chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
This case was reported in a literature article and described the occurrence of febrile seizure in a subject of unspecified gender born between 1974 and 2008 who was vaccinated with Hib (manufacturer unspecified), MMR (non-gsk) and varicella virus vaccine (non-gsk). This case refers to a subject. Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Hib vaccine (administration site and route unknown), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of varicella virus vaccine (Non-GSK) (unknown). 5 days after vaccination with Hib, MMR (Non-GSK) and varicella virus (Non-GSK), the subject experienced febrile seizure, thrombocytopenia and viral illness. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immuno-suppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Sinus congestion; Like hay fever symptoms; Coughing; Stuff coming out while she cough like phlegm; Shortness of breath when walking, A little shortness of breath at rest; Lot more pain than with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing) and PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericarditis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, HYDROXYCHLOROQUINE for Diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MESALAZINE (LIALDA) for Ulcerative colitis.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Lot more pain than with the first shot). On 04-Sep-2021, the patient experienced SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest). At the time of the report, PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, COVID-19 Test: negative Negative.         No treatment information was provided.   This case was linked to MOD-2021-316241 (Patient Link).
Heart palpitations with strong pulse sensations throughout entire body.  Hands and feet sweating (which are normally cold).
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 26-JAN-2017, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered and was diagnosed with sarcoidosis, Bechet disease, infection of the central nervous system, vasculitis, acute transverse myelitis, demyelinating disease of the central nervous system and encephalomyelitis. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. By reason of the foregoing, the patient and his spouse has necessarily paid and has become liable to pay for medical aid, treatment, monitoring, medications, and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. By reason of the foregoing, the patient and his spouse has been caused, presently and in the future, the loss of companionship, services, society and ability which has been impaired and depreciated, and the marital association between the patient and his spouse has been altered, and as such, the patient has been caused mental anguish and suffering. As a direct and proximate result of ZOSTAVAX, the patient has sustained and will continue to sustain severe physical injuries, severe emotional distress, economic losses and other damages. Upon internal review, sarcoidosis, Bechet disease, infection of the central nervous system, acute transverse myelitis, demyelinating disease of the central nervous system and encephalomyelitis were considered to be medically significant. Additional information has been requested.
(Moderna) adverse reaction: 100 x 75cm raised rash around injection sight(Rt) burning then numbness, tingling  in right arm.  treatment: ice sight, prednisone, zyrtec
fever/fever of 101; very tired; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A male patient of an unspecified age received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was running a fever of 101 and very tired on 17Jan2021. The patient got Tylenol. The outcome of the events was unknown.  Information about batch/lot number has been requested.
sun burn; itching; redness; This spontaneous case was reported by a nurse and describes the occurrence of SUNBURN (sun burn), PRURITUS (itching) and ERYTHEMA (redness) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUNBURN (sun burn), PRURITUS (itching) and ERYTHEMA (redness). At the time of the report, SUNBURN (sun burn), PRURITUS (itching) and ERYTHEMA (redness) outcome was unknown.        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.
Information has been received from a physician concerning an approximately 33 year old female speech pathologist with hypothyroidism and asthma and a history of hypertension who in 1993 and 200 was vaccinated with the first dose and second dose of varicella virus vaccine live (Oka/Merck), respectively. Concomitant therapy included levothyroxine Na (SYNTHROID). In June 2007 (last week), the patient had an antibody test drawn at the hospital and she failed to seroconvert. The patient sought unspecified medical attention. No product quality complaint was involved. Follow-up information was received from the physician who reported "I did not immunize the patient, but she gave a history of receiving immunization x 2 without becoming immune." No additional information is expected.
This spontaneous report as received from a registered nurse refers to a currently 4 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 19-AUG-2014 the patient was vaccinated with PROQUAD, 0.5 ml, subcutaneous in the right thigh, lot number J015595, expiration date 05-JUN-2015, (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions, and swelling after an injection PROQUAD (merck). The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Seizure lasting 10 minutes.  Did not break when Diastat was given at 5 minutes
The patient experienced no symptoms; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not provided.     On 13-DEC-2019, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not provided; lot# reported as S020158, expiration date reported as 30-JUN-2021) by subcutaneous route for prophylaxis. The sterile diluent used for administration was properly stored. The temperature excursions included -11.4 Celsius degree for 8 hours and 15 minutes. Temperature previously excursion was -11.7 Celsius degree for 4 hours and 3 minutes. There was a data logger involved. The patient experienced no symptoms.
A report has been received from a consumer concerning a, female patient, who had been receiving FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started during 2015. The patient experienced strep throat. FLUMIST was discontinued during 2015. The outcome of the event strep throat is unknown. The report was considered to be non-serious.
Evening of 2nd vaccination - uncontrollable chills/tremors/shakes, fever with burning eyes & ears, took 2 tylenol, 3am (01/27) heavy blood in urine, went back to My Urgent Care so they could record side effects, they said not side effects but possible UTI although culture was negative, prescribed 5 days of Keflex, 01/27 blood pressure high and incredible headache started in the evening, blood in urine  gone by Sunday 01/31, televisit with primary care on 02/03 for sudden change in BP and discuss the "UTI",  Primary care prescribed a second dose of losartin, by Sunday, 02/07 - BP so elevated, trip to ER and blood back in urine,  ER did CT Scan to make sure no kidney stones, negative, and bladder/kidneys look fine, however, still have IUD, so may want it taken out since post menopausal, 02/08 in office visit with primary care, administered clonidine to get BP down because was up again, he had me do 24 hr urine collection, said go ahead and have IUD taken out, but also see a nephrologist as well as prescribed clonidine as need for BP issues, since that visit BP has seemed to regulate with a few spikes requiring clonidine, IUD removed 03/09 and will see nephrologist on 03/15,  when I saw Gynecologist, she mentioned a doctor's wife who had similar issues with Moderna, and that I should report
Patient was sitting in observation area and felt numbness and tingling in her lips. Taken to EMS room for observation. In observation area, no facial swelling noted. States lips symptoms are improving.
Within 13 hours, I broke out in full body hives and red bumps covering the majority of my body with the exception of my feet and face. For the past 24 days, I have itched from head to toe. I have developed blisters on the back of my leg. Multiple times a day, I break out in a severe case of hives redness and red bumps and itching that is uncontrollable.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in an unknown arm and developed localized pain in the arm where the vaccine was given. This case was linked with US2018155150, reported for same patient for 2nd dose of SHINGRIX.
My daughter has played every sport every year after getting her 2nd dose of GARDASIL she started having vision problems, started having breathing problems, very bad migraines, is so tired all the time, she really never had any of these problems until she received her 2nd dose of GARDASIL and is currently being seen for her symptoms.
c/o numbness to arm that was vaccinated. VS WNLs, symptoms resolved after 15 minutes and cleared by medical provider to go home.
On 1/7/2021 in the morning she woke up with severe pain in her left shoulder with arm weakness, inflammation  and inability to move her arm.  She went to an urgent care center and the provider started her on prednisone for a 5 day course.   She plans to follow up with her PCP on 1/11/21
31 yo female with PMHx multiple non-anaphylactic food allergies, oral allergy syndrome, chronic idiopathic urticaria, and Hashimoto's thyroiditis, p/w itching and 1 hive after vaccination with Moderna vaccine.Pt with h/o delayed reaction (hives) to influenza vaccine in 2016, and MMR.H/o non-anaphylactic allergies to shellfish, peanuts, tree nuts, and wheat.  Oral allergy syndrome to raw stone fruit.She had seen her allergist, on 8/31/21 for allergy skin testing to PEG and polysorbate, found to be negative and cleared to receive the COVID vaccine. She was to be monitored for 30 min post-vaccine and if she was to get delayed hives, was to take benadryl 25 po q6 hrs PRN or allegra 180.Pt received her 1st doe of the Moderna vaccine at 1:50 PM, but accidentally received the half-dose booster shot instead.  Within 5 minutes, developed itching around her neck (externally), lower face, L arm (vaccination site).  +itching of her R hand with one small raised wheal (~2 mm) on the dorsum of the wrist.No other hives or rash.No erythema.No lip/tongue/throat swelling/itching.No confusion, CP, SOB, palp, wheezing, LH, N/V, abd pain, diarrhea.VS (1:55 PM): BP 147/68, HR 121, SaO2 98% RA. VS (2:06 PM): BP 145/95, HR 107, SaO2 96% RAVS: (2:55 PM): BP 126/87, HR 96, SaO2 99% RA;VS: (3:15 PM) BP 142/92, HR 91,SaO2 99% RAGen: WDWN, NADHEENT: NCAT, sclera anicteric and w/o injection, MMM OP clear.Neck: supple, good ROM.CV: tachy, reg rhythm, S1, S2.  No m/r/g;Pulm: CTAB.  No wheezes or crackles;Abd: S, NT, ND.  NABS. No rebound or guarding;Extr: no c/c/e;Neuro: A&Ox3.  No focal deficits;Given benadryl 50 mg po x1 (1:55 PM) with marked improvement in symptoms.  Pt discharged from clinic with aftercare instructions for vaccine reaction.  Pt to take benadryl 25 mg po q6 hrs PRN per previous allergist recommendation and will follow-up in clinic.
Moderna COVID-19 Vaccine EUA One week and one day after the above vaccine, I developed itching and a rash on my upper left arm. It is about 2 inches by 3 inches. Red, warm to touch and bumps in it. No pain or fever. Using cortisone cream on it.
Chest pain, tightness, shortness of breath, and coughing.  Symptoms progressively cleared after a couple days. Pain started on Thursday the  day after the vaccine, and continued until Saturday morning.
Pt did report some tingling to tip of tongue and declined staying past her 30 minute time frame with itching to rt leg. She stated that she had both tingling in her tongue at times and has had "Itchy skin jthis winter" patient states she has no other signs/symptoms of reaction. Staff encouraged her to stay longer than 30 minutes but she continued to decline. Bp was 153/67 p 80, RA sats of 99% per RN at 1315 and at 1324 bp was 158/75, pulse 87 and 97%RA. Patient states minimal itching to leg, no tingling and continues to decline being monitored at this time even with staff conversation/encouragement to stay additional 15 to 30 minutes. Encouraged her to notify her PCP of events and signs/symptoms to call 911
Employee reported to us on 3-6-12 that she had a "red blotched area > 4 inches" on arm after 2-1-12 vaccine administration.
A week after the first dose it started with rash on my skin. The dermatologist said it was urticaria from the vaccine. The second dose on April 20th the condition got worse and it hasn't gone away. In greater or lesser quantity but still there. I had to go to the hospital after waking up with swollen mouth. I have taken BENADRYL, ZYRTEC, XYZAL daily since the rash started and It hasn't gone away.
redness and warmth to arm; redness and warmth to arm; This is a spontaneous report from a contactable other HCP and consumer. A 64-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and warmth to arm and she never had that with same vaccine in past. The patient agreed to notify MD.   Information on the Lot/Batch number has been requested.
Mom called at 0015 regarding 5 year old, who received influenza shot earlier in the day, with complaints of headache and fever, also vomited x 1.  No diarrhea.  No recent illnesses in family. No photophobia.  Denies sore throat.  Is not irritable or lethargic. No rash.  Discussed most likely is coming down with viral illness, unlikely that due to flu shot.  Rec ibuprofen or tyelonol, and rest.
Pt received second dose of Pfizer COVID vaccine and felt fine.  About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest.  At this time we recommended she be escorted to the Emergency Department for assessment.  This was completed and she was later released home without any longstanding concerns.
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information as provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
WHILE THERE WAS INITIAL ARM/MUSCLE PAIN AT THE INJECTION SITE THAT WORE OFF AFTER 2-3 DAYS. SHOOTING ARM PAIN AND LIMITED RANGE OF MOTION BEGAN AS THE STEROID TAPER CAME TO AN END. IT HAS CONTINUED TO PRESENT. THERE IS A DULL ACHE AT THE INJECTION SITE WITH SHARP SHOOTING PAINS WITH MOTION.
caller stated that bruising was seen on the patient's posterior part of the patient's arm.; Flublok was inadvertently administered subcutaneously vs.intramuscular; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via call center on 11-Nov-2020.  This case involves adult female patient who experienced bruising was seen on the patient's posterior part of the patient's arm (contusion) and flublok was inadvertently administered subcutaneously vs intramuscular (incorrect route of product administration), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, via subcutaneous route, lot number not reported via subcutaneous route.  On an unknown date (unknown latency) after vaccination, the patient developed a non-serious caller stated that bruising on the patient's posterior part of the patient's arm (contusion) and reported flublok was inadvertently administered subcutaneously vs intramuscular (incorrect route of product administration) (intensity: not applicable).   Action taken was reported as unknown for contusion and as not applicable for incorrect route of product administration.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for contusion and as not applicable for incorrect route of product administration.  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.    No further relevant information was reported.  Additional information was received on 12-Nov-2020: Action taken for the event contusion was corrected from the previous version. Corresponding fields and narrative were updated accordingly.
Bilateral lower ext rash & edema. *Note* Delay in report due to original ER report on 11/16/11 did not specify poss reaction to vaccine. On 12/13/11 received updated report from ER stating poss reaction to vaccines.
Moderna: Intense itching at injection site 8 days following initial injection. Resulted in rash and discoloration at site for at least 4 days. Took Benadryl and waited for side effects to subside.