chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 60 Year old female patient developed a local reaction after receiving RabAvert.  The patient received the first doses of RabAvert on days zero, three and seven with the fourth and final dose given on 03/26/2004.  The patient was bitten by a squirrel on 03/12/2004 and had been treated with the first doses of RabAvert without any reported adverse effects.  In addition to the RabAvert the patient was given Tetanus Toxoid and Gamma Globulin intramuscular injections. On 03/28/2004 the patient presented to the emergency department with complaints that her upper right deltoid area was discolored, red hot to the touch, swollen and very itchy.  The patient was treated with oral Keflex 500 mg to be taken four times a day for ten days.  She had a complete recovery within seven to fourteen days.
Mild case (<50 lesions) of papulo-vesicular rash after exposure to sibling (or he and sibling may have been exposed to the same index case).
rash on thighs; Patient took Fluzone Quadrivalent multidose vial  instead of prefilled syringe; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient who experienced rash on thighs (rash), while he/she received vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient was asked to receive vaccine from a prefilled syringe (INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]) only.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious rash on thighs (rash) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It is also a case of actual medication error due to Wrong vaccine administered.  Other relevant tests were not reported.  Final diagnosis was rash on thighs and pain in lower legs.  It was not reported if the patient received a corrective treatment.  The patient outcome for the event rash on thighs and muscle aches was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
Constriction of throat Heart palpitations  Patient was in observation ADA 2B, patient reported dizziness to RN.  Pt. then reported ?constriction of the throat? and history of allergic type reaction to  other medications.  Patient reported history of Hashimoto's.  Patient took her medication this morning- Levothyroxine 50 mcg.  Upon medic arrival, BP- 172/100 and HR- 78, O2 Sat 99%.  Patient reported feeling better after medic arrival.  B/P 128/78, HR- 71 and O2 Sat 100%.  Patient stated ?feeling much better? and patient wanted to go home.  No transport and patient stable upon leaving.
flu; ill; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced flu (influenza) and ill (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and ill (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Noted pain and erythema and edema. size of a  coaster with blister formation at inject site RUA approx 5-6 hours after receiving  injections. These Sx lasted approximately 3-4 days with gradual decrease in swelling. No respiratory px noted with episode.
Brain hemorrhage; Allergic reaction; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Hands were itching; A spontaneous report (United States) was received from a consumer a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced brain hemorrhage, allergic reaction, face, eyes, ears, lips and hands were swollen, and hands were itching.   The patient's medical history, as provided by the reporter included allergy to gadavist and tromethamine. The concomitant medications reported included diltiazem, atorvastatin calcium, ezetimibe and hydrochlorothiazide for unspecified indications.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021, the patient experienced brain hemorrhage, allergic reaction, face, eyes, ears, lips and hands were swollen, lips looked as an overdose of botox and hands were itching. The patient was taken to the emergency room (ER) and treated with intravenous diphenhydramine and steroids. It was stated that the swelling lasted 36 hours and the patient was prescribed prednisone to treat symptoms after leaving ER.   Action taken with mRNA-1273 in response to the events was not provided. However, the healthcare professional recommended patient to cease with the vaccination series due to probability of the patient being allergic to tromethamine.  The events, allergic reaction, face, eyes, ears, lips and hands were swollen, and hands were itching, were considered resolved on 20 Jan 2021. The outcome for the event, brain hemorrhage, was unknown.; Reporter's Comments: This case concerns a 74 year old, female patient, with a medical history of allergy to gadavist and tromethamine, who experienced a serious unexpected event of Cerebral hemorrhage, hypersensitivity after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable other HCP via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Mar2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. No patient identifiers were provided- it was unknown if the reporter had a specific patient in mind. It was reported that patient received first Pfizer on 03Mar2021, 21 days after that the patient tested positive for COVID-19 in Mar2021, patient was advised to wait 3 months for 2nd dose. HCP asked how to proceed. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective with the suspect drug BNT162B2.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). On 11th August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The reporter agreed to follow up. This case is 1 of the 8 cases, reported by the same reporter.
Headaches starting on 11/10/21 @ 0800 through now (as of 12/9/21 when completing this form). Drooping of left hand on 11/16/21.  11/23/21 full loss of control of left hand. severe headaches, nausea. admitted to hospital 11/23/21. discharged 12/2/21. still having headaches, cause undiagnosed upon discharge.
Diarrhea; Sick for 5 days; Achy; Black and Blue at injection site; Yellowish ring around injection site; Stomach didn't feel right and didn't throw up; Arm ache; no appetite,No appetite to eat,Little appetite; pain at injection site; More tired than usual; nausea; Hurting; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache) and DECREASED APPETITE (no appetite,No appetite to eat,Little appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Hurting) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache), DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days), PAIN (Achy), VACCINATION SITE PAIN (pain at injection site), FATIGUE (More tired than usual) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 08-Apr-2021, PAIN (Hurting) and INSOMNIA (Couldn't sleep) had resolved. On 12-Apr-2021, ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN (Achy) and FATIGUE (More tired than usual) had resolved. On 13-Apr-2021, DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days) and NAUSEA (nausea) had resolved. On 22-Apr-2021, VACCINATION SITE DISCOLOURATION (Black and Blue at injection site) and VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site) had resolved. On 13-May-2021, DIARRHEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm ache) and VACCINATION SITE PAIN (pain at injection site) had resolved.            This case was linked to MOD-2021-054381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: First dose details and treatment medication updated. New events added.
Attacks of very red rash and welts with severe itching.  Treated with cold compresses and Ibruprofen.
Severe headache (won't go away with Tylonol or Advil), sore, swollen arm.
mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Apr-2022 Reporter's comment: The case was received by the patient via Shingrix. The patient stated that you (GSK) and your people never got back with him/her the other day after they texted and chatting over a half an hour about his/her concerned in receiving the second vaccine. The patient was now actually experiencing a mild case of shingles. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Numbness/pain in feet, traveling up legs. Followed by numbness in hands and arms, mostly left side. Numbness in face.
2x3" rash at injection site, Covid-arm.  Slight headache, brain fog, achy feeling and balance is off.  Tiredness.  Eye pain.
pt recv vax 18AUG95; fever occurred 19AUG95 & 20AUG95; febrile sz 20AUG95;
The patient was 12 when she presented for her first dose and received a pediatric dose instead of the recommended adult dose.  She received the adult dose for her second dose.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 11:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 11:23 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine administration time 11:23:12. The patient was administered booster dose that went into 2-8c thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Starting on 3/3/21, my menstrual cycles started to become abnormal: started 5 days earlier than should have. Next month it started later than should have. In July, my cycle came on Day 41 instead of Day 27 as had been my usual. My cycles started messing up 2 months after completion of second dose of vaccine. I have still not gotten back to "normal" for myself which is a cycle every 27 days. Prior to getting COVID vaccine, my cycles always started on Day 27.
Pain in arm; can only lift up arm so high and then has a problem; Still has a little knot there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for pneumonia. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumovax injections, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "not recovered", described as "Pain in arm"; VACCINATION SITE MASS (non-serious) with onset Oct2022, outcome "not recovered", described as "Still has a little knot there"; MOVEMENT DISORDER (non-serious) with onset Oct2022, outcome "not recovered", described as "can only lift up arm so high and then has a problem". Additional information: Pneumovax injection is a Pfizer product. The patient got a pneumovax injection about a month ago at (Specialty pharmacy). Has never had reaction to an injection before. The patient has pain in arm, at times unbearable, can only lift up arm so high and then has a problem. About a month ago, pain started the same day as caller received the injection, pain got worse next day, got worse, but has gotten a little better maybe not even a week ago, and then the last 2 days started getting more uncomfortable again. Still has a little knot there. Can't even get jacket off by caller's self. Pain started somewhere around 06Oct2022 or 07Oct2022, could have been 08Oct2022 or 09Oct2022, not sure. The people at pharmacy said maybe something 20, maybe Pneumovax 20 but did not say that was the pneumovax injection the patient received. Gave the patient the 1 injection and said to come back in a year for another one. The patient has had prior pneumovax injections for at least 20 or 30 years, has never had a reaction. The patient stated that is unknown which pneumovax injections received before, was at least 7 or 8 years ago. Patient complained that just put alcohol on arm and jabbed and that was it, very unprofessional. Has had pneumonia over 25 times. The patient having pneumonia was prior to he receiving the pneumovax injections, he has not had pneumonia in probably at least 30 or 35 years. Concomitant products: On tons of medications, has been on those medications for 40 years, so caller stated none of those medications would be relevant to include in report.   Follow-up attempts are completed. No further information is expected.
Swollen left arm, Friday 11/12/99, given tylenol. C/O pain at all times, no problems with previous vaccines. Lump in deltoid area at approximate area of injection, pain when pressed, no restriction of movement.
21OCT93 chills & fever 102, mild nausea, loss of appetite 3-4 days; sweating, achiness;
Severe pain. Unable to move arm most times and unable to sleep for 2 nights due to pain and unable to position arm
On Monday (6/6/16), patient was given her 6 month vaccines, soon after mother noticed that the site of vaccine, right lateral thigh area, became a bit hard. The next day the patient had an axillary fever of approximately 101 and the site became red and swollen. She called her PCP who recommended warm compression but that provided no relief. The patients mother then gave Tylenol for pain relief. The redness and pain persisted at the night of admission (6/12/16) the patient had a fever of 101.9 as said by mother, so the mother bought her to the emergency room. Patient has tachycardia and redness and tenderness of the right lateral thigh extending to her right lower abdomen. Cellulitis was suspected so and IV was inserted and labs were ordered (CBC, CMP, BMP, CRP, blood culture). She was started of cefazolin 100 mg/kg/day divided Q8H and she was admitted for IV antibiotics.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: A few minutes after the patient's second dose of Pfizer was administered, the patient stated that she feels winded, like she just ran a few miles. She described chest discomfort and feeling lightheaded. We offered to call 911 but she refused. We monitored the patient and took her blood pressure (within normal limits, not hypotensive). We helped her get some fresh air outside the pharmacy after she was agreeable to it and soon she felt better and comfortable enough to depart the pharmacy.
hypotension and inability to raise left arm for 3 days.  She also felt fatigued and had fever to 101 degrees F
15+ hours, Day after booster shot  I developed a tolerable, but not mild,  stomach pain, waves of nausea, loss of appetite and extreme fatigue. Went to bed early and was absolutely  fine the next morning. On November 25 had relapse of same symptoms, not as extreme but accompanied by chills through the night. Thereafter have had severe night sweats needing to change my top and pillow case 1-4 times a night almost every night. Was severely fatigued one morning after a  night of soaking wet sweating to point of thinking I needed to go to ER. It occurred to me I might be severely dehydrated due to excess sweating. After determined hydration I felt much better and have been careful to hydrate through the night after night sweating since. Last night (December 15) is the first night I did not have night sweats since Thanksgiving night. I am still drinking a lot of water just in case.
It started three days 04/03/2021 after my first shot and lasted three days 04/22/2021 before my second shot. I was having neurological tingling. It was coming every few minutes, it felt like the nerves in my brain were tingling kind of like when your foot falls asleep or you hit your "funny bone". It didn't hurt but it was enough to make me pause and wait for the feeling to go away.
On last Wednesday, I just felt funny like I was coming down with something or about to have a fever. By the following day I had a fever and chills and started having nasal congestion. It continued to progress and in lots of pain all over my body and I felt like crap. I tested myself on Saturday and I was positive for COVID-19. I wasn't able to reach a doctor until Tuesday. I did a telehealth, and I was put on molnupiravir and I have a couple days left. I started to feel better within 24 hours, but I am still testing positive. Still recovering and dealing with fatigue and congestive cough.