chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site and 3 inches around it is red; Swollen; itches; looks like a welt or hive; tender to touch; headache; A spontaneous report was received from a health care professional concerning a 57 year-old patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache.  The patient's medical history was not provided. Concomitant medications included losartan and hydrochlorothiazide.  On 26-JAN-2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot#: 013L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness, swelling, itching, hives, and tenderness at/around the injection site and headache. Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
feeling very cold the morning after the vaccination; loss of appetite; Diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite), DIARRHOEA (Diarrhea) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite), DIARRHOEA (Diarrhea) and HEADACHE (headache). At the time of the report, FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite) and HEADACHE (headache) had resolved and DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Pt recv vax & devel inj site rxn of redness, warmth & swelling.
doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005516: US-009507513-2001USA005518: US-009507513-2001USA005520:
One week after injection:   left armpit is sore and swollen in lymph node area, movement of arm above shoulder height is painful and restricted, symptoms lasted 48 hours before diminishing, symptoms fully cleared in 72 hours  injection site is hard, red and itchy, reaction is 1? in diameter, no change in 48 hours at the time of completing this form
1" by 1 1/2" inflamed redness, hotter to the touch than the neighboring area.  Still there after 24 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 034F21A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Covid rebound, tested positive 3 days after a negative test and 6 days after completing Paxlovid; Negative, notes: Covid rebound, tested positive 3 days after a negative test and 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included with Paxlovid from 27Dec2022 to 01Jan2023.
Patient came to the ED with worsening shortness of breath and cough.  Patient was admitted to hospital with Covid pneumonia and COPD exacerbation.
9/20/07 right arm dorsum of humerus from first below shoulder to above elbow with axillary nodes 10cm x 10.5cm erythema, indurated and warm to touch. 9/26/07 Right arm decrease 14 x 12.5 erythema. 9/21/07 Called today increase redness to be seen 9/22/07 - Did not come in phone call ---much better - very little redness.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Feb2021 (Lot number: EL0140) at the age of 77 years as dose 2, single and administration date 27Jan2021 (Lot number: EL0140) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient took Ibuprofen and Tylenol. The patient reported that she hardly had any problem, she just had a sore arm. The patient had a Booster dose and experienced sore arm that was really painful.  No follow-up attempts are possible. No further information is expected.
Fever, HA, chills, nausea, rash and swelling of arm. Covid arm worsened for days. Is hot to touch on Tuesday.  Tylenol and rest.
Metal taste in mouth, dizziness, dull headache that has lasted 4 days, lethargy, muscle pain in neck and shoulders, all over achiness, pain in underarms, swollen lymph nodes, pain at injection site and pain underneath the arm behind the injection site. Loss of appetite, vomiting and diarrhea. I am feeling much better on the 4th day after injection.
Hives all over my body when itched or scratched. Diagnosed as Dermatographia from dermatologist. Treating with two Claritin once a day. Symptoms have remained the same since first occurring.
w/in 72hr of vax pt devel an inj site rxn characterized by a 5-6cm area of redness & swelling;pt was seen by MD & recovered w/in 2-3 days w/o tx;
Hospitalization: 2/19/2023 - 2/20/2023 (36 hours) Presentation to the ED: 3 days nonproductive cough weakness body aches nausea SOB COVID + date: 2/19/2023 Treatment: remdesivir Discharge to: home.  028L20A 2/16/2021 030A21A 3/16/2021 045J21A 12/3/2021
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant drug were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, strength, route, lot # and expiration date unknown) for prophylaxis. On an unspecified date "several years ago", the patient "developed a varicella like rash" on an unspecified area of the body. Action taken with the vaccine was not applicable. The outcome of the event was unknown. The relationship between the event and vaccine was not reported.
The day after the shot I went to a cardio exercise class and fainted after 1/2 hr.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Aug2021 (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not take other vaccine in four weeks and did not took other medications in two weeks. The patient not had covid prior vaccination and not tested for covid post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On 26Aug2021 10:00AM, the day after the shot the patient went to a cardio exercise class and fainted after 1/2 hr. The patient not received any treatment for the event. The clinical outcome of the event was recovered on 26Aug2021.  No follow-up attempts are possible; information about lot/batch numbe cannot be obtained.
inadvertently diluted daptacel with a sterile saline solution to 1ml with no reported adverse event; only 0.5ml of the diluted vaccine was administered with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who administered only 0.5ml of the Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] which was inadvertently diluted with a sterile saline solution to 1 ml with no reported adverse event 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) for Prophylactic vaccination.  On 09-May-2023, the patient received a dose 4, 0.5 ml dose, frequency: once; of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of standard strength, with lot C5980AB and expiry: 06-Apr-2024 via intramuscular route in the right thigh for immunization; which was inadvertently diluted with a sterile saline solution to 1ml with no reported adverse event (product preparation error)(latency: same day) and only 0.5ml of the diluted vaccine was administered with no reported adverse event (incorrect dose administered) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently diluted daptacel with a sterile saline solution to 1ml with no reported adverse event and only 0.5ml of the diluted vaccine was administered with no reported 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.
After receiving flu shot: Immediate burning pain deep in arm that stopped when needle was removed. Numbness and tingling to  left hand and outer two fingers (pinky and ring finger)-has faded but ongoing. Tingling on left side of face and lips within five minutes of injection; faded after one hour. Deep muscle pain and sore neck. No treatment sought or received.   Moderna covid vaccine administered after flu shot without incident.
had it, after my first vaccine.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (have had it 3 times in the last 16 months).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles 3 weeks after first vaccine.
Fatigue began around 12:30 pm, around 3 hours after shot and increased the next day. Pain around injection lasted about 3 days. Muscle aches and joint pain started on second day and continued mildly on third day.  Chills experienced on second day, no fever.
A few days later the lymph nodes on the right side of my neck swelled up. I went to my MD and they prescribed penicillin
Intense pain in arm, redness around arm, hard knots, skin peeled, rash had developed bumps surrounding injection site and a few ran down arm to elbow. By 2/13/21, most scabs resolved, however red bumps are still visible.  She called doctor but did not go to see doctor.   no treatment.
In Septemer 2021, after my second vaccine dose, I had two periods within one month, with 11 days of spotting in between. In addition, I had extremely heavy bleeding (soaking pad and tampon every two hours) for 7 days each period. This has never happened to me before. Two of my female co-workers had the same experience after being vaccinated with the Covid 19 vaccine so that alerted us that this might be vaccine related. Since then I have returned to a regular cycle and normal period bleeding.
24 hours after administration developed severe fatigue, polyarthralgias, and whole L upper arm became red, hot and swollen. Reaction lasted 72 hours. Symptoms were somewhat relieved by Iboprofen 400 mg q 4-6 hours.
This is to report accidental administration of 2 flu shots for the patient 10/11/2019 and 10/20/2019. The patient has not reported any adverse events yet
Mild arm pain; The vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted; potential quality issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm pain"; PRODUCT QUALITY ISSUE (non-serious), outcome "unknown", described as "The vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted; potential quality issue".  Additional information: Reporter stated, I am calling because so my son had the Covid vaccine yesterday and I already went online and reported his mild arm pain same day he reported this morning so, that's covered he didn't have any side effects, but I wanted to pass along some feedback of the Health care professionals administering the vaccine and there wasn't a spot to do that online because that's not an adverse event. It's a packaging kind of feedback, potential quality issue but more of just like a packaging thing. So I don't have a specific Lot. I know the Lot my son received, but I don't know the Lot. It just applies to every Lot. It's probably around all the vaccine just similar but the feedback that the vaccine administrators, the Healthcare providers provided is that the vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted it with whatever they diluted with and I told them, I will pass the feedback along. Actually, it's possible if you need it. I took a picture of the vial because I never seen one in person working on the vaccine, but the clinical trial not the actual manufacturing. I might have a picture of the Lot if that matters. Reporter stated, "No, again I only know my son's Lot number. I do not know the Lot numbers of every batch they got and again this is a general comment about all of the vials.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was initially received on 11-May-2016. The case report was received from a(n) Health Professional and concerns a 20 year old male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA, on 09-May-2016 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml and on 11-May-2016 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 09-May-2016, the patient received AFLURIA (batch number not reported). On 11-May-2016, the patient received second administration of AFLURIA (batch number U55306) at a dose of 0.5 ml once (overdose). The patient did not report any side effects. The outcome was unknown. Reporter's assessment: Non serious.
Approx. 15 minutes, post vax, pt fainted, hitting head on floor. No prior complaint of dizziness. Physical exam performed showed no signs of severe reaction ie hives, wheezing, SOB or decreased blood pressure.
Very confused . Dissinez. Throat pain . Musvlr ache all over My body. Blurred vision..still affecting me.
Patient received the vaccine and reported approximately 3 minutes later that her heart was racing. Blood pressure was ~188/90 and pulse was 110. She stated that she does not typically have high blood pressure but that she does have anxiety. She had brought her Xanax prescription with her. She took one tablet of Alprazolam 0.25 mg while here. Several minutes passed and blood pressure was now ~170/90. After 30 minutes of being here, she was feeling much better. Before going home, blood pressure was 158/90 and pulse was 82.
Left deltoid area was swollen, warm to the touch, red and itchy. Her mom said she recalls it happening the last time the child got a flu shot. Symptoms & signs improved after one day.
Pt also reported redness and swelling at injection site same day following vaccine pt started feeling weakness in arms and legs. Reports fever for 1 day sx lasted through weekend and started resolving on 6-22-15. Pt reported complete resolution 6-23-15.
Patient with PMH type 2 DM, cataracts and dry eyes and allergy to penicillin (anaphylaxis) recevied Pfizer Covid19 vaccine at 1529 3/31/21 (lot #ER8733) in left deltoid.  No known sequela after first shot.  Patient received her second dose of Pfizer vaccine (lot #EW0162) in her left deltoid on 4/21/21 at 1556. During initial observation period, she felt dizzy.  At 1614, she felt tingling in her throat and tongue. VSS and no other symptoms.  Patient was given juice and monitored x10 additional minutes without resolution of symptoms. Provider was made aware and assessed the patient. 25 mg IM diphenhydramine was given via right deltoid. Patient monitored an additional 30 minutes and symptoms resolved.
gallbladder issues which result in having it removed; diagnose of hypertension after vaccination; Gallbladder disorder; This spontaneous case was reported by a consumer and describes the occurrence of CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder). At the time of the report, CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company Comment  This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.; Sender's Comments: This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.
Pericarditis diagnosis after a visit to the ER on 12/07/2021.
Muscle aches, chills, migraine like headache, nausea, and fatigue. All lasted for approximately 48 hours with nausea and headache peaking at 12-24 hours after vaccine. I took ibuprofen for headache when I could keep it down and ginger tea for nausea. General rest, fluids, and gentle foods throughout.
Patient received Pfizer COVID vaccine on 3/11/21 and 3/31/21. On 1/10/22, patient went in to hypoxic respiratory failure, intubated by paramedics, and admitted to our CCU with positive COVID test result. Patient extubated on 1/11/22, then transferred out of CCU to med/surg unit on 1/12/22. As of today (1/13/22), patient is still admitted in our med/surg unit.
2 weeks after receiving flu shot I started falling and have been in a wheelchair since Feb 2005. Medical records state decreased reflexes, ALS. 60 day Follow-up Information 29-SEP-2006: I am still in a wheel chair. I am gradually regaining strength in my arms and legs and am crawling. I am getting oriental-accupuncture which is helping remove toxins.
Febrile seizure activity 8/1/12. Resolved. Here in office 7/31/12, well-check, received one vaccine Hep A - on 7/31/12, Fever of 102 degrees prior to seizure activity. 911 called child transported, stabilized and discharge same day