chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, had an abnormal electrocardiogram (ECG), two days after he received the following vaccines (also reported as 10 days post vaccination): an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 04 February 2013. On 06 February 2013, two days post vaccination, the subject developed moderate shortness of breath, considered moderate severity, with intermittent one minute episodes of shortness of breath with no identified exacerbating factors. The subject had an abnormal electrocardiogram (ECG) noted to have ST segment depression at visit two on 14 February 2013, 10 days post vaccination (also reported as start date 06 February 2013). Troponin was reported as normal times two (x2) on unspecified dates. The subject also reported congestion and cough with onset six days post vaccine, resolving three days later. The subject was referred for care. No treatments medications were prescribed. The adverse event and outcome of abnormal ECG was considered not resolved, not recovered and outcome was also reported as lost to follow-up. According to the investigator, the event of abnormal ECG (potential myopericarditis) was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Information has been received from a company representative concerning a patient who was vaccinated with 1 dose of varicella virus vaccine live. Subsequently, the patient developed shingles. It was noted that this was third hand information and no additional information was provided. Additional information has been requested.
second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021). At the time of the report, MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021) outcome was unknown. Not Provided          No concomitant information was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-068636 (Patient Link).
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GLJ2524) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 22Apr2021 as dose 2, single (Lot number: 019B21A), in left arm and on 29May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history (No chronic health problems, No known allergies). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110129 same patent, different drug/event;
Sore arm (much more than normal), headache, aches, tired and low fever.    Symptoms started about 8 hours from the shot and continued for 30 hours
Lpn Mix and Drew covid vaccine with a less amount of Saline. Vial was mixed with 1.3ml instead of 2.2 ml, Patient received a Higher concentrated dose of the vaccine itself.  As per CDC pt doesn't need a 3rd dose.  2nd dose covers 2nd & 3rd. as per mom pt doesn't have any symptoms Pt is cover with all series until CD changes any guidelines .
Patient received Pfizer maroon bivalent for dose 3 when dose 1 and dose 2 were Moderna
Vaccine given without complication in right deltoid.  Patient noted that she didn't feel the injection at the time of administration.  Within 1-2 hours of administration, patient complained of soreness in deltoid where injection given.  Overnight, pain in upper extremity worsened.  Pain noted with movement of extremity or pressure to area.  Patient used heat to area and ibuprofen for symptom control.  Symptoms continued without improvement.  On 6/13/13, patient was evaluated by MD.  No redness at site, no swelling, no induration, no localized reaction noted.  Patient complaint of pain was several inches below the site of injection.  No pain at site of injection.  Patient was unable to abduct right upper extremity without excruciating pain.  No sign of infection or localized reaction at site.  MD recommended to continue ibuprofen po every 6-8 hours and heat to area.  On 6/14/13 pain and ability to abduct right upper extremity improved.  On 6/16/13 symptoms had resolved completely.  No residual effects noted.
Patient complained of  pain at injection site in left deltoid x 2 days following second COVID-19 vaccine administration at that site 2 days ago.  Pt reports associated pruritis at the injection site w/ redness, swelling, TTP, and the area feeling firm.  Pt reports the symptoms began several hours after the injection and the affected area has been changed appreciably since onset.  Pt reports no meds/creams utilized for these symptoms.  Pt reports chills, malaise, and decreased energy level yesterday that since resolved.  Pt reports no systemic symptoms today.
Headache, body aches, chills, nausea and vomiting.  Tool Ibuprofen at start of symptoms, and an additional dose later in the day.
Left upper anterior arm with 6cm x 7cm area erythema and edema surrounding immunization site. Treatment Benadryl 1 1/2 tsp PO 2 Motrin 1 1/2 tsp PO.
11/19/09 At night at home, mom noticed about 1 inch redness and swelling, no pus or drainage. 11/21/09 Mom came back for PPD reading at clinic mom noticed increase swelling, redness, warmth, firmness. Firmness/swelling 20cm by 12cm. Doctor diagnosis cellulitis and gave Cephalexin.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional (office staff) by phone. This case involves a 24 months old female patient who was vaccinated with an expired 0.5 ml first dose of ACT-HIB (Batch number: UI821AAA and expiry date: 19-Nov-2018, route of administration were not reported) in the right thigh on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PEDIARIX on an unspecified date. It was a case of actual medication error due to expired vaccine used because the patient was administered with an expired dose. 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 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. Documents held by sender: none.
1115: After receiving the Covid vaccine, the patient c/o feeling weak, nauseous & diaphoretic 1117: Pt supine in driver seat, alert. BP 100/-- HR 37; repeat BP 100/60 HR 43 SpO2 96-100%. O2 2L N/C given to pt.  Juice given.   1121: HR 60 SpO2 98%  Pt alert & talking 1142: BP 98/64 HR 68 1205: Pt released home
TINNITUS -Ringing in ears , I have been experiencing this since the shit and I am still experiencing it.
received 1st dose 10/16/2021, 2nd not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix on 16th OCT 2021.).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter stated that the patient never returned back over the weekend to get 2nd dose.  The reporter also stated that 2nd dose had not been administered at time of call. No additional data available. The reporter give consent to follow up. Additional Supportive Information: The patient had not received 2nd dose which led to incomplete course of vaccination. This case is linked with US2022153074 reported by the same reporter.; Sender's Comments:  US-GSK-US2022153074:Same reporter
12/25/2022 that evening I had a sore throat, stuffy nose and I had a fever the next day. I took a at home COVID-19 test and is positive. I contact my PCP on the telephone, He have me PAXLOVID the smaller dose because of my kidneys. I was having symptoms for about four days. I tested negative on 01/01/2023. I got rebound COVID-19 on 01/07/2023. Now I have a very stuffy nose and a fever yesterday 100.4. It was fever chills and a stuffy nose all day today as well.
THE NEXT MORNING I FAINTED  ?ND LOST MY CONSCIOUSNESS. INTENSE HAIR THINNING ALL OVER THE SCALP AFTER 3 MONTHS.    NO TREATMENT HELPED ME.  MY THINNING GOES ON AND HAS NOT STOPPED.
I was thirsty starting about 1hr after shot. Could not quench the thirst.  Then around 0130-0200 I had a massive headache.   Headache was debilitating, along with sever joint pain. I could not even stand up straight.  I had a fever that would come & go.  Also, the skin at the hip area was hot/warm to the touch. The side effects lasted about a day & a half.  I had to call off work because I could not function.  I still get headaches,  off & on.
Arm became progressively more sore within 1-2 hours but never swollen or reddened. Within 4-5 hours, extreme fatigue, chills, dizziness, and nausea set in and these symptoms persisted through the night. Symptoms have mainly subsided as of mid-day the following day, with residual elements of fatigue and intermittent bouts of nausea (with one bout of vomiting around 5 PM) still persisting. I expect to be on the 2-3 day recovery trajectory described in your article, pretty typical I guess. Thanks for the education!!
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 1st June 2015 15:10. The subject's estimated date of delivery was in June 2015. The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided as follows: Concomitant products included minerals nos + vitamins nos (Prenatal Vitamins). The reporter did not have the date of the patient's last menstrual period.
Imz given on 3-15-19. Pt stated on 3-18-19 that soreness was immediate and there was also some minor swelling. Pt also stated that redness about the size of the palm of her hand started on 3-17-19. Area was a little warm to the touch. Pt took advil and as of the time of this report, pt still has some redness. Pt stated she does not feel bad. She contacted dr who advised her to call pharmacy since that was where vax was given. Advised pt to continue with Advil for soreness and if redness still persisted on next day to see doctor.
Wife called us on 10/15 to inform that patient did not do well after the vaccines. He was on ventilator for 5 days, then passed away.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 2nd patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
This spontaneous report as received from a pharmacist via company representative refers to a 62 year old female patient. The patient's medical history was not reported. On 04-MAR-2015, the patient was vaccinated with single dose of ZOSTAVAX lot # K016320, expiration date 24-DEC-2015, subcutaneously (dose and administration site were not reported). The vaccine was reconstituted with sterile diluent lot # K011199, expiration date 29-MAY-2017. In March 2015 (reported as after receiving ZOSTAVAX, the patient experienced an area 2-3 inches with redness, that was hard and warm to touch. The outcome of injection site erythema, injection site induration and injection site warmth was unknown. This is one of several reports from the same reporter. Additional information has been requested.
upper arm neck has been hurting quit a lot / pain; upper arm neck has been hurting quit a lot / pain; Rotator cuff discomfort / rotator cuff is acting up; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st October 2020, the patient received Shingles vaccine. On 5th November 2020, 5 days after receiving Shingles vaccine, the patient experienced pain in arm, neck pain and rotator cuff injury. On an unknown date, the outcome of the pain in arm, neck pain and rotator cuff injury were unknown.   It was unknown if the reporter considered the pain in arm, neck pain and rotator cuff injury to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient stated that last two days upper arm neck has been hurting quit a lot. The patient don't know whether the pain is from the shot or rotator cuff is acting up.
In the hours following the first dose on 3/19/2021, sustained fever between 100 - 102 degrees, headaches, chills, clammy.  The symptoms continued all day on the 3/20/2021.  Sometime after 5:30 am on the 3/21/2021 she could not breathe.  Pulse oximeter registered 57.  contacted ambulance, within their arrival 10-15 minutes later, pulse oximeter was down to 43.  Lips were blue skin was pale and clammy.  At hospital she received high doses of oxygen and was treated for other symptoms.
Patient woke up with spotty rash on face and a stiff neck. I told her to check with doctor if rash got worse or didn't go away.
My cancer marker in Oct2020 was 25. In Jan2021 it was 8.  And in Mar2021 was 24. cancer marker go up and down; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 70-year-old female patient received the first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), both via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cancer of the womb from 1983 (I started out with cancer of the womb which was removed in 1983), lumpectomy from 2003, cancer: outside of the vulva from 2011, right breast removed from 20Dec2017, and chemotherapy from 2003. Concomitant medications included letrozole (FEMARA) from Jan2018 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); diclofenac (VOLTAREN [DICLOFENAC]); ergocalciferol; furosemide (LASIX [FUROSEMIDE]); irbesartan (AVAPRO); levothyroxine sodium (SYNTHROID); omeprazole (PRILOSEC [OMEPRAZOLE]); potassium chloride; rosuvastatin calcium (CRESTOR); hydrochlorothiazide, triamterene (MAXZIDE); and valaciclovir hydrochloride (VALTREX). The patient stated, "My cancer marker in Oct2020 was 25. In Jan2021 it was 8. And in Mar2021 was 24. My heart doctor put me rosuvastatin 10mg at end of 2020 which may have had an impact on my cancer marker going down to an 8. My understanding is that Letrozole is made by Pfizer and the covid vaccine is made by Pfizer. I would like understanding how this medicine works that made my cancer marker go up and down. I would like for you to speak with my cancer doctor or her administrator because these numbers are important to me." Per patient, she will be obtaining her current lab values from the office today and will follow up with her doctor on 19Apr2021. The reporter considered the event as serious medically significant. The outcome of the event was unknown.  Information about lot and batch number was requested.
Pt recvd vax 17DEC92 & exp severe pain @ site of inject w/chills & fever;
Information has been received from a radiology technician/vaccine coordinator referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the patients were vaccinated with an improperly stored doses of VAQTA lot # M011116 with an expiration date 17-JUN-2017 and lot # M002268 with an expiration date 20-SEP-2017 (dose, route and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
swelling in her sinuses; feel swelling in upper throat; Swelling of face; Cheek swelling; felt lips swell up; tongue swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling) and LIP SWELLING (felt lips swell up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling), LIP SWELLING (felt lips swell up) and SWOLLEN TONGUE (tongue swell up). At the time of the report, SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling), LIP SWELLING (felt lips swell up) and SWOLLEN TONGUE (tongue swell up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs provided no treatment drugs provided
Severe dizziness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had none known allergies. Concomitant medication included macrogol 3350 (MIRALAX). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 08:00, the patient experienced severe dizziness. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with over the counter (OTC) medicine. The clinical outcome of the event severe dizziness was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.