chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received both AFLURIA and PNEUMOVAX in the same arm and ended up getting cellulitis.
received the Shingrix vaccine and I had shingles at the time; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported The patient received the Shingrix vaccine and had shingles at the time of vaccination, which led to off label use.  The patient did not notice the shingles for reasons to lengthy to go into here bit now and wondered if it would be the serious issue. Follow up was not possible as no contact details were provided.
The patient first complained of left knee pain in August of 2021. he then had a self-resolving episode of right knee arthritis in October 2021; he was treated with ibuprofen for a week and the episode resolved. he was evaluated at the clinic on 11/15/2021 and he had no evidence of arthritis. He received the first dose of the vaccine on 11/13/2021 and the second dose of the vaccine on 12/4/2021. he started complaining intermittently of left knee pain in February 2022 and on 2/21/2022, his left knee became visibly swollen. He also started complaining of left elbow pain. He was evaluated at the clinic on 2/28/2022 when he had evidence of left knee and left elbow arthritis. The left knee arthritis was confirmed by MRI. He was diagnosed with JIA. The patient was treated by means of intra-articular corticosteroid injections of his left elbow and left knee on 3/18/2022; at the day of the injections he still had ongoing arthritis of his left elbow and left knee.
I had my shot at 11 AM on the morning of April 4th and had a mild headache.  That is the only reaction I had had with the other 3 shots previously.  At night I applied Voltaren cream to my inner thighs.  In the morning when I had bruising on both inner thighs where I had applied the Voltaren.  You could see the stealing where my fingers had minimized the amount of Voltaren.
Patient developed a large area (12cm x 13cm) of erythema, firmness, tenderness & increased warmth on her left thigh.  The center was hard & yellowish = 4.0cm x 2.4cm.
Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 15th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
On 03/07/2005, pt received immunizations. Grandmother c/o infant with fever and diarrhea that started day of immunizations.
Swelling of arm at injection site, diarrhea, vomiting, fever. Symptoms began 24 hr after vaccine. Erythema, edema of Rt deltoid. BP decreased.   6/24/09 Hospital ER record DOS 4/6/09 and Inpatient Hospital records and DC summary received DOS 4/8/09 to 4/24/09. FINAL DIAGNOSIS: Cellulitis and abcess of unspecified sites. Patient presented with laceration of L hand and abrasion to abdomen. Laceration  was cleaned and sutured and pt given tetanus prohylaxis, and discharged. 2 days later patient presented with shoulder swollen, erythematous, tender, and warm to touch - area of vaccine injection site. Vomiting, diarrhea, fever, anxious. IV antibiotics administered. Incision and drainage of R shoulder. ICD-9 Codes: 882.0
I was fine for a while but on the 10th (4/9) day after taking my first shot I started feeling my throat swell up. The next day (4/10), my body shut down. I was in bed and slept most of the day. My throat was sore and swollen and had general fatigue. The third day (4/11), I brought myself to a medical clinic and got a strep test, negative; rapid covid test, negative. I also received the PCR test which turned up negative a few days later. My throat culture results are still pending. 4th & 5th day I was still coughing with a sore throat and fatigue. Day 6 is today and I am still fatigued with a sore throat but I seem to have turned a corner. I am able to get up and walk a little at a time.   This may not be related to the shot but it was close enough where I felt the need to report it. I am scheduled to take my 2nd Pfizer shot on 4/20 and am curious if I should push it back or not.
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 38  days.  Appropriate steps were taken to notify and are coordinating efforts to notify patients to repeat vaccination.
Patient admitted on 8/29/2021: Patient is a 70-year-old gentleman, who tested positive for COVID on Monday. He was treated with __________, has been at home and has been improving.  He said his onset of symptoms were the middle of last week.  This afternoon, he was walking when his right lower extremity became painful and then numb.  He has no antecedent claudication.  He came to the emergency room.  A CTA was performed, which shows a thrombus in the popliteal artery.  Patient discharged 9/1/2021: This is a 70-year-old gentleman, who is COVID positive that presented with acuteonset of right lower extremity pain, followed by numbness.  He underwent CTA that showed acute popliteal artery thrombosis with limb-threatening ischemia.  His foot was cool, pale, and beginning to become mottled with loss of sensation and movement and he also had absent Doppler signals below his groin.  It was felt that he would require emergent thrombectomy.  He was taken to the operating room on August 28th and underwent the above-stated procedure.  A long portion of acute thrombus was removed from his popliteal artery and below and he was noted to have good back bleeding and positive Doppler signals at the end of the case.  Postoperatively, he has done well.  He has been placed on warfarin therapy and currently is therapeutic with an INR in the 2-3 range.  We will alternate 7.5 and 5 mg of Coumadin daily. He is ambulating without difficulty.  His pain is controlled and he is ready for discharge home.
Pt passed out in chair about a minute or so after administration of vaccine. He brought along his girlfriend who was in the consultation room with him. Prior to administration, pt informed me that he was afraid of needles.  After administration, we discussed the type of needle that was used (vanish point syringe) and the mechanism of how it works. He seemd anxious so I advised that it was ok for them to sit in the room for a few minutes instead of getting up to wait in the lobby, I left the door open for them.  I walked back into the pharmacy and his girlfriend alerted me that he had passed out. He regained conscious within a few seconds. I advised he sit with his head between his legs, as he mentioned feeling light headed, feeling hot and sweaty. he threw up a little into the trash. pt sat in room for at least 30 minutes until he felt better. was given a few cups of water while sitting. did not leave until he felt comfortable and no longer light headed. pt mentioned that his last vaccine was about 2 years ago and the same response occured then.
The patient is immunocompromised and instead of receiving 0.25 ml for the second booster dose received 0.5 ml
w/in 3min of vax pt devel erythematous rash on face, chest, & back, + pale on faces;
A physician reported the occurrence of injection site cellulitis in a female child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in March 2003, the subject received her fourth injection of Infanrix (lot DTPA572A). On an unspecified date post-immunization, the subject developed injection site cellulitis characterized by redness, swelling, and warmth involving the subject's upper arm. As of 4/28/03, the outcome of the injection site cellulitis was unknown. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
On vaccine day (day 1) 1/4/21, started having right shoulder and upper arm pain, area of vaccine warm and very stiff, no redness or swelling.  Very limited ROM.  Day 2-1/5/21 continued with right shoulder and arm pain, stiffness, tenderness, very difficult and limited ROM even with donning clothing.  Day 3-1/6/21 still very sore and still ROM getting slowly better, soreness at vaccine site, and pressure causes pain could not sleep on arm first 3 days.  Day 4-1/7/21 right shoulder and upper arm are sore, but greatly improved and no further limited ROM can move arm and shoulder fluently.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Rash started on left arm where vaccine was given 4 hours after administration of vaccine. It then spread to the right arm, and went away on the left arm. Today, 22 days later, patient came in to report this event and ask for something for the rash. She was treated with hydroxyzine 25 mg TID, Triamcinolone 1 ML IM, Betamethasone 1 ML IM, Prednisone 20 mg 6 day taper, and triamcinolone 0.1% cream BID.
Patient was given 2nd dose of Moderna too early.  Patient had 1st dose 01-04-2022 and then 2nd dose 01-25-2022.
Extensive erythema, pain and swelling of arm. Began soon after immunization. Lasted 3d. Resolved spontaneously.
I experienced vertigo type symptoms for the first time in my life the evening of taking the shot, the next day I felt tired and achy, day 3-I had a few episodes of vertigo-dizziness. These episodes have continued almost daily for the past two months.  The degree of severity varies..sometimes the vertigo is mild and sometimes I have difficulty walking a straight line or must stop and rest. The episodes last only a few minutes at a time and I often only have 2-3 episodes a day.
It Started actually with the 12/17/21  booster shot modern 03H21B. Upper Right Arm Pain. Then this last one. 12?17?22 , Pain all on my Right Side of my body..That has subsided, but My shoulder still hurts
pt recvd vax 26JAN94 & 27JAN94 devel 5-6cm localized red area, fever, infected ears, congestion & rales; chest x-ray on 31JAN94 revealed pneumonia in the lt lower lobe of the lung & t101.6; 3FEB94 pt noted to have dec appetite;
Patient received Moderna pediatric 6 to 11-year-old vaccine on 7/15/2022. This dose should have been a second dose of Moderna but instead given a Pfizer pediatric 5 to 11-year-old vaccine instead.
Body stiffness, possibly a  polymyalgia rheumatica flare; dizziness; loss of balance and fall. Vomiting.
Same day post vax, the pt experienced severe upper arm pain. The next day she awoke with headache, total body aches, fever, sweats, swelling, localized hives on left upper arm and left breast. These symptoms lasted 3 days.
After the first inoculation, I started having the side effects two weeks in with fever, chills and muscle pains throughout the body. I also experienced a certain mental restlessness and adrenaline rush while feeling physically tired. It went away after 3-4 days. Following the 2nd shot, I started feeling hazy and mentally restless again with physical fatigue the day after the inoculation. A week later, I had really strong stomach cramps with numbness in the entire right shoulder where I got the 2nd inoculation. Mental restlessness and physical fatigue were also common daily,
swelling, tightness, redness w/in 24hr;advised pt 5DEC96 warm compress, advil, as needed;
1st GUARDISIL vaccine administered 7/8/08 pt report hives all over body within hours of injection lasting 3-4 days.  Tx with BENADRYL.
Chief complain of increased heart rate, sweaty,  EMS checked  VSS 161/101, HR 105, increased to 103, 99%,  on RA , Temp 98.5  Last B/P 145/91
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (MERCK). On 01-FEB-2018, the patient was vaccinated with a dose of PROQUAD lot # M039447 with expiration date: 20-MAR-2018, via subcutaneous, as prophylaxis (Strength and dose were not reported) instead of the M-M-R II that was prescribed the reason provided was human error.
Patient received varicella injection and three and half weeks after injection the patient was still having symptoms at PCP visit of pruritus/rash/swelling of neck lymph nodes. The patient was given an injection of KENALOG, a MEDROL dose pack, BENADRYL, and antibiotics for treatment by the PCP. Symptoms have since resolved. Triamcinolone 40 mg once IM. Methylprednisolone 4 mg every day PO. Cephalexin 500 mg BID PO.
Hospitalized 23AUG91 through ER w/high fever & diarrhea; dx leukocytosis also felt maybe DPT reaction;
Nausea; Vomiting; Dizziness; Aches; Extreme back pain; Tiredness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 19May2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 20May2021, the patient experienced nausea, vomiting, dizziness, aches, extreme back pain and tiredness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, dizziness, aches, extreme back pain and tiredness was not resolved at the time of this report.
Patient held Xeljanz for one week after the vaccine and stated during that period she did feel RA S/S come back; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her past drug included XELJANZ from 07May2020 for rheumatoid arthritis and reported NO SE. On an unknown date in 2021 patient held XELJANZ for one week after the vaccine and stated during that period she did feel rheumatoid arthritis (RA S/S) come back. As corrective treatment she restarted XELJANZ. Patient had been on XELJANZ for about a year and reports NO SE and stated it worked well for her RA. Patient held XELJANZ recently, per DRs instructions, as she had the Covid-19 vaccine. Patient held for one week after the vaccine. Patient stated during that period she did feel RA S/S come back but once restarting XELJANZ, they resolved again. On an unknown date in 2021 the event was resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Rheumatoid arthritis aggravated cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8731), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan1992. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Sep2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2023) positive, notes: Tested positive on 02Sep2023; (05Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (06Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (07Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (08Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (09Sep2023) positive, notes: Symptoms returned on 09Sep and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Swelling began where vaccines Hep B & MMR administered and were painful yesterday but not today. LSQ 3-4cm area swollen - D 2cm area swollen.
Tiny, blister like "pimple" 4" below injection site. Not itchy. No pain, swelling or itching at inj. site. Appeared 4 days after IZ. Feels well otherwise.
Information has been received from a female who on an unspecified date was vaccinated with a 0.5ml dose of MMR II (route and lot# not reported). On an unspecified date the patient had an allergic reaction. At the time of the report, the patient's status was unknown. Additional information has been requested.
8APR96 return pc to mom-pt c/o rash to MD;had vax 5APR; c/o itching pink/red, no signs of hotness or swelling;mom reported had some s/s  @ 15mos vax;
Stomach ache, diarrhea, vomiting. About 12 hours following vaccine, experienced stomach ache, diarrhea and vomiting. Not sure if it was due to food poisoning as we?d eaten  food from outside. However no one else in the household had any symptoms  I?m about 1 month out from recovering from TAH/BSO, omentectomy and debulking
This spontaneous report as received from a physician and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. Since 14-OCT-2016, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of M030380 and an expiration date of 02-JAN-2019; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 8 hours: 35 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
The vaccine wa stored in freezer, we take out one to two vails and place in fridge each day as needed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine wa stored in freezer, we take out one to two vails and place in fridge each day as needed) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine wa stored in freezer, we take out one to two vails and place in fridge each day as needed). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine wa stored in freezer, we take out one to two vails and place in fridge each day as needed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment given to patients.