facility, because her VZiGg was Negative,  She had never received the vaccine, but may have had chickenpox as a child.  On 3/18/22 in the evening, she started getting a headache, & stomach ache and noticed a red rash on her right arm (below the injection site). On 3/19/22, her headache worsened, she had stomach cramping, body aches and joint pain, and eye pain (in the back of her eyeballs), and the red, raised and itchy rash had spread to both arms and on right torso (in the back) and right lower abdomen. She went to clinic and was given Benadryl and Toradol.  They told her to take Ibuprofen and sent her home.  On 3/20/22, she slept most of the day.  On 3/21/22, all of her symptoms had worsened.  New symptoms were: chills, sensitivity to touch, and weakness. She never had SOB nor throat nor face swelling , tachycardia, dizziness, nor hives.  She went to ED on 3/21/22.  She gave her an IV (1 liter of fluid), IV Benadryl and Toradol. They drew labs which were WNL. Diagnosis was Viral Syndrome.  On 3/22/21, she slept most of they day, had reduced appetite and stomach cramps, mild headache, less body aches but lack of energy.  Today, 3/23/22, she still has a mild headache, reduced appetite and stomach is still cramping and still feeling very tired.
Inadvertently PEDIARIX and pediatric Hepatitis B (.5 ml) were given.
Eye inflammation getting worse; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflammation getting worse) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Ulcerative colitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflammation getting worse). At the time of the report, EYE INFLAMMATION (Eye inflammation getting worse) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
couldn't stand on feet; has a large swollen area/swollen twice the normal size/hardness belowhis elbow; has a knot in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) and DYSSTASIA (couldn't stand on feet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced MUSCLE MASS (has a knot in his arm). On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSSTASIA (couldn't stand on feet) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DYSSTASIA and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow), DYSSTASIA (couldn't stand on feet) and MUSCLE MASS (has a knot in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email address of primary reporter was added, peripheral swelling was updated as serious due to hospitalization, new event "couldn't stand on feet" and duration of hospitalization was updated.; Sender's Comments: This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Heavy nosebleed 2 hours after injection.  Headache started about 5 hours later.  Headache continued continuously for 10 days, then off and on until 5/27/2021 2nd nosebleed (not heavy) on 5/20/2021
Temperature Excursion - CDC recommend revaccinate .   Patient has not revaccinated yet.
Dtr started with high temp on 05/18/2019  was as high as 104.9 -lasted about 5 days- had bumps on her face arms and legs = ruled out for Hand Foot and Mouth and was listed as "virus" - Dtr had been bitten by tick 04/26- MD stated unlikely lyme.
Patient received vaccine at Public Health Clinic. Patient ended up having a seizure 3 days later and ended up in the hospital. Found to have right lobe pneumonia and low depakote level. Patient noted to have multiple seizures at hospital, issues with stabilizing HR and BP, and passed away on 1/20/21.
On 2/27/00, the pt experienced a fever, and on 2/23/00, was presented with breakthrough varicella at a physicians office. There were 20 lesions on the trunk. Another case of varicella was reported following vax. No further information is available.
Flu shot given in left arm. After 6 1/2 weeks, continued soreness and limited range of motion in the left arm.
Left Deltoid swollen, warm to touch and appears red below injection site. Patient unable to move affected arm
Woke up on 4/3 with heart rate of 150 and BP 180/120.  I was in AFib
Developed fever, flu-like symptoms and ongoing infection which resulted in pneumonia. Also developed lupus which resulted in pneumonia caused by pseudomonas and staphaureous infection-IV for 4 weeks after one week hospitalization. The medical record received on 2/11/04 states short of breath, vomiting, chest pain, constipation and productive cough.
Pt recvd 3 doses of Engerix-B 22OCT90 & 21NOV90 & 27JUN91 it was determined that pt was a non-responder; no tx given;
seasonal flu shot  in left shoulder.  Reaction: chills @ 6 hours. Fever, vomiting and body aches @15 hours.  Fainted in shower @ 15 hours and began having chills again.  Resolution by 36 hours
Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose). At the time of the report, UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  While administering 2nd dose of vaccine the syringe exploded and vaccine splashed out and needle got stuck in the patient's arm. The vaccine leaked into patient's arm and splashed into the pharmacist face.  No treatment details were provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
No additional AEs.; HCP called in to report a temperature excursion and also reported that the vaccine, GARDASIL 9 was administered; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, (dosage regimen, strength, route of administration, and anatomical location were not provided) as prophylaxis, which underwent a temperature excursion (Product storage error). No additional adverse events (AEs) were reported.
KINRIX administered on 7/24/13 noted by parent's localized reaction 7/26/13. Would not use shoulder or arm, red, warm to touch in office visit 7/27/13, using arm today. Approx area 15 cm x 17 cm involved, still red.
It was discovered that the MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the patient should be vaccinated at 6 months visit.
no adverse effect; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.         On 14-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460, expiration date 20-MAY-2021, dosage detail and strength were not provided) subcutaneously for prophylaxis. The vaccine was constituted with MRK sterile diluent. It could not be determined if the MRK sterile diluent was properly stored. Administered doses of vaccine experienced temperature excursion of -11.5 degrees Centigrade (C) for 76 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
After screening patient's immunization questionnaire, vaccine was given around 4:00 p.m.. Instructed patient to stay in the pharmacy for 15 minutes to see if experience any signs/symptoms. Patient left pharmacy after 15 minutes saying she was doing okay. Patient went to the ice-cream stand tried to buy ice-cream and that was when she started to feel chest pain, difficulty breathing and dizziness. She was able to get herself sitting down on one of pharmacy's displayed chair. She administered 1 dose of her nitroglycerin lingual spray. She told us she felt better and refused the Epipen when offered. She wanted to go home but we told her to stay in the pharmacy for about 15 to 30 more minutes to make sure the symptoms were going away. She told us she was fasting and had not had any food the whole day. After about few more minutes, she started feel worse again and stated that her left arm felt sore and numbed. She administered another dose of nitroglycerin lingual spray. We called 911 and about 4:30 p.m. they took her to the ER. Patient stated she had a history of heart attack. Patient stated she did not think this was caused by the vaccine because she knew her medical condition.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
body aches, headache, nausea, chills, fever, diarrhea (onset 2 days later for 2 days)
Patient's mother called the vaccine clinic hotline to report that the patient had a syncopal episode on 10/24 after receiving Dose 2 of Pfizer vaccine on 10/23. She reports that patient did not have any other symptoms except for fatigue and was kept in the ER for approximately 10 hours and was then discharged home and advised to follow up with cardiology. Patient is now home and is doing well.    Patient's mother informed RN that her other child also received Dose 2 of Pfizer on 10/23 but did not experience any reactions except for fatigue.   RN instructed patient's mom to call 911 or to go to their nearest ER if this recurs or if patient experiences any other reactions and is welcome to call the vaccine clinic hotline for any questions or concerns and she verbalized understanding.
After receiving vaccine, became dizzy with nausea & vomiting which persisted. Called physician & received script for compazine suppositories. On 12/23, Pt stated symptoms continued, felt weak, N&V. Not able to keep food/fluids down. On 12/24 pt. stated feeling much better & able to tolerate fluids.
facial redness; some tingling; numbing in the front of her face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face). At the time of the report, ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. Benadryl was used as treatment medication.
missed second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stomach discomfort and Gallbladder operation NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose). On 07-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
He came to clinic the morning after receiving his first dose of a Covid vaccine complaining of left sided chest pain.
Received Hepatitis B vaccine and MMR on 7/28 AM. Throughout the day on 7/28 child felt warm & had decreased activity. Approximately 9:30pm child had febrile seizure (? no focal component involving (L) side). Exact duration of seizure unclear. Had post-ictal period in ER of approximately 1 hour.
I missed my second dose; I missed my second dose; I have been sick for 11 days with a respiratory thing; I have been sick for 11 days with a respiratory thing; I still have some cough; I still have some congestion; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) of unspecified age (pregnancy is unknown) female patient receive first dose of bnt162b2 (BNT162B2, Solution for injection), via unknown route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states "I received the first dose of COVID-19 vaccine on 19 February 2021. I have been sick for 11 days with a respiratory thing. I was tested negative to COVID. It was reported that I still have some cough and congestion. I missed my second dose last week. Should I post pone my appointment which is today at 9:50?" and in response to informed caller I am not aware of the clinics policy and procedure. They might not accept you at the clinic if you show COVID like symptoms. Please discuss this with the clinic and bring your negative result with you. These symptoms have not been listed as contradiction in receiving the second dose of the vaccine. However, if you are still symptomatic please discuss this with your HCP to determine if you should get the vaccine now or post pone it. The outcome of events for "I missed my second dose", and "I have been sick for 11 days with a respiratory thing" was "Unknown", and for "I have been sick for 11 days with a respiratory thing", "I still have some cough", and "I still have some congestion" was "Not recovered".  Information on the lot/batch number has been requested.