chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 month-old child received the DTap-IPV portion of Pentacel vaccine received without the lypolized ActHIB portion/no AE; 4 month-old child received the DTap-IPV portion of Pentacel vaccine received without the lypolized ActHIB portion/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old patient who received single second dose of only DTAP-IPV portion of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 06-Mar-2020 without the lypolized ActHIB portion for prophylactic vaccination via intramuscular route in the left vastus lateralis(product preparation issue), (product use issue) [batch number and expiry date of Pentacel not reported; for ACT-HIB batch number UJ258AA  and expiry date 04-APR-2021; for DTAP- IPV batch number UJ315AA and expiry date 04-APR-2021 respectively]  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (no dosing details reported for both vaccines).  It was of actual medication error case due to inappropriate reconstitution technique and product use issue.  It was also reported that Patient will be re-immunized with Act-HIB from that vaccine.  At the time of reporting, no adverse event was reported.  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 and Module VI of the 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.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-MAY-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered  painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
This spontaneous report as received from a medical assistant, refers to a 68 year old female patient with drug hypersensitivity to codeine. Concomitant therapies included sterile diluent(manufacturer unknown). On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) for prophylaxis. On 23-AUG-2016, 3 years 6 months 12 days after onset of therapy the patient experienced herpes zoster and rash (reported as "shingles like rash"). The outcome of herpes zoster and rash was reported as recovered/resolved.
arm started to swell-next day got red-went to ER was dx w/cellulitis;
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 0168AE, expiration date 06-MAR-2013) on an unknown date. It was reported that the patient developed swelling and redness on her arm at the injection site after receiving ZOSTAVAX. This dose of ZOSTAVAX had been stored in the refrigerator for an unspecified amount of time prior to administration to the patient. The patient sought for medical attention by calling to pharmacy department. The outcome was unknown. Additional information is not expected.
FEVER, Fatigue, Muscle or body aches, Headaches and Congestion or runny nose
This case was reported by a consumer via call center representative and described the occurrence of herpetiform lesion in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes simplex type i (Herpes type 1 since 1970's for at least 30 to 40 years). Concomitant products included acyclovir. On 25th March 2019 10:30, the patient received the 1st dose of SHINGRIX. In March 2019, 16 hrs 30 min after receiving SHINGRIX, the patient experienced herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister. On an unknown date, the outcome of the herpetiform lesion was unknown and the outcome of the muscle pain, shivering and headache were recovered/resolved and the outcome of the mass, burning sensation and blister were not recovered/not resolved. It was unknown if the reporter considered the herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister to be related to SHINGRIX. Additional details were provided as follows: The patient usually take Acyclovir. On Monday, the patient received a dose of SHINGRIX. On 26th March 2019 at 03:00 AM, in the next morning after vaccination, the patient experienced muscle aches, chills, shivering, and headache. On 28th March 2019, at around 06:00 AM in the morning, 2 days, 19 hours and 30 minutes after vaccination, the patient noted that a lump or blister, underneath the patient's right side under the chin.  The patient also reported that, the site of the lump was burning. The patient noticed that, the patient had a recurrence of herpes lesions. At the time of reporting, the symptoms were improved except for the lump under the chin and the burning. The patient should not took Acyclovir after getting SHINGRIX, since the patient read. The reporter did not consent to follow-up.
pt recv vax 1NOV95 & devel a fine,pink rash on face,back & arms;also c/o itchiness;pt was treated w/DPH & is recovered;
SUSPECTED VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, age group, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on unspecified date MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome-CoV-2) test (NR: not provided). On an unknown date, the patient was diagnosed with a breakthrough case of COVID. The patient experienced suspected vaccination failure, and suspected covid19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected vaccination failure and suspected covid19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210817422.; Sender's Comments: V0':20210818073-covid-19 vaccine ad26.cov2.s-Suspected vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Severe itching. Welts on chest and neck. Face itchy and flush.  4 days later I am still very itchy with out allergy meds.
Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5 ml dose VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information has been requested.
Came to Emergency Department on 1/8/2021 and was assessed at 5:21 pm.  Symptoms of hives, and upper lip swelling. Complaint of fever, nausea and headache. No airway issues. No shortness of breath. Mild hives improved with diphenhydramine.  Patient self treated with diphenhydramine at 3:00 pm on 1/8/2021.  No fever found on assessment.   Medications given: diphenhydramine, decadron and pepcid.  Discharged from facility at 7:30 pm.
Felt little worse than he did; 2nd dose received more than 35 days apart from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt little worse than he did) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt little worse than he did). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose) had resolved. At the time of the report, VACCINATION COMPLICATION (Felt little worse than he did) outcome was unknown.            Concomitant medications also included basic blood pressure medications. No treatment was received.  Patient reported that she felt little worse than he did after receiving the first 2 doses of the Moderna vaccine   This case was linked to MOD-2021-378102 (Patient Link).
Patient came back to pharmacy in November to receive the SHINGRIX vaccination and mentioned that about a week or so after the injection for flu, her arm started tingling pain down to hand, she was going to follow up with her primary physician, and I let her know I would report as well.
Swollen lymph nodes/lymph nodes are swollen on both sides; pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), via an unspecified route of administration in the left arm on 27Jan2021 at 10:10 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 28Jan2021 at 07:00, the patient experienced swollen lymph nodes. The patient stated that the lymph nodes were swollen on both sides (or so he thought, as he couldn't see the uvula at all). The patient stated, "it looks about the same right now", but the pain (onset: Jan2021) has decreased. The patient stated he had taken several COVID-19 tests prior to the vaccination, on unspecified dates, all negative. The last test, a nasal swab was on Jan2021 with negative results. The clinical outcome of "swollen lymph nodes/lymph nodes are swollen on both sides" and pain was resolving.
Patient received Menactra vaccine on February 25th and 24 hours later on February 26th he developed fever 101.8, dizziness, nausea, headache, and inability to stand up. He was administered Acetaminophen and Ibuprofen.  On February 27th the fever continued as well as dizziness.  On February 28th fever increased to 102.5 as well a deep cough, with complaints of difficulty in breathing with exertion. I took patient to see Dr. at the Urgent Care center and he ordered antibiotics and took an XRAY, which was negative.  Fever and lethargy continued along with increasing cough on March 1. As of March 2 Fever subsided, patient now on Zithromycin and peak flows have worsened. Patient is displaying symptoms of an asthma attack and is taking ProAir, Advair, Singulair, Nasonex, Allegra, and Sudafed.
devel inc redness, swelling @ inj site & blistering 24-48hr p/vax;
Postive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Postive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 22-Jan-2021.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Postive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Postive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Prior to vaccine, I had a slow growing kidney stone which was being monitored by Urology Associates since March of 2018.  This monitoring was being done via abdominal xray approximately every six months.  On my last monitoring visit of March 25, 2021 it was determined that since the stone had not moved or grown since last visit, was tucked high up in the kidney and causing no adverse symptoms, I would not have to return for a year for my next xray as it appeared everything was still quite stable.  On 04/14/2021, I received the first dose of the moderna covid vaccine.  On 4/20/2021 I began having severe left flank pain, began vomiting profusely,and suffered extreme vertigo.  I was taken by ambulance to a hospital where I was treated for my symptoms.  I then underwent 2 procedures within a week of each other at Urology associates outpatient surgical center to remove this stone.  I now apparently have another stone which is almost double the size of the first stone.  Not sure how first one could appear and grow so slowly only to have a much larger one appear within 7 months of my second covid vaccine which was given on May 13th 2021.  I have read that there have been some adverse effects regarding the covid vaccines and the kidneys so I feel this information is worth reporting in case it may be any way related to the vaccine.
THROMBOSIS-THROMBOCYTOEPNIA SYNDROME--- LEFT LEG DVT
Vaccine expired 04/24/23 and given 05/05/23. No immediate symptoms.
Patient received Pneumovax 0.5 ml SQ injection on 10/21/14. He notfified Dr of a fever and aches on 10/22/14. On 10/23/14 patient states his fever was 102. The inj sirte is red and swollen.
She got all the Pfizer COVID-19 vaccine but the concern she had a problem with her thyroid hormone level but now it's normal; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), outcome "recovered" (2022), described as "She got all the Pfizer COVID-19 vaccine but the concern she had a problem with her thyroid hormone level but now it's normal".  Additional information: she was concerned because she had read that there had been some people who have developed problems with thyroid as a result of having the studies hypothesizes conclude that from getting the Pfizer vaccine. and he asked any advice or information about it.  No follow-up attempts are possible. No further information is expected.
Lesions compatible with C-pox all over body, blisters open and scabs. Itching. Temp 99.6 Treatment Atarax
Noted getting Moderna Covid vaccine - 1st one Jan 27, 2nd one was Feb 24th -- > fine for 2-3 days.  Noted extreme dizziness, tinnitus, audiology said hearing loss on left, tingling in face, GI issues for 7 months (x7 months), feet rashes. Notes persistent ear fullness, tinnitus.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. 4 years ago in 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). Pharmacist reported that the patient who was at the time of the phone call in the pharmacy to receive dose 2 of GARDASIL which woul dbe late. Dose 1 was administered 4 years ago. No symptoms reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information is not expected.
2 hours after vaccine given pt experienced basilar h/a. Next morning had twitch in (L) eye, swollen lips & tongue, muscle ache in shoulders & upper back, tiredness/weakness, nasal congestion.
Pt recv vax on 6/3/98; on 6/17/98 pt exp a strong injection sensation at vax site
received her first Shingrix vaccine in February 2022, in unknown arm and her second Shingrix vaccine on 1-14-2023, in unknown arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5ml in February 2022 in an unknown arm intramuscularly).   On 14-JAN-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 14-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received her first Shingrix vaccine in February 2022, in unknown arm and her second Shingrix vaccine on 1-14-2023, in unknown arm). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 22-MAY-2023 The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016, the patients were vaccinated with ROTATEQ lot # L013193, expiration fate 20-JAN-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received ROTATEQ that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32F and it was during the timeframe of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a three unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On multiple unknown dates, the patients were vaccinated with doses of M-M-R II dose, (route of administration, lot number and expiration date were not provided) for prophylaxis, reconstituted with sterile diluent (lot # and expiration date were not provided), after each patient was individually vaccinated one time before with M-M-R (dose, route of administration, lot number and expiration date were not provided), M-M-R II several years ago. No adverse effects were reported. Additional information has been requested.
Some fatigue; This is a spontaneous report received from a contactable consumer (patient's wife) from medical information team.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Some fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tachycardia 160?s, Sharp Left Jaw Pain, Left Facial Swelling, Tingling/Numbness Roof of Mouth and Tongue
Day after shot- 11/18/09- injection site red, itchy & hot to the touch 3" in diameter. Cold compresses and BENADRYL 1 tsp po q 6 hours per Dr.
pt states has passed out before with shots however was feeling okay with getting second dose due to not having episode during first dose, pt however received vaccine and 2-3 minutes after receiving shot felt dizzy, clammy, nauesous, and hot. pt notified staff and was assisted to floor with feet on chair. stretcher taken to pt   pt assisted to stretcher pt appears pale upon first assessment.  lying flat in bed brought back to OBS for further assessment.  placed on vs monitor  vs as noted.  feeling better since laying down. pt given water tolerated well.  pt gradually repositioned to sitting, dangle  then standing without further symtoms  color improved. pt okay to leave. pt ambulated to exit without difficulty at 1515 vs 2:59 hr 72 po 94 bp 98/64  vs high fowlers hr67 po 99 bp 103/71  vs dangle 1509 hr 63 bp 109/77 po 100   vs standing 1514 hr 68 bp 110/73 po99
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were 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.