chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild itching, fatigue, rash, muscle aches. Moderate headache. Patient described rash as red blotchy spots on forehead and sides of her temple. Ears also were hot to touch.
Patient experienced allergic reaction15 minutes after vaccenation. Onsite EMS was called vitals were taken BP 148/88 100% O2 room air HR 77. Patient Treated, Transported by the EMS to the hospital.
period is now eight days late; body feels like she was menstruating (cramps, groin area soreness and aches); nausea; Head pain; body feels like she was menstruating (cramps, groin area soreness and aches); feeling more run down; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9266 and Expiration date not reported), via an unspecified route of administration in left arm on 13Feb2021 13:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation in workplace clinic. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccine in four weeks. Patient had not been tested for COVID-19 post vaccination. On 28Feb2021, patient reported that her period was eight days late. Patient stated that she gets very regular periods consistently. Patient stated that her body feels like she was menstruating (cramps, groin area soreness and aches) even though she was not. Patient also had some nausea, head pain and feeling more run down in the last two days. Patient is due for her second shot this Saturday (06Mar2021) and patient was wondering if she should get it due to these symptoms and them potentially becoming worse. Patient did not receive any treatment for the events. Patient had taken two pregnancy tests that were negative on an unspecified date of 2021. The outcome of all the events was not resolved.  Follow up activity have been closed and no further information is expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist concerning a female patient who was part of a group of "24 reported reactions" out of 200 vaccinated employees and was vaccinated "during the first week of October, 2003" wit a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy "during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request. The patient developed inflamed lymph nodes. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the "entire weekend in bed after being vaccinated on a Friday and some missed work for a few says after that". The pharmacist suggest Ibuprofen or Tylenol for the "symptoms" and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated "all from Lot 0676M". Unspecified medical treatment was sought. There was no products quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 "reported  reactions" and were vaccinated with dose of pneumococcal 23v polysaccharide vaccine.
On 30 January 2021 at around 5:30 pm my left arm at the injection site started to itch. I had on a long sleeve shirt inside my home. At around 6 pm I went into the bathroom and removed my shirt to apply a minor amount of trade name "Cortizone 10". As I looked in the mirror I had a red rectangular rash with small raised bumps that was about 3"x4".  I showed my wife and she took a look and then applied  a small amount of the "Cortizone 10". The itching stops. I examined my arm again at 10:05 pm and the rash appeared the same. I went on the web-site and for Moderna, this appears not to be an uncommon reaction, not to worry and go ahead with the second vaccine. It is scheduled for 16 February 2021.
accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of DTAP/IPV/HIB, with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who experienced accidentally administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq).  On 28-Feb-2023, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection lot FY2475 expiry date 31-dec-2024 via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, with no reported adverse event" (extra dose administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA068119:
shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342, Expiration Date: 23Jun2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete unknown manufacturer), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders".  Additional information: The reporter called to report some side effects for his mother patient. She has shearing pain in the lower part of the back of her head and it goes down to her neck into her shoulders.  No follow-up attempts are possible. No further information is expected.
Patient's arm was red and appeared to be swollen. Notice a purple color and swelling near the inside of the elbow
Left thigh with persistent redness, swelling, nodular firmness at injection site 2cm x 4cm x 12 days.
Hurting all over that night (bad pain), bad Headaches, elevated temperature, cold, felt sick-unable to eat or sit up long, drank ok,  felt too bad to do anything April 7th; started sweating it out that night & 8th until mid afternoon. Then almost normal after that.
I experienced pain in the shoulder for two days, severe breast tenderness after two days, lasting for six days, and an unexpected menstrual period four days after the shot, as well as, mild fatigue.
Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday-Thursday-Friday for work. By Monday 6/7 I was very sick with bronchitis. It got very bad, went to ER. Went ER a second time and they did a CT Scan. Found fluid buildup on heart- Pericarditis.  Hospitalized, sent to ICU. Two days in a row BP 85/35 HR47. Finally a Thoracic Surgeon agreed to take me to surgery following morning. Drained 300ml fluid off heart. Heart arrhythmia went into afib. Chemically converted- released on 6/22/2021.  Chronic cough has lingered for 10 weeks.
Itchy rash/redness/swelling at injection site. Symptoms worst for 3 days, lasted 5 days total.  Treated with benadryl.
sever low back pain after all 3 immunizations.  After first dose resolved after steroids, after second dose resolved after corisone injections in low back.  STill experiencing low back pain after 3rd dose.  Required ER visit for pain managemnet, steroids, morphone, L5 epidural and repeating L5-S1 epidural on Tuesday.  Not 100% sure if this is an adverse reaction to the vaccine but it is coincidental I had low back pain with in a week of all 3 immunizations and have not had any injury to my low back.  I  suspect the immunization caused an autoimmune flare.
Patient presented to clinc for smallpox check up. He c/o red bumps on torso and arms. Pt stated he was taking of his band-aide and washing the site in the shower. Pt has alot of swelling around the site and two papules; one above and one below the smallpox site.
Got up in the night to use restroom and got very dizzy.  After leaning on counter, I woke up on floor.  I was still very dizzy and couldn't stand up and had to crawl back to get to  bed.  Woke up the next morning feeling tired but fine, and have been fine ever since.
Arm swelled up, knot on right arm hot moist heat, antiflammatories
I almost passed out; sore arm; dizzy/lights started getting darker; heart was racing; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I almost passed out), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy/lights started getting darker), TACHYCARDIA (heart was racing) and HEADACHE (headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PRESYNCOPE (I almost passed out), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy/lights started getting darker), TACHYCARDIA (heart was racing) and HEADACHE (headache). On 07-Mar-2021, DIZZINESS (dizzy/lights started getting darker) and TACHYCARDIA (heart was racing) had resolved. On 11-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 13-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PRESYNCOPE (I almost passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live Follow-up was added on 16-APR-2021, New Event Added (almost passed out) On 12-May-2021: Live follow up added on 12-May-2021 in which Updated Email id. On 16-Jul-2021: Follow-up doc attached and It was reported that patient no longer wanted to fill in any additional forms for Moderna.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 1/2/04 pt states that he fell at home and he "felt like I lost balance and strength in my arms and legs". Pt was able to get to the phone and call 911. Was taken to the ER. Nurse follow up on 05/18/04 states: confusion, reflexes absent, sensory loss. Nurse follow up on 05/18/04 states: UTI:Infect Urinary Tract, CAD, Hypercholesterolemia, Osteo-arthritis (Cardiovasc Dis, Hypercholester, Arthritis).
Myalgia Narrative:  Since receiving the vaccine, pain in my left shoulder has increased. At first, I thought it was related to standard injection site soreness. Pain progressed and on New Year's Day, I heard crackling (sounded like crepitus) when trying to rotate my shoulder, Ibuprofen has been adequate for pain control but without it, I'd give the pain a 7/10 with movement and 4/10 at rest.
injection site reaction; Arm started to feel warm; Itchy arm; reaction grew 6 inches in diameter and looked like hives; A spontaneous report was received from a 38-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a delayed skin reaction, injection site warmth, pruritus and urticaria.  The patient's medical history included allergies and she had an epinephrine pen in case of any severe allergic reaction.  On 15 Jan 2021, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced what she described as "Covid arm".  The patient's arm felt warm and itchy and the reaction grew 6 inches in diameter and looked like hives.  Treatment for the events included diphenhydramine, acetaminophen, and a warm compress.  Action taken with mRNA-1273 in response to the events resolved.   The outcome of the events injection site reaction, arm started to feel warm, itchy, reaction grew 6 inches in diameter, looked like hives were considered resolved on 24 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
imporoperly stored vaccine was administered to a patient; This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were unknown.   On 16-MAR-2020 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (route and dosage information were unknown; lot # s025993 expiration date 17-OCT-2020) for prophylaxis.  The medical assistant reported that the vaccine was improperly stored at 68.58 F for 9 hours and 41 minutes.  The previous temperature excursion was at 46.1 F for 7 minutes.  It was not due to a data logger issue. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Injection site was itchy; Injection site was red; Injection site was swollen; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The action taken with the drug was Not applicable.
After leaving the clinic, patient began having a rash on her arms / legs and torso. Treated with one dose PO Benadryl.
Client was Lethargic, sleepy , pain that radiates from back of neck to back of head and Occipital area, and confusion
My entire left arm is having pain, all the way to around my thumb, injection site is tender and upper arm is swelling off and on and feels warm. I can't lift my arm or use it much at all.
6 days after my injection the site was very swollen, red, hot to the touch and I had a low grade fever and chills.
diarrhea loose, yellow, mucusy for 1 week; fever 101.4- 24-28 hours. Fluids & electrolytes
Fever [temp 100.6], chills, sclerae reddened, purulent drainage from both eyes, lump in throat, difficulty swallowing, chest tightness.  Duration unknown.
Aches, chills, nausea, 101.5 temperature for one day after shot #2 only
SWOLLEN, RED AND ENLARGED LYMPH NODES UNDER ARMPITS ABOUT THE SIZE OF A SMALL MARBLE. HPV VACCINE #2 GIVEN ON 5/19/2015.
Both injections sites, left and right thigh, had a raised rash around injection site. (Pentacel and Pneumococcal vaccine). Then rash spread from injection site up to crease in leg and to knee.  This also happened with the Hep B vaccine given at one month old.
Patient came in to pharmacy on 9/14/2018 with a large red swollen area that was hot to the touch at the injection site.   She stated that this had begun a couple days after the injection on 9/10/2018.    She was advised to take Benadryl, Tylenol or Advil if needed and ice the area.
vial put in refrigerator 11/1/2021. used past 31 days.
Reports right lateral upper arm pain since injection in November. Started the day of injection. Hurts more at night. Patient returned to clinic 5 days after administration with significant amount of swelling of right deltoid area.
Information has been received from a LPN concerning a 9 yr old white male with no pre existing allergies, birth defects, or medical conditions who on 25May98 in the AM when he was 3 yrs old, was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 625379/0308H). There was no illness at the time of vaccination. Concomitant therapy included a tine test (lot 01000H) in the left forearm. On 23Apr05 the pt developed chickenpox. The nurse stated that the child had no more than 50 lesions, but she did not see the child herself. The child did not have a fever when brought into the office. Mild care was noted. No adverse effects were noted. No additional information was reported. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Follow up information received from a LPN indicated that the pt fully recovered with no adverse side effects on 27Apr05. There were no adverse events following prior vaccination of the pt or his siblings. No diagnostic tests or lab data were reported. No additional information is expected.
small blood clots all over lungs; D-Dimmer elevated; Tenderness and pain in left calf muscle; pain in left calf muscle; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Back surgery" (unspecified if ongoing), notes: had last year and nothing showed up on lab work at that time regarding blood clots or any issues. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, (Confirmed just received two doses)), for COVID-19 Immunization. The patient stated he never had issue blood clots whatsoever. Then, on 24Mar2023, the patient stated he had symptoms that seemed to be related to a DVT. He went to urgent care and was referred to the Emergency Room. They did a lot of test. Thought was almost came done, but then blood work came back. The marker D-dimmer, showed indicative of blood clots. Due to this elevated marker in blood results and this was the only thing elevated also had CT Scan. The CT Scan was done which showed small blood all over lungs.  Also, had genetic testing to see if pre-disposed to blood clots and none came back positive. He does not have any genetic component to it.  The patient had to do follow-up with primary care for more blood work. This was when they did the genetic testing component to see if it was positive and it was not. The patient later clarified the DVT symptoms experienced to be tenderness and pain in left calf muscle which started on 19Mar2023.  This feeling then subsided, but then they reemerged and by 24Mar2023 thought needed to go to urgent care. This tenderness and pain has gone away. It went away 28Mar2023. The events AE required visit to: Urgent Care, then referred to Emergency Room; had to have follow-up at Physician Office. The outcome of the events Tenderness and pain in left calf muscle was recovered in 28Mar2023; the outcome of the other events was unknown. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (24Mar2023) Unknown results, notes: Result: small blood clots all over lungs;  Unit: Not Provided; Fibrin D dimer: (24Mar2023) Elevated, notes: Unit: Not Provided. Therapeutic measures were taken as a result of pulmonary thrombosis which includes blood thinner, Xarelto 15mg for the next 21 days twice daily then dosage is escalated to 20mg after that, then assuming this will be the dose on for the remainder of the 3-6 months course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.