chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Nurse reported an adverse event 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again 100 adult male patients were involved.  Treatment information was not provided.  This case contains information for 50th of 100 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Moderna Covid Vaccine EUA  After almost two weeks, I developed an area of redness at injection site, approximately 2'x2" with tenderness, hot to touch,. Articles call it "Covid Arm"
Convulsing; Really sick; Twitching; Sore arm; Armpit swelling; Whole body hurt; 102.7°F fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced SEIZURE (Convulsing) (seriousness criterion medically significant), VACCINATION COMPLICATION (Really sick), MUSCLE TWITCHING (Twitching), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Armpit swelling), MYALGIA (Whole body hurt), PYREXIA (102.7°F fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, SEIZURE (Convulsing), VACCINATION COMPLICATION (Really sick), MUSCLE TWITCHING (Twitching), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Armpit swelling), MYALGIA (Whole body hurt), PYREXIA (102.7°F fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-301455 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Post vax, the pt developed a mild fever and diffuse myalgias. She also developed significant local edema with erythema/pruritus. 72 hours post vax, the pt developed 5-6 cm diameter area of induration, erythema, and warmth around injection site.
At 1155 Patient reported feeling like mouth was swelling and being flushed.  Cheeks were flushed.  No shortness of breath noted.  Patient was administered 50 mg of oral Benadryl at 1205.  Blood Pressure was 160/90, pulse 99, Oxygen Saturation 99% on Room air.  Patient reports not feeling short of breath.  Patient reports this has happened previously and has taken Benadryl.  She did take Zyrtec prior to arriving.  Patient was able to have conversation with no difficulty.  She drank water and a juice box with no problems.  1218 blood pressure was 142/88, pulse 95, Oxygen saturation 96%.  Patient did not report any improvement at that time but did not feel like she was worsening.  Visually patients cheeks were not as red or flushed as when she first was being assessed.  At 1226 patient blood pressure was 142/94.  No change in symptoms but symptoms not worsening.  Patient reported wanting to go home and lay down.  Patient repots that she feels fine to go home with no further assessment or treatment.  Provider did review symptoms with patient, listened to lungs, and reviewed vital signs.  Provider advised if she felt ok to return home then was able to leave.  She was educated to continue to monitor signs and symptoms as the day progressed and to call 911 if she worsens.  Patient left clinic with friend who brought her.
started the day p/vax pt had high pitched scream, inc irritability, clumsiness-all lasted 3 1/2wk then completely resolved;no fever noted;
Brain Seizures Stop Dead on movement Extreme Muscular Pain Extreme Bronchitis with green sputum Lame leg on left side Red Cell Count was low
A few minutes after administering Moderna vaccine, pt stated she was hot. I went over to the observation area to check on her. She was starting to show symptoms of vasovagal effect (pale and dilated pupils). I had pt elevate her legs and gave her cool paper towels, within minutes she was better. She never lost consciousness. We had her remain in the observation area for at least 30 minutes after symptoms started.
This case was reported by a consumer (the subject's mother) and described the occurrence of stomach cramps in a 9-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 17 September 2011 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced wrong vaccine administered. The subject was younger than the indicated age for administration of FLULAVAL. On 3 October 2011, 16 days after vaccination with FLULAVAL, the subject experienced stomach cramps. On 4 October 2011, the event was resolved. The consumer reported that her two children had experienced adverse events after vaccination with FLULAVAL. See case ID A0949171A for details of the other report. Follow-up received from a healthcare professional on 07 October 2011: Concomitant medications included salbutamol sulphate. The healthcare professional reported that the subject received FLULAVAL vaccination at his father's work clinic. The healthcare professional reported the maladministration only and did not provide any adverse event information.
Vertigo, Ringing in Right ear, loss or muffled sound in right ear, headaches, jaw soreness right side, neck pain right side
patient said she got the vaccine and a few hours later she noticed arm was swollen and painful. Swelling  continued through out the night and ended up past her elbow
RED, SWOLLEN, PAINFUL AREA AT INJECTION SITE (HOT TO THE TOUCH) JOINT PAIN IN ELBO AND SHOULDER MUSCLE PAIN IN ARM INJECTED
Both of my legs were itchy and then progressed to my arms and back and eventually my whole body. When I scratch it, it turns into hives; 11/20/21- the itching comes and goes. I had swelling in my throat that lasted for 12 hours. I was referred to an allergist.
Pt received COVID booster and high-dose flu shot on 10/11/21, 8 hrs later had chills, fever, and cough. Dx'd with pneumonia Nov 3rd, then found to have swollen submandibular glands around Nov 9th. 11/14/2021 70-year-old female, non-smoker, who has been treated over the past month for progressive cough and shortness of breath. Symptoms started mid October and for a week or so she tried a number of over-the-counter medications. He was then put on a course of amoxicillin. A chest x-ray in November 3 showed some mild basilar infiltrates and she was put on doxycycline. She had a course of prednisone as well. She began to develop fever and worsening cough this week and on November 11 had a chest x-ray that showed increasing infiltrate. She was therefore put on azithromycin and cefuroxime on Thursday, November 11. She came to the emergency room tonight after having shortness of breath with home oximetry showing sats 89 to 90% and temperatures to 102. She describes her cough is dry and nonproductive. She had one episode of vomiting with a cough. She has noticed over the past week or 2 significant the swollen lymph nodes under her jaw as well. She has had some mild diarrhea. She has had a Covid vaccine and Covid PCR was negative tonight as it was on November 9. She says that ever since her teens she has had occasional bronchitis but is never persistent like this. She never has smoked tobacco. She is no pulmonary toxic exposures
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-MAR-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and for the long term prevention of shingles and zoster related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 28-SEP-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Mom reports that the injection site is red and indurated. Rash started approximately 24 hours post injection and lasted 3 days. No pruritis and no aches/pains.
Received A Dose of Heplisav-B, and a Dose of Engerix B; Initial Report Received on 20-Mar-2023  This spontaneous report was received from a pharmacist regarding a 48-year-old female patient who received Heplisav-B for the first dose and Engerix-B for the second dose.   Medical history was reported as unknown.   Concomitant medications were not specified.    On 11-Aug-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, and NDC were 43528-002-01), was administered.  On 20-Sep-2022, the second dose of a hepatitis B vaccine administered, which was Engerix-B.    The reporter stated that there was very little information regarding the patient as they had received the 2 prior doses "at a different place".  The reporter had no further information regarding the prescriber or the Heplisav-B dose in question.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Large red, itchy inflamed area at injection site - about a 3-4 inch oval area. Looks like a giant hive.  Still present. No treatment.
Uncontrollable shaking/convulsing, high fever, hallucinations, loss of coordination, chills, extreme muscle pain, extreme fatigue, mild nausea/abdominal pain. Shaking stopped after a couple hours. The rest of the symptoms took 24 hours.
Next day post vax, the pt developed a fever of 102, irritability, and tiredness. Symptoms resolved with Tylenol and time.
pain in his chest, near his heart; This is a spontaneous report from a Pfizer-sponsored program.   A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, after having his first dose, on an unknown date, he developed pain in his chest, near his heart. He told that he would get to an "appointment with his doctor because the pain he felt was going to calm and it had not and he did not want the second dose to be worse. Reportedly, he had an appointment for his second dose on Wednesday. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Received undiluted Pfizer Vaccine, no adverse reactions noted or reported, no additional treatment needed
I have feel racing heartbeat on 1/6/2023 and 1/7/2023, I have developed symptoms of shortness of breath and chest pressure on 1/8/2023, I still feeling bad on 1/9/2023
pt recv vax 30APR97 & states had a h/a & was given APAP;11:50 itching on neck;1:00 pt went to nurse for spots on neck, had welts on neck, was taken home welts progressed to neck, stomach, hip & upper legs;
fever is around 102/ pretty seamless fever for past 18 hours or 19 hours; I am also achy, body aches; Headache; I feel like I have the flu; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported for himself  that he received the second dose of BNT162B2 (Lot number: ER8731) at single dose on 24Apr2021 for Covid-19 Immunization.   Relevant history included the patient may have some immune condition but was not established yet but he had done blood work and he may have some autoimmune issues. The patient had blood work done in past 6 month. There was evidence on his blood work but it's not diagnosed yet. Relevant concomitant drug was unknown.  The patient previously received the first dose of BNT162B2 (Lot number: EP7533) on 02Apr2021 for Covid-19 Immunization. After the first vaccination he did feel light headed but those were the worst thing, the light headed and the next day felt like he was coming down with something but it never got bad. The patient got the second shot (Covid 19 vaccine) about 32 hours ago and he had pretty seamless fever from 18 hours (on 25Apr2021). He was wondering what would be as his fever is around 102 (Fahrenheit) and he hint that may be contributing to and he was wondering what was a time frame to maybe be concerned, since the fever was too lasting and too high. He got the second shot of vaccine 32 hours ago and he had a fever for past 18 hours or 19 hours (as reported), he was also achy, body aches, headache. Those were the primary issues, but the fever was kind of most concerned about. He was taking Tylenol because he had been 18 hours into having a fever. He felt like he had the flu and he was surprised how was the fever been. The patient received Tylenol on 25Apr2021 morning, 500 mg probably every 5 or 6 hours because of his fever. He was drinking lot of water and trying to just rest.  The patient stated it was about 20 hours into it. It was the same unfortunately actually okay, so body ache had improved somewhat, headache worsened in the past 20 hour and fever stayed about the same (not recovered). The outcome of other events was unknown.
Armpit swollen/ lymph nodes swollen with a rash in the inside of my armpit and right breast.  I went to urgent care on Saturday (08/08/2020) Dr proscribed Cephalexin.
uncontrollable shaking; uncontrollable chills; sore arm; fever; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 65-years-old female patient who experienced uncontrollable shaking (tremor) and chills, sore arm (pain in extremity) and fever (pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   While going through a transplant many years ago, it was found patient have an antibody to Platelets, and he would have a rejection reaction if the donor platelets were not HLA-matched. During the very scary rejection reaction, it started as a chill then mild shaking, then extreme uncontrollable shaking and chills. The doctor would give me a Darvon injection to abate the reaction.    The patient's past vaccination, concomitant medication and family history were not provided.  In 2020 at 14:00, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2020, the patient developed a horrible reaction It was began with shaking (tremor) (at 19:00) and by 20:00 she woke her husband to help her because she was terrified, the shaking had become so bad and became uncontrollable. Staying under a layer of two blankets, she had put on a shirt, a sweatshirt, winter socks, and then slipper socks over those to try to abate the chills. It was not until she added putting on winter gloves that the chills began to subside a bit. But it was the uncontrollable shaking that was the most unnerving. Also had a usual post-immunization reactions of sore arm (pain in extremity) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  Event description: Patient feels shaking and chills similar to that rejection reaction to platelets with the uncontrollable shaking and chills.  The event outcome was unknown for all events.  There will be no information available on the batch number for this case.
My adverse event started on 09/06/2022 not sure about the time exactly. It was between 4th and 5th dose. I had some kind of virus not really sure. I had fever and started vomiting. I took Aleve for fever but I didn't see any doctor for it.  My back felt tight after 4th dose. After the 5th dose the tightness along with pain. I couldn't sit for long time. I was experiencing Sciatica pain in my back. I went to see my doctor on 09/13/2022. They gave me an Anti-Inflammatory shot on my back  and Cyclobenzaprine ( muscles relaxer). They did an  X-Ray  which was abnormal and they thought I had Arthritis. I  called and requested an MRI which was done on the same month where they ruled out  I had Herniated disc.  I am  recovering as of now but I have to be careful of what I do in my daily life. I have to be careful of bending or trying to carry heavy things since I still have the back pain.
Severe headache onset immediately after vaccine and continued at this severity for 3 days, patient is still experiencing a headache today but not as severe. Her eyes were severely red post-vaccine. She experienced fever/chills the day following the vaccine and persisted for 5 days. She developed a severe cough to the extent that her ribs were in pain and having to keel over. The cough persists today but not as intolerable. She describes not being able to take a full, deep breath. She took aspirin and Tylenol for the headache which did not provide any relief. She took DayQuil for the cough. Patient states she developed a tremor in both hands post-vaccine where she has trouble gripping, but no loss of sensation. Patient states she has no appetite.
Pt started with a sore neck a few hours after getting shot. Progressed to stiff neck and by the next day late morning couldn't move neck without much pain. Pt is going to contact Dr.
Patient was administered Hep B and HPV-9 vaccines, and after a few minutes, pt complained of lightheadedness. Pt re-entered vaccination room and was inclined to lay down on the floor for approximately 2 to 3 minutes. Offered pt water and then had pt sit down and wait for another 25 minutes. Both me and a colleague checked on pt periodically in the lobby. When pt left, she had notified colleague that she was feeling fine.
Swelling, red, itchy area 8x14 cm around immunization site 24 hours after injection per mom.
13 y/o F 1st Pfizer COVID vaccine 5/13, developed left eye pain started 6/5 associated with redness, periorbital swelling, and light sensitivity.  Symptoms worsened on 6/8 and able to see an Ophthalmologist who diagnosed acute anterior uveitis.  Started on topical prednisone drops.  Had2nd COVID vaccine on 6/14 and felt her eye symptoms weren't improving with the treatment until after 6/22.  Diagnosis confirmed by two Ophthalmologists, including uveitis specialist.  I am seeing her for possible Juvenile idiopathic arthritis, but this diagnosis has not been confirmed.
headache; I'm experiencing shortness of breath; pain all over my body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I'm experiencing shortness of breath), MYALGIA (pain all over my body) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I'm experiencing shortness of breath), MYALGIA (pain all over my body) and HEADACHE (headache). At the time of the report, DYSPNOEA (I'm experiencing shortness of breath), MYALGIA (pain all over my body) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Pt had some nausea and anxiety after vaccine . Pt was  OBS in car and released
This spontaneous report has been received from a nurse, referring to a 20 year old patient of an unknown gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units were not provided) injection (dose scheduled, route, lot# and expiration date were not provided) for prevention of Hepatitis B. The patient's concomitant therapies were not provided. It was reported that the patient failed to seroconvert (seroconversion test negative). The outcome of seroconversion test negative was unknown. At the time of this report, the causality between RECOMBIVAX HB and the above mentioned event was not provided.