chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included 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 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion).  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Moderna Covid-19 Batch number reported as AS1416B, 018C22A, 024H22A, 044C22A. HCP stated hundreds of patients were administered with vials of Moderna COVID-19 Vaccine monovalent and bivalent that experienced a temperature excursion with cumulative time (between 2Dec2022 and 8Dec2022) of 50 minutes with minimum temperature of 1.3°C in the fridge.  No Concomitant medications were reported by reporter. No Treatment medication was provided by reporter.
4-5 days after the vaccination, I began having a pain in my left armpit. I believe it is a swollen lymph node. It has now been painful for 3-4 days. The pain varies from mile soreness to hard-to-ignore. It has woken me up at night from a full sleep at least once.
Thursday 100pm 3/8 noticed hive on chill - 3/8 evening had hives arms. legs, hands and feet. Slight arm and abdomen. Friday 3/9 had swelling on hands and feet - by Saturday 3/10 mostly all faded out. On Sunday 3/11 had more hives again - Sunday afternoon 50% improvement - Sunday evening 75% improvement. Monday AM had 1 new hive on face - faded - came back several times - went to MD - was given Benadryl - hive disappeared. No Tuesday 3/13/07 - never had fever or irritability. History: hives.
Knee/joint pain, headache, nausea, chills. Resolved after 24 hours.
Within minutes of receiving the vaccine, I experienced a metallic taste which went away within a few minutes. Experienced swollen lymph nodes on left side. No respiratory issues, no nausea, no vomiting.  Symptoms with left ear, load strange noises when laying down at night or noise. Progressed to right ear. Right ear was , fully resolved. Tinnitus systems still are ongoing but not as bad.
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient Reports: fatigue, body aches, persisting migraine headaches
Patient received inj. (SQ) on 18 May to left arm. No reaction appeared until Sunday 22 May. Area appears red (approx 5 cm) and feels a "bit itchy" color has changed from red to purple. Does not seem to be enlarging. Reported to doctor on 5-24-11 at 12:19 pm. Dr. off on Tuesday - will review & address on 5-25-11.
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product 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.
full body itchy rash 11 days after receiving second dose and it is now developing in his private area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included ADALIMUMAB (HUMIRA), ATORVASTATIN CALCIUM, ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN 81), TAMSULOSIN HCL, TRAMADOL HCL, SAW PALMETTO [SERENOA REPENS], VITAMIN D3, VITAMIN C [ASCORBIC ACID] and ZINC SULFATE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area). At the time of the report, RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area) outcome was unknown.            The patient's pharmacist told him to use Calamine lotion on his rash which was not effective. On 05-Apr-2021, the patient's physician prescribed him with treatment medications including Diphenhydramine cream, Cortisone 10 cream, and Prednisone oral tablet. The treatment medications were effective at the reporting time.
none Covid19 vaccine expired 11/22/2022 Given 12/12/2022
fibromyalgia; joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (fibromyalgia) and ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (fibromyalgia) and ARTHRALGIA (joint pain). At the time of the report, FIBROMYALGIA (fibromyalgia) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
on vaccine site there is an area of 15 diameter circumference, raised erythematous borders with central clearing
This is a spontaneous report from a contactable physician via Pfizer Sales Representative, who reported for her daughter. A 19-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Sep2015. The patient medical history and concomitant medications were not reported. On Sep2015 she had headache, which caused her to stay in bed for two days. She was treated for headache with TYLENOL or ADVIL, that didn't help her. The final outcome of the event was unknown. Follow-up (30OCT2015): Follow-up attempts are completed. No further information is expected.
Tenderness, redness, and swelling of injection area since 4/10/2021.
hard for her to breathe/hard time catching her breath; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A20A and 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain). At the time of the report, DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain) outcome was unknown.            No concomitant medication reported   No treatment medication reported
Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient's miscarriage or abortion was considered an other important medical event. Additional information has been requested.
Patient noted that several hours after receiving the Flu Vaccine, 11/04/05. She broke out with an itching rash,and hives. She called the ER and they recommended that she take benadryl and and cool bath. The next day,11/05/05 she still had the hives and again called the Er. They advised her to continue taking the benadryl, which she did and then slept most of the day and night. On 11/06/05, she woke with a fever(100), aches all over, a swollen upper lip, and broken out further with hurtful hives. Her family took her to the ER about 3:30 P.M. At the ER she as given SoluMedrol 250mg.I.M. She had decreased itching and was given a second dose of SoluMedrol 250mg I.M. She at no time had any respiratory problems or evidence of Hives in her mouth. She was considered stable and was discharged  about one and one/half hours after admission. She was prescribed Prednisone 20mg; six(6) tablets;take twice a day for three days. She was also to followup with her family physician in two days, A telephome call was made to the patient 11/08/05 to check her status. The hives  have diminished and she can only see the outlines at this time. Has an appointment with her family physician 11/08/05 in the P.M.
Fever and joint pain so intense that I could not sleep for 1st 36 hours, bedridden until Tuesday. From Friday through today, Thursday, fatigue, shakiness, dull headache and occasional tingling on top of head, dizziness, and nausea, making it difficult to carry out my normal daily activities. I feel unsteady sitting or standing up. Also, I had 2 PM nosebleeds on Tuesday and Wednesday.
Pt was not treated or diagnosed in our facility. Diagnosed with Guillain Barre's syndrome at a medical center.
Day 1--Pain/ache in LT calf muscle a few hours after shot.  Lasted for at least 8-12 hrs.  Very tired  Day2-Day3--Muscles in both legs ached.   Diarrhea lasted for several days
p/vax pt devel a recurrent rash every 5 to 6 wk p/vax;mom thinks rash looks like chickenpox;itching & scarring occurs along w/the episode;devel impetigo tx w/bactrim;dx w/scabies;
PATIENT CALLED ON 2/25 STATING THAT SHE HAD AN ITCHY RASH DEVELOPING ON HER ARM AT THE INJECTION SITE. SHE CAME IN ON 2/28/22. THE RED RASH WAS APPROXIMATELY 5 INCHES BY 3 INCHES ON HER ARM. IT CONTINUED TO BE ITCHY. IT DIDN'T CAUSE PAIN. I RECOMMENDED BENADRYL AND TO REACH OUT TO MD IF IT GOT WORSE OR DIDN'T RESOLVE
Received phone call from patient employer, that he had gone to the ER yesterday 6/9/14 due to dizziness and/or unresponsiveness. Employer unsure of details, but the ER physician was concerned due to history of vaccination. Attempted to call patient, telephone disconnected.
Information has been received from a registered pharmacists as reported by a physician concerning a patient who on an unspecified date, within the last four years was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route no reported). The pharmacist reported that the patients developed shingles after receiving the vaccine (on an unspecified date). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was no reported. Additional information has been requested.
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a patient of an unspecified age and gender.  The patients' medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location and indication: not reported). The batch number reported was 346341 and expiration date: 28-Apr-2023.   On 21-Sep-2022, 18h to 24h (during the night) after receiving Fluad Quadrivalent, the patient experienced nausea and diarrhoea. Nurse Practitioner claimed that as they were nauseated, they gave the patient 7up and an acid. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from the events. The patient no longer had these symptoms.  The reporter did not provide cusality assessment.  The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204738, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Information has been received from a 59 year old female with allergic PENICILLIN, SULFONAMIDE and ERYTHROMYCIN, and no pertinent medical history, who on 07-JAN-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported).  Concomitant therapy included unspecified thyroid medication.  On 07-JAN-2009 the patient experienced swelling, redness and feeling "getting poked with 10,000 needles" at the injection site.  She also stated that she doesn't "feel good" and has diarrhea.  The patient sought unspecified medical attention.  None lab tests were performed.  As of 16-FEB-2009, the patient was recovering.  Additional information has been requested.
Admit for COVID pna. Husband home with COVID infection. Likely cystitis on admit as well. Steroids, HFNC, remdesivir, rocephin, cefepime, levaquin, singulair, zinc, lovenox. Progressively worsened and was placed on comfort care. She expired 8/25.
4 inch area of redness and swelling at injection site with some soreness (mom did not report which arm). Area less swollen and red by next morning.
Very fatigue; Very tired; Very achy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigue), FATIGUE (Very tired) and PAIN (Very achy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), LISINOPRIL and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very fatigue), FATIGUE (Very tired) and PAIN (Very achy). At the time of the report, FATIGUE (Very fatigue), FATIGUE (Very tired) and PAIN (Very achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details  were not included .  Action taken with mRNA-1273 in response to the events was unknown.
The evening following COVID-19 booster, began to develop vesicular rash at ankles. By the next day, I had hundreds of papular bumps across both lower extremities. These were red and extremely itchy. On my wrists I had vesicular small lesions. Over time, I developed a rash that extended up both arms. Tops of feet and legs ended up with thousands of elevated erythematous bumps. I did not experience any vaccine site irritation, not did I have problems breathing. My trunk and face were spared. I am a physician and the Monday after the Friday booster, I called a dermatology colleague of mine and was seen. He prescribed topical steroid (clobetasol propionate) and antibiotic (mupirocin) as well as an antihistamine (hydroxyzine hydrochloride 10mg up to 6 tabs/day). The lesions progressed and evolved over a 2 week period at which time I could shave my legs again. I reported the response on my daily V-safe and was asked to go online and report this reaction.
3days p/vax pt devel anorexia & mild diarrhea requiring hosp;
Patient showed a red non-raised rash around injection site measuring about 1 1/2" in diameter. Patient states she received vaccine on 2-4-19 and rash appeared the following day on 2-5-19. Pt came in to pharmacy to show rash on 2-8-19 and rash appeared to be resolving. Patient had a doctor from her place of employment look at rash and made a pen circle around rash. Rash had not appeared to grow in size.
Information has been received from a registered nurse concerning a 6 month old patient who on 31-JAN-2011 was vaccinated with a dose of ROTATEQ PO. The patient older than 12 weeks of age received dose 1 of ROTATEQ. No symptoms reported, and no other details. No further information is available.
Information has been received from a physician and a registered nurse concerning a 15 year old female with a drug sensitivity to SEPTRA and a  history of seeing a neurologist and cardiologist for neurocardio syncope (Vasovagal) who on 26-MAR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. On approximately, 16-JUN-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 657868/0523U). There was no concomitant medications. On 16-JUN-2007, while in the physicians office, the patient fainted and then had a grand mal seizure. The patient was given oxygen. The office called for an ambulance and the patient was taken to the emergency room and released. There were no laboratory or diagnostic test performed. On 16-JUN-2007, the patient recovered from fainting and the grand mal seizure. On 18-JUN-2007, the patient was seen in the physicians office and was referred to a neurologist. Upon internal review, grand mal seizure was considered to be an other important medical event. The registered nurse is requesting a lot check. Additional information has been requested.
After the second Shingrix dose, I developed a  fever about 12 hours post-injection, and slept very poorly that night.   The following morning, at 22 hours post-injection, I woke up with significant upper-body muscle and joint aches, and fatigue.    I was not expecting this severe a reaction, since I had no reaction at all to the first dose.
Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that a child was given only DTaP/IPV component of PENTACEL without the powder. No adverse event was reported. Documents held by sender: none.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 11-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Vaccines given RT IM and SQ next to the MMR SQ site tissue started to turn dark pink with 2x2cm induration. Dr. informed ordered BENADRYL gave orally. Reassessed within 15 minutes inflammation decreased.
Blistors on left arm for the last three days that are spreading over shoulders and right arm (patient).  Generalized vaccinia.
1 hour after the vaccine developed low-grade fever, dizziness, nausea, fatigue, headache. Then later in the afternoon developed dry cough, sore throat, runny nose. Also diarrhea that seems to be getting a little bit worse. Also with SOB w/ activity that started a few hours after the vaccine.   3 days post vaccine - Continued symptoms include low-grade fever (not checking temperature), fatigue, (improving body aches), dizziness.