chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient received COVID-19 vaccine (Janseen)  on 8/25/21. About 2 weeks after receiving the vaccine he reports left calf pain (~9/8/21). A few days after the pain started, he reports numbness/tingling plantar surface of the foot and heel. He states the calf fees swollen. Was seen in the ED on 9/15/21. No family history of VTE, no other risk factors for DVT, no long distance travel. He is ambulatory, was given an outpt rx for rivaroxaban and discharged from the ED.
Vertigo; Migaine; Super dizzy; Arm was really sore; Migraine; Lightheadedness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), MIGRAINE (Migaine), DIZZINESS (Super dizzy), PAIN IN EXTREMITY (Arm was really sore) and MIGRAINE (Migraine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and MELATONIN for an unknown indication.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore), MIGRAINE (Migraine), DIZZINESS (Lightheadedness) and PYREXIA (Fever). On 31-Oct-2021, the patient experienced VERTIGO (Vertigo), MIGRAINE (Migaine) and DIZZINESS (Super dizzy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. On 30-Oct-2021, PAIN IN EXTREMITY (Arm was really sore), MIGRAINE (Migraine), DIZZINESS (Lightheadedness) and PYREXIA (Fever) had resolved. At the time of the report, VERTIGO (Vertigo), MIGRAINE (Migaine) and DIZZINESS (Super dizzy) had not resolved.       This case was linked to MOD-2021-370388 (Patient Link).
Case number PHEH2014US024996 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
pt recv vax & approx 2 wk p/vax pt devel a chickenpox rash w/21 lesions;1wk later devel enlarged lymph nodes;lab eval revealed WBC count 9400;dx w/acute myelogenous leukemia;pt hosp & placed on chemotherapy;PE prior to vax was nl;
March 20: Onset of SEVERE facial pain, left side. Cheek, ear, jaw area to occiput. March 22: Pain lessening, taking Gabapentin. March 23: Sudden onset of L facial paralysis, drooping, tearing, lips and tongue numb, trouble drinking and swallowing, difficulty speaking. Saw PCP, sent for stat MRI ER. Result show inflammation and compression of several cranial nerves. Put on high dose prednisone, antiviral, and upped Gabapentin dosage.  March 24: Today RIGHT side of face, numb lips, unable to smile, drooling and difficulty drinking and speaking.  L side of face the sam, no improvement. NOTE: Had 2nd Shingles vaccine dose on February 16th, 2021, 16 days after 2nd Moderna.
Myalgia, Fever, NauseaVomting, FATIGUE Narrative:  Other Relevant History:
Swelling, Redness, Knot on arm about 2-3 inches wide, Warm area, Pain  - This began about 1/2 hour after vaccine given.
cannot sleep/up all night; soreness; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache) in an elderly female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache). At the time of the report, INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache) had resolved.            No treatment medication was reported. No concomitant medication was provided. The action taken was Not applicable as the 2 doses were administered.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up email received on 17-JUN-2021: TCR (Telephone Contact Report) Adverse events outcome were updated.
Chills x 2-3 hrs with whole body shakes, severe weakness (unable to lift 10 lbs). Low fever. No treatment. Resolved within 24 hrs.
After I received my second dose of the vaccine, my arm felt a bit sore. By later that evening, and definitely the following day, I could not lift my arm higher than like 5 inches. It was like my shoulder would not rotate in the socket.   Beginning that next morning, practices that used to be routine and commonplace, such as reaching behind me when driving to grab my seatbelt were nearly impossible without using another body part to compensate.   Prior to the vaccine, I was working it consistently snit after the  vaccine, I had no desire to work outand no real feelings in my left shoulder.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L025208, expiration date 07-JUL-2017, route not specified). No adverse effects reported. Additional information is not expected because there was not consent for follow up.
Pt complaining of red visible rash spreading around injection site. Area is red, swollen, warm to touch, itching. Pt advised to try BENADRYL and cold compress at this time.
Patient received Menactra at 1346 PM, per nursing staff patient had left building then returned 30 minutes later with complaint of right hand tingling, shortness of breath, throat itching, hives to right wrist and face. Injection was to left deltoid and no reaction at site.  On exam: patient alert, speaking in full sentences, lungs CTA bilaterally with good air movement, Heart rate regular without murmur Wheal approximately 3 mm noted x 2 to right wrist, cheeks flushed/pink with approximately 3 small wheals noted. Injection site clear.    Patient given Diphenhydramine 50 mg po at 1420; still complaining of shortness of breath, throat itching, nausea. Epi Pen given at 1440. Patient stated her itchy throat and shortness of breath improved, EMS notified and patient transferred to monitor.   1523 patient arrived at ED. Initial SpO2 considered adequate. Upon examination, patient is well-appearing, in no acute distress. Vital signs are stable. 1545 Solu-Medrol 80mg IV given. 1628 Patient re-evaluated and reports feeling improved. Tolerating apple juice. 1650 patient reports nausea and itching increasing. Famotidine 20mg IV and Ondansetron 4mg ODT given. 1900 patient discharged home with return precautions.
Patient passed out in vaccination area. Pt. brought to medical screening via wheelchair Seen by onsite EMT.  Pt.went home with mother. Pt. discharged home at 13:30 p.m. recorded by RN
Information has been received from a consumer concerning his 30 months old daughter with no pertinent medical history who received her ROTATEQ series at age 2 months, 4 months, and 6 months. There was no concomitant medication. "About 5 days ago", on approximately 30-JAN-2010 the patient had a case of diarrhea that resembled a rotavirus infection. She was not dehydrated and seemed "normal" except for the diarrhea. It had not been officially diagnosed as rotavirus but there were cases of rotavirus reported in the local area. Also the infection had not spread to her brothers. The patient did not seek medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. No further information is available.
Severe headaches , forgetfulness, chest pains, muscle pains, left arm numbness and hand, BP higher than normal
I am not sure which type of flu vaccine I was given, we were given no paperwork. 36 hour after the vaccine my entire left arm started with radiating pain and numbness. Every joint of my left hand feels swollen. My hand feels both numb and painful, like it is burning.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patient. This is the 13th of 13 report.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week. on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Swelling in ankle; She had improvement in her arthritis; First dose received on 28-Mar-2021 and second dose on 15-Apr-2021; bad reaction to covid shot / covid vaccine made her symptom really bad; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in ankle), IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad), THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021). In 2021, the patient experienced IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad). On an unknown date, the patient experienced JOINT SWELLING (Swelling in ankle) and THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis). At the time of the report, JOINT SWELLING (Swelling in ankle) and IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad) was resolving and THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: All ok.         It was unknown if patient was enrolled in a COVID-19 Vaccine.  No concomitant product reported by reporter.  The patient had ankle swelling and she did ultrasound scan and all was ok. She had bad reaction to covid shot which was very bad three weeks after. She had improvement in her arthritis. It was reported that, covid vaccine made her symptoms really bad.  The reporter's causality for the event(s) of SWELLING IN ANKLE and COVID SHOT REACTION with  RINVOQ(UPADACITINIB) was no reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Live Significant Follow up received. Vaccination dates updated. New events added and reported causality updated.
Pt was give a high dose flu vaccine. She should have been given quadrivalent vaccine.
Information has been received from a doctor of pharmacy concerning a female who on 31 JUL 2001 was vaccinated with hepatitis b vaccine recombinant (yeast) in her upper right arm. A few days later, in August 2001, the patient experienced itching and developed a mild rash on her lower right arm only. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of ROTATEQ. In August 2007, the patient experienced bloody stools. The patient sought unspecified medical attention and was treated with Lactobacillus. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting nurse practitioner indicated that the infant was "doing fine." Upon internal review, bloody stool(s) was determined to be an other important medical event. This is one of several reports from the same source.
accute hypothermia (93.3 degrees),pounding  headache, pain from base of neck all down spine. temp came up gradually in 2 hrs. head and back pain continued 2 days. Temp continued low 95.5 and up every am and came to normal.  returned to without head pain 5 days later. still have lingering symptoms thru today, ie temp is normal than low, than normal after arising in morning, still have moderate back pain and slight headache but nothing debilitating now. never had anything like this before. quite healthy and athletic ie running half-marathons til covid hit.
Severe exacerbation of autoimmune symptoms.  Ten weeks after shot, still mostly bedridden with very low energy and flu-like symptoms. Increased MCAS symptoms. CCI worse.
Around 7 pm on Feb 22 I started feeling very fatigued and I had some body aches. I decided to go to bed early to try to sleep it off. About 5 am on Feb 23 I was woken up by a splitting headache. I also felt feverish and had the chills. My head hurt so bad, worse than any migraine I had ever had. I got out of bed to take some ibuprofen and could hardly even walk my body hurt so bad. I took the ibuprofen and went back to bed until about 8 am. When I woke up at 8 I felt okay other than a slight headache that lasted until about 7 pm when I took another dose of ibuprofen.
Lt arm 8 1/2 cm erythematous warm, raised area distal to vaccine site with tenderness, no itching; started on KEFLEX.
allergic reaction to vaccine; This spontaneous report was received from a company representative via physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were unknown. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, single dose (1 dosage form) (route of administration, anatomical location, lot number and expiry date were unknown) for prophylaxis (unable to confirm if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the patient had drug allergy to vaccine (drug hypersensitivity). The outcome of hypersensitivity was reported as recovered. The reporter considered hypersensitivity to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). No product quality complaints (PQC) were involved.
Severe, ongoing multi-joint pain began 2/10/21 accompanied by fatigue, muscle weakness, activity intolerance. Low-grade fever onset 2/10/21, ongoing intermittently until 6/15/21. Primary medicine, rheumatology, and neurology specialists were consulted. Treatments have included long-term steroids, OTC fever reducers and pain relievers, muscle relaxers. Rheumatologist arrived at a diagnosis of Rheumatoid Arthritis and Sjogren's in June 2021 after extensive diagnostic studies and symptom observation. No prior family history of autoimmune disease exists. Symptom onset of autoimmune diseases correlate with onset within one month of second dose of pfizer vaccine.
Fever 104.0, Nausea, Vomiting, Dizziness, Fatigue, Shortness of Breath
This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported.  No treatment information was provided.  T
This spontaneous report was received from a nurse refers to a 12 year old female patient. On 20-DEC-2013 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2013 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 28-AUG-2013, second dose 25-OCT-2013 and the third dose of GARDASIL on 20-DEC-2013. Nurse states clients were vaccinated at another health care facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Pt did not receive the vaccine in our health system so I don't know the version but it was the first shot.  Rash spread to torso and upper extremity, chest pain & swallowing pain - went to ED.  Workup didn't show any acute issues, patient will follow up with PMD.
Two patients received bivalent expired doses; Two patients received bivalent expired doses; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses).    It was reported that two patients received bivalent expired doses from lot 030g22b with beyond use date 04 Dec 2022. No concomitant medication were reported. No treatment medication were reported.
End of the second day, severe migraine has not gone away for 2 months some days debilitating other days not, fatigue, brain fog, nausea and vomiting don't know if it's due to the migraines or the vaccine or both
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 04-AUG-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Mercury poisoning, deterioration began around 12-18 months of age. Mercury chelation started on 5/01. The annual follow up states, "Autism spectrum disorder-mercury poisoning. We have spent over and look now on therapies and biomedical treatments for pt. He is finally able to communicate some, but has a long ways to go. Requires an aide in school and still does five hours of ABA a day outside of school."
Patient reported that following the shot she had numbness & loss of strength in her (L) arm, pain at injection site.
nausea, vomiting, and diarrhea for 3 hours. Body aches and stiffness.
My brother received his second dose of the Pfizer vaccine  on March 6, 2021. He called me that afternoon to show me the auditorium.  On March 7, 2021 he was pronounced dead. He died in his sleep from an apparent heart attack. I believe it was from the second shot. He was healthy, and active. This  never should have happened. We are all devasted.  On the following page I put ?unknown vaccine ? I was unable to change it. He had no other vaccine prior to the  Phizer