chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose and route were not reported; lot# K021624 with expiration 07-FEB-2016; lot# K026365 with expiration 15-MAR-2016; lot L006392 with expiration 25-MAY-2016; lot# L012039 with expiration 07-JUL-2016; lot# L032184 with expiration 25-NOV-2016) (incorrect product storage). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sales representative. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on Apr2021, at dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the full vaccination (as reported) at the end of Apr2021 and developed Covid over a week ago from the time of report (19Aug2021). Also reported that he was very sick. The outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
This 22 yo presented for follow up evaluation of adverse events to H1N1 Mist vaccine received on 1/7/2010. Initial eval was by PCP 3 hours after vaccination on 1/7/10. SM received H1N1 vaccine approximately 0830 on 7 Jan 2010. Upon arrival and prior to vaccine receipt, SM requested SIQ prior to vaccination reporting "she always gets sick" after her vaccinations. She remembers feeling ill prior to her shot with "cold symptoms" to include body aches and malaise. Approximately one hour later, she began to feel nauseated, her vision became prism like, felt dizzy with sudden sharp stabbing frontal sinus-like headache that extended to back of head and felt hot all over. The headache was 8/10 pain scale. She sat down returning to medical about 1100 hr. Here she complained of headache, nausea, pressure in head, body aches, and left leg tingling/twitching abd pain, rash, pruritis, congestion or any other signs of allergic reaction.. She advised this headache was similar to past "barometric" headaches experienced since childhood and common to past "flu shot reactions". She described her left leg tingling/twitching being located along the lateral left leg between hip/knee while sitting driving. She denied any difficulty walking. Her exam was unremarkable with the physician diagnosing with headache. She refused any medication for her headache and was given SIQ for 24 hours. She reported her headache, malaise, and fatigue lasted for <24 hours resolving while asleep. Her leg twitching lasted <8 hours with spontaneous resolution. As of 14 Jan 2010 interview she reported no reoccurrence of the above symptoms. Symptoms: nausea w/o vomiting, headache, general and Paresthesia.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 20 years and 6 months old. No concomitant medication information was provided. No treatment medication were provided.  On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there were no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Patient got Moderna with vaccine Ndc code.
Left arm swollen, red, hard, itchy, and warm to the touch, given Benadryl and Keflex 250mg qid x 10 days.
Injection site black and blue mark; Bruise; Something tickle down my arm when I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Injection site black and blue mark), CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Injection site black and blue mark), CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine). At the time of the report, INJECTION SITE BRUISING (Injection site black and blue mark) was resolving and CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
developed sudden onset of "PAC" premature atrial contraction. Medication treatment plan: Metoprolol (Beta Blocker)
Atrial Fibrillation events went from 1/month or less, at one day, to 50% of all days. Still at that level as of July 4, 2021. The events now last 3-7 days.
? Dose administered after improper storage and handling (more than allowed time after first vial puncture).  Vial reconstituted at 0822, expired six hours later at 1422.  dose administered at 1532, 70 minutes after expiration
I started having very mild nasal congestion with clear nasal drainage. I also had a tickle in my throat for about 2 days. The 3rd day I started to cough but it wasn't consistent. I started to wheeze but it was mild and began taking my inhaler. I got a prescription for PAXLOVID due to my history of asthma. Fatigue.
After the first shot, Her eyes stopped focusing and she got migraines. After the second shot, which she recieved on 8/3/09 Her ankles started to swell and be very painful. Her legs turn blue. Her knees, ankles, hips, elbows, and shoulders fall out of place. Her hands, feet, and legs also swell. She is constantly cold. her hands and her head shake uncontrollably. She has heart palpatations. She cant sleep.At times it is to painful to get out of bed. She has trouble concentrating. She has been to the er, then doctor, then the er again, then the rheumatologist, the er again, and the childrens institute where she may have to stay for two or more weeks for intense physical therapy, although to week at this time. She has to be built up before she can begin.
Shortness of breath 1 day post vaccination. Sx almost resolved by next day when pt evaluated.  No other complaints
Dtap and Hep A were administered at the incorrect interval. Patient had received forth dose of Dtap on 3/21/23 and first dose of Hep A on 3/21/23.  Mom called to report a small lump and an area of redness about the size of a pea on the right thigh on 4/25/23. Advised to apply a cold wash cloth and call back if the area of redness increased. Patient seen of other concern on 4/26/23 but reported nodule to right thigh and increased fussiness to provider. 1cm nodule per provider. Advised Tylenol/Ibuprofen for pain.
My father went to the emergency room at local HCF early on 28 October after suffering from severe chest pain and difficulty breathing.  He was completely awake and lucid.  After a few hours in the emergency room, they were unable to resolve the issue and lungs were filling with fluid.  My father was intubated and shortly had 2 cardiac events.  He was dead by 7AM on 28 october.  The reason I am reporting this is because there is no way a completely healthy Human being becomes completely dead in the space of a few hours.  It is my opinion that something triggered the mRNA instructions and the hospital was unable to stop the spike protein from taking over my father's system.  I am not a doctor, but I have read a lot about Covid and the so called vaccine, and it is my belief that the lack of a 'shut off' valve related to the mRNA instructions caused the process to overload my father's system and a cytokine storm that the emergency room was unable to stop.  The doctor did not come out and say this, but he implied that he had not seen anything like this and was unsure why it occurred.
pt recv vax 4NOV97 & 5-6hr later arm started turning red, is hot to touch & is swollen, arm felt better Wednesday AM but by PM it had started swelling & was red down to below elbow;arms still swollen & warm;pt states not painful;
Continued ringing/ buzzing of ears , disconnected feeling, fatigued since the evening of the shot
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fm7553) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes a COVID 19 Treatment from 03Feb2023 to 07Feb2023.
Patient states injection was given subcutaneous instead of intramuscular.  Patient states she has a red area at the injection site.
SWOLLEN LYMPH GLANDS ON BOTH SIDES OF NECK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swollen lymph glands on both sides of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph glands on both sides of neck. This report was non-serious.
Vaccine was exposed to 32.9 degree Fahrenheit for 24 hours/ no AE; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician via Regulatory Authority (Reference number- 00799327) and transmitted to Sanofi on 05-Oct-2021.  This case is linked to case 2021SA332413(CLUSTER).  This case involves a 76-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was exposed to 32.9-degree Fahrenheit for 24 hours with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ715AC and expiry date 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported " A temperature excursion yesterday and caller stated the temperature given at that time was not correct for the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated the time of the excursion was for 24 hours and the minimum temperature of the refrigerator was 32.9 degrees Fahrenheit and the maximum temperature was 35.9 degrees Fahrenheit. Caller also stated that the Vaccine was given to 5 patients prior to reporting the excursion".  Product used: Used. First time product used : Yes. Still using product : No.   It was a case of actual medication error due to Incorrect product storage (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
Tiredness, body aches, fever, chills, rash, migraine headaches and lump at base of head on the back of neck.
kidney pain; Lower back pain; Dry heaves; Sick for 4 hours during the night; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included AMLODIPINE, TAMSULOSIN, METFORMIN and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting). At the time of the report, RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-06-2021 contains no significant information.
I was pretty much covered in hives; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunization. The patient was 49-years-old at the time of vaccination. The past medical history and concomitant medications were not reported. On 05Feb2021 the patient experienced i was pretty much covered in hives, therapeutic measures (took Benadryl) were taken as a result of i was pretty much covered in hives. The patient wondering, she got the vaccine on Tuesday night and she was doing fine and last night at 2 o' clock or 2:30 in the morning, she woke up and she was pretty much covered in hives, when she looked on her paperwork, said that, that could happen but like usually within an hour of vaccine. So, she was wondering if that could still be the side effect of the vaccine." When paraphrased the concern, consumer stated, "No, not two nights later, it was last night." (clarified as 5Feb2021). The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot # N023650 and expiration date: 20-MAY-2019) intramuscularly from a pre-filled syringe which broke right after the administration. It was unknown whether the prefilled syringe had any defects prior to the administration. It was reported that the luer lock broke off at the tip of the glass of syringe. No known adverse effects reported. Product quality complaint was filed.
Deep aching muscle pain, subsides with no use of arm, pain is constant with movement remains tender to touch, localized from elbow to shoulder had 2 w/o pt with effect days U sound and E stimulus.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced wrong technique in product usage process. The outcome of wrong technique in product usage process is unknown. The reporter considered wrong technique in product usage process to be not related to VAQTA.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2011, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
In the day after getting the shot, Headache and body ache all day. Nausea off and on. Vomiting in the evening
Redness and swelling at injection site; Body aches; Fatigue; Chills.
No adverse event; administered an expired dose of the bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number - 027L20A) on 07-Jan-2021, Moderna COVID-19 Vaccine (Dose 2, lot number - 012M20A) on 05-Feb-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 4, lot number FK9729) on 09-Sep-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 5 and lot number - 030G22B) on 22-Sep-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 3 and lot number 32030BD) until 30-Oct-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hypertension.    On 19-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Patient not had adverse events after the administration.   Dosage text was reported as unknown.  Treatment details was not reported by the reporter.
Expected pain, swelling, and redness for approximately 3 days after the vaccine (including the day of).  The site was also "knotty" under the skin. Side effects decreased and subsided during the 4th and 5th day after vaccination. Beginning with the 6th day, mild soreness resumed, along with increased redness, increased "knottiness," warm to the touch, and itchiness. These side effects continued and somewhat worsened into the 7th and 8th days. On the 8th day, my school nurse recommended I visit a doctor. I spoke with a nurse practitioner over the phone, and then visited her in person. Upon examination, she determined I had cellulitis. She prescribed an antibiotic (Keflex).  (Today is the 8th day - 2-4-21.)