chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since 9 December he has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body and typically occur at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect palms and soles, and resolve without post-inflammatory changes. Single transient episode of difficulty swallowing early in onset of symptoms which led him to be seen in the ER several times where he was initially diagnosed with strep throat and treated with oral antihistamines, oral antibiotics, and oral corticosteroids. He denies generalized cutaneous, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 2 December, seven days prior to onset of symptoms. He has used oral antihistamines with control of symptoms. He denies constitutional symptoms. UCT score today is 26 (3, 4, 4, 3, 4, 4, 3, 3).
Severe chills, lasting a little less than a day Note first 3 shots were Pfizer and did not have this reaction.
Coldness in my chest, heart. I had coldness in my right lung  and the P.A. thought I might have pneumonia so I was given ZPAC. It did nothing. She then told me I had inflamation in my lung and it would go away in weeks .I kept having a hard time breathing which finally stopped on the 18th day. I did have a covid test which said negative. When I got the first Moderna shot the coldness transferred and went straight to my heart area from my lung. It started getting better in the first 3 weeks but by the 4th week it was feeling stronger. The 2nd dose has helped a lot but the coldness inflamation in my heart comes and goes all day. It is very slowly improving. The inflamation and hard time breathing actually started on Dec. 31, 2020. The inflamation in my heart started April 6, 2021 and as of today May 26, 2021 I still have it.
pt recvd vax 17OCT92 & 18OCT92 exp aching of joints & muscles; 27OCT92 devel fever, aching, chest tightness; 2 days later devel nausea, vomiting, diarrhea, & lightheadedness; also exp dizziness, anorexia, 10lb weight loss;
headache, nausea, lightheaded, chills, tired, muscle bone pain (lower back and pelvis) lasted 10 days
Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: small rash/bumps on lower left arm and a few bumps on chin-Mild, Systemic: Headache-Mild, Additional Details: small bumps on lower arm and some on face after a few hours and had chills and headache. pt took some benadryl at home and reported symptoms getting better the next day
First pregnancy, 18 weeks at time of second dose. Estimated Due Date July 3, 2021. Symptoms began the evening after receiving second dose and have continued for over 5 days now. Itching, red bumps, and raised rash appear. Have shown up on arms, legs, chest, back, neck, ears in patches sometimes small, other times covers entire back. Appear for about an hours then resolves only to show up in a different area shortly after. Have had similar reactions in the past due to reaction to cosmetics/detergents but have not used any new products recently. Have also tried to moisturize to rule out dry skin and has not worked. Currently been treating by icing the area, hydrocortisone cream, and Benadryl.
Medication Administration Error.  Patient received 0.5 mL of Pfizer bivalent vaccine instead of 0.3 mL. Staff read the wrong instructions and gave the Moderna dosing.
chest pain, multiple types of heart arrythmia, multiform PVCs, dizziness, 104 fever, extreme body aches. Continued PVCs to present day
Diarrhea x days, body ache, right arm slightly swollen, red and warm x 1 day.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2015, the patient 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 provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to 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 the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 7th October 2014, the subject received Flu Seasonal QIV Dresden. The subject's past medical history included miscarriage (around 5-6 week gestation in early July 2014). The subject's last menstrual period was on 26th May 2014 and estimated date of delivery was 11th April 2015. The subject received FLUARIX at week 13 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. The patient received a FLUARIX vaccine while pregnant. Gestational age was 13 weeks. Last menstrual period 26 May 2014, but the patient experienced a miscarriage around 5-6 weeks gestation in early July 2014. This current pregnancy occurred before having another menstrual period. The patient had a twin pregnancy.
Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Memory loss. Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided.
her arm was sore, red, and swollen up./ a lump on her arm; A spontaneous report () was received from a consumer concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar was unknown.
adverse reaction to a Tetanus shot; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. GMI number: 01219979  This case involves an unknown age female patient who experienced adverse reaction to a tetanus shot while receiving vaccine TETANUS TOXOID.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On unknown date in 2011, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for purposes of allergy testing component parts.  On an unknown date, the patient developed a non-serious adverse reaction to a tetanus shot (allergy to vaccine) (unknown latency).  Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable.  It was not reported if the patient received a corrective treatment for the event (adverse reaction to a Tetanus shot).  At time of reporting, the outcome was Unknown for the event adverse reaction to a tetanus shot.
chills began at 9:40 pm 01/19 by 2am on 01/20 temp was 103.8, extreme dizziness, fatigue, severe pain to both feet with burning sensation to both, slight headache- symptoms continued until 11:45pm on 01/20 when fever finally broke
Initial report was received from a consumer, who was the patient's grandmother, on 28 June 2012. A patient (gender not reported) who was 17-months-old at the time of the report had received a dose three injection of PENTACEL (lot number, route, site and date not reported) at six-months of age. The patient also received doses of PENTACEL at two-months and four-months of age. After the child received the third dose, the patient experienced high fevers to 104.6 degrees Fahrenheit (40.33 degrees Celsius) or 105 degrees Fahrenheit (40.55 degrees Celsius). Ever since then, the child has had high fevers to 104.6 degrees Fahrenheit (40.33 degrees Celsius) or 105 degrees Fahrenheit (40.55 degrees Celsius) every month which last for 4 or 5 days. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Exactly 10 hours after the vaccination, I developed a slight headache with some back body ache.  About 12 hours later I had to bed with a pounding headache, body aches, chills, and a temperature of 100.4 degrees.  Took 2 IBU to help with body aches.  Several hours later, temp was up to 101.4 degrees and I had a severe headache, body chills, ache all over, eyes hurt, nausea, took 2 aspirin.. and used ice pack to deal wIth head ache.  Hardly any sleep due to headache and body pain.
Red, itchy rash near injection site began 8th day after vaccine and persisted for 7 days
Mild to severe headache, stuffy nose, clear to yellow mucous, thick yellow in AM. Feeling sensation of mass down the throat and legs itching. Sore throat, hoarseness of voice for 2 days. Fatigue w/puffy eyes. Rx-TYLENOL and BENADRYL.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment information not reported.
Localized reaction to left deltoid, warm to touch and swollen to elbow.  1225 PA ordered grandmother to ice pack area for 10 minutes and patient to take Motrin for pain.
Suspected vaccination failure; shingles in her eye; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed after the injection by an eye doctor that she had shingles in her eye. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. The reporter did not consent to follow-up.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored ROTATEQ (lot number reported as L038534 and expiration date 19-AUG-2017, lot number L026740 and expiration date 16-APR-2017, orally, dose was not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
never received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 3 years ago from the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix 3 years before and was unable to get second dose, which led to incomplete course of vaccination. No further events was reported. The reporter consented to follow up.
I have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear". The event "i have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller developed tinnitus. A pulsating tinnitus, a swishing noise in the ear. Started getting after took the Covid Vaccines. Was looking things up and one of the side effects is tinnitus. Patient reported that "I have horrible tinnitus and have seen 2 ENTs and most recently a neurologist. It is a 'pulsating tinnitus' that is a swishing noise, not ringing in the ear. It is horrible and unbelievable, and it is 24/7. It has been suggested that it may be related to the Pfizer Covid 19 vaccine; I do not have my vaccination card with me so I don't know the dates of vaccination or formulation, but it is the Pfizer Covid 19 vaccine. The first dose was a couple of years ago, then 6 months later I got the second dose, so that was about a year ago. It did not occur with the first dose but was several months after the second vaccine dose when I noticed the pulsating tinnitus and getting worse now, where it bothers me a lot. MRI is normal. My neurologist is trying to figure it out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither relevant medical history nor the concomitant medications were reported. The product expired on 05-Feb-2012. On 10-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
seizures , headaches, fatigue, dizziness, loss of balance,  left side electric pulses, these started early July with migraine headaches until patient started seizing in September. since then patient had at least three seizures and one caused a huge car accident.
SARS-CoV-2 RNA Resp Ql NAA+probe~SARS-CoV-2, qPCR performed on 7/18/21. Test came back positive. Case investigation interview completed as of this note. Documentation from case manager mentions case experienced starting 7/16/21 cough, muscle aches, fever and fatigue.
Initial misuse report received from a health care professional on 29 October 2013. The cases were received on 21 March 2014 at GPV. An old patient (over 64 years) had received unknown dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse events was reported. List of documents held by sender: none
Oral mucosa ulcerations and vesicles, Fever, fatigue, throat pain, myalgias, headache.
Information has been received from an 82 year old male with an unspecified blood pressure disorder and a history of sulfonamide and statin allergy who on 01-FEB-2007 was vaccinated subcutaneously with 0.65 ml of Zostavax (Oka/Merck) ( Lot # 656413/1477F).  Concomitant therapy included "beta blockers" and "blood pressure medication".  In DEC 2007, approximately one month prior to reporting, the patient developed a rash on his arms and the center of his back after receiving the Zostavax (Oka/Merck) vaccine.  The consumer reported that the rash lasted approximately three weeks.  At the time of reporting the consumer noted he was recovering.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information is not expected.
c/o nausea, vomiting, R upper arm very sore, swelling in this arm, hot, red, sweaty, achy, dizzy.  no shortness of breath, swelling of tongue, wheezing.  Refused to go to ER.  Recommended icing area for short period, being quiet, ibuprofen/tylenol and if things changed to go to the ER.  Arm was swollen approx 3x the size of the other arm on day 2.  Also had fluid which extended down to elbow.  Very red, very hot.  On day 5 fluid was disappearing, swelling down, and heat and redness disappear.
Patient received Pfizer COVID 19 Vaccine on 2/8/2021 Patient received 2nd COVID 19 vaccine on 3/1/2021, he received Moderna instead of Pfizer. Pt is well, no adverse reaction from event.
Case number PHEH2014US003798 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow up report received from the pharmacist on 24 mar 2014. This report refers to a 61 years old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) in the past which was tolerated well. It was reported that this patient, over 55 years of age, was vaccinated with a dose of MENVEO (batch number: A11052, expiry date: Sep 2014) intramuscularly into his left deltoid at a dose of 0.5 ml on 21 Sep 2013 at 12:15. No adverse events were reported following the maladministration (inappropriate age at vaccine administration). Follow up report was received from the pharmacist on 24 Mar 2014. The patient demographics, vaccination history, batch number of MENVEO, anatomical site of vaccination and time of vaccination were updated.
Patient had a febrile seizure 2 days after immunization fever lasted total 4 days then patient broke out in what looks like a roseola rash when fever broke
Extreme hotflashes  Extreme nightsweats Anxiety before these events above I had none of these symptoms before the vaccine. They started on the day of the vaccine and have not stopped.
I felt dizzy for several days and four days later my blood pressure was low. I only started to feel better on the sixth day after getting the second dose.
Immediately after vaccine was administered, excessive bleeding, swelling, and bruising occurred at the injection site. Swelling was slightly larger than a quarter in diameter. Diphenhydramine 25 mg was given by mouth to patient. Patient denied any lightheadedness, dizziness, or trouble breathing.  Patient was monitored for several minutes and then released.
Weight loss, fatigue, joint pain, low sodium, low vit D, high sed rate, high c reactive protein, etc
5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E.  During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE:   patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well   Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.
HA, fever, flu like symptoms, eye twitching, joint pain same S and S after last hep B on 09/06/2001