chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot arm; Very sore arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PAIN (Very sore arm) and VACCINATION SITE SWELLING (swollen arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PAIN (Very sore arm) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, VACCINATION SITE WARMTH (hot arm), VACCINATION SITE PAIN (Very sore arm) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Advil and Tylenol
Reddness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly male patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 66 years or 67 years. After receiving Shingrix, the patient experienced redness at injection site which lasted for 3 days.
Fever, headache, short of breath, tired, achy. Took Tylenol and slept. First day was worse than the second. Feeling better today. Temp didn?t go above 99.
Patient missed her dose with no AE; all the medicine came out from syringe with no AE; Initial information regarding an unsolicited valid non-serious was received from a Nurse via Medical Information (Reference number- 00619945) and transmitted to Sanofi on 28-May-2021.  This case involves a 22 years old female patient who missed her dose (product dose omission issue) of suspect IPV (VERO) [IMOVAX] (lot T2A47 and expiry date: 17-Jun-2022) as all the medicine came out from syringe (syringe issue) on an unknown date.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was reported that reporter picked up the vaccine from the pharmacy whom purchased it from their wholesaler. Nurse state that when reporter was preparing the Imovax. Reporter reconstitute the medicine and pulled the Imovax up using the syringe the vaccine came with and when reporter was drawing it up nothing stopped and it completely opened up the syringe came out and opened up at the bottom and all the medicine came out. Reporter states the syringe was loose at the bottom and completely slid open it was thought the rubber was too small for the syringe. Reporter states she was pulling medicine out of the vial.  It was also a case of actual medication error due to missed dose (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain, swelling under arm that was injected with the vaccine. Pain and swelling was worse the next day and the patient went to the ED to receive care. Tests were performed and she received morphine IV and Ketorolac IV. She was discharged to home after symptoms improved.
I am pregnant, I am 3 months pregnant; I started last night with fever and the cough; I am pregnant, I am 3 months pregnant; I started last night with fever and the cough; My body hurts; I am pregnant, I am 3 months pregnant; I started last night with fever and the cough; This is a spontaneous report from a contactable consumer (Patient). This consumer or other non hcp reported information for mother. This is a maternal report. This is the 2nd case of two cases; in this case consumer is reporting for self. A 36-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she was taking prenatal vitamins for her pregnancy. The patient reported "i am pregnant, i am 3 months pregnant; i started last night with fever and the cough, my body hurts on 10May2021. On an unspecified date the patient reported I am pregnant; I am 3 months pregnant; I started last night with fever and the cough (Maternal exposure during pregnancy first trimester. The mother reported she became pregnant while taking bnt162b2. The mother was pregnant with 1 baby. The fetal outcome was pending. Therapeutic measures were taken as a result of i am pregnant, i am 3 months pregnant; i started last night with fever and the cough (cough). Patient received Tylenol 500 mg, just one, one tablet as a result of events. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 22 year old female with a history of penicillin allergy and no pertinent medical history who on 17-DEC-2007 was vaccinated with a third dose of GARDASIL (lot# 659653/1448U) 0.5mL IM. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) which the patient has been taking for more than one week. On 17-DEC-2007 a few hours her third dose of GARDASIL the patient developed a red rash on her chest, back and arms. At the time of reporting the patient was recovering. No other information was available. Additional information has been requested.
She received GARDASIL # 1, fainted and had sm seizure last about 8 sec. 1030 = Mom called back and stated she had severe Ha (History migraines.  11/24/09 and 11/25/09 MR and Vaccine record received for DOS 10/14/09 S/P vaccine, Pt experienced fainting, seizure for 18 sec and severe headache. Pt recovered. 12/01/09 Medical records received for DOS 10/07/09 - 10/14/09. Syncope after vaccine. Very brief tonic clonic movements. Upon  PE alert, neuro  exam neg.
Facial outbreak of blister like rash 3 days after jab of second dose.  Not itchy.  But woke up with little white heads over face...took a shower and they all burst like chicken pox. Very red.
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 027L20A)  with no associated AEs.; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 027L20A)  with no associated AEs.
Tested positive for COVID-19 April 23, 2022. Had a sore throat on April 21, 2022. I've had mild cold symptoms that have almost gone away.
1st dose 2019, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th October 2019, batch number 3HT5J, expiry date 26h January 2022 in left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
About 3:30 am woke up with headache; slight fever; nauseous; Dizziness/vertigo; Dizziness/vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 24Feb2021 at 15:00 pm (Batch/Lot Number: e19265) as dose number unknown, single for covid-19 immunization (at the age of 61-years-old). Medical history included stiff person syndrome, myasthenia gravis, Sjogren's, antiphospholipid protein syndrome, hashimoto's, autonomic dysfunction and chronic lymphocytic leukemia stage, all were from an unknown date and unknown if ongoing. Concomitant medication(s) included aspirin [acetylsalicylic acid]; liothyronine sodium (CYTOMEL); diazepam (VALIUM) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took propranolol and experienced allergy. Facility where the most recent Covid-19 vaccine was administered was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient has not been tested for Covid-19. It was reported by the patient that on 24Feb2021 at 15:00 pm she received the first dose of vaccine and on 25Feb2021 about 3:30 am she woke up with headache, slight fever, nauseous and dizziness/vertigo. She mentioned that she got dizzy 12 hours after the covid vaccine. She further mentioned that by the morning, everything went away except for vertigo sometimes slight, sometimes more intense. It never lasted a really last time, but it was still happening. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The patient was not recovered from the event of vertigo and was recovered form rest of all other events in Feb2021.   No follow-up attempts are needed. No further information is expected.
Pt passed out after getting vaccinated. Her BP and pulse were normal. Pt stated that she did not eat anything since morning breakfast around 9am. Paramedics were called to verify that Pt was doing ok. Gave pt both orange juice as well and some food ( chicken nuggets). After 30 minutes pt was calm and stated that she was feeling well.  Called pt on 4/7/21 at 9:05am to verify that she was doing all right. She stated that other than sore arm she was doing fine and did not go to the hospital.
First dose on 4/17 (in same facility).  Around 3:30-4pm started feeling bad, bad headache, drained then it got worse.  In the evening started feeling nauseous and dizzy.  By bedtime patient had chills.  Patient woke up at 3-4am with fever and couldn't sleep. Took Tylenol but did not help much.   Patient went back to bed to sleep.   There was a lot of pain in arm which lingered for more than 1 day.   Contacted clinic on 7/1 but they did not take information just specified lot number was different from first dose.   Husband had vaccine at same time with no issues. By Monday issues resolved.
VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report was received from literature. This report concerned 4 multiple patients of unspecified sex, age, race and ethnicity. The objective of this study was to characterize anti-PF4 antibodies in VITT. (Janssen Johnson & Johnson) vaccines against COVID-19 have been associated with thrombotic thrombocytopenic reactions referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT) characterized by the presence of platelet-activating, anti-PF4 antibodies. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry: Unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced vaccine induced immune thrombotic thrombocytopenia. Laboratory data included: Reactivity of VITT anti-PF4 antibodies to un complexed PF4, PF4-Polyvinyl sulfonate (PVS), and PF4-heparin targets was evaluated, and the platelet-activating ability of these antibodies was examined in the PF4-dependent P-selectin Expression assay (PEA). Anti-PF4 antibodies were isolated from patient blood samples using PF4-treated heparin sepharose beads, and isolated antibodies were subject to mass spectrometric evaluation (Liquid Chromatography Electrospray Ionization Quadrupole time-of- ight mass spectrometry [LC-ESI-QTOF MS]) were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced immune thrombotic thrombocytopenia was not reported. The authors emphasized that development of platelet-activating anti-PF4 antibodies and the thrombotic thrombocytopenia syndrome seen after Ad26.COV2.S vaccination resembles HIT, these findings demonstrate that clonally restricted anti-PF4 antibodies mediate VITT while polyclonal anti-PF4 antibodies mediate HIT. It is also likely that high levels of monoclonal/oligoclonal anti-PF4 antibodies cause the severe thrombotic phenotypes seen in VITT and Spontaneous HIT. The high mortality rate and reports of disease refractoriness therapy in VITT may warrant consideration of additional therapeutic modalities like rituximab and therapeutic plasma exchange in select cases. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220238408 - covid-19 vaccine ad26.cov2.s- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per Agency and is therefore considered potentially related.
My arm felt sore after shot and hurt to move, but that often normal and I had a sweater on all day.  Evening I removed sweater and my upper arm was warm, very swollen and hard.  It was painful on movement. I have never had a reaction like that to any vaccine.  I took ibuprofen and applied an ice pack to the arm.  The next day, that part of my upper arm was still swollen, but less, still sore but less.  Swelling still there a little on Saturday as well, not completely gone until Sunday 10/27.  Called pharmacy to report on Friday, he said would report, but took no information.
6 hours post vax, the pt had a fever of 104. No other symptoms were experienced.
ON 10-21-08 AT 1100 RECEIVED VACCINE 1115 COMPLAINT OF FEELING DRUNK AND THEN TOOK BENADRYL 25MG AND CALLED MEDICAL  ARRIVED IN MEDICAL AT 1130 COMPLAINING OF METALLIC TASTE IN MOUTH AND FEELING LIKE SHE DRANK A 6 PACK OF BEER AND HAVING NUMBNESS AND TINGLING IN HANDS COMPLAINED OF THROAT CLOSING AND CHEST TIGHTNESS VITALS 100/70-96-22 AND PULSE OX ON ROOM 99% EPINEPHRINE 1/1000 0.3MG WAS ADMINISTERED, AMBULANCE CALLED, NO SOB AND NO HIVES, OXYGEN APPLIED TRANSPORTED TO ALTOONA HOSPITAL ER. I SPOKE WITH EMPLOYEE TODAY AND SHE SAID THAT SHE RECEIVED BENADRYL IM IN AMBULANCE AND AFTER ARRIVEING IN ER SHE DEVELOPED A HEADACHE AND BEGAN TO ITCH ALL OVER BUT NO RASH OR HIVES DEVELOPED. SHE SAID SHE RECEVED A STEROID INJECTION IN THE ER AND WAS FINALLY RELEASED FORM THE ER AT 1615. SHE WAS PRESCRIBED STEROIDS X 7 DAYS AND BENADRYL PRN FOR TICHING.  SHE IS STILL COMPLAINING OF A HEADACHE AND ITCHING AND FEELS SOME CHEST TIGHTNESS WHICH SHE ATTRIBUTES TO THE RAPID LABORED BREATHING THAT SHE SAYS SHE DEVELOPED AFTER THE ADMINISTRATION OF THE EPINEPHRINE.
I became pregnant in early August. Began bleeding September 11th. Went to doctor after 3 weeks of bleeding and they told me it was likely a miscarriage. Multiple visits, calls, scans  and mistaken diagnoses later, it turned out I had an ectopic pregnancy, I was bleeding internally, and I needed an emergency laparoscopy and salpingectomy on October 12th. I was treated with antibx during surgery, opined pain medication after surgery, and as of this point in time, my menstrual cycles are absent since the surgery.
PATIENT DIAGNOSED WITH BILATERAL OTITIS MEDIA ON APRIL22, 2019, PRESCRIBED CEFDNIR. PATIENT DEVELOPED MACULOPAPULAR RASH ON FACE, TRUNK, EXTREMITIES ON APRIL 24, 2019.
Information has been received from a health care worker in a physician's office concerning a 34 year old female with a codeine allergy an no other medical history who on 05-MAY-2000 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 25-AUG-2007, the patient did not have protective antibodies with an antibody titer that was less than 0.91 for IgG/IgM. Medical attention was sought via contacting the physician. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Patient was registered in database by her parent to receive a Pfizer Covid 19 vaccine, even though the system clearly stated that the vaccine was indicated for ages 16 years and older in two places. Facility attempted to contact the parent prior to date of vaccination, however parent never responded to messages left. Volunteers at large community clinic checked patient in and patient proceeded to receive vaccine, Patient's age was discovered when the volunteer registering recipients for their second dose  attempted to register her. Mother was informed that vaccine was indicated for 16 years and older and she stated she had a note from the patient's primary care provider to receive the vaccine due to her severe asthma. Patient was scheduled to receive second dose after her 16th birthday.
I began feeling nauseous 15 minutes after the shot was administered. The nausea was mild to begin with, then became moderately uncomfortable, and then faded, over a 2-3 hour period. After that, approximately 4 hours after the shot, I experienced tightness and pain in the muscles in my upper back between my shoulder blades. That went away in about an hour. The following  couple of days I experienced intermittent mild nausea that went away after a few minutes.
Pt called that after receiving PNEUMOVAX 23 on Sunday later she had severe upper arm pain, swelling, red hot area, had difficulty lifting arm, now on antibiotics.
Same day of vax, pt developed cellulitis. The pt was treated with a 10 day course of oral Augmentin three times daily. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune.
Rheumatoid arthritis aggravated; Pain; This is a solicited report based on the information. (manufacture control number: 21K-163-3895202-00).  A contactable consumer (patient) reported that a 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation; and upadacitinib (RINVOQ), oral from Feb2021 (Batch/Lot number was not reported) and ongoing, at 15 mg, once daily for moderate to severe rheumatoid arthritis/rheumatoid arthritis without rheumatoid/Rheumatoid Arthritis Without Rheumatoid Factor, Multiple Sites. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rheumatoid arthritis aggravated and pain. It was further reported that patient had increase in bothersome rheumatoid arthritis symptoms/flares in hands after day of quilting and incredible pain with upadacitinib. The patient had rheumatoid arthritis flares in hands after day of quilting. After covid-19 vaccines (Pfizer) had reaction both times. She was still in incredible pain and had been for over a week since second covid-19 vaccine. She had pain in hands and feet for a few days but this second one pain was still on eight (pain scale: 8). She had called her physician. She had an increase in bothersome symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was unknown. The patient was recovering from rheumatoid arthritis aggravated while outcome of pain was not yet recovered. The reporter's causality for the events with upadacitinib was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Rheumatoid arthritis cannot be totally excluded.  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.
Gums are burning / texture is rough. No visible ulcers or bleeding.  (Upper and lower)
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), injection, lot # S032355, expiration date: 14-OCT-2021, subcutaneously (exact dose and injection site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (MERCK) lot # S032591, expiration date: 16-AUG-2022. The administered dose of vaccine experienced temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (13.6 degrees Fahrenheit) for 12 hours (multiple excursions) and 15 degrees Fahrenheit to 46 degrees Fahrenheit (16.0 degrees Fahrenheit) for 30 minutes. The digital data logger was involved regarding the temperature excursion details. No previous temperature excursion had occurred.