chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ring around the redness in the injection site, the edges are like a board of dark red; Arm got really big; (Injection site) had a red rash; Ring around the redness in the injection site, the edges are like a board of dark red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red). At the time of the report, VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported Caller called asking if her side effects are normal: She received the 1st dose of the Moderna Covid19 Vaccine on 2February2021 . She said that the last 2 days her arm got really big, had a red rash, and a ring around where she got the injection. Says she read about the covid arm, similar to what happened to her as around where it is red, the edges are like a board of dark red. States symptoms are still ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: Patient feeling fine and requested no further followup.
Pt reported dizziness. Vitals: 108/81, 83, 22, 100% -- > 118/74, 77, 18, 100% -- > 103/68, 79, 16, 100% Pt stable and released from the vaccination site in the care of her mother.
This spontaneous report was received from a nurse who is also a patient via company representative. No relevant medical history was reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number was not reported). On an unknown date, the nurse reported that she had about 10 hepatitis b vaccinations. The nurse could not rule out RECOMBIVAX. It was unspecified as to why she had so many doses. The patient did not confirm that she had negative titers. No adverse effects were reported. Additional information has been requested.
8-10 hours of severe nausea, headache in frontal lobe, muscle aches, joint pain, chills, 100 degree fever, sweating, ringing in ears, lymphs swollen, overall fatigue, chest pain with breathing, elevated heart rate, site of injection pain for 2 days deep inner ear pain for 6 days, headache subsided after the second day but came and went for 5 days I stayed in bed all of 3/22/21, stayed hydrated, took light soup toward the end of the day was able to walk 3/23, and resume eating regularly
The following evening - right at 24 hours after receiving the vaccine, left part of upper lip was numb and swollen.  No other unusual events.  Patient had been achy from the vaccine earlier in the day, but by that time was feeling ok.  Numbness lasted about an hour, swelling lasted about 12 hours.  Patient did not feel ill or itchy or anything that would constitute an emergency. Patient does have photo documentation of the swelling.
Bad headache; Nausea; Left arm swollen at the injection site; A spontaneous report was received from a consumer concerning a 51-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad headache, nausea, left arm swollen at the injection site, symptoms increased besides the tylenol he took.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided.) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) bad headache, nausea, left arm swollen at the injection site. On 28 Jan 2021, the patient experienced the event(s) symptoms increased besides the tylenol he took.  Treatment details included Tylenol since 27Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bad headache, nausea, left arm swollen at the injection site, symptoms increased besides the tylenol he took was unknown.
Kinrix was given to a 3 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :18 July 2022 Reporters comment: The three year old patient received Kinrix.  The no symptoms reported. The reporter consented to follow-up. Additional Supportive information: Three year old patient received Kinrix, which led to inappropriate age at vaccine administration.
Pressure in the chest; Arm pain; Chills; Fatigue; Congested coughing; congested; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 24Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. concomitant medications were not reported. It was unknown whether, the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced pressure in the chest, arm pain, chills, fatigue, congested and coughing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events chest, arm pain, chills, fatigue, congested and coughing were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
01/10/22 presented to ED for "dyspnea". PMHx of "HTN, CHF"
Observed patient and at 1226 c/o tightness to throat, escorted to Obs rm 10, BP cuff placed to Rt arm and Pulse ox placed. 1226: BP: , HR: 65, RR: 16, Sat: 97% room air, clear to all lobes with no increased WOB, no redness, hives or itching 1230: BP: 115/61 (77), HR: 77, RR:16, %98, remains clear to all lobes with no increased WOB, no changes to skin, patient states throat still feels tight, no swelling to mouth or lips. 1236: patient complained that voice feels different, asked to recite alphabet. Patient  had to stop due to her concerns that her throat felt tight. 1238: Epi pen administered to Lt thigh by RN, 911 called by nurse. 1243:BP 122/65 (81), HR: 83, RR:18, Sat: 98%, clear to all lobes with no increased WOB, no changes to skin, patient finds there is some relief to tightness in throat. 1251: EMS present, patient refusing to be transferred to the hospital at this time. Per patient she feels safer at home and lives close to a hospital. 1256: Sat %98, HR: 81, Per patient her throat feels better. RN  spoke with patient re: concerns of not going to the hospital for further evaluation. Patient agreed to go to hospital, left with EMS.
per pt one week after first dose her lymph node was swollen. It does not hurt when she touches the lymph node and has not been sick at all recently.
After 10mins of vaccine shot, her vision was getting slightly blurred and her head started to throb a little around the temple.  After 30mins her she felt a little better and stepped outside for fresh air. Symptoms did not fully go away so the nurse on site took her blood pressure reading 195/100.  Nurse on sight assumed that it was due to anxiety of the shot  and her progress was getting better and blood  pressure was slowly dropping. Nurse said it was ok to go home and rest.  4 hours later, blood pressure was measure at home with a machine and it read 135/85. Next day(3/30/2021) around 12PM, 1 hour after taking her blood pressure medication, her blood pressure jumped to 190/100. The blood pressure medication is a daily routine and have been taking it since January 2021.  Blood pressure then dropped back down to 135/85. Then it went up to around 190/100 again. She was taken to hospital Emergency room where they monitored her for 5 hours. Was given medication to help her blood pressure go down. After it stabilized, she was discharged and was prescribed 5mg of Amlodiphine Besylate.  During her time in the ER she was given a CT scan and blood work. Results came out negative 3/31/2021 currently have no issues with blood pressure.  Still monitoring closely at home.
Patient states that she started feeling like her heart was racing and she felt dizzy and short of breath about 5 minutes after receiving the Tdap immunization.  She also received Flu mist.  She did not return to the clinic, but went home.  Symtoms worsened, peaking about 7:00 PM.  She said that she also had chills and felt angry. She said her left eyelid was drooping.  She said it was not swollen, but it was drooping, like her eye was half-closed. She started feeling better about 11:00 PM.  She contacted me the next day (12/1) at 11:30 AM and described above.  At the time she spoke with me, she said she felt fine except for a slight sore throat and that it was difficult to take a deep breath.  I told her that if her symptoms worsened again, she needed to go to the ER, as she does not have a private provider. I contacted her again at 5:30 PM on 12/1/10. She said she felt fine except for a bad headache and that her breathing was back to normal. She was taking Tylenol for the headache. She thanked me for calling her. I thanked her for calling to report this and repeated my previous instructions about going to ER if symptoms worsened.
Postprocedural hemorrhage of a digestive system organ or structure following a digestive system procedure
Adverse effect of vaccines and biological substances, subs on 2016-04-05, Advrs effect of pertuss vaccine, inc combin w pertuss, sqla on 2016-04-06.
Is really sore/He is experiencing some arthritis pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included surgery on an unknown date and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took etanercept (ENBREL) for rheumatoid arthritis from unspecified date to 15Feb2021 (also reported as 16Feb2021). The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 for COVID-19 immunisation. In Feb2021 after the second dose vaccination, the patient reported sore though it was maybe due from arthritis or the vaccine. Patient reported he had difficulty getting out of bed. The patient stated he had surgery on an unspecified date and will see his hand doctor. The patient was not sure if he needs cortisone shot in the fingers and was asking if he can take the steroid shot or other medication for pain such as Advil Motrin or Tylenol. The patient reported that he receives an Enbrel shot once a week for rheumatoid arthritis,  but was told to skip these injections a week before and a week after the doses. He did have an Enbrel shot on 15Feb2021 or 16Feb2021. After the second vaccination, he was experiencing some arthritis pain and wanted to know when he can take another Enbrel shot and wanted to know what other pain relievers he can take right now. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant lower back pain and stiffness. Especially around my herniated L5 disc.  Much pain and can't stand all the way upright. Slight improvement today(3rd day).
Patient arrived at observation area after getting vaccine at 5:40 PM. Patient complained of SOB and feeling unwell. V/S taken. Patient feels fine after sitting for 10 minutes.
When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (on the right side of the left leg).  I felt a lump,  It was about 2-3 inches above the knee.  It was what I would describe as a medium-sized lump.  I called my doctor to leave a message about my symptoms.  My doctor called  a few minutes after 11 am and asked me to immediately come in so he could see the lump.  He thought I might have a blood clot.  This lump was not present late last night because when I put lotion on my legs after my shower, I felt no lump or soreness.  I worked out this morning and by 11:00, it seemed to me the lump was not as big as it was when I was getting dressed earlier this morning.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 57-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804086 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
pt recvd vax;v & d & abdo pain started 1mar95 & cont;advised to take to er;pt seen in hosp;given IV glucose & meds;PC to PT 15mar,still has d,pt is 6 wks post partum,now has a rash;
After getting 2nd vaccine, during the night I had:  Chills & fever, temp. 101. Freezing, then I'd get so hot, felt like skins on fire, severe constant headache, muscles ache, feet and hands get numb and Tingley now & then, visual hallucinations - seeing grim reaper in peripheral vision. Smell - hyper. Taste - cream Soda - horrible, The evening after 2nd vaccine, left arm started to get stiff, edematous, and hurt. My arm progressed with large red, hot, hard edematous, painful, itchy, with orange peel look and feel to skin. Monitoring arm at this time & applying cool compress, advil prn. If it gets worse or lasts really long will see doctor
Patient came to clinic 1/30/03 with inflammation, swelling, pain on left thigh. Inflammation area approximately .4 inch in diameter. Child complaining of pain on walking. 1/30/03 vaccines (DTaP/IPV) received 1/28/03. Seen by clinic doctor 1/30/03; reassured that symptoms were reaction to vaccine.
Ache; No energy; Haven't been able to eat; Have been in bed ever since (the dose); Fever as high as 107F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 807770273-10) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F). At the time of the report, PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include blood pressure medicine. Treatment details included Tylenol, Unspecified medication for diarrhea
given a patient PENTACEL instead of PEDIARIX with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/hib(PRP/T) vaccine [Pentacel (Vero)] instead of pediarix with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a dose 1 Primary dose 0.5 ml of suspect Suspension for injection of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/hib(PRP/T) vaccine instead of pediarix (wrong product administered) (Latency: same day) (Batch number: UJ844AA, expiry date: 02-Mar-2024, strength: standard, Frequency: Once) via intramuscular route in the left arm as immunization. First time product used : Yes Still using product : No  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
The first two days only consisted of pain at injection site. 7 days later, I developed rash at injection site and hives on my lower abdomen, followed by gradually worsening headache x 5 days ( ocular, temple, and occipital region), not alleviated by Tylenol or Advil. I then developed fever on day 10, which lasted for 2 days ranging from  100 to 103 with chills with full body ache). I was unable to  see my own patients by this point.  On day 12,  temp ranged from 98 to 99, and I  had decreased range of motion in my neck with excruciating pain.I took 2 Advil?s, put ice,  and I saw no relief.   I got worse throughout the day as my neck and shoulders  felt quite stiff. Then at bedtime,  I took 300mg of gabapentin and 2 Advil?s and rubbed some menthol ointment on my neck, and the following morning ( day 13), I had  regained some range of motion in my neck,. Pain and stiffness continues but more manageable than yesterday. I will continue Advil and once a day gabapentin with the ointment for now.
I experienced heavy menstruation for 3 weeks after the booster shot; dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:00 (Lot number: FH8030) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Idiopathic Thrombocytopenia Purpura" (unspecified if ongoing), notes: other medical history: Idiopathic Thrombocytopenia Purpura; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "osteopenia" (unspecified if ongoing), notes: other medical history: osteopenia. Concomitant medication(s) included: TRI-SPRINTEC; MOMETASONE FUROATE; FLORAJEN. Past drug history included: Neomycin, reaction(s): "Known Allergies: Neomycin"; Tetracain, reaction(s): "Known allergies: tetracain". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Right, Vaccine Administration Time: 02:15 PM), administration date: 02Apr2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "I was already menstruating for several days prior to getting the shot"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 02:15 PM), administration date: 23Apr2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "I was already menstruating for several days prior to getting the shot".  The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 19:00, outcome "unknown", described as "dose received: 3"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Nov2021, outcome "unknown", described as "I experienced heavy menstruation for 3 weeks after the booster shot". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination: vitamin. Since patient was already menstruating for several days prior to getting the shot, the menstruation ended up lasting for 4 weeks straight. Patient reported that she did not know whether she was recovered because she did not know if next month's period will be affected, but bleeding has stopped as of earlier this week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.