chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 13 years old patient. The patient was vaccinated with ZOSTAVAX (Lot# unspecified) on 20-AUG-2012, instead of the intended (Merck) VARIVAX. At the time of this report, the patient had just received the dose of ZOSTAVAX; for that reason, the reporter did not know if the patient was experiencing any adverse effects. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Approximately 30 minutes after receiving the vaccine, I began to experience coughing and a tightening in my chest. This lasted for another 30 minutes.
Fussy after shots, temp 100.5, increasing to 103; Tylenol given with no relief.  Went to ER, evaluated, no blood work, or urine or x-rays; no meds given in ER; advised to give Advil at home & follow up with pediatrician.  Pediatrician wants vaccines to be given at different intervals, not all on same visit for series #3.
Narrative: Patient reports injection site reaction for one day. He also states he had dry cough and took a test for COVID- 19 by outside provider. Pending results.  Other Relevant Hx: Symptoms:  & injection site reaction, dry cough Treatment:
I received the shot in my right arm.  Within an hour or so, my left hand with CRPS (complex regional pain syndrome) in remission felt very tight and stiff.....within 4 days on Monday March 15, I woke up with Petechiae on my left hand only.  It felt even more stiff and tight.  By March 17, most of the Petechiae spots have started to fade, thankfully.  But I will not be getting the 2nd dose.  I?m terrified my CRPS will come back.
Dose was given and patient was alert and oriented.  Had him sit for 5 minutes; then when he stood up to let his sibling have his chair he fainted.  He came to right away and I had him sit on floor (cool concrete)  for a few minutes.  He was ok. then asked to lay down  and fainted again.  I put cool compress on back of neck and had mother sit with him  on the floor until he was alert enough to sip some Gatorade.  His pulse and breathing  were good.  After another 5 to 10 min he was fine.
Patient reported right chest was feeling "funny" and hand achy/tingling. She also stated that she had mental fogginess after her first dose and felt it was happening with this dose as well.  Vitals were monitored and stable for the time she was here ~45 minutes.  At time of dismissal she was feeling better and her husband was here to transport her.
Information has been received from a physician, through the pregnancy registry, concerning a 36 year old female with no known allergies, past medical history or previous pregnancy who had her last mentrual period on 01/01/2001. On 01/25/2001 her pregnancy test was negative. On 01/31/2001 was vaccinated with one dose of varicella vaccine. There was no concurrent medicaiton. The pt did not have a local reaction, varicella symptoms or herpes zoster post-vaccination. On 02/06/2001 her pregnancy test was positive. On 02/15/2001 and 03/15/2001, the pt underwent routine ultrasounds which were normal. The pt declined an amniocentesis and alpha fetoprotein tests. In approximately September 2001, the pt experienced pyelonephritis and received treatment with Keflex for treatment until delivery. On 10/09/2001 the pt delivered a normal female baby weighing 8 lb. 5 oz. It was noted that the pt experienced cephalopelvic disproportion during labor/delivery. There was no concurrent medical condition. The infant did not have any feature of congential varicella zoster syndrome. No further info is available.
No adverse event took place.  I am reporting this because I inadvertently gave this child MMRV and varicella vaccines.
Pt received MMR/Varicella complained of tinnitis right ear 15 minutes after shot (not left ear). No dizziness, no nausea. Lasted 5-10 minutes then gone.
DEVELOPED ACUTE SHINGLES ON THE EVENING OF 2ND MODERNA VACCINE
Information has been received from a medical assistant concerning a male patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant therapies reported. On 30-JAN-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot number M036643 with expiration date of 19-NOV-2017 (strength, dose, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 20 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000434.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "controlled high blood pressure" (unspecified if ongoing), notes: controlled high blood pressure; "controlled hyperlipidemia" (unspecified if ongoing), notes: controlled hyperlipidemia; "known allergies: wheat, peas and Corn" (unspecified if ongoing), notes: known allergies: wheat, peas and Corn; "known allergies: Tomatoes" (unspecified if ongoing), notes: known allergies: Tomatoes; "known allergies: Eggs" (unspecified if ongoing), notes: known allergies: Eggs. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin; Vicodin, reaction(s): "known allergies: Vicodin", notes: known allergies: Vicodin; Lyrica, reaction(s): "known allergies: Lyrica", notes: known allergies: Lyrica. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Slight Positive, notes: On 01Jan2023 I started coughing. I tested on 02Jan2023 and had a very slight positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had other medication in 2 weeks. Treatment with Paxlovid was started on 23Dec2022 and completed on 28Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
symptom; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptom) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptom). At the time of the report, VACCINATION COMPLICATION (symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was Reported.  No Treatment information was Reported.
Headaches, cramps in the abdomen were observed. Tears of sadness and sorrow were shed.
Information has been received from a pharmacist and a nurse concerning a 61 year old female with allergies to "Ilosine" and CODEINE who on 17-NOV-2008 was vaccinated with ZOSTER vaccine (lot # 663194/1415X). Concomitant therapy included tramadol HCl. On 20-NOV-2008 the patient developed a quarter size red area at the site of injection with a red ring around it. The area between the quarter size red area and ring was clear. It was unspecified if the patient sought medical attention. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow-up information received on 23-DEC-2008. Vaccination with ZOSTAVAX was given subcutaneously on the left upper arm. Patient developed a lump at the injection site on 19-NOV-2008, two days after given. It became itchy and patient then developed a halo like rash around site on 21-NOV-2008, four days after injection. At the time of the report the rash had subsided but areas was still discolored. No further information is available.
Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; Local arm rash at injection site, itchy, red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 08Apr2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 14Apr2021 at 16:00, the patient experienced local arm rash at injection site which was itchy, swollen and red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events local arm rash at injection site, itchy, red and swollen were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2.5-year-old patient received an adult dose of Havrix; 2.5-year-old patient received an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 30-month-old female patient who received HAV (Havrix adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that an adult dose of Havrix was administered to a 2.5 year old patient, which led to adult product administered to child and overdose. The reporter consented to follow-up. The reported batch number J95HZ was not available in sales data sheet, hence updated to J95H7.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: DEPO-ESTRADIOL, start date: 07Dec2017; PROGESTERONE, start date: 09May2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical information: The patient had COVID-19 in 2022 and received PAXLOVID as treatment from 20Dec2022 until 25Dec2022. It was stated that the patient was negative for consecutive tests each 24 hours apart in Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sore arm; Flat Rash at the injection arm; Redness at the injection site; Chills; Low grade Fever; Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever). On 15-Jan-2021, the patient experienced RASH (Flat Rash at the injection arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever) 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.   Concomitant medications were not provided. Treatment information was not reported.
High pitched uncontrollable crying - 2 1/2 hrs, small reddened nodule on R anterior thigh.
Multiple Cold Sores on bottom lip grew. I have had one on occasion- maybe 2-3 times a year. But 2 days after shot I felt multiple breaking out at same time. Wound up with 3 spaced across bottom lip.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
feeling bad; Had no energy; everything spins inside the room/ went black; everything spins inside the room/ went black; This is a spontaneous report from a contactable consumer reporting for himself. An 83-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer- BioNTech, lot# lot# EL1284), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing wheelchair user, blood pressure abnormal and prostate infection. Patient's body weight was 218-220 pounds. Concomitant medications included acetylsalicylic acid (ASPIRIN) for many years at 1 DF daily, an unspecified prostate medication and an unspecified drug for blood pressure at 20 mg, another unspecified drug that is mixed and eye drops. The patient experienced feeling bad, had no energy, everything spins inside the room/ went black all in Feb2021 with outcome of unknown.
Chest pain, dyspnea, fatigue 6 days post primary SPV, AVA #2 Dyspnea (shortness of breath) Start: 06/18/2007, Chest Pain, sub-sternal Start: 06/18/2007 Fatigue, Malaise <60 Days Start: 06/18/2007.  9/17/2007 MR received for DOS 6/21-25/2007 for Discharge DX of Myocarditis 2' to Smallpox vaccine. Secondary DX hypothyroidism, dyslipidemia, systolic dysfunction. Pt presented with c/o chest pain. Pt also experienced light-headedness, diaphoresis, and abdominal cramps on a 4 hr march which was self treated with po fluids on the day preceding chest pain.  The following morning he woke with substernal chest pain which was exacerbated by lying down. Pain increased throughout the day and SOB and nausea developed at which time he went to the ER. Discharged with a Lifevest external defibrillator. F/U cardiology visit 7/23/07 clinically improved except for some mild fatigability. 8/24/2007 MR received for several OVs r/t Acute Myopericarditis dx. Pt had a severe cardiac reaction to Smallpox immunization requiring 5 day hospital stay and pacemaker.  Still having chest pain which is relieved with ibuprofen/mobic. Pt gets SOB easily.
Patient unable to provide vaccination card nor does he remember his exact dates of vaccination.  Stated he received Pfizer in July and August 2021.
She got the 2nd vaccine, started off with a slight headache and fatigue.  Then she started getting nauseous and vomited and then had diarrhea.  She then had bloody diarrhea, and several blood stools, and then it stopped, this lasted for a couple of hours.  Then she felt just washed out from all of that.  No problems with the vaccine site.  She is still tired, but feels back to her normal.  She did not take anything for the reaction and called her GI doctor who told her to watch it and if not to go to the ER, but it did stop.
This spontaneous report was received from a physician referring to multiple unspecified patients unknown age and gender. Information regarding the multiple patient's concurrent conditions and medical history were not provided. The physician reported that multiple patients received GARDASIL (lot # K006960 with an expiration date on 19-FEB-2017) (dose and route were not provided). This vaccine was improperly stored. No adverse effects were reported. The storage temperature was 34 degrees F, the time frame: 120 hours and there was no previous excursion temperature. This is one of several reports received from the same reporter (MARRS # 1604USA010522). Additional information is not expected as the physician cannot be contacted.
The area where the injection was administered is red, a little swollen and didn't appear until over a week of having the injection. It itches a little bit but not much and feels a little warm.
extremely exhausted; having extreme pain; she already had an immune problem but now it's worse; she already had an immune problem but now it's worse; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection), via an unspecified route of administration on an unspecified date (a week ago; as reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Caller stated that on an unspecified date she received her first dose of the Pfizer Covid-19 vaccine a week ago and she would like to know if there any statistics on people with immune problems after vaccination. Stated that she already had an immune problem but now it's worse. She has been feeling extremely exhausted and having extreme pain. The report was non-serious. Outcome was not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a physician referring to a 7 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 16:45 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Circular raised silver-dollar sized area around injection site with 2 finger size striations on arm + 1 into side of neck. Sore to the touch.
Resting heart rate increased significantly.  Felt heart palpitations.  I previously had COVID and recently tested for antibodies and still had them from 9 months ago.
Began with mouth soars for 8 months than spread to body mass with skin peeling when scratched and then open soars that didn't heal quickly.  As if 6/26 Prednisone 5 mg on 7/27 Doctor adjusted dosage to 10mg
Pt presented to ED with right sided headache then vision loss in L eye and shaky legs. Diagnosed with CVA.