chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-5 days following the vaccine I began to feel weak had no interest in eating. I could not look at food. I lost 15 lbs in a weeks time. Neurologist placed me in hospital. I had my blood cleansed through plasma treatment for 5 days.  11/16/07 Reviewed hospital medical records which reveal patient experienced weakness, loss of appetite & pain/paresthesia of LEs. Neuro consult done as outpatient.  Reflexes were 1/4 & symmetric.  Admitted 10/16-10/22/2007. Tx w/plasmapheresis x 5 & improved. FINAL DX: acute peripheral neuropathy, likely autoimmune s/p vax; anemia, likely due to NSAID use; heme (+) stools. 11/27/07 Reviewed pcp medical records of 8/30/07 visit which included vaccination lot# & reveal patient was in usual state of good general health on day of vax.  VAERS database updated w/vax info. 12/14/07 Received outpatient EMG done 10/5/07 which states patient had bilateral leg burning pain s/p zoster vax x 1 month.  EMG/NCS abnormal & c/w mild sensory neuropathy & bilateral anterior tarsal tunnel syndrome w/related chronic axonal injury.
Painful; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Memory loss.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful). At the time of the report, PAIN IN EXTREMITY (Painful) 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 includes thyroid medication.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No NewInformation
June 4th tested positive for Covid. Have head and chest congestion. fatigue and body aches. had low gread fever on June 5th.
A FILLING NEEDLE WAS USED TO EXTRACT AND PREPARE 26 DOSES OUT OF A MODERNA VIAL SEQUENTIALLY UNDER 5 MINTUES TOTAL PREP TIME. MODERNA AND DOH WERE NOTIFIED AND WE ARE AWAITING RESPONSE FROM MODERNA REGARDING STERILITY OF THE PRODUCT.  NONE OF THE POSSIBLY EFFECTED PATIENTS REPORTED ISSUES OR ADVERSE REACTIONS. VAERS BEING FILED BECAUSE OF DOH GUIDANCE.
I experienced a breakthrough case of COVID-19 with stuffy nose, cough, fatigue and brain fog.
Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
Pt's mom reports entire arm above elbow red swollen hot to touch. Left arm resolved 5 days later.
Patient received COVID-19 Moderna vaccine on 5/21/21, she had fever for 2 days for which she took Tylenol. After 4-5 days patient started having itching and small rash over her neck which kept spreading all over her neck. She also started having rashes on her abdomen area, patient did not see a doctor but stopped at pharmacy on 6/8/21 evening to report about side effect. Pharmacist advised to consult doctor as soon as possible but patient mentioned she may not have time till Thursday or Friday to visit a doctor. Pharmacist advised to use hydrocortisone cream with oral benadryl/zyrtec to temporarily help with rashes till she go sees a doctor. Pharmacist will follow up with patient tomorrow
Body aches; Low temp; Headache; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Nov2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced body aches, low temperature (low temp) and headache. On the same day, the patient underwent body temperature test and the result was low (low temp). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, low temperature and headache was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt admitted on 4/19/21-4/15/21 bilateral pulmonary emboli & heart failure. Currently on Eliquis, carvedilol, Entresto. No prior pulm or cardiac history. Pt received Pfizer dose #1 on 3/16/21 + dose #2 4/21/2021. Of note pt seen in office 11/2020 with ongoing symptoms of wheezing, orthopnea
RASH DEVELOPED AFTER ABOUT 24 HOURS. WAS RED AND TURNED DARKER. SPOKE WITH PATIENT ON 9-27 AND IT WAS BETTER THAN THE DAY BEFORE.
Pt recv vax on 7/10/98; on 9/15/98 pt exp heart palpations, muscle tremors of entire body w/ weakness & fatigue, loose bowels
include sore throat- cough- fever- sinus congestion- nasal congestion- - post nasal drainage- chest congestion- sneezing. starting 12/1/21
pt recv vax 17APR96 & 19APR96 pt devel acne-like rash localized around forehead, perinasal area & chin, & on lt side of neck;pt was referred to a dermatologist & tx w/med;
2 hours after rcving FLUARIX pt c/o local tenderness at inj. site. 20 min after going to bed pt c/o "heart hurting", sternal region side "jabbing pain" - caused pt to flinch. Sun at ER -> Imp. "esophageal spasm & shot inflammation, HR WNL, lungs clear, no CXR.
Patient received vaccine around 2:45 pm. At 2:52 pm while in observation area, patient reported feeling her "heart racing." Patient was seated in a comfortable position and assessed for other symptoms of possible allergic reaction. No other symptoms reported and no signs of anaphylaxis noted (no SOB or rashes, etc). Denied any history of anxiety. At 2:55 pm, BP was 154/84 and HR was 60. Patient was provided emotional support, encouraged to take slow, deep breaths, and asked to stay for monitoring for an additional 15 mins. Patient later disclosed a history of panic attacks and reports being hypertensive during doctor visits. At 3:15 pm, patient's BP/HR were reassessed: BP 146/72/HR 62; patient reported the ?heart racing? sensation had resolved and denied any other symptoms.
Nauseous, headache, aches - arms and legs, fast heart beat, sore throat, slight cough. Symptoms from 10/25/2001, 12:00 noon. Thorough weekend and still have headache and some aches.10/28/2001, 1PM.
Expired Havrix administered; Dose given over 12 months after dose 1; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (Received 1st dose of Havrix on an unknown date).   On 9th February 2023, the patient received the 2nd dose of Havrix (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The reporter reported that a patient received dose of Havrix in left deltoid at the time of reporting.  This dose was also late- given over 12 months after dose 1 of Havrix.  The reporter transferred to MI for more information. The reporter consented to follow up. Additional supportive Information: The reporter reported that a patient received dose of Havrix in left deltoid at the time of reporting and this dose was also late-given over 12 months after dose 1 of Havrix, which led to expired vaccine used and lengthening of vaccination schedule. The case had been linked to US2023021176, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023021176:Same reporter - male patient
immunocompromised; received the 3rd dose; received the 3rd dose; asthma; sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).   A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot number was not reported), dose 3 via an unspecified route of administration on 16Aug2021 (at the age of 64 years), as DOSE 3, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 in May2021 for covid-19 immunization (Patient initially received 2 doses of Pfizer COVID 19 vaccine in May2021). The patient stated, initially received 2 doses of Pfizer COVID 19 vaccine in May2021. She received the 3rd dose of the Pfizer COVID 19 vaccine 2 days ago. She would like to know how much protection she had against Delta variant. She read on the news efficacy was 42% some other says 95%. Patient was not sure if she was considered immunocompromised as she had asthma. She also developed sore arm after the 3rd dose. The patient was concerned whether 3rd dose of the vaccine give a positive result for rapid antigen test. She had a cruise travel and it required her to have an antigen test. The clinical outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
12/27/21 presents to EC ED for "fever and dyspnea". PMHx of "CAD, HTN, HLD."
Pt got 3 imzs. ZOSTAVAX and FLUZONE HD in right arm. PNEUMOVAX 23 in left arm. These were administered on 11/10/17. Pt came into pharmacy on 11/12/17 with a rash on her left arm above and below the injection site. I told pt to take BENADRYL, NSAID, and use ice to reduce swelling / allergic reaction. Pt said the rash had gotten better since the first day when she got the imz. Told her to monitor it and if it gets worse to go in to the doctor.
Patient states she was diagnosed as having the Flu (Type A) by her doctor's office.  They performed a nasal swab.
My injection site started to hurt and I started to feel hot. I took some Tylenol and had redness and swelling around the injection site. I had a high fever and took some more Tylenol. My injection site swelled up even bigger by the next morning. I had body aches and I had chills and extreme headache. My throat was hurting and I felt like I could not swallow. I took some Benadryl. I broke out in what seemed like hives. This proceeded for 3 days.
Reports "feeling bad" about an hour after the shot.  Had breakout of "blisters" starting on 8/22/2009 + more on 8/23/09, located mostly on chest, abdomen, + back.  Some on arms.
No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to a 15-years-old female patient. The patient's pertinent medical history and previous drug reaction, and allergies were not reported. The patient's concomitant therapy included sterile diluent injection.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020, but upon internal validation established as 10-MAR-2020 (exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccine administered to the patient was exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA006066: US-009507513-2003USA010101: US-009507513-2003USA010169:
Shot administered on 11/30 at/around 5:45pm Day 1 post vaccination - arm very sore, large amount of swelling at injection site, sore in armpit Day 2 post vaccination - arm still very sore, swelling same at injection site, armpit extemely sore, lower left arm very achy, hand tingly Day 3 post vaccination - everything begins to get better; most of the swelling gone at injection site, lower arm/hand is fine, arm pit still very sore Day 4 post vaccination - everything back to normal 12/12 - Day 12 post vaccination - woke up and went for am walk & upon my return/entering home, the palms of my hands began to inch.  I also had a localized itch on my lower left side torso w/ what looked like a small amount of prickly heat rash.  It eventually went away after about 20 mins. Around 1pm, the itching returned to my palms, between my fingers, my arms, and soles of my feet.  I began breaking out in hives on the lower insides of my arms only.  I applied the equivalent of calamine lotion.  The event lasted about 25 mins.  As the day progressed, I began having more and more incidents of chronic itching/scratching.  At 12:30am on Monday, 12/13, I woke up due to the chronic itch on my torso and upon review, my torso was bright red w/ what looked like heat rash.  My hands and soles of my feets were also very itching along w/ my private area.  The event lasted about 45 mins.  As Monday progressed, I had itching all over except my back and back of legs.  I also had itching inside my ears and vaginally. I had a 3pm doctor appointment later in the day, where I was prescribed a six day dose of Methylprednisone, hydroxyzine 10mg, OTC allegra, and to get my TSH and T4 bloodwork completed to ensure not a thyroid issue.  My bloodwork was drawn at 4pm on Monday 12/13, prior to beginning any medication, which came back fine.  Monday evening I began the oral steroid (6 pills) and took one hydroxyzine (which i will never take again because of the hangover the next day).  Tuesday 12/14 - upon waking up, all itching was gone.  Wednesday 12/15 - no itching; Thursday 12/16 - while out running errands, the center of my face (both cheeks and center of nose) became hot, beat red, and slightly swollen.  This may be due to the warmer temps of 65 degrees and the sun hitting my face while on a steroid.  I immediately turned the air conditioner on in my car to cool off my face which felt good.  I went home after this event to get out of the heat and away from any of the suns rays.  My upper chest also felt flush.  Upon arriving home, I immediately took an Allegra (180mg) with 20 oz of water just incase the "flare" wasn't related to the heat/sun/steroid.  We are now current thru 12/16 3:19pm
significant allergic reaction; eyes swelled up; nose was congested; throat was swollen; throat was sore; itching throughout her body,ears, butt, on back; itching on eyes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (throat was sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Information has been received from a physician concerning a 7 year old pt who on 01/30/1998 was vaccinated with a dose of varicella virus vaccine live. On 02/14/2000 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no Tx given and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. thirty nine other cases (WAES 0407USA01446 and 0409USA01855 to 0409USA01857 and 0409USA01859 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live . Additional information is not expected.
Moderna COVID-19 vaccine administered to a 16 year old. No adverse reactions noted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2007, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Patient developed swollen arm with pain and hot to touch. Diagnosed with cellulitis ~24 hours after injections administered. Patient was evaluated and treated with cephalexin.
Fever of 103 lasting 24 hours; fatigue; continued shortness of breath still
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; RUNNY NOSE; SORE THROAT; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported, (dose number in series 1), 1 total administered on 10-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced runny nose, sore throat, fever, tiredness that lasted 3 days (13-JUN-2021) after vaccination. The Patient stated he had shortness of breath and cough since 25-NOV-2021 (reported since thanksgiving day). Also, the patient reported since 13-DEC-2021 (reported as Monday), he had chills, fever and sore throat. On 15-DEC-2021 (reported as last night), the patient underwent a covid-19 antigen rapid test, which came positive (suspected clinical vaccination failure, suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, sore throat, fever, and tiredness (on 13-JUN-2021), had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207555. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211237796 -COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Itchy , looks like a big mosquito bite. Was itchy and swelled up. Was able to put an icepack on it and take a Benadryl. It stopped bothering me after 1 day.
Several hours after receiving the injection, patient developed numbness in his 4th and 5th fingers, left hand.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 15th of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
swelling & erythema @ collarbone w/pea-sized lump @ center of swelling;tenderness @ inj site;placed on ATB