chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included FLUTICASONE, FAMOTIDINE, ASA, LOSARTAN, ESCITALOPRAM, LORAZEPAM, MIRTAZAPINE, OMEPRAZOLE, MECLIZINE [MECLOZINE], CETIRIZINE, BENZONATATE, KETOTIFEN FUMARATE (ZADITOR), ATORVASTATIN, ESOMEPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA), GLIMEPIRIDE and METFORMIN for an unknown indication.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested positive within last month. The expiration date was 25 Mar 2022. The vaccine adminstration time was 09:35. Date and time the vial was initially stored in the refrigerator on 25 Feb 2022. No treatment medication information provided
Patient received expired Moderna COVID-19 Vccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone temperature excursion.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022.
PT RECEIVED FIRST MODERNA COVID SHOT IN LEFT DELTOID, A FEW MINUTES LATER PT FELT FAINT AND WHEN TO THE FLOOR.  PT WAS GIVEN ICE PACK AND BEGAIN TO REGAIN CONSCUOISNESS.  911 EMERGENCY SERVICES WERE CONTACTED AND ARRIVED ON SCENE, PT WAS FEELING BETTER.
Temp 101.3, local reaction - lt deltoid, rash, adenopathy.
Pt was given a dose of Kinrix for her 2 month visit. Pt is only 2 months old so is not of age to receive this vaccine.
tons of muscle aches/tons of body aches; achy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), NAUSEA (nauseous) and MYALGIA (tons of muscle aches/tons of body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Apr-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) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced MYALGIA (achy) and NAUSEA (nauseous). On 19-Apr-2021, the patient experienced MYALGIA (tons of muscle aches/tons of body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 16-Apr-2021, MYALGIA (achy) had resolved, NAUSEA (nauseous) outcome was unknown. At the time of the report, MYALGIA (tons of muscle aches/tons of body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
My father got shot #1 of Moderna, and 10 days later, he collapsed while vomiting and having diarrhea full of blood. He was taken to the ER, and treated with blood clotting agents and stomach medication. A scan showed he also had bleeding in his brain. He also had bad arrhythmia and had a pacemaker implanted. He convalesced in another hospital for a few weeks before returning home. He then got shot #2, and within two weeks, was again vomiting and having diarrhea full of blood. He was taken back to the hospital and was told that he needed to have surgery on his stomach. He was told that he would die without it.  He felt so sick and worn out, that he rejected the surgery, went home, and later died on September 2nd. In the last days of his life, he kept the arm that he had gotten the shots in, curled up by his face (like a dead insect). He would scream out in pain if he tried to move his arm. So he didn?t. And that?s how he died. With the injected arm all curled up, like a dead insect.
Hard lump appeared on my lymph node in the clavicle region. Appeared there following my Pfizer dose 2 back on 04/15/2021. I also believe there may have been some heart inflammation. I went to the doctor back in April but did not for the lump that appeared following my booster.
Information has been received on 08-MAY-2017 from a Licensed Practical Nurse regarding a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The reporter did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004963: US-009507513-1705USA004961: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004962: US-009507513-1705USA004967: US-009507513-1705USA004964: US-009507513-1705USA004952: US-009507513-1705USA004960: US-009507513-1705USA004965:
Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:30 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single; time: 10:00am; site: left arm), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "Soreness". The following information was reported: HEADACHE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (Mar2021), described as "Headache". Therapeutic measures were not taken as a result of headache.  Additional information: The patient did not receive other vaccine within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
high pitched unconsolable cry x 4 1/2 hrs, vomiting had been given APAP;
Red bump at injection 2 weeks after injection, then 3 other red bumps that itch.  Referred patient to Doctor.
This spontaneous report was received from a nurse regarding a 75 years old female patient. The patient's pertinent medical history, concurrent conditions or drug allergies and concomitant medications were not reported. On 16-FEB-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M043424, expiry date: 06-JUN-2018 (strength, dose, frequency were not reported) for prophylaxis. The nurse reported that the PNEUMOVAX 23 "was administered closer to the bicep region rather than the recommended deltoid region." Nurse also stated that "the patient said she felt discomfort in her arm right away after the injection" and that the patient experienced "redness, swelling, warmth, and discomfort around the injection site" at an unspecified time after the injection. The patient returned to office to have an unspecified physician assistant "look at her arm" on 17-FEB-2017, no information provided on treatment or follow up (incorrect route of drug administration, injection site swelling, injection site erythema, injection site discomfort and injection site warmth). The outcome of the events was unknown. The reporter did not provide the causality assessment for the events. No product quality complaint was involved. Additional information has been requested.
Received FLUZONE High-Dose and PREVNAR 13 on 8/29/16. Couple hours later, patient broke out in a rash all over body. Came back to pharmacy on 8/30/16. Recommended BENADRYL.
Sharp and sudden, neck and head spasms starting a few days after the swelling and rash. Lasted about 6 weeks.
Pt is G2P1, currently 30.5 weeks gestation. EDC: 12/17/2021. Patient reports arm/shoulder pain and decreased ROM.
Severe pain in body, now o. Prednisone, better but have headache every day and jaw hurt
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 12-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Myocarditis documented by MRI; Concomitant diagnosis of Type A inflo; This is a spontaneous report from a contactable physician. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200; Expiration date was not reported), intramuscular on the right arm on 11Mar2021 (15:45) as a 2nd dose, single, for COVID-19 immunization. Medical history included hereditary haemochromatosis. The patient's concomitant medications were not reported. The patient previously took erythromycin and cefaclor (CECLOR), and had allergies with these medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264; Expiration date was not reported) on 17Feb2021 (13:00) (when the patient was 32 years old) intramuscular on the right arm for COVID-19 immunization. On 08Jun2021, the patient had myocarditis documented by magnetic resonance imaging (MRI), and a concomitant diagnosis of "type A inflo". The events had resulted into a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for six days (in Jun2021) due to the reported events, and had received cardvedilol, sacubitril, valsartan (ENTRESTO) and "life vest. diurectics" as treatment for the reported events. The outcome of the events was not recovered. The patient had no COVID-19 prior to vaccination. The patient's COVID-19 nasal swab on 08Jun2021 was negative.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and the event myocarditis cannot be excluded. Event influenza based on the known drug safety profile is assessed as unrelated to  BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Persistent hiccups for 3 days.  Would last 3-4 hours then 1-2 hours relief.  Ended 10pm on the third day.
SOB, numbness & tingling of upper extremities, anxious, tingling lips, uncontrollable shaking, weak, achy joints;APAP x 2;DPH;
Pt recvd vax approx 9AM & approx 10AM was feeding approx 1330 was playing was sitting & toppled over & was out approx 8-10min; skin warm & dry to touch; t99.4 R; color pale;
This spontaneous report as received from a medical assistant referred to her co-worker who a 21 year old female patient. On 22-FEB-2013 the patient was drawing up a dose of live ZOSTAVAX (lot # H019040, exp date as 17-JAN-2014). Patient was flicking the syringe to remove airbubbles and inadvertently splashed live ZOSTAVAX in her right eye. The eye was red and painful, and an eyewash was done for 15 minutes. The eye was no longer painful after washing, but continued to be red. The coworker had not yet seen a physician concerning eye exposure. No lab diagnostics studies performed and no treatment was given for events. The relationship was not provided. Additional information is not expected.
Patient states that her arm was sore after the injection. She states by the end of the evening she had a lot of redness and some inflammation. She went to the urgent care clinic on 10/29/18 because she experienced continued redness, swelling and warmth at and around the injection site and she became concerned because it was not getting better. The urgent care provider prescribed BACTRIM DS antiobiotic (1 BID x 7 days) and diagnosed her with an injection site infection.
heart attack; back pain; felt very bad; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient thought like he was having a heart attack in the first day or two after having the back pain. He stated 12 hours after getting the back pain. He woke up in the middle of the night he felt very bad. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions or allergies and with no pertinent medical history and do not pregnant at the time of reporting. On 24-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot number: H012643, expiration date: 30-MAR-2015) (dose and route of administration were not reported). At the same date patient was vaccinated with MENACTRA and diphtheria toxoid (+) tetanus toxoid. There was not more concomitant medication. After receiving the vaccines on 24-APR-2013 the patient immediately fainted. When the patient fainted she bumped her head and then quickly developed an extremely painful headache. On 24-APR-2013, after leaving physician's office the patient was sent for Computed Tomography Scan at an unspecified site. The results of the diagnostic procedure was not reported. on 25-APR-2013 the patient was fully recovered. The patient sought unspecified medical attention. The relatedness between faint after receiving the vaccine and extremely painful headache and GARDASIL was unknown. Additional information has been requested.
Patient (self) felt burning immediately as vaccine dose was being injected into muscle.  Arm became sore and stiff minutes later.  Stiffness and soreness seemed to spread to elbow moments later.  Stiffness in joints, shoulders and neck were experienced a few hours later.   Nausea and headache were experienced about 9-10hrs after injection.  Also, inside of right arm near wrist and left arm near elbow is itching.
Spoke with mother, reports son is fine, that he is "perfect". States MD from clinic has advised that hx vaccine (he did not have it to give) when child arrived here. Advised to contact this facility if there are any adverse effects. Gave client FLUMIST with hx asthma (12 yrs) instead of Flu injection.
Fatigue and fever for most of the day. Then a major tonic clinic seizure at 7:58pm on 11/23. Lasted around 2 minutes. Difficult to return to coherence. Ambulance called and evaluated by EMTs. Did not require hospital transport at that time.
(L) arm redness, pain & swelling at injection site persistent; patient treated with KEFLEX and loratadine and ibuprofen.
having allergies like sinus in his eye areas; Caller is a patient who received the 1st dose of the Pfizer Covid vaccine in May and tested positive for Covid-19 on 9 Jun 2021; This is a spontaneous report from a contactable consumer via medical information team. This consumer (patient) reported for himself.  A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176 and Expiration date: unknown), via an unspecified route of administration, administered in Deltoid Left (left shoulder, like the side of the arm) on 28May2021 (at 11 AM or 12 PM) (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not ill at the time of vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not received Prior Vaccinations (within 4 weeks). No relevant tests before vaccination. On 28May2021, patient received first dose of vaccine and then he had a cold and tested positive for covid-19 on 09Jun2021 at about 12 in the afternoon. He confirms he was having a cold, he clarified that it was like he was having allergies like sinus in his eye areas and he reported that he had a viral infection and then he tested positive for COVID. He was supposed to get his second dose on 16Jun2021. He wanted to know should he continue and take the second dose or not. The reporter wanted to know if it is okay to get the 2nd dose of the Pfizer Covid vaccine on 16Jun2021. He confirmed he called about the COVID 19 vaccine by Pfizer. The patient was not used any antipyretics. The patient was not visited to emergency or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jun2021. Response included The CDC has provided interim considerations for the use of mRNA COVID-19 Vaccines during the Emergency Use Authorization. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. The outcome of events were unknown.
After 10 days injection site became hard, swelled and is rash-like in appearance. Treated with warm compress but rash-like appearance remains.
immed (10 mins) reaction to MMR periorbital swelling, swelling of lips, nasal congestion, neck tenderness, pruritus; gradual resolution of sx p/DPH; eye swelling lasted 24 hrs;
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). This case was associated with a product complaint. On 2nd June 2015, the patient received KINRIX (intramuscular) .5 ml. On 2nd June 2015, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site erythema, injection site warmth and product complaint were unknown. It was unknown if the reporter considered the injection site erythema injection site warmth and product complaint to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects. Nurse had 7 more prefilled syringes left on the box and she preferred to have a different box to replace the one she already had as she is concerned about using the remaining prefilled syringes. Nurse is sending the product back to the company. Company is replacing product for the physician's office.
rash on his nose (1/4 of inches); This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his nose (1/4 of inches)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-2019 and Anxiety (guessing). Concomitant products included LOSARTAN from 15-Jan-2019 to an unknown date for Blood pressure, MULTIVITAMIN [VITAMINS NOS], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) from 2018 to an unknown date, VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash on his nose (1/4 of inches)). On 24-Feb-2021, RASH (rash on his nose (1/4 of inches)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported. multivitamin Indiactionis for   well being. COq-10 indication for heart health.   This case was linked to MOD-2021-255653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Updated patient demographics (Height, weight, Race], medical history.  Added suspect drug is given to left arm. Concomitant medicines .Added Vaccination centre details.   Added  event start date and end date. Updated outcome of events from Unknown to Recovered.