chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; temperature excursions have been administered to patient; temperature excursion that had occurred in a refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Sep-2022 at 4:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator). On 15-Sep-2022 at 4:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient).    Concomitant medication was not reported.  It was unknown if the patient had ever tested or been diagnosed with COVID-19.  The patient received 3 primary doses of Moderna vaccine intramuscular in deltoid.  Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # J016186 with expiration date 24-OCT-2016, K008874 with expiration date 23-FEB-2017, K011077 with expiration date 30-MAR-2017, and K025005 expiration date 21-JUL-2017; dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Within months, I was newly diagnosed with left carotid atherosclerosis and nodules in both of my lungs.
a 64.5 year old patient having received Fluzone High Dose, no AE; a 64.5 year old patient having received Fluzone High Dose, no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse via phone.  This case involves a 64.5-year-old patient (gender was not reported) who was vaccinated with a 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, batch number and dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  No adverse event reported at the time of reporting.  The nurse wanted to know is it dangerous if a under 65 year old patient received Fluzone High Dose.  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.  There will be no information available on the batch number for this case
he has been having an increase in weakness in his legs for the last 2 to 3 weeks. He needs to be interviewed. He was having some back and chest pain prior to the vaccine
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received MMR II. The MMR II was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938 and 1405USA011939 (same reporter link). Additional information has been requested.
This spontaneous report was received from a medical assistant concerning an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reaction or allergies were not reported. The reporter stated that, since 11-JAN-2016, the patients were vaccinated with doses of M-M-R II, lot # L012482, expiration date 10-APR-2017 (dose, dose number, route, and anatomical location were unspecified) that were exposes to 47.9F during 5 minutes. No adverse experience has been reported. This is one of several cases received from the same reporter. Additional information has been requested.
This case was reported by a consumer and described the occurrence of reaction to vaccination in a male subject of unspecified age who was vaccinated with influenza vaccine, (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced reaction to vaccination (described as "caused me damage"). The subject reported that the "flu shot caused me damage." No further details were provided. At the time of reporting the outcome of the event was unspecified.
itchy at injection site; Bright red oval around the injection site, gets bigger every day; Arm soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE PAIN (Arm soreness at the injection site) and VACCINATION SITE ERYTHEMA (Bright red oval around the injection site, gets bigger every day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness at the injection site). On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (Bright red oval around the injection site, gets bigger every day). The patient was treated with SULFAMETHOXAZOLE for Adverse event NOS, at an unspecified dose and frequency. On 20-Feb-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (Bright red oval around the injection site, gets bigger every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
she had a 2x2 red ring around the injection site; shaking the vials like a "paint can" and administered her vaccine low close to the elbow; This is a spontaneous case received from a contactable consumer (patient) via COVAX US Support. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated that they were shaking the vials like a paint can and administered her vaccine low close to the elbow, caller said Onsite was fired the second day, Caller also stated she had a 2x2 red ring around the injection site for a couple of days. The outcome of the events was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
RIGHT ARM RED AND SWOLLEN AND HIVES PRESENT.  MOM APPLIED BENADRYL CREAM AND GAVE HER ZYRTEC.
Employee received Fluad influenza IM vaccine in L upper arm at hospital wide employee vaccine clinic on 10/25/21. Later that night she developed L lymph node swelling in armpit area about 3in-2.5 inch and painful. She also developed R knee swelling and pain the next day. Initially she also had numbness in L thumb. (PL). As of 10/29 symptoms improving and does not plan to see provider
Experienced Chest pain and dizziness shortly after the first vaccine shot, but did not last too long. Is this a normal side effect of the vaccine shot?
Never had acid reflux prior to the vaccine and it started 2 days after the vaccine on both shots.
Memory loss. Muscle pain - very serious - joint & pain upset stomach - cramps - diarrhea. Swollen legs and hands continuous colds.
I tested positive for COVID-19 on 10/26/2022. I had congestion, fever, cough, runny nose, body aches, joint pain, unbelievable fatigue and was given PAXLOVID and was COVID positive for 3 weeks. I took it and was given an albuterol inhaler, also took a Z PAK. I also took TUSSIN X cough medicine. I received my flu shot 2 weeks prior. I went back to work on 12/2/2022.
almost 2 weeks later.  rash, swelling, itching, soreness, pain at injection site,
Initial report received from a healthcare professional on 09 Jul 2010: This patient inadvertently received a intramuscular dose of the liquid component (only) on MENVEO (batch number: 1000005) instead of being reconstituted with the lyophilized component. No adverse effects were noted following this administration. MENVEO that was not reconstituted with powder before administration and the lyophilized portion was not administered. No re-vaccination performed. No adverse event had occurred. Follow up information report from healthcare professional received on 30 Jul 2010: The patient demographics were updated. The outcome of event was unknown.
3 days after the vaccine I started feeling extremely jittery with numbness in my arms and legs. My heart rate increased and I was finding it very difficult to stay calm or focused. This has been persistent since. Body seems warmer than usual and numbness/tingling sensation is still an issue.
At 1026, pt reported feeling "swollen" and "tight" around side of face/jawline. No obvious swelling of tongue or throat observed, pt able to swallow without difficulty. Vitals monitored every 5 minutes, At 1034, pt reports that feeling has subsided around sides of face and now migrated to lower throat. At 1040, pt reports feeling has diminished completely. Dc'd from clinic stable.
Pfizer 2/9/21 and 3/2/21. Positive on 1/3/22
cardiac arrest; seizures; his is a spontaneous report form a contactable consumer. This contactable consumer reported for a male patient (reporters brother).  A 34-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient experienced Cardiac arrest on 23Jun2021, Seizures on Jun2021 and patient was hospitalized for both the events and his status has gone out of control. The outcome of event was not recovered.   Information on the lot/batch number has been requested.
I developed Psoriasis on the 3rd day after receiving my 2nd COVID shot on 2/5/21.  I have visited twice with my primary care physician and with 2 dermatologist  and have developed hives all over my body including my scalp. I have been applying cremes and shampoos and taking Otezla samples that my Dr. gave me. I cannot afford Otezla and this is not my fault.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered). At the time of the report, VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-044466 (Patient Link).
The patient states that about one week following her second shingrix vaccination, she started to have pain on her left side, including left upper arm (underside), left breast and left clavicle. She has been following with her PCP to rule out other causes. She continues to have pain and discomfort in these areas, as well as tingling and burning in her left clavicle area and down into her left upper arm and axilla area.  Has been taking oral anti-inflammatory medication with some relief. Her PCP has discussed with her that this could be due to the shingrix vaccine. The patient has had shingles in the past. Her PCP discussed the option of treatment with Elavil to help with nerve pain. This treatment has not been started yet. The patient has had symptoms now for about one month. The patient suspects that she may be  currently dealing with shingles.
she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID; she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982) on 21Jan2021 (afternoon), and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9867) on 12Feb2021 (morning), both via an unspecified route of administration, administered in left arm, as single dose for COVID-19 immunization. The patient medical history was none. Concomitant medications were not reported. Patient did not receive any other vaccine four weeks prior the vaccination. On 03May2021, patient had two instant tests prior to the full one that were positive for COVID-19. On 04May2021, the patient has done three tests and COVID-19 was confirmed. Patient stated that she was fully vaccinated with the Pfizer COVID vaccine at the end of FEB2021 and she still got COVID. The patient underwent lab tests which included two times instant SARS-CoV-2 test on 03May2021 and full one for SARS-CoV-2 test on 04May2021, all the tests with Positive results, also patient described that NYU did some unspecified extensive test. Patient had the full test because her doctor was so shocked that she tested Positive, and doctor wanted to let Pfizer know. Patient thought that it was going to protect her from getting COVID. Patient has gone all of the time and never got COVID and then she gets the COVID vaccines and gets freaking COVID. Patient thinks that she has no predisposing factors for getting COVID but that the only thing that she was worrying about was that she lives in an apartment building and they had parties going on in her building and was trying to track that down. Patient did not go to the party though, but she wonders if COVID can be in the air in the building. Patient only concern was that this COVID vaccine was a bummer, got vaccinated and then got COVID. The outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Patient received Fluzone Lot u2768aa on Wednesday 11/5/08 about 9 AM.  She began to experience fatigue, body aches and pains, bright red eyes with burning, fever, and at 2 pm lung tightness. She went to bed at 7 pm, experiencing a headache about 9 pm.  Thursday am she felt better but still had bright red eyes.  She suspects ocular respiratory syndrome
Approximately 4.5 hrs, post vaccination employee broke out into a rash,described 'fine little hives'. She was treated in the ER (where she works ) with Benadryl. Rash resolved within 48 hours. Employee did not alert employee health nurse of possibly  having tonsillitis prior to vaccination.
Erythema Nodosum Syndrome at site of injection ((R) upper arm) ? if this due to shot.
Started having indigestion/acid reflux. Was vomiting on occasion. Started to investigate if I had a gall bladder issue but before that could be done I had a heart attack. No blockages or blood clots. Have not gotten an explanation yet but I was in great health before a shoulder surgery in December. EKG done before surgery was good.  I had some viral sinus issue that Dr gave me Prednisone for just before the heart attack so any heart inflammation would have been masked by medication.
Hip pain that turned into extreme pain that left me unable to sit, stand or put pressure on hip; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 48-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 17:30 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation in Public Health Clinic facility. The patient medical history was not reported. Patient is not Pregnant at the time of vaccination. Patient received other medications within 2 weeks of vaccination (unspecified).  the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2 (Pfizer, Batch/lot number: Unknown) at 48 years old into right arm on 12Apr2021 04:00 PM for COVID-19 Immunization. The patient experienced hip pain that turned into extreme pain that left her unable to sit, stand or put pressure on hip (hospitalization for 4 days) on 06May2021 08:00.  AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. no covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab post vaccination on 15May2021: negative. It was unknown if treatment received for the event. Outcome of the event was recovering. It was serious report. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all No.  Follow attempts are needed; further information has been expected.
Pt had a very high fever p/last shot & pt was taken to MD the next day; MD felt pt should not recvd any more DTP (t103);
not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I tested positive for COVID-19 04/23/2022. My symptoms was mild and lasted about 4 day. I had a running nose, coughing, sneezing, body aches and fatigue.
This spontaneous report was received from a registered nurse referring to a patient of currently 7 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Day of the injection I started having pain in the left shoulder and I got an egg yolk size ball at the injection site with a lot of redness. The swelling resolved in about a week, but the has not gone away. It comes intermittently, but when it happens it is more intense.
Patient states his high blood pressure is a direct result of receiving the 2nd shingrix shot. He also states he is not able to lift his arm up due to severe pain from both shingrix shots.