chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients received an improperly stored dose of VARIVAX (lot # M025867 expiration date: 24-MAY-2018; lot # M032494 expiration date: 06-JUL-2018) (dose and route of administration were not reported) for prophylaxis. No adverse effects reported. Temperature excursion details: Temperature: Between 5 °F and 14 °F; highest temperature: 5.46 °F Time frame: 55 hours Previous temperature excursion? Yes, 13.12 °F for 42 hours and 55 minutes.  A data logger was used. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001818:
Fully vaccinated patient who admitted to the ED with decreased responsiveness who was found to be positive for COVID.  Provider d/c note below:  "78 y.o female with a PMH of Parkinson's disease, asthma, DM, hyperlipidemia, HTN, Legally blind, dysphagia s/p Peg tube, neurogenic bladder s/p suprapubic catheter, TIA's, DVT (2016), Hx PE and A-fib on chronic anticoagulation, asthma and COPD who presented to the ED for reduced responsiveness and foaming of the mouth on a face time call with her daughter. Family reports for the last two weeks she has been a bit less responsive but has had no additional complaints. Patient and daughter who is the primary care giver were found to be COVID positive. Patient was initially requiring oxygen via nasal canula but was able to be weaned to room air quickly. She received two doses of remdesivir and two doses of decadron. She will be going home on continued decadron and supportive care with mucinex and tylenol prn fever"
Patients reports passing out in her kitchen 2 days after receiving the vaccine. When she regained consciousness she called the paramedics to help her up. Upon their arrival she passed out again and they took her to the hospital. She was observed for a few hours and they could not determine a cause; everything looked fine and she was sent home.
Red, raised area approx 4 inch x 5 inch, circular on upper (R) thigh, warm to touch. On day 2 post vaccination increased in size to approx 6 inch x 6 inch end of day 2 post vaccination. No treatment. Warmth and redness subsided day 3 post vaccination.
Body felt extremely hot but was freezing cold. Severe headache and fever.  Temperature got up to 104.5.  Fought high temperature for over a day.  Experienced extreme fatigue.  Drank plenty of fluids and took Tylenol every 4 hours.
Noted itching of body at 2400 was not severe. completed shift, went home and to bed. Woke up and was itching severely all over body no visible rash. Except had raised welts around waist and skin pink/red. Developing welts behind both ears which are raised and some on face. Denies respiratory difficulty.
1st dose in 2021, has to get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 23rd November 2021, received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 20-Jan-2023. Reporter's Comments: The reporter reported patient received 1st dose of Shingrix at a different pharmacy/provider's office thus he does not have the lot number, confirmation of which arm it was given in, or if it was given intramuscularly. The patient had yet to get dose 2 and it was beyond the six month window. Consented to follow up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Last night on 1/17/21 i noticed my arm was raised and a little itchy, and this morning it was a little pink and warm. Slightly swollen
Redness around injection sight in arm. Did nit show up for 10 days after injection. Not swollen just red. No discomfort.
Developed red, warm and swollen area approx 4" diameter at site of injection right deltoid. Pt states no itching but very sore. Alternating warm and ice packs applied. Shot was given 9/3/03. Pt reported 9/4/03. Arm checked at that time. Completely resolved by 9/8/03 as reported by phone 9/9/03.
~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cramping (gas-like), and rapid heart rate with elevated blood pressure (normal 120s/80 but up to 146/84), was advised to come to EC for evaluation but patient declined
had the worst hay fever symptoms she has ever had in her life; clothes on her body/could not feel feet in shoes/could not feel pressure; sore at the injection site for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life), HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) and VACCINATION SITE PAIN (sore at the injection site for a couple days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life), HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) and VACCINATION SITE PAIN (sore at the injection site for a couple days). At the time of the report, SEASONAL ALLERGY (had the worst hay fever symptoms she has ever had in her life) and VACCINATION SITE PAIN (sore at the injection site for a couple days) had resolved and HYPOAESTHESIA (clothes on her body/could not feel feet in shoes/could not feel pressure) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided. she was taking supplements
We recently did a vaccine clinic at the   on Sunday 7/25, and we had a patient who had a record on his phone that he received his vaccine on 5/21 and never got his second dose.  He said he received Pfizer, but it turns out he was wrong and actually had received Moderna (he did not have his CDC card on him at the soccer event)  Per the info  sent below (in yellow) the patient should be 100% okay, because he received 2 mRNA vaccinations with proper minimum spacing.  But it will still require a STARS/VAERS event for the "Pfizer" shot listed below (RX: 1328363).  Since it was at the game we weren't able to register him in IC+ so upon getting back from the event, we see that we do not have a working phone number on file.  We just want to let him know that he is fine, but to not get any additional vaccinations because the CDC does not recommend it at this time.
I started feeling symptoms of a 30 mile bike ride. I got very tired and had to turn around. The next morning I felt very feverish, muscle aches, headaches, cough, muscle aches. I had these symptoms for 2 days. On the 3rd day, the fever stopped. I took an at home COVID-19 test that was positive. I contacted my doctor. The fatigue and cough persisted. I contacted my doctor again and was prescribed a cough medication. I still have a cough but have tested negative.
Narrative: Moderate headache 12/31/2020. Mild fever, muscle pain and fatigue 1/21/2021.Severe headache onset 1/20/2021 8:00 PM. Resulted in unable to work 1/21/2021, 1/22/2021, 1/25/2021. Evaluated primary care 1/25/2021. Started sumatriptan and Excedrin 1/25/2021 qam. Improved headache. Headache returning in afternoon with associated temple and eye pain. PMH unspecified headaches. Not diagnosed. Typically 4-6 x a month, for last 4-6 years, persist hours. Self treats with Excedrin within 30 minutes of onset. If unable to take the Excedrin quiet area and sleeps until headache is relieved. Instructed to report to PCP for further evaluation of chronic headaches.
Patient was supposed to get the Pfizer paedraiatic bivalent but the patient was mistakenly  injected  the  the  primary dose booster. An incident report has been filled out in the store
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age (reported as 58 (no units provided) ethnicity and gender received PREVNAR 13, via an unspecified route of administration and FLU SHOT, via an unspecified route of administration, both administered on 20Sep2016 as single dose for immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shingles on an unspecified date in 2016. The event was described as patient received both the flu shot and PREVNAR 13 vaccine on the same day, 20Sep2016, and came down with shingles within 2 weeks; patient was certain this was caused by having both vaccinations at the same time. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable. The outcome of shingles was unknown.
7 hrs p/DTP/OPV #3, 7FEB91 pt to ER w/hypotonic hyporesponsive collapse. Admitted & observed for 3 days. Febrile to 104 @ time of event & has no residual.
Inconsolable crying, fever, spasm in legs, eye crossing, w/inability to concentrate on outside stimulus, minor convuls;
had to sleep more than usual; so much pain at the injection site; very very tired - extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (had to sleep more than usual), VACCINATION SITE PAIN (so much pain at the injection site) and FATIGUE (very very tired - extremely tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SOMNOLENCE (had to sleep more than usual), VACCINATION SITE PAIN (so much pain at the injection site) and FATIGUE (very very tired - extremely tired). At the time of the report, SOMNOLENCE (had to sleep more than usual), VACCINATION SITE PAIN (so much pain at the injection site) and FATIGUE (very very tired - extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Fever of 104.8, hr up to 160. Body aches headache dizziness, Nausea and vomiting . Body work lactic acidosis was 3.9. Given four liters of fluid but hr still around 110 so was admitted to pcu for observation. Six days later still has headache.
Pt had varivax injection on 3/3/98 and on 9/20/01 he developed low-grade fever and chickenpox. Saw doctor on 9/21/01and was treated with Zovirax.
I thought I had a cold and cough. I just kept coughing. I tested negative for COVID-19 on 11/22/2022. On 11/23/2022 I was told to see provider due to symptoms and they tested me for COVID-19 and it was positive. Provider prescribed Codeine-Guaifenesin and Paxlovid, Vitamin D3, Vitamin C, Zinc, Tylenol. I also drank Pedialyte to help with hydrated.  Then on 11/25/2022 I went to the hospital due to worst symptoms but thy let me go after test and monitoring. I still have cold sores till this day on my lips.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported), for prophylaxis. On the same day, the patient experienced swelling at injection site (injection site swelling). The outcome of injection site swelling was unknown. Causality assessment was not provided by the reporter.; Sender's Comments: US-009507513-1708USA008981:
pt who had not had a seizure in 10 years suffered a seizure after 2nd moderna vaccine
Tingling sensation down your injection arm; 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 PARAESTHESIA (Tingling sensation down your injection arm) 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 29-May-2021 at 12:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation down your injection arm). At the time of the report, PARAESTHESIA (Tingling sensation down your injection arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
sore arm near injection site starting day of the injection and improving by next day. Soreness within expectations, expected to be fully recovered soon
Vaccine at 11am 08/17/2006 complain of headache 08/18/2006 am with a headache which increases in intensity, complained of nausea, dizziness as headache increased. Complain of general achiness, "like someone" pulled out rug from under me" described.  States called in sick for Saturday/Sunday due to headache.
Vaccine very painful-burning when injected  Arm sore and tender for full week following injection Approx 15 hours following injection was woke from sleep with full body aches, chills, fever (100-101) - this continued for approx. 24-48 hours
sore throat, headache, body aches, cough, loss of appetite, chills, OTC tylenol, cold and flu  monoclonal antibody infusion
24 hrs p/vax & exp tingling hands/legs & burning pain lt cheek;
In March, 2000, the pt received her 1st dose of Lymerix. Initially, she reported experiencing pain in her hips. She also reported pain and stiffness in her other joints when sedentary which lessens when mobile. A genetic marker test (NOS) was performed. The physician reported she experienced 'generalized arthritis', but he was not the prescribing physician. He stated no testing was done to rule out arthritis versus arthralgia, but "concurs it is probably arthralgia". Treatment included ibuprofen. The pt reported the symptoms lasted 1.3 months which became intermittent and are now occasional. A few days ago in June, 2000, the pt reported her shoulders, wrists and elbows ached and then resolved.
The patient received Proquad (MMRV) and Varicella vaccines same day.   It should have been plain MMR and Varicella or just the Proquad which contains both in one shot.  The provider was made aware and the patient's mother was notified same day.  No reports of issues to date.
From telephone correspondence received at AP on 10/28/2002, it was reported that a 41 year old adult female was vaccinated with TD ADS ADULT, Lot # U0530AA, on 10/24/2002.  The patient experienced spasms in arm where injection was administered and went to ER.  The reporter did not know if spasms were still persisting at the time of the report.  The patient's treating physician at the vaccine facility wanted to know if there were other problems with this lot number, and was informed that there were no other adverse reports.  It remains unknown whether the patient recovered.
Devel edema at inject site and down arm into breast - red and painful. Treated with Claritin & Cefzil for cellulitis.
On the first 24 hours I felt my arm was very heavy, couldn't lift my arm above my shoulder. 2nd day I felt very fatigue, 3rd day I started to have moderate to severe sinus headache accompanied motion sickness, I took phenylephdrine  with Advil and Tylenol.  As of today my 8th day, I still have slight sinus headache with dizziness.
Swelling and redness 4 inches in diameter that lasted 6 weeks until gone.
Patient had an annual visit with PCP and MD placed an order for a Influenza vaccine. I explained vaccine side effects, contraindications and CDC recommendations for vaccine. Patient given VIS. Patient reported never taken the influenza vaccine before. Patient reports allergies to Nuts only. Patient denies allergies to eggs, gelatin. Patient also denied history of Guiliam Barre Syndrome. I administered Afluria flu vaccine as per MD ordered on the left deltoid. Patient tolerated well no complains right after given vaccine. As Medical Assistant drew blood from patient approximately 10 minutes after patient reported red spots appeared on bilateral forearms. I immediately inform MD, and RN of reaction. Patient denied SOB, itchiness, neither swelling of face. MD assess patient lung sounds- negative wheezing. MD ordered PO Diphenhydramine. RN administered Diphenhydramine 25 mg as per MD ordered. Patient was observed for an hour after administration of medication. Patient denied any new symptoms, patient was informed to call office if new symptoms arise, also a prescription was sent to pharmacy. At time patient left no more concerns or questions. RN left voicemail to patient the following day. I called back patient as well to find out how he was feeling. Spoke with patient. Patient reported feeling well. Red spots are still there looked the same. Patient denies SOB, itchiness, or swelling. Patient informed no new spots appeared. Patient only felt a tight lower back later Wednesday. MD was made aware of this.
Home tested positive on 2/5/23 and started on Paxlovid on 2/6/23. Had nausea and vomiting and present to ED.
30 minutes after shot, numbness and tingling up left side face and shoulder, including tongue.  No swelling except at vaccine site. Did not get worse. Resolved completely in a few days.  Doctor took note but said I should still get second shot next month.   1 week post vaccine, swelling and itching at site.
On 4/23/2021, the day after my second shot of Moderna, I experienced side effects, including headaches, fever, body aches etc.  However, I also experienced lots of pain and a feeling of swelling in my right ear canal.  The side effects went away after about 2 days.  The pain in my ear also went away.  However, a couple of days after, I noticed a high pitched buzzing sound in both of my ears.  After about 2 weeks, I went to the ENT.  I described the above to her.   We did a hearing test, and noticed the hearing in my right ear was borderline hearing loss.  She prescribed prednisone to me for 2 weeks.  During my follow up visit, we did another hearing test and my hearing was back in normal range.  My ENT indicated that I suffered a sudden hearing loss due to the vaccine and the steroid (prednisone) was able to reverse the damage. She said that she had treated about a dozen people with the same story that I had.   However, she told me the buzzing sound is called Tinnitus and the prednisone did not seem affective in treating it in my case.  Since this time, I have consistently had tinnitus in both ears over the past 8 months.  I have never had tinnitus in the past.
Syncope Patient felt faint after a few minutes after receiving the vaccine. Purchased a water and sat down again. She then passed out while sitting down and fell out of her chair. Patient was unconscious for about 10 seconds before coming back. EMTs arrived on site a few minutes later, assessed the patient and escorted her out on a stretcher to the ambulance
I've had a cough ever since taking the vaccine; 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 COUGH (I've had a cough ever since taking the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (I've had a cough ever since taking the vaccine). At the time of the report, COUGH (I've had a cough ever since taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.     Reporter did not allow further contact
Patient received first dose of Moderna around 1147 1150: Patient reported "feeling numbness in the hands, throat tightness and itching, heart racing, hot" while waiting in post observation area. Patient escorted to extended post vaccination observation room for monitoring. Dr.  notified. 1153: Dr.  at bedside. VS: 151/82, HR: 96, RR: 20, SPO2: 98% on RA. Patient throat assessed. AOx4. NAD. Able to communicate and make needs known without any difficulties. Pt appears anxious. C/o of throat swelling, itching, nausea, and feeling flushed. Denies any dyspnea or CP. Patient reports allergies to Morphine and history of anaphylaxis reaction from Morphine, per patient benadryl was given and helped with reaction.        1156: Benadryl 25 mg PO given per Dr.order. Patient able to swallow benadryl and drink water without any difficulties    1205: Patient given Albuterol inhaler per Dr. order.    1215: patient resting comfortably. Calm. Reports that throat feels better. Able to communicate without any difficulties. VS: 111/77, HR: 82, RR: 16, SPO2: 98%.    1230: patient remains stable. Dr. at bedside to reassess patient. Patient report feeling better and "ok to go home". Patient significant other, , at bedside. Patient discharge home safely.
Swollen and sore axillary lymph nodes 5 days after vaccine. Lasted for about 1 week.  Rash, redness, swelling, itchy at administration site. Started 7 days after vaccine, lasted 2-3 days.  Sore arm first 2-3 days following vaccine.
patient received extra dose of Shingrix on 6/24/2022; patient received first dose of Shingrix on 1/11/2018 and the second dose on 7/10/2019; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th Jan 2018 ).   On 24th June 2022, the patient received the 3rd dose of Shingrix. On 10th July 2019, the patient received the 2nd dose of Shingrix. On 10th July 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 24th June 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.       Additional Information: GSK receipt date:12-AUG-2022 Reporters comment: The reporter was daughter in law of patient. The patient received first dose of Shingrix on 11th Jan 2018 and the second dose on 10 July 2019. The patient received 3rd dose of Shingrix on 24th June 2022, from their pharmacy.  The reporter given consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix  which led to Extra dose administered and patient received 2nd dose late which led to lengthening of vaccination schedule.