chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with GARDASIL on an unspecified date. On an unknown date the patient experienced hives. The outcome of the hives was not reported. This is one of several reports from the same source. Additional information is not expected.
c/o body aching & fever x 3 days; denied any other sxs; states is feeling much better today 18JAN93; plans to see MD today;
approximately 4 days following the vaccine, I developed rashes on neck, shoulders, legs, back, and armpits. Benadryl and steroid cream used and helped initially.
Ongoing pain in LLE that has been worsening since injection. No redness at injection site.
Received vaccination at 4 pm 11/15/05, at 10am 11/16/2005 developed chills and left arm began to be sore, swollen and red at site of injection. As day progressed began headache, fatigue, dizziness and shortness of breath,muscle pains, back ache. Went to ER at 3:30pm, received 80 mg Advil, Temp at that time 103 and Toradol.
got COVID; got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) 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 2023, outcome "unknown" and all described as "got COVID". Clinical course: Patient mentioned that he started getting the Pfizer COVID vaccine the very first month that it came out but he got COVID and he wanted to know what Pfizer claim that the vaccine did.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy; headache; chills; fatigue; left armpit lymph node swollen; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EP7534) in the left arm at 12:00 PM), administration date: 16Mar2021, when the patient was 30 years old, for COVID-19 Immunization, reactions: "Sore arm", "slight headache". The following information was reported: DIZZINESS (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "dizzy"; HEADACHE (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "left armpit lymph node swollen". Therapeutic measures were not taken as a result of dizziness, headache, chills, fatigue, lymphadenopathy.  Additional Information: The reporter classified the events as not serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. The patient received antihistamines within 2 weeks of vaccination. The patient experienced being dizzy, headache, chills, fatigue, and left armpit lymph node was swollen and still slightly swollen 5 days after the 2nd shot.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392749 Same patient and drug, different dose and events
The Pfizer vial was not correctly diluted with saline. Instead of 1.3 mL of saline, it was diluted with 0.13 mL of saline. Causing the patient to receive a more potent dose of Pfizer. Pt showed no adverse affects. Patient was monitored for 15 minutes post vaccination. Patient was stable.
she denies any further AE/PQC; patient has received the vaccine prior temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 28-DEC-2020, the patient received an improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T021828, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of -6.7 degrees Celsius, for a time frame of 22 hours, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013452:
Ischemic colitis; The patient received 75 mL of Omnipaque 350 without incident. She is started on buspar, follow up for colonoscopy in 6 weeks. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
swelling underneath the arm that got the injection, in the pit area; sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection) and VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Hysterectomy (a year ago) in 2020. Concomitant products included METHOTREXATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FOLIC ACID and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection). On 09-Oct-2021, the patient experienced VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection) and VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication steroid low dose  was reported.
My husband tested positive for Covid on 5/19. My daughter and I went for a PCR on 5/18 due to a known exposure but that was negative. My symptoms began on 5/21 with cough and fatigue. I went to urgent care on 5/22 for another PCR and that was negative. Through that day, my symptoms got worse with chest tightness, pain in neck and shoulders, worsening cough and fatigue. I slept all day that day and Monday, 5/23. Since 5/23 my symptoms have gotten progressively better and today I am feeling basically normal. I received another PCR test yesterday on 5/24 and am still waiting on the results.
About 24 hours after my booster shot, I started running a fever of 102.6, muscle aches, arm swollen and rashy at injection site. This lasted for 2 - 3 days.
tongue and throat swelling started 6 minutes after injection.  Gave EPI autoinjector X1 with relief. EMS on site and transported to Hospital
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 16-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Pt received ADACEL 10/26/06 and presented in office 10/28/06 with swollen lips and rash at site of injection.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T040207, expiration date: 18-JUL-2022, oral for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). On 23-DEC-2021, the doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) had a temperature excursion (product storage error) of 27.4 degree Celsius for 52 hours and 30 minutes. There was no previous temperature excursion.
Client vaccinated with Pfizer vaccines for Covid x 2 in May, 2021.  Symptoms started on 12/9 - loss of taste and smell, fatigue.
Body aches, chills and hot flashes late the night of the dose, continuing through the day and night after. Back and neck stiffness on the right side, same as the injected arm starting the day after the dose, continuing for two more days. Shingles pustules concentrated at the hairline on the right side of the back of the neck and behind the ear, skin sensitivity and warmth along a nerve line behind the right shoulder blade, starting two days after the dose. Shingles were diagnosed 5/26 at 10:30 AM by doctor at healthcare facility, who prescribed 3 daily doses of 1g Valacyclovir for 7 days.  Today, the second day of treatment, more pustules have raised at the same site, but the rash hasn't spread.
Its swollen lymph node; I have it like mass forming under in my armpit; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm; Its swollen lymph node; I have it like mass forming under in my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0179) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; ELETRIPTAN taken for migraine; VENLAFAXINE taken for depression.  The following information was reported: LYMPHADENOPATHY (non-serious), AXILLARY MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "Its swollen lymph node; I have it like mass forming under in my armpit"; PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I just got my first dose of the vaccine its pretty painful; getting like tingly feelings in my finger tips on my left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, paraesthesia, pain, axillary mass.  Additional information: Its swollen lymph node or what should be going on, but the patient had it like mass forming under in armpit. The patient just got first dose of the vaccine on Saturday but it was pretty painful and getting like tingly feelings in finger tips on left arm and got the arm the vaccine. The patient stated that he had just been resting pretty much and drinking water. When probed for any medication, the patient took for treatment, the patient stated as no.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 3 year old who was vaccinated with Varicella virus vaccine live (0.5ml), SC.  Subsequently, two days later the pt's father who had recovered from multiple myeloma and a bone marrow/stem cell transplant "broke out with chickenpox."  The physician did not believe it could have been the vaccine strain of chickenpox.  IT was also reported that the father had to have his gall bladder removed during his chickenpox outbreak.  Unspecified medical attention was sought.  At the time of the report, the father had not yet recovered.  Upon review gallbladder disorder was considered to be an other important medical event (OMIC).  Information received on 04/07/04 contained the following adverse experiences: gall bladder removed.  Additional information has been requested.
Pt felt light headed an nauseous with vomiting x 1 Pt denies pain in ABD, itching or swelling to  throat and pain. Clinical impression of vaso vagal response  Treatment: Rest, water, Crackers. additional observation time.  Pt states she feels tired.
Bone Pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Pain), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Bone Pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, BONE PAIN (Bone Pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information for the events was provided.
rash very itchy; another 5 days it spread whole chest and torso back other arm shoulder flared up; within 5 days left shoulder where I had the shot rashed out; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 032L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out). The patient was treated with LEVOCETIRIZINE at a dose of 5 mg for about two weeks. At the time of the report, RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out) had not resolved.            No concomitant medication were reported.  The patient stated he has been taken levocetirizine 5 mg for about two weeks. Before that, he was taking an over-the-counter antihistamine. The levocetirizine seems to help more, but it's not taking it away.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On 08-FEB-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # L027735, expiration date: 12-JAN-2017 (route of administration was unspecified) for prophylaxis. No adverse events were reported. Additional information has been requested.
Headaches, bodyaches, chills, fever, fatigue, nausea, vomiting, very very very intense chest and heart pain
Weakness, cool, clammy skin; dec BP, inc respirations; c/o tightness in throat; irreg pulse; approx 5 mins p/administration of vax 23APR92 AM c/o leg soreness;
Subacute Thyroiditis / enlarged her thyroid; rash from wrist to arm and shoulder; arm was swollen and sore.; arm was swollen and sore.; neck glands / were swollen; thyroid around left side were swollen / Thyroid and it was enlarged; This case was reported by a consumer via other manufacturer and described the occurrence of subacute thyroiditis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (no name,manufacturer, lot or expiration.), allergic reaction to analgesics (no name,manufacturer, lot or expiration.), bee sting hypersensitivity, grass allergy and ragweed allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling. On an unknown date, the outcome of the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling were unknown.   It was unknown if the reporter considered the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced enlarged her thyroid and glands and threw everything out of whack. The patient had a rash from wrist to arm and shoulder, her arm was swollen and sore, her neck glands and thyroid around left side were swollen. The patient had it on her left arm and contacted her doctor and she had her see an endocrinologist. An Ultrasound of her thyroid was performed and it was enlarged. The physician advised not to get the second dose. Till the time of reporting, consent to follow was unknown. Note- there was descripancy in reported information. In narrative the statement is reported that Shingles vaccine reaction 18 Oct 2019, Shingrex two part one. The first one is the one that she had the reaction to. But this date is not specified was of 1st dose, 2nd dose or reaction onset date
Lowgrade fever; This non-serious case was reported by a consumer via patient support programs and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included malignant neoplasm of fallopian tube. Concomitant products included niraparib tosilate (Zejula).   On 13-FEB-2023, the patient received Shingles vaccine. On 13-FEB-2023, less than a day after receiving Shingles vaccine and 238 days after starting Zejula, the patient experienced fever (Verbatim: Lowgrade fever).The outcome of the fever was not reported.  It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 The case was reported by a consumer via patient support programs.  The reporter was the patient. The patient stated that she received Shingles vaccine and ever since had low grade fever every morning. A week after the patient received Shingles vaccine, she underwent biopsy of breast. The patient disconnected from the call. The reporter did not consent to follow up.
Patient called on 9/20/20 at 3:15PM reported swelling and warm to the touch at site of injection.
Shortness of breath; Higher heart rate; Dizziness; Nausea; Fatigue; Full body ache; Shivers and chills; Arm pain; Soreness; A spontaneous report was received from a 40 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, higher heart rate, dizziness, nausea, fatigue, full body ache, shivers, chills, arm pain and soreness.  The patient's medical history included asymptomatic asthma and TRAPS (autoinmune condition). Concomitant medications reported was cetirizine hydrochloride.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection .   On 04 Jan 2021, 1-3 hours administration, the patient experienced higher heart rate, shortness of breath, dizziness, nausea. She stated that fatigue started 5 to 6 hours after administration. She reported full body ache, shivers and chills. All of them except nausea stopped before going to sleep that day. The patient was still experiencing arm pain and soreness at the time of report. Treatment for some of the symptoms include ibuprofen.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, higher heart rate, shortness of breath, dizziness, fatigue, full body ache, shivers and chills, were resolved on 04 Jan 2021. The outcome of events, arm pain and soreness were ongoing.   The outcome of events, arm pain soreness and nausea were ongoing.; Reporter's Comments: This report refers to a case of 40-year-old female patient who experienced same day onset of unexpected events of higher heart rate, shortness of breath, dizziness, nausea, fatigue, full body ache, shivers, chills and arm pain soreness for mRNA-1273. De-challenge and re-challenge are not applicable. Based on the information provided which includes evidence of temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.