chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-SEP-2022 Reporters comment: The medical assistant stated that Bexsero was exposed to 29.8 F and was administered to a patient. The reporter consent to follow-up via mail. Additional Supportive information: The patient received Bexsero was exposed to 29.8 F which led to incorrect storage of drug. This was one of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022132076:Same reporter. US-GSK-US2022132077:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132075:Same reporter.
Feeling faint; dizzy; shaky; racing heart began 10 minutes after 1st shot.; Sense of dizziness and vertigo has persisted now; ringing in ears; tingling sensation in back of neck, legs and feet; This is a spontaneous report from a contactable consumer (reported for herself). This 49-year-old not pregnant female received first dose of BNT162B2 (Solution for injection, Lot number was not reported) via an unspecified route of administration in left arm on 03May2021 08:00 AM, as first dose, single for COVID-19 immunization. Medical history included migraine headaches. The patient had known allergies: Doxycycline, latex, sensitivity to Relpax, Minocyclin, aspartame and stevia. Did not receive any concomitant medications within two weeks of suspect. On 03May2021 08:15 AM, the patient experienced feeling faint, dizzy, shaky, racing heart began 10 minutes after first shot, sense of dizziness and vertigo had persisted for 2 1/2 weeks later episodes of racing heart and feeling faint, ringing in ears, tingling sensation in back of neck, legs and feet. She did not receive any treatment for events. She did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. She was tested post vaccination: Saliva pool test on 07May2021 and on 14May2021 was Negative. The outcome of the events of Feeling faint, dizzy, shaky, racing heart began 10 minutes after 1st shot, Sense of dizziness and vertigo has persisted now, ringing in ears, and tingling sensation in back of neck, legs and feet was not recovered.  Information about lot/batch number had been requested.
Exposure at work. Onset of symptoms the day of his testing, 12/9/21.  Current symptoms include myalgias, fevers, cough, without dyspnea.
Pt experienced aching in both arms, left more than right. The pt states entire arm aches, numbing and tingling, in fingers. Throbbing in fingers. Arms feel like they want to collapse under load. Can't lift weights for exercise. Pt is losing sleep and can't sleep on sides.
patient had swollen arm, itchy rash and are was warm to the touch, area went outside of injection site, circling around her arm
Information has been received from a physician concerning an 8 year old female patient who 27-FEB-2001 was vaccinated with first dose of MMR II (dose, route and lot number not reported).  On 10-FEB-2004, the patient received the second dose of MMR II (dose, route and lot number not reported).  The physician reported that the patient developed mumps on 13-JAN-2010.  The patient was diagnosed with mumps on 14-JAN-2010.  Laboratory test performed on 14-JAN-2010 included IgM (0.29), IgG (5.37) and amylase (147).  The patient had right parotitis.  The patient was exposed to other with mumps (date unspecified).  The final outcome for mumps was not reported.  This is one of several reports from the same source.  No further information is available.
Breakthrough case admission after 2 vaccines Pfizer 4/21/21 lot# EW0162;  Pfizer 5/19/21 lot# EN6200
ADULT OBSTRUCTIVE SLEEP APNEA, MILD ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/17/2022,  10/31/2022,  12/28/2022,  12/9/2022, 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fluarix Quadrivalent Intramuscular Suspension Prefilled Syringe 0.5 ML (Influenza Virus Vaccine Split Quadrivalent)5mL was ADMINISTERED by ERROR to the above named patient who is 89 years old.   Fluzone High-Dose Quadrivalent Suspension Prefilled Syringe 0.7 ML (Influenza Vac High-Dose Quad) was ordered for residents 65 and over and was NOT given.  The resident was monitorerd by licensed clinicians with no adverse reaction observed to this date.
Patient received Moderna Bivalent Booster today at 1120 right deltoid in the Vaccine clinic. At 1150 patient notified medical assistant that she was experiencing chest tightness and notified me. Patient stated she felt chest tightness in the middle of the chest that was constant. She denied any chest pain or tingling/numbness of the left arm. Patient stated she was experiencing "arthritis-like pain" in right arm right after vaccine. Described it as sharp pain when moving joints in hands and rated it 4/10. Patient denied shortness of breath. No significant past medical history. Allergic to ibuprofen. Vital signs taken at 1150: BP: 109/69 LA, P: 72, O2: 98% on RA, RR: 24, regular and unlabored. A&Ox4. Patient stated she has chest tightness for her last booster, but went away within 15 minutes.    Patient declined going to Emergency Department. Transferred care to urgent care and handed off to urgent care RN at 1210.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 Sep 2014, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty ban-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX injections and they had seen a higher number of injection site reactions. This is one of 7 cases reported by the same reported for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
The first sign was numbness in my chin  and cheeks which would come and go. The next sign was muscle pain followed by severe joint pain followed by nausea,and a loss of appetite.The next sign was chills and weakness.This went on for a day and a half and went away .During this time I took extra strength tylenol
pt recv vax 23JAN97 & 7 to 8 wk p/last dose a serum titer was performed & reported to be greater than or equal to 0.1 level;
She got the vaccine and started with a headache and dizziness.  Then all of her joints started to hurt her, started at the ankle, knees and then her wrists which stayed.  She still has her right leg from her knee down to her ankle that still has a tightness even 4 days after the vaccine, it does not feel right.  She also had chills, felt like she had the flu.  She went to bed Easter Sunday and not able to go anywhere and felt horrible.  All the other symptoms have gone, just the calf area of her right leg doesn't feel right.   She also felt heaviness in her chest and labored breathing.
This literature marketed report as received from an other health professional refers to a 48 years old female patient who had no response to pneumococcal immunization. The patient with a medical history of Behcet syndrome unresponsive to multiple immunosuppressive medications presented for further evaluation of episodic pneumonia infections occurring 3 to 4 times per year, frequent sinusitis, and recurrent skin infections. Pathergy test results were negative. The patient was diagnosed as having Behcet syndrome when she was 38 years old. Her symptoms included arthralgias, diarrhea, headache, aphthous and genital ulcers, uveitis, focal neurologic deficits, frequent cutaneous squamous cell carcinomas, and episodes of sepsis. Various immunomodulatory therapies were attempted with only minimal symptom improvement, including colchicine, hydroxychloroquine, dapsone, prednisone, rituximab, methotrexate, cyclosporine, leflunomide, cyclophosphamide, infliximab, interferon alfa, penicillin, and acyclovir. Immune evaluation was initiated, and the patient was found to have low levels of IgG (315 mg/dL) and IgM (30 mg/dL) and no response to pneumococcal immunization. Common variable immunodeficiency (CVID) was diagnosed at this time. The patient was subsequently prescribed intravenous immunoglobulin (IVIG) infusions at optimal doses (1 g/kg) every 3 weeks. Since beginning IVIG, the patient reported a decreased number of sinopulmonary and skin infections and a marked decrease in the amount of oral aphthous and genital ulcers, symptoms of uveitis, and arthralgias, At 6-month-follow-ups, IgG trough levels were well within range (1, 502 mg/dL). In this patient, the proper dose of immunoglobulin controlled the previously unresponsive inflammatory processes of Behcet syndrome and preserved remission for a period of at least 2 years. The case at hand described the first patient diagnosed as having Behcet syndrome complicated by CVID in which immunosuppressive therapies for Behcet syndrome failed but was successfully treated with ideal doses of IVIG. Although this was the second case of CVID combined with Behcet syndrome, it was the only documented case with the successful use of a therapeutic dosage of IVIG. The authors concluded that patients who possessed the dual diagnosis of Behcet syndrome and CVID might pose a treatment dilemma in that they were immunocompromised, requiring thoughtful therapeutic strategies. An optimal dose of r-globulin might provide the necessary effect to decrease symptoms in these patients. Additional information has been requested.
After first shot, swollen lymph node in neck left side.  Sore arm, tingling sensation in arm and hands. After second shot, quite sick with fatigue, muscle soreness general sick feeling for about 4 days.  Later blood sugars out of control and finally in July I had a low blood sugar of 28.  Called paramedics and talked to doctor.  I had recently changed insulin but he said that shouldn't have effected my blood sugar levels.  Usually my blood sugar says fairly level after my shot doesn't plummet more than 100 points as it did that night I called the paramedics.  I have since started taking my shots in the morning so I can monitor more closely.
Noticeable itchy, red rash grew from upper arms to lower arms. Had to see doctor since it became uncontrollably itchy even with using skin cream.
Patient was seen in the ED. Received 5yr immunizations and presented 30 min later with anaphylaxis with hives, swelling of her lips, difficulty breathing. She was given her EPIPEN along with BENADRYL by parents. Clinically she looked okay on arrival and ED give dexamethasone and H2-blocker and observed for four hours.
admitted for MSSA empyema requiring thoracotomy and decortication of the left lung
This spontaneous report was received from a healthcare worker referring that on multiple unspecified dates, multiple unspecified patients were administered improperly stored doses of PROQUAD, (lot #s L023111 and L023112, expiry date 24-DEC-2016). No adverse effect reported. This is one of two reports from the same reporter source (MARRS linked 1510USA004177). Additional information has been requested.
Dry heavy cough; Fever; This is a spontaneous report from a non-contactable consumer (patient) from medical information team. A female patient of an 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 19Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced dry heavy cough and fever on Mar2021. The patient underwent lab tests and procedures which included body temperature: 99.9 Fahrenheit on Mar2021. The outcome of the event was unknown.  Follow-up (26Mar2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction right anterior lateral thigh 13cmx4cm; slightly swollen and non-tender to touch. Received DTaP #4 and HIB #4 in right thigh. HIB series is finished. Needs one more DTaP. MD will ? omit pertussis.
Patient's mother states that pt's right thigh is warm to the touch, hard and redness is present. Also a blue area the size of a softball surrounds injection site.
weak; tired; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), FATIGUE (tired) and NAUSEA (nauseous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ASTHENIA (weak), FATIGUE (tired) and NAUSEA (nauseous). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) on 16-Mar-2021 for Adverse reaction, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weak), FATIGUE (tired) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    Reporter did not allow further contact
Immediately after receiving 3rd injection patient slumped forward. He was assisted into reclining position. Eyes dilated. Unresponsive for a matter of seconds. Skin warm and dry. Color good. Vomited later in the day. Experienced diarrhea.
Received Lymevax after being treated for Lyme a year before- became very fl-like-strong pain-muscles and joints. Nothing relieved till pt had and IV treatment.Pt still being treated /tested
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 10:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.09 years old. Concomitant products were not provided. On 03-Mar-2021, Excursion time was 09 AM, 10 AM and 01PM, temperature was 51, 34 and 35, total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36 and 5 PM: unknown. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
the evening of 1st round of vaccination began with joint pain, which has continued.  initially had fever that has resolved at time of exam.  Pt with hx autoimmune arthritis but has not had any recent flairs, and describes this pain as worse.  no rash, swelling of mouth or face, difficulty breathing, or other anaphylactic symptoms.
the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to go to the ER because it was really bothering me. They only helped with the anxiety and did an eye exam. It seemed to have gone away some but now it's coming back and it's like having dirty contacts in and having hypersensitivity to light and dark textures.
Patient states that he has a z shaped bumpy rash on his chest, he also has a small line of rash on his bicep as well as his left shoulder blade. He states that nerve pain is accompanying these rashes.
Right deltoid area started to ache and kept from sleeping, small bruise noted. No redness noted but felt small, hard lumps under the skin. This went on for a couple of weeks before she went to the doctor. The doctor gave her some Voltaran gel which made it feel better temporarily. Continues to have aching and lumps in her arm.
12/27/05 child woke up with 15-20 lesions on trunk, legs, arms & face.  Mom called description classic chicken pox.  Child has no fever.  Advised Benadryl & Calamine lotion.
patient woke up two days later on sunday with a rash on the inside of her arms at the elbow and on her chest underneath the breasts
This spontaneous report was received from a physician concerning multiple patients who were vaccinated with doses of ZOSTAVAX (lot# not reported) in October 2012. This physician reported that multiple patients, age and genders unknown received the ZOSTAVAX injection, unknown dose and frequency for vaccinations on unknown dates in the month of October 2012. All the patients' relevant medical history, concomitant medications, and past drug history were unknown. On 20-OCT-2012 the office staff realized all the ZOSTAVAX vaccines had expiration date of 05-OCT-2012 and they had been giving them to patients all month. It was unknown if there was any relevant laboratory data. As of 20-OCT-2012 it was unknown if any of the patients would get the ZOSTAVAX again, and the outcome of multiple patients receiving expired ZOSTAVAX vaccines were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was unknown. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous. No co-suspected or concomitant medications were reported. The pharmacist reported that while administering the ZOSTAVAX, some of the ZOSTAVAX came out of the sides of the syringe and the patient did not receive a full dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Patient had redness and swelling in left arm.  Reaction was just above the elbow line, below the deltoid muscle.  Reported to pharmacy on 5/11/17.  I identified that it was below where the injection site would have been.
Child noted to have a hive at injection site of DTaP and IPB 4 days after vaccine administered. Hive resolved in 3-4 hours without treatment, although pt takes Zyrtec daily for allergies.
By 3:30pm I had a fever and experienced arm soreness to my right arm. By 11:30pm I could not move my arm and also could not pick my son up who  weighs 30 pounds. On the following day I continued with severe  body aches  and joint pain. I went to see a doctor about 10:00am who examined me and advised my to take Tylenol and Ibuprofen  for pain.  They did a Covid-19 swab which as negative.  My symptoms are improving and I can say that it took about 24 to 48 hours to recover from my right arm.
Headache, Myalgia & Diarrhea Narrative:  Other Relevant History:
Anxiety - panic attack soon after first GARDASIL according to mom - but mom did not report - till 9.7.07- when she was seen in office said that - she has been having for past 1 yr - 11.17.07 - syncope 11.18.07 numbness LT forearm and hand. Hospitalized - Dx migraine. Rx TOPAMAX. 11/07 - possible seizures. 12/07 - Neuro consult. EEG normal. Rx KEPPRA - now under control but continues to have confusion.
This spontaneous report as received from a pharmacist refers to an 18 year old female patient. On 03-JUL-2013 the patient was vaccinated by a nurse with expired GARDASIL (lot # 667930/1561Z, expiry date 23-MAR-2013) (strength and total daily dose not reported). No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
On May 9, 2021 - 3  months after 2nd Covid-19  ( which I got Feb. 12, 2021) I began having pain and some stiffness in my body. Pain and Stiffness progressed  all of May and June 2021.  I could hardly get out of bed  or get up of couch or lift arms etc. due to bad aches !!! On June 29,2021 along with the pain/stiffness I got dizzy and was vomiting as a result. I called a Dr.  and got antinausea medicine.  Then on July 8, 2021 I went to Rheumatologist Dr. The blood work and his sonogram machine showed I had high level of inflammation in my body.  He started me on 15mg of Prednisone.  In 3 days the pain went away. However as he is reducing the dosage.....I am having eyesight changes, temporal pressure on left and right sides of my head,  and the beginnings of returning pain  again in the body areas affected by PMR.   I was perfectly healthy before I got the Covid-19 shots.
Pt started vomiting the day of immunizations and vomited all afternoon and til 9 PM that night.
Pt states 3 days after receiving the flu injection, she became congested, with a headache and muscle tightness in her neck.
I got a rash around my eyes for a month in a half. I had to go to the ER because it spread all over my body and I severe muscle pains to where I could barely move. They diagnosed me with Dermatomyositis and the prescribed me medications.
At 2am 4/30/2021 woke up with Nausea- fatigue-felt the chills.