chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; Due to extended duration of excursion, the reporting nurse reported possible administration of the FLUZONE QUAD QIV with no reported adverse event; Initial information received  on 25-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.    This case involves a 52 years old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and this situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and due to extended duration of excursion, the reporting nurse reported possible administration of the fluzone quad qiv with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 11-Oct-2022 this situation is reported as a potential medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) Nature of Excursion was unsure, data logger showed excursion. No human error was there. Maximum/Minimum Reported Temperature was 52 F and Maximum Time Period Exposed was 14 DAYS.   On 25-Oct-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7680NA/ UT7761NA and expiration date: 30-Jun-2023 in via intramuscular route at unknown administration site as Immunization.     On 25-Oct-2022 due to extended duration of excursion, the reporting nurse reported possible administration of the fluzone quad qiv with no reported adverse event (poor quality product administered) same day following the administration of suspect vaccine.    It was reported that the influenza vaccine given may have been ineffective.   Action taken was not applicable.   Outcome: Unknown for all.   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 the 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.     Additional information received on 09-Nov-2022 from Other Health Care Professional: Therapy date added for suspect fluzone QIV accordingly event onset added for Poor quality product administered. Flublok captured incorrectly in this case deleted as separate case already create for same. Narrative updated.
at 4:00 am   on 2/14  (14 hours after shot)woke up to injection sight rash 3 inch wide, swollen and red fast heart rate 184 , chest pain and fast breathing  was addmited to hospital   hospital didn't mention vaccine on the hospital visit i have no heart issues prior to this.
moderate amount scattered varicella type lesions on trunk, face, elbows, back, back of knees-afeb, throat inflamed-?lesion on uvula;cleared up & returned to work on 27FEB98;
This spontaneous report was received from a pharmacist referring to a 3 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not reported. In 2014, the patient was vaccinated with the 1st dose of M-M-R II (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. On the same date, after the patient's vaccination, he experienced a "really bad" anaphylactic shock. Due to this, the patient was hospitalized for an unspecified period of time under treatment for the reaction. Subsequently, it was found out that the patient was allergic to gelatin (contraindicated product administered). At the time of the report, the outcome of anaphylactic shock was reported as recovered on an unspecified date. Additionally, causality was not provided between the adverse event and vaccination with M-M-R II. Anaphylactic shock was considered to be life threatening and serious due to hospitalization by the reporting pharmacist and medically significant upon internal review.
Every day I just noticed like new spots and they're very itchy; Broke out in a diffused Rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash) in a 35-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer (The last dose she received was Moderna everything else was Pfizer and 1st dose was in 2020 or 2021.). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 21-Oct-2023, the patient experienced PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL DM) at a dose of 2 dosage form once a day. At the time of the report, PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient was taking concomitant Synthroid for 20 years. Patient received the Spikevax vaccine which was fourth or fifth dose and a couple of hours later broke out in a diffused Rash. The patient noticed that the rash was more like all the ankle and wrist. For the first actually sign was like the wrist of the arm, where the vaccine was given and then noticed it in ankles. Every day new spots were noticed and they're very itchy. The last dose was Moderna everything else was Pfizer, the patient received 1st dose in 2020 or 2021.
Initial report received on 20 NOV 2014 from a healthcare provider (nurse). It represents one of the cluster of 50 to 100 patients reported by the same reporter who each experienced adverse events following administration of FLUZONE HD (batch numbers UR4722AA and UT4721AA) The events for the other patients are captured in case numbers 2013SA22028 and 2013SA123404.  An unidentified patient was administered FLUZONE HD into the deltoid, batch numbers reported as UT47222AA and UT4621AA. The vaccination was administered during clinics sometime between 07 OCT 2013 to 20 NOV 2013. Within 24 hours the patient experienced pain from arm to wrist, headache, breathing difficulty. The patient went to the emergency department for steroids and was released. The patient was not ill at the time of vaccination. The patient is now doing well. The patient's medical history and concomitant medications were not reported. A quarter of the patiens had the FLUZONE vaccine the previous year. No further details were available at the time of this report. The patient outcome is recovered on an unreported date. Documents held by sender: None.
This spontaneous report was received from a pharmacy technician (other) refers to multiple patients of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the multiple patients were vaccinated with RECOMBIVAX HB lot # L025738 exp: 14-AUG-2017 that was stored improperly at a temperature of 1.1 degree Celsius within a time frame of 45 minutes. Previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt devel fever 102-104 14JUN91 & 15JUN91, rash 19JUN91;
pt admitted to hosp 10 dys after being diagnosed positive for COVID with worsening SOB x 4 days; c/o wet productive cough, fever; states has been bed bound for a while due to progressive peripheral neuropathy; started on steroids, antibiotis, dexamethasone; DNR/DNI; became confused and septic; condition worsened; pt was made comfort care and died in the hospital
Pt had local site reaction on upper outer left arm of erythema, warmth, swelling 2.5" x 2.25" and soreness upon presentation at provider facility 07/21/11 @ 1530. Per pt's mother 7/22/11 @ 0830, pt swelling gone, slight erythema and warmth.
Large (10 x 15 cm) warm,, red, indurated tender/itchy local shot reaction over left deltoid.
achy; feverish; could hardly breathe good; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could hardly breathe good), MYALGIA (achy) and PYREXIA (feverish) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Asthma and Allergy. Concomitant products included LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe good). On an unknown date, the patient experienced MYALGIA (achy) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (could hardly breathe good) had resolved and MYALGIA (achy) and PYREXIA (feverish) had not resolved.            Treatment medications taken were antibiotics Action taken with mRNA-1273 in response to the events were Not Applicable
Muscle and joint weakness, primarily in the legs, began the day after the vaccine. Weakness has continued since. Compression sleeves and crutches are being used to assist with walking.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine administered after 11 days of puncturing the vial) in a 74-year-old patient, of unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Aug 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 10, 2021, patient administered expired product (vaccine administered after 11 days of puncturing the vial). On Aug 10, 2021, patient administered expired product (vaccine administered after 11 days of puncturing the vial) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained updated event verbatim.
Immediately after administration  the patient started bleeding and swelling/small bump appeared at the injection site. The patient's arm was elevated and the bleeding stopped. An ice pack was applied to the swelling for about 20 minutes. The patient was observed for a total of 40 minutes by pharmacy team. No further bleeding occurred and swelling/bump was going down when patient left pharmacy and he was advised to continue applying ice pack and go to ER if any further swelling, redness, itch or trouble breathing occurred. Pharmacy followed up with patient the morning after vaccine administration and he reported no further bleeding or swelling had occurred.
Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Error: Wrong Dose of Vaccine - Too High-, Additional Details: parent gave ibuprofen evening of vaccination
?Covid Arm? Raised Rash size of whole hand Redness  Very warm and painful to touch No puritus  Same reaction reported after 1st dose in same left arm which noted appeared 2 weeks post vaccine and lasted for 2 days.  Advised to take Antihistamine  prior to 2nd vaccine, in which I took Claritin.  Other:  ?Covid Arm? with injection site tenderness was the only reaction to 1st dose. 2nd dose felt ?off?/brain fog? about 1hr post. 16 hours post 2nd dose experienced flu like symptoms;  chills, fatigue, aches
RED BRUISE ON LEFT ARM; INJECTION SITE WARMNESS; TINGLING SENSATION IN LEFT LEG; INJECTION SITE BULGING; INJECTION SITE REDNESS; LEFT ARM PAIN; FEVER; WEAKNESS; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included gluten allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced red bruise on left arm. On 12-APR-2021, the subject experienced injection site warmness. On 12-APR-2021, the subject experienced tingling sensation in left leg. On 12-APR-2021, the subject experienced injection site bulging. On 12-APR-2021, the subject experienced injection site redness. On 12-APR-2021, the subject experienced left arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, and weakness on 12-APR-2021, and had not recovered from red bruise on left arm, injection site warmness, tingling sensation in left leg, left arm pain, injection site bulging, and injection site redness. This report was non-serious.
Redness, hot, swelling, hard in the area injected, and sore muscle.
p/vax pt exp a rash w/less than 50 lesions presenting on back & legs w/some itchiness;pt also c/o itchiness on arms;pt sought unspecified medical attention;
Muscle pain in both legs; Weakness in both hands; Body aches; Rectal pain; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient had no other medications in two weeks of receiving the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. On 31Mar2021 the patient experienced muscle pain in both legs, weakness in both hands, more pronounced in the left hand. Body aches and rectal pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for muscle pain in both legs, weakness of hands, ache and rectal pain. The clinical outcome of the events muscle pain in both legs, weakness of hands, ache, rectal pain was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Negative for antibodies after second dose; minimal sore arm for second dose; This spontaneous case was reported by a nurse and describes the occurrence of ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose) and PAIN IN EXTREMITY (minimal sore arm for second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, ALPRAZOLAM (XANAX) and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (minimal sore arm for second dose). On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose). At the time of the report, ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose) and PAIN IN EXTREMITY (minimal sore arm for second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was not provided.  Nurse reported that she had some blood work done for antibody testing (IgG) which came back negative (tested 5 weeks after completion of vaccination series).   This case was linked to MOD21-075603 (E2B Linked Report); Sender's Comments:  MOD21-075603:Cross linked case
At 7 days after injection, I experienced a rash at injection site that is red, itchy, and hard.  It has continued for at least one day with the rash expanding from an initial area of about 1 inch circle to a 3 inch circle.  It is warm to the touch as well.
3:am  on Friday  I woke up with severe generalized pain  , headache and temp of 102 .  My left I took  2 Tylenol.  It didnt help. The next morning the pain level was about  5 and fever was down to 100.  By the 3rd day my temp was normal and I just had mild muscle aches
Body Aches around 6PM on day of vaccination.  Fever of 101.5 at 9PM.  Fever for the next 18-20 hours, high of 103.  Never going below 100, ever with the helped of ibuprofen.  Some of the worst chills and body aches I have ever had. Also, a bad headache.  Fever broke 24 hours after it began. I also had indigestion and some bowel upset.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX about 5 months before the date of reporting.   The patient was unable to recall specific date of shot and was unable to provide phone number for the pharmacy. The patient requested to be anonymous. The patient stated, at some point after receiving SHINGRIX, she developed shingles which lasted for about one month. The patient was treated with Valtrex and Shingles was resolved. She had a 2nd outbreak of shingles later on and was again treated with Valtrex. The patient was unsure if the shingles had resolved yet or not.
This spontaneous report as received from a pharmacist via a company representative refers to an "over 60 years old" female patient. "At a previous unspecified date" the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # not reported) subcutaneously. It was reported that "right after" the vaccination, the patient developed a rash at the injection site. The patient did not seek medical attention. And the patient treated herself with OTC antihistamines. The adverse event improved and the outcome of rash at the injection site was reported as recovered. Additional information is not expected.
Information has been received from the patient's mother referring to her daughter of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 30-NOV-2016, the patient was vaccinated with her first dose of GARDASIL (lot# and expiration date were unknown) intramuscularly for prevention of human papillomavirus (HPV). In approximately 2016, since the administration, the patient experienced malaise, overall not feeling well and headache. The outcome of the events was reported as not recovered. Causality was not provided. Additional information is not expected as it is not permitted to be contacted.
Case number PHEH2012US005886 is an initial spontaneous report received from a nurse on 13 Mar 2012: This report refers to unknown age and gender patient. The patient was received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: M10027) intramuscularly, without reconstituted with Men A lyophilized powder component on an unspecified date in Jan 2012. No adverse reaction was reported following this drug administration error.
Immediately following vaccine, patient reported burning at the injection site that felt like it travelled up her right arm (where she received the vaccine), up through her neck and behind her ear. She reported feeling fine about an hour later.
anomic aphasia Narrative: Patient received first COVID-19 vaccine on 3/11/21, after which he experienced fatigue/fogginess, intermittent chest pain. He was seen at an outside hospital on 3/27/21 for pleuritic chest pain (troponins were negative, CTA chest was negative). His chest pain resolved 1-2 days prior to this hospital admission on 3/29/21. Wife indicates that patient started to seem "off" and mumbling words and saying the word "plug" frequently. Patient would also misidentify items; patient would call a soda can a "cup" repeatedly. He has difficulty finding words now. He could not recall what his new medication for diabetes was called; he called it "diabetics". During an interview, he was asked to name multiple objects, but only correctly identifying 3/10 correctly. CT imaging showed a possible hypodensity in the subinsular area of the left hemisphere on CT. Further evaluation showed complete occlusion of his left internal carotid artery with MRI evidence of acute nonhemorrhagic left MCA territory infarct. Throughout hospitalization, had slow improvement in his word finding difficulties.