chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really bad sore arm; Dizziness; shaking uncontrollably with the chills; fever with a 103 degree temperature; horrible muscle pain and joint pain; golf ball-size lump on collarbone and neck; soft and very tender; nausea; sweats; body aches; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Really bad sore arm), DIZZINESS (Dizziness), CHILLS (shaking uncontrollably with the chills), PYREXIA (fever with a 103 degree temperature) and MYALGIA (horrible muscle pain and joint pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Really bad sore arm), DIZZINESS (Dizziness), CHILLS (shaking uncontrollably with the chills), PYREXIA (fever with a 103 degree temperature), MYALGIA (horrible muscle pain and joint pain), LYMPHADENOPATHY (golf ball-size lump on collarbone and neck), TENDERNESS (soft and very tender), NAUSEA (nausea), HYPERHIDROSIS (sweats), PAIN (body aches) and FATIGUE (fatigue). The patient was treated with METHYLPREDNISOLONE at a dose of 4 milligram and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 800 milligram. At the time of the report, PAIN IN EXTREMITY (Really bad sore arm), DIZZINESS (Dizziness), CHILLS (shaking uncontrollably with the chills), PYREXIA (fever with a 103 degree temperature), MYALGIA (horrible muscle pain and joint pain), LYMPHADENOPATHY (golf ball-size lump on collarbone and neck), TENDERNESS (soft and very tender), NAUSEA (nausea), HYPERHIDROSIS (sweats), PAIN (body aches) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) 103 degree.         no concomitant medication given
Received Flu vaccine on 1/24/14. Symptoms started to appear round 2/9/14. Started as weak and heavy legs, intense burning. Progressed to constipation and legs getting weaker through March 2014. Saw Dr. during this time and he diagnosed as Neuropathy-started me on Gabapentin. Legs continued getting weaker. Referred to Dr. 5/9/14-still diagnosed with Neuropathy. Continued getting worse. Dr. did MRI's, blood work and a "lumbar puncture". Showed possible MS, Tumor, or TM. Outpatient I.V. steroids for 3 days and oral prednisone for 2 weeks. Started P.T. 10/07/14. Incontinence and falls started to occur. Referred to different neurologists and after having another fall, I went to E.R. Spent 6 days with staff neurologists. Another MRI, blood work and lumbar puncture. Received I.V. steroids again for 5 days. Neurology team said, "TM due to Flu Shot". They advised looking into the Vaccine Compensation Fund.
I knew on Sunday that I had it. I had a very runny nose and lots of sneezing on Thursday and Friday. On June 11th I just felt off but Sunday. I was not able to get out of bed, I was coughing a lot. My nose was like a faucet. I found out I was exposed on Wednesday. I tested Thursday, Friday, Saturday and Sunday. I tested positive on Sunday. I also did a PCR test at a lab and it was positive on June 16. I was prescribed PAXLOVID and drank a lot of water. I started it Sunday night. On Tuesday I was still feeling very weak but better and by Wednesday I was feeling much better. I would say that I only started to feel completely better by this past weekend in. My voice is still raspy and deeper than it was before but I feel better.
Feeling sad; This is a spontaneous report from a contactable nurse (Patient). An unspecified age of female patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: not reported, Expiry Date: not reported) via an unspecified route of administration, administered on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced, consumer calling states she has taken the first dose of the Pfizer COVID 19 vaccine three weeks ago and will get the second dose tomorrow. She has not called into to report before but after the first dose she has had a sad feeling. She is asking has this been commonly reported, when ask if she would be willing to complete the report today she states in the fact sheet it said to report to CDC first and she does not want to report to Pfizer and declined to report. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient reports when he woke the morning after vaccination, he had severe pain in his upper back as well as a large, central blind spot in his vision. Symptoms like this have never occurred in the past and patient has tolerated all vaccines previously with no similar reactions. He notes the back pain lasted for a few weeks and was evaluated with an x-ray that showed inflammation.  He was given meloxicam which he took for 3 doses and pain resolved. The large central blind spot in his eyes lasted for a few days and resolved on its own slowly with the spot becoming smaller over time. Patient describes the appearance as reddish-orange appearing, as though he was staring at the sun for too long. He did not take any medications for these symptoms. He did not have any immediate evaluation done around time of vision problems. He has no other known eye issues and has a formal eye exam  regularly. No accompanying symptoms such as fever, itching, rash, lip or tongue swelling, chest pain, shortness of breath, abdominal pain, vomiting or diarrhea, muscle weakness, headache. He was otherwise in his usual state of health when he received the vaccine and did not have any illnesses preceding vaccination. No use of new medications.
About 5:30 p.m. 6/11/2018 -- about 5:00 pm 6/12/2018: flu-like aching all over body, especially shoulders, back, knees and legs; intermittent chills and cold sweats; treatment: TYLENOL ER (650mg) at 6:00 pm, 3:00 am and then 2pm the next afternoon. By 5:00 pm on 6/12 the symptoms lessened dramatically and were completely gone by 7:00pm that day. Local of vaccination, upper left arm, from moments after the injection; sore, increasingly red, increasingly warm, pain with touch and movement, especially lifting arm. These symptoms are still present today, 6.13, although lessening.
I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. 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. This case was 10 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
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 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:07 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.   Age of patient was reported as 70.23 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
On 9/25/09 the pt received FLUMIST (never had before--previously received influenza injection), HepA (2nd or third dose) and typhoid (possibly #4) at 0730. Approximately 45 minutes later the pt noted generalized itching and about 15 minutes later she noted hives on her arms and face. Within 10 minutes the pt complained of difficulty swallowing and breathing, increased hives and "lip swelling". The pt was taken to the medical dept where she was treated with epinephrine, oxygen and IV fluids. The pt states that she was unresponsive (?almost fainted) for a short period of time. At 1300 the pt was d/c home with some minor skin redness remaining. The pt denied and further episodes of hives, angioedema, difficulty breathing or swallowing. Pt had no new foods or medications prior to the immunizations. No history of prior adverse reactions to vaccinations; Pt has seasonal allergies which she treated with BENADRYL or ZYRTEC prn. Pt denies prior formal allergy testing. No food/latex allergies.
Received high dose flu vaccine from pharmacy and 2 hrs later felt throat closing and SOB, went to Urgent Care.
Began with dry cough. Progressed next morning to weakness, nausea, wretching, loss of appetite, myalgias, headache, chills, diaphoresis X 1. Lost 4 pounds in 4 days. Cancelled all activities for 4 days. This is day #6;  feeling almost normal except some lingering weakness.
This spontaneous report was received from a medical assistant, and refers to a 52 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2018, the patient was vaccinated with improperly stored ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccine was reconstituted with sterile diluent (MERCK). It was unknown if sterile diluent (MERCK) was properly stored. Digital data logger was involved. No adverse effects were reported. This is one of three cases received from the same source. Sender's Comments: US-009507513-1807USA010666: US-009507513-1803USA002223.
No adverse event. Vaccine given after expiration date, no expiration date on vial or box.
Patient presented with worsening SOB x 14 days. Patient also has productive cough, body aches, generalized, weakness fatigue and multiple episodes of non-bloody diarrhea.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to follow up from GlaxoSmithKline.
Visited PCP on 3/8/21 with reports of nausea, fatigue, and anorexia following COVID-19 vaccine. Reports body aches, nausea without vomiting, abdominal pain, diarrhea, runny/stuffy nose. Presented to ED on 3/9/21 and reported shortness of breath started 2/28/21. Had COVID positive contact on 2/24. Required supplemental oxygen on presentation. Admitted to ICU on 3/14/21 until present.
After vaccine,  had sore arm and joint/muscle pain, tiredness for 24 hours. I have had very mild to mild tinnitus most of my life. Noticed 2x increase in tinnitus loudness on April 5. Tinnitus is louder in right ear, and there seems to be 20% hearing loss in right ear.
allergic reaction; Inappropriate Reconstitution Technique; inappropriate dose of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA08A, expiry date 31st March 2021) for prophylaxis.   In June 2019, the patient received Menveo. In June 2019, less than a week after receiving Menveo, the patient experienced allergic reaction, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the allergic reaction, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient experienced allergic reaction. No details regarding patient or further details regarding allergic reaction were available. The reporter stated that, the medical assistant was unsure when patient was vaccinated. The reporter consented to follow up.
Dizzyness and light headheaded.  BP: 204/99 - 250/100; HR: 77 - 86
chills; headache; muscle aches on arm; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 Immunization, reaction(s): "muscle aches in arm". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches on arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received vaccine on 1/6. Woke up on 1/7 at 1 AM with severe headache and chills. Took ibuprofen, which helped. The chills lasted for a couple hours. Still has slight headache and fatigue on 1/8.
Fever as high as 103.5, massive pain in that right arm, and aches in my head, neck, and lower back, chills, and sweats, dry cough.
Day after: tired, run down feeling. Body aches. Lasted full day. Couldn't do normal activities. Next day a little tired but much better. Took ibuprofen. Arm is still red after 3 days. Experiencing some itching by 3rd day. No rash.
19MAY devel rash on arm lt @ inject site; 21MAY about 1155 pt devel difficulty w/breathing was very frightened, sz to lt side; mom states pt in coma for short time; pt had no feeling in lt leg below knee; seemed to drag toes;
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 16-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002762: US-009507513-1905USA002769:
Moderna administered to patient 17 years of age. No adverse reaction. Patient did receive both doses. Family aware.
This spontaneous report as received from a registered nurse refers to her husband, a male patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (unknown date, dose and strength) in the back of the upper arm instead of in the deltoid region of the upper arm which is outside the labeled recommendations in the ZOSTAVAX prescribing information. No adverse effect was reported. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Shortly after receiving vaccine; whole right side of her face went numb. Pt took Benadryl after injection afraid it was an allergic reaction.  Pt seen by MD in office; noted with right facial dropping .
Post vax, the pt developed pain and swelling at the injection site for 6 days followed by malaise and disinterest.
itching; Red; Ugly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Erythema, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided Patient was treated symptoms with using Ice   This case was linked to MOD-2021-018461 (E2B Linked Report). This case was linked to MOD-2021-018437 (Patient Link).; Sender's Comments:  MOD-2021-018461:wife's case
Patient's mom says patient had shakes and not knowing where she was for 1 minutes.  Fingers and chest feel slightly tingling.  After 1 minute patient has anxiety attack and was crying .  After taking 5 deep breaths and drinking water and gatorade for 10 minutes she was ok.  Ambulance was called and take to hospital. Patient seem to be ok when in stretcher.
Pt was given 2nd dose 1 wk early. Pt came to vaccine clinic for his 2nd dose on 4/6/21, but following administration provider realized his first dose was given on 03/23/21 making him 1 wk early. pt states  he  was infected with covid over 3mo ago, he was made to sit and additional 20minutes . no adverse reaction noted during wait. f/u with pt 4/14/21 pt stated he had "no problems" occurrence report made.  advise to make vaers report by employers for awareness.
Case number PHEH2013US025575 is an initial spontaneous report received from a health care professional on 09 Dec 2013. This report refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 Dec 2013. The FLUVIRIN PFS and unopened MDVs reached 10 C from 05 Dec 2013 through 07 Dec 2013, reached 9.7 C on 08 Dec 2013 and reached 11.7 C on 09 Dec 2013. No adverse event was reported following this administration error.
covid vaccine breakthrough  dose 1 3/11/21 Moderna 001B21A dose 2 4/8/21 Moderna 045A21A dose 3 11/7/21 Moderna 058F21A