chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN presented in room to administer MMR, HPV9, Tdap, Meningococcal vaccines Patient identification verified by 2 forms. RN Patient denied any known drug and food allergies RN administered MMR, HPV9, Tdap vaccines RN unable to administer Meningococcal vaccine During vaccine administration, patient's spine arched back in chair, arms bend upward, and eyes rolled back Patient unable to communicate verbally with RN Movements lasted for approximately 20 seconds in chair RN remained with patient and called for help MA arrived first in room to help RN RN and MA slowly lowered patient to ground, RN kept hand on back of head Patient had tonic-like movements while lowering to ground Once patient was on the ground, patient continued to have tonic-like movements of body Patient positioned on right side and RN kept hand on back of head Tonic movements lasted approximately 30 seconds, no visible frothing at the mouth noted by RN Patient remained continent of bowel and bladder Patient did not have head strike of LOC PCP, resource nurse, and another RN assisted Patient's vital signs were taken: Vitals:   09/02/20 0827 09/02/20 1010 BP: 110/72 110/74 Pulse: 77 103 Resp: 18   Temp: 98.2 °F (36.8 °C) 97.6 °F (36.4 °C) TempSrc: Oral Axillary SpO2: 100% (!) 74% Weight: 112 lb 12.8 oz (51.2 kg)   Height: 5' 5" (1.651 m)   Following tonic-movements: Patient was able to communicate verbally Patient stated that she was having difficulty breathing Patient denied any history of seizure activity Patient denied eating breakfast before visit Patient's body became progressively cold to touch Emergency blanket utilized Patient desaturated to 74% on RA Patient was put on 2 L of Oxygen via Nasal Cannula Patient's oxygen and heart rate were continuously monitored Patient's oxygen saturation elevated to 95-100% on NC Patient stated that she was unable to feel her body Patient's hands remained clenched and tonic Patient remained to have subtle jerky movements of arms and head Emergency services arrived and report of event was given Emergency services was given face sheet, problem list, updated med list, PCP visit summary Patient was able to assist in walking to stretcher in hallway Emergency services are transferring patient to Emergency Care.
This spontaneous report was received from a pharmacist who referred 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 an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Asthma with acute exacerbation -  Pt was admitted, started on nebulizer treatments and IV solumedrol.  She was given oxygen supplementation. Pt has had gradual improvement over the last several days. She has been off oxygen for several days and her breathing is improved.  She still has some wheezing. She will be sent home on a prednisone taper, and to finish the flovent from the hospital.  She is given a new RX for albuterol inhaler as needed. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
The dose for the Moderna vaccine is .5 mL. This patient inadvertently received 0.01 to 0.02 mL. The manufacturer instructed us to contact the patient to inform them that the increased dosage could lead to side effects that could be local or systemic. No serious adverse effects were reported by the patient.
Badly swollen right arm near shoulder - very painful between shoulder and elbow on muscle at rear of arm.  Nurse gave shot on back of arm in this muscle-shot was painful, fever of 101.  Also ached over entire body.  Call doctor, he started to take Tylenol.  Stay in bed and drink warm chicken soup, which I did.  It took almost three days for the swelling to go down though I only stayed in bed one day.
mark swelling from rt armpit to elbow red, warm to touch, hot &cold, possible cellulitis;applied ice & ibuprophen;
I started getting that feeling that my heart was racing and the erratic heartbeat. It would come and go for 2-3 weeks. I noticed it was positional and I would notice it more at night when I was lying down at night or in the morning and it would happen during the course of the day as well. I was thinking that it would go away, but it just stayed. I was scheduled for a procedure for my bladder. On April 13, I went in for the that procedure and was going to get a filler and they put me on a heart monitor, and I was having a fib, at 110-140 beats per minute and spiking at 150-160. The surgeon said he wouldn't do the surgery with a fib. They said I needed to go to the ER, and I was discharged on 4/15 from the hospital. They did an EKG and echocardiogram. They diagnosed me with A fib and scheduled me with a doctor. They also put me on medication in the hospital and didn't release me until the heart rate was down to regular rate. I was put on metoprolol 50mg twice daily. They also put me on blood thinner Eliquis 5mg twice daily as well. I went to see the doctor and he did a cardiogram and I'm still in a fib but he suggested having a cardioversion. He told me to think about it. I'm on the medication and I have a follow up in 6 months. He said I can decide when I want to get this procedure done and to follow up if I don't want to, or if it gets worse. I'm still in a fib but I can still do whatever I was doing prior to this event according to the doctor. From the doctor at the hospital and from the other doctor as well, both indicated that my heart did look healthy.
I made an online appointment at this pharmacy for my son to receive the COVID19 vaccine. Upon arrival we told the clerk that we had a vaccine appointment. The clerk informed us that he could not find the appointment and so he was going to create one manually. He handed me the vaccine consent form and told me that I just needed to answer the exclusion criteria questions and then sign and date it on behalf of my son. He placed the vaccine prescription label  on the form as I was walking away to the waiting area. The pharmacist did not confirm which vaccine was being given to my son, just cleaned his arm and injected. When asked for the lot info to put on the vaccine card, the pharmacist replied with, "Oh we don't usually do that for flu vaccines. Was this supposed to be Covid? Upfront told me it was flu!" They then proceeded to draw up the covid vaccine and give that to my son. They only provided info on the covid vaccine and not on the flu vaccine. I had to return to the pharmacy to ask for the influenza vaccine information and also got the consent form that I signed which shows that I did not check any box for which vaccine was indicated. The clerk just assumed that it was influenza, and the pharmacist did not confirm before administration.
Dizziness; Nausea; Vertigo; Motion Discomfort; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not and concomitant medications were not reported. The patient previously took Morphine and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) in the left arm on 15Mar2021 at 13:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 06:00 the patient experienced dizziness, nausea, vertigo and motion discomfort. No therapeutic measures were taken as a result of the events. The  events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness, nausea, vertigo and motion discomfort was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Seriousness criteria other medically significant (OMIC). Initial report received from a nurse on 4/3/06. A 40 year old female pt received a 0.5ml injection of Adacel, lot number C2151AC on 3/31/06 in the left deltoid. She also received Tybersol, lot number C2141AB, intra dermally (administration date and site not reported. She is currently on folic acid, albuterol and prenatal vitamins. She has had 9 previous pregnancies with normal/viable outcomes and the date of her last menstrual period was 11/28/05. The pt did not experience any adverse events. Follow up information received on 10/16/06. It was reported that the pt developed pre eclampsia and was delivered at 35 weeks gestation. An ultrasound on 3/17/06 was normal. The pts delivered a single live female neonate via vaginal delivery on 7/26/06. The baby's APGAR Scores were eight and nine. There were no congenital anomalies. Based upon the new information in this follow up report, this case is being upgraded to serious.
Got my booster on Thursday, around 4pm site was sore and tender, woke up. Around 2am left arm swollen, difficulty moving and lifting. My lymph nodes underneath where swollen and painful, tried heat and taking Tylenol with little relief. Trying to massage area hoping it will feel better soon but if it continues passed the weekend will contact my Healthcare provider.
Moderna COVID-19 Vaccine EUA Having pain under left breast implant  (began 3-16-21). Covid vaccine was given in left arm on 3-3-21. Have pain from movement and from deep breaths. Finally went to doctor on 3-25-21 with pain and was instructed to take an NSAID (I took Meloxicam). Also, was told to use hot and cold compress. It seemed to help some, I was feeling a little better. Did light yard work on 3-29-21 and pain returned as before. Today, still having pain. I have now purchased Turmeric and began taking it tonight in hopes of reducing the inflammation (3-30-21). Will be getting second vaccine for Covid tomorrow (3-31-21).
Initial report received from a consumer on 18 May 2011. This case is not medically confirmed. A 5-year-old male patient had received a dose of DTP vaccine (trade name, manufacturer name and lot number unknown) on an unspecified date and had a reaction and died 24 hours later. The reporter declined to provide any further information regarding the event. She declined to provide any other contact information for follow-up, and she did not wish to be contacted any further. No further information is expected. The reporter for this case is the same as for case 2011-02908. Documents held by sender: None.
pt recvd vax approx 2PM-mom reports APAP was given 230PM; pt played about 30 mins, took bottle & went to sleep-woke up 30mins later shaking all over & vomited milk; t103.9 MD said pt had rigor secondary to inc fever;
13 Days after second dose of Pfizer covid vaccine developed severe tinnitus in right ear.  Continuous ringing of varying intensity from mild to severe.  Prescribed 5 day course of azithromycin and prednisone.  No change.
Immediately after the vaccine was administered the patient complained of pain in the arm.  I escorted her to a chair in the waiting area for 15 minute observation and she said she didn?t feel right and I should get her husband .  She began seizing in the chair and I held her safely during the episode.  Her husband came in and she became oriented, but still complained that her arm hurt from the injection. .  Before her vaccine I questioned her about her seizures and she said the seizures were being controlled by medicine.  After the episode when talking with the patient?s husband he said her seizures are quite frequent, the last one being  about 1 month ago.  EMT?s came to the pharmacy to monitor her before she was released to go home.
Rheumatoid arthritis flare up; Intentional misuse; Frustration; Anxiety; COVID-19; COVID-19; Night sweats; Weight loss; Loss of energy/no energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie (Mfr. Control No.#: 21K-163-4110316-00). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2016 (Batch/Lot number was not reported) to 23Jun2021, at 40 mg (40 mg, 1 in 2 wk) for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced frustrated, possible misuse, anxiety and rheumatoid arthritis flare-up. In 2021, the patient experienced weight loss, no energy, night sweats and covid 19. The patient was treated with Prednisone. The patient underwent lab tests and procedures which included covid test: positive on 05Aug2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn on 23Jun2021. Outcome of event weight loss, rheumatoid arthritis flare-up was not recovered; other events was unknown.  The reporter's causality for the event(s) weight loss, no energy, frustrated, possible misuse, night sweats, anxiety, covid 19 and rheumatoid arthritis flare-up was not provided for suspect Humira and was reported as possible for suspect BNT162b2.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Throat started to close within 5 minutes of getting the injection. I also started to cough, itch, and had shortness of breath.  Later on in the afternoon I got a severe headache that didn't go away until 4:00am.  The next day my lips swelled up with blisters on my lips and my gums hurt a lot.
itching & hives on body & face (breast & between legs) for 2 days; chest & joint pain 2 days later;
3/8/17 - no pain when vaccine was given but became red. 3/9/17 - redness spreads/fever/chills. 3/10/17 - fever/chills redness from shoulder to elbow. 3/11/17 - ED visit and Dx: cellulitis. 3/15/17 - am: reported to pharmacy/pm: arm seen by other RPh and possible arthritis type reaction.
redness and soreness at the site of her pneumonia vaccine along with a fever and body aches
Engerix-B vax given @ 330PM then 415PM red, raised rash on inner aspects both upper arms down to elbows resolved w/in 2 hrs seen in ER & given DPH;
fever of 100.5 / fever of 100; i want to throw up / Nauseated; headache; weak; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In March 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, nausea, headache and weakness. On an unknown date, the outcome of the fever, nausea, headache and weakness were unknown.   It was unknown if the reporter considered the fever, nausea, headache and weakness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received 2nd dose of Shingles vaccine and experienced weakness, headache, nauseated and fever 100/100.5degree F. The patient stated that his/her stomach was not upset but he/she wanted to throw up. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018218333:same reporter
ARM pain.   Significant pain in deltoid muscle of arm, still continuing now for 2 months after injection.
1st dose was given by Family Physicians on 04/26/2018. She was also administered Pneumovax 23 at that time. Per patient, after these two vaccines, she was very tired and slept for 2 days.  Patient signed up for 2nd dose at pharmacy and waited several month on the waiting list due to product shortage. She was administered 2nd dose on 08/29/2019 at pharmacy.  After 2nd dose, she had high chills and increased need to urinate starting approximately 8 hours or so following administration.  Patient says she lost approximately 2 pounds from the increased urination.
It was reported that an 11-year-old boy received a TD-Adult vaccination on 12-Jun-2000. Reportedly that same day, the patient developed hives. Further information requested.
The infected areas are best described as red, swollen, itchy, scally, and leaves a dark ring or dark areas.  The infected areas resemble chicken pox, ringworm, and fine bumps that look like a heat rash.
After 6 hours I got an extreme headache. I hadn't had migraines in years, and I started to feel them. I have a kit for high blood pressure and I started to use it. I was ranging over 160 over 102. I had a shortness of breath, it didn't last the entire day, but it would come and go. The blood pressure lasted for 10 days. I would monitor daily. On either the 25th or 26th, I sent my cardiologist an email that I didn't want to risk the second vaccine. They asked that I still take the vaccine. They wanted to figure out a medication if I did have some sort of complication. I do 5 mile walks, it didn't happen with my walks, but when it would happen I got heaviness in my chest and I had pain on my upper right back. My medical professionals convinced me to take the second vaccine. My migraines lasted about 3 weeks.
318 patients received dose from vials beyond 30-day use by date; 318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Date of refrigeration is 07 May 2021.   This case was linked to MOD-2021-363773 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On or about 13-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 29-APR-2016, he was treated for intermittent pain along the course of a nerve, which was diagnosed as neuralgia (onset date unspecified). The patient was prescribed gabapentin for management of his painful symptoms and chronic pain. On or about 21-MAY-2016, he sought subsequent treatment for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed gabapentin and hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster, neuralgia and post-herpetic neuralgia was unknown. The reporter considered the events to be related to ZOSTAVAX.
patient complains about pain to wrist and thumb, pain sensation to toes and headache. Tylenol and Ice pack recommended on inject site . If no relief, patient should go to hospital because she has no PCP
pt recvd vax & exp fever & sweats; 3 wks post dose 2 exp fever 101.5, fatigue, chills, clamminess & sweats;
1310:1st dose Pfizer vaccine administered (client is an employee at facility). Client was anxious about receiving vaccine.  1314: client slumped/ head down in chair unresponsive. Assisted to floor (no injury with transfer) legs placed up on chair. Pallor appearance, radial pulse 1+, 67bpm, RR 14, BP 118/82 1315: drowsy but slowly responds to voice, A&Ox4, ice packs applied, radial pulse thready, continuous pulse/ox applied. BG 102. sp02 94% 1316: drowsy, sternal rubbed to get vocal response. A&Ox4. EMS called. pulse thready 67 bpm. Pupils 3mm.  1323: 108/78. drowsy, responsive to loud voice. RR 20, shallow breathing, sp02 97% radial pulse 2+ 70 bpm.  1325: EMS arrival. client continues to be pale and drowsy. Assisted to chair x3. Client immediately felt dizzy again and asked to lay down. Complete transfer to stretcher. Client agreed to go to hospital for assessment.  1330: client left with EMS. Daughter working at facility at time of incident. Updated daughter in person and husband over the phone.  1339: client arrived at Hospital ED2