chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse referring to a 15 year old non pregnant female patient. The patient's concurrent conditions were not reported. No allergic reactions were known for the patient. Concomitant therapies included an unspecified birth control pill. On 29-AUG-2017, the patient was vaccinated with the first dose of intramuscular GARDASIL 9 0.5 ml, with a non-valid lot number of N003702 with an expiration date of 29-OCT-2019, as vaccination (strength and anatomical location were not reported). On an unspecified date in September 2017 (reported as ''one month ago''), the patient experienced menstruation irregular and due to it she underwent a laparoscopic procedure.   On 30-OCT-2017, the patient was vaccinated with the second dose of intramuscular GARDASIL 9 0.5 ml, with the same previously non valid lot number (strength and anatomical location were not reported), as vaccination. On 31-OCT-2017, the patient experienced dizziness and nausea while attending school and on the same date, she sought medical attention and she was evaluated in the office. No medical treatment was prescribed and no laboratory diagnostics studies were performed. The outcome of menstruation irregular was unknown and the outcome of dizziness and nausea was reported as not resolved by the time of reporting. The patient would continue to be monitored. No further information provided. The causal relationship of the events and the GARDASIL 9 vaccine was not provided. Upon internal review the event of menstruation irregular was considered to be medically significant due to a laparoscopic procedure performed.
Rash on abd-back-arms-legs consisting of scattered tiny vesicles on red base.  No fever or other symptoms, minimal itch, no yellow crusts.
2 siblings have well child check appts (10 yrs and 4 yrs), both were very nervous and moving around during vaccination time. Mother of child did really good job by holding them, but still both were really afraid and moving a lot. I grabbed the wrong tray of vaccines, I had 2, but still grabbed the wrong one. Mother of child saw and said, "I think you bragged the wrong tray" "I think that one is for my 4 yrs child." Once I notice I stopped and explained MOC about the incident. Explained technically patient got extra vaccines today and it wont hurt patient. Explained will speak with Dr about this incident. MOC did not argue, states agree and continue to vaccine patient.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 20-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up.  She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again.  It's like she is having allergy and hay fever type symptoms.  The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.  She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Started around 7pm with massive headache and light sensitivity, then by 10pm started running fever  that lasted until morning and ranged between 100.7 to 101 F.  Fever broke around 4:30am and gradually returned to normal temp by 9am.  Since fever started and continue to have: chills, skin sensitivity to touch, nausea, headache, fatigue, and body soreness.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 12-APR-2017, the patient was vaccinated with one dose of improperly stored VARIVAX, (lot#, expiry date, route of administration and anatomical location were not reported). No adverse experience was reported. The data logger was involved. VARIVAX, went through the following excursion: Temperature/Time frame: -14 Celsius degrees to -10 Celsius degrees for 30 minutes; -9 Celsius degrees to 8 Celsius degrees for 5 hours. There was no previous temperature excursion. Additional information has been requested.
04 4/11/21, I began experiencing shortness of breath I feel the need to take a deep breath. I'll try doing so and I can't get a full, deep breath. I'll wait and try again. I'm eventually able to get a deep breath, but moments later, I'll feel the need again & the same process continues. I've seen 2 doctors & they both think it's anxiety. (I was tested for covid & it came back negative). I honestly feel the vaccine did something to me. I was prescribed anti-anxiety medication (hydroxyzine pamoate 25mg), but it doesn't seem to be helping.
This is a spontaneous report from a contactable consumer who reported for the mother-in-law. A 67-year-old female patient received a single dose of PREVNAR 13 and a dose of influenza vaccine in Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. In Nov2016 she had an injection site reaction with initially limited arm movement and then progressed to becoming swollen and red. She has since taken ADVIL for the swelling and pain as well as applied an ice pack to the injection site. The final outcome of the events was unknown.
pt recv vax 19APR96 & pt broke out w/chickenpox 18JAN97 & was seen by MD 20JAN97;
I am bleeding & bruising & the bruising just appears I am not hurting myself or anything & if I get a scratch or little cut it bleeds for several hours. I am now on Cyclophosphamide & prednisone
Hours later I had pain at the injection site and in limbs, inside my muscles. I could not move my arm or hand. It is still affecting me today and I have limited movement. I went to my PCP and I had an MRI. I had some injections. It is still painful.
tired; 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 FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medications was provided.   This case was linked to, INC.-MOD-2021-081741 (E2B Linked Report).; Sender's Comments:, INC.-MOD-2021-081741:Cross-Linked to wife case
pt recv vax 24OCT96 & pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist relater there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by pharmacist;
no adverse effects reported; improperly stored MMR II was administered on 15-AUG-2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-AUG-2019 (also reported as 16-AUG-2019), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, subcutaneously, lot # R027063 and expiration date 20-SEP-2020 (exact dose was not reported) for prophylaxis. The temperature was 70 F with a time frame of 4 days. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. The outcome of product storage error was unknown.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA007236:
Approximately 24 hours after vaccines were given, child developed redness and swelling which initially was small area and progressed to left upper arm. In ER Benadryl was given to r/o allergic reaction. No change noted. Admitted for IV antibiotics and area so responding treatment.  6/1/07 Received hospital medical records which reveal patient experienced near circumferential redness, swelling, warmth & itching of his injection site left arm from shoulder to elbow the day after vax received.  Admitted to hospital 3/27-3/30/07. Started on IV antibiotics & peds ID consult done.  Improvement noted by d/c to home on continued oral antibiotics & close f/u w/PCP. FINAL DX: reaction to vaccine & cellulitis.
SUBJECTIVE: HPI: Patient is a 79 y.o. year-old who presents today as a follow up  visit to discuss:   Medical Issues:  COVID vaccine reaction Saw Dr.  Felt symptoms most likely a vasovagal reaction.  Recommended Moderna mRNA vaccine to reduce risk of repeat reaction.     Patient states that she is looking to get a different vaccine.  Has a lot of concerns about getting vaccinated.  Also understandably worried about getting COVID.
Woke up in the middle of the night and her left arm was really hurting. The next morning, she noticed that the backside of her shoulder/arm all the way down to her wrist was discolored, darker than the rest of her skin. It does not hurt or each. She describes it as it looks like the vaccine ran down her arm.
EXPLOSIVE DIARRHEA OUT OF THE BLUE JUST THE 1 TIME AT HOME
Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/25/2021 in the morning. Per her hospital admission note, she stated that she felt fine, stood up, became dizzy and was able to lower herself to her chair then went unresponsive for a few minutes, but did regain consciousness. When she arrived to the emergency department, she was in atrial fibrillation with RVR with rate in the 140-150s. While the AFib is long standing, the RVR is new and potentially unexplainable. This was resolved with cardizem drip ending at 2220 on 01/25/2021.   Alternatively, this patient is being put into VAERS as there are 2 other patients hospitalized with cardiac issues and received vaccine from the same pharmacy with the same lot number.
Patient has experienced muscle and shoulder pain since the injection. She received BOOSTRIX on the same day in the other arm and it has been fine. Patient has had to seek medical treatment for the issue.
Fatigue, weight gain, pain in feet upon awakening, flu-symptoms, fever and sore throat. The annual follow up received on 7/17/03 states, "since vaccie I have suffered with chronic fatigue and over the years I've developed severe joint pain in both feet and now my knees. I have had nerve conduction tests done because my toes are numb. I have never had problems with my feet before the vaccine. Just recently I had MRI's confirm chronomalacia in my knees. I believe I probably have rheumatoid arthritis but no one has diagnosed that yet. I don't know why maybe because I'm 36 and RA usually occurs later, don't know."
At 3:00am on 1/9/2022, patient woke with chest pain, difficult to move entire body, and difficulty breathing. Pain at injection site.
Pt stated experienced discomfort and cramping from the first shingrix vaccine (right arm). Once the second vaccine (right arm) was given, pt experienced severe muscle cramping, diarrhea, flu-like symptoms, spine tingling. She believes the vaccine caused her fibromyalgia to flare. She was in severe pain, was considering going to the emergency room, but did not.   Vaccine info for 2nd vaccine: Lot N4C23 EXP: 11/15/21, Diluent Lot: ks549 EXP: 1/29/22 Vaccine info for fluzoneHD: Lot: UJ221AB EXP: 04/01/20
Swollen lymph nodes, extreme in left armpit going on day four and has not subsided. Have been using warm compresses and acetaminophen daily.
Severe chills for 4 hours (10pm to 2am) starting on April 10th, 2021 Fever of 103 at 1:00am on April 11th, 2021. Fever went down after 600mg of Tylenol. Fever would come back every 6 hours. Continued to treat with 600mg of Tylenol.  Nausea and fatigue for 24 hours starting 10pm on April 10th, 2021 Headache and migraine starting night of April 12th, 2021 and continues Uterine cramping and menstrual breakthrough bleeding starting morning of April 13th, 2021
1/6/21 Large swollen lymph node noted to R axillary area, pain returned to R upper arm at injection site 1/7/21 large red circle appeared outlining injection site on R upper arm. Appointment with physician and antibiotic, Bactrim DS, ordered for cellulitis. Ultrasound R breast and R axillary ordered
5 inch band (below injection site) of redness and swelling, cold compress applied night of 11/14/07.  11/15 - patient said getting better, swelling gone down.
Patient suffered a stroke, prior med history is unknown, currently hospitalized, length of time unknown, cognitive, memory, expression, use of right side fully impacted.
Anaphylaxis  Narrative: After immunization felt nauseated and was diaphoretic, B/P 70/42, HR52, Fio2 100%, RR 12. IV 18g started left AC she appeared initially to be a vagal response. NS initiated and then she started complaining of throat issues and  not being able to move arms. HR decreased to 40 and 1M epinepherine 0.3mg given left deltoid. Fluids NS rapid infused and 50mg of benadryl given IV. 02 at 10 1pm via none rebreather started. VS 126/67, 84, 20 100% 02 sat. Taken to the  ER for further evaluation.
mom stated pt screamed like had never done a/for 10 mins & MD ruled a rxn;
This spontaneous report as received from a medical assistant of physician via company representative refers to a 12 month old infant (gender unspecified). This case is referring one infant out of the twins who developed a red lump at the injection site after administration of VARIVAX (Merck). Patients medical history, drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with VARIVAX (Merck) subcutaneous injection, (lot number: J006732, expiry date: 30-MAY-2015), 0.5 ml, subcutaneous in the right thigh. Concomitant therapy reported as none. The medical assistant reported 12 month old infant developed a red lump at the injection site after administration of VARIVAX (Merck). The infant was evaluated at a local urgent care facility and were diagnosed with a local reaction from the vaccine. The patients are scheduled to be evaluated by the physician on 13-FEB-2014. No treatment was given for the event. No lab diagnostic studies were performed. No product quality complaint was involved. The outcome of event was unknown. The reporters causality assessment for the event local reaction from the vaccine with the therapy of VARIVAX (Merck) was not reported. No further information provided. This case is linked with case 1402USA009360 as sibling report. Additional information has been requested.
Chills, fever of 102.5 F night of injection  vomiting, diarrhea, flu-like symptoms, sore arm with swelling and itching at site of injection, fatigue day after injection no symptoms 2 days after injection
Initial report received from a health care professional on 13-Sep-2013. A 57-months-old patient administered with FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Vertigo with involuntary eye movement when trying to get up and any time I moved my head even lying down.  Next day on 7/14/2016 8AM, lessening of severity of vertigo, but general dizziness and the mind feeling "foggy" and unable to concentrate.  No sign of fever or any other symptom.
Patient was nervous and anxious about receiving vaccine. He stated he hates needles and may pass out. Gave vaccine at patients request. He stated he needed to get it for a job. After receiving the shot, patient became warm and clammy and his head started to bob with his eyes wide open. He did not respond to me calling his name. I held his head up and tapped his arm. He responded saying he had a weird dream. One of my technician got him a bottle of water and he took a few sips. said he felt like he was going to vomit. put a garbage can in front of him. He sat in the counseling room for another 10 minutes or so then moved out to the waiting area where it was much cooler. Stayed there until he felt fine to walk. His color looked much better. His friend was with him and told me his mother said this happened to him one other time.
Elevated liver function enzymes; Swelling and pain at the injection site; Swelling and pain at the injection site; This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (lot# K009770 and expiration date October 2015) subcutaneously (dose and frequency not reported), diluted in Merck's sterile diluent (lot# and expiration date not reported) for prophylaxis.  On an unspecified date in 2014, the patient experienced elevated liver function enzymes (hepatic enzyme increased), as well as swelling and pain at the injection site (infusion site swelling, injection site pain). It was reported that the patient sought medical attention due to the events, but it was unknown if the patient received any treatment. At the time of the report, the outcome of the events was unknown.  The causal relationship between the suspect therapies and the mentioned events was not reported.
At approximately 10:32 AM, client arrived to vaccine site and requested a second Moderna vaccine. Per Nurse, client stated, "I'm here for my second Moderna dose". Nurse proceeded to administer second Moderna vaccine (left arm, LOT # 068H21A, Expires 4/2/22, at approximately 10:32 AM on 03/26/2022   and verified client's COVID-19 vaccine card which displayed one first Moderna on 04/20/2021.      At approximately 2:45 pm, staff member reported to Lead Nurse and Nurse that client's record displayed 2 doses of Moderna vaccine (04/20/2021 and 12/31/2021)  and staff stated that client "needed Moderna booster, not a second Moderna dose".  Nurse called client twice to attempt to clarify client's vaccination record.  Nurse left 2 messages with a return phone number on 3/26/22 and 3/29/22).  No response from client.  No further details left on client's voicemail.
Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to when I had Covid.
I need to go back to my records because this was so long ago. Bare with me, I kept track of all of my symptoms. It started out with fever and chills at the same time just hours after the vaccine. The fever wasn't a major part at the time, the chills and diarrhea and throwing up all at the same time. Everyone kept saying it would subside within a few days but it didn't. For almost ten days I was bed ridden. Head pounding and everything like that for ten days I was bed ridden. Everyone I know just kept saying, "yea yea that is normal". The major, major symptoms were chills but running a fever at the same time. Every muscle, even ones I did not know I had, Hurt like I had been run over. Like I had said I was throwing up and also diarrhea. I even had to call my husband away from work. He had to stay home and take care of me. And I am still not back to normal. And since that first shot I still am not back to normal, I do not have a full appetite. I was supposed to get my 2nd shot on Friday at 21 days. But I missed the appointment, and I am not sure if I should even get it but my DR says to go ahead. I saw my DR and she knew what was going on during this time.