chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While an 8 year old patient who had received Varicella for the first time had been sitting  his mother alerted clerical staff that the child was having trouble breathing. Upon assessment the checklist for previous reactions or contraindications were all negative with previous vaccines. The child was immediately taken to the back and placed on exam table for assessment. Breath sounds were clear with no stridor or rales noted. O2 sat was 96%. O2 was administered at 6L/mask. Mom was at the bedside with information being related through the HD translator. Mom told translator the child has asthma and she thought he just got upset over getting shots. Ventolin was given X 6 puffs per metered dose inhaler. EMS was called and assessed child and found him to be stable. 02 sats and vital signs were repeated after 02 had been removed and 02 sats remained at 99% on room air. Patient was watched for an additional 20 minutes after EMS left and was alert and oriented, RR regular and non-labored. Discharged to home per private vehicle with mother. Attempted follow up phone call to the phone number given, but they were not receiving calls.
Pt vaccinated with DT developed hives over entire body. Sx decreased w/ Seldane, Benadryl, Cyproheptadine, Hismanal - hives lasted 3 days.
ADMINISTERED IM INSTEAD OF SQ, NO ADVERSE REACTIONS REPORTED BY PATIENT AT THIS TIME.
The patient fainted about 2 minutes after the injection was administered. I moved her on the floor. I checked for breathing and she was breathing. She became conscious about 1 minute afterwards. She waited about 30 minutes and was given some cranberry juice and her color began to return.
Outbreak and cold after shingles vax. Patches on various parts of skin with moderate itching - blisters appearing but only temporary. Cold/flu symptoms with muscle weakness.    Used an "afterbite pen" (meant for bug bites) for itchiness.  Still experiencing outbreaks as recent as 12/8/2022.
sinus tachycardia for 2 hours, rate up to 171. required ER visit for 2.5 hours. associated dyspnea and delayed onset rash later in day. Not given epinephrine. treated with IV saline and observation.  Symptoms began within 1 minute of administration of IM vaccine
I've had 5 Pfizer shotsm every booster you can get and I still got Covid; I've had 5 Pfizer shotsm every booster you can get and I still got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had 5 Pfizer shotsm every booster you can get and I still got Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
PAIN AT INJECTION SITE; FEVER; SEVERE BACK PAIN; HEADACHE; RINGING IN THE EAR; CLOUDY VIAL CONTENT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: L-1805020, and batch number: L-1805020 expiry: 25-MAY-2021) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced pain at injection site. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced severe back pain. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced ringing in the ear. On 05-MAR-2021, the subject experienced cloudy vial content. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and ringing in the ear on 06-MAR-2021, was recovering from severe back pain, had not recovered from pain at injection site, and fever, and the outcome of cloudy vial content was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# M025185, expiry date 18-MAY-2018; exact dose, route of administration and albumin status were not reported), and with an improperly stored dose of VARIVAX injection (lot# M037008, expiry date 25-AUG-2018; exact dose and route of administration were not reported). Both doses were reconstituted with properly stored sterile diluent (MRK). The doses of the vaccines were exposed to a temperature excursion between 47 and 77 degrees Fahrenheit, on an unknown date, for a time frame of 24 hours. There were no previous temperature excursions. A Digital Data Logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a 69 year old male consumer reporting on himself, with penicillin, erythromycin and sulfa drugs allergies and a history of heart attack (11 years ago), who on 26-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapy included "a lot of medications, including heart medications". The consumer reported that "within a half-hour to an hour" of being administered the vaccine on 26-JUN-2012, he got a headache that was still present. No labs diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient did not seek medication attention. Additional information has been requested.
Constant vertigo, fevers on and off, flu-like symptoms, ear aches, tinnitus on and off, metal taste in mouth, brain fog, cognitive impairment.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
AFTER ADMINISTERING PROQUAD VACCINE, THE SITE OF INJECTION INSTANTLY SWELLED INTO A BUBBLE FOLLOWED BY THE LEG TURNING RED AND HOT TO TOUCH.
On evening of 4-14-17 she states she started having fatigue and joint pain. On 4-18-17 patient describes a rash starting. Per D.O. visit on 4-19-17-Abdomen with 2 well defined somewhat annular areas of erythema with slightly raised areas. No central pore. Pruritic and "burns."  2x5 cm and 3 cm diam. Take over the counter pain medications as needed. Follow up on 4-26-17.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUL-2014, the patient received VARIVAX (lot# J003223, expiration date: 15-MAR-2015) 0.5 ml, subcutaneous, which was stored improperly. The patient received Diphtheria toxoid, Pertussis acellular vaccine (unspecified), Tetanus toxoid (reported as Pediatric TDaP booster) and MENACTRA. No adverse effects were reported. Additional information has been requested.
Both legs very red, swollen, hot to touch in area where vaccines were administered. Child woke up Tuesday morning with legs swollen, fever, tired and groggy. Doctor prescribed cortisone cream and oral BENADRYL.
mom's hx, fever of 100-103 in 2-3 hrs p/vax, h/a fever reduced w/APAP; rx Advil ped susp 1-1 1/2 tsp;
screaming x 3 hrs non-stop since shot given; significant swelling @ inject site; leg w/good color;
inflammatory reaction; Not a rash, like a bite 20-30 of them and different sizes, back of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammatory reaction) and VACCINATION SITE REACTION (Not a rash, like a bite 20-30 of them and different sizes, back of arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Biopsy (Inflammatory reaction).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammatory reaction) and VACCINATION SITE REACTION (Not a rash, like a bite 20-30 of them and different sizes, back of arm). At the time of the report, VACCINATION SITE INFLAMMATION (inflammatory reaction) and VACCINATION SITE REACTION (Not a rash, like a bite 20-30 of them and different sizes, back of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Inflammatory reaction appeared 5-7 days after receiving the first dose. Concomitant medications were not provided. Treatment information was not reported.
c/o tenderness-edema-warmth @ inject site (rt deltoid) noted erythema of the site;
Vaccine given on 6/1/04, began with rash and mild hives later that day at vaccine site and back of neck.  6/3/04: Hives on abdomen. 6/8/04, rash on groin area.  Took own prescription of Allegra.
Client received second Varicella vaccine on 07/24/2017 and the first varicella vaccine was given on 06/26/2017. When asked if pregnant or thinking about becoming pregnant client reported No and was not thinking of becoming pregnant at either visit. Vaccines were given per protocol. The client returned to office on 08/03/2017 and reported a home pregnancy test taken on 08/02/2017 that was positive. Unknown how many weeks pregnant.
Vaccine given 13 feb per pt.  one week later developed severe joint and muscle aches as well as pleuritic chest pains and fever.  By 23 Feb - sx's intolerable and pt presented for evaluation at local emergency room.  Per pt, eval consisted of blood work and CXR.  Treated for systemic rxn to vaccine with vicodin. The 60 day follow up states dyspnea on exertion and chest painf rom slowly resolving peri/myocarditis.
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.
temperature excursion for PROQUAD administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T016990, expiration date 11-NOV-2021, subcutaneously (SQ), dose/frequency reported as 0.5 milliliter (mL) x 1 dose (dose number and anatomical location were not reported) for prophylaxis (product storage error).  The vaccine administered to the patient was stored improperly for the time frame of 37 minutes in the temperature of 7.3 degrees Fahrenheit (F) on 25-JUL-2021.  This is one of several reports received from the same reporter.
Patient given MMR vaccine on 1/25/08. Patient developed parotitis, excess salivation on 2/4/08. Patient taken off work for 9 days after onset of symptoms and referred to Infectious Disease physician for one time evaluation.
Fever, Chills, Bodyache, Headache, Severe pain in lower abdomen similar to Kidney stone pain
Two days after receiving the COVID-19 vaccine, my taste and smell changed. It didn?t go away, but has been distorted ever since. I cannot tolerate eating eggs, chicken or anything made with either of those as an ingredient. The taste and smell are BOTH affected.  It is unlike any taste or smell I have ever experienced before so it is hard to explain but it doesn?t taste anything like it should and it is repulsive. It only affects anything egg/chicken related. Even fried foods, due to batter used to fry things often having eggs as a component.
8 days p/vax pt got a sudden rise in temp 102 & pt fell over w/a sz;pt had no prev sx & had a very nl day a/this sz;
Left deltoid red and swollen with small lump, swollen lymph nodes under left arm, which started 5/1/03. Seen 5/2/03. Dx'd with arthus reaction - advised symptomatic care. Return to clinic if symptoms worsen.
On 3/1/2021 at about 7:30AM, I became nauseous and my stomach began to feel tight and knotted up. The pain was so intense that I cried! About an hour later, I noticed that my period had begun. The flow was extremely heavy, dark, and malodorous. I put on both a pad and a tampon and laid down on my bed. I work from home, so I tried working on my laptop as I lay on the bed, but I couldn't get comfortable, so I signed out a short while later. I tried moving my body in a variety of positions in an effort to get comfortable, but nothing worked. Also, the menstrual flow was so heavy that the pad and tampon were insufficient protection and it soaked through my pants. I tried drinking tea and eating soup to make myself feel better, but it only exacerbated my nausea, and I began throwing up. I ended up covering myself up with a comforter and lying on the floor until I finally dozed off. In April 2021, I went to a doctor, and she told me that it was possibly a cyst and that I should just wait and see what the following period would bring. Every period I had in the subsequent months was extremely painful and characterized by dark, heavy, malodorous flow. In January 2022, my period was longer and lasted for 2 weeks. At the time of this writing, I am currently having my period, and it has already lasted more than a week. On 2/3/2022, I saw a NP. The NP conducted a pap smear and scheduled me for an ultrasound on 2/24/2022.
very bad reaction to vaccine/Postural orthostatic hypotension; very bad reaction to vaccine/Postural orthostatic tachycardia syndrome; very bad reaction to vaccine/blood pressure fluctuated so much; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included postural orthostatic hypotension from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, patient had a very bad reaction with the second dose of Pfizer COVID vaccine, patient had postural orthostatic hypotension (had this prior to the vaccine as well), Postural Orthostatic Tachycardia Syndrome (POTS syndrome) and his blood pressure fluctuated so much. Patient's mother asked can he take the booster dose, what precautions he should take and also asked that they say do not switch to Moderna for booster dose if you have received Pfizer, is that correct. The outcome of all the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.
Irregular period? about ten days after the vaccine (which was my second dose) my period came early (I am usually on a 28 day cycle that has only ever been disrupted by pregnancy or nursing). It was accompanied by very heavy cramps, fatigue and general PMS symptoms. The period was very heavy and lasted two full weeks. My typical period is four days with only a day and a half of heavy period.  When I got my third shot in  November 2021, I had a skipped period in December, followed by two irregular periods in January. I will submit a different form for this one.
Over the past week I have developed severe shortness of breath, pounding heart with slight physical exertion. I?m also experiencing extreme tiredness and fatigue.
Patient treated several times since 12/13/21 for unresolving pneumonia, cough and SOB.  Patient subsequently found to have a malignant neoplasm of the lung. Patient passed away 1/24/2022.
Feverish in evening, 12/10 102.6 temp, general ill feeling, innoculated arm swollen, very red and very sore. 12/11 temp 101, still very ill feeling.  12/12 feeling much better but weakish.  Resume normal duties 12/15. 12/19 Arm still sore and hard knot at innoculation site.
Nirmatrelvir-ritonavir 300mg (150mg x2)-100mg
MMR #1 and Varicella #1 vaccines given 08/01/2003; 7 days later developed fever to 103.5, intermittently for 3 days which may have been associated with an otitis media.  About 2 weeks after vaccines, vaccine site developed progressive welt which appeared pruritic, had some serosanguinons drainage and crusted.  About 16 days after vaccines developed diffuse, predominantly maculopapular non-pruritic rash on trunk, arms, face with a few vessicles and crusted lesions.
pt recvd vax & exp hives; tx DPH, Vistaril, Tagamet & Celestone;
Pt presented to clinic w/ approx 3-4 d of vesicular rash on erythematous base on chest, abdomen, back, neck and upper arms.  Non-pruritic, non-painful.  No systemic sx.  No specific tx warranted.
Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) in a female patient of an unknown age 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   Company Comment   Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Information has been received from a pharmacist referring to a male patient of unknown age with no pertinent medical history and drug reactions/ allergies. On 07-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and frequency unknown), lot # K010648, expiration date: 30-OCT-2015. There was no concomitant medication. The patient was still experiencing swelling at the injection site (onset date unknown). The patient sought medical attention via going to see a doctor. No treatment was given for the adverse event and no lab diagnostics studies were performed. The outcome of swelling at the injection site was reported as not recovered/not resolved. The relationship of the adverse event and ZOSTAVAX has been requested.
Received Pre K vaccines 9/6/06 woke at 9/7 am with swollen left upper arm, pain and erythema.
fever was 102.8 and for some reason could not get it below 102; the patient was so sick for 6 hours; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 01-Nov-2020.  This case was linked to cases 2020SA308140, 2020SA308110 and 2020SA307964.  This case involved a 68 year old female patient who was so sick for 6 hours (illness) and her fever was 102.8 and for some reason could not get it below 102 (pyrexia) and, while she received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was so sick for 6 hours (illness) and her fever was 102.8 and for some reason could not get it below 102 (pyrexia), unknown latency following the administration of INFLUENZA VACCINE.   It was reported that the patient almost went to hospital. The patient will never take it again, her husband always gets one and never gets sick at all.  Final diagnosis was the patient was so sick for 6 hours and fever was 102.8 and for some reason could not get it below 102.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
On  day 5, similar to 2021 booster shot, flu-like symptoms.  Headache, fatigue, mild chills. Previous dose in November 2022 (PFIZER COVID Booster 1) caused same symptoms after 7 full days.