chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of power in the pharmacy and several products compromised; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not received Shingrix. On 17-SEP-2023, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: loss of power in the pharmacy and several products compromised).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 It was reported that there was loss of power in the pharmacy and that several products may had been compromised which led to intercepted product storage error. He was being transferred to GSK Customer Response Center for questions about shelf stability.
Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
in the same  arm of the injection, swelling in that area; it is hurting in armpit area in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031h21a, 027c21a and 042b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection) outcome was unknown.            Concomitant product use was not provided by the reporter.
I went home and took a nap, when I woke from my nap my right side (injection side)  was numb. My face around my nose was numb down to my waist line. It was like half of my body was asleep, like when your arm or foot goes to sleep, that was the feeling on my right side. Everything was normal on the left side.  Woke up the next morning and my migraine started, I kept a migraine for the next 4 days.  3 Days later I started getting feeling back everywhere except my shoulder blade and arm. Once I regained most the feeling I had cramps where I would normally have menstral cramps.  Thursday 5/13 I started spotting. It was more of a flow and stopped by Sunday afternoon.  as of Tuesday 5/18 my right arm has a little feeling but it comes and goes mainly my upper arm and shoulder are numb still.
GARDASIL administered Friday afternoon. Passed out with seizure Saturday afternoon. Hospitalized with appendix attack, numbness of all limbs, rash all over, fever, dizziness. Appendix removed following Monday, released Tuesday. Still having trouble walking, numbness still in feet, aches all over, very fatigued.
Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am.  AT 3 am awoke with chills and 102.5 fever, nausea and followed by sweats.  This has continued thru 3/23/21, so far.  On 3/23/21 fever maintained between 100 & 100.8.  Still felt badly.  Awoke this am 3/24/21,  sweaty but no fever thus far.  Feeling better.
03/26/21   blood-tinged sputum expectorated around 5pm. Once event so far.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Approximately 5 minutes after administration, patient fainted while seated in chair.  After awakening, patient reported feeling faint and tingling in her extremities.  Patient was breathing heavily.  After breathing normalized, patient reported severe menstral cramps.  Patient was given Midol, water, and pretzles.  Shortly after, patient stated that she was still light headed so she laid on the ground.  Patient eventually recovered and left pharamcy.
Course consistent with varicella zoster 1/4/06 after Varivax 5/11/05 and no previous hx of varicella like illness.
Site of injection site still sore from several wks ago, now other problems on same side of body - Staph ear infection, eye, 2 stys on eye not healing, pain radiating arm down leg on left side, now swollen on calf (arm is worse now over time) Discussed w/Dr. Suggest flu vaccination possibility, not sure if related.
Right when I got the vaccine i had a chilling effect to my body my arm was sore, headaches, body aches, chills, then Wednesday was worse headache chills body aches and queasy stomach started yesterday then last night the cramping was so bad on the right side that I could hardly get my breath, then this morning I lost control of my bowels with cramping and having a hard time being active. I still have a headache.
Clinical Summary Patient is a 80 y.o. female with a history of Alzheimer's disease, hypertension and glaucoma who presented to hospital 4/13/2023 with fever and altered mental status. Patient found to have COVID 19, labs with BMP, CBC, BMP, HFP, lipase unrevealing. LA 1.1, UA without infection. Admit VBG with pH 7.4, pCO2 and pO2 stable. CXR non-acute.  CT head with no acute intracranial findings, noted acute pansinusitis.    1. COVID 19 Infection: Presented as above. Vaccinated and boosted, denies prior COVID infections. Symptom onset 4/12/23. Admit CXR non-acute. Not requiring O2 on admit, therefore defer decadron or remdesivir. Consult to ID and started and completed course of paxlovid. Symptoms improved.  2. Sepsis: Met criteria with Temp 100.8, tachycardia on presentation. Secondary to COVID as above. CXR and UA without infection. CT head with pansinusitis. Procal negative. On Vanc/Zosyn in ED, held on further antibiotics on admit as suspect viral etiology or sepsis criteria with COVID. Given 1.5 L bolus in ED. Now dry lung strategy with COVID. Treat as discussed and monitor.   3. Acute Metabolic Encephalopathy on Chronic Dementia: Family describes 3-4 month cognitive and functional decline with history of Alzheimers dementia. Per family, prior baseline was alert and oriented with short term memory deficits. Recent baseline waxes and wanes, minimal short term memory. Family feels patient is at recent baseline on admit. Oriented to self, general location, month, year and family on admit. Continued home Remeron. Delirium precautions.  4. Oral thrush: Noted 4/15/23. Nystatin swish and spit continued. 5. Elevated Troponin: Admit Trop 19, second trop 17. Admit EKG with sinus tachycardia, no acute ischemic changes. No chest pain on admit. Suspect demand ischemia with above. No other ischemic eval planned.  6. Acute sinusitis: Diagnosed on admission. Completed Augmentin course 4/18/23. 7. Fall: Secondary to weakness at home. Unable to get off toilet and assisted to ground by family. Denied injuries or hitting head. PT/OT consulted, family interested in SNF on discharge.  8. Hypertension: Per history, continued home Cozaar with hold parameters. Monitor and titrate PRN.  9. Glaucoma: Per history, continued home eye drops.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
one week after 1st round, 1/4/21, area where vaccinated was swollen, itchy, red and emanating heat
itching first swollen lymph nodes back of neck then rash to torso joint pain ankles and wrists Clinic visit to primary care: Benadryl Rx given by primary care physician
Vaccination site erythema; injection site inflammation; arm swelling; Wiped out feeling; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sore mouth, facial pain and oral surgery. Previously administered products included Acyclovir. Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced erythema of extremities, inflammation localized, swelling arm and worn out. On an unknown date, the outcome of the erythema of extremities, inflammation localized, swelling arm and worn out were unknown.   It was unknown if the reporter considered the erythema of extremities, inflammation localized, swelling arm and worn out to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient has a long history of viral sore outbreaks inside of mouth and facial pain following use of sonic dental cleaning and was treated successfully with Acyclovir, so refused sonic use for dental cleaning for many years. In February of this year the patient decided to have oral surgery to remove her last wisdom tooth, totally embedded in right lower jaw, so was prescribed Acyclovir to ward off viral outbreak, but it was not enough or enough for that or the later discovered filling of a deep cavity in the tooth next to the removed tooth. The patient was on a maintenance 500 mg dose per day of Valacyclovir and feel, but could not see, mild viral like symptoms at the corners of her mouth. The patients husband and the patient finally got Shingrix shots. The patient only definite after affect was a sore, now fading red inflammation down the front of her arm and a completely wiped out feeling for which she often rests.
Vaccination site became infected. Arm hurt and there was a mass that was warm to the touch. Doctor prescribed antibiotics.
Cellulitis of left upper extremity ; Post vaccination reaction . Patient got admitted in Hospital for 4 days and required IV antibiotics.
patient today inadvertently received an expired dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-JAN-2023 Reporter's Comments: The pharmacist reported that a patient today (on the day of reporting) inadvertently received an expired dose of Twinrix. No additional information was known.  The reporter did not consent to follow-up.   Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Sharp pain in chest especially when inhaling; clicking at left of sternum with heart beat; unable to get deep breath. Given IV anti-inflammatory.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On an unknown date (reported as "several days ago") the patient received ZOSTAVAX (strength, dose, frequency, Lot # and route unknown). Concomitant therapy was not provided. The patient was now beginning prednisone therapy (20mg daily for 5 days) for an unspecified reason. The outcome of adverse event was unknown. Additional information has been requested.
Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half dollar size red area which is hot to the touch with hardness or a knot at injection site. tHIS IS STILL PRESENT.
Got Vax and got shingles, does not work/suspected vaccination failure; Got shingles, really bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Vax and got shingles, does not work/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles, really bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's relative via interactive digital media. The patient got the shingles vaccine and got shingles. The reporter stated that it was really bad and the shingles vaccine did not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067014:Same reporter US-GSK-US2023AMR067015:Same reporter
Immediately following vaccine administration, Patient became lightheaded, faint feeling, nauseated and dizzy.  Patient shared that he hadn't eaten much.  Patient was assisted to exam table to lay down initially, then provided saltine crackers, water, and apple juice once able to sit up safely.  After 25 minutes of rest, Patient felt  he able to sit up, then stand up and felt ok to report to work.  Patient denied the need to be evaluated in the ED.  Patient continued to "not feel well" the following day.
Information has been received from a physician concerning his mother-in-law who in approximately 2006 was vaccinated with Zostavax.  In approximately 2006, post vaccination, the patient developed a rash at the injection site, an elevated fever and body aches and pains.  The patient did not seek treatment at the time.  Subsequently, the patient recovered from the events.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician concerning his mother-in-law with no pertinent medical history who in approximately 2006 was vaccinated with ZOSTAVAX vaccine (Merck). There was no concomitant therapy. On an unspecified date in 2006, post vaccination, the patient developed a rash at the injection site an elevated fever and body aches and pains. It was reported that "the arm" was red and swollen at the site of the injection for one week. Subsequently, the patient recovered, on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
admitted to University of South Alabama Medical Center on 4/20/21 with bilateral Pulmonary embolus
Breakthrough case admission after 3 vaccines Moderna 3/1/21 lot# 010A21A; Moderna 4/2/21 lot# 018B21A;  Moderna 12/20/21 lot# 066H21A
I had fever; Felt yucky for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and only had a sore arm, refer case US2022AMR081003).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feeling abnormal. On an unknown date, the outcome of the fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR081003   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient waited months to get second shingles shot. The patient got the 2 shingles vaccine and had fever and felt yucky for a couple of days.  The reporter stated that, it was worth feeling yucky to know he/she would not have to go through the horrible things as these other people had and were going through, he/she thought and prayed for all of them. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081003:Same reporter
1/10/2015 Weakness and vomiting, 1/11/2015 CT scan of her abdomen showed ascites and fluid around the pancreas. 1/11/2015 Lipase 1528 and Amylase 162. She was NPO and on IV fluids until Lipase decreased to 49 then she was on clears for 1 day (1/18) then breast milk and solids low fat on 1/14/15 and did fine to 1/15/15.
getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.   The treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and updated Patient Demographics. added lot number of vaccine.
Woke in the middle of the night to soft, itchy, quarter-sized lump under the skin around injection site ten days after vaccination.  Persistent when scratched.  No obvious inflammation observant to the eye but can be observed by touch.
Patient c/o redness and swelling at injection site greater than 6 inches in circumference.  Reported feeling feverish and measured fever on 1/6/21 at 101.6 F and 100.6 on 1/8/21. States she went to the emergency room where she was diagnosed with cellulitis and prescribed an antibiotic for which can cannot remember the name of.
Silver dollar sized erythematous/indurated area left lower and central  surface at site of injection.
My right arm started to get sore at injection site several hours after shot. It became more sore as night approached, even though I kept up arm movement, it was difficult to raise right arm completely or pick up a milk jug. I rubbed a small bit of arnica cream on before bed. The next morning my arm was less sore, but my nose was running/drippy, had a bit of sneezing/coughing. I felt a little tired throughout the day.  My ears, particularly my right ear, started ringing some throughout the day, which is not normal for me. But it would last a minute or so than go away.  By the next day, arm is only a little tender to touch, can move it around normally, I don't feel tired, my ears are not ringing, and sneezing/coughing gone, still a bit of runny nose. Will not deter me from getting 2nd shot, and was not difficult to deal with side effects, pretty much expected them.
2 raised large red spots. Extreme soreness. Hot to the touch. Extreme lethargy. Dizziness. Nausea.
Patient received larger dose of Moderna vaccine than needed (full dose). She had already received full dose of Moderna three times in the primary series and needed booster dosing.
reported to school that pt devel hives (severs) on evening of vax;MD recommended discontinuation of series;
Headache, brain fog, lightheaded, lost of sensitivity on right leg and fatigue.
Large erythematous patch from site of vaccine extending to lateral chest wall/axilla, treated with abx for cellulitis.
Breakthrough case admission after 3 vaccines Pfizer 4/16/21 lot# Ew0169;  Pfizer 5/7/21 lot# Ew0172;  Pfizer 11/18/21 lot# FH8028
12/15/2020 615 received vaccine 2pm belly pains, relief 'not like normal bowel movement', 'urge to go'  5 belly pain, relief self'not like normal bowel movement', 'urge to go'   8-10 pm body chills, covered with 3+ blankets 10 pm body chills subsided 12/16/2020 fatigue; not exercise; 5miles per day (only able to walk 2 miles)  Flu vaccine;  'pretty sure it was 09/2020'; Unknown brand