chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was throbbing Sunday night, but Monday morning I could barely keep my eyes open, I was chilling all day, even with a sweater and space heater facing directly on me, and I was achy.
Information has been received from a medical assistant concerning a female who (on an unreported date) was vaccinated with MMR II (Lot # not reported). It was reported that the patient had a negative titer for the measles (date not reported), but that she was able to seroconvert rubella and mumps from a MMR II that was received in the past (date not reported). The patient had no symptoms. There was no product quality complaint. Additional information has been received from the medical assistant who, on 21-AUG-2008, reported that the patient failed to seroconvert for measles after two doses of MMR II. The first dose was administered at 1 year of age and the second at 10 years of age. Lot numbers unknown. Titers were performed "about 1 month ago". Medical attention was sought as the patient had an office visit. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA007912:Original Case : 1701USA003168 US-009507513-1701USA007922:Original Case : 1701USA003168 US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Patient noticed the morning on 9/4/19 that there was itching on her arm. There was a red area about 2 inches from where the injection site was. Later in the day she noticed there were 3 red areas.
Pt with local swelling induration approx 5cm in diameter at site of injection. Appeared withing 2 hours of administration.
I have never had any allergies. No seasonal,  food or pet allergies. Since my first vaccine, I get a runny nose EVERYTIME I eat.  It doesn't matter if the food is seasoned or unseasoned, meat or oatmeal. No matter what I eat or at what time,  it runs. I feel like I have an allergy to food now.  I thought it might have been a cold,  and waited it out.  But it's been over a week since my second dose and it is still a daily occurrence.
I received the Flu-Mist on 14 November 07 at approximately 0815.  I had the sinus drainage in my throat throughout the day.  Since then, I have had a sore throat and "head cold" like symptoms: nasal and sinus congestion.  When I got the Flu-Mist, I was not having any of these symptoms.
26JUN 2PM little bumps 4x2 1/2 area over inject site; looked like heat rash- very itchy; 8PM whole body felt hot (over heated) lasted until midway; 1130PM fever (did not measure) very hot lasted about 1 1/2-2 hrs; 1130PM nausea lasted 1 hr;
develops a numbness and tingling of the mouth and tongue immediately following the first dose; develops a numbness and tingling of the mouth and tongue immediately following the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose) and PARAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Angioedema.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose) and PARAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose). At the time of the report, HYPOAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose) and PARAESTHESIA ORAL (develops a numbness and tingling of the mouth and tongue immediately following the first dose) 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.   No relevant concomitant medications were reported. no treatment medications were reported. Per physician reporting the event, patient had history of angioedema with other medications, and developed reactions of numbness and tingling of mouth immediately following first dose.   This case was linked to MOD-2021-023363, MOD-2021-019227 (Patient Link).
Fever started on 2-18-2013 102 axillary. Went to ER CBC, urine & urine culture. Flu & RSV test, chest x-ray completed. All normal. 2-19-2013: Pt c/o 101 temperature and a petechial rash that started that morning of 2/19/2013. Rash started with a small tiny red dot beside the left eye & left side of mouth.
"15mins post vaccination, pt c/o redness & itchiness to left ear and injection site.  Pt stable and released from the vaccination site.  Recommended patient follow up w/ thier healthcare provider. F/u instructions provided.  PMH significant for Lumbar Disc herniation, spinal stenosis, s/p laminotomy for microdisc L4/5 L5/S1 3/2021, Impaired mobility, and vitamin D insufficiency. Pt was recently seen for Mastodynia and RUQ abdominal pain. Current Medications: Vitamin D3 1000units PO daily Famotidine 20mg PO BID Gabapentin 300mg PO TID Meloxicam 7.5mg PO Daily Nortriptyline 10mg PO QHS Sumatriptan 25mg PO PRN migraine Nexplanon inserted 2016; unclear if replaced or removed since that date. "
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles. In approximately January 2014, reported as about 3 months ago, the patient was vaccinated with ZOSTAVAX (Dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. In approximately March 2014, reported as about 2 weeks ago, the patient experienced a "shingles outbreak". Patient sought medical attention by contacting physician. The patient started treatment on acyclovir (manufacturer unknown). At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Initially itching intensely at site (left deltoid) followed by significant swelling, redness, size 16 x 20cm and warmth.
Mother awakened at 01:00 on the day after injections to child throwing up. He had 3 seizures before rescue personnel got him to ER. He had 4 seizures in ER but was afebrile and nothing unusual was noted prior to seizures. All test WNL.
received an expired dose of Twinrix on 22Jun2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (expiry date 20-MAY-2023) for prophylaxis.   On 22-JUN-2023, the patient received Twinrix. On 22-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Twinrix on 22Jun2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Jun-2023 The vaccine administration facility was the same as primary reporter. The health care professional (HCP) did not have the patient's date of birth or the lot number Patient received a dose of Twinrix on 22 June  2023, which was expired on 20 May 2023, which led to expired vaccine used. The reporter consented to follow up with the HCP via email.
Apparently began to get ill about seven days prior to admission. He had noted onset of fever and diarrhea. He subsequently tried to tough it out at home, but was showing severe shortness of breath by the morning of the 4th and came to the Emergency room where he was evaluated and found to have O2 sats in the 80% range on room air, and was diagnosed with COVID. His chest x-ray was markedly abnormal consistent with COVID. Transferred air lifted=
Hospitalized 12/25/2021-still currently admitted; COVID-19 positive 12/25/2021; fully vaccinated plus booster HISTORY OF PRESENT ILLNESS:   This is a very pleasant 73-year-old woman with history of polycystic kidney disease status post renal transplant, insulin-dependent diabetes.  She she was recently hospitalized 1 week ago for E coli bacteremia secondary to pyelonephritis.  The symptoms resolved, she was discharged home on 12/21.  On 12/22 she developed upper respiratory symptoms, cough congestion.  Today she developed fever and weakness.  She had poor appetite for several days. She presented to the ER with a fever of 39.6, heart rate 113, blood pressure 110/54, 88% on room air.  She is stable on 2 L of oxygen.  Chest x-ray showed bilateral infiltrates.  Lactic acid is normal.  Urinalysis shows resolution of her prior urinary tract infection. ASSESSMENT/PLAN:  a 73 y.o. female with:  COVID 19 pneumonia Hypoxemia - discharged from hospital 12/21, developed respiratory symptoms on 12/22. - increase steroid to decadron 6mg daily - remdesivir not recommended with eGFR 18 - continuous pulse ox - check sputum culture to evaluate for possible bacterial superinfection 12/31/2021 notes: #Hemorrhagic shock #Suspected upper GI bleed Overnight, patient noted to have syncopal episode with code blue being called for loss of pulses for 7 seconds. Patient's hemoglobin 6.4 with dark red bowel movements. Concern for upper GI bleed.Our team spoke with GI who believes the patient is too unstable for the endo suite and would need to be stabilized or be in the ICU before being able to intervene. Hemorrhagic shock remained despite fluid and blood resuscitation. Reached out to MICU regarding need for vasopressor support.  -Start peripheral Levophed for pressure support -Discontinue Heparin gtt -Start protonix gtt -Patient given IVF -Given 2u PRBC -Held anti-hypertensives -CBC q6h -GI consulted -Patient will be transferred to MICU service for continued vasopressor support #Acute hypoxic respiratory failure #Pneumonia secondary to COVID-19 Currently on 4L NC, with respiratory symptoms starting 12/22. COVID+ test on 12/25.  Pulm rehab found patient to require 3L at rest and 6L with exertion.  -Increased steroids to IV Solumedrol at 40mg BID -Albuterol inhaler q4h -Repeat CXR -Continue oxygen support -Wean O2 as able, pulse ox 01/05/2022 notes: Intubated 12/31 in setting of COVID-19 pneumonia, shock due to GI bleed, requirement for EGD Current respiratory support: Device (Oxygen Therapy): ventilator GI prophylaxis: PPI infusion DVT prophylaxis: subcutaneous heparin  Plan:  SBT, assess for extubation / continue PSV as tolerated  * Pneumonia due to COVID-19 virus COVID+ test on 12/25. Assessment & Plan NO proning or paralysis Treatment No Remdesivir due to AKI on CKD Steroids (chronic prednisone 5 mg daily, held) Dexamethasone 6 mg daily 12/26 - 12/31 Methylprednisolone 40 mg IV Q12h 12/31 -  Antibiotics None Anticoagulation 12/30 doppler with left peroneal DVT Heparin gtt 12/30 - 12/31, discontinued due to hemodynamically significant GI bleed Current SCD's
This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (had an outbreak every month). Previously administered products included unknown vaccination (received seven years ago, and started getting outbreaks three years after receiving the shot). On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On 12th March 2018, 38 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not provided. Seven years ago, the patient received the former immunization (Zestar?? from Merck) and started getting outbreaks three years after receiving the shot. In time, the patient had an outbreak every month. The patient received the first of two SHINGRIX shots. Today, the patient had an outbreak. Naturally, the patient was shocked and most disappointed at this. The patient got his immunization to prevent shingles. The patient wanted to have some information of the efficacy of this product. Needless to say, the patient was not impressed so far. So when the SHINGRIX immunization became available, the patient had hopes. The reporter wanted more information.
Patient began vomiting around midnight, 8/2/14, around 9:30 am pt had first seizure like episode and was taken to ER. Patient continues with seizure like episodes per mother.
Approx 20 minutes after vaccination, I felt a slight headache and my tongue felt thick. The roof of my mouth and throat were tingling so I felt like my tongue might be swelling. I took a Claritin 24hr pill that I had in my purse and drank a bottle of water. After 30 minutes the allergic symptoms seemed to subside. I only had tongue tingling until the evening. My arm hurt, nose started running and I felt flushed 4 hours after vaccination. I woke up feeling more normal the next day. 10 days after the vaccination I had a cough, fatigue, chills, congestion and tight chest. Felt feverish but no fever. I used my inhaler and was fine after that. I called my doctor and they suggested that I do not take the 2nd vaccine. I have completely recovered from these symptoms.
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored PROQUAD (Merck), (lot#, strength, dose, fre4quency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
63 year old male with hx HTN, Pre diabetes, HLD, BPH, presents for evaluation of SOB and midsternal chest discomfort-pressure like pain which occured when he went to the bathroom. He had a cough and fatgue over last weekend and tested positive for COVID 19 on 2/15/22. His wife and child are ill with COVID as well, mild symptoms. He is fully vaccincated and was boosted on 12/12/21 with pfiezer. In the ED he had a chest xray which was negative, he is not hypoxic, 100% on room air, no acute ecg changes, and d dimer is negative, otherwise his markers are minimaly elevated. He has no fever or chills but broke into a sweat. No nausea or vomiting or changes in taste or smell. Troponin negative so far and he had a baby aspriin in the ED.
This is a spontaneous report received from contactable reporter(s) (Physician and Nurse) from medical information team. The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster), 1.8 ml single (Lot number: FK9729) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, NDC number, lot number, expiration date: EP6955), administration date: 12Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (2nd dose:, NDC number, lot number, expiration date: PR8734), administration date: 02Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (3rd dose:, NDC number, lot number, expiration date: FF2590), administration date: 24Oct2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: OVERDOSE (non-serious) with onset 31May2022, described as "receiving 1.8mL of the Pfizer COVID-19 Vaccine/ given an overdose of the vaccine, given a 1.8ml dose of the vaccine each, the whole vial, so 6 times what the dose should have been which should have been .3ml only"; PYREXIA (non-serious), described as "fever"; CHILLS (non-serious); INFLUENZA LIKE ILLNESS (non-serious), described as "like having the flu"; ASTHENIA (non-serious), described as "weakness". Additional information: Patient was received a 1.8ml dose of the vaccine, the whole vial, so 6 times what the dose should have been which should have been .3ml only. Emergency Room: No, Physician Office No, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No, Other Conditions: No, Other Products: No. The type of medication error was overdose. The stage of medication error was preparation and administration. The contributing factors to the medication error was a floater between offices and thought that it wasn't a multidose vial and gave the whole vial. It was her first time giving the Pfizer Covid vaccine. The patient and they are doing well with no issues. Follow-up (17Jun2022):  This is a spontaneous follow-up report received from a contactable consumer (Practice manager). This consumer (Practice manager) reported in response to Non-HCP letter sent which included that: Updated information included: Reporter information added, Product coding updated. Clinical information added in narrative. Sender's Comments: Linked Report(s) : PFIZER INC-202200794834 same reporter/drug/event, different patient;
Patient experienced a 2.5 - 3 cm reddened area on her left deltoid where I had administered a Dtap 2 days previously.  I administered the Dtap on 9/17/2007 and the reddened area appeared about 36 hours later on 9/18/2007.  There was no swelling, itching, pain at the site.  There were no signs of an allergic reaction (systemic).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2021; TRIAMTERENE HCTZ, start date: Jan2019; VENLAFAXINE HCL, start date: Jan2019; ALLERCLEAR, start date: Jan2017; PROPRANOLOL oral, start date: 09Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Negative; (29Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: I tested negative on 25Nov2022. Felt fine. Began getting cold symptoms the next day. But thought was mild cold. Cough. Stuffy nose. Scratchy throat that cleared up. Headache. Tested positive again on 29Nov2022. It was reported that the event onset was on 27Nov2022 at 2:00 AM. Outcome was reported to be recovering.   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.
Vaccine admin on 11/26 by pharmacist. Pt came in on 11/30 saying that there was some slight itching at site. On exam site was slightly red in appearance w/ no swelling. Advise pt to watch site. Use hydrocortisone to reduce itching. If gets worse, see MD & call us.
He thinks he has sinus infection; Pain on the arm of injection; felt like he was coming down with something; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like he was coming down with something), SINUSITIS (He thinks he has sinus infection) and VACCINATION SITE PAIN (Pain on the arm of injection) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZ0A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Asthmatic.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced FEELING ABNORMAL (felt like he was coming down with something) and VACCINATION SITE PAIN (Pain on the arm of injection).   On an unknown date, the patient experienced SINUSITIS (He thinks he has sinus infection). At the time of the report, FEELING ABNORMAL (felt like he was coming down with something), SINUSITIS (He thinks he has sinus infection) and VACCINATION SITE PAIN (Pain on the arm of injection) outcome was unknown.      Lately the patient had been around people who are sick with cold and allergies. He did not think the sinus infection is related to the vaccine he received. Concomitant product use was not provided by the reporter. No treatment information was provided.
I was menstruating at the time of the injection and 2 week later I started my period again. Not a full 28 cycle had passed. Definitely abnormal for me.
Woke up at 2:00 am with emesis times 6 in one hour. Wheezing, pale, and fever to ER. Fever was 101.8. No treatment or laboratory tests at ER. Sent home.
Projectile vomiting, listlessness, went to urgent care, 48 hrs after vaccines due to vomiting. Per mom had similar reactions after 2 mo vaccines (9/7/05) and 4 mo vaccines (11/11/05).