chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered vaccine after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT  048C21A.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up contains  Non Significant information.
FAST HEART RATE; OCCASIONAL LIGHT STOMACH PAIN; HORRIBLE SKIN PAIN; SEVERE JOINT ACHES IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination (series 1).The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced fast heart rate. On 08-DEC-2021, the patient experienced severe joint aches in body. On 08-DEC-2021, the patient experienced occasional light stomach pain. On 08-DEC-2021, the patient experienced horrible skin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from occasional light stomach pain, and the outcome of fast heart rate, severe joint aches in body and horrible skin pain was not reported. This report was non-serious.
Loss of vision in lower right quadrant of left eye. Swelling of optical disc observed by ophthalmologist, retinal specialist,, neuro-ophthalmologist. Patient presented at ER on  April 14,2021 with above vision loss and pain in left ear and was later admitted. Was seen by neurology and vascular surgeons, who desired to biopsy the temporal artery (patient refused). CT scan, MRI and spinal tap were performed. Patient treated with IV steroid (1000 mg in 50 mL drip) daily for 5 days. Patient was released on April 20, 2021. Follow up visit with Dr on April 23, 2021. Further follow up with neurology pending.
Within 6 hours after shot severe chills, shaking, fever, nausea, vomiting, fever, sweating, muscle pains, joint pains. Symptoms last all night, were 90% gone within 24 hours after injection.
12/03/2021 at 3:00AM I woke out of a sleep with moderate abdomen pain, upper to mid abdomen. I have never had pain that significant in that spot before. I thought if I get up it would feel better, it subsided within an hour and I was able to go back to sleep. I did have less pain on 12/03/2021 throughout the day, it was a lower-level pain all day. I messaged my doctor the morning of the 12/03/2021. Because I did not have any other symptoms, they told me to hydrate and wait it out. 12/04/2021 around midnight I got the pretty moderate abdominal pain again. I finally was able to fall back to sleep at 2:00 AM. I have recovered from the adverse event.
This is a spontaneous report from a contactable consumer, reporting for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration in Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband both had pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shots in the beginning of Dec2018. On 01Jan2019, she was diagnosed with pneumonia and her biggest fear was that her husband can get it too because they had same shot. The patient was wondering how secure it was because she was having side effects. The outcome of pneumonia was unknown. The information on the lot number and expiry date has been requested.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Within 5-10 minutes of administration of vaccine, patient began to experience shortness of breath/difficulty breathing, itching of face and eyes, chest pain.  Ambulance called. Albuterol MDI administered prior to arrival of patient at ER at 1209.  At ER, IVF of NS started and patient given Zantac 50 mg IV x1, Benadryl 50 mg IV x1, SoluMedrol 125 mg IV x1.  Discharge medications were given and patient was dc'ed home at 1400.
This case was reported by a pharmacist and described the occurrence of erythema in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included ibuprofen and TYLENOL. On 3 December 2008, the subject received 3rd dose of ENGERIX B (20 mcg, unknown). On 3 December 2008, less than one day after vaccination with ENGERIX B, the subject experienced erythema, swelling and pharmaceutical product complaint. Pharmacist reported a female subject received the 3rd dose of ENGERIX B series on 03 December 2008. Vaccine was given in the outer aspect of the arm and by the evening, the inner aspect of the arm was red and swollen. By 04 December 2008, these symptoms had gotten aggressively worse so the subject went to the emergency room. At the time of call, subject was still at the hospital. The pharmacist indicated that the "healthcare facility does not want to use remaining vaccines with same lot number but return them". The pharmacist considered the events were disabling. At the time of reporting the events were worse. The pharmacist considered the events were probably related to vaccination with ENGERIX B.
Within ten minutes, I had pins and needles in my left hand.  Within fifteen minutes, I had trigeminal neuralgia in my right cheek.  Next morning, I had bruises all over my upper legs, arms, and breasts.  Bruising issues lasted almost a month, and I was instructed by my PCP to stop ALL NSAIDS and any other meds that thin the blood.  Within the next two weeks, I had two blood clots in my left leg after a VERY minor bump from my dog.  The lump kept getting bigger, and it got the size of half a baseball until I stopped it from growing by the application of ice.  Next day, I went to get out of bed, and my leg gave out on me when I went to get out of bed.  I could not use it at all to walk due to weakness in the leg and pain at the sight of swelling.  I put heat on it for twenty minutes, and it reduced swelling by half.  Still had difficulty walking remainder of day.  Put heat on it again in the evening, and the remainder of swelling disappeared.  When I woke up the next morning, it was black from massive bruising.  Dog bumped into me again a couple of days later, and another clot formed, and I repeated whathappenened as  stated above.  Two weeks after vaccination, I bumped my head on counter, and again, I got a bleed that did not want to stop.  Had seizure like episode with my tongue hanging out and my left side of face was drooping.
Headaches, neck pain, general body aches, nausea and vomiting.  No treatment required.
Breakthrough case admission after 2 vaccines ; pfizer 4/13/21 Lot# Ew0158;  Pfizer 5/4/21 Lot# EW0172
Body aches; Severe fatigue; Slight nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea). At the time of the report, PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745689:Wife case
Narrative:  Per Health Note on 02/25/2022, patient had a severe reaction to COVID-19 PEG component characterized by anaphylaxis. No further documentation of the reaction identified. Per Regulatory Authority review, patient received the Moderna Immunization at the Hospital, however this is not reflected by Health Authority review. Patient lacking documentation to support this ADR. No supporting documentation in database or Regulatory Authority. Per note, patient received at Public Health: Moderna vaccine x 2. Anaphylactic reaction x2 per patient Per review of medication history, patient was not taking any other medications that are well known to cause an allergic reaction. Has hx of anaphylaxis to peppermint oil as well. No additional treatment for this severe ADR or any hospitalization notes identified.
Random chest pain and heart pounding. Chest pain and out of breath when lifting medium heavy objects, taking stairs, feeling anxiety/mental stress. Plantar Fascia kind of symptoms (maybe not unrelated).  At first, I thought this might just be because my cholesterol levels have gone up and aging symptoms but later realized this is all happening after COVID19 vaccination and researched about it online to confirm it.
-Developed Cellulitis 7x3 cm on medial aspect of left upper arm with redness, heat to touch, and soreness. -Member Treated with Dicloxcillin.  -Member fully recovered.
7:50 AM 4 injections given. Immediately after completed, client was pale, moaning, extremities stiff and flexed, eyes open but unresponsive. Client was sitting in a chair assisted by myself and mother to floor. Client responded to mother's voice. Mother states client passed out prior when giving blood. Client c/o nausea without emesis, c/o being hot. Client remained on side able to drink water and eat crackers. 0800 AM Color pink but c/o severe menstrual cramps treated with heat. 0830 AM client recovered and left with mother.
inflamed lymph nodes/ lump/ cluster of lymph node; lump in neck; viral reaction; mucous / a lot of thick mucous; stuffed up; post nasal drip; injection site lump; Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of lymphadenitis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (with post herpatic neuralgia) and post herpetic neuralgia. Previously administered products included Shingles vaccine (received on an unknown date).   On 28th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 5 weeks after receiving Shingrix, the patient experienced lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the lymphadenitis and local swelling were recovering/resolving and the outcome of the viral infection was resolved with sequelae and the outcome of the mucus discharge, nasal stuffiness, injection site lump and injection site pain were recovered/resolved and the outcome of the postnasal drip was unknown.   It was unknown if the reporter considered the lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain to be related to Shingrix.  Additional details were received as follows: The patient found a lump in her right neck after vaccination. The lump was not in the gland but in front of the gland and below the gland. The patient went to her internist who recommended an ultrasound. The ultrasound showed inflamed lymph nodes and a cluster of lymph nodes and he recommended another ultrasound in a month.   The patient also reported that she had a bit of a reaction to the Shingrix vaccine including a viral reaction with a lot of mucous and she was stuffed up. The patient reported a lot of thick mucous and she took Mucinex and she has since stopped taking it but she still has post nasal drip remaining. The patient also experienced lump and soreness at the injection site. The patient consented to follow up.
Patient reported "extreme" migraine and nausea for 2-3 days post vaccination.
Feb 1 symptoms: Fever reaching high of 103.5, shortness of breath, mild intermittent chest pain right of center, high heart rate (105-139 bpm vs 70 resting), red lump slightly larger than a quarter at injection site, and pain around injection site. Feb 2 symptom changes: less frequent/severe chest pain, ~100-120 heart rate, fever 101.5, swelling and intense pain in armpit (lymph node?), injection site spot grew to slightly smaller than a half dollar, injection site pain, and shortness of breath still present.
Received H1N1 vaccine on 12/6/09 4pm. 24 hrs later: chills, fever 101-102, headache, scleral injection. 48 hrs later: facial rash. 72 hrs later: much improved low grade fever.
(Janssen) use for COVID-19 under Emergency Use Authorization (EUA): COVID-19 under Emergency Use Authorization (EUA). While speaking with a patient for a clinical assessment, he reported having a fainting episode after receiving his COVID19 vaccine. When asked about specific circumstances, he reports getting up that night and falling. He described it as "his feet coming out from under him". Unfortunately he wasn't able to provide additional details surrounding the incident but he clearly felt that the vaccination and his symptoms were linked.
Has shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Has shingles) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HERPES ZOSTER (Has shingles). At the time of the report, HERPES ZOSTER (Has shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. Patient has scheduled her second dose on 15 Feb 2021 and wanted to start treatment and asked an antiviral drug can conflict her second dose which was scheduled.
Almost 3 days after receiving the Moderna Booster, I have broken out with the worst case of cold sores on my lips and sores inside my mouth. To the point I cannot eat and barely drink. I have had herpes simplex 1 since I was a child but never have I experienced ANYTHING like this!  All I can do is wait it out and use the topical treatment creams but I cannot go outside or to work like this!
Patient got a rash on the arm she received the flu shot a few days after administration. It then spread to other arm, chest, and back. Rash still present after 1 month. Patient tried peroxide & rubbing alcohol. Would scratch the bumps open & they would bleed.
0400 Woke up, felt weak and sick, passed out on toilet.  Husband transported to ER.  Full body convulsions, weakness.  Treated with Benadryl and Dilaudid via IV.  Discharged to home after feeling better.
7JUN91 devel sore throat, malaise, lymphadenopathy, stiff neck, fever; 12JUN92 awoke w/rash; 14JUN91 awake w/severe aching/pain in hands, ankles, rt big toe; 16JUN91 awoke w/swollen hands & fingers, wrists, ankles; pt cont to exp arthralgia
Tinnitus- ringing in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route on 27Feb2021 at 10:30 hours in the left arm (at the age of 65-years-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history of the patient included high blood pressure and shellfish allergy (clams). The patient previously received Claritin (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication and experienced drug allergy. The patient received other medications (unspecified) within 2 weeks of the COVID-19 vaccine. The patient did not receive other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route on 06Feb2021 at 10:30 hours in the right arm as single dose for COVID-19 immunisation. Since the vaccination, the patient was not tested for COVID-19. On 01Mar2021, the patient experienced tinnitus- ringing in right ear. No therapeutic measures were taken as a result of the  reported event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of tinnitus- ringing in right ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Itchiness and hives 10 days later.  Went to urgent care and was prescribed Benadryl, Claritin, and Famotidine. After breaking out in full-body hives on day 13 after moderna booster, I went to out of state dermatologist  and was prescribed a prednisone taper. I am still experiencing rashes and some breathing/chest spasms, so my local dermatologist has me taking Zyrtec twice a day. I have an appointment with an allergy specialist in 3 days. I have been messaging with my primary care provider.
Pt. Reports fever and malaise which began approximately one week following vaccines. Pt. States she developed pruritus and vesicle/lesions on her trunk, back, arms, and face. Lesions persisted for a month before resolving.
Woke up in the morning with a really sore throat and possibly an ear infection because my ears hurt. I went to get tested for strep and that was negative. They tested me COVID and I was positive. I had traveled and that is where I must have gotten COVID. During the time frame of having symptoms I really did not have any COVID symptoms and only experienced those I mentioned that I thought were strep.
Started with itching at injection site on Monday, April 5, exactly one week after shot. Welts appeared, and it looked like a red potato on my left arm.  Used hydrocortisone cream during the day and took Benadryl at bedtime. Tuesday, April 6, rash had spread farther down my left arm, and the itching was unbearable. The rash area was hot to the touch and swollen. Put ice on it for 30 minutes with no relief.  Contacted PCP and sent photos. Went to doctor office late in day on April 6, and received steroid injection and  cephalexin 500 mg prescription. Wednesday, April 7,  rash and swelling had spread to my elbow, and it looks like a jelly sac with fluid at my inner elbow. Itching a lot. Talked to PCP, and they told me I could take Benadryl in addition to having the steroid shot and taking antibiotics. Will do that at bedtime tonight.
I woke up around 7am feeling fevered and my arm felt fevered as well. The injection site was swollen like a baseball and very painful (1-10) 5. I was able to lift things, but it was very uncomfortable and painful. I took 100 milligrams of Tylenol and it helped with the fever but not with the pain in my arm. The medication was taken within an hour of me waking up. The fever only lasted for 24 hours but my arm lasted for the next 3 days. The pain in my arm was bad and the pain stayed at a 5 until about 3 days later the pain subsided.
Pt reported area under armpit was swollen and raised the day after the shot. Reported got larger and larger and was filled with a fluid (jelly-like) substance. Went away by 3rd day.
Swelling in the right arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received approximately 1 year ago from day of reporting).   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 71 or 72 years. The patient received vaccine in unknown arm. The patient mentioned that she received a flu vaccine (unknown manufacturer) sometime last week and experienced swelling in the right arm. The VAERS details were reported for 1st dose of Shingrix. This case was 1 of the 3 cases, reported by same reporter. The reporter consent to follow up.
The next after I got my shot, I was feeling fine. About 9AM, I was feeling little off. About 10am, I felt sweaty, clammy, and light-headed. I was just standing there. Then I fainted. I was clammy and had no color. They called the ambulance. They checked me out. I went home. I feel fine now.
diffuse itching/urticaria and dermatographia 24 hrs after vaccine- starting w hands/feed and moving centrally