chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 4-AUG-2022) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. Age at time of vaccination 42 years old. No concomitant medications were reported. On 17-FEB-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558439, 20220558455, 20220558390, 20220558823, 20220558852 and 20220558638.
Dizziness, nausea, numbness of the arms, weakness of the arms and legs, numbness in the face, severe gait, headache, slurred speech, confusion.
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; received vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to analgesics (Percocet), Hyperthyroidism and Hepatitis C. Concomitant products included ALBUTEROL SULFATE, FLUTICASONE FUROATE (ARNUITY ELLIPTA), ATORVASTATIN, HYDRALAZINE, AMLODIPINE, HCTZ, FLUTICASONE and PANTOPRAZOLE for an unknown indication.    On 06-Apr-2022 at 3:38 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:38 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 vial was initially stored in the refrigerator. It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022   Vial did not undergo any temperature excursions  HCP confirmed that the patients were not experiencing any side effects yet.  Patient had not tested COVID-19 within last month. No treatment medication information was given.
Headache for 32 hours, Severe pain at injection site 48 hours, Aches all over body 32 hours, Possible Low grade fever 5 hours, Rash on upper abdomen continues
At first uncontrollable shaking for 10 minutes . Then inability to sleep, severe headache, nausea and rash at injection site
Pt stated significant (L) arm pain with tingling down to fingers. Which has kept him up at night and has continued as of 2/1/10. Vaccine given 1/27/10.
Patient was only given half dose of Moderna Bivalent Booster 0.25mcg and was to be given 0.5mcg. Wrong dosage given.
I woke up with a temperature of 100.7 at about 7:30 a.m. I took two Tylenol, which brought my temperature to 99.0 around 9 a.m. At 1 p.m., my temperature was 101.3. I was experiencing aches, pains, and fatigue so I took a nap. At 2 p.m. my temperature was 102.1. I took two more Tylenol which reduced the temperature to 100.3 by about 4 p.m. I also have redness, swelling, and significant pain at the injection site. The hard, hot swelling is about 2 inches in length and 1 inch in width. I am now alternating Tylenol  as needed for the fever with Ibuprofen for the inflammation. I also developed a dry cough over the course of the day. Have been advised to force fluids. It  has been less than 24 hours since symptoms onset, so hopefully I will improve tomorrow.
S/P injection pt was tearful, hyperventilating, VSS. At one point pt vomited. No LOC. Presumed anxiety attack AED ED notes.
nearly faint; Feeling of throat closure; rapid heartbeat; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 32-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling of throat closure, rapid heartbeat and nearly faint. The patient did not received any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of ZOSTAVAX. On an unknown date the patient experienced swelling at the injection site on the back of her arm. Patient sought medical attention (unknown type). No PQC (product complaint was involved. The outcome of swelling at the injection site was unknown. The relatedness between ZOSTAVAX and the event was not reported. This is one of several reports from the same source. Additional information is not expected because the pharmacist did not give the consent for follow-up.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694), 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 and 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 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 01Mar2023 to 06Mar2023.  No follow-up attempts are possible. No further information is expected.
Patient states that later that night after recieving vaccine, patient started having facial paralysis. patient face felt numb on one side, eyes on left side started watering and was unable to blink
AFTER ADMINISTRATION OF VACCCINES (5:20PM), PATIENT CAME OUT OF THE EXAM ROOM AT 5:25PM ASKING FOR WATER STATING THAT SHE FELT LIKE SHE WAS GOING TO FAINT. ASSISTED HER TOWARDS A CHAIR WHEN SHE COLLAPSED-WAS ABLE TO GUIDE HER ONTO THE FLOOR WITHOUT HITTING HER HEAD. SHE STATED THAT SHE WAS LIGHTHEADED. VITAL SIGNS WERE: BP AT 113/69 PULSE AT 102, OXYGEN AT 97%. PT WAS ABLE TO SIT UP AFTER A FEW MINUTES AND WAS PROVIDED WITH WATER. PATIENT WAS OBSERVED FOR 25 MINUTES THEREAFTER AND WAS GIVEN THE OKAY TO LEAVE PER PROVIDER INDICATIONS.
Lack Of Response - Information has been received from a physician concerning a 31 year old caucasian female patient 2ho on 11 Feb 1997 and 28 Mar 1997 was vaccinated with the first and second doses of varicella virus vaccine live.  There was no concomitant medication.  In march 2000 the patient sought medical attention and a serum varicella roster virus antibody test revealed a low titer.  On 06 mar 2000 laboratory evaluation revealed rubella antibody IgG nomimmuna.  It was reported that the patient wanted to get pregnant.  No further information is available.
doses were given beyond the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported The vial was initially stored in the refrigerator on 08-Dec-2021. The vial was first punctured on 03-Jan-2022 at 2:45 PM. The vial stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Three times total for drawing up the doses, each time no more than 2-5 minutes. No Treatment medications reported   This case was linked to MOD-2022-444843 (Patient Link).
13 yo male healthy moved 1 week prior. Seen at the clinic for vaccinations. Patient received Tdap, HAV, HPV#1. MCV vaccines. Within a few minutes after receiving vaccines. Patient was standing up in room. Patient per sister patient complained of feeling dizzy (said in a different language). Then fell forward and landed in prone position on floor. No loss of consciousness was turned over & noted to have about 1 cm chin laceration. Crying EMS was called and pt taken to ER for further evaluation. Pt was awake, alert, crying but able to follow commands. PARRL chest CTA, RRR with BP 120/80 was noted to have erythema on (L) side of chest and (L) arm much improved without intervention. No urticaria.
Patient received Flucelvax in the left arm and a few minutes after receiving the shot collapsed onto the floor in the aisle directly across from the pharmacy. Her husband was with her while this happened. She seemed very confused and appeared very weak and pale. I observed her for any swelling of the face or lips. She did not have any. She said she was not having any trouble breathing. I called over  front-end supervisors and they brought her some water and a wheelchair. After about 10 minutes I asked her how she was feeling and I could tell she still appeared weak and pale. At this point I asked the front-end supervisor to call an ambulance and about 10-15 minutes later the EMTs came and took her to the hospital.
This spontaneous report was received from a physician concerning two patients of 3 month old (gender unspecified). On 14-FEB-2013, the patients were vaccinated with a dose of VAQTA (lot number, expiry date, dose and route unspecified), 25/0.5 units per milliliter U/ML) instead of RECOMBIVAX HB (reported as RECOMBIVAX (lot number, expiry date, dose and route unspecified). No adverse symptoms were reported. Additional information has been requested.
Painful red itchy rash all around injection site. Appeared on 7th day after injection. Also sore throat and lethargy
Received vaccine at 4 pm on Wednesday 4/28/21.  I started feeling typical vaccine side effects between 7-8 pm, and by 9 pm I went to bed exhausted.  My symptoms included SEVERE headache, fatigue, muscle aches, chills, hot flashes (no fever), nausea, stomach pain, and pain at the injection site.  I also experienced slightly blurry vision, hearing distortion, & decreased hearing -- all of which I attributed to the severe headache and assumed they would resolve when the headache resolved.  I treated with a dose of ibuprofen and later a dose of acetaminophen (I try to avoid NSAIDs and acetaminophen due to a history of ulcers in my past and current NAFLD).    My side effects lasted until 11 am Friday 4/30/21, however my hearing has not returned to normal.   My hearing in my left ear is muffled.  There is a fullness in my ear.  Although I can hear, the sound is VERY distorted -- it resembles a bad cell phone connection that sounds like it's going through a tin can and has a reverb quality to it.  I went to an ENT for evaluation on 5/5/21.  Physiologically my ear appears normal.  He started me on a 15 day taper of high dose prednisone.  I'm currently on day 12 without any improvement.  I had a thorough evaluation by an audiologist on 5/12/21 and there is hearing loss in the low range in my left ear.  At this point, I'm not hopeful that my hearing will return to normal.
2 hours after vaccine given patient developed severe redness, swelling and pain over injection site spreading to the chest and down the ipsilateral arm to the wrist; patient required antihistamines with gradual improvement
Left posterior deltoid pain when arms are at 90 degrees and forward. No erythema. Questionable induration 1cm central deltoid.
Days after vacine, I began to feel extremely tired and.out of breath. After second shot, went down hill fast. Immune system was destroying red blood cells. Haemoglobin 5.6 when admitted to hospital. 8units RBC. Now seeing hematologist. Rutuxan and heavy steroids. Blood tests weekly and Dr. Now just about low normal. Found out today. MR is seeing 3 or 4 other patients with same time lines of vaccination and illness. I was diagnosed with hemolitic Anemia .  Now I have.to work my way back to health. I had Moderns vaccine. Any more information for me?
Swelling, redness and itching on injection site. Muscle and joint pain on left arm
Shortness of breath (still to this day)  Headache Body pain Blister in left side of stomach that resulted in wound. Wound on left lower back with skin coming off from light scratch Severe redness on injection site (left arm) that was hot to touch and lasted for 2 weeks post vaccination.
Pt was given Covid monovalent instead of the Covid Bivalent vaccine.  Pt was monitored for 15 minutes after injection and no reaction noted.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 (Lot number: FF2589) at the age of 66 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Onset date: Unknown, Stop date: Ongoing, Pertinent details: N/A; "Hypercholesterolemia" (ongoing), notes: Onset date: Unknown, Stop date: Ongoing, Pertinent details: N/A; "AV block", start date: Apr2021 (ongoing), notes: Onset date: Apr2021, Stop date: Ongoing, Pertinent details: Pacemaker Insertion (Permanent); "Transient Global Amnesia", start date: 2019, stop date: 2019, notes: Onset date: 2019, Stop date: 2019, Pertinent details: N/A; "CV Prophylaxis" (ongoing); "Back pain/Radiculitis" (ongoing); "Back pain/Radiculitis" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB taken for back pain, radiculopathy (ongoing); LOSARTAN taken for hypertension (ongoing); ATORVASTATIN taken for hypercholesterolaemia (ongoing); BABY ASPIRIN taken for prophylaxis (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 26Feb2021, Route of administration: Intramuscular, Batch/Lot Number: EN6202), administration date: 26Feb2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Date: 19Mar2021, Route of administration: Intramuscular, Batch/Lot Number: EN6204), administration date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Chills". The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "not recovered", described as "erectile dysfunction"; SLEEP APNOEA SYNDROME (non-serious), outcome "not recovered", described as "sleep apnea"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "leg cramps"; LUMBAR RADICULOPATHY (non-serious), outcome "not recovered", described as "lumbar radiculitis"; INSOMNIA (non-serious), outcome "not recovered", described as "insomnia". Therapeutic measures were taken as a result of erectile dysfunction, muscle spasms. Clinical course: There was no relevant test and Specific relevant test done. The patient did not receive any other vaccines within four weeks prior to the vaccination. Pharmacy or drug store was the Vaccination Facility Type. Gabapentin and Tadalafil used as treatment drug for Leg cramps and Erectile dysfunction. Follow-up attempts are completed. No further information is expected.
About 3 hours after vaccine she developed chills, could not get warm and started shaking violently. This lasted lasted 12 hours.   She developed diarhea after this and still has it today but it is getting some better.   She contacted her oncologist for medical advice. She had the Covid Virus after getting the 2nd covid vaccine dose that lasted 7 weeks.
patient reports tingling in her left pinky finger that moved to her hand and then her ring finger that started at 11 am on 5/25/21
Cold sore breakout even while taking valacyclovir.  Increased valacyclovir dose to 2 grams every 12 hours for 1 day and started gabapentin 300 MG.
Resident very lethargic, unable to speak in full sentences. Face flush, Vitals stable beside heart rate. Very irregular heart rate.
Dizziness / vertigo, new onset PVCs.  In retrospect, may have been happening for several days and attributed to medication side-effects.   Initially identified when a severe enough episode warranted taking vitals for communication with PCP.  Noted skipped beats, confirmed with spouse and then utilized smart watch to obtain a Lead I ECG which showed frequent PVCs.  Immediately engaged EMS, spent night at Hospital under observation.    Tx included aspirin, potassium, meclizine and IV NS.
received kinrix instead of boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Aug-2022 Reporter's comment: A nurse reported that a patient received kinrix instead of boostrix inadvertently. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received kinrix instead of boostrix, which led to wrong vaccine administered.
Two months after second COVID-19 vaccine developed-fatigue, cough, headache, abdominal pain, and loss of smell and taste. Patient in isolation now til 4/22/2021.
Information has been received from a physician concerning a 68 yr old (also reported as 86 yr old) female with no known allergies with sickle cell disease, asthma and arthritis who on 14Dec05 was vaccinated with pneumococcal 23v polysaccharide vaccine, .5ml. There was no concomitant medication. On 16Dec05 the pt experienced urticaria and rash. Unspecified medical attention was sought. The pt's urticaria and rash persisted. Additional information has been requested.
Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) 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) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Client stated that she felt "pain, discomfort in rectum 1 minute after vaccination."  Client observed for 20 minutes, reported a decrease in discomfort.  Declined further observation.  Driven home by spouse.
throat, mouth and face numbness/tingling; throat, mouth and face numbness/tingling; throat, mouth and face numbness/tingling; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6198, Expiration date: unknown), via unspecified route of administration, in the right arm, on 23Feb2021 at 11:00 (at the age of 26-years-old), as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included spironolactone taken for unspecified indication start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. Patient was not tested for COVID post vaccination. On 23Feb2021 at 12:00, 1 hour after vaccination patient experienced the throat, mouth and face numbness/tingling, similar to an allergic reaction to food. AEs resulted in doctor or other healthcare professional office/clinic visit. Patient received the treatment for events: Benadryl. Outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Swollen lymph nodes on left side of neck (same side as vaccine), headaches and fatigue, fever
This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored VAQTA (Lot# K012457; expiration date: 04-JUN-2017) (dose and route not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same source. Additional information has been requested.
Pt received injection in left arm. Pt had no initial pain. Approximately 5 minutes after injection became flushed, started seeing spots, felt like he may black out, felt numbness and tingling in the left arm that radiated up into the left side of the face and jaw.