chrisvoncsefalvay/vaers-outcomes huggingface dataset:
re-tested-positive following a negative test. Symptoms appear to be mild; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017e21a, O11m20A and O11m20A) for COVID-19 vaccination.     The patient's past medical history included Palindromic rheumatism. Concurrent medical conditions included Drug allergy (unspecified drug). Concomitant products included HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) from 01-Dec-2020 to 27-May-2022 for an unknown indication.   On 02-Feb-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 4:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022 at 4:00 AM, the patient experienced COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild). At the time of the report, COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Co suspect drug name given as Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. Concomitant drug Amneal was reported with active substance Hydroxychoroquine form 01-Dec-2020 to 27-may-2022.  Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Patient reported that dysgeusia and re-tested-positive following a negative test.  Company Comment: This is a spontaneous case concerning  a  60-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 217 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  60-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 217 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
She had imm at 6-7-07. She had diarrhea at 6-21-07 and developed bloody stools (with mucous, brown blood) colitis patient admitted to the hospital on 6-22-07 Ba enema colon performed narrow of rectosigmoid colon.  6/29/07 Received vax record from pcp which confirms RO lot & dose #.  7/24/07 Received hospital medical records which reveal patient experienced watery bloody diarrhea for approx 1 week & vomiting 1 day prior to admit. Admitted 6/23-6/26/07.  Formula changed & patient improved.  GI consult done. FINAL DX: Cow's milk protein allergy.
No adverse event; Vaccine was given "Off-Label" to a patient who is 17 years old. She did not experience any side effects or adverse reactions from the vaccines from 3/15/21 to 4/5/21.
No known knowledge of adverse event.  Vaccine given past known stability date.  Vaccine in refrigerator 75 days.
Arm soreness, low grade fever, flushed cheeks, Hives that started in face  7 hours after injection. Upon waking 4/28/21  started taking Benadryl. Now spread to arms and thighs on 4/30/21. Still taking Benadryl.  Face not so red or itchy.
Redness, soreness and large blister at site of injection & swelling under armpit.
SWEATING; SICKNESS; NOT ABLE TO DO EXERCISE FOR WEEK; ANXIETY; FEET AND TOES WERE NUMB; NUMBNESS IN CALVES; SORE ARM; NOT FEELING WELL; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was usually very healthy and did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 03-AUG-2021, the patient experienced sweating. On 03-AUG-2021, the patient experienced sickness. On 03-AUG-2021, the patient experienced not able to do exercise for week. On 03-AUG-2021, the patient experienced anxiety. On 03-AUG-2021, the patient experienced feet and toes were numb. On 03-AUG-2021, the patient experienced numbness in calves. On 03-AUG-2021, the patient experienced sore arm. On 03-AUG-2021, the patient experienced not feeling well. On 03-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and numbness in calves on 05-AUG-2021, had not recovered from sore arm, not able to do exercise for week, and feet and toes were numb, and the outcome of fever, not feeling well, sickness and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Info has been received from an RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox breakthrough. Additional info has been requested.
15 minutes after administration of the vaccine, patient was noted in the clinic waiting room to have a rash that wrapped around his back and abdomen and towards his neck. Rash was flat and red. No signs of trouble breathing. MD assessed patient and spoke with mom about further treatment and further signs of a reaction to watch for. Baby left clinic with mom.
leg swollen, indurated, red, tender approx 1 1/2 the size of opposite leg;better in 4-5days;given antihistamine & ATB;
severe malaise, lethargy, myalgia, bone pain, difficulty concentrating, subjective fever, chills, sweats.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
diarrhea the morning after, fatigue for 1 day, and arm pain for 1 day
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, 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 was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010, stop date: 01Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measure such as Paxlovid was taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt called 8/3/19 to say super achy, feels like glands are swollen and neck is sore. Pt doesn't have a fever and is able to move neck side to side and can touch chin to chest.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (had multiple bouts over the past 2 years). Concomitant products included SYNTHROID. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd April 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, pain in arm, chills and lymph node pain. In June 2018, the patient experienced shingles. The patient was treated with TYLENOL. On an unknown date, the outcome of the shingles was unknown and the outcome of the fever, pain in arm, chills and lymph node pain were recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the fever, pain in arm, chills and lymph node pain to be related to SHINGRIX. Additional information was reported as follows: At 09:30, the patient received the SHINGRIX in the left arm. The patient had sore arm right after receiving the SHINGRIX which persisted for 4 days. She put an ice pack on her arm which helped. About 10 to 12 hours after receiving the SHINGRIX vaccine, she developed fever (body temperature 103.1 degree F) with chills for a couple hours. Less than a day after receiving SHINGRIX, the patient developed lymph node pain for a day. She took half a TYLENOL for the symptoms and went to bed early. About 6 weeks after receiving the SHINGRIX, she developed shingles. She hope that, this would be the last. She planned to receive the 2nd dose of SHINGRIX towards the end of June.
Combination of neurologic symptoms. A few days after receiving the vaccination, the patient began to experience eye pain with movement. She also developed a headache, lightheadedness, and some N/V. One week later, the patient developed a low-grade fever and arthralgias/myalgias. She was given Augmentin as an outpatient. Patient presented initially to our hospital with a 2-week history of lower extremity weakness, headache, pain with eye movement, arthralgias and myalgias, stiff neck, and fever. She was started on IV fluid hydration, Motrin, and Ceftriaxone 2000 mg IV Q 12 h empirically. On the second day, the patient's neurological symptoms progressed to diffuse extremity weakness with 1-2/5 strength bilaterally. 1+ upper extremity reflexes, 5+ lower extremity hyperreflexia, + 5 beats of clonus at the ankles and wrists, upgoing Babinski sign bilaterally, diffuse paresthesias over the anterior leg, the abdomen and lower three quarters of the back. At this point, she was started on Methylprednisolone 250 mg IV Q6h and Morphine 3 mg IV once. Her symptoms progressed to lower extremity weakness and hyperreflexia bilaterally and ascending over the course of 2-3 days to the upper thoracic level.  On day 6, she received Acetaminophen 650 mg once for fever. The patient has stabilized and her neurological exam is steadily normalizing as of hospital day 6. 1/26/09-records received for DOS 12/11/08-DC DX:Aseptic meningitis. Two days after receiving vaccinations C/O pain associated with eye movements bilaterally as well as headache that began behind the eyes. Symptoms continued for several days and seen by PMD at that time felt to be a viral infection. Complaints continued to progess with emesis, diarrhea, cough and upper respiratory infection symptoms including runny nose, sneezing. Began regime of Augmentin. On day of admission C/O weakness and difficulty with walking and increased back pain and leg pain and stiff neck. Headache started 2 days prior continued throughout. C/O paresthesias of bilateral lower extremities, abdomen, hands and back. Positive Kernig sign.
It triggerred my skin allergy, I have urticarias and rashes all over my body on and off from April till now  (July)  Itook Benadryl or Zyrtec seems help. Went to my family doctor and he suggestd to a specilaist.  Scheduling an appointment to the dermatologist in August.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic or long standing health conditions.     On 06-Feb-2022 at 10:08 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:08 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  A series of patients approximately 540 patients received lot number 066H71A past its 30 days expired date. Vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medication was reported by reporter.
12hrs after vaccination I got chills and muscle aches and headache that necessitated remaining in bed for the next 16hrs. All of my colleagues that had previously had covid and then got vaccinated suffered similar SEs
Patient stated she has had arm soreness since the injection on 6-14-18. She has seen her several Drs since the injection none could find any issues as a result of the injection. She would not give me the name of her Dr.
Malaise, chilling "global headache" states "most severe headache I've ever had" gradual onset that increased to "throbbing" and involving entire head, especially left temple area. Took 2 Tylenol tabs without relief; did not sleep all night due to pain. Additional Tylenol tablet taken next morning, then came to clinic. Denied nausea, vomiting, visual disturbances. Headache resolved 48 hours after onset.
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored VAQTA lot # K018531, expiration date: 28-APR-2017 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
During the evening of March 26, 2021 at home I could not pronounce words to describe something on TV. This condition lasted only a few minuted.
small red circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (small red circle at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20a) for COVID-19 vaccination.     The patient's past medical history included Cellulitis (Cellulitis with mosquito bites) and Swelling (Swelling with mosquito bites).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (small red circle at injection site). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and VANCOMYCIN at an unspecified dose and frequency. In January 2021, VACCINATION SITE ERYTHEMA (small red circle at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, White blood cell count: inconclusive (Inconclusive) count was 35,000.         No concomitant drug information provided.   This case was linked to MOD-2021-026113 (Patient Link).   Reporter did not allow further contact
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 12-APR-2018, the patient was vaccinated with VARIVAX lot# M033214, expiration date 13-JUL 2018, route of administration reported as "injection" (strength, dose and frequency were not reported) instead of ZOSTAVAX. No adverse effects reported.
Information has been received from a 74 year old male physician with prostate cancer that was treated with radiation who in approximately December 2007, "winter 2007", was vaccinated with a dose of ZOSTAVAX. In January 2009, the patient experienced shingles outbreak "now". The patient spoke to his physician. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (dose and route were not reported) lot # K010215 with expiration date 05-MAY-2017. No concomitant therapy was provided. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
injection site pain; chills; fever; shingles in eye / did a procedure on eye / reaction; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (especially the right eye, numerous times years ago from reporting). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (original Shingles vaccines a few years ago and did not experience any side effects not did I get shingles again) and Shingrix with an associated reaction of ophthalmic herpes zoster (first dose received on 15th June 2022 and also experienced injection site pain, chills and pyrexia, refer case US2023008656). Concurrent medical conditions included blood cholesterol increased. Concomitant products included metoprolol succinate and lovastatin.   On 6th December 2022, the patient received the 2nd dose of Shingrix. On 6th December 2022, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain, chills and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the injection site pain, chills and fever were unknown.   The reporter considered the ophthalmic herpes zoster to be related to Shingrix. It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2023008656   Additional Information: GSK receipt date: 20-Jan-2023 Reporter's Comments: The patient self-reported this case. The patient received second Shingrix vaccination and experienced both the injection site pain and the chills or fever like with the initial vaccination; however, she had now had Shingles in her right eye since 6th December 2022.  The patient had now spent over 1,000 dollars out of pocket for doctor visits, prescription, lab work, and treatments.  She had been to an urgent care clinic run by her PCP (primary care physician) practice, been to the eye doctor at least 5 times, and her PCP once.  The patient now being treated by a cornea specialist who did a procedure on her eye and who she had to go back to next week. The patient still had the shingles and it was directly related to getting the 2nd vaccination of Shingrix.  All of the health care providers she had seen said that none of the literature on the vaccine lists this as a possible reaction. If nothing else, she was letting GSK know so GSK could rectify that. The adverse event shingles in my right eye symptoms were treated. The reporter gave permission to contact.; Sender's Comments:  US-GSK-US2023008656:same reporter - 1st dose
5 minutes after receiving my injection I started sweating a lot my face became red and my eyelids started to swell a little  my throat got itchy and I had to pull down my mask to feel like I was breathing better
Patient received the vaccine at 9:40 am on 08/11/2021.  That evening, he experienced some shortness of breath when lying down to go to sleep.  He has the same experience the following evening.  He thought it was anxiety, so he took a valium.  He did sleep a little better, but he still felt like it was difficult to take a deep breath.  He returned to Clinic on 08/13/2021 for evaluation and advice.  At his visit, it was discovered that his heart rate was 150-160 bpm.  He was referred to hospital.
Pt developed acute angioedema, facial and perioral with 2 hours of receiving vaccines listed below; given oral Benadryl at home, seen by me in the ER and given prescription for Prednisone, took Benadryl for the next 24 hours and one dose of the Prednisone.  Motrin was taken right after the immunizations and is the possible culprit
1 minute after patient received the vaccine he began to seize and was unresponsive for approximately 30 seconds.  We laid the patient on his back and he began to respond and said he felt light-headed.  Ems arrived and checked his vitals.  He was released by EMS 45 minutes later.