chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    Concomitant product use was not provided by the reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12-Feb-2022. Of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  Treatment information was not provided.  This case contains information for the 16th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Patient states he had no problems immediately after injection. About 1 month later he experienced pain and numbness at injection site.  Reports continued numbness around the injection site.
Called to report that the evening she received dose, she experienced extreme fatigue and body aches. Woke up during night on 1/12 with fever, chills, joint pain and body aches. Spoke with her this morning 1/13 and reports feeling better today other than fatigue. Plans to return to work 1/14.
Cellulitis (R) upper extremity 12/8/11, antibiotics started.
Feeling flush, dryness in throat, tongue feeling thick.  Dr. evaluated client. Assessed and noted lungs to be clear. No medication additionally given. Client observed for extra 30 minutes. Patient was noted to feel better and released out to family.
The day after the vaccine the patient's arm swelled around the tri-cep area down to the elbow. It felt squishy like it was fluid filled. This lasted for about 1 week. He also experienced fever, chills, and bodyaches requiring him to miss work.
Information has been received from a physician concerning a 17 year old female who on 27-JUL-1994 and 14-OCT-1994 was vaccinated with the first and second doses of MMR II (route and lot # not reported).  On 10-DEC-2009 the patient experienced mumps.  On 11-DEC-2009 the patient was diagnosed with mumps.  The parotitis was on the right side.  The patient was afebrile.  On 11-DEC-2009, a first blood work was performed, and showed that : IgM, <1:10; IgG, 1.68; serum amylase, 22.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
shortness of breath; tiredness; slight headache; joint pain; neck pain; She said she felt terrible and felt as if "somebody beat her with a stick or run her over with a car."; She said she felt unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified blood thinner. She mentioned that she experienced side effects after receiving the vaccine on Friday (22Jan2021). She experienced shortness of breath, tiredness, slight headache, joint pain and neck pain. She mentioned that she felt terrible and felt as if "somebody beat her with a stick or run her over with a car." She said she felt unwell. She also mentioned that yesterday, she felt a little better, but still felt tired. The patient inquired if these side effects are normal, and if she should still get the 2nd dose despite experiencing these side effects. She also mentioned that she is on a blood thinner, but said that prior to getting the vaccine, she told the vaccination provider about it. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovering.  The following information on the batch/lot number has been requested.
weak immediately after vaccine for several days, got better then started with temperature and chills and severe headache. Started to vomit and passed out, called the ambulance, went to ER, they stated it must be a really bad virus as they could not find anything wrong.  Discharged from ER, remained weak over next few days but recovered
The Quadracel vaccine was given to a two-year old patient, no adverse event; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a two years old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5500CA) vaccine in right thigh on 01-Apr-2019   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It is an actual medication error due to Inappropriate age at vaccine administration.  It was reported that the Quadracel vaccine was given to a two-year old in the right thigh.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
According to pt's physician, child drank only 10 oz of formula, was semi-somnolent but not really lethargic.
severe muscle pain; very bad headache; A spontaneous case report received from a consumer concerning a 82 years old, female patient  received the 2nd Dose of the Moderna Vaccine Patient on 4th of Feb 2021. The patient is now experiencing Myalgia aggravated, and Headache. Patient received the injection in the Right Dominant arm.  What medication can she take to treat symptoms?  Is this normal to experience these symptoms?  Report Source- Other,  Age- 82 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- severe muscle pain - Unknown,very bad headache - Unknown.
Not able to remember where I was meeting my daughter, My mind felt foggy, unable to drive car, unsteady in my gait, need to use a cane now, speech was difficult .
Large red bump, very itchy. Applied OTC anti itch cream and took a dose of Benadryl. Itch went away within 24 hours. Redness stayed for several days
Headache, Fever, Tachycardia, inj site sorenss, bump, itchy; chills lasted x3 days, HA on days 7 and 8 Narrative:
pt states that vaccine was given too high on left arm, hurt, later was not able to use/lift arm, going to dr today 10/15/20 to assess
patient received 2 vaccines. fluarix in left arm, boostrix in right. she had no issues directly after the injection however the next day she experienced intense pain on the site of the boostrix injection. she visited the pharmacy today 9/5/22. we examined the injection site and noticed a palm sized bruise and a hard lump. we advised the patient to visit ER or urgent care, she said she'll wait to see PCP tomorrow since hes closed for the labor day holiday. In the meantime I recommended benadryl 25mg tablet to be taken in case this is an allergic reaction. Reaction is local to the injection size, no other symptoms expressed.
swelling in right arm/swollen arm; occassional aches in that arm where the patient got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in right arm/swollen arm) and VACCINATION SITE PAIN (occassional aches in that arm where the patient got the vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (allergic to PCN) and Drug allergy (statins allergy.).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-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 experienced PERIPHERAL SWELLING (swelling in right arm/swollen arm) and VACCINATION SITE PAIN (occassional aches in that arm where the patient got the vaccine). At the time of the report, PERIPHERAL SWELLING (swelling in right arm/swollen arm) and VACCINATION SITE PAIN (occassional aches in that arm where the patient got the vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Non-Significant follow up: swollen arm and aches were similar events mentioned in initial document.
Immediately  after Moderna #3 booster she said she was sick for three day "was so sick and could not get out of bed" then on day three she started with diarrhea so bad that she feels she can't make it to toilet. The problem persists to this day. She visited her PCP and was given a round of cipro for presumed gastroenteritis she said that the antibiotics did not help the problem at all.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started with numbness and tingling on her left side of her face after 15 minutes of observation in the store.  During the next 30 minutes the numbness moved to her right side of her face and lips.  Patient was instructed to contact her PCP after she left the store.  Patient was no experiencing any other symptoms.
No adverse effect; Patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 01-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot# R003300 and expiration date 01-FEB-2020, for prophylaxis (strength, dose, route and frequency were not reported). No additional adverse effects reported.
Patient came in for 1st covid vaccine. Patient had prior anaphylactic reaction to either MMR or hepB vaccine. They were given at the same time so it was unclear which she reacted to. After discussing with patient that she can receive the covid vaccine today, but we will have her stay for monitoring for 30 minutes after; patient consented to receiving vaccine. Pfizer covid vaccine was administered at 0940 in left deltoid. Patient was kept in room with door open. Advised I will check on her every 5 minutes, however if she starts having any symptoms before or between checks to come out or send person that is with her to the nurses station immediately. Checked on patient at 1045. Patient reported she felt some pressure on her esophagus. Denied tongue or throat swelling, difficulty breathing, or any other symptoms at that time. I consulted with PA. He instructed no intervention needed at this time, and to continue monitoring patient with every 5 minute checks. Checked on patient at 1050. Pateint reported she felt the same, some pressure on her esophagus but no other symptoms. Checked on patient again at 1055. Again she reported she felt the same, still the pressure feeling on her esophagus, but no tongue or throat swelling, difficulty breathing, or any other symptoms. At 1058 individual with patient came out to nurses station and said she was having problems. Requested provider assistance and went into room. Patient c/o not being able to swallow or breath. Was grabbing at her throat. Provider arrived in room. Ordered 0.3mL of 1mg/ml epinephrine. 10:00-0.3mL epinephrine administered IM in left deltoid. O2 checked and was 87%. Provider order O2 4L and placed on via NC. 10:02 HR 142, O2 sat 99% on 4L O2. Patient breathing very rapidly. Encouraged to take slow deep breaths in through her nose and out through her mouth. MA instructed to call EMS. At 10:03 50MG benadryl administered IM in right deltoid by  RN. At 10:05 HR 117, O2 99% on 2L O2. O2 had been turned down by provider.  During course of care 2 IV attempts were made, but unsuccessful. EMS arrived at 10:10. Care transferred to EMS, left at 10:20 for transport to the ER.
MITRAL VALVE WORSENING; PNEUMONIA; WATER ON LUNG; This spontaneous report received from a patient concerned a 60-year-old male. The patient's weight was 116 pounds, and height was 64 inches. The patient's concurrent conditions included mitral valve leak, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug usage, no recent history of exposure to a person with covid infection, no flu test performed, no recent infections and no other known laboratory examination and/or pathological finding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered at right arm on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. The patient denied any concomitant medications.  Between 16-APR-2021 and 22-APR-2021, the patient experienced fever, pneumonia and water on lungs, the former two symptoms due to mitral valve worsening. Patient was hospitalized on 22-APR-2021. When the patient was hospitalized, laboratory data included: Body temperature 100.4 F (highest) and 99 F (lowest), COVID-19 virus test was Negative, an unspecified diagnostic procedure which was inconclusive for endocarditis. Treatment medications (dates unspecified) included: Lasix (Furosemide). Patient received an antibiotic for the pneumonia which started with letter "L" but declined Levaquin or levofloxacin. Patient stated that his mitral value condition deteriorated rapidly in the last 4 weeks and would eventually require a surgery.  Patient was hospitalized for 5 days and discharged on 26-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and water on lung, and had not recovered from mitral valve worsening. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556507- covid-19 vaccine ad26.cov2.s-mitral valve worsening. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210556507- covid-19 vaccine ad26.cov2.s-pneumonia, water on lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Not feeling great; Sore arm; pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full term birth) on 08-Oct-2018. Concurrent medical conditions included Fruit allergy, Allergy to nuts, Latex allergy, Gestational diabetes and Hypertension (Chronic). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Discomfort, at an unspecified dose and frequency. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm) had not resolved.        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.   Patient Estimated due date was reported as June-2021 . Lab data included Ultrasound .  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain and feeling abnormal), a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain and feeling abnormal), a causal relationship cannot be excluded.
Patient received pneumonia vaccine (PNEUMOVAX) ON 10/1/11. She called 10/3/11 to state she was experiencing pain in her shoulder joint area and it was difficult to move her arm. The pain started about 20 minutes after vaccine administration and was severe throughout the following day. She took acetaminophen for the pain. She stated that there was some improvement on the 3rd. I followed up with her on 10/5 and she stated she had more improvement but that it was still painful. She sought medical attention and was told that she most likely had a severe muscle injury or rotator cuff injury, though it is not clear whether or not the prescriber thought it was related to the vaccine.
Administered TDAP on 3/31.  Patient developed red, itchy, maculo papular rash on all sun-exposed areas except face on 4/2.  Rash still visible 4/5.  Advised BENADRYL, rash improved.
Double vision. I also read about Guilluan Barre and respiratory and sinus infection of which I was just diagnosed w sinusitis and bronchitis, of which I've never had in my life.
Initial report received from other company (Merck) on 15 April 2014. This case was initially reported by a non-healthcare professional. A 77-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid, (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient developed swelling and redness at injection site. The patient also had allergy to Tetanus. Complementary investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Leg red, hard, swollen the day after immunization given DTAP in left leg.
Itching at site of injection that presist  until today's date  04 20 2021 No rash no swelling just itching. Intense at times.
This spontaneous report was received from 64 year old female consumer with drug hypersensitivity to ampicillin and with no pertinent medical history. On 17-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as 1 ZOSTAVAX injection)(lot number and expiration date were not reported), subcutaneous route. The patient was not on co-suspect and concomitant therapies. The patient reported that on 21-JAN-2015, she experienced tingling under her bottom lip and she developed what looks like a "cold sore" and three pimples surrounding it. At the time of the report, the outcome of "tingling under her bottom lip" and "cold sore" was unknown. The patient seek medical attention at the infirmary at her job. No lab diagnostics test were performed. The patient was treated with "Savex". Additional information has been requested.
A non-serious, spontaneous report of aches, fever and sore throat was received from a consumer concerning a 30 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 17-Oct-2008. Three days later the patient stayed in bed for 10 days and experienced aches, fever and sore throat. She was taking over-the-counter Theraflu. The outcome of the events was not reported.
urticaria rash began 6hr post inj reported to hlth dept 11MAR97;oral DPH for tx;
Left arm redness and swelling 50mm x 30mm 2 days following vaccines. Painful. Cold compresses, HYTONE and MOTRIN. F/u 2 days.
This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored PNUEMOVAX23 (lot # K022886 and expiry date: 09-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported PNEUMOVAX23. This is one of several reports from the same reporter. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, blister at injection site Narrative: Employee stated she developed a fever, headaches, joint pain and muscle aches and a blister at the injection site. Stated blister popped and clear fluid drained. Events happened on friday, employee stated yesterday, blister returned and now had blood blister and tenderness to left arm. Examined by Occ Health provider.