chrisvoncsefalvay/vaers-outcomes huggingface dataset:
today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; This is a spontaneous report from a contactable Pharmacist.   A 23-years-old female patient received bnt162b2 (Pfizer Covid-19 vaccine, Formulation: Solution for injection) dose 1 via intramuscular route of administration on an unspecified date (Lot unknown-not reported) as dose 1, single for COVID-19 immunisation. The patient medical history included PEG (unknown product, unknown reaction). The patient previously received Typhoid vaccine (unknown reaction) and patient experienced allergy. The patients pregnant condition was unknown. Patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose. Patient observation continued and it was found that after calling patients mother that the patient did have a reaction to the Typhoid Vaccine in the past with a noted PEG Allergy. The outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Severe nausea, vomiting all day, could not keep water or food down for at least 12 hours straight. Mild diarrhea symptoms. Sore arm at injection site.
sluggish; very dehydrated; little hot; tired; sore arm which was for about 3 days; woke up with coughing; itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm which was for about 3 days), COUGH (woke up with coughing), THROAT IRRITATION (itchy throat), SLUGGISHNESS (sluggish) and DEHYDRATION (very dehydrated) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (woke up with coughing) and THROAT IRRITATION (itchy throat). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm which was for about 3 days), SLUGGISHNESS (sluggish), DEHYDRATION (very dehydrated), FEELING HOT (little hot) and FATIGUE (tired). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm which was for about 3 days) was resolving and COUGH (woke up with coughing), THROAT IRRITATION (itchy throat), SLUGGISHNESS (sluggish), DEHYDRATION (very dehydrated), FEELING HOT (little hot) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported
Patient describes a rash/boyles on her back within 1 month of receiving influenza vaccine that she has had to take antibiotics for since. She also reports intermittent pain in right arm with overuse.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
5hrs after dose: Fever, chills, body aches. Tried to sleep it off and go to bed  15hrs after dose: nausea, dizziness, syncope . Woke up in the early morning and fainted in the bathroom after feeling nauseous
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot # not reported, expiration date: 20-SEP-2014) 0.65 ml, subcutaneous. The ZOSTAVAX was supported and properly stored. No adverse effect was reported. Additional information has been requested.
Mom called Sat 1-21 early afternoon. He had temp of 102 and chills and hot sweats only at night since Wed. He has regular temp during day. Mom giving him alternating ibuprofen & TYLENOL, coughing Friday nite gave him cough syrup.
sore/pain injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm) on 17Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. The patient previously received bactroban ointment and experienced allergies. Patient is a registered nurse working in a small, rural hospital. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced sore/pain injection site. Outcome of the event was unknown. The patient has not been tested for COVID-19 since vaccination.
Severe headaches, chills, muscle aches onset with 3 hours and lasting 36 hours
Feeling really bad all day; Feels cold and warm at the same time; Her bones hurt; Her head hurts like stitches; Pain all over body; Arm hurts; Swollen; Purple where the picket is; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over body), FEELING ABNORMAL (Feeling really bad all day), FEELING OF BODY TEMPERATURE CHANGE (Feels cold and warm at the same time), BONE PAIN (Her bones hurt) and PAIN IN EXTREMITY (Arm hurts) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), SWELLING (Swollen) and SKIN STRIAE (Purple where the picket is). On 11-May-2021, the patient experienced MYALGIA (Pain all over body), FEELING ABNORMAL (Feeling really bad all day), FEELING OF BODY TEMPERATURE CHANGE (Feels cold and warm at the same time), BONE PAIN (Her bones hurt) and HEAD DISCOMFORT (Her head hurts like stitches). At the time of the report, MYALGIA (Pain all over body), FEELING ABNORMAL (Feeling really bad all day), FEELING OF BODY TEMPERATURE CHANGE (Feels cold and warm at the same time), BONE PAIN (Her bones hurt), PAIN IN EXTREMITY (Arm hurts), SWELLING (Swollen), SKIN STRIAE (Purple where the picket is) and HEAD DISCOMFORT (Her head hurts like stitches) outcome was unknown. Not Provided      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.   No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Shingles ( outbreak experienced in between the first and second dose of the vaccine); sore arm (right arm- first dose); This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)) and VACCINATION SITE PAIN (sore arm (right arm- first dose)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Polymyalgia rheumatica. Concomitant products included TOCILIZUMAB (ACTEMRA) for Polymyalgia rheumatica.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm (right arm- first dose)). On an unknown date, the patient experienced HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)). At the time of the report, HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)) and VACCINATION SITE PAIN (sore arm (right arm- first dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose of Moderna vaccine on 2-MAR-2021 with lot no. 024M20A in an unknown route. No treatment medications were reported.   This case was linked to MOD-2021-107082.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Physician details added.
rheumatoid arthritis flare up in finger; deep cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443530-00 (AbbVie).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare up in finger"; COUGH (non-serious), outcome "recovered", described as "deep cough". The action taken for upadacitinib was unknown.  Clinical Information: Solicited report from the USA by a consumer of an adult male with events of non-serious Rheumatoid arthritis flare up in finger and Deep cough with Rinvoq (Upadacitinib) . There was no reported medical history. On unknown dates, the patient experienced Rheumatoid arthritis flare up in finger and Deep cough. on unknown dates, Rheumatoid arthritis flare up in finger and deep cough resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event (s) of Rheumatoid arthritis flare up in finger and Deep cough with Rinvoq (Upadacitinib) was no reasonable possibility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
given expired Fluzone Quadrivalent administered to patient / no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA262280.  This case involves a 4 years old female patient who was administered an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot UT6375LA (Expiry date JUN-2019) via intramuscular route in the left thigh on 13-Sep-2019.  The patient's past medical history, vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At a time of reporting No adverse reactions 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.  List of documents held by sender: none.
Mother called on phone and stated son said he had broken out in hive on trunk and was coughing.
I had sudden onset of vertigo and I had my visual perception was constantly going from right to left over and over again. I also was extremely sleepy. That lasted for a day and a half. I woke up with it because it persisted for a day and a half those 3 problems. I called my Doctor and they sent me a prescription for dizziness and it did not help at all. I couldn't walk without assistance for a day and a half, I could only sit with my eyes closed or lay down. I didn't go to the hospital because I couldn't walk across the room and I was out of town at that time. It cleared in about a day and a half. I saw Dr. when I returned home on July 28th. And Cardiologist July 21st. And Dermatologist July 22nd.
Blood Pressure shot up to 170/100. took 3 hours to return to normal.; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), via an unspecified route of administration in the left arm on 05Jan2021 07:00 at a single dose for covid-19 immunization. Medical history included arthritis, allergy to plants and arthropod sting. the patient was not pregnant at the time of the reporting. The patient's concomitant medications were not reported. On 05Jan2021 07:00, the patient's blood pressure shoot up to 170/100. It took 3 hours to return to normal. The outcome of event was recovered. No treatment was required/given due to the event.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Patient reported a 3 inch diameter bald spot on the back of his head which started to form about 3 weeks after his second Moderna vaccine.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: patient first had this reaction when he received a covid shot so mom was aware he gets light headed after vaccines and can have a vasovagal effect
Initial misuse report received from a  nurse on 01 November 2013. The female patient had received FLUZONE HD (route, site not provided). Reporter stated that dose ran down her arm, should she get another HD or a regular. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Health Department on 03/14/2022 to report child's reaction. Mother reports a generalized rash "all over" child's body which appeared approximately 2 days after the administration of Pentacel & Prevnar. Mother denies n/v or fever. Mother also denies any other symptoms.
I started getting sick on April 30th headache cough sort throat fever. got worse over the week, saw  doctor after covid test to see doctor. Sever head uncontrolled cough, sinus inflamed. teeth hurt, nasal drip. Prescribed levaquin may 4th first dose 10 dose course, stopped on may 10th due to muscular/skeleton pain. back to doctor on may 10th and blood work drawn to test for rabado which showed to not be the case. prescribed rephinance liquid 100-10mg at bed time for cough. started guience tablets on own every 4 hrs. Started on amoxilan for 14 day course every 12hrs.  CT of sinus, showed significant sinusitis.
Information has been received from a physician concerning an 80 year old female who in January 2008, was vaccinated with ZOSTAVAX (Merck), and a few weeks ago she presented with ophthalmic zoster.  At the time of this report, the patient was recovering. The patient sought medical attention in the physician's office.  Follow up information has been received concerning the female patient with Penicillin allergy who on 30-JAN-2008 at 12:00 PM, was vaccinated in the physician's office with the first dose of ZOSTAVAX (Merck) (Lot # 658210/1079U), subcutaneously, under the left arm.  On 09-SEP-2008, the patient developed pain and typical lesions of ZOSTER but not lesions that could be swabbed for viral culture.  The patient experience required an ER/doctor visit.  Additional information has been requested.
Approximately 2 min after HPV given in (L) deltoid pt. (sitting on exam table) slumped over in (R) side and twitched several times, episode lasting at 1-2 min, then pale and clammy for at 20 min.
Pt called 9/29/10 to report she was feeling fine until 4 pm. 9/28/10 when her (L) arm and neck started to hurt. Went to bed at 4 pm after taking some TYLENOL. Woke up during night for more TYLENOL. Was weak almost passed out. Had to lay on kitchen floor. Went to work 9/29/10 had to go home due to generalized weakness and (L) arm ache.
SECOND DOSE OF PFIZER COVID VACCINE WAS ADMINISTERED 1 WEEK EARLY THAN  THE RECOMMENDED SPACING OF DOSE 1 TO 2.  SITUATION EXPLAINED TO PATIENT AND ADVISED  HIM THAT RECOMMENDATION WOULD BE THAT HE REPEAT THE SECOND DOSE IN 3 WEEKS. PT VERBALIZED UNDERSTANDING.
Extreme headache, lethargy, body aches and fever up to 102F within first 12 hours of vaccine. Tylenol given for fever - no resolve. IBU then given 4 hours later and fever broke. Above symptoms resolved at approximately 48 hours mark. Diarrhea began around 36 hours after vaccine.
Fever over 100, chills, nausea, headache, body aches for approx. 24 hrs.
Dizziness, Headache, NauseaVomiting, DRY MOUTH. Narrative:  Other Relevant History:
On 4/26/99, the pt received her 1st Lymerix and her ongoing headaches persisted. A neurologist evaluated these headaches and he felt they were tension type with exacerbations of migraines. The radiologist felt the differential dx of such lesions included:deep white matter ischemic disease, MS, Lyme disease, and migraine headaches. She was treated with nortriptyline and Naprosyn. On 6/10/99, the pt received her 2nd dose of Lymerix and 6 days later, 6/16/99, she began to have left-sided facial weakness. Further evaluation revealed left-sided palsy. The physician stated this would be consistent with minimally elevated Lyme antibody from the recent vaccine. She was examined by an ophthalmologist, and he found the pt had palsies of the left IV, VI and VII cranial nerves. The most recent information received on 7/29/99 reports the symptoms are ongoing. The reporting physician stated it highly unlikely that Lyme disease is the cause of the pt's cranial neurapathies. She is seronegative, and her spinal fluid analysis are normal. "It has been postulated that she may have the cranial neuropathy secondary to the Lyme vaccine. It does seem temporally related." The etiology of the pt's cranial nerve palsies is uncertain. "The fact that the headaches began prior to her ever receiving the vaccine makes me think it is unlikely secondary to the vaccine and that she has some other underlying illness. MS would still be a possibility." However, the neurologist and ophthalmalogist feel that it is unlikely. Additional information has been requested.
Chills and general pain pain and weakness during first 4 hours, general muscle pain and weakness, fever, and headache for another 4 or five hours. Pain at injunction site continues as of today.
sc pain on immunization site the night  after shot c progression    & tender on whole deltoid area and alot of  pain & tenderness L subaxillary
Rash between tows on the left foot, the skin bumps occur on the place of rush after itching
This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 23-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2012. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
All symptoms started 6 hours after second moderna vaccine - CC - Fatigue ++, swollen glands, body aches - back pain, fever.  Fever for 5 days. Bad headache.   + bleeding gums 3/4/21 with rash to hands, arms today.
Biological false positive fourth generation HIV antigen/antibody (ag/ab)  test approximately 11 weeks following full strength third dose of Moderna covid-19 vaccine. I have been on Descovy for HIV pre-exposure prophylaxis (PrEP) for over a year with near-perfect adherence. I was previously on Truvada for PrEP. On Jan 3, 2022 I had a routine STI screen with the following results for HIV ag/ab, 4th generation, with reflex: HIV ag/ab repeatedly reactive, HIV-1 antibody negative, HIV-2 antibody negative, HIV-1 RNA undetectable by qualitative real-time PCR. During the same week, I received a notification from a program that I had been near someone with a covid diagnosis on or around December 29, 2021. At-home SARS-CoV-2 rapid antigen test was negative Jan 6 or 7, 2022. Prior HIV screenings going back years had been negative, most recent prior negative result was 09/08/2021. In consultation with my PCP I stopped my Descovy for two weeks (last dose Jan 11, 2022) and repeated HIV testing in 2 weeks with the same results on Jan 25, 2022: HIV ag/ab repeatedly reactive, HIV-1 antibody negative, HIV-2 antibody negative, HIV-1 RNA undetectable by qualitative and quantitative PCR. I resumed Descovy (PrEP) and repeated labs again on Feb 8, 2022 with the same results: HIV ag/ab repeatedly reactive, HIV-1 and -2 antibodies both negative, HIV-1 RNA undetectable. We have discussed multiple possible explanations for this result, including the possible association with my covid vaccination (although it was given approx. 11 weeks prior to my first reactive HIV screen) and my possible covid exposure the week prior to my labs on January 3, 2022. I also had a seasonal flu shot 10/06/2021. I do not know the manufacturer or lot #.
PEDIARIX PLACED ON LEFT DELTOID, AREA RED, SWOLLEN, HOT TO TOUCH.  CHILD HAS NO PAIN PER MOTHER.
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4.  Left arm pain with enlarged lymph nodes left axillary area.  Fatigued. Headache became debilitating around noon.  Extra strength Tylenol decreased temperature and body aches but did not help with headache.  Fatigued all day.  1/27/21 10amFatigued, headache, body aches gone.
Hives, severe itching on trunk and arms, Benadryl.  Migraine?
12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM.  CONTACTED PCP TO SEE IF CAN TAKE IBUPROFREN. CALLED COVID HOTLINE AND THEY REFERRED ME TO CALL MY PCP. 12/24/20210INJECTION SITE SEVERE PAIN, COULDN'T MOVE ARM. 'FELT LIKE STABBING WITH A KNIFE', SOB, AND FEVER AND CHILLS 12/25/2020 COLD SYMPTOMS AND FEVER 12/26/ COLD SYMPTOMS, RUNNY NOSE, FEVER, FATIGUE 12/27/2020 FEVER, SOB, ACHY JOINTS; MILDER SYMPTOMS 12/28/2020 STARTED TO FEEL BETTER