chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given Pneumovax on 7/16/05 at 8:00 a.m.  On 7/18/05, it was noted that the patient had red, hot, swollen area resembling cellulitis below the injection site.  Cephalexin 500 mg po qid was started.
To ER w/high fever 1FEB91; f/u w/MD 2FEB91 dx bronchitis, URI, & ear infect;
About two weeks after the 1st shot, 4/15/21, I started having vertigo symptoms when I woke up in the morning. They have persisted through today , 4/19/21, and I have felt mostly dizzy with some balance issues but balance was the worst on the first day and has been rare since then.
Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.
3JUN98 devel fever 102 x 2 days;irritable, dec intake, rash devel 5JUN98 on neck then spreading to face, abd, trunk, pt comforted w/APAP, DPH & observed;still w/rash 8JUN98;
Large rash on upper chest, centered and symmetrical half moon shape from clavicle down to bottom of ribs.
Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022; No adverse event; 4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 18-Jul-2022 and best used date was reported as 17-Aug-2022.  The patient did not report any side effects. No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-699002 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-699002: Master case ID
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for COPD exacerbation. Vaccination took place on 3/31/2008. According to the physician the relationship is 'Unlikely'. We would be happy to forward the Study's SAE reporting form upon request.
mom states pt given APAP w/in 15mins of vax;shortly w/in few hrs afterward; pt had 2hr episode of inconsolable, high pitched (mom's spontaneous description) crying-took to PMD ofc, & was told probably shouldn't  have DTP again;t100; DT only
PATIENT STATED THAT HE DEVELOPED A HUGE KNOT WITH WARMTH AND REDNESS BY BEDTIME THE DAY OF THE VACCINATION. HE SAID THE REDNESS EXTENDED DOWN THE ARM AND INTO HIS BICEP AND WAS VERY SORE TO THE TOUCH, SO MUCH SO THAT HE HAD DIFFICULTY SLEEPING FOR ALMOST A WEEK.
itching, rash on left elbow and forearm, nose, cheeks, rt earlobe
p/vax pt exp redness, warmth, induration & swelling at inj site;
Day 2-4: Small redness area size of 1x3", hardness, and pain Day 5-9: Redness and skin irritation gone Day 10-13+:  Red, itchy ski and sore to the touch.  Redness with bullseye pattern darker in center at injection site, lighter, then darker again on outer edges.  Redness area roughly 6" in diameter and has been increasing slightly each day for 4 days.
drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; neck pain; hard to get into sleep last night; This is a spontaneous report from a non-contactable Other-Healthcare professional. A 31-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Formulation: Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 16Mar2021 (age at vaccination 31 years) at single dose for Covid-19 immunization. Reportedly, there were no known allergies to medications, food or other products other medical history. Patient did not have COVID prior to vaccination. Patient was not tested for COVID post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was complaining of right facial weakness since 04Apr2021 (the day before yesterday), drooping face, has difficulty closing right eye. It was associated with headache, neck pain. The neck and headache pain scale was 7/10 for 4-5 days. It was reported that pain comes and goes. The headache was less when he works and exercise. But the headache was more severe at night. It was hard to get into sleep last night. There was no n/v/c/d, blurred vision, cp, sob, doe, fever, chills, cough, sore throat, runny nose, etc. There was no rash, numbness. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the case as non-serious with no seriousness criteria (Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect). No treatment was given for adverse events. Outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drooping face cannot be excluded. 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.
trouble breathing, sleepy, generalized weakness. Evaluated by EMS-Refusal to transport.
I was doing a double physical (sibling) when checking out the orders I accidentally prepared HPV ordered 08-05-22 that was already given. Overlooking date as usually given on physicals. he was given a 3rd dose  12 days after his 2nd dose. I verified prior to administration and it wasn't caught until after administration.  ***no adverse/side effects to report
Started 11 hours after booster. Extreme headache base of skull and across eye area, fever, swollen armpit and lymph nodes, uncontrollable shaking and tremors, sweating, nausea, feeling of vomiting and diarrhea but, not having either, cramping, burning throat and hands, overall feeling of extreme illness, dizziness and fatigue. These symptoms last for 3 days and have been for EVERY single vaccine or booster.
Significant increase in pain and tenderness of right arm where I had fallen/broken my radial head at the olecranon. Also worsening of hip pain on the right where i have chronic hip pain.
The dose was given in the lateral right deltoid on 02/25/21 and on the morning of 02/27/2021 the patient noticed a roughly circular area of erythema and edema about 2 inches in diameter on the FRONT side of the deltoid muscle (not at the injection site--until this occurred, there had been no dermal reaction, so none at the actual injection site). The area was warm to the touch, itchy and mildly tender. On 02/28/21, the area as described had relocated , moving down the right arm approximately 2 inches (the skin at the original location of the symptoms had returned to normal). The area of erythema, edema, warmth, tenderness and pruritus had enlarged and reshaped resembling a well delineated triangle several inches across and covering the patient's bicep and surrounding areas. On 02/29/21, the area remained roughly the same and on 03/01/21, the area had migrated to a wide crescent shape encompassing the upper arm from mid-bicep to the antecubital area, laterally both on the interior and exterior aspects of the upper arm. Erythema, edema and pruritus continue but warmth and tenderness are somewhat improved.  No treatment has been given.  Of note, the patient had a similar reaction following the first dose, but the symptoms were restricted to the area surrounding the actual injection site (did not migrate), lasted approximately 4-5 days and resolved without treatment.
Pt recvd vax 5AUG92 & on the same day recvd Novocain for a tooth extraction that evening devel hives w/itching; the next day the rash worsened;7AUG92 presented to MD who described rash as being erythema multiforme w/papillar lesions & hives
PHARMACY INADVERTENTLY DISPENSED EXPIRED COVID VACCINE TO NURSING HOME WHICH WAS ADMINISTERED.
Patient developed next day redness/soreness at injection site. The pain spread into armpit and became worse. Patient visited physician after the worsening reaction. She was diagnosed with infection and treated with antibiotics.
Day after receiving injection, my arm was sore (as expected). However, soreness has gotten worse. Pain has travelled up into shoulder area, difficulty in lifting arm, entire left arm is in throbbing pain. Difficulty in extending elbow completely out, and pain traveling up my neck.
An expired 2nd dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  The vial didn't undergo any temperature excursions.
A nurse reported that a male received injections of Flu Shield '00-'01 and tuberculin, PPD on 11/20/00. On 11/22/00, the results of the pt's tuberculin test were reportedly positive. This is 1 of 2 pts from this facility who developed a positive tuberculin test following receipt of Flu Shield lot 4008183.
6 Days after i got my second moderna shot i developed hives exactly as you described; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described). At the time of the report, URTICARIA (6 Days after i got my second moderna shot i developed hives exactly as you described) outcome was unknown. 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Treatment product Paxlovid treatment started on 06Jul2022 to treatment stopped on 11Jul2022 for indication treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1-2 hours after receiving Moderna vaccination patient began complaining of chest pain to family members but refused to seek medical attention. He was found deceased this morning (03/19/21) by his family. Medical Examiner determined time of death was around 8:40pm on 03/18/21.
Initially felt jittery inside and itchy but no uticaria. VS normal, but pale.Very anxious. With in 1/2hr n/v, occipital HA and vertigo. In ED Tylenol, Meclizine, Zolfran ODT, and Advil
This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a female patient. On an unspecified date in 2013, the patient received a flu vaccine (manufacturer and batch number not reported). On an unspecified date in 2013, the patient developed a headache that lasted one month. Outcome was not reported Linked to 2015048093
PT HAD SWELLING/EDEMA ON THE LEFT SIDE OF HIS FACE WHERE HE PREVIOUSLY HAD SHINGLES (1 YEAR AGO).
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Influenza A; Ineffectiveness of flu vaccine; Initial information received on 02-Mar-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a patient (of unknown demographics) who was diagnosed with influenza A (Influenza), while he/she received vaccine INFLUENZA VACCINE [Flu vaccine].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On an unknown date, patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [Flu vaccine] (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (3 days ago), the patient was diagnosed with serious influenza A (Influenza ) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that it was an ineffectiveness of flu vaccine (vaccination failure). These events  were assessed as medically significant.  Laboratory data was not provided.  Final diagnosis was influenza.   It was not reported if the patient received any corrective treatment.  The outcome of the event was not reported at the time of report.   Information on the batch number was requested.; Sender's Comments: This case concerns patient (of unknown demographics) who was diagnosed with influenza A virus infection after and despite administration with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown.The patient's past history, medical condition at time of vaccination and lab test ruling out predisposing etiologies were not reported. Based upon the reported information, the role of the suspect vaccine and a case of vaccination failure cannot be assessed.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No concomitant medications reported. No treatment medications reported.  It was reported that patient received booster shot 2 days ago.
Patient complain of tingling in tongue and numbness to left lower lip. Patient received 50 mg PO Diphenhydramine.  Vital Signs stable prior to  and after receiving medication. Patient informed  staff of improvement to lip and tongue.
At 4:00 pm the day of the vaccines, the child noted a rash. The rash was on his face, chest, back, arms and legs. The patient was treated with Benadryl.
Case number PHEH2013US015744 is an initial spontaneous report received from a physician on 19 Jul 2013. This report is also a quality complaint (QA reference number: 242310). This report refers to a patient whose identifiers were not reported. This patient's medical history and concomitant medications were not reported. After the dose was administered, a small crack was noticed in the vial of MENVEO (batch number: M12129, expiry date: 04 Feb 2019) on 18 Jul 2013. It was reported that the nurse was cut by the crack in the vial. No other vials in the box were cracked or damaged and there was no damage to the inner or outer packaging of the vial. There were no problems in withdrawing a full dose from that vial and there was no leakage from the vial and the nurse was not exposed to the vaccine. The outcome of the event injury was not reported. No other information was provided.
Body Ache, Covid like symptoms, Headeache. for about 24 hours.
Pt has been experiencing arm pain and soreness since the covid shot. She has tried icing and rubbing alcohol to alleviate the pain however it has not subsided. Her healthcare provider is now suggesting we make an appointment with an Ortho doctor.
Pt comes after a recent zoster vaccine 5/30/23.  Per pt sooner after the same day after 3-4 h pt started having chills, body aches, intense arm and posterior L chest pain.  The day after she develop severe n/v/watery diarrhea x6 episodes. The day after per pt had some cough but resolved after 1 day.  Only able to drink fluids.  No appetite.  Self limited after 6 days.
1/26/21-afternoon through evening dizziness, arm pain, body aches 1/27/21-after midnight-fever of 100.3, chills, arm pain 1/28/21-severe headache  1/29/21-headache gone by end of day
Pt recv vax on 4/6/99; on 4/7/99 pt exp light headedness, blurred long range vision
I had achiness near my breast and under arm on both sides, Its not severe, Its kind of like when I move I feel it. Its a surprise shot of pain. And a slight headache.
Had fever, vomiting and diarrhea. Developed several days after vaccines - seen in minor ER x 1 and in office x 2 over 1 wk period. Parent felt condition due to vaccines and not viral gastroenteritis.
LOW GRADE FEVER, HEADACHE, MUSCLE PAIN, SHALLOW BREATHING, HIVES ON NECK AND CHEST.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F and other one for 216 hours with lowest recorded temperature of 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient experienced tingling in her right arm, followed by redness and pain on right side of body, as well as chest pain. Redness lasted 4-5 days, chest pain lasted 2-3 days per patient.
expired vaccine unknowingly administered due to short dated product being supplied. found out when manufacture issued a recall on product after the fact
Pt recvd vax 17NOV92 & on 17NOV92 pt devel severe pain in entire lt arm immed following vax; sx worsened; w/in 24 hrs pt pain had diminished; pt cont exp shoulder pain;
Narrative: Ice pack and water provided. Patient reported  feeling resolution of symptoms, able to ambulate without  assistance.
Approx 10 mins after vaccines administered, thump was heard coming from patients room.  MA entered and Patient stated he fell backwards and hit head on wall, did not fall off table,  No visible injury noted, patient never lost consciousness, appeared pale and weak.
Patient described having fatigue, fever, malaise, chills, and extreme Parkinson movements/shaking/trembling that prevent the patient from even holding a temporal thermometer or holding any object. The patient had to go lay down and wait for the shaking to stop.