chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss; Ringing in his ears; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st November 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix. On 8th January 2020, 2 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional Details were provided as follows: The age at vaccination was not reported but it could be 66 or 67 years. The reporter stated that, after vaccination with 2nd dose of Shingrix, the patient experienced ringing in his ears followed by hearing loss. The ringing in his ears followed by hearing loss was ongoing. The patient has scheduled an appointment with an ear, nose, and throat (ENT) doctor. The reporter consented to follow up.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      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 (Expired vaccine used).    No concomitants are reported.The patients age was reported as 76.5 years. No treatment information was reported.  The NDC ID was reported as 80777027398.  Person number was reported as 125797.
Around 1:30pm on Tuesday April 6th, I was sitting at my desk in my home office, working. I began experiencing moderate chest pain and shortness of breath. These symptoms continued to worsen for the next hour. I had difficulty breathing, and taking a full breath was painful enough to prevent me from doing so. I drove myself to the ER. While waiting in the ER, I began experiencing chills, severe joint pain, and moderate pain generally throughout my body beginning around 4:00pm, which I advised ER staff. While being examined by the ER doctor around 7pm, there was some tenderness noted in my right upper quadrant. My blood pressure was extremely high (205/130) and I developed an intense headache. I was admitted overnight and discharged the afternoon of April 7th. While the chills and pain improved on April 7th, my chest pain and shortness of breath continued for another week or so. The night of April 7th at home, I woke up several times with difficulty breathing and ended up sleeping fitfully while propped up at a 45 degree angle so I could at least breathe mostly normally. The chest pain and difficulty breathing slowly improved over about 10 days until I was no longer experiencing symptoms.
All over body aches, chills, headache, abdominal pain, diarrhea, rash in the face, hive breakout in armpit underneath injection site, nausea, motion sickness when attempting to drive, unable to wear contact lenses.
POTS, Dizziness, racing heart upon standing and walking, headache, shortness of breath, feeling of almost passing out.
My sister is pregnant and just found out that 3 weeks ago when she went to get the new maternal RSV vaccine, pharmacy accidentally gave her Arexvy instead. She?s had no negative effects thus far.
presented with SOB, cough x3d; CXR - bilat PNA; dx Covid PNA; Labs: D-dimer 0.51, CRP 17.37; Ferritin 307; Tx zithromax, maxipime, rocepine, decadron, remdesivir, zinc, Vit C, Singulair, lovenox, Initially on HFO2 2/12 CT with PE; lovenox adjusted to full dose anticoagulation;  2/15 afib; cardizem gtt for tx 2/16 converted NSR; 2/22  Developed bilat redness and itching in both eyes; 2/23 discharged with eye drops for eye infection, home O2
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 11-year-old male. Neither relevant medical history nor concomitant medications have been reported fro this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
The day after the first Moderna shot, I noticed small bumps all over my thighs. The next day the bumps were all over my torso, spreading to my arms, and a week later to my neck. It didn't itch at first but 5 days after getting the rash it itches. While noticeable if you look, you can feel it, and it turns red in the shower. I am about to call my family doctor for help with the itching and advice on whether I should have the second dose of vaccine.
I HAVE HAD A HEADACHE FOR THE PAST 2 WEEKS -I HAVE TAKEN EXCEDRIN MIGRANE AND TENSION AND IT LIGHTENS UP AND THEN COMES BACK, I'VE USED MY INHALERS FREQUESTLY- MOSTLY AT NIGHT WHEN I LAY DOWN AND SOME DURING THE DAY, AND MY SHOULDERS AND ELBOWS ARE REALLY SORE IN THE JOINTS- THERE ARE DAYS IT REALLY HURTS JUST TO LIFT A CUP-THIS COMES AND GOES. I WAS JUST THINKING IT'S JUST ALLERGIES, BUT MY DAUGHTER SAID TO CALL MY DOCTOR THAT THESE ARE SYMPTOMS OF REACTIONS SHE WAS TOLD. SO I REACHED OUT TO MY DOCTOR WHO TOLD ME TO FILE THIS REPORT.
Patient received her dose of vaccine and was in the waiting area for 5-10 minutes when she started to feel lightheaded and weak.  She moved from her chair to lay down on the floor.  I saw her do this and went over to check on he  She reported being able to breath alright, but saw spots in her vision, very weak and had a full body sweat.  After 5-10 minutes laying down she was able to sit up and drink some water and reported feeling tired but getting better.  She was fully recovered from the episode after 20-30 minutes.  No long term effect reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "P.O.T.S" (unspecified if ongoing), notes: Other medical history: P.O.T.S; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FAMOTIDINE. Past drug history included: Demerol, reaction(s): "Allergy", notes: Known allergies: Demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Sep2022 to 29Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rash; This is a spontaneous report from a non-contactable consumer (patient's mother). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date the patient experienced, the reporter stated that her son was due for his second dose of the Pfizer COVID-19 vaccine at place on 09Jun2021, but they plan to go and receive his second dose one day early and she was informed by the Pharmacist at her place that the vaccine can be refrigerated for a longer period of time now. She called to verify if this information was accurate. She stated that she thought the vaccine could only be stored in the refrigerator for 3-5 days, however, the Pharmacist told her that it can now be stored for 30 days. The reporter stated that her son received the first dose of the Pfizer COVID-19 vaccine around 19May2021, she was not entirely sure of the exact date, however she reported that he did develop a rash on the tops of both of his arms. She stated that it had mostly resolved but it was still slightly visible, and she can still barely feel it when she rubs his skin. She stated that he had very sensitive skin and he put on a shirt at his grandmother's house the night that he received his first dose, and he received a haircut that night as well. The patient's mother was not sure if the rash that appeared was associated with the shirt that he wore and the detergent that it was washed in or if it had to do with the Pfizer COVID-19 vaccine. The patient's mother wanted to know if side effects with the second dose of the Pfizer COVID-19 vaccine could be worse than with the first. She stated that her son did not really have any side effects with the first dose other than the potential rash that occurred. The patient's mother stated that she specifically had concerns about diarrhea with the second dose. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer and described the occurrence of red welt at injection site in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 11 January 2013 at 15:30 the subject received unspecified dose of INFANRIX (.5 ml, unknown, left deltoid). On 25 January 2013, 14 days after vaccination with INFANRIX, the subject experienced red welt at injection site, injection site hives and injection site pruritus. The subject developed red welts, hive and itching at local injection site. The father of the subject stated he panned to follow-up with the subject's physician and have an evaluation with an allergist on 30 May 2013. At the time of reporting the red welt at injection site, injection site hives and injection site pruritus were improved.
Information has been received from a physician assistant for the Pregnancy Registry for HPV vaccine concerning a 20 year old female patient with no known drug allergies, who on 01-AUG-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 660620/0571X) IM. On 03-SEP-2008, the physician reported that the patient was administered her first dose of HPV vaccine and was pregnant. The patient's LMP was on 22-JUL-2008 and EDD 29-APR-2009. No adverse effect was reported. Follow-up information has been received from a physician assistant who reported thath the patient experienced spntaneous abortion on 01-OCT-2009 (appreximately 10 weeks from LMP). It was unknown if the products of conception examined. It was unknown if the fetus normal. Follow-up information has been received from a licensed practical nurse who reported that the patinet had gotten her first GARDISIL injection administered on 01-AUG-2008 at their office. The patient reported to them that her last menstrual period was on 29-JUL-2008 (previously reported as 22-JUL-2008). There was no notation in the patient's chart of any concomitant medications or vaccines. It was noted in the patient's chart that she had a spontaneous abortion. The reporter reported that the patient had an ultrasound on 01-OCT-2008 which diagnosed the spontaneous abortion. The ultrasound results were as follows: irregular gestational sac, no embryonic pole or yolk sac seen. The reporter indicated that the patient underwent a dilation and evacuation (D&C) at a hospital. The products of conception were sent for evaluation but they did not have the results of the study because she was being followed by her OB/Gyn practice. Follow-up information has been received from a office manager of an OB/Gyn who reported that the patient went to the emergency room on 01-OCT-2008 with vaginal bleeding. And ultrasound was performed as stated above. On 05-OCT-2008 the patient was admitted to hospital for D&C as a result of an incomplete spontaneous abortion. The pathology results from the analysis were ; female trisomy %, 8 and 23. The patient was seen a few weeks later for her post operative visit and everything was within normal limits. All of the patient's PAP smears since have been within normal limits as well. Neither office had any record of susquent GARDISIL injections. No further information is available. The patient was seen in Washington hospitalAdditional information has been requested.
Exactly one week after injection (2/16), a rash began to develop. It started about the size of a quarter. It was a red circle and hives (?) were on the rash. It would sometimes itch. It was warm to the touch. As of 2/18, the rash has tripled in size with a clear bullseye pattern. The overall mark is about 3.5" across and 2" tall. The inner-most red circle continues to have bumps on the skin, though it is not itchy.  The rash does not hurt, but it is very warm to the touch. For any concerns about Lyme disease, I have had no contact with ticks.
Gave wrong vaccine. Due to patient's age, they should have received pediatric dose, not adult dose. No adverse reactions noted.
Could not sleep on arm for over 2 months. Loss of normal arm use-Putting on clothes, taking off clothes. pain when trying to do normal movement of upper arm. It's still there.
Within approx 12-15 minutes of injection, I began to feel slightly light-headed. I didn't say anything at the time, because it was so slight, and I attributed it to being a little nervous. It continued, for perhaps hours 3 or so hours, getting slightly worse before subsiding.  I had eaten my usual breakfast in the am before I went for my injection.
Patient c/o of severe pain 10/10 left arm immediately after vaccine given. She had stiffness of left arm causing her to miss work. I believe  she stated she had fever, chills and severe pain of left arm. After 2 weeks the ;left arm pain remains a 6-7/10
This is a spontaneous report from a Pfizer-sponsored program [Pfizer First Connect]. A contactable pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A 31-year-old male patient of an unspecified race received TRUMENBA (lot N16808 or NI6808, NDC number: 00005010005, Expiry Date: Jul 2017) for Immunization via intramuscular route in the left arm, at 0,5ml single dose on 23May2017. No medical history was reported. concomitant tm medications were unknown. On unknown date the patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236106 same reporter/drug/event, different patient.
6/29- Patient was seen in office and states that she received the Men B vaccines on 6/9. States that when she received the vaccine there was no pain. States that after the vaccine (she received vaccine in her left upper arm), started with pain at the site and trouble lifting her arm. Now she states that's he has a hard time getting up in the morning. Denies fever, diarrhea, emesis. States that she has to walk hunched over. Also with finger swelling and joint pain. States that the worst pain is in the morning and the pain wakes her up in the middle of the night.
First dose Pfizer Vaccine for Covid-19 causing RA flare-ups in arm and elsewhere after two weeks.  Second dose performed on 03/15/2021 in right arm also produced RA flare-ups after two weeks.  Nerve damage done both times at site of injection.  It has gotten better over time, but symptoms still exist today.  No treatment by medical professional.
Rash that had a sudden onset. It was present at his chin, trunk, & leg which included redness but no associated fever.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 187th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
pt recv vax 6JUN96 went to ER on 8JUN96 w/ c/o fever, hardness & redness, pain @ inj site;ER gave pt med for cellulitis of lt arm
Same day after getting second dose got a headache, site of injection was red, hot and soar, the second day had very bad muscle aches, fever and fatigue, third day started feeling nausea, fever went away fourth day, on  the fifth day starting throwing up.  Everything else is gone except for the fatigue and nausea, feels like she is going to throw up but does not.  Laying down makes her feel better, nothing makes it worse.
Patient brought in to Clinic on 8/29/2007.  Noted 3x3 cm induration with redness and itching to posterior aspect of right arm at injection site.  Per parent had gradually gotten worse over 24 hours.  Patient evaluated by Dr. and treated with Benadryl po and Keflex.  Upon follow up after 24 hours treatment, parents stated patient doing better.  Follow up after 5 days, completely resolved.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-MAY-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
I had all your listed symptoms minus the vomiting / I have a severe reaction to it; I was bedridden for 7 days.; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus (for 46 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced adverse event and bedridden. On an unknown date, the outcome of the adverse event was unknown and the outcome of the bedridden was recovered/resolved.   The reporter considered the adverse event and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that they took their first shot over a couple of months ago. They had a severe reaction to it. They had all company listed symptoms minus the vomiting. The patient was bedridden for 7 days. The patient was due for shot 2. The patient did not know if they should or not take it. The patient was very apprehensive about it. The patient had a question are their reaction considered an allergic reaction.
Admitted through ED from her nursing home after being found to be hypoxic.  Patient went into respiratory failure.  Provider note below:  "Severe respiratory failure, with existing care limitations DNR, no re-intubation. Unable to come off BiPAP support for any length of time despite HFNC, essentially using BiPAP in this manner equates to mechanical ventilation. Discussed with Guardianship case manager who was in agreement with Comfort focused care. Discussed with patient's family who were also in agreement. Orders placed and palliative treatment for symptoms related to end of life initiated, bipap discontinued ~6:30 pm. Notified by RN patient died at 6:53 PM on 1/5/2022."
facial tingling Narrative:  Experienced 1-2 episode of anterior facial tingling while driving home about 30-60 minutes after vaccination. Ran through all immediate allergic reactions, anaphylaxis s/sx, and vasovagal s/sx - which were negative.