chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL injection, lot # K011562, expiration date 08-APR-2017 (dose, dose number and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Red band around arm; warm; itchiness; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Red band around arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL for Hypertension, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FOLIC ACID for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness). On 18-Feb-2021, the patient experienced VACCINATION SITE REACTION (Red band around arm). On 18-Feb-2021, VACCINATION SITE PRURITUS (itchiness) had resolved. On 20-Feb-2021, VACCINATION SITE WARMTH (warm) and MYALGIA (soreness) had resolved, VACCINATION SITE ERYTHEMA (redness) outcome was unknown. On 23-Feb-2021, VACCINATION SITE REACTION (Red band around arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 03-MAY-2021 and contains concomitant medications, events out come, new events were updated.
Pt develop red raised pimples on checks; upper lip and chin approx - 7-8. No c/o pruritus or draining. Two days later pt developed 103 degrees - head scan 2 days. Pt assessed by PMD unsure if this is a virus - 12-15-09 MD diagnosed as staph infection.
pt recvd vax in oct90 using material which was past its expiration date; at time of report,no adverse exps noted
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (lot#, dose, strength and route unknown). On an unknown date the PROQUAD was exposed to temperature excursions on 6F for 8 hours and/or 10F for 11.5 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Patient stated has had rashes/hives continuously all over body since receiving shot. Benadryl makes go away but continues to come back after stopping.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.
APril had a high pitched scream in the afternoon p/having the vax that morning; lasted about 1 hr;
BREAKTHROUGH HOSPITALIZATION CASE.  VACCINATED FOR COVID-19 IN MARCH 2021. 10/9/21-STARTED HAVING SOB AND FATIGUE INCREASING IN SEVERITY, THEN HE PRESENTED IN THE ER ON 10/10/21.  HE C/O HAVING BODY ACHES, FATIGUE, NON-PRODUCTIVE COUGH AND SOB WITH EXERTION. TEMP 102.7F. HIS WIFE TESTED POSITIVE FOR COVID-19 SEVERAL DAYS BEFORE. HIS TEST WAS NEGATIVE AT THAT TIME.  HE WAS TESTED AGAIN IN THE ER AND WAS POSITIVE FOR COVID-19.  HE IS A FORMER SMOKER.   HE WAS STARTED ON 2L OF O2.  HE WAS DIAGNOSED WITH ACUTE HYPOXEMIC RESPIRATORY FAILURE, COVID-19 VIRUS INFECTION AND PNEUMONIA DUE TO COVID-19 VIRUS.
This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced sexual problems, dysfunction of male organs and/or swollen or painful scrotum. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
1st dose on Jun/25/2020 / 2nd dose on Jul/02/2020 / 3rd dose on Jul/09/2020; Vaccine administered at inappropriate site; 1st dose on Jun/25/2020 / 2nd dose on Jul/02/2020 / 3rd dose on Jul/09/2020; 1st and 2nd dose was administered at left gluteus Medius; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a 44-year-old female patient who received Rabies NVS (RabAvert) (batch number 639011C, expiry date 1st July 2020) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) (batch number ARB6621B, expiry date 1st October 2021) for prophylaxis and Rabies NVS (RabAvert) (batch number ARB6621B, expiry date 31st October 2021) for prophylaxis.   On 25th June 2020, the patient received the 1st dose of RabAvert. On 2nd July 2020, the patient received the 2nd dose of RabAvert. On 9th July 2020, the patient received the 3rd dose of RabAvert. On 25th January 2020, unknown after receiving RabAvert and not applicable after receiving RabAvert and RabAvert, the patient experienced vaccine administered at inappropriate site. On 2nd July 2020, the patient experienced vaccine administered at inappropriate site and drug dose administration interval too long. On 9th July 2020, the patient experienced drug dose administration interval too long. The action taken with RabAvert was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site, vaccine administered at inappropriate site, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional case details were reported as follows: On 25th January 2020, the patient received 1st dose of  RabAvert via left gluteus Medius, which led to vaccine administered at inappropriate site. On 2nd July 2020, the patient received 2nd dose of  RabAvert via left gluteus Medius, which led to lengthening of the vaccination schedule and vaccine administered at inappropriate site. On 9th July 2020, the patient received 3rd dose of  RabAvert via left gluteus Medius, which led to lengthening of the vaccination schedule.
This spontaneous report as received from a registered pharmacist refers to a 52 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # H013943; exp date 25-OCT-2013) (dose and route not reported) on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 09-DEC-2012 the patient went back to the pharmacy, to pick up MEDROL dosepack. The reason for use of MEDROL dosepack was unspecified. No lab diagnostic tests were performed the outcome of the unspecified event was unknown. The relatedness for the event was not provided for ZOSTAVAX, Additional information has been requested.
After the first dose, exactly one week to the day I developed a red, itchy raised bump at the injection site. Self resolved within a few days.  Less than a week after the second series,  I developed an irregular heart beat with ?skipped? beats that lasted approximately one month.
pt recv vax 10NOV97 1150AM & approx 1min later pt fainted;pt responded when placed on floor;12:05PM became pale, sweaty & lethargic;placed on  02;BP 110/80, P88, R20;
50 year old female with PMH of fibroids and ovarian cyst who presented to hospital with subacute abdominal pain. Patient still has menstrual periods every 28 days and has noted some mild inter-menstrual spotting over the past year- she has never been pregnant, has no known STI history, and is not currently sexually active. There is no known family history of breast or gynecologic malignancy. Patient will follow up with gynecologic oncology as an outpatient for further discussion of treatment. She did not tolerate Dilaudid or Tramadol due to nausea and dizziness and has an allergy to the Norco, so she was switched to Percocet. IR was consulted for biopsy of pleural nodules noted on chest CT, but determined they we not accessible due to size, and patient is encouraged to have the nodules surveyed with serial imaging at 3 month intervals. Patient had a mild fever to 100.2 without leukocytosis, we held Percocet and gave Tylenol, which resolved the episode. She is to follow up with gynecologic oncology within 1 week of discharge. Patient was medically stable for discharge with pain and anti-nausea medication.
she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Medication suspected of leading to the adverse reaction: PEDIARIX - combination vaccine--0.5ml/im- Reaction preventable-e.g., inappropriate or lack of dose adjustment, excessive dosing, known drug interaction, drug allergies, other contraindications, or inappropriate drug administration technique-; unknown. Type of reaction: Idiosyncratic - unanticipated rare adverse reaction not dose related, unexpected deterioration in respiratory status. Likelihood that the reaction was a result of the medication: Probable - reaction resolved when drug was discontinued/reaction could not be explained by existing clinical condition. Result of the reaction on the level of care: Oxygen administered. Incident Description: Within hours of PEDIARIX administration the patient's respiratory status declined resulting in an unusually elevated and unexpected number of events of apnea, desaturation and bradycardia. While some of these were self-resolved, at least 50% required stimulation and/or oxygen administration in a patient whose respiratory status had been stable in room air up to the time of the vaccine administration.
This spontaneous report as received from a 57 years old female consumer with drug allergy to penicillin and iodine refers to herself. The patient's historical drug included pneumonia shot a few months before the ZOSTAVAX vaccine. The patient was vaccinated subcutaneously with single dose 0.65 ml ZOSTAVAX (lot number unknown) on 16-JUN-2012. No other co-suspects were reported. Concomitant medications included warfarin. On 16-JUN-2012 the patient experienced serve knee pain, along her knee caps immediately following her injection with ZOSTAVAX. The pain had continued and she had also developed severe headache. The patient had sought unspecified medical attention. Treatment with ibuprofen and hydrocodone were given for adverse events. No laboratory diagnostics studies were performed. The outcome of the events was recovering. Additional information is not expected.
It was reported that a pt (11 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested.
Patient left the exam room about 630 pm as she was leaving thru the waiting area she fell down, was very pale. She was laid flat on carpeted floor legs raised, after few seconds color was back radial pulse was 90/minute BP stable. She stood up walked after taking lollipop.
Day after vaccine very tired, diarrhea. Dry scaly tiny bumps on entire left shoulder. It traveled across my chest between the bottom of my neck to top of breasts and my right shoulder. Dr. doesn't want me to get the second dose. I still have it only it is getting much better. I had a HZV (zoster) vaccine on Oct. 30, 2009. I got shingles Sept. 16, 2015 on my right side, on my back, under my shoulder blade. Stabbing pains, but no skin outbreak. I went to the clinic and saw Dr.
presented to outside ED with complaints of new onset chest pain that radiated to the back and down his arms with concurrent nausea. Patient was sitting in the living room around 2030-2045 when he developed midsternal and epigastric region pain. Pain radiated to his upper middle back and down both left and right arms. There were no notable exacerbating or relieving factors. Pain was a 4-7 in severity. He was also nauseated. He was given tums by his mother without significant change in symptoms. After 45 minutes they decided to go to the ER. At ER labs were notable for elevated troponin (2-- >15-- >9). EKG with J-point elevation. Non-contrast CT chest/abd/pelvis was unremarkable. He was given ASA 325 and famotidine in the ED. Pain eventually subsided around 2345. He was transferred to another hospital for further evaluation of troponinemia.
Concern for PD catheter cuff infection. She was sent in by surgeon.  Seeing for dialysis needs   History of Present Illness: Seen/examined. She and I have met before She was seen 2 days ago; notes reviewed C/o back pain and was back on Gabapentin EDW 48.5 kg Poor appetite, daily Reglan Told staff that she had "drainage" from abdomen opposite side of exit site Seen for exam (photos in chart) , +purulent drainage   Per colleague: " There is an indurated swelling with openings on the skin. Pus came out when pressed. It's very close to the current exit site which has no external cuff(thus, tunnel is no longer sealed. No pus coming from the tunnel even though it's no longer sealed and therefore, it seems the abscess is not connected to the tunnel. " Culture from that time:
Diarrhea, fatigue, & headache approx 4.5 hours after vaccine
Has received flu vaccine every year since birth (2012). Hives following 5 days after flu vaccine  in 2021 and 2022.  Resolved after 5 days in 2021. This is day 2 of hives this round, appt scheduled with allergy clinic.
Within 2 hours my 1 month old had a 101.5 fever, labored breathing, refused to eat, lethargic, gasping for air, shaking, vomiting, wheezing.
Moderate fever, nausea, headache, lethargy, lightheadedness, nausea, aching skin, brain fogginess/difficulty focusing, sore throat,  severe arm pain at injection point although no visually apparent swelling, chills.
Extremely itchy wetly rash; Rash on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest). At the time of the report, RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
headache; a little bit of fever; tired; arm was sore; This is a spontaneous report from a contactable consumer (parent). A contactable consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Lot number was not provided), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single and on an unspecified date of 2021 as dose 2, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced headache, a little bit of fever, tired and arm was sore. It was further reported that the patient got his COVID-19 vaccine about 3 months ago, he had both doses and had a headache, a little bit of fever, was tired so he slept and his arm was sore but overall he flew through both doses (meaning he was not worried about it all). The outcome of the events was unknown.  The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127262 same reporter and drug, similar events but different patient
pt was confused.  she presented with a copy of her vaccine card but forgot she received the booster 9-22-2022.  No adverse effects noted at the time of this submission.
Hepatitis B antibody negative. This case was reported by a consumer and described a female patient who did not respond to the hepatitis B component of immunization with hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). A physician or other health care professional has not verified this report. The patient's past medical history included hepatitis C. Concurrent medications included carvedilol, aspirin, frusmedie, paroxetinel, metoclopramide, venlafaxine, simvastatin, fluticasone propionate+salmeterol xinafoate, memetasone and Combivent. On an unspecified date, the patient received the third dose of Twinrix. Subsequently, on 16 January 2004, the patient underwent a "blood test."  The resulting hepatitis B surface antibody titer indicated that, "the Twinrix vaccine did not provide coverage for hepatitis B."
Pt. received ZOSTAVAX injection on 2/4/12. Pt. presented to pharmacy on 2/6/12 with 5" cellulitis at injection site (red & hot) - Tx included MEDROL dose pack and ZYRTEC 10mg PO QD.
a lot more irregular heart beats; couldn't catch my breath; arm (felt) was ice cold; trouble breathing; eyes got "blinky-eyed" / couldn't keep eyes open; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Irregular pulse, Coronary artery disease, Osteoarthritis and High cholesterol. Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, ACETYLSALICYLIC ACID (ASPRIN) and ATORVASTATIN for an unknown indication, FAMOTIDINE.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath). At the time of the report, PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Novalin N and Novalin R. Patient states her blood sugar (A1C) went up. Was at 9.2 (before shot) and then went up 9.8 (done by CBC) reported a couple weeks after the shot. Patient states she is supposed to get second dose on 26May2021 but is hesitant. Patient states she's notice that she has been having "a lot more irregular heart beats" at night. Patient states she think was doing fine until getting the vaccine.  Treatment information was unknown.    Reporter did not allow further contact
This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age. The patient has drug allergies with sulfamethoxazole, BACTRIM, acetaminophen, DARVOCET-N and sulfa drugs. The patient's medical history included history of herpes simplex. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date was not reported and route subcutaneous). No concomitant medications were reported. On 10-DEC-2012, the patient breakout of a cold sore after receiving ZOSTAVAX. The patient was prescribed antivirals for the cold sores however she was advised by her unspecified health care professional not to take the antiviral medication since she was just administered the ZOSTAVAX on 27-NOV-2012. The outcome of the event was unknown. It was unspecified if patient sought medical attention. Additional information has been requested.
10/9 received vaccine, 10/10 approx 1am diarrhea, 10/10 9am severe nausea, stomach cramps, back and leg pain, fever progressed throughout day on 10/10. 10/11 symptoms continue notified emp health nurse 10/11 about 10am.
Two days after dose-2 of Moderna COVID-19 vaccine I developed tinnitus in my right ear. This was nearly 3 weeks ago.   It's a constant, persistent humming like a fan or refrigerator sound. It's quieter in the morning and gets louder throughout the day. It can make me dizzy and queasy while driving a car. Sometimes this sensation occurs even while walking around my house.
Patient received the Pfizer Covid-19 vaccine at 2pm today, 3/10/2021. Approximately 10 minutes after the vaccine he became diaphoretic and weak.  He was asked if he had any reaction to any vaccines and he stated no.  Since a temperature was not able to be detected on the digital thermometer and a pulse was barely detected, I administered 2 doses of epinephrine (Epipen) 10 minutes apart.   The physician came to attend to the patient as well as nurses and the EMS.  He was taken to the ED for observation.  Prior to his departure to the ED, patient had normal O2 sats and a normal blood pressure.
She began to experience body wide tingling, headache and nausea.  She did not have lightheadedness, chest pain, shortness of breath, pain at the injection site, rash or wheezing. She went to urgent care in the facility to be evaluated. Patient was placed on a monitor and observed.  Vital signs remained  stable.  She never developed rash.  For her nausea she was given Zofran  4 mg as a disintegrating tablet which was helpful.  She received 650 mg  of Tylenol for her headache pain.  Observation continued during which  time she was entirely stable.  She requested to go home.