chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who was given solution and was not mixed with the powder for the dose of PENTACEL lot number not reported via unknown route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event occurred or not. 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 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. List of documents held by sender: none.
I started having a stroke. I went to the emergency and found out I have bells palsy, they gave me steroids. I also went to the eye doctor, they saw my eyes are super dry and they gave me eye drops. I am feeling much better but I am still swollen on my face.
Onset of headache approximately 5 min after (2-21-14 approximately 4:00 pm) vaccination and still ongoing on (02/24/14). Patient is currently on Excedrin for HA.
4 unknown patients, all over the age of 13 years old, were inadvertently administered a dose of PROQUAD (unknown lot/expiration date) on unknown dates instead of MMR II.; 4 unknown patients, all over the age of 13 years old, were inadvertently administered a dose of PROQUAD (unknown lot/expiration date) on unknown dates instead of MMR II.; No adverse effects were reported; This spontaneous report was received from a paramedical referring to 4 unknown patients, all over the age of 13 year old and unknown gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the 4 patients were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) intramuscularly (dose, frequency, lot number and expiration date were not reported) for prophylaxis  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent was used. No adverse effects were reported.
unspecified number of pt, from various locations, recv vax & exp a red bump or rash @ the inj site;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II lot # M008588 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to M-M-R II.; Sender's Comments: US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1706USA005754:  US-009507513-1707USA000536:
three patients that had clots after the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "three patients that had clots after the covid vaccine".  Clinical course: Patient Gender: (Male/Female): unknown (3 patients not one- she works in Cardiology -hospital also). Reporter stated "I am vaccinated myself with the bivalent and booster. I believe in the vaccine, however I got recently three patients that had clots after the covid vaccine and they had to be in heparin for 6 months) I would like studies about this problem from the scientific point". The adverse event took place after Pfizer product use. Specify Pfizer Suspect Product(s): Bivalent Pfizer covid 19 vaccine. Date Reported: Sunday, 12Feb2013 at 4:15 pm mst (yes, I confirm the visit actually took place on Sunday at a Urgent care facility)."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event thrombosis and the suspect drug cannot be 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.,Linked Report(s) : US-PFIZER INC-202300067081 Different patients, Same reporter, drug, event.;US-PFIZER INC-202300067082 Different patients, Same reporter, drug, event.;
(injection site) very mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ((injection site) very mild arm pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for Immunisation.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced VACCINATION SITE PAIN ((injection site) very mild arm pain).            This case was linked to US-MODERNATX, INC.-MOD-2021-016319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016319:Linked with first dose case
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID positive test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Mar2023 to 08Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for the reported events COVID-19 and drug ineffective. This case will be reassessed upon receipt of additional information.
J&J vaccine 3/5/2021 COVID Positive 3/29/21  3/29/21: COVID positive. This is a 35-year-old male with complex past medical history including bilateral lung transplant and renal transplant performed several years ago.  He both of them and regarding his transplant management.  He is on immunosuppressive medications.  He is here today out of concern for exposure to COVID.  He was vaccinated with Johnson Johnson vaccine on  3/4.  He is here cause overnight he started developed fever headache sore throat muscle aches.  If continued through today.  He was test in the outpatient setting but the results have not yet returned.  He is here today with continued symptoms.  He is well-appearing on exam but mildly tachycardic, low-grade temperature here no significant increased work of breathing no conversational dyspnea lungs are clear heart is regular but tachycardic without murmur he has no signs or symptoms of DVT currently.  His chest x-ray shows all isolated left lower lobe infiltrate.  His labs are unremarkable with normal renal function, normal electrolytes but is rapid COVID test is positive.  Given his immunosuppressive status in infiltrate seen on x-ray initially recommended admission for observation even though he is not initially on any supplemental oxygen is work of breathing is quite comfortable.  I was able to discuss with his transplant surgeon In addition I talked to admitting physician who then discussed with pulmonology here .  In their opinion the best management for the patient would be to provide him with the monoclonal antibody treatment but this can only be performed in the outpatient setting given he has no increased work of breathing no supple ox requirement currently that he is stable for discharge.  He has a pulse monitor at home will also enroll him in a COVID home program.  Pulmonology will call him for follow-up tomorrow.  When I discussed with  they currently do not have any beds available at the hospital for transport.  The patient does not want to go to an outside facility that has a transplant team other than the risks of.  Ultimately the patient would like to go home.  I will add doxycycline for bacterial possibility of his pneumonia seen on x-ray today.  He also had very strict return precautions.  He understands likely had a possibility of worsening symptoms understands to return immediately if any new or worsening symptoms or no improvement.  Patient was given the monoclonal antibody treatment in the ER after ordered by Dr..  He will ultimately be discharged with very close follow-up.
Pt. received vaccine 4/4/16. He came back to health center having symptoms severe pain to (L) deltoid, muscle aches, fever, and upper arm very red.
Very painful vaccination, left big bruise. Chills, 101F fever for two days. Red rash and pain on the whole top of the arm for 5 days, itchy and painful.
The patient presented to the clinic and was seen by doctor.  The patient was in good health at this time.  She obtained a pneumovax/pneumococcal vaccine, Dose .5cc, Lot # 1137F, in her Rt deltoid, and it was administered by an MA.  Within hours of having the vaccine, the patient developed cellulitis.  2 days after having the vaccine, the patient was taken to the emergency department with a chief complain of fever.  Paramedics had to help her  into her car because of how weak she was.  She also complained of soreness in her arm, swelling, fever, and nausea.  It has continued to get worse.  The patient is still in the hospital, 4 days after the injection. 02/13/07-records received and reviewed for DOS 01/10/07-1/11/07- DC DX:probable cellulitis right arm question autoimmune reaction to pneumonia vaccine versus serum sickness hypokalemia, resolved hyponatremia mild thrombocytopenia mild anemia  Presented to ER with right arm pain and fever, redness after injection. Temp in ER 38.9.
Rash, UrticariaPruritus, fatigue Narrative:  delayed onset localized rash around area of injection. Also reports fatigue.
Participant  arrived at a bivalent  booster clinic for their work clinic- received booster bivalent dose - no adverse event noted.  Participant aware and spoken to.
Fever, chills, uncontrolled shivering, sweating, nausea, dizziness, mostly in the order listed, starting about 9 hours after vaccine dose and completely gone by 24 hours after vaccine dose.
experiencing arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of oral herpes (1st dose received on 18th May 2018, refer case US2022111778) and Shingles vaccine with an associated reaction of oral herpes (received in 2004).   On 19th October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022111778, US2022AMR112249.  Additional Information: GSK Receipt Date: 27-Jul-2022. Reporter's Comments: The case was self reported by the patient. The patient received Shingrix in the left upper arm (left deltoid). The reporter reported that he was experiencing fever blisters prior to getting a different, earlier Shingles vaccine that only required one dose (caller was unsure of the name of earlier vaccine received) in what they believe was 2004. The patient experienced arm soreness after receipt of Shingrix.  The reporter consented to follow up with health care professional.; Sender's Comments:  US-GSK-US2022111778:Same patient, different dose US-GSK-US2022AMR112249:Same patient, split case
Patient had local symptoms to the area where the shot was given.  He had swelling at the site and in lymph nodes under the arm vaccinated.  He also had body aches as the second synptom.
After receiving Shingrix vaccine on 05/01/23 pt presented right arm pain, erythema, and swelling the following day, along with 1 episode of nausea and vomiting on the morning of 5/2. Pt was referred to the ED due to concerns of compartment syndrome, upon assessment and CT arm pt had right upper arm fasciotomy on 05/3/2023. As of 05/4/2023 Pt remains admitted for in-patient care with expected release date 05/09/23
pt recv vax 5JUN95 & 15JUN95 pt devel a fever of 104, syncope, maculopapular rash of 4 lesions & a h/a; pt was hospitalized for tx; pt's severe h/a persisted;
Information has been received from a health professional concerning a 6 year old male who on 2/11/99 was vaccinated in the right anterior thigh with a first dose of varicella virus vaccine live (lot # 62849/1325H). Concomitant vaccination the same day included a first dose of MMR (lot # 628905/1362H) given in the left anterior thigh. There was no illness at the time of vaccination. On 5/2/04 the patient developed a rash. The rash erupted on his ears, stomach, back, neck, genital area and continued to spread quickly on various areas of the body for 4 days. He was seen by the physician. Three isolated areas of redness were noted and he was given mupirocin. Subsequently, the patient recovered. Additional information is not expected.
10/7/03- received anthrax #1, together with influenza, typhoid, hep B #1, Hep A #2, and repeat smallpox vaccines 10/16/03- started to feel a "burning, itching sensation" on his lower left calf- noticed a large blister surrounded by multiple small blisters on his lower left calf- lesions nontender, moderately pruritic, eryematous and edematous- no c/o f/c or malaise. 10/17/03- size and number of lesions decreased- most blisters "got popped" and some have already "crusted over"- no longer c/o burning sensation- less edema, erythema, and pruritus noted- patient seen at the clinic - denied any other blisters on body or having any lesions in his mouth- h/o chronic dry skin o/w unremarkable- FH insignificant- no h/o allergies- on no meds- no recent exposure to poison ivy or Chicken pox- no field exposure- no recent h/o friction/trauma to the area- no recent new skin product use- patient in NAD- afeb 10/20/03- no c/o sx/sx of infection 10/27/03- Lesions now replaced by dry black-colored scabs- no c/o sx/sx of infection- will obtain sera for the presence of pemphigus antibody  A copy of the patient's summary mailed to VAERS via FedEx on 11/12/03
patient fainted after getting first pfizer vaccine . patient was conscious all the time , he refused us to call 911, he stated he is feeling fine , he was a bit pale, he stated he didn't eat anything all day and it was 6pm when he got the shot. I checked his blood pressure which the bottom number was kind of low, patient had water and ate some snack and felt better after, his blood pressure was better after that and he got his color back.
TINY RED SPOTS ON BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. 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) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-JUN-2021, the subject experienced tiny red spots on body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiny red spots on body was not reported. This report was non-serious.
diagnosed her with shingles; itching; red patch on the dorsal lateral top of her right foot; blistering; This case was reported by a physician via sales rep and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 1st May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 12 days after receiving Shingrix, the patient experienced shingles, pruritus, skin red and blister. On an unknown date, the outcome of the shingles, pruritus, skin red and blister were unknown.   It was unknown if the reporter considered the shingles, pruritus, skin red and blister to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient felt fine until 12th May 2020 evening. On 13th May 2020, the patient noticed an itching, blistering red patch on the dorsal lateral top of her right foot. Up until that point, she had no other symptoms after she received the vaccine.  The reported stated that, since this patient actually works for the reporter as phlebotomist, he/she looked at her right foot in morning of the date of reporting and diagnosed her with shingles.
a dose of expired Daptacel was administered today; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.   This case involves a 6 months old patient (gender not reported) who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expiration date: 16-Mar-2019) (batch number, dose in series, route and site of administration were not reported) on 20-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.   Information on the batch number was requested.  Documents held by the sender: none.
pt came in on 9/16 stating that the arm was painful to the touch. Upon inspection, reaction was not at site of injection, but more medial. Reaction included radiating heat, swollen, red, and painful to the touch. Advised pt to take 2 doses of tylenol and use an ice pack. Pt returned to the store on 9/17/20. Reaction has significantly been reduced. No redness or heat observed and patient states that it is only a little painful.
General body pain; Blurry vision; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), NAUSEA (Nausea) and VISION BLURRED (Blurry vision) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for Blood pressure.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (General body pain), NAUSEA (Nausea) and VISION BLURRED (Blurry vision). At the time of the report, PAIN (General body pain), NAUSEA (Nausea) and VISION BLURRED (Blurry vision) outcome was unknown.        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.
pt reports head pressure and  acute stabbing pain in head.  Also, numbness on head.
Patient reported symptoms of slightly swollen and red upper left arm, Pt had shortness of breath and body aches yesterday but that subsided.
injection site warm to the touch; flu like symptoms; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE WARMTH (injection site warm to the touch) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced INJECTION SITE WARMTH (injection site warm to the touch). At the time of the report, INJECTION SITE WARMTH (injection site warm to the touch) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Myalgia, Arthralgia, Fever, Pain/Discomfort at injection site, chills Narrative:
5 days after shot noticed red circle at the site - it became larger and hard underneath. Exam - Red, hot circle 4 cm x 3.5 cm, hard lump under and surrounding circle 7 cm x 5 cm. 10-12-15 redness and hardness have reduced by 50% and continues daily.
This case was reported by a consumer and described the occurrence of bedridden in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 April 2011 the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject was bedridden for at least two days at the time of reporting. No additional details were reported. At the time of reporting the outcome of the event was unspecified.
High fever (102 degrees F), very ill feeling. Lasted 12 hours. No treatment required.
Hives all over body. Started at arm pits and quickly spread to entire body. Taking 40 mg daily of loratadine, 150 mg hydroxyzine 4 times daily, 50 mg Benadryl to keep itching and hives under control. Have had hives and itching since 11/26/21 and continue to have them. Beginning to lower medication to 20 mg. Loratadine and 50 mg hydroxyzine as tolerable. Continue to have itching currently but hives mostly gone.