chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; Swelling at injection site; Tiredness, Slept like a baby; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date, refer case US2023AMR064993.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swelling at injection site) and tiredness (Verbatim: Tiredness, Slept like a baby). The outcome of the injection site pain, injection site swelling and tiredness were not reported.   It was unknown if the reporter considered the injection site pain, injection site swelling and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, injection site swelling and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR064993   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she just received his or her second dose of Shingles vaccine. The patient experienced pain and swelling at the injection site which was bearable and tiredness. The patient stated that after received both the doses he or she was slept like baby. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR064993:Same reporter  - Case for 1st dose
Dr. ordered a third Moderna Monovalent 6m-5y for a non-immunocompromised 2 year old patient.  I prepared and administered this dose initially thinking  I was giving a second dose, and afterwards realizing it was the third.  Reviewed this later in the day with Dr.
patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t; patient administered a dose from an excursed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist believed was opened on Monday 27-Sep-2021 (but he was not sure). Pharmacist was unsure if it was the patient's first or second dose and unsure which arm vaccine was administered in. It was also reported that administered a dose that was stored for over 30 days to a patient. No other adverse events have been experienced.  Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow up received on 02 OCT 2021 contains : Reporter information updated, patient demographics added and lot number updated. On 05-Oct-2021: Folow up received on 05 oct 2021 contains No New Information.
Patient described a delayed allergic reaction with extensive raised nodules and itching throughout the area of immunization.
Received Pfizer vaccines on 4/14/21, 5/10/21 Positive for COVID 19 by PCR on 11/1/21 Admitted to Hospital on  11/2/21 d/t COVID pneumonia underlying renal cell carcinoma
shipment of FLUZONE HD QIV was delivered too late. It was supposed to have been returned but it wasn't / no reported AE; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via regulatory authority (under reference 00792823).  This case involves a 72-year-old female patient who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] of which the shipment was delivered too late and it was supposed to have been returned but it was not, and three doses were administered (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 29-Sep-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ763AC, expiry date 30-Jun-2022 ) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported "pharmacist/manager states a shipment of FLUZONE HIGH DOSE (HD) Quadrivalent (QIV) (522 - FLZ HD HV QIV) was delivered too late and caller had already spoken to Pasteur CS. However, 3 of the vaccines in the shipment were administered to patients so Pasteur CS transferred her to us to get more information about how to move forward. Call transferred from Pasteur agent Caller states that they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it was not, and three doses were administered."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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 the 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.
On Tuesday, I had a sore arm and a bit of fatigue. On Wednesday evening, I had what looked like a sunburn on my arm. It was swollen and hot. On Thursday - it was really swollen and really red. Painful to touch: Injection site to left shoulder to front chest - pain. Friday, I woke up and it was still cherry red and painful to the touch. I had a really bad headache Thursday and into Friday. Luckily, they could get me into a doctor right after chiropractic appt. My doctor gave me an antibiotic for an infection - it was Cephalexin - 500 mg. It started clearing up with the antibiotic. I got the flu shot the week prior to this shot on my right arm. I don't know the brand name or lot number. I got it also at a facility. That Saturday before the Monday of the shot I gave platelets.
pt inadvertently received 3 total doses of janssen. 4/10/21 - 1st dose 11/5/21 - booster dose 1/27/21 - non-indicated additional dose
The injection site swelled up dramatically and looked like I had been punched. That evening I got extremely sick and threw up for three days. My stomach was very sensitive and it was very hard to keep any food down. I went to an apothecary gave me herbs to help calm my stomach and I was able to start eating again.
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  Employee states: He was fine the day of second vaccination except for sore arm. During the night he began to have serious bone and muscular pain in his back, hips, arms, and legs. The left arm of injection was quite painful upon moving. Also experienced a slight headache at times and nausea. The pain lasted a total of 15 hours and generally subsided except for the pain at injection site which is still sore.
Chills; Low fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Low fever) and VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced CHILLS (Chills), PYREXIA (Low fever) and VOMITING (Vomiting). At the time of the report, CHILLS (Chills), PYREXIA (Low fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported.  Treatment medication were not reported.
Pain In Arm at Injection Site, Fatigue, Sharp Muscle Aches, Joint Pain, Acute Headache, Blurry Vision, Pain Over Eyes, Chills, Fever,  Severe Bloating and Severe belly discomfort both at upper and lower intestines, Diarrhoea, Rhinorrhea, Shortness of Breath, Dry Cough, Wheezing, Low O2 levels, Fast Pulse Rate 100, High Blood Pressure.
Diffuse erythema, warmth and tenderness over entire deltoid area with lymphangitic streak to axilla. Mild positive axillary lymphadenopathy. Arthus Reaction
Appendicitis, had to have appendectomy.   Symptoms started 02/21/21, appendectomy performed on 02/22/21.
No additional AE information provided; the patient was administered an improperly stored dose of VAQTA; This initial spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. This report concerns one patient and one combination product.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S020241, expiration date: 23-AUG-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse event information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
mother stated that on Friday 6/3/22 she first noted a "rash" around the injection site. 3 or 4 raised bumps, like bug bites, solid no fluid, not crusted located next to the injection site on the right arm. mom stated child stated they "hurt" when she touched them while applying any pressure to the area. no fever, no fine rash, no pain with just touch without pressure to the area. some itching to the area per mother. this morning 6/6/22 mom noted the bumps are much smaller, "going away" and pt. stated it no longer hurt when she applied pressure to the area.  no longer itchy.  mom did not seek medical evaluation but waited until this morning to call me. I advised mother if pt. develops a fever or the bumps get bigger or spread to call UC and have a doctor evaluate immediately.  but since they were going away to continue to monitor, take pictures in AM and PM for evaluation by MD in future if needed. suggested to mother it could have been a mild allergic reaction and in the future she should go to a UC for evaluation and not wait for me to return to the office for the weekend.  Pt. had full energy and did not complain of other issues. mother declined referral to regular physician or UC at this time since bumps are smaller and pain is gone. mother stated brother had one bite on his stomach the same day but it is not longer there. I advised mom it was impossible to evaluate if the bump is gone and that one bump doesn't constitute a rash or reaction since neither child had fever.  not a contraindication for vaccination in future. mother is vaccine hesitant and getting only 4 - 6 vaccines per year at this time. child is not in public school at this time.
My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient).  A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
Narrative:  A 79yo male with PMH of multiple medical problems which included, NSTEMI, HTN, CAD, BPH, Cervical Stenosis, Obesity BMI 30+, Cervical Radiculopathy, OA, Recurrent Major Depression, PTSD, CKD stage III, Persistent Protein Urea due to Type II DM, Recurrent Angina post PTCA and Hypercholesterolemia. On September 18, 2022, attending physician reported the patient had an acute respiratory failure observed on September 16, 2022, possibly caused by PF- Pfizer Covid - 19 Booster vaccine-(12y and up). received on September 14, 2022. The administering RN documented, "He was provided with all required information, fact sheets regarding the vaccine and denied any prior severe reaction to the vaccine, its components or any vaccine or injectable therapy." The patient was admitted to Medicine and per the Attending Physician's note received Life Sustaining Treatment, had a Pulse Ox of 85% in the ED which improved to 94% after being placed on 2L nasal cannula. It was also documented the patient reported "he developed SOB two days ago after he received his 5th covid vaccine".
received a 0.25ml dose as a first dose by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a first dose by mistake) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 01-Jun-2022, the patient experienced ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a first dose by mistake). At the time of the report, ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a first dose by mistake) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  A patient instead of receiving a full dose of the Moderna COVID19 vaccine received a 0.25ml dose as a first dose.
pt recvd a combination of 3 series of Engerix-B & Recombivax-HB; 1MAR89 titer was neg; booster dose given 22MAR89 & 26JUN89 titer was pos; booster dose of Engerix-B given 27APR92 titer pos;
did not have full movement could not close his hand; red,The whole back of his hand was red; Right hand was swollen , swollen the other day (right hand); chills,terrible chill,terrible, terrible, terrible chills; achy all over; hands were tingly,  could not close his hand; felt like it (hands) was bruised; exhaustion; headache; fever; Reaction hit that night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand) and ERYTHEMA (red,The whole back of his hand was red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 012A21A and 13M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and TADALAFIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction hit that night). On 05-Nov-2021, the patient experienced MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), FATIGUE (exhaustion), HEADACHE (headache) and PYREXIA (fever). On 06-Nov-2021, the patient experienced CHILLS (chills,terrible chill,terrible, terrible, terrible chills). On an unknown date, the patient experienced HYPOKINESIA (did not have full movement could not close his hand), ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)). On 09-Nov-2021, ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)) had resolved. At the time of the report, MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand), FATIGUE (exhaustion), HEADACHE (headache), PYREXIA (fever) and VACCINATION COMPLICATION (Reaction hit that night) outcome was unknown and CHILLS (chills,terrible chill,terrible, terrible, terrible chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 99.4 (High) temp 99.4high.         No treatment medications were provided.
i got breathless like in 2 weeks; 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 DYSPNOEA (i got breathless like in 2 weeks) 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 DYSPNOEA (i got breathless like in 2 weeks). At the time of the report, DYSPNOEA (i got breathless like in 2 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
1 min after getting the vaccine , I went to sit down and  felt a wave over my body .. .. Heart rate and blood pressure was up.. after a few mins I felt cold all over my body . I felt off .. I stayed for observation for about two hours.
Hives; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. it was unknown if the patient was allergic to any food, medications or other products. Concomitant medications included apremilast (OTEZLA), fish oil, tocopherol (OMEGA 3), B12, Probiotic; started on unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the patient experienced hives. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed lightheadedness and nausea 2 minutes after receiving her vaccination. She was taken to a private section of the arena and monitored. Bloof pressure and heart rate were within normal limits.
Blistery lesions, over left buttocks and left posterior leg, itchy and painful to touch. Put on antiviral by family physician which lessened pain in leg on 12/27/18. Had also previously inoculated with the Zoster Vax at age 60.
Nurse administered the vaccine right where my upper arm meets my shoulder. No pinch, but  much, much higher than I have ever been injected in my 67 years. It was far more painful than previous shots I have ever received. She asked me to massage the area of the injection, which I had never experienced before. I couldn't do it because of the immediate soreness around the beginning of my shoulder bone. The pain wore off within 24-hours. But two days later, I began to feel sharp pain in my entire shoulder and lost my range of motion.  Right after the injection, I spoke with, emailed and texted some of my co-workers. I told them about how unusually high on my shoulder the vaccine was administered, and that I was concerned. Those dialogues continued when my shoulder pain lingered and then got worse. It's been 10 months and my shoulder is more painful than ever. My range of motion is as slight as ever.
Patient just felt dizzy 10 minutes after injection, in the waiting area. Did not lose consciousness,but felt weak. Front manager and pharmacist on duty sat with patient until he felt oriented. Gave bottle of water. He sat for an additional 1/2 hour. Reported the incident to our Risk Management Department