chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient got a second dose from a vial past the Use by Date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 0939902) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up appended and updated race, ethnicity, Route, Body site.
Information has been received from a physician concerning a 54 year old male with diabetes and no drug allergies, who on 20-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 657628/0556U). Concomitant therapy included metformin and aspirin. On 22-SEP-2007 the patient developed angioedema of the lips. The patient was treated with BENADRYL. The angioedema resolves but recurs every time BENADRYL is discontinued. The patient was seen in the office. Laboratory diagnostic were performed with the following results: complement 3 and 4 levels. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 07-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804082 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
*PATIENT recieved a FLU shot back on 10/30/2015. Patient came back in on 12/10/2015 (41 days later) and claims her arm is still sore and she thinks it may have something to do with the FLU shot. She initially claimed that the medicine went into her muscle and that she did not feel right. When it was explained to her that it is in fact an INTRAMUSCULAR INJECTION, she then claimed that perhaps it was injected "TOO HIGH" on her arm. She and her husband appeared to be looking for some sort of compensation. Pharmacist on duty (me) looked at her arm and there NO SIGNS of swelling or infection whatsoever. Patient was advised to see her MD and this could be unrelated to the FLU shot but patient insisted that she felt the FLU shot is responsible for her shoulder being sore.
c/o macular rash that started on Day 4 and progressed down towards the elbow over the next couple of days.  The rash receded until it is almost gone by Day 8.  Only other sx was itching at the injection site.  No hives, skin breaks, swelling, or lymphadenopathy.  She did call her HCP and took one dose of Benadryl with relief.   She had no incapacitation with ADL's or sensory or movement problems with her limb.     She has no hx of allergic reactions to any vaccine ingredients such as PEG.  However, she reports a history of allergy to Penicillin and statins.  She also noted she develops hives on occasion particularly after wearing wool scarves or clothing.
Feeling sick; Sleepy; Felt horrible,miserable; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), SOMNOLENCE (Sleepy), FEELING ABNORMAL (Felt horrible,miserable) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Loose bowels. Concomitant products included METOPROLOL, WARFARIN, SILDENAFIL CITRATE and DILTIAZEM for an unknown indication.   On 05-Nov-2020, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.125 mg every eight hours. On 22-Mar-2021, 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 and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 mg. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 mg and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 26-Mar-2021, the patient experienced MALAISE (Feeling sick), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Felt horrible,miserable). On 26-Mar-2021, MALAISE (Feeling sick), SOMNOLENCE (Sleepy), FEELING ABNORMAL (Felt horrible,miserable) and FATIGUE (Tired) had resolved.            26 Mar 2021, The patient has taken her first Orenitram dose at regular time of 8 am and at 10 am she was not sure what medication she has taken, it was either one metoprolol or two more Orenitram (wrong dose). The patient went back to bed around 11 or 11:30. Patient was feeling ok at the time of reporting.  The reporter assessed the causal relationship between PO Orenitram and the event of diarrhea as possible. The reporter did not provide causality for the event of dyspnea exertional. No treatment for the events was reported.  The action taken with mRNA-1273 in response to the event was not applicable.
NONE, PATIENT RECIEVED VACCINES THAT WAS BEYOND USE DATE IN FRIDGE.  DAY 34 INSTEAD OF DAY 31
pt recv vax & devel approx 5 lesions on stomach;3/23/98 pt devel lesions from head to toe;pt also exp a low grade temp for approx 24hr;
Twelve hours after administration of booster; Twelve hours after administration of booster, rigoring and fever occurred.  Symptoms persisted for 24 hours after onset.  Symptoms were alleviated with oral acetaminophen.; Fever occurred; Maternal Exposure During Pregnancy, second trimester; Off label use; This is a spontaneous report from a contactable consumer. A 35-year-old pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 28Sep2021 at 12:00(at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient's last menstrual date was on an unknown date in May2021. The patient was due in Mar2022. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Sep2021 at 00:15,  twelve hours after administration of booster, the patient experienced rigoring and fever occurred. The symptoms persisted for 24 hours after onset and symptoms were alleviated with oral acetaminophen. Therapeutic measures were taken as a result of the events and included treatment with oral acetaminophen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rigoring and fever was recovered 30Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/2 hr p/dose of Engerix-B pt reported a rash & c/o itching; pt was taken ot ER & given Epi & then according to pt BP & pulse went way down to 60/min & below 100 systolic; events resulted in hospitalization s/poss reacted fr Epi;
I tested at home test for COVID-19, and it was positive on 12/28/2022. I contacted my provider via telehealth I started 12/29/2022 PAXLOVID due to provider prescribed. I treated myself for 5 days. I started feeling better within 3 days of medicine. I was very congestion and had a headache. I had a massive headache due to prone to headaches due to stroke 9 years ago, but I did follow up with PCP on 01/13/2023 and I was fine.
Symptom onset 6/22/2021 of runny nose, nasal congestion, headache, fatigue, nausea, loss of smell and loss of taste. Tested positive for COVID-19 via PCR on 6/24/2021
Red area with warmth to left upper arm, (+) itch treated with Clindamycin- change Augmentin ES
She is sick to her stomach; has 102F temperature/fever; vomiting; This is a spontaneous report from contactable consumer via a Pfizer-sponsored program. A consumer reported for patient (mother).  A 64-year-old female patient received BNT162B2 (Pfizer-BioNtech Covid-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 64-years-old) as dose, 1 single for COVID-19 immunisation. Medical history included diabetes (reporter does not know what type of diabetes his mom has, but she does not use insulin for it). Concomitant Medications were nothing new, but she has not been able to take her medication (unspecified medication) on day of report. On 11Feb2021, the patient was experiencing 102 F temperature/fever, and vomiting, on an unspecified date, patient was sick to her stomach. The reporter would like to know what to do and if this was related to the vaccine. Patient went to the doctor office for 102 F temperature/fever, and vomiting, and the doctor said that it sounded like she had a stomach bug, he did not even test her for Covid or do any tests. The patient second dose of the vaccine was scheduled for the day of this report, so reporter would like to know if they should wait until she feels better or get tested for Covid-19. The patient underwent lab tests which included Height: 5 feet 3 inches or 5 feet 4 inches, Weight: 120 lbs (she was about 120lbs, give or take) on an unspecified date and Body Temperature: 102 Fahrenheit on 11Feb2021. The outcome of the events 102 F temperature/fever and vomiting was not recovered and event sick to her stomach was unknown.  Follow-up attempts completed. No further information expected.
Sudden loss of earing in left ear - lost all ability to hear.   Some hearing has returned after 2 rounds of steroids and an injection of steroids into the ear.
Increasing redness and itchiness, swelling, and discomfort at injection site on R arm, delayed response not present at time of injection, symptoms began 12/27/20 and gradually worsened since then, no improving. Tried Benadryl and cold compresses, as well as Tyelnol.
Fever to 102 with chills.  Gave EXCEDRIN and MOTRIN.  Went to hospital ER for evaluation.
CHIP IN HIS ARM/SPOT ON HIS ARM THAT WAS HARD AND PROTRUDING ON HIS DELTOID MUSCLE; This spontaneous report received from a patient via a company representative concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 23-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. No concomitant medications were reported. On 30-SEP-2021, the patient experienced chip in his arm/spot on his arm that was hard and protruding on his deltoid muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chip in his arm / spot on his arm that was hard and protruding on his deltoid muscle was not reported. This report was non-serious.
Vaccine was given beyond the 6 hour time limit after opening. was given in 6.45 hours after opening the vial.
Patient stated that after getting vaccination she had a light headache. The next day the headache got worse. She also noticed that her left foot is swollen. If she lifts anything she get light headed. Walking up stairs she is out of breath. She has a pin in the left arm like a stiff heaviness.
Fever of 102, waxed and waned over 12 hours with diffuse myalgias.
I was feeling sick, I had a low grade fever. By Friday I developed an arm rash and swelling. It started to fade after 3 days. I would also say fatigue, muscle aches, also I had  some achiness in my chest. I also noticed a change where I started to have more orthopedic type injuries. 2 of my fingers started to get an arthritic rhythm-that never happened before until after I received the booster. I've also noticed some hair loss but not sure where that came from.
Fever to 104.3 F x 24 hours, rash on trunk. Fever treated with Motrin/ Tylenol - on meds - 101-102. 100 - 101 presently.
Information has been received from a licensed practical nurse (LPN) referring to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX, (lot# and expiration date were unknown) 0.65 ml, subcutaneously. The number of doses and patients were unspecified. There was no adverse event reported. Additional information is not expected as there is no consent for contact.
arm was sore, swollen, very itchy, hard, and hot to the touch; pain between her shoulder blades on her left side; arm was sore, swollen, very itchy, hard, and hot to the touch; arm was sore; arm was sore, swollen, very itchy, hard, and hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was sore, swollen, very itchy, hard, and hot to the touch), VACCINATION SITE INDURATION (arm was sore, swollen, very itchy, hard, and hot to the touch), VACCINATION SITE PAIN (arm was sore), VACCINATION SITE SWELLING (arm was sore, swollen, very itchy, hard, and hot to the touch) and ARTHRALGIA (pain between her shoulder blades on her left side) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37020A(?)) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE SWELLING (arm was sore, swollen, very itchy, hard, and hot to the touch). On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (arm was sore, swollen, very itchy, hard, and hot to the touch). On an unknown date, the patient experienced PRURITUS (arm was sore, swollen, very itchy, hard, and hot to the touch) and ARTHRALGIA (pain between her shoulder blades on her left side). At the time of the report, PRURITUS (arm was sore, swollen, very itchy, hard, and hot to the touch), VACCINATION SITE INDURATION (arm was sore, swollen, very itchy, hard, and hot to the touch), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE SWELLING (arm was sore, swollen, very itchy, hard, and hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 at 10:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Had mild chest tightness 10 minutes after vaccination that resolved 10 minutes later. No shortness of breath, no swelling
pt exp local patchy spot (30mm) which was circular, raised, dry patchy, itched, & was over the inj site;
Headache - post immunization evening - continuing at time/date of call on 02/12/09. Given MOTRIN by mother - Mother related - Some relief - but once MOTRIN dose wore off - teen c/o headache again.
Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age was received Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03386) and concerned a patient of an unspecified age and gender, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005144 and 202005146 (the same reporter).  Company comment: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
1/2-1 hr after injection pt. notes itching at site. Redness/swelling Sat eve 2x2 1/2 knot warm, red thru Sun. Today, 1/17/12, 2 x 1 1/2 pink and warm. Pt. called Dr. office to report this. AM using Cortisone cream and TYLENOL Allergy and Sinus.
I broke out in hives, my arm was hot and swollen. I started itching uncontrollably. Saw a Dr in April 2001. I'm still itching and on Zyrtec. By appt finally April 2001.
Body Aches, Fever, went to MD 10/27/2009 given Tylenol 3 for discomfort.  On 10/28/2009 tried to miscarry due to dehydration and fever.  On bedrest for 3 days.  Doing fine now. 11/24/09 Medical records received for dates 10/28/09. DX: Pre term labor 32 wks gest. Presenting c/o receiving H1N1 vax approx 5 days ago per pt. 3 days later pt. states c/o severe body aches, now presenting with consistent uterine contractions every 5 min. Pt. is 32wks pregnant, G4 P2. Assessment: pt. appears pale, uncomfortable, (+)pre-term labor. Pt sent to L&D for eval.
Employee developed severe right shoulder & upper arm pain after receiving an influenza vaccination, FLUARIX QUADRIVALENT.
1050 Patient in general observation area, signaled to nurse. Color pale, lips cyanotic. taken via w/c to private observation. BP 57/39. States he donated plasma this morning at 0900 and then came for vaccine. Last ate and drank at 0830 1100 BP 79/57; HR 59 offered patient water. Drank 16 oz   EMS called 1104 120/84 HR 79 Color pink  1107 Bp 116/81 HR 70 States he feels much better.  1121 BP 128/85; HR 70  EMS on site, EKG done 1123 BP 127/89 HR 65  1126: EMS released patient. Pt. ambulated to vehicle accompanied by RN Gait steady, No lightheadedness.
Fever of 101 when going to bed. Took 200mg of ibuprofen. Fever of 103 when waking up. Took 200mg of ibuprofen.
seen in ER 14MAR97 @ 815Pm for periodic hallucinations/delusions: c/o something crawling in throat;easily agitated suspicious-these periods lasting 15-20min then nl behavior-had been evident 3x/during the day 14MAR as well;d/c from ER
Constant ringing in ears that started within hours of receiving the vaccine and hasn?t gone away yet.
Vaccinated 1/20 at her PCP. Pt was seen by NP via telemedicine urgent care complaining of severe persistent headache and all-over body pain since 1/23, reportedly in too much pain to even move out of bed all day on day 4 after COVID vaccination (1/24). Still in pain today, primarily in arms and shoulders, but is able to ambulate and conduct ADLs. Headache persists with some dizziness.  Encouraged to rest, hydrate, and take Tylenol PRN. Strict ED precautions for any CP, SOB, syncope, or evidence of allergic reaction.
The 1st 24 hours I experienced: chills,  intense nausea, muscle aches, headache, restless legs, joint pain and sleeplessness. Most of these effects passed after about 30 hours. I woke up this morning with a headache and my left eye really hurts. I have a subconjunctival hemorrhage in my left eye that fills about 1/3rd of the eye white with blood..... Headache, stiff muscles and overall tiredness are the only other remaining side effects besides a blood-filled eyeball at this point.
Pt received vaccinations on Friday on Sat AM. Pt noted swelling and pain on left side of neck, collar bone area, also reported achiness. On Sunday am reported to provider. Provider noted swelling in lymph nodes on left side of neck and clavicle area. Also noted warmth in area.
Information has been received from a nurse concerning a 21 year old female patient with rheumatoid arthritis, chronic anemia and a history of hip replacement in 2003 due to Rheumatoid arthritis who in 09-JUL-2007 was vaccinated 0.5 ml IM with a dose of GARDASIL vaccine (yeast) (lot # 657737/0522U). Concomitant therapy included etanercept (ENBREL), ethinyl estradiol (+) norelgestromin (ORTHO EVRA). In October 2007, about 2-3 months post vaccination of GARDASIL vaccine (yeast) the patient developed Rheumatoid arthritis flare up that was not controlled with the etanercept (ENBREL) therapy. The patient switched to infliximab (REMICADE) therapy which controlled her symptoms. At the time of this report the patient recovered. Additional information has been requested.