chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Male patient in his 40?s with no underlying conditions was vaccinated and boosted ended up testing positive for COVID; Male patient in his 40?s with no underlying conditions was vaccinated and boosted ended up testing positive for COVID; fell ill again; headache; sore throat; congestion; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient in his 40's 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) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Male patient in his 40?s with no underlying conditions was vaccinated and boosted ended up testing positive for COVID"; ILLNESS (non-serious), outcome "unknown", described as "fell ill again"; HEADACHE (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Description of Event: The patient was vaccinated and boosted ended up testing positive for COVID. The patient was sick and symptomatic for about a week then started feeling better and then during the next week fell ill again. His symptoms were a sore throat, congestion, headache. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
After receiving the vaccine patient walked back to waiting area to sit with his father. Within 1 minute he was having trouble standing and was guided to the chair. Started to lose consciousness and father attempted to keep him awake via light slapping on face. Was having some difficulty breathing and was coughing. 911 was called and arrived within 3 minutes. Patient stabilized and fully regained consciousness. Did not leave with paramedics.
Numbness in my legs and arms; Tingling glass; Bleeding a lot; pain is terrible in my legs; her skin felt tough like leather; impaired work ability; A little bit more tired/ drained; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness in my legs and arms) and PARAESTHESIA (Tingling glass) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in my legs and arms) (seriousness criterion medically significant). an unknown date, the patient experienced PARAESTHESIA (Tingling glass) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather), IMPAIRED WORK ABILITY (impaired work ability), FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever). At the time of the report, HYPOAESTHESIA (Numbness in my legs and arms), PARAESTHESIA (Tingling glass), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather) and IMPAIRED WORK ABILITY (impaired work ability) outcome was unknown and FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever) was resolving.            No concomitant drug information provided. The patient used pads and unspecified creams for treatment. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requests.   This case was linked to MOD-2021-311170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received includes no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requests.
97 Male PCR positive 4/28/2021. Vaccinated with Pfizer 1/6/2021 & 1/28/2021. Hospitalized 4/28/2021- 5/6/2021 for COVID PNA & fatigue, SOA, diarrhea. Placed on Rocephin for UTI. Required more than 4L of oxygen, decreased appetite. Developed hematuria due to Pseudomonas. Transferred. Passed away 5/13/2021.
10Apr90 pt vax;  May90 devel h/a, rash, & petechiae w/ mucosal bleeding.  Platelet count of 43,000.  June90 h/a, rash resolved; platelet count betw. 60,000 & 128,000.  ANA test was neg.  MD unsure whether pt exp due to ITP or vax. See worm
Patient's Shoulder aches badly and when he lifts his arm forward a shooting pain shoots down his forearm. No fever, no injection site redness or swelling.
I woke up 6 days after receiving the vaccine and I had some pain at my collar bone. It felt bruised and I felt something that felt like a ball rolling around. I called advice from clinic and they scheduled me a visit with Dr. for a video visit. At my visit with him, I explained what it was and I mentioned that I heard about lymph node enlargement after the vaccine. He told me that he hadn't heard anything about that, but scheduled an ultrasound for me. I scheduled an appt with my PCP and she told me that she did hear about the lymph node enlargement from the vaccine. I had the ultrasound on 03/30 and the results came back benign. Dr. called with my results and requested a follow up in 3 months.
Felt funny and anxious while sitting in observation area. Brought to litter listened to lungs no wheezing, rales or rhonchi, no stridor. Gave 25 mg Benadryl PO after 15 mins patient felt normal ate a cookie and went home with mom to eat dinner and be observed. Call 911 if difficulty returns.
Complained of very swollen left arm where shot had been given and had hard time moving it. Complained of pain radiating to fingers.
Felt feverish, achy, chills, vertigo, vomited, "can't get off the couch" per wife
59 year old female with history asthma presented to Immunizations clinic on 29 March and received PNEUMOAVAX 23. She had previously received PNEUMOAVAX 23 in 2010. Approximately 12 hours after receiving the vaccination she noted pain affecting the vaccination site and her left upper arm. Over the past two days she notes redness and swelling affecting her left upper arm which she feels has progressively increased. She also complains of mild discomfort in her left axilla. She denies fever/chills, purulent drainage from vaccination site, generalized cutaneous symptoms, and systemic symptoms. She denies prior vaccine adverse reactions. She has been taking OTC Benadryl and Ibuprofen for the past day. A/P Large local reaction to PNEUMOVAX 23. Discussed with her that this reaction represents a delayed (cell-mediated) reaction to the vaccine or its components. No systemic symptoms. No signs/symptoms suggestive of infection. Discussed diagnosis, recommendations for treatment, expected course, and indications for urgent/emergent evaluation (fever/chills, purulent drainage, streaking, systemic symptoms). Recommend resting and elevating extremity, application of cool compresses, Zyrtec 10mg daily at bedtime, and ibuprofen 600mg with food every 8 hours as needed for the next 48-72 hours. If her symptoms persist or worsen will have her return to my clinic. VAERS report entered. She indicated she understands and agrees with the plan.
Swelling of breast that was visibly noticed and felt; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 Unknown manufacturer), for Covid-19 Immunization. The following information was reported: BREAST SWELLING (non-serious) with onset Nov2022, outcome "recovering", described as "Swelling of breast that was visibly noticed and felt". The events "swelling of breast that was visibly noticed and felt" required physician office visit. Therapeutic measures were not taken as a result of breast swelling.  Additional information: Administration time for suspect was 02:30pm on unknown date in Nov2022, adverse event start time was 07:00am on unknown date in Nov2022. No other medication in 2 weeks. It was unknown did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine, it was unknown prior to vaccination, was the patient diagnosed with COVID-19 and it was also unknown that since the vaccination, had the patient been tested for COVID-19. Device Date: 29Nov2022  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
High Blood Sugar; High Blood Cholesterol; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol). At the time of the report, BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-103695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103695:
Questionable complex spot on the soft palate. Skin has multiple vesicular noted, none of which are excoriated or oozing at the present time.
2/13/21 onset 1200, left axillary node tenderness/not swollen. 1600 fatigue onset. 2200 temperature 101.3 and noted redness at injection site, hard and tender with increased pain at injection site, red area hot to touch. redness spread over 10 hours as evidenced by circle outline observed at 1000 on 2/14/21. diagnosed with cellulitis 2/14/21. As of 2/14 1530, fever resolved, pain, redness, hot to touch and axillary tenderness remain.
Herpes simplex outbreak on lower lip and filtrum, plus low grade fever continuing even after 6 days.  Wife also got herpes  simplex outbreak on her knee after taking second Pfizer shot.
Myalgia right deltoid, arm up to shoulder, swelling, temperature 101. Treat symptomatically Motrin/Ibuprofen for pain, inflammation, fever prn. 12-11-02 patient afebrile but still c/o pain in limb.
Really nothing -- a little pain in left arm, where shot was administered.  The same feeling -- not quite pain -- that I had with the very first flu shot I received over 35 years ago!
About 15 minutes after the shot I had a wave of dizziness and felt like I was going to pass out. When I got home, I felt incredibly dizzy, worried I would lose consciousness, and like I was having some sort of allergic reaction. This faded within a few hours, at which point I started having the expected flu-like symptoms from the shot. These flu like symptoms lasted weeks instead of days. Then, since getting my 2nd Covid shot, I have never felt back to normal or back to 100% health like I was before vaccination. During these 5 months after the shot I have had 4 allergic reactions (two of which required medical assistance, and one required steroids), and have had a few infections (bronchitis, colds, and covid). It feels like my body and immune system became very sensitive after the shot, and I have had an infection or allergic reaction every 2-3 weeks since the shots, and this was not the case before. I had very strong health for the year and a half leading up to the shot with no infections and no allergic reactions. Today, I am left with constant exhaustion, and a feeling that CFS, POTS, and MCAS as been reactivated starting with the shot. I have not had a single day where I have felt good after the shot.
I am vaccinated and have contracted covid; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
began w/pain, swelling 24 hrs p/inject area of inject became red, swollen, t100-101, general aches; 6x7 cm red based area w/central 1.5cm raised area;
On April 8, 2022, I Licensed Immunized 10 patients with an expired dose of Moderna, which I immediately realized when I filed the documents and stopped the vaccination process. The Covid-19 Vaccine delivery document stated that deadline date and time to use these vaccines was day 6 of month 4 and year 2022 at 7:10am.
Scalp burned but no rash or anything. Continued through Sunday morning then stopped. Last washed  hair previous Wednesday. Other reactions same as others report, fatigue, chills, body aches, slight fever. All resolved by Sunday morning.
ENTIRE MOUTH GOT SO DRY; COULD NOT SWALLOW; LIPS SWELLED; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; TONGUE STARTED TO TINGLING; This spontaneous report received from a patient via other manufacturer (Moderna) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose not reported, administered on an unspecified date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date, within 2 minutes of taking the shot, patient's tongue started to tingling, entire mouth got so dry and could not swallow (dose number in series 2). Patient waited for 45 minutes and went home. 2 hours later patient's lips swelled (dose number in series 2). Patient said they got a Kenalog shot from the doctor the next day and a Prednisone pill. The Kenalog helped with the dryness, the prednisone did not help stopping it. Treatment medications (dates unspecified) included: prednisone, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from entire mouth got so dry, and the outcome of tongue started to tingling, could not swallow, lips swelled and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
gum infection on the same side determined to be a shingles infection / Suspected vaccination failure; she lost vision in her right eye (optic ischemic neuropathy); she lost vision in her right eye; gum infection; gum infection on the same side determined to be a shingles infection; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure) (serious criteria GSK medically significant), ischemic optic neuropathy (Verbatim: she lost vision in her right eye (optic ischemic neuropathy)) (serious criteria GSK medically significant), loss of vision (Verbatim: she lost vision in her right eye) (serious criteria GSK medically significant), gingival infection (Verbatim: gum infection) and oral herpes zoster (Verbatim: gum infection on the same side determined to be a shingles infection). The outcome of the vaccination failure and gingival infection were unknown and the outcome of the ischemic optic neuropathy was not resolved and the outcome of the loss of vision was resolving and the outcome of the oral herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2023 The patient self-reported this case.  The patient stated that she lost vision in her right eye (optic ischemic neuropathy).  The patient developed an upper and lower gum infection on the same side, which was determined to be a shingles infection, and caused her loss of sight.  The patient had a loss of vision of 50 percent at first. It had now improved but was at 25 percent now.  This was potential legal case. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L025204 expiry date 07-JAN-2017; lot # L031600 expiry date 18-FEB-2017 (dose, route and site of administration not reported). No adverse effects were reported. Temperature: 0.05C Time frame: 9 hours 20 minutes. Based on these supportive parameters the improperly stored vaccines were administered after first excursion. No doses were administered after second excursion. There was previous temperature excursion (-7.4C for 8 hours). This is one of the several reports from the same reporter. Additional information has been requested.
Metallic taste in mouth starting 10-15 minutes after vaccine was given. Went away after about 14 hours.
17 year old female patient received  Flublok Quadrivalent/ NO AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 17-years-old female patient who received once 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number: QFAA2007, expiry date: 23-May-2021, strength: standard, route and site of administration not reported) (product administered to patient of inappropriate age) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication and pregnancy details were unknown.   It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event was 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.
30 MINUTES AFTER VACCINATION, PATIENT COMPLAINED OF NUMBNESS/TINGLING IN VACCINATED ARM, TONGUE, FACE, AND LIPS; FEELING A BIT OF CHEST PRESSURE; COORDINATION DOESN'T FEEL AS USUAL; CAN'T PUT WORDS TOGETHER; NAUSEA; PRESSURE IN BACK OF HEAD. PATIENT'S BLOOD PRESSURE WAS INITIALLY ELEVATED 165/88  AT 40MIN POST-VAX AND THEN CAME DOWN TO 139/82 AT 50 MINUTES POST-VAX. PATIENT WAS SHAKING UNCONTROLLABLY. PATIENT HAD NOT EATEN MUCH THAT DAY AND WAS OFFERED WATER AND A GLUCOSE TABLET.
Ended up with full symptoms, nausea, vomiting, lightheaded, fatigue, loss of appetite, sore at injrctionsight, ended up at ER with hypomagnesmia, hot/cold flashes. Body aches and cough with sore throat.
Just a local reaction to the injection. This was her last DTaP in a series. Given a prescription for Cefzil.
AFTER RECEIVED VACCINATION, PATIENT DEVELOPED CONVULSION ONLY LEFT SIDE OF BODY. HOWEVER DURING THE ENTIRE EPISODE PATIENT REMAIN CONSCIOUSNESS, ORIENTED TO DATE, PLACE.
Phone call from mother on 8/30/07. Client got hives on trunk of body 1/2 hr to 45 min after injection. Symptoms subsided with Benadryl.