chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site very tender; severely incapacitated; headache; Body and headache; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date for further tolerenace refer case US2020AMR215128).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 2n dose  of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 1st dose of Shingrix, refer case US2020AMR215128; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215128:same patient, 2nd dose
Information has been received from a consumer concerning a 4 year old female who in 2002 was vaccinated SC with a 0.5ml dose MMR. There was no concomitant medication. In 2002 the patient developed a 105.7 degree fever that caused brain damage and deafness in left ear and was hospitalized. At the time of the report, the patient had not recovered. Additional information is not expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 35.47.  No concomitant medications were reported.  On 15-Apr-2021, 18 vials were moved to clinic.   The vial was initially moved to the fridge on 06-Apr-2021 and proposed beyond use date was 09-May-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 15-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning a pt who in approx. 4/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (dose series unk). The pt developed hives and an acute skin reaction with swelling and itching from the injection site to her elbow within minutes of receiving the vaccine (approx. 4/02). It was reported that the pt  was given a skin test for reactivity against pneumococcal vaccine 23 polyvalent. The pt tested positive for minute dilutions of 1:10,000 of pneumococcal vaccine 23 polyvalent and 2 controls were done which were negative. The physician planned on getting 8 more controls. The physician also noted that the pt has had a positive IgE to pneumococcal vaccine 23 polyvalent and will be published. It was unknown if the pt had any past medical history, concomitant therapies or had sought medical attention. A return visit was scheduled. The physician also reported that another pt developed bronchospasm after vaccination with pneumococcal vaccine 23 polyvalent (WAES 0204USA02764). Additional information has been requested.
expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 28th November 2021) for prophylaxis.   On 3rd January 2022, the patient received Boostrix. On 3rd January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Medical Assistant called to report that, an expired Boostrix dose was given to the patient by error, which led to expired vaccine used. The reporter consented to follow up by email.
A male pt 9age unk) was treated with Oncotice for an unk indication and for an unreported time period. reportedly he experienced bladder pain and had trouble retaining Oncotice. Dysuria.
pt recvd vax 9MAR94 & had fever 3 days later 13MAR93; had sz; taken to ER did well;
Administered 0.5ml dose of Pfizer booster to the patient instead of the indicated 0.3mL dose.  Expected vaccine reactions: arm ache; No residual symptoms.
pt recv vax & devel unusual & new jerky movements;since DEC96 pt has underwent extensive testing for development dely  & for sz;w/all test negative (including EKG x2) x/for partially compensated hypothyroidism;
Patient was given wrong covid vaccine.  Was supposed to receive first in series.  Patient was given bivalent 0.3mg.  (adult dose) Bivalent was not approved for patient's age at this time.
itchy flaky scalp, puffy eyes, itchy skin, diarrhea blurry vision, anxiety, The symptoms started in July/2021
5 hours after vaccine developed severe migraine, 8 hours after vaccine developed nausea, vomiting, severe leg pain, chills, and sweating. Developed diarrhea 20 hours after vaccine. Symptoms began to lessen 35 hours after vaccine.
Anaphylaxis; hives on limbs and back; lip swelling; throat tightness; swelling; dose received 3; dose received 3; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right at the age of 65 years old on 09Oct2021 02:45 (Batch/Lot Number: 30135BA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), hypothyroidism, migraine, mid high blood pressure, and anaphylaxis (known allergies: CT dye). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (Batch/Lot No: EN6203) on 26Feb2021, second dose of BNT162B2 (Batch/Lot No: EP6955) on 20Mar2021 for COVID-19 immunization. The patient previously took rocephin, Levaquin, Omnicef, Reglan and Bactrim and experienced drug allergies. On 09Oct2021 at 04:30, the patient experienced anaphylaxis, hives on limbs and back, lip swelling, throat tightness and swelling. The patient went to emergency room and was treated with Epipen, IV steroids, Benadryl, Claritin. The outcome of the events was recovered with sequel.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Anaphylactic reaction, Urticaria, Lip swelling, Throat tightness, and Swelling and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
hypotonic event ? sz hosp x 1 days neg inject by culture-EEG 26JUL
>35 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days after first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Dec-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 PRODUCT DOSE OMISSION ISSUE (>35 days after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days after first shot) had resolved.            No Concomitant medication were reported. No treatment medication were reported.  It was reported that the patient was scheduled to have second Moderna vaccine on 19 January and was unable to make it.   Reporter did not allow further contact