chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose in Aug2021 and 3 weeks after given the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given the 2nd dose) 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.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in Aug2021 and 3 weeks after given the 2nd dose) outcome was unknown.            Agent confirmed that they got the Moderna Covid-19 vaccine. Vaccination card was not with the caller during the call.  Caller wants to set an appointment for the booster dose.  No concomitant medication were reported.   No treatment drug were reported.
About 10 minutes after recieving the vaccine, I felt dizzy and weak, but assuming this was due to the normal histamine and blood flow reactions I have when confronted with new things in or near my body, I thought everything was fine. That night, however, I felt very anxious but oddly giddy. I couldn't sleep, even though I tried everything to make myself fall asleep. It was a sort of out of body experience, as I normally would have become frustrated and gotten up to do something, but I just laid there and stared at the wall. Around 3, maybe 3:30 AM, my limbs started to feel extremely heavy and achy. This feeling traveled to my whole body, and I started to feel like the aches were radiating from my spine. After about 30 more minutes, I became extremely disoriented, and it felt like the room was spinning. My vision was very blurry, and was fading in and out from black. At around 5 AM, I got up to use the restroom, but passed out for maybe 5 seconds, after a few steps. When I woke up, I was very nauseous. I was trying not to vomit, because I had an tube in, but it was the most intense feeling of nausea that I think I've ever felt, and I ended up vomiting forcefully (it was only bile, but a lot of it. I should also mention that I hardly ever vomit, as my gag reflex does not work very well). Because my tube came out when I vomited, we had to call the ambulance, but oddly, I felt almost completely better after vomiting-- the only symptom that remained was slight dizziness and stomach pain from my tube being vomited up. However, at the ER, I had a fever of 101.3 F, and moving was beginning to increase my stomach pain. The nurse pulled my tube out (it had been dangling out of my mouth and nose), and gave me Zofran (I do not remember the specific dosage). By around 6:30 AM, my fever had decreased to 99 F. I was discharged from the ER shortly after 7 AM. By Monday (November 1) evening, my symptoms were entirely gone (although I felt sick from my tube being forcefully removed when I vomited, and had just a few residual aches). Currently, I feel like I have recovered other than my tube being out (therefore I'm unable to receive all the nutrients I need). We are working on getting an appointment for a replacement tube.
After count of daily vaccines administered, it was discovered that patient was probably given Pfizer dose from 6m through 5th birthday lot. Patient was 5 years and 5 months old at the time of vaccination. Telephone call with, patient's mother. Patient was re-vaccinated per CDC recommendations on 9/16/22 with the appropriate Pfizer product. No signs of adverse reactions on 9/16/22. Telephone call to mother 9/19/22, Patient and his sibling are both experiencing stuffy nose, sneezing, and mild cough since 9/17/22, home covid testing is negative. Discussed how these symptoms are unlikely a vaccine reaction. Encouraged mother  to reach out to agency with any additional concerns.
Patient reported that her lips and throat were tingling at 3:07. Her cheeks were flushed and her neck under her jaw was reddened. After observing patient and asking a few questions (no difficulty breathing or swallowing, no injection site soreness or swelling), I decided to give her 25 mg of diphenhydramine syrup at 3:15.  Gave her a cup of water.   3:28 : BP  was 155/93 P 88 R-16.  Patient feeling lightheaded and still flushing at 3:33, so I gave another 25 mg of diphenhydramine (after deciding 180lb required 50mg diphenhydramine).    3:53 BP was 133/87 P 73.  4:05 Patient reported feeling better.   Patient left at 4:20.  Patient was instructed to call 911 if symptoms arose again.
I called into both of my drs for what I thought was a reaction to the vaccine activating Shingles.  Very similar pain with the exception of the shooting pain/burning down legs and up into face. Mid section, spine & stomach were on fire.  For days I couldn't get out of bed and was so exhausted it was difficult to walk to bathroom. My heart felt like I was having an attack, with severe pressure &pain.  Shortness of breath where'd I have to stop every few feet to catch my breath. Nearly went to the ED multiple times, and probably should have. For weeks this went on while I took antivirals for Shingles.  Although I never had the rash, I decided to continue on a 2 week regiment.  It took months before my heart would allow me to walk without stopping to catch my breath get relief of the pain. I still experience pains today in the lumbar area that wraps around to my pelvis.    AS of today, Monday Nov. 14th, 2022, I am still struggling with swollen lymph nodes, pain and fatigue.    My PCP has listened to my heart and doesn't hear a murmur.  I've autoimmune diseases which could contribute to my reaction this particular time (3rd booster).  I am not sure if the agents in the vaccine were different this time, or if my immune system just had enough on whatever I had come into contact via the shot.    I have NEVER, ever had any reactions to any vaccines throughout my life.  However, I wanted to make note of this particular episode since I am still dealing with lingering symptoms.  As always, I believe in vaccinations for the good of public health.  However, It might be in our best interest to study how a disregulated immune system might react differently when vaccinated with CV19. Major inflammatory response
This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered ROTATEQ (lot: L013206; expiry: 29-JAN-2017) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger.  This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA010325:same reporter.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 30-NOV-2011, the patient was vaccinated with improperly stored VARIVAX lot#: 669601/0138AA, dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Started with a sore arm around 5:30  pm same day then began a migraine at around 3:00 am  that night. Still ongoing  7 hours later even with taking ibuprofen.
Information has been received from a physician concerning a 36 year old pt with no known drug allergies, mild asthma and a history of a traumatic splenectomy at age 16 years who on 6/29/01 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. It was noted that the pt had received pneumococcal vaccine 23 polyvalent in the past, with no problems. On approx. 7/1/01, the pt experienced severe pain and swelling of the right axillary lymph nodes and red streaks going down the right arm. The pt went to the hospital and was treated with IV and oral antibiotics. The pt was never admitted to the hospital and was released to home on oral antibiotics. It was reported that, based on clinical findings he presented within the ER, the pt was dx'd with a streptococcal infection. No cultures were performed. The pt is recovering and is finishing his course of oral antibiotics. The reported expressed a concern with the lot 1197K. Upon internal review the pt's experience was considered to be an "Other Important Medical Event".
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed  tinnitus/chronic ringing, with outcome of unknown. Additional information: Patient reported chronic ringing in her ear since the COVID-19 vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Perimyocarditis- chest pain, worse lying, better sitting, worse with deep inspiration. Troponin elevation to 13.2. diffuse ST elevation in ECG. Normal BNP, ECHO. no arrhythmias. Admitted overnight and discharged the next day.
Severe headache lasting >24hours, aching joints, elevated temp (99-100F), loose stool x2 after 6 hours and over 12 hour period
pt recv vax; devel red, swollen area around inject site; this area began to devel pus; area looks like abscess has formed;
Fever and chills. Temp @ 104 at the clinic @ 0915 today.
Hyperemesis beginning about 19 hours after the administration of the vaccines.  He was having emesis and dry heaving q 1/2 hours.
Swollen clavicle lymph nodes. Right side lymph node is protruding from the body and can visibly be seen. I; Itchy skin and large rash on back.; Itchy skin and large rash on back.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient had swollen clavicle lymph nodes, itchy skin and large rash on back. The right-side lymph node was protruding from the body and could be visibly seen. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with steroid medication (unspecified) and diphenhydramine (BENADRYL). The clinical outcome of the events swollen clavicle lymph nodes, itchy skin and large rash on back was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Viral rash to left arm (arm that vaccination was given). Triamcinolone prescribed to the affected area.
(R) upper arm to elbow swelled. To ER Sat 10/17.
Right after the vaccine, I experienced no symptoms. I had stomach problems and I felt very woozy and had diarrhea, and I also fainted. I hit my head but not bad at all. I went to the ER. I was dehydrated and they gave me IV. They told me drink liquids and Gatorade. It did help with symptoms. They said that it could have been a virus that was going around or it was food poisoning, one or the other.
A report from a 41 year old male pt with a follow-up from a lawyer. On 7/7/99, the pt received his first injection with Lymerix at an unspecified dose with no effects. On 8/10/99, he received the second dose of Lymerix and shortly afterward he experienced severe soreness in the arm where the shot was given. Within less than an hour, the pt experienced severe unusual fatigue/exhaustion. He felt so fatigued he had to stop driving his car and rest inside his car. After a short rest he drove home and rested in bed for a few hours. He returned to his office but still felt bad. As the days passed, the arm soreness resolved. A day or two after the shot, he experienced severe soreness in his fingers, knees, hips, ankles, toes, elbows and other joint in his body. the pt continues to experience nagging pain in his finger and knee joints. The pain and stiffness is worse in the morning, however, the condition usually improves a little later in the day. He also feels slightly fatigues most of the time. Occasionally, he suffers from an overwhelming feeling of severe fatigue, the same feeling he had about an hour after the second shot.  Aspirin, ibuprofen and Tylenol have been used as treatment. The most recent information received on 2/17/00 reports the symptoms are ongoing.
administered with vaccine which underwent temperature excursion; administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 038A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that they had a temperature excursion involving 14 Moderna Covid-19 vials. She mentioned that they had 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022- plus 5.11 F which occurred for 7minutes; thermometer in the freezer and the other 2 data loggers did not record any. This was just found out when they had an inspection with the state department, and they were advised to call Moderna to determine the viability of these vaccines. 4 doses were administered to patients from one vial and the dates of administration were 12-May-2022 (1 dose), 18-May-2022 (1 dose) and 25-May-2022 (2doses). Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: freezer The vials were stored as quarantined in the freezer now. Vaccine was still frozen; frozen at that time the temperature excursion happened. 14 vials were impacted but one vial had been used to administer 4 doses to patients. The vials were not punctured and no previous excursions with the impacted vials.  No treatment information was reported.
Pt. in the evening on 1/29/14 developed a seizure that lasted 15 minutes, but was also febrile at the time. Received ATIVAN x 1 and seizure resolved.
He started to limp, favoring the left leg, although not complaining of pain. He has continued to limp since then, now x5 days, with no improvement.  No c/o pain. Still walks and plays, but with limp.   Mom noted he is tender right behind the knee (popliteal fossa).   He can bend knee ok, but cannot straighten it all the way, and walks and runs with it bent. 10/26/2016 physical exam reveals swelling of the left knee, and limited range of motion. xray negative. review of systems otherwise negative. no history of trauma known. no recent illnesses, exposures, or travel. negative family history.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (doses, injection sites, lot numbers and expiration dates were not reported). Administered doses of ROTATEQ underwent temperature excursion at 47 Fahrenheit degrees. At the time of reporting, the time frame of temperature excursion and information about the previous temperature excursions were unknown. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hives and rash about 9 days after the injection. The hives and rash are not at the injection site. They are all over my back, chest, neck and scalp. I am taking 20mg a day Zertec and 40 mg Pepcid as well as 2.5% hydrocortisone cream.
A 61-year-old man developed multiple crusted erythematous papules on face, trunk and extremities starting 2 weeks after receiving the first recombinant zoster vaccine dose (Shingrix) on October12,2020. He received the second vaccine dose on December 15, 2020 and developed increase in number of lesions worsening. Skin biopsy 2/22/21 revealed T-cell lymphoproliferative disorder, clinically consistent with Lymphomatoid Papulosis. Patient required treatment with steroid injections and oral methotrexate for suppression of skin eruption.
he had a tremendous amount of fatigue set in; he has body aches all over as well; frequent urination; punched in the left arm on the bicep where the injection site was. Caller stated it hurt a lot; This is a spontaneous report from A contactable other health care professional reported that a 42-year-old male received first dose of bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 28Jan2021 at 16:15 as single dose in left arm for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller stated he received the first dose of vaccine on Thursday 28Jan2021 at 4:15 pm. Caller stated he felt fine he went to class. Caller stated he went to bed and he didnt really have any site contact for the point of needle in the left arm. Caller stated it didn't hurt that bad. Caller stated the next morning he work up and it felt like he got punched in the left arm on the bicep where the injection site was. Caller stated it hurt a lot more than any flu shot he had ever received before. Caller stated he went about his day on Friday and then by Friday evening he had a tremendous amount of fatigue set in. Caller also stated he has body aches all over as well. Caller stated he thought his symptoms would go away after a day or so but here he was at day 5 and he was still experiencing a high degree of fatigue and he had to skip out on his internship today. Caller stated he was also experiencing frequent urination. Caller stated he was scheduled for his second dose on 08Feb2021. Outcome of event fatigue was not recovered and for remaining events it was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10-15 minutes after injection (no history of reaction after first injection.)  History of underlying cardiac problems, hypertrophic myopathy, V-Tach. Post injection syncopal episode; patient was bradycardic rate 40, pale, weak, alert & oriented x 4 . Medical staff on site ,care immediately turned over to staff, IV established, Fluids given, BS checked. Sustained bradycardia in 40s for approximately 10 minutes raising to mid 50's following fluid. Patient has a defibrillator/pacer stated that no lower demand set. Pacer for V-tach.  Patient stated her defibrillator has fired over 200 times but did not feel defibrillator fire at time of episode. Transferred  to Hospital as per patient preference stated this is where cardiologist and records are, cleared through Base prior to transferring. Seen in  ED then discharged later that afternoon.
Pt fainted about 2 minutes after receiving the vaccine. He was safely lowered to the floor, administered an epipen, and he regained consciousness withing 2 minutes.
p/vax arm sore;devel severe pain in deltoid 10/2 & 10/2 & 10/4;no fever, no itching, no systemic sx;tender deltoid;no redness, no nodule, no heat;
Markers for ESR and CR were more than double what they should be; Markers for ESR and CR were more than double what they should be; This is a spontaneous report from a contactable nurse reporting for herself. A 71-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9269), via an unspecified route of administration, on 02Feb2021, at single dose, for COVID-19 immunisation and methotrexate sodium (unknown manufacturer) (exp date 12Nov2021) tablet, via an unspecified route of administration, from 2014 and ongoing, at 7 DF weekly (it was 17.5 mg), for rheumatoid arthritis. Medical history included pain and ongoing rheumatoid arthritis. Concomitant medication included folic acid (unknown manufacturer). The patient experienced markers for ESR and CR were more than double what they should be (red blood cell sedimentation rate abnormal) in Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: more than double in Feb2021, red blood cell sedimentation rate: abnormal in Feb2021. The action taken in response to the events for methotrexate sodium was unknown.
Information has been received from a physician concerning a 6 year old female child with no medical history or allergies who was vaccinated with 10/14/1999 at another practice with the first dose of varicella virus vaccine live (lot unavailable). There was no illness at the time of vaccination. The physician reported that on 4/25/2005 the patient had developed cases of mild breakthrough (with few vesicles). The physician described it as clinical varicella. The patients present status was reported as recovered. It was also noted that the patients unvaccinated father also developed varicella. No product quality complaint was involved. The physician also reported that the patients sister also developed varicella (associated WAES0504USA04570). Additional information is not expected.