chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More than 36 days after the first dose without receiving the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) 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 medications were provided. Treatment medications were unknown.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
2 days later: nausea, vomiting, body aches, loss of appetite, resolved within 2 days. Tested negative for COVID-19 on 1/11 and 1/13. No known sick contacts.
Patient mother called pharmacy to report that her daughter as flu like symptoms from the flu shot. Mom states that she needs Tamiflu and I told her that the flu shot is inactivated and that the flu is already circulating in the community. I told her that if she is having high fever she would need to be seen by a physician to get a prescription for Tamiflu.  I told mother I would report  adverse effect.  Mother made comment that her daughter did not have insurance and cannot afford to see a doctor.  I advised to give Tylenol or Advil for fever.
Arm has a huge lump red itchy scratch under armpit is swollen enlarged pain down in side of arm to breast muscles
pt recv vax & leaned against door began falling over became unresponsive;father lowered pt to chair;pupils dilated, resp ext shallow, unable to palpate pulses;unable to obtain BP;very pale, cold & clammy;c/o h/a;
Initial report received on 22 September 2008 from a consumer, who is the patient's mother.  A 26 year old female patient, with no medical conditions and several allergies, received on 18 September 2008 a left arm injection of DAPTACEL (lot number not reported).  The patient had been scratched in the eye by a dog on 08 September 2008.  No other vaccines were administered within four weeks prior.  Concomitantly, the patient took VITEX (herbal) and her allergies were to gluten, DIMOTIL, HYCOTUSS, ERYTHROMYCIN, "INAPED", MEDAZINE, VICODIN, and latex.  On 19 September 2008, one day post-vaccination, the patient developed a "red round area five inches wide" at the injection site, her arm was sore to touch and difficult to move, and she had a "severe headache worse than migraines".  On 20 September 2008, she had a fever of 102 F.  The patient's mother and sister have both had similar reactions to TETANUS.  On an unspecified date, the patient had an emergency room visit.  Corrective treatment was not reported and the patient's outcome was reported as unknown.
Caught COVID; Caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "Caught COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: Caught COVID again 8 weeks later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A few days after receiving my vaccine, a reddish slightly raised small shape appeared under my chest. Over the next several days, I started to develop more of these same marks (different sizes) on my stomach, under chest, and and on back. I didn't feel them at all and they aren't itchy.  I sent this information, and photos, to my dermatologist at the time, who suggested it might be pityriasis rosea, might last up to 3 months.  After my second Pfizer dose (Lot #EL9266) on 2/15/2021, the old spots had disappeared but some new ones started to pop up on 2/15 (again I sent photos and information to my dermatologist at the time, so I have contemporaneous record keeping). I didn't feel the new marks at all, they were barely raised, and mostly appearing on my side of my abdomen (notably the same side as the first appearances) and under my chest.  Today, 8/15/2021, 6 months later, I have a few of the same rashes still left over from 2/15/2021. They are very faded, but still visible, and the same exact rashes from 2/15.   I am reporting this information because I see on Google now that pityriasis rosea is a known possible side effect of the COVID vaccine. I thought I should share this information with the CDC.
Patient received the Boostrix that expired on 7/15/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 21-AUG-2023, the patient received Boostrix. On 21-AUG-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Patient received the Boostrix that expired on 7/15/2023).  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: 24-AUG-2023 The reporter did not reported any reaction. A patient received an expired dose of Boostrix, which led to expired vaccine used. The reporter did not consent to follow up.
Information has been received on 3/26/02 from an RN concerning a male child who in 9/01 was vaccinated with a dose of MMRII. It was reported that "later", the pt had a positive IgM and had a swollen gland. The pt was reportedly taken to the hospital, was dx'd with mumps and had "drainage and culture" of the gland. The reporter did not think this was a vaccine failure and was concerned how long an IgM and IgG remained elevated, post vax. Follow-up information received on 4/1/02, reported that the child was admitted to the hospital for a staphylococcal infection, "that had nothing to do with the MMRII vaccination and that he child did not have the mumps". Additional information has been requested.
3:00 am  fever 102 Diarrhea  Headache  Body aches Tachycardia- 140
This case was reported by a healthcare professional and described the occurrence of arm redness in a 4-year-old female subject who was vaccinated with diphtheria an tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) plus a separate injection of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) for prophylaxis. The healthcare professional reported this case directly to VAERS. The subject had no pre-existing medical conditions and no illness at the time of vaccination, 26 September 2006. Concurrent medications included Multivitamins (Multivitamin). On 26 September 2006 at 6:30 p.m., the subject received 5th dose of Infanrix in the left deltoid and the 4th dose of IPOL in the left arm. On 26 September 2006 at 6:30 p.m., the subject also received an injection of live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine, Merck) in the right arm. The "evening" of 26 September 2006, less than one day after vaccination with IPOL and Infanrix, the subject experienced left arm redness. The subject was treated with ibuprofen (Motrin). On 27 September 2006, the redness extended from the upper left arm to the elbow. On 28 September 2006, the left arm swelled "to twice the size of the right arm." The left arm was "red, swollen on top of the shoulder, hard, feverish, and the size of a baseball." By the evening of 28 September 2006, the arm redness turned a "brownish reddish color." At 7:30 p.m. on 28 September 2006, the subject experienced arm pain. At 9:00 p.m. on 28 September 2006, "little blisters appeared on th arm in the brownish red area." The subject was seen in an emergency room on 28 September 2006. At this time, the blisters "had grown to pencil eraser size with smaller blisters appearing." The subject was treated with steroid (Steroids). On 29 September 2006, the subject was seen at a physician's office. At the physician's office it was noted that the arm redness and swelling were decreasing, but that the blisters had "increased in size to nickel and quarter sizes." The physician prescribed silver sulfadiazine (Silver sulphadiazine) for the blisters, clindamycin phosphate (Cleocin) for a "possible staphylococcal infection," and prednisolone "for the allergic reaction." On 02 October 2006, the subject was again seen at the physician's office. As of 02 October 2006, the reporter noted that the subject, "improving, arm is now covered, some blisters have broken; no secondary infections, skin on the arm is rough." This case was also reported from the health professional via a sales representative. Additional information included that a sibling of the subject had swelling and a feverish reaction at the injection site following receipt of the 5th dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel). The health professional considered the events to be probably related to vaccination with Infanrix.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium
Shingles; blister inside nose (possibly shingles); soreness (at injection site); fever; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus operation (in September 2018).   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and heart rate increased. On 23rd July 2019, the patient experienced shingles and blister. On 20th July 2019, the outcome of the injection site pain, fever and heart rate increased were recovered/resolved. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, injection site pain, fever and heart rate increased to be related to Shingrix.  Additional information received were as follows: The patient experienced blister inside nose (possibly shingles). The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up.
I initially had a scratchy throat and a runny nose along with a cough for the 1st 12 hours. I called my doctor the next morning and was prescribed Paxlovid. I completed at at home COVID-19 test and was positive. My wife came home from her college reunion and was positive which was how I got it. I treated it with over the counter flu medicine and it worked. I am still testing positive for COVID-19 but I feel fine. I do still have a little phlegm in my throat. I am still quarantining until Monday.
(R) arm 3rd day post vaccine - painful - hurt to move. Pain and soreness got better a little at a time. Now have a burning sensation when lifting arm up and out. No treatment. Advise to see PCP.
Breakthrough. Started getting a sore throat,  headache and nasal congestion. I took a  Home  COVID-19 test and it was positive.  Went to Urgent Care because I was having chest pains.  They gave me a Rapid COVID-19 test and it was Negative at Urgent care. Send out a PCR test and it came back positive the next day. She noticed me wheezing and prescribed Albuterol Inhaler. Come back if I felt like I was getting worse. A few days after that I started having severe burning knee pain. I went to Orthopedics Dr and they thought it may have been due to COVID vaccine. Injected Depo-medrol into knee and it helped.  Feeling better now.
pt recvd vax & approx 2 wks later had routine office visit & reported to MD that for 2 days following vax had fever of 100.5, erythema-6" long & soreness @ pnu-immune inj site;rx APAP;recovered;
States "(L) arm was red and warm to touch from shoulder to elbow Monday afternoon (10/13) till this AM 10/15". (L) deltoid swollen area (3 1/2 x 3 1/2 cm) and 2 x 3 1/2 area in inch above elbow red and warm to touch at 18:50 on 10/15. Stated "was painful to raise arm for 2 days, okay now" full range of motion.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a unknown. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226688. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2018, the patient received a first dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (Lot U6016AA), in the right deltoid and HPV Vaccine VLP RL1 4V (Yeast) on same visit. It was a case of actual medication error due to poor quality drug administered. (Other relevant tests included No lab test.) Final diagnosis was MENACTRA shipment at 3 days instead of 2 days and administered. The patient outcome is reported as Not Applicable for MENACTRA shipment at 3 days instead of 2 days and administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt said she was experiencing tightness in her throat and facial tingling.  This began at 3:30pm.  Pt was kept on site and observed with Benedryl standing by.  No meds were given and her symptoms did not progress.  Pt was kept on site for approximately 30 mins until a friend arrived to drive her home.   A follow up call was done next day, and pt reported that she felt fine.
Broke out in rash next day following vaccination of Twinix.  Rash predominanty on midriff, front and back.  No itching, red, raised bumps.
Suspected vaccination failure; Shingles; Got a shingles shot in 2018.  Last year he got the new shingles shot; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in 2018 and he did not had any shingles for a year. As soon as he got the new shot in 2019, he had shingles. This also led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow-up.
Vaccinated with Pfizer on 1/23/21 and 2/3/21.  Symptom onset on 7/10/21 with cough, runny nose, shortness of breath, chills, fever, nasal congestion.  Tested positive for  Covid 19 on 7/13/21
Diabetes; This is a spontaneous report from a non-contactable consumer (patient). A 76-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. The patient developed diabetes on an unspecified date. Patient would like to enroll in Covid booster trial. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with 2 Moderna COVID vaccinations, last dose 04/21/21, who admitted to hospital with positive COVID test.  Provider discharge note below:  "86 YO male with h/o parkinsons, alcholism, presenting to the ED for evaluation of generalized weakness.    Came in for 3-4 days of ""extreme weakness"". Has had productive cough, nausea without vomiting as well. He was found to be positive for COVID-19. Denies shortness of breath or fever. He was confused on arrival to the ER, and labs were notable for alcohol level of 217. Otherwise vitals and labs are stable. He was placed in ER obs overnight to see if weakness and confusion would resolve with his intoxication. Unfortunately this morning he is still requiring 2 person assist for ambulation. Previously was able to do all ADLs independently. Lives with his wife. No need for support devices at baseline.    Patient is a poor historian and not able to add much to this history. He is now oriented x4. He denies any alcohol use despite positive blood alcohol level.   Hospital Course:  1. COVID-19 infection - causing generalized weakness and inability to ambulate unassisted. Patient not hypoxic and remained hemodynamically stable during the entire duration of hospital stay. Patient received dose of Regeneron. Patient was able to participate with therapy, who recommended to return home with therapy.    2. Parkinson's disease - continue pta sinemet, namenda  3. Vascular dementia - namenda 4. Orthostatic hypotension due to parkinson's, continue Florinef.    5. Paroxysmal Afib - on eliquisReported bradycadic episodes on loop recorder, though more likely related to #1.  6. Hx CVA - on eliquis   7. ?Alcoholism - patient denies drinking. EtOH level high on admission though did not exhibit any signs of withdrawal   8. AMS: suspect due to sundowning."
This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Nurse reported patient received improperly stored RECOMBIVAX HB (lot # M044031, expiry date: 21-DEC-2019) on 30-MAY-2017 (incorrect product storage). The vaccine was exposed to 32°F to 35°F for 1 hour and 20 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effects were reported.  This is one of the two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001679:
Patient called pharmacy to report he was still having pain at injection site after 3 months. Pharmacist told him to contact PCP to rule out shoulder tendon injury. Patient said feels like knot in muscle and not shoulder. MD said to try to apply heat to arm to see if muscle issue.
A little soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in the injected arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Fever (A high fever of 102 F.) since March 2021.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A little soreness in the injected arm). At the time of the report, PAIN IN EXTREMITY (A little soreness in the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Additional information received on 09-May-2021 had an event added which is soreness in the injected arm.
This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Patient didn't have vaccine card availble so we looked up his vaccine record along with other pt.'s.  I thought I heard staff (RN) say he received his second dose in February, and patient wanted to get his booster.  I administered a Pfizer booster shot.  Upon revicion, patient had received his second dose on 7/13/21 which means he got his booster dose early.
This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly doses of RECOMBIVAX HB (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.