chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3:00 AM Saturday, December 18th: Muscle & joint pain sets in 7:00 AM Partial throat swelling, tongue swelling, muscle & joint pain 9:50 AM Above symptoms become worse, frequent urination, no voice 2:00 PM Sore neck, very sore arm with injection site (hard to lift), swelling of throat and tongue, skin hurts all over, frequent urination, no voice, muscle and joint pain becomes horrible 8:00 PM Swelling in throat and tongue, cough starts, frequent urination (every hour), no voice, sore neck, very sore arm, extreme muscle and joint pain, extreme weakness & fainting.  Unable to support self in a standing or sitting position.  Collapse onto kitchen floor.  Does not loose conscienceness.  Unable to get up unassisted. Excruciating pain just to be touched. Screaming when being touched for assistance.  Dizziness.  After being on the floor for about twenty minutes is able to try to get up and to bed.  Become unable to undress/dress for bed. 9:00 PM Some sleep with cough, extreme muscle and joint pain, no voice  8:00 AM Sunday, December 19th: Awaken very weak.  Feels as though I just ran a marathon or been run over by a truck. Pain everywhere! Remain in bed through out the day. Sore and swollen throat and tongue.  Extreme muscle and joint pain. No voice. Extreme weakness. Frequent urination. No appetite. Cough.  Unable to sleep or stay awake. 2:00 PM All of the above with headache. 6:00 PM  Realize chills have set in.  Make appointment to see doctor in the morning.  Breathing has become labored.  Begin to take temperature every 20 minutes. 6:20 PM Temperature 99.4* 6:40 PM Temperature 100.5* 7:00 PM Temperature 101.4* 7:20 PM Temperature 103.5* 8:00 PM  Return to bed with assistance.  Extreme weakness, muscle & joint pain. Cough.  Throat and tongue swelling and pain. No voice. Frequent urination. Chills. Fever. Labored breathing. No appetite. Pain to the touch.  Husband monitors temperature and breathing regularly through the night. 11:00 PM  Husband awakens me insisting we go to the emergency room.  Temperature 104.9*  Require assistance to stand and dress.  Pain everywhere and to the touch.  Labored breathing. Temperature 105* 11:15 PM Arrive at Hospital Emergency Room
his first Shingrix dose (received March, 2019), as it has been more than 6 months from the first; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: his first Shingrix dose (received March, 2019), as it has been more than 6 months from the first). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient asked if he should repeat his first Shingrix dose, as it had been more than 6 months from the first. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
his shoulder hurt when he received the vaccine because of the needle; This is a spontaneous report from a non-contactable consumer (patient himself) via Medical Information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, expiration date was unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that his shoulder hurt when he received the vaccine because of the needle on 20Jan2021, but no other symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Same day after vaccination she  developed left sided headache,  3 days later seen in ED for headache, rx ibuprofen, 5 days later seen in clinic for headache, received trigger point injections and baclofen, 6 days later developed left neck rash diagnosed shingles and prescribed acyclovir and prednisone, 8 days later developed left facial droop, seen in ED, CT brain and MRI brain did not show bleed or stroke, LP CSF positive for Varicella Zoster Virus antigen positive, started on Acyclovir IV for zoster meningitis.
Patient had second hip replacement Feb 2021, diagnosed with CRPS Chronic Regional Pain Syndrome, June 2021 bladder and kidney inflammation after both covid vaccine (Pfizer) first required hospitalization to relieve pressure and stones
No additional AEs or PQC reported; expired MMR II administered to patient; This spontaneous report was received from a consumer referring to a 2-year-old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 15-NOV-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S035356, expiration date 05-NOV-2021; strength, dose, route of administration, anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) was reported.
Appendicitis: felt sharp abdominal pain, vomiting, loss of appetite, fever and severe chills. Started Saturday Oct 1st upon waking (7:30am), continued through Sunday to ER visit and diagnosis (Oct 2nd @ 6:30pm). Had laparoscopic surgery to remove appendix (8:30pm) and an overnight hospital stay to recover. Released to return home Monday Oct 3rd at 5pm.
8 hours post vaccine patient had vomiting, high fever, shakes, and severe headache
Large area of swelling and pain after injection. Recommended ice and Tylenol and to seek medical attention if worsens.
Information has been received from a 26 year old female consumer who on 08-NOV-2010 was vaccinated with the first dose of GARDASIL (Lot# not reported). It was reported that on 11-NOV-2010, the consumer experienced pain at the injection and she could not lift her arm. The consumer did not seek medical attention. At the time of the report, the consumer had not recovered. No further information is available.
The patient is a healthy 7 yo male received FLUARIX (lot # not documented) on 19 Oct 2015. Mother states he received IIV and 3 days later noted a large area at the injection site of erythema, edema and warmth to touch from shoulder to 2/3 of upper arm. She thinks it might have been tender but he did not specifically complain. She noted no pruritus. She treated it with warm soaks and it resolved in approximately 3 days. There were no vesicles, urticaria, macules, papules or scaling. She states he has not received IIV since he was a baby and consistently has done well with FLUMIST.
Patient is pregnant at 33 weeks and 2 days, this is her first pregnancy.  Estimated date of delivery
Greater than 21 days between first and second doses of the Pfizer Covid Vaccines.; Extreme, debilitating, arm and shoulder pain; Extreme, debilitating, arm and shoulder pain; Fatigue; Caller states that his shoulder pain after the injection wasn't just like a sore arm after an injection; it felt like it spread, like an infection.; This is a spontaneous report from a contactable consumer (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FD0809), via an unspecified route of administration, administered in left arm on 26Aug2021 (age at vaccination: 48 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8737) via an unspecified route of administration, administered in left arm on 21Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient had greater than 21 days between first and second doses of the Pfizer covid vaccines. On an unknown date in August2021, the patient experienced extreme, debilitating, arm and shoulder pain, fatigue, reporter stated that his shoulder pain after the injection wasn't just like a sore arm after an injection; it felt like it spread, like an infection. Reporter stated that his arm hurt more on the second day and lasted for about 4 days, on the third day he was about ready to go see his doctor about it if it got any worse. On the fourth day it was starting to get better. Fatigue was during the late morning or early afternoon he has been feeling like he needs to take a nap. The outcome of fatigue was not recovered and all the other events were recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Severe arm pain at pneumococcal vac site, unable to move arm, tx with Advil, Benadryl, Ice.
Patient is asymptomatic, but vaccine was given to a 16 year old, where manufacturer recommends 18 years and above.
Breakthrough pain; Bilateral pain in wrists and fingers (joints); This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for Pneumocystis carinii pneumonia, Pneumocystis pneumonia, Pneumocystosis, Interstitial plasma cell pneumonia, Pneumocystis jiroveci pneumonia and Pneumocystis jirovecii pneumonia.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in December 2022.    On 16-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 22-Sep-2023, the patient experienced BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)). The patient was treated with IBUPROFEN at a dose of 600 milligram twice a day and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)) had not resolved.            Concomitant medication was not provided. Patient had bilateral pain in wrists and fingers (joints) increased over time. OTC NSAID usage helped but breakthrough pain continued. Patient went to PCP and was told it was likely a vaccine response.  Patient was prescribed with 50mg Diclofenac sodium, but haven't taken it yet.
Injected at 3:15 PM patient experienced left arm tingling, burning sensation and numbness after 15 minute observation (3:30PM) Dr. examined patient, no irritation nor swelling was noticed. Monitored patient for additional (30) minutes symptoms were relieved and per Dr. okay to go home. patient notified if symptoms worsen please go to emergency room or contact his Primary Care Provider for additional assistance .
Medical Assistant didn't follow appropriate steps to check vaccine expiration and double check with Licensed Provider before giving an expired vaccine.
pt recvd vax;in er w/ myalgia, low grade fever, chills, localized urticarial rash(deltoid & trunk), erythema & swelling at inject site; tx w/ antihistamine & steroids
three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably; headache; stomach ache; fever; This is a spontaneous report received from contactable consumer. The reporter is patient's father. An 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE taken for thyroid disorder (ongoing); OXCARBAZEPINE taken for seizure (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot: FK5618, left shoulder at 17:45), administration date: 10Nov2021, when the patient was 11 years old, for COVID-19 immunization, reactions: "tardive dyskinesia", "Headache", "Stomach ache". The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset Dec2021, outcome "not recovered", described as "three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "stomach ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper, pyrexia.
My periods are very predictable and the same each month. I finished my cycle on Thursday. I received the vaccine on Friday morning. On Saturday morning, I began to bleed again and continued to bleed for two days. I am still spotting.  My left arm is also numb and my hand is not working strongly. This is the arm that I received the injection in. The muscle is still sore, but I have a tingling in my arm down to my hand.
Came to pharmacy 10/26/13 at 10am. Patient presented with red, splotchy, "area about 2" below injection site. Patient stated it was painful but not itchy. She had no problems breathing. She had been applying heat. Advised her to see a doctor.
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better.  Chills continued throughout the night.  Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes.  Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise.  Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years.  Monday shaky feeling somewhat better still malaise.  Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4.  Continued body aches.
This spontaneous report as received from a healthcare worker (Certified Medical Assistant (CMA)) refers to a 12 month old patient. On 05-JUL-2016 the patient inadvertently received an "extra" dose of ROTATEQ, oral (dose was not reported, unspecified lot/unspecified expiration). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
had a change in body temperature; chills; had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature), PAIN IN EXTREMITY (had arm pain) and CHILLS (chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (had arm pain). On 10-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature), PAIN IN EXTREMITY (had arm pain) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-433482 (Patient Link).
Rash  in different parts of my body.  Arms, legs, stomach, side of the hips, back of my legs, in my back. Looks like chicken pox, red small dots in my body. Very itchy, especially at  night.
Narrative:  COVID infection following COVID vaccine series 02/22, Pfizer, dose #1 03/17, Pfizer, dose #2 08/05 pt cc: cough, chills, diarrhea, fatigue, loss of taste or smell, rhinorrhea, fever, headache myalgias exposure: unknown 08/14 COVID swab, result: detected
lymph node swollen; 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 LYMPHADENOPATHY (lymph node swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node swollen). At the time of the report, LYMPHADENOPATHY (lymph node swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided
2 days after MMR injection-fever and localized reaction. 8 days after MMR injection-macular rash covering trunk and head, arms some legs.
Patient and mother stayed in exam room after shots given to monitor for reactions, patient checked at 0857, noted to have an area of redness and slight swelling in are where varicella vaccine was given, mother states patient has not been scratching at this and does not seemed bothered by it, informed provider so she can view the site and mother agreed to stay in exam room for area to be monitored. Patient was checked again at 0908, raised area was same in size, area of redness slightly larger, provider viewed this and took a picture for documenting, mother states patient does not seemed bothered by it and is not scratching at it, patient and mother stayed in exam room and patient was checked again 0925, no changed in raised area and redness is the same,
according to pt mom, pt exp sz like activity w/jerking motions of head, arms & legs;pt was also pale & sweaty per mom;pt has hx of  CP & known sz activity on tegretol for many years;
Pt woke up in AM with foot pain. 10/26/03 No known injuries. 10/29/03 pain has moved into ankle, neuroma vs cellulitis/phlebitis. 11/3/03 4th day of antibiotic, tendon ROM ligs stable. Tendon anterior tib 1/3 up pain on palp arch of foot plantar dorsal.
Weakness, flushing, difficulty standing up, Nausea, lightheadedness, rapid heart beat
Patient felt itching on chest, stomach and posterior right and left thighs; identified rash, urticaria and erythema at these sites; took 50 mg po diphenhydramine shortly after becoming aware of this reaction; when awakened the next morning, rash and urticaria were absent; patient reports no other signs or symptoms of reaction.
Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination
Second dose, chills; fever; body ache; loss of appetite; migraines; joint pain; stiff neck; back aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: Ff2590) at the age of 30 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone for known allergies: Prednisone. Vaccination history included: Bnt162b2 (Previous dose lot number: FF2590, dose administration date: 18Oct2021, dose number: 1, dose vaccine location: Left arm), when the patient was 30 years old, for COVID-19 immunization, reaction(s): "crippling migraines", "back aches", "joint pain", "stiff neck". The following information was reported: CHILLS (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "Second dose, chills"; PYREXIA (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "body ache"; DECREASED APPETITE (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "loss of appetite"; MIGRAINE (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "migraines"; ARTHRALGIA (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "joint pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "stiff neck"; BACK PAIN (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "back aches". Therapeutic measures were not taken as a result of AEs.  Additional Information: Patient had no other medical history. Patient did not receive any other vaccine in four weeks nor received any other medications in two weeks. Patient had COVID prior vaccination. Patient had not COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Swelling/Itching  of Injection site area beginning 8 days after vaccine was given.   Sudden onset 9 days after vaccine and it was erythematous warm and measuring 5 x 7 cm
Patient was receiving her first Moderna 0.5ml vaccine on 11/23/21. At the time of vaccine administration, a small amount of vaccine leaked out of patient's arm.  An additional 0.25ml dose of Moderna vaccine was given.  A follow up phone call was made to the patient on 11/24/21.  She reports that she just had a headache after the vaccine, but other than that, feels fine.