chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; This spontaneous case was received on 02-Nov-2020 from other non-health professional (consumer) via the agency (reference number: SEQW20-04654) and concerned a 77-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in late Oct-2019, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, route of administration, anatomical location and dose: not reported) for influenza prophylaxis. The batch number was not reported. The vaccine was one for seniors, recommended for age over 65.  On an unspecified date in 2019, within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. The patient was sick for a month and had to see her physician who stated that she was dehydrated and had to be administered intravenous (IV) fluids.  On an unspecified date in Jan-2020, the patient was still sick and was diagnosed with the flu.   At the time of initial reporting on 02-Nov-2020, the patient had not recovered from the event and she was not the same since vaccination.  The reporter did not provide causality assessment.  The event of 'flu' was considered serious due to medically significance by a physician within agency.  This case is linked to 202005985 and 202005986 (the same reporter).  Company comment: A 77-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. Within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. Reportedly, on an unspecified date in Jan-2020, the patient was diagnosed with influenza. With information available, chronology is plausible and causality is assessed as possibly related.; Sender's Comments: A 77-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. Within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. Reportedly, on an unspecified date in Jan-2020, the patient was diagnosed with influenza. With information available, chronology is plausible and causality is assessed as possibly related.
Red rash noted to bilateral arms and legs. Patient reported symptoms started day after vaccine administered. Patient taking PO BENADRYL at home. PCP updated by patient.
Patient verbally states 4 days after receiving PCV13 vaccine, she develops itching, swelling, tenderness and redness to the injection site. As per the patient, 12/15/2019, she went to ER. Patient states at that point, she could hardly move her arm and the swelling had spread to the back of the arm. Patient verbally states that after several tests, she was told that she had an infection. Patient states two types of antibiotics were prescribed and after completing antibiotics, her arm was back to normal.
red circle in the injection site (second dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)). At the time of the report, VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included steroids. Treatment information was not provided.   This case was linked to MOD-2021-314562, MOD-2021-314599 (Patient Link).
pt recvd vax & cried uncontrollably for 3-4 hrs w/in 48 hrs of vax; 2 wks later mom noticed pt had 10 sec episodes of tremor w/eyes closed, when feeding; cont to have tremors about once a wk;
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to a lot of adolescent patients (gender not reported). On an unknown date (dates) the patients were vaccinated with GARDASIL (dose, route and lot number were not reported). The patients complaint that GARDADSIL was cold after being injected in (date unspecified). The outcome of the patients was not reported. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Around Aug 2021 she fainted and hit her head on the door knob. She had A-Fib. Went to the doctor.
Initial literature report received on 06 Sep 2010: This article deals with pancreas rejection after H1N1 vaccination or infection. This patient with type 1 diabetes mellitus underwent pancreas transplantation (portal-enteric drainage) using basiliximab induction and triple maintenance immunosuppression 09 and 05 years before, respectively from a cadaveric donor in Apr 2001. The patient was vaccinated with H1N1 (manufacturer and batch number unknown) in Dec 2009. After the vaccination, the patient experienced hyperglycemia, lost insulin independence and was diagnosed with acute rejection in Dec 2009. The repeat testing showed broad sensitization against more than 18 different human leukocyte antigen (HLA) class I and more than 13 human leukocyte antigen (HLA) class II antigens. It was reported that, no anti-HLA immunoglobulin G (IgG) evident in Jan 2009 and the patient never received blood component transfusions. The outcome of events was not reported.
Extreme dizziness, vomiting, hallucinations, body aches and pains, extremely low body temperature (93.5F), headache, severe dehydration, inability to sit or stand under own power, racing heart, cold sweats.
This spontaneous case reported by a consumer, describes the occurrence of coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on chest and body) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 26, 2021, patient experienced coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on his chest and body). The patient treated with Mucinex (guaifenesin) at an unspecified dose; and frequency and Aspirin EC (acetylsalicylic acid), at an unspecified dose and frequency. At the time of the report, coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on chest and body) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medications include Mucinex and Aspirin.
brain ringing and it is debilitating; brain ringing and it is debilitating; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced brain ringing and it was debilitating. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331312 Same reporter/drug/events; different patients
suspected vaccination failure/Got shot and got shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. Age at vaccination was not reported. The patient received a shot of Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
This spontaneous report as received from a physician refers to a patient of unknown age and gender with no drug reactions or allergies and no pertinent medical history who on unspecified date, was vaccinated with VARIVAX (merck) (lot # and dose not provided). No concomitant medications were reported. The physician stated that on unspecified date, a patient received 2 doses of VARIVAX (merck) separated by 21 days, the dates of administration were unspecified. No known adverse effects. Additional information has been requested.
profound neurological deteoration with loss of speech, ability to walk, incontinence, difficulty sitting.
a 12 years-old patient received FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other health care professional via Global Medical Information (Reference number- 00337309) and transmitted to Sanofi on 29-Oct-2020.  This case was linked to case 2020SA306627 (8 years old patient).  This case involved a 12 years old patient of (gender unknown) who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2010 and expiry date: 30-Jun-2021) via an unknown route in the left deltoid, on 20-Oct-2020, for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medications given to patient.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of report, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Numbness/tingling on right side of the body.  Most severe in the leg/foot.  This has been occurring since late Wednesday night (4/28).   Felt very tired most of Thursday.  Pain/numbness has decreased but still present as of Sunday (5/2/21).
Patient is a 80y.o.male  with h/o Afib and MVR on warfarin, CKDIII, HTN who lives at home w/ 24h caregivers presents with weakness. Tested positive for COVID in EC so symptoms attributed to acute COVID but on further investigation patient had COVID several weeks prior so +test did not represent acute infection.  Unclear cause of patient's symptoms but possibly different virus as he did have mild fever and cough. He was quite weak on admission but over next few days he regained strength and was able to be d/c'd home w/ his usual 24h care.
I got COVID-19 in September. I went to the doctor at the urgent care and tested positive. He prescribed PAXLOVID, I was sick from Sept 7 to Sept 30, but I did not go the hospital. I had sore throat, headache, diarrhea, running nose, fever and fatigue. I tested metal in my mouth, doctor said it could be the PAXLOVID.
thrombocytopenic purpura w/platelet count 1000, anti platelet antibody IGG positive, tx w/ IV immune globulin p/referral; good response, no recurrence
pt recv vax 13OCT97 & 30min p/vax pt exp a severe h/a;2hr later @home pt reportedly became delirious, went unconscious & had fixed, dilated pupils;to hosp & adm to ICU;WBC 19,000;duration of hosp approx 2.5d;facial paresthesia;
pt. reports tingling & numbness of the tongue & some lightheadedness.   pt. denies any difficulty swallowing / breathing and/or other s/s.  tongue does not appear swollen & pt. confirms her tongue is not swollen.  pt. waited an additional 15 mins. which in that time her symptom resolved.
Day 1: After 11 hours the horrible body & joint aches began, then severe shivering. I moaned and groaned all night bundled up w/ sweatshirts and blankets. Day 2:  I slept most of the next day w/ shivers covered in blankets. Drank lots of liquids & had soup. That night I broke a fever. Day 3: Shivers went away. Body aches were mild but I was still very tired and napped during the day. Day 4: Aches were gone, just felt a little run down. Day 5: Okay
Pt was nervous about getting vaccine and stated she usually cries and hates needles.  5 minutes after vaccine she stated she feels dizzy and has blurry vision.   I had her sit down and gave her an instant cold pack which she applied to her forehead and neck.  After a few minutes she felt better.  She called her son in law to come pick her up.  I asked if we can call EMS and she stated she was feeling much better and she wants to go home
81 days of severe vaginal bleeding resulting in D and C and ablation procedure, resulting in sterilization.
Initial unsolicited report received from a consumer on 31 August 2016. This case involves a 69-year-old female patient, who was vaccinated with a dose of IMOVAX and IMOGAM (batch number, expiry date, dose, dose in series, route and site of administration was unknown for both vaccinations) on 19 August 2016. The patient had a medical history of Hashimoto's disease. Concomitant medications was unknown. On 19 August 2016, same day following the vaccination, the patient experienced increased palpitations, lethargy and depression. Laboratory data and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
his right arm started to have a problem where he could not use longer it; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program.   A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as 1st single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that he was done with the two doses of the Pfizer vaccine BNT162B2. The patient reported that after a month of getting the first dose, his right arm started to have a problem where he could not use longer it. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received her Flucelvax injection in left arm on Tuesday 10/06/20 at around 1pm.    On Tuesday patient states she had some soreness and discomfort but didn't think it was abnormal for a injection.  When she went to bed that night she states that it was particularly uncomfortable throughout the night.  The next morning the patient states she woke up with radiating pain from her shoulder down her entire arm to her hand.  When asked to describe the pain, she described it as if she had a hard work out and her entire arm was sore.  This discomfort in her entire arm lasted all day on Wednesday.  Thursday morning, she states that she woke up and no longer had the radiating arm pain but had pronounced swelling and pain in her armpit.  She proceeded to call the pharmacy for information.  I received a call from the patient around 9:15am when I gathered all the information about her symptoms.  After hearing about her symptoms, I advised her to see a doctor to examine her for the adverse reaction she was reporting. She was working throughout the day and told me she would attempt to see her provider.  Again, I reiterated that she should see her provider as soon as possible and to let me know what is the result and determination of the adverse reaction.  I also advised that I would be more than happy to reimburse her for her doctors visit with a receipt.    I followed up with her at 4:45pm and she was able to see a Dr who gave her antibiotics.  I asked if she had a diagnosis or infection and she was not sure (said Dr was hard to understand).  She did not know which antibiotic she filled them at the clinic.  Her arm is still very painful, swollen and tender at her underarms.  She said she did not require any reimbursement for her visit and I told her I will follow up in a couple of days to see how she's doing.
Father describes fever 99-100 F, c/o tiredness, s/ nausea. Gave Tylenol.
Information has been received from a pharmacist concerning a female (age not reported) who was vaccinated subcutaneously with a single dose of Zostavax. The pharmacist reported that the patient experienced "dizziness" almost immediately attention. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Extreme pain in upper arm, hurt to move, low grade fever - for approximately 7 days
Dose Number: 3, Positive Binax test result 4/8/22; Dose Number: 3, Positive Binax test result 4/8/22; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 1, single (Lot number: 037A21B), in left arm and on 26Apr2021 as dose 2, single (Lot number: 045B21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Dose Number: 3, Positive Binax test result 4/8/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Positive Binax test result 08Apr2022. Therapeutic measures were taken as a result of covid-19 treatment drugs which include Advil and Tylenol.  No follow-up attempts are possible. No further information is expected.
Red rash at point of SQ injection. Took BENADRYL 25 mg TID. No reported temperature. Area was warm.
HAD FLU-LIKE SYMPTOMS - WEAK, TIRED, WANTED TO SLEEP FOR LONG PERIOD OF TIME, RED AT SHOT FOR ABOUT 2 WEEKS SIZE OF ORANGE, ITCHING, HEADACHES FOR SEVERAL DAYS AFTER SHOT
Beginning 1 hour after the vaccination I experienced the feeling of not being able to breathe. This lasted for approx 15 minutes. At approximately 6:00 PM I experienced extreme nausea. Nausea continued until about 10:00 PM on 3/4/2021. On 3/10/21 my face broke out in a rash around my ears and temple area. This has continued to date (5/24) At this point, the rash is also under my right eyebrow and on my neck and cheek on the left side of my face, and on both ear lobes. My face has an uncontrollable itch that begins from underneath the skin and terrible. I have never had skin issues prior to the vaccination.
Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can´t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia.   The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache.  On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan.  Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a "calming medicine". b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   +  b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt. states received 2nd Phizer 07/07/2021  07/09/2021 Body ache, fatigue after 3 days different parts of the body started to swell (under arm pit, behind ear) Ear pain intense 07/13/2021 Primary visited (continue Ibuprofen) Follow Up 07/15/2021
68 yo female who received her 1st dose of Pfizer vaccine for covid 19 developed an immediate raised non pruritic rash on her bilateral forearm. Patient denied any other adverse reaction. Patient reports a rash to be common with other IM injections of vaccinations. She was given 50mg Benadryl and was observed and monitored for 35 minutes following the administration. Patient was discharged home.
Swelling of rt parotid gland 2x2 cm w/amylase 693 on 17JUN91; Tender; 20JUN91 swelling gone; No tenderness;