chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shakes and chills really bad, I couldn't stop shaking; Shakes and chills really bad, I couldn't stop shaking; Sick to the stomach; No appetite; Feeling tired; Have like pressure in my forehead and a little bit in chest; Have like pressure in my forehead and a little bit in chest; burning sensation in my throat and like tightness; burning sensation in my throat and like tightness; neck hurts a lot, just real tight; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient stated, got my second shot on Monday at 10 AM and about 9 PM, got the shakes and chills bad, could not stop shaking, so took two extra strength Tylenol (treatment). I woke up about at 02:45 and was sick to the stomach and again at 03:30, just went up at the sofa with bucket, no appetite, feeling tired, had like pressure in my forehead and a little bit in chest and just like almost burning sensation in my throat and like tightness and my neck hurts a lot, just real tight, had no symptoms after the first shot. Consumer further enquiring about Tylenol, she took oftenly. The outcome of the events was unknown. Therapeutic measures were taken as a result of shakes and chills really bad, could not stop shaking (tremor), shakes and chills really bad, could not stop shaking (chills).  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
pt devel large welt @ the inj site imed p/vax on 30OCT96;this was one of three cases reported by a RN;cross reference w/MFR report # 010150960041 & 010150960042;
Left upper arm. Warm to touch, bruising, redness that is spreading down arm, soreness, itching. Pt had PREVNAR vaccination on Thursday 9/29/16 and believes rash could be an allergic reaction. She has a large erythematous area over the medial side of her left bicep extending from the midline of the biceps muscle down to the back of her arm and extending from about mid way down the biceps muscle distal to the elbow. Surrounding this petechial rash she has a yellow discoloration of the skin that extends over the entirety of the seventh muscle in the lateral portion of the arm up to just below the deltoid muscle. The erythematous portion is warm to touch. No tenderness to palpation. Very minimal edema is present.
Irritability for 3-4 hrs, eyes rolled-up, shaking of legs-? sz; sleeping little more than usual, dec feeding, tongue thrusting, frontal bossing;
Mucsle aches, joint aches, bone aches, headaches, sore throat, cough, ear ache, nausea, dizziness trouble swallowing, Left arm very sore could barely use for 4 days. Developed a hard red spot under left arm for 2 days. Hoarsness.
Pain in my upper left arm 3 months after my second shot. I can't lay on that side at night. It hurts when I stretch my arm or lift it over my head.
I received a call from patient on 10/14/18 at the store. She notified me that day of a potential adverse effect from a flu vaccination received on 10/01/2018. She said that ever since her shot, she has had numbness and tingling all over, but it had localized to arms and legs now. The daughter recalls the vaccine having a pink tint to it and a pharmacist with short hair giving her shot. I spoke with RPh and she did not recall any vaccine that was pink on that day. I have been in touch with mom several times to check on her. I did advise at our first conversation that she be seen by a provider and have some blood drawn. Symptoms have continued and pt is to see a provider on 11/02/18. Mom denies pt ever having a fever.
Information has been received from a registered nurse concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot#665708/0651Z). On the next day, the patient developed edema and cellulitis and the patient had to miss work. At the time of this report, the patient's outcome was not reported. Edema and cellulitis were considered to be disabling by the reporter. This is one of several reports from the same source. Additional information has been requested.
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers.  Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing.  Felt like a truck ran over my chest.  I was weak, dizzy and nauseous as well.  The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals.  Vitals seems normal, Blood Pressure and Pulse were high.  I am asthmatic but did not bring my inhaler with me.  Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had.  After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
I administered an Adacel immunization. (we did not have Boostrix in stock). About 10 -15 minutes later the patient said she was a little dizzy and had a bitter taste in her mouth. We gave her some water to drink. Shortly thereafter she shopped for a few items and checked out at the pharmacy. We tried twice to phone her later to see how she was doing, but it went to voicemail. The bitter taste is an unusual side effect from the Adacel immunization, so I will fill out a VAERS
PT. WAS GIVEN JANSSEN VACCINE 3/19/21 AND GIVEN MODERNA VACCINE TODAY.
Area around vaccine site is inflamed and red. Nursing is monitoring for increased size, warmth, fever.
Achy for a short time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy for a short time) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concomitant products included PREDNISONE for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and METHOTREXATE (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN (Achy for a short time). At the time of the report, PAIN (Achy for a short time) had resolved.            No treatment information mentioned. No medical history provided.  Patient had a fever after the first vaccine for 24 hours and felt achy for a short while after the second vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-620820, MOD-2021-620836 (Patient Link).
Patient developed pain and vesicular rash on one side of face, along dermatome from ear to chin. Diagnosed as shingles (herpes zoster). No reported history of shingles or chickenpox infection in patient. Were unable to obtain specimen for strain genotyping (rash now resolved). Vaccine information from parent-held medical records, some information unknown; patient received varicella vaccine on 08/09/00 and 12/18/09. No secondary varicella cases reported among contacts.
pt recv vax & approx 1wk p/vax pt devel hives, which started @ the inj site & progressed to trunk;the rxn persists as an ongoing dermatitis;pt has seen numerous dermatologists & undergone biopsies & other studies;rash & pruritus persist;
Systemic: Fainting / Unresponsive-Mild, Additional Details: known issue of fainting when pt experiences events involving needles. mother and pcp are both aware of recovery.
Received Varivax #2 1/11/07 to left deltoid after cleansing with alcohol. Shortly after shot while still in office developed very small area of redness around injection site. Evaluated by doctors, given Zyrtec pill. 1/12-phone follow up rash better. 1/13-rash spread to 1-2 inches wide started on Augmentin. Developed streaking prior to starting Augmentin.
Information has been received from a physician referring to a patient of unknown age and gender. There was no information about pertinent medical history or drug reaction. On an unspecified date the patient received the first dose of GARDASIL (dose, frequency, strength, route, lot# and expiration date were not provided). On 20-MAY-2015 the patient was vaccinated with GARDASIL 9 (dose, frequency, strength, route, lot# and expiration date were not provided) as a second dose. No concomitant medication was reported. No adverse effects were reported. The outcome and causality were not reported at the time of report. Additional information has been requested.
Tender, swollen supraclavicular lymph node on left side observed 5 days following first vaccination.  Approximately 2 weeks pregnant at the time (did not know then), estimated date of delivery November 27, 2021.
Pt was given KINRIX instead of PEDIARIX. Pt was up to date on Hep B vaccinations. Pt had no adverse effects.
1 week after injection, my left arm now has a rash, some swelling, a lump, warm to the touch and itchiness at the injection site.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 16 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 03-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Raised erythematous area 5x4cm on (L) upper arm at site of DTAP. Not tender or warm.
Patient claimed that he woke up at 1:30 am in excruciating pain. He stated that he had a shooting pain running up from his arm to his neck and head. He also claimed to have limited ability to move his arm. Pt went back to his normal activities. No doctor visit was needed. Pt is OK. per wife.
Began with a few dizzy spells in the afternoon. 10:00 p.m. while sitting in bed, became extremely dizzy with room spinning. Began vomiting and continued all night even with a slight turn of the head. Unable to move.
Pt. received first dose of Pfizer COVID-19 vaccine on 3/18/21 and subsequently admitted to the hospital with COVID-19 on 4/1/21.
Injection site redness, swelling  and warmth at SQ site where Varicella was administered.  Bilateral eye inflammation .  Pt was seen yesterday at PCP and given prednisone and dose of epi in the office.  The area of redness was measured at 13.5 cm X 10 cm per the PCP.  Line of demarcation drawn on 12/19/19 and on 12/20/19 the redness was expanded beyond the mark.  Photos taken by pt per the PCP.  Provider is continuing to follow up on pt as of 12/20/19.
Left arm with erythema and edema and itching from deltoid to wrist, began within 48 hours of KinRix adminsitration to left deltoid. Treated as allergic vs. cellulitis with Benadryl and Keflex and rechecked one day later with considerable improvement.
Chest tightness and palpitations started day of shot and continued for 1 week.  Seen in hospital ER on Sunday night.  Sent home with a heart monitor.  He continued to feel weak and dizzy.  He was extremely tired and slept a lot.  Missed 6 days of work due to condition
33 year old pregnant female received injectable 9/29/2010. The two weeks prior to 10/18, she experienced intermittent edema of face, legs and abdomen, that she believed were related to pregnancy. On 10/18 at 1am she experienced sudden onset nausea, vomiting and abdominal pain. She was admitted to the labor and delivery ward and was diagnosed with pregnancy induced hypertension BP 160/80, with mild proteinuria. She was observed for 48 hours while receiving steroids for possible preeclampsia. Worsening abdominal pain, nausea, vomiting and hypertension 180/90, confirmed preeclampsia on 10/20. At that time she went into active labor and required an emergency c-section at 27.5 weeks at 3pm that day. Laboratory results confirmed HELLP syndrome. Platelets of 19 at the nadir. LFTs in the thousands (2000s). Elevated ddimer. Drop in hemoglobin. With steroids and time her condition stabilized. Baby was born at a weight of 1 pound 5 ounces. Baby is still alive but after 21 days of life still weighs less than 2 pounds; baby had intrauterine growth restriction diagnosed after a normal ultrasound was documented in late 8/2010. Pt's hypertension is returning to normal range.
Information has been received from a nurse practitioner concerning a 24 year old female pt, with no relevant medical history, who in 1996 and 2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no concomitant medication. It was reported that the pt "wasn't hospitalized". The pt was undergoing a health evaluation in an outpatient clinic and a recent titer was negative for rubella. No additional info was available. No specified medical attention was sought. Additional info has been requested.
On Monday 25NOV91 pt fever was 101-102, on 26NVO91 fever was up to 103.7 & mom could not get fever below 102; On 26NOV91 fever was 104.2 ax @ 6PM; Pt was seen by MD- no rash, no nausea or vomiting; pt was fine on 27NOV91;
Contracted virus after vaccination; contracted COVID-19; 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 female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), outcome "unknown", described as "Contracted virus after vaccination"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "contracted COVID-19".  Clinical Course: Reporter considered that events caused by suspect product. Patient and her husband received the Comiranty vaccine and then contracted COVID-19 after the second dose   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Having low grade fever, nausea, headache and fatigue; Having low grade fever, nausea, headache and fatigue; Having low grade fever, nausea, headache and fatigue; Having low grade fever, nausea, headache and fatigue; She got her period within 12 hours of getting the vaccine which was 2 weeks early; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0176; Expiration Date: 01May2021) via an unspecified route of administration, in Arm Left on 01May2021 15:50 (age at vaccination 46years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration, on unspecified date as single dose for covid-19 immunisation. The patient experienced having low grade fever, nausea, fatigue on 02May2021 and headache, she got her period within 12 hours of getting the vaccine which was 2 weeks early on 01May2021. Clinical course was reported as I received my 2nd dose on 01May2021, aside from having low grade fever, nausea, headache, and fatigue that was more than usual, I also got my period within 12 hours of getting the vaccine, which was 2 weeks early. I know it's not as common. The patient received treatment for headache with Tylenol. The clinical outcome of the event was recovered in 02May2021 and another event was recovered in May2021. Therapeutic measures were taken as a result of having low grade fever, nausea, headache and fatigue.  No follow-up attempts are possible. No further information expected.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient and reports that received ACTHIB reconstituted with sterile water diluent, while she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included PREVENAR; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR). On 29-Nov-2018, the patient received a dose of 0.5 ml suspect HIB (PRP/T) VACCINE (lot number: UI905AA and expiry date: 24-Oct-2019) (dose in series and route was not reported) in the right thigh. It was a case of actual medication error due to wrong solution used in drug reconstitution as ActHib reconstituted with a diluent other than the specific ACTHIB diluent, reconstituted with Merck sterile water instead of proper diluent. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt recvd 2nd dose of Hep B vax on 14MAY91 & 2 days p/vax the nature & intensity of h/a changed; pt exp pain w/generalized w/stiffness in neck; tx meds;  26JUN91 nausea, memory loss & hot flashes; CSF protien, albumin & lymphocytes;
Sudden onset of menstruation, and significantly longer duration than normal. Lasted about 9 days, usually only 1-3 days long. Currently using nexplanon birth control.
I contracted COVID-19 on 05/22/2022 with symptoms of sore throat, congestion, headache, productive cough, night sweats, fatigue, and slight diarrhea. I began taking Tylenol, vitamin C, and zinc. I received Monoclonal Antibodies on 05/25/2022. My symptoms are resolving; although I still have a slight cough and fatigue.
I had a soreness in my arm. The two weeks later on the 21st of January, I had a routine OB appointment and we did an US only to find out that the fetus was no longer alive.  I had to have a DNC the following week. Participant is not sure if it is vaccine related but wanted to file a report anyway.
Rash, Swelling and redness after 24 hours of injection with no decrease in size by day 3.
I was exposed to COVID-19 from someone I cared for that had just came out of the hospital. I started to feel tired and what felt like allergy like symptoms. I had a headache and sinus issues. I also developed a cough. I took a rapid test that day and the following day. Both came back negative. On 05/19/2022 I had a PCR test and it came back positive. On 05/21/2022 I was offered an antiviral. I took it for 5 days. By day 2 I felt a significant improvement. Today I feel fine aside from an occasional dry cough.
no reaction until six days following inoculation of 1st dose. Swelling , redness and itchiness at injection site. This lasted for approximately 4 days .
Received GARDASIL #1 vaccine on Mon. 3-12-12. Patient began on following Tues. night with hand tremors at rest which con't into Wed. & Thurs. No tremors today on Fri. March 16th. Patient also complains of sore neck & back muscles. No treatment.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 11:04 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 31-Jan-2022 at 11:04 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered was provided as 31-JAN-2022 11:04:59. Patient received booster dose. Patient ethnicity reported as withheld. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment medications were reported.
Severe diarrhea, exhaustion and body aches started 4 days later. Low grade fever as well. Had to leave work and work from home
Patient has complaint of pain right arm that radiates to neck. Right upper arm edematous with 7 x 8 in erythema. Also experienced some dizziness & nausea & lightheadedness.
p/ pt recv 1st & 2nd dose of vax 20apr98 & 20may98 respectively the pt exp tightening in chest & difficulty breathing, resolving  itself in 6hrs. the episode p/1st dose was light. addl info requested