chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to unspecified female patients of unknown age. The patients' pertinent medical history and drug reactions/allergies were not reported. The reporter heard from other colleagues that on unknown dates, the patients experienced "premature ovarian failure" after receiving GARDASIL (dose, dose number, lot# and route were not reported) on unknown dates. The outcome of the event and the causality were not reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and CHILLS (Chills) in an elderly female patient who received mRNA-1273 ( for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273  (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273(Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain) and CHILLS (Chills). At the time of the report, BACK PAIN (Back pain) had not resolved and CHILLS (Chills) had resolved.     No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
In usual state of health prior to Moderna vaccine, golfing 2-4x/wk, walking neighborhood, maintaining our apt, walking up 2 flights of stairs w/o difficulty. I had No reservations re: Covid vaccine.  1st Vaccine 2/13/21-pain started around 2/19/21 in right shoulder area. 1st seemed localized but then progressed to a larger area(neck, l shoulder) . Sought out orthopedic, and was prescribed pysical therapy for shoulder-without resolve ( 18 visits) pain spread down the back, hamstrings to knees.  2nd vaccine-3/1/3/21, pain in r arm shoulder area intensified and spread immediately and making normal activies of bathing, getting out of bed , self care and sleeping difficult, necessitating help from my partner.  Cortisone shot R shoulder  3/26/21 Bloodwork 4/26 showed high inflammatory markers. MRI-4/21/21 Med Center, no tear-severe inflammation along entire arm.   6/1/21 xrays and cortisone shot r shoulder.  Blood work shows elevated markers of inflammation.  6/8-seen on semi urgent appt-for evaluation. Dx -PMR-polymyalgia rheumatica rheumatica and progressed into GCA Giant sell Arteritis.  I am now on high dose steroids, had temporal biopsy 6/15/21 and unable to do normal activities of daily living as before.
Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated intramuscularly with 0.5 ml of first and second doses, respectively, of GARDASIL (lot#s not provided).  It was reported that the patient claims that her period started thirty minutes after each dose of GARDASIL was given.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  No additional information available.  Additional information has been requested.
Mom called clinic 13MAR92 to report pt was listless & lt arm was "hard & swollen", also black & blue; stated entire lt arm affected & pt would not move arm; pt seen 13MAR92 @ hosp;
Diarrhea, fever blisters on tongue, runny nose, called 3 days after vaccination to report.
Sore and swollen at injection site.  Headache, nauseous, muscle aches.
Raised rash around injection site.  Rash seems to have fever in it.  It feels warm to the touch.
Anthrax lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per MILVAX direction.
the temperature at 5:30 and it was 20 degrees Celsius due to dusting behind the refrigerator and knocked the switch off; redness and sweling at the injection site; redness and sweling at the injection site; redness and sweling at the injection site; Based on information received on 01-Oct-2019, the report previously considered as non-valid became valid: [patient detail and event details were reported].  Based on additional information received on 01-Oct-2019, this case becomes medically confirmed.  Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked with 2019SA284746 (same reporter).  This case involves a 22 year old patient (gender not reported) who experienced redness and sweling at the injection site (Vaccination site inflammation) (Vaccination site erythema) (Vaccination site swelling), while he/she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5660AA and expiry date: 06-Aug-2021) via intramuscular route in the left deltoid. On 20-Aug-2019, the patient received a dose of suspect VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)] not produced by Sanofi Pasteur lot S015402 via subcutaneous route in the left arm.  On 27-AUG-2019, the patient developed a non-serious redness and sweling at the injection site (vaccination site inflammation) (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)].  It was also a case of actual medication error due to incorrect product storage. It was reported that the temperature at 5:30 was 20 degrees celsius due to dusting behind the refrigerator and knocked the switch off.  Final diagnosis was redness and sweling at the injection site.  The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]).  The patient was recovering from all the events (reported as improved condition).  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 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.  Follow up information received from a other healthcare professional on 01-Oct-2019.  Case became valid and new events were reported. Event description updated.  List of documents held by sender: none.
had heavy breathing/shortness of breath; itching/ hands and feet were red and itchy; and a rash on her hands and feet/ hands and feet were red and itchy; lethargy; migraines; body aches; hives on her face/ face and neck she had welts; numbness on her face, hands, lips and feet/ numbness in her face lips and tongue; numbness on her face, hands, lips and feet; This is a spontaneous report from a contactable consumer reporting for self, via the Pfizer-sponsored program. A 58-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in left shoulder on 14Jul2021 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization.  Medical history included allergic to insect bites, shellfish, and she had COVID in Mar2020. Concomitant medication(s) were none. There were no vaccinations in the 4 weeks prior.  The patient previously took epinephrine (EPIPEN) for severe allergic reaction and pneumonia vaccine on 23May2020 (at age 57 years old) and experienced migraines. The patient reported she had many side effects after her first dose such as numbness, itching, migraines, body aches, lethargy, hives on her face, and a rash on her hands and feet. She had the numbness on her face, hands, lips and feet started immediately after administering the vaccine (14Jul2021). She took Tylenol so it wouldn't get worse and she took Benadryl because her hands and feet were red and she also experienced body aches (onset 14Jul2021). She states she has an EPIPEN she carries just in case of a severe allergic reaction because she was allergic to insect bites, shellfish, and things like that, but she did not use it after she received the vaccine. She only took Benadryl. She also had heavy breathing/shortness of breath as a symptom. On her face and neck she had welts and she didn't see the rest of her body because she had pajamas on. When she got up to use the restroom she was trying to figure out why she was itching. She saw welts on her face and neck. Her hands and feet were red and itchy. There was no investigation assessment. At the time of the report, the numbness in her face lips and tongue was gone (recovered in Jul2021) but the numbness in feet and hands remain (not recovered). There was no treatment for this event. The welts on her face and neck had started 30 mins after she departed got in the car and went home, and had gone away on 14Jul2021, after Benadryl (recovered). The migraines had started about 6pm on 14Jul2021; they were dulling and were going away, but was still on the back of the head. It was persisting (not recovered). Treatment for the migraines was just the Tylenol. The body aches were treated with Tylenol and were ongoing (not recovered). The events did not require a visit to the Emergency Room or Physician's office. She wanted to know when these symptoms would go away .If she takes dose 2, she wanted to know what can she do as preparation for this because she heard the second one is worse.
no additional ae reported; 11 month old received a dose of MMR II and VARIVAX on the same visit; This spontaneous report was received from medical assistant and refers to an 11-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, approximately in November or December 2022, on the same visit, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, route of administration and anatomical location were not provided for both) as prophylaxis. The patient would turn 1 year old in 10 days (inappropriate age at vaccine administration). No adverse effects and no additional adverse event (AE) were reported.
Anaphylaxis with widespread urticarial rash, difficulty breathing, agitation, itching all over body. Given Epinephrine 0.3mg SC Claritin 10mg po. Solumedrol 80mg IV, HCT ringer's 1 liter IV, Ibuprofen 800mg po.
Low grade fever starting around noon following day.  By 3 PM had a fever of 102.8, aches, chills, and headache.  High fever lasted until the middle of the night peaking at 103.1 but staying between 101 and 103 over a period of about 12 hours.  Following morning I felt much better but again had low fever of 100 and fatigue in the afternoon.  I treated myself with rest, Tylenol, and Ibuprofen.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX lot # M006157, expiration date on 05-FEB-2018 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. No product quality complaint was involved. Additional information is not expected since there was no consent for follow up.
This spontaneous report was received from a Nurse Practitioner concerning a female patient of unknown age. On 15-JAN-2009, the patient was vaccinated with the first dose of GARDASIL. On 21-JUN-2011, the patient was vaccinated with the second dose of GARDASIL. No other co-suspect therapy was reported. Concomitant medications were not provided. At the time of the report, patient's outcome was unknown. No adverse effect reported. Additional information has been requested.
Right arm red, swollen, hot to touch, child says itches and has been scratching. Mother advised cold compresses Q20 min (20 min on 20 min off) x's 24. Ibuprophen Q 4-6 hours. Prn Temp. Benadryl for itching (per bottle instructions) RTC 8/11/05 if no improvement.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergic/drug reactions were reported. On 16-OCT-2015 20:10, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.5 and 1.2 respectively. There were no product quality complaints (QC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I had my 2nd Moderna vaccine on 2/23/2021 and was told that being past one month after that vaccine, it was fine to get the 2nd pneumonia vaccine. Later in the afternoon my upper arm swelled up dramatically; there was a hard knob the size of a lemon, and it was warm and very sore. I kept ice on it and it became really painful, I couldn't get comfortable and lost sleep. The next day it was still swollen and very painful. I was advised by a nurse at the clinic to ice it for 48 hours then try heat. Saturday I started having serious pain in other arm muscles and limited range of motion without sharp pain. The muscles in the inner arm that connect to my shoulder, I believe, were impacted by the swelling due to the vaccine. I'm trying hard to do physical therapy motions to regain normalcy and will be in touch with the clinic tomorrow (Monday) to request a PT referral. I'm reporting this as it's my (non-professional) opinion that the reaction to the vaccine caused damage or trauma to other muscles. This is not listed as a possible adverse reaction to the vaccine.
Significant swelling of lymph node of right underarm. Continued significant pain at site of injection and throughout the right arm, right shoulder and right side of neck even 4 days after vaccine. Pain was most intense starting the day after vaccine and lasting through third day after vaccine accompanied by a strong headache on the day after vaccine. My endurance has been significantly reduced to the point that I have gotten out of breath and felt a bit dizzy while climbing stairs, particularly starting the second day after the vaccine (Monday 4/8) through the current day (4/10). I feel that I can rule out an unassociated virus or infection because I have no fever, no runny nose, no diarrhea or symptoms other than those described above.
cardiac arrest; This is a spontaneous report from a contactable consumer (patients Son-in-Law). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that week 1/2 after 1st vaccine the patient went into cardiac arrest. In hospital in (withheld). The outcome of the event was unknown.   Follow up needed, Information on the lot/batch number has been requested.
Arm injected swelled from shoulder to elbow.  Then on 11/04/09 her hands both turned purple from the wrists down while sitting in church.  She was seen in the ER and diagnosed newly with Raynauds Phenomena. Her hands continue to be painful and blue gray in color.  She was seen the next morning by her PCP and it was felt this was NOT Raynauds but a allergic reaction to something!
1000; patient reports that she feels hot and states "I don't feel well but I can't describe it."  BP 106/63,  HR 69, SpO2 99% 1003; Patient is diaphoretic appears anxious.  Paitnet reports that she feels clammy, shaky, nauseous.  BP 107/67, HR 62, Spo2 98% 1006; Nausea subsided.  remains diaphoretic, but not pale.  BP 118/74, HR 62, SpO2 98% 10:18; Patients states "I feel better, I'm not hot or shaky anymore."  She sat up on the side of the bed.  BP 114/76, HR 75, SpO2 98% 10:27; Patient states, " I don't feel good again"  and laid back down.  She reported that she feels hot again.  BP 105/72, HR 80, Spo2 99% 10:34; Pt states "Ok I'm  want to try and sit up again." 10:36 Patient states, "Ok, I'm doing good."  BP 135/81, HR 82, SpO2 99%. 10:38 Patient states" I do feel much better."  No evidence of diaphoresis, anxiety, tremors.  BP 128/78, HR 82, pt ambulates steady to private vehicle
Temperature, chills, extreme body ache, nausea, fatigue ,headache , extreme muscle pain
pt recv vax 215PM woke in the noc w/hives;the next day had hives & was itching that noc;took DPH to lessen rxn so could sleep;again woke in noc w/more hives;
3/7/08, awoke with pain in rt ear.  3/8/08, tingling around mouth, drooping rt eye, mouth, and side of face, was seen in ER.  5/2/08 Reviewed ER medical records of 3/8/2008. FINAL DX: Bell's palsy Records reveal patient experienced right sided throbbing HA, right sided facial droop & numbness x 1 day.  Tx w/IV steroids in ER & d/c to home on tapering oral steroids & antiviral med.
Administration error : On 05/03 patient received 1st dose of vaccination was Janssen, and received Pfizer vaccination on 10/14.
Guillain Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria death and medically significant). The patient died on 05-Sep-2021. The reported cause of death was Guillain Barre syndrome. It is unknown if an autopsy was performed.            No concomitant medication information was provided. The patient died after having side effect from COVID vaccine. She had gamber ray side effect from the COVID vaccine also known as guillain barre syndrome. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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. No treatment medication was provided.  Company comment: This spontaneous case concerns a 96-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for rheumatoid arthritis (start date not reported) who experienced the unexpected serious fatal AESI Guillain-Barre syndrome on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient reported gamber ray side effect from the COVID vaccine. Clinical course and treatment details were not reported. Patient died 8 days post vaccination, with the reported cause of death as Guillain-Barre syndrome and unknown if autopsy was done. Co-suspect  Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 96-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for rheumatoid arthritis (start date not reported) who experienced the unexpected serious fatal AESI Guillain- Barre syndrome on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient reported gamber ray side effect from the COVID vaccine. Clinical course and treatment details were not reported. Patient died 8 days post vaccination, with the reported cause of death as Guillain Barre syndrome and unknown if autopsy was done. Co-suspect  Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Reported Cause(s) of Death: GUILLAIN BARRE SYNDROME
blood clots in her lungs; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program. A 86-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on an unspecified date in 2020 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; tofacitinib citrate (XELJANZ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that his neighbor was taking Xeljanz and got the COVID 19 vaccine (unknown manufacturer) and died from blood clots in her lungs. She died on an unspecified date and the family was blaming Xeljanz. The patient was diagnosis with blood clots about a month ago. She got COVID Vaccine around Christmas 2020. She was in hospital for 5 days with blood clots. The reporter inquired if vaccine cause blood clots. Seriousness of the event was reported as death and hospitalization. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was fatal. It was not reported if an autopsy was performed.  Follow-up attempts are needed. Information on the lot/batch number is expected.; Reported Cause(s) of Death: unknown cause of death
Initial report was received via a search of the scientific literature on 10 September 2013 which involved a cluster of two patients. According to the author, in two patients (patient identifiers not reported), rhabdomyolysis with acute, transient renal dysfunction occurred after influenza administration to patients concurrently treated with HMGCOA reductase inhibitors (statins) with/without a fibrate. Speculatively, the concomitant use of myotoxic drugs increased the risk for muscle breakdown in these patients. The influenza vaccine manufacturer, lot number, route, site and date of administration was not reported. Outcome was not reported. The reporter for this case is the same as for case number F2000-01658. Documents held by sender: None.
1st dose a year ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter reported a patient had yet to receive the Shingrix . The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to complete course of vaccination. The case had been linked to US2023019040, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019040:Same reporter / male Case