chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was admin. 8/21/09. Noticed reaction 8/22/09 in evening 8:30pm. Rt thigh swollen increase to hip area down to ankle 0 hard warm to touch - taken to Emergency room for evaluation
Patient developed a sore throat during the day on Wednesday, 12/14/22, which continued into Friday, 12/16/22. Because that was her primary symptom and she had heard other kids at school had had strep, I took her to a local urgent care to get tested for strep. She was tested for strep, COVID, RSV, and 2 strains of flu. All tests came back negative. Her symptoms continued to progress - her sore throat lessened but she developed nasal congestion and runny nose. She also had a fever under 102 on 12/17 and 12/18, requiring her to miss school on Monday 12/19. She was fever free on 12/19 and able to return to school on 12/20. Around that time she transitioned from the runny nose to a cough which has since resolved. Note that we had discontinued Patient's asthma inhalers around the end of November 2022. We restarted them during this illness, but her cough had calmed enough by 12/23 that she stopped the inhalers again. She also took tylenol on 12/17 and 12/18. We did not use any other medications.
Within 2 weeks of the vaccine, patient developed significant right leg pain and fatigue. Within 3 weeks, she was unable to bear any weight on her right leg and was diagnosed with CRPS. She developed dysautonomia (POTS, gastroparesis) within 4 or 5 weeks of the vaccine. She has tested positive for anti-B1 and B2 adrenergic receptor autoantibodies plus M2 muscarinic and ganglionic receptor autoantibodies. Her case was written up. Of note, she also developed extreme fatigue and right leg pain after GARDASIL #1, though did not have full blown CRPS symptoms or dysautonomia symptoms until after vaccine #2.
Info has been received from a registered nurse concerning a 74-year-old male who on 02/26/2003 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). It was reported that the pt developed swelling and redness. The pt has not been seen, and the reporter is not sure if the reaction has resolved. Unspecified medical attention was sought. The reporter indicated that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01236 and 0303USA01442). The reporter expressed concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research was released. Additional info has been requested.
Numerous unexplained skin rashes (eczema) all over legs, arms and back. Will fade and reappear and itch.
Patient was seated post-vaccination and fainted while in his chair.  He recovered within seconds and was lucid shortly after.  No difficulty breathing or apparent allergic reaction
Hives, vomiting, and abdominal pain w/in 48 hours of vaccine administration.
Excrusiating pain in left arm, unable to move or raise arm, muscle pain all over body, joint paint all over body, fever (sweats and shills} for three days, headache, nausea, red, rectangular rash two inches below injection site, numbness and tingling of left arm including hand, swelling of left arm and hand. Excrusiating left, lower back pain and left side of neck, including shoulder, shoulder blade and back.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A) for COVID-19 immunization. No medical history reported. Concomitant products included Copaxone (glatiramer acetate) for an unknown indication. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm hurt). At the time of the report, pain in extremity (arm hurt) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided. This case linked to MOD-2021-080162 (patient link).
Patient had fever, chills, muscle aches, and head "felt weird- almost like hallucinations".
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 51-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX. On 17th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved.  It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccine administration, the patient had reaction and redness developed. The pharmacist reported that the redness was the only thing which was out of the ordinary. No further details provided.
This is a spontaneous report from a contactable colleague who reported on himself. A 55-year old male received a dose of PREVNAR13, injection on 12MAR2012. Relevant medical history included sleep apnea for 12  years and nasal polyps since an unknown date. Concomitant medications included NASONEX starting in MAR2012 for nasal polyps. The patient reported that  he received the vaccine at work. The patient experienced swelling at injection site on 12MAR2012. The patient reported he had a sore site of inoculation. Therapeutic measures takes as a result of the event were reported as none. The patient had not recovered from the swelling at the injection site as of 13MAR2012. The clinical outcome of the event sore site of inoculation was unknown. Follow-up (21MAR2012): Follow-up attempts completed. No further information expected. Follow-up (13APRIL2012): New information received from a contactable consumer includes: reaction data (added: sore site of inoculation). Follow-up attempts completed. No further information expected.
A few days after my shot I started feeling very tired and groggy.  My head was dizzy most of the day.  Five days after the vaccination I started to go into a sweat if I exerted myself too much.  I continued to have a dizzy head and my stamina was greatly reduced.  I used to ride my exercise bike for 90 -150 minutes a day but  after the vaccine I could only go 20 minutes the first week and then I got progressively weaker and more dizzy.  I could barely walk a half block.  I also experienced some shortness of breath and a racing heart at times.  The third week out was the worse.  I could hardly care for myself.  I started to get a lot of pain behind my eyes and other sinus pressure.  Also the lymph gland under my ear was swollen and painful.  I was extremely tired for a couple of days at that point but have found it hard to sleep on most other nights.  I have strange dreams that are almost like an hallucination.  I also have head aches but they seem to have improved as the weeks have gone by, especially since I have been taking Aleve every day.  I am unable to exercise and have very little energy still.  The dizzy head continues to persist even  6 weeks out.  I had this same kind of dizzy head in August when I had Covid but it went away in a week or two.  I get dizzy just reading a book or looking at my piano music also.  Having had Covid twice I am very confident that these symptoms were caused by this vaccination.  It also seemed to make my blood sugar more volatile.  The sad thing is that I was feeling perfectly normal when I went in!  I am devastated by these symptoms and they have completely altered my life.  I am so discouraged that they never go away.  Some days I feel like I am improving and then they pop up again.  I was a very active person and now I can hardly do anything.  I think I got the shot too close to when I had covid and that it has triggered an immune response that is overwhelming my body.  Will it ever get better?  I can't stand to go on like this!
Pt had several hive-like erythematous patches covering torso and upper legs, in office on Day #1 following vaccinations. Mom reports "swollen face" this morning, not current however.
Patient  received  vaccine  and  threw up.  After  some  water  and snacks  she felt better.   Started throwing up   happen occassionally when gets    piercings or shots Got water  and some snacks   felt a lot better after Had a friend around to help drive her home
nausea; headache; joint pain; fatigue; This is a spontaneous report from a contactable health care professional for a patient enrolled in a Pfizer-sponsored program; this report regards events occurred with suspect product BNT162B2 not included in current Pfizer-sponsored program. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. The patient's medical history included cardiomyopathy from 2000 (defibrillator was place due to diagnosis of cardiomyopathy 21 years before the present report) and breast cancer. The patient's concomitant medications included palbociclib (IBRANCE) 125 mg, oral from 13Jan2021 and ongoing at 125 mg, cyclic (21 days on, then days 7 off) for breast cancer. The patient previously received first dose (1st shot) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. It was reported that IBRANCE for 21 days on, then days 7 off. Patient reported symptoms after IBRANCE the month of the present report (Apr2021) that lasted for a couple days and have all resolved at the time of this report: nausea, headache, joint pain, and fatigue. Patient said that she noticed these symptoms started after her second (2nd) COVID vaccine (date unspecified) and lasted for a couple days after the vaccine, but she felt fine the day of the present report. Medical doctor (MD) was not made aware. Patient agreed to inform MD. Patient stated that she started the last cycle of IBRANCE one day later than usual in Mar2021 due to planned surgery to place a defibrillator (date unspecified), but patient said that she spent one night at hospital after procedure. Patient said that defibrillator was place due to diagnosis of cardiomyopathy 21 years before the present report (2000) (before IBRANCE) patient denied any symptoms that prompted surgery and she said it was planned for a long time prior to IBRANCE start. No other info known about this history. No adverse event reported from missed dose (as reported). The events were reported as serious with hospitalization criteria (reported as initial or prolonged hospitalization). The outcome of the events was resolved.  Information about lot/batch number has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt had dentist appointment the morning of vaccine. After pt got vaccine and was seated in observation area pt got dizzy and passed out and hit head. BP was taken and was 84/54. 911 was called and pt went to ER due to continuous low blood pressure.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL per vial instead of 0.25mL/ vial.
Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms of a 'chest cold' and was having pain in left rib/lung/chest area. One morning walking at work and was noticing increased phlegm and chest congestion, spit up a wad of blood. Sharp left lung pain with taking a deep breath. Notes after episode, coughed up darker blood a few more times. Went to ER on 6/14/21 - imaging  found with pulmonary embolism/blood clot in left lung. Discharged with Eliquis started pack 2 tab BID for 7 days, then 1 tab BID.  New patient consult on 6/16/21 with myself, APRN - continuation of blood thinners initiated, referred for hematology consult, and echocardiogram ordered.
SMV thrombosis; This is a spontaneous report from a contactable healthcare professional (patient). This 48-years-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in right arm, on 04Feb2021 at 09:45 (lot EL9269), at 48 years of age, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 14Jan2021 at 09:45 (at 48 years of age), lot: EL3248 intramuscular, in right arm. Medical history included GERD, hiatal hernia and Hasimotos dx. Prior to vaccination, the patient was not diagnosed with COVID-19. Past drug history included clarithromycin (BIAXIN). Concomitant medication included esompeprazole (NEXIUM). On 01Mar2021 the patient experienced GI/epigastric pain, back pain, abdominal pain. She was diagnosed SMV thrombosis. The events required Emergency room/department or urgent care, Doctor or other healthcare professional office/clinic visit, hospitalization for 3 days and treatment with heparin. The events were reported as serious also as life-threatening and per disability. The events were resolving at the time of report. On 07Apr2021 the patient underwent COVID-19 test with negative result.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mesenteric vein thrombosis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Death Narrative: 4/12 patient had fatigue/dyspnea -Per NP visit/note: -" reviewed with office/clinic team MD on phone, clinically does not appear to have fluid overload, has chronic LE edema which is no worse than usual, could be pneumonia possible aspiration related to dyaphagia. patient does not want to go to hospital for evaluation and treatment. Spoke with patient's daughter, confirms DNR and LST wishes, no hospitalization, no cpr/ventilation/feeding tubes. She is agreeable to treating with low dose diuretic and antibiotic in effort to help symptoms. She is agreeable to hospice consult. -cipro 250 mg po bid x 7 days, furosemide 10 mg qday and kcl 10 meq x7 days called into pharmacy. caregiver to pick up today. reviewed s/e and precautions with meds in addition to indications - caregiver encouraged to keep patient upright in chair or bed for easier breathing. "
Moderna COVID-19 vaccine EUA After a week my left arm is again tender.  Also, it's red and swollen.
No additional AE reported; a patient who is not on dialysis nor will be starting dialysis received the dialysis formulation of RECOMBIVAX HB (larger than recommended dose).; This spontaneous report was received from a pharmacist and referred to a patient with unknown age or gender. The patient's concurrent condition, concomitant therapy and medical history were not reported. The drug reactions/allergies were not reported.  On 03-APR-2023, the patient was administered with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (1 milliliter (ml), lot #, expiration date, route and anatomical location were not provided) for prophylaxis. The patient who was not on dialysis nor would be starting dialysis received the dialysis formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (larger than recommended dose) (incorrect dose administered). No additional adverse event (AE) reported (no adverse event).
A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; This is a spontaneous report from a contactable physician. This physician reported for a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient got the first dose of the covid-19 vaccine and within 5-7 days got covid-19 on an unspecified date with outcome of unknown.    Information about batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and within 5-7 days got COVID-19.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the COVID 19 likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Initial and follow-up information has been received from a licensed practical nurse concerning a 66 year old female who on 12-JUL-2007 was vaccinated SC in the left arm with a dose of Zostavax (Oka/Merck) (lot# 652965/0622F) which expired on 11-JUN-2007. The patient developed localized pruritus (also reported as no adverse experience). It was unspecified if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
patient's upper lip and lower lip started to swell ( a thin line on the mucosa just undereath the vermillion bordre.
Hives developed on right leg within 10 minutes of administration of vaccines. Administered 4ml of benadryl (12.5ml/5ml) at 3:55 pm and patient was starting to develop hives on forehead, cheeks, scalp, with no signs of distressed breathing, vomiting, lip swelling. Upon leaving the clinic, child was comfortably asleep in Mom's arms without urticaria, although some erythema still present at the injection site. Lungs were clear to auscultation, RR was WNL, no reactions/cyanosis/grunting/wheezing, pulse ox was WNL. Parents sent with appropriate Benadryl dosing and told to call our 24/7 on-call service if anything changes or worsens in the coming hours. A referral to an allergy specialist was also given. Left at 4:25pm.
Initial report was received from a health care professional on 26 September 2011. A 34-year-old male patient had received an FLUZONE HIGH-DOSE intramuscular injection in left deltoid, lot number UT480AA on 24 September 2011. The patient experienced chills followed by fever (102), aches and lethargy. The events resolved within twenty four hours. The patient will follow up with his primary care physician. No further information was available at the time of the report. The patient's outcome was recovered/resolved on 26 September 2011. Follow up information was received from a healthcare professional on 09 January 2012. The patient was not evaluated by healthcare professional. No corrective treatment provided. Documents held by sender: none.
On 03-28-08 patient phoned to report that she developed cold sores on her lips and they have continued to erupt. Time from 3-14-08 thru 3-28-08 . She developed one near her eye also. Valtrex prescribed.
pt recvd vax 23SEP92 & 24SEP92 @ 20 wks of age, pt devel erythema, swelling, induration & an abscess @ the site of both vaccinations; pt taken to ER; area healed w/cutaneous atrophy/scarring; No further details were provided;
Cluster hives on elbow where vacc was administered. Patient was given 25mg Benedryl. More outbreak of hives as of 2/9/2014 and chills. Taken to Dr., said was stomach virus. Mother not happy.
Postmenopausal bleeding; third dose of BNT162b2; third dose of BNT162b2; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 2590), administered in the left arm, on 12Oct2021 at 20:30 (at the age of 67-years-old) at dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multivitamins (vitamins nos), vitamin C (ascorbic acid), gabapentin (GRALISE 600mg) taken at 600 mg, colecalciferol (VITAMIN D); all reported as other medications the patient received within 2 weeks of vaccination. The patient received the first dose of BNT162b2 on 17Jan2021 and the second dose of BNT162b2 (lot number: EM9809) on 07Feb2021, both in left arm at the age of 66-years-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced postmenopausal bleeding on 17Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if a treatment was received for the event. The outcome of the event was unknown.   Follow-up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Information was received on 18-APR-2017 from a medical assistant who reported that improperly stored doses of VARIVAX were administered to unspecified patients from 28-MAR-2017 to 31-MAR-2017. The reporter confirmed that the sterile diluent used to reconstitute the VARIVAX was not stored improperly. No adverse effects were reported. Name of vaccine involved: VARIVAX (lot # M033905, expiration date 20-JUL-2018). Temperature and Time Frame: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit for 45 minutes. Was it administered?: Yes. Previous temperature excursion?: Yes, 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit for 12 hours and 50 minutes. Was call because of a "data logger"? Yes. No further information was reported. Additional information has been requested.
COVID19 (Pfizer-BioNTech)Patient began experiencing difficulty breathing with visible tonsilar swelling upon oral evaluation 20 minutes post 2nd pfizer injection. Epi 0.3mg was administered IM to left thigh at 1125 and patient was transferred to ER for further evaluation at 1130. Spoke with patient at 4pm and states he was discharged home in stable condition after receiving steroid and benadryl injections.
Extreme pain in arm (similar to what would be expected as the result of arm surgery), fever, chills, sweat, joint pain, body ache, fatigue, nausea, loss of balance.
This spontaneous report as received from registered nurse refers to a 41 year old female patient with anxiety, depression, vaccination, myofascial pain syndrome and drug allergy to sulfonamide. Patient had an allergic reaction with sulfonamide on an unknown date. On 03-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, (dose unknown) single dose with lot # K004281 and expired date 22-MAR-2014. Concomitant therapies included VENTOLIN, XANAX, atenolol (manufacture unknown), BENTYL and furosemide (manufacturer unknown). On the same day after administration of PNEUMOVAX 23 patient developed severe pain in right arm, from shoulder to elbow. Patient self treated the events with analgesics. Patient called office for medical attention to the events. No laboratory test was performed for diagnosis of events. The outcome of severe pain in right arm, from shoulder to elbow was reported as not recovered/not resolved. The outcome of 41 years patient received PNEUMOVAX 23 was unknown. The reporter did not provide the causality of severe pain in right arm, from shoulder to elbow to PNEUMOVAX 23. No further information was provided. Additional information has been requested. This is one of several reports from the same source (MARRS 1409USA003160 and 1409USA002618).
Swelling and erythema of right thigh beginning 24 hours, post vax.
Janssen on 3/11. Positive on 9/1 admitted 9/4 to current