chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweats; Injection site hot to touch; Redness on the injeciton site; Fatigue; Headache; Fever; Nausea; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to Codeine).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 17-Jan-2021, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 21-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) had resolved and VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE ERYTHEMA (Redness on the injeciton site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021: Added patient medical history, allergic conditions and update in events outcome.
Pt's arm swelled over the right deltoid, where the DTaP vaccine was given IM. The swelling started between 14 and 20 hours after administration.
24 hrs p/vax pt had episode of emesis then became limp & pale & hypotonic was seen in office w/duration of these sx 3 hrs;
I started to feel symptoms 9 days after my first shot. I woke up to the normal soreness from the injection, but it was itchy and had a few small warm bumps. Throughout the night into the following next two days the site grew from quarter size to 4-6?, with hotness, itching, redness and slight pain.  I took Benadryl and ibuprofen once daily  to help with the itching and pain, and it seems the rash peaked on Saturday, May 23rd, and started to go away drastically by  Sunday, May 24th, evening, with little to almost no rash  Monday, May 25th.
Patient received vaccine nine days prior to coming into the clinic. Patient presented with pustule on upper left arm. Site was surrounded with redness, warm to touch and firm skin around vaccine site.
Patient was driving on 3/24 when her vision became blurry in her left eye. She saw her eye doctor on 4/21 and was sent to a specialist. On 4/23 she was diagnosed with a blood clot in her left eye. She is to begin eye injections for treatment.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (exact dose, route, lot # and expiration date were not reported). The vaccine doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in a proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
arm pain night after injection.  Fatigue, aches, pain, headache, shortness of breath on day after.   Neck and chest hot to the touch.  Bright red rash across chest and stomach on second day.  Rash is hot to the touch and surrounding skin that isn't red is cool to the touch.   Alternate chills and sweating.
Patient fainted but was guided to the floor by medical assistants. Patient woke within a few seconds with ammonia. Patient was helped onto a bed from the closest exam room. Vitals were taken by doctor and oxygen was given to patient. EKG was done and Glucose was checked. Glucose was low and was given sweet snacks. Patient was later discharged in stable condition.
In the early morning hours i had to go to the bathroom and i just could not get up. I finally had the strength to push myself up and flung myself up onto my partners neck. She thought i was choking her. I got off and crawled to the bathroom. I just voided all over myself. She took off my nightgown. When i could i crawled back to my chair. When i could get up which was about 4 hours later. I finally was able to pull myself up and carefully walk to the bathroom and wash up.
Very low fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Very low fever) and MYALGIA (Body ache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 022C21A) for COVID-19 vaccination.     No medical history information was rported.  Concomitant products included MINOCYCLINE for Rheumatoid arthritis, DILTIAZEM HCL and NAPROXEN for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Very low fever) and MYALGIA (Body ache). On 09-Apr-2021, PYREXIA (Very low fever) and MYALGIA (Body ache) had resolved.            Patient reported that she did Antibody test 20 days after the 1st dose and the report came as no antibodies detected. Patient did Antibody test after 2nd dose as well and report awaited. No Treatment information provided
No reaction.  This patient was given covid 19 vaccine after it's beyond use by date. It was stored in the refrigerator after the 10 weeks recommendation.
Acute appendicitis and inflamed gallbladder. Required appendectomy 2.5 weeks after 2nd dose of modern covid 19 vaccine
Vertigo persisted daily for 4 months; This is a spontaneous report from a contactable other hcp.     A 43-years-old female patient received bnt162b2 (BNT162B2 BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:45 as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was Reported that, the patient experienced vertigo persisted daily for 4 months on Jan2021 with outcome of recovered on 30May2021. The patient underwent lab tests and procedures which included biopsy breast: negative on 06Jan2021.  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed practical nurse concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot number N025656, expiration date: 19-APR-2019 (strength, dose and route were not reported) for prophylaxis. On the same date, after vaccination, the patient had a red, swollen left arm near injection site and down the left arm. At the time of the report, the outcome of the events was unknown. The causality between the events and the PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1711USA013799.
Vaccine given 3/8/17. Pt. went to gym and was fine 1st hr., 2nd class arm starting hurting and swelling. Went home and applied ice/heat. Stopped by PHR 3/9/17 to ask if should have avoided exercise. Swelling (above elbow, not inj. site). Advised continue treatment. Fri. p.m., arm worse and M.D. marked to rule out blood clot. Diagnosis cellulitis. M.D. to phone in antibiotic.
metastatic melanoma; Acute axillary lymphadenopathy; This is a literature report for the following literature source(s):  A 53 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Family history included: "breast cancer" (unspecified if ongoing), notes: In a Grand parent. The patient's concomitant medications were not reported.  The following information was reported: METASTATIC MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "metastatic melanoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Acute axillary lymphadenopathy". The patient underwent the following laboratory tests and procedures: biopsy: atypical intraepidermal melanocytic, notes: proliferations on his right upper extremity and right lower back 1 year prior to presentation; unknown results, notes: Biopsy was performed prior to the 18FFDG PET/CT; computerised tomogram thorax: unremarkable; diagnostic aspiration: consistent with metastatic melanoma, notes: performed less than 2 months after receiving the vaccine, revealed a background of lymphocytes with scattered malignant cells positive for SOX10 and negative for pan-cytokeratin; lymphocyte count: with scattered malignant cells positive for sox10; negative for pan-cytokeratin, consistent with, notes: metastatic melanoma; magnetic resonance imaging head: unremarkable; physical examination: palpable left axillary lymphadenopathy, notes: measuring approximately 5 cm in diameter; positron emission tomogram: demonstrated, notes: intensely avid left axillary and supraclavicular adenopathy without visualization of a primary lesion; skin test: negative for any cutaneous lesions, notes: suspicious for a primary melanoma. Therapeutic measures were taken as a result of metastatic malignant melanoma, lymphadenopathy.  Follow-up activities completed. No further information is expected.  Follow up(02-Feb-2022):This is a literature follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: patients identifiers.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event metastatic melanoma and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dad phoned answering service 8/24/04. Complained of right arm is quite swollen and red. Temperature 102. Patient was taken to ED and started on cephalexin and Benadryl given.
patient broke out in hives, is treating with zyrtec and might add on benadry , patient's father has called pediatrician however pediatrician has not seen rash as of yet
This spontaneous report was received from a male patient's mother refers to her son of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # not reported). The reporter stated that the patient developed an "unspecified adverse reaction" after receiving VARIVAX (Merck) (dosage unknown). The reporter then stated, my son received VARIVAX (Merck) years ago (specific dates and dosage unknown) and developed an unspecified adverse reaction then as well. It was unknown if the patient sought medical attention. The outcome of the events was unknown. Additional information is not expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with GARDASIL 9 injection, lot # M011840 with expiry date 01-FEB-2018, lot # N003703 with expiry date 29-OCT-2019 and lot # M034780 with expiry date 15-APR-2019 (dose, route of administration and vaccination site were not specified) for prophylaxis. Administered doses of GARDASIL 9 underwent a temperature excursion between 32 Fahrenheit degrees and Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA013075: US-009507513-1709USA007903.
p/vax pt devel redness @ the inj site which extended from shoulder to wrist;area was pruritic;
blood pressure got elevated; blurred vision; This is a spontaneous report from a contactable female consumer via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She has taken both doses of the Pfizer BioNTech COVID-19 vaccine. After the first dose, she called 911, 3 days after the shot because her blood pressure got elevated and she had blurred vision. The paramedics checked her, and she was fine. After the second dose, she got the same reaction but it occurred for a longer period and she went to urgent care. She said that she has already notified Pfizer about these adverse events. Despite these reactions, she said that she likes the Pfizer COVID-19 vaccine and wanted to register her son for the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: elevated. The events resulted in a visit to emergency room. The outcome of events unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a patient's mother refers to a 23 year old non-pregnant, female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown dates, reported as "when she was 11 years old", the patient completed the series of GARDASIL and was vaccinated with three, 0.5 ml doses (lot# and expiry date were not reported). On 01-NOV-2016, the patient was diagnosed with HPV (vaccination failure). No treatment was given for the event. No lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The relatedness between the events and GARDASIL was unknown. Additional information is not expected as no contact details were provided.
night of vaccine developed bad headache and vomiting, vomited 10 times on 10/5, subjective fever, HA persisted until 10/8
ACUTE NON ST ELEVATION MI HYPOXIA 11/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Received shot on 7/23/02. On 7/26/02, right arm became very swollen and red with red rash on both arms, neck and face; low-grade fever today, 7/29/02. Seen at office and continues to complain of rash.
a patient received only the DTaP-IPV portion of PENTACEL vaccine/ No AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 16 months old patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6395AA, expiry date: 24-Apr-2021, dose: 0.5 mL) via intramuscular route in left vastus lateralis site on 03-Sep-2020 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of report, no adverse event was reported.  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.
Patient experienced fibromyalgia exacerbation for almost 6 weeks. She doesn't recall ever having such a severe fibromyalgia episode. Her dose of Savella increased but she didn't start feeling better until almost 6 weeks later.
Sore arm; Tiredness; Body Aches; This is a spontaneous report from a Contactable Consumer(other Non HCP). A 20-year old non pregnant female patient started to receive first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231),via intramuscular route of administration in left arm on 15Jan2021 02:15 PM as 1st dose single dose for COVID-19 immunization. The patient medical history was reported as none, No known allergies reported. Patient received medications within 2 weeks of vaccination which was Penicillin. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 15Jan2021 at 8:00pm the patient experienced Sore arm, Tiredness, Body Aches. The patient did not receive any treatment for the adverse events. The outcome for the events were recovered/resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
I had a headache that was not responsive to any anti-inflammatories. It lasted about two weeks in total before it went away. I was seen in the emergency room a week after it started and treated for a migraine. I saw my primary doctor who prescribed me IMITREX as needed. I had a second event in March that lasted a week and a half. I continued to take the IMITREX that didn't fully help, but then I followed up with my primary doctor who recommended me stop taking my birth control.
Injection site reaction. Swollen, red, and skin peeling. 1 week.
Vial was diluted with 0.8 mL.   Patient present for follow-up appointment on Sept 23, 2021.  No adverse effects noted.
Significant chills (I assume fever), body aches, headache, nausea (enough to result in vomiting), stomach upset.  I'm as sick as I can recall being in quite a while.
patient called on 11/04/2021 and stated that she hasn't been able to lift her arm all the way up since receiving the vaccine on 09/20/2021
she has a shooting pain; blood glucose went high; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has a shooting pain) and BLOOD GLUCOSE INCREASED (blood glucose went high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (diabetes with neurological complications) and Osteoporosis (bone pain due to osteoporosis). Concomitant products included TAPENTADOL HYDROCHLORIDE (NUCYNTA) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 28-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood glucose went high). On an unknown date, the patient experienced PAIN (she has a shooting pain). On 28-Feb-2021, BLOOD GLUCOSE INCREASED (blood glucose went high) had resolved. At the time of the report, PAIN (she has a shooting pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was The patient has used her pain medications which she was using prior to having the first dose for her bone pain symptoms since having the first dose. She uses under the prescribed level of pain medication because she is afraid of the pain medications. Her insulin pump gave a basal dose to correct for the high blood sugar. She kept trying to get her blood glucose under control using the pump until midnight when the blood glucose went down and was able to be controlled.
Information has been received from a registered nurse via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # and route unknown). On an unknown date the patient experienced  possible injection site reaction. The outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning a female who in June 2007, was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). In September 2007, the patient developed shingles. It was reported that the patient's husband also developed shingles after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0710USA00954). Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity Tiredness Treated with 2 tablets of Extra strength Tylenol