chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient incorrectly received the adult (12+) Pfizer COVID-19 vaccination. Patient is 10 years old and should have received the pediatric (5 to 11-year-old) vaccination.
Aphasia, headache and neck pain onset 10 min after administration.  Went to Medical Center emergency room at 4 pm on 2 Oct.  Saw  triage nurse who ruled out stroke.  Waited 2 hours without seeing doctor , symptoms were subsiding  and self- discharged at 6 pm.
7 days after first dose. Redness, pain, swelling at injection site. Migrating down arm and causing sever pain
Patient contracted persistent diarrhea x10 days within hours of administration. Requiring ER visit for dehydration. Also occurred with 2 month dose less severe, no medical care.
Boostrix below recommended temperature, subsequently administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 31st March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022.  The lowest temperature was 30.2F.  The readings were then ranging from 32.9F to 41.8F.  The duration was 7 hr. 45 min.  A dose was subsequently administered on 31sr March 2022.  The reporter did not have lot number, expiration date, or patient information aside from initials.  Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error. This is one of five cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter
Chills, cellulitis of injected arm from (R) arm injection site (bicep) to wrist. Rash, bruising on forearm, ache in back. General malaise.
Patient stated that his arm was sore on the day of the vaccine and for two weeks after. He denies needing medical care or any other adverse reaction. He said he had the same reaction after the first dose, which was already reported.
58 HR, 200+ HR. my BP 200/110, asked supplemental oxygen. Had to wait 15 minutes before they would call 911. The shot went in and felt like fire. Gasped for air for 15 minutes. Requested for them to put monitoring machines on me. BP came down to 180s, HR dropped to 110 hovered there with visual disturbance and racing heart race for another hour and 20 minutes. We called a friend to come and take me to a private physician. And they saw me, they didn't give me any medication. I was told to go home and follow up with them through telemedicine for the next 7 days. I was bedridden for the next 7 days. I was not able to do any of my normal ADL, extreme pain in left arm, no other issues but I could not sit up straight. Could not get out of bed, slept for 23 hours one day. Day 7, I could finally sit upright and when I went to go get my blood drawn, my liver enzymes were elevated and was drawn into diabetes type 2. My doctors were unable to see me so my endocrinologist put me on medication to help with the edema. I unfortunately got a spider bite and got cellulitis, have new allergies. Contacted my allergist and they're waiting to draw blood to see what vaccine components I'm allergic to. Then I recently got COVID-19 on January 28, 2022. Cardiologist, Allergist, Endocrinologist. Primary MD, and Urgent care MD, all doctors I've seen. Currently seeing cardiologist, allergist, and MD to follow up. Endo visit was just a few weeks ago on January 7 was my last day. Now going back to primary MD. Saw my allergist January 18, 2022. Also had COVID-19 March 2019. Reconstructive open heart surgery of 2001. I also had to stop using N-95 masks because of sudden allergies to the material of the masks. Currently using a paper. Didn't have period for a while (4 months), then had a menstrual period on Aug 20, 2021 and have had one every month since then. I had Endocrinologist, prior note for him not to mention COVID-19 due external forces.
headachey; both times arm felt sore where the shot was injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (both times arm felt sore where the shot was injected) and HEADACHE (headachey) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (both times arm felt sore where the shot was injected). On 25-Apr-2021, the patient experienced HEADACHE (headachey). At the time of the report, VACCINATION SITE PAIN (both times arm felt sore where the shot was injected) and HEADACHE (headachey) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
pain at site day after injection, itching day afterat site, unusual swelling day after at injection site
This case was reported in a literature article and described the occurrence of distal acquired demyelinating symmetric neuropathy in a 74-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number not provided. 2 days after vaccination with Influenza vaccine, the subject experienced proximal and distal numbness and weakness. The subject was diagnosed with distal acquired demyelinating symmetric neuropathy. This case was assessed as medically serious by GSK. Relevant test results included: CSF protein: 166 mg/dL; Nerve conduction studies were performed; slow conduction velocity and conduction block were observed; F waves were absent. The subject was treated with normal immunoglobulin (IVIG) and Corticosteroids. At the time of reporting the outcome of the events was unspecified. Neuropathy after vaccination is a rare event. Chronic immune-mediated polyneuropathy developing in the postvaccination period is distinctly unusual and not well described. Almost all such patients have been reported as having typical chronic inflammatory demyelinating polyneuropathy. Distal acquired demyelinating symmetric neuropathy, unlike classic chronic inflammatory demyelinating polyneuropathy, is characterized by distally predominant sensory symptoms with no or mild distal weakness. Vaccine-associated distal acquired demyelinating symmetric neuropathy (DADS) may suggest a vaccine-triggered immunologic event directed against myelin associated glycoprotein below detectable concentrations. More likely, we suspect vaccination in this subject triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the form of demyelinating symmetric neuropathy. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Approximately 5 minutes after vaccine was administered pt. fell out of chair and lost consciousness for approximately 5-10 seconds. Pt. was turned on his side until consciousness was regained.  911 was called, EMS arrived and evaluated pt. because pt. struck his head when he fell out of the chair. Vital signs were stable and pt. refused any further medical treatment. Pt. remained with nursing staff until 30 minutes after event. No further signs/symptoms of any adverse effects noted. Advised pt. call 911 immediately if shortness of breath, dizziness, difficulty breathing, swelling of the face, lips, or throat develop, chest pain, or any additional emergency arise. Pt. verbalized understanding. From beginning of the event to pt. regaining full consciousness with no symptoms or complications was approximately 5 minutes.
swollen arm; sore arm; warm sensation in arm; covid arm; red; itchy; sore; mettalic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (mettalic taste in her mouth), HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (asthma) on 17-Jul-1968. Concomitant products included SALBUTAMOL SULFATE (PROVENTIL HFA [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DYSGEUSIA (mettalic taste in her mouth). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm). On 19-Feb-2021, DYSGEUSIA (mettalic taste in her mouth) had resolved. At the time of the report, HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) outcome was unknown and PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received VAERS addition of second dose information, addition of three new events swell arm, pain in arm and vaccination site warmth
Zostavax vaccine given on 9-20-07 in left arm S.Q. On 9-21-07 client c/o left arm redness, swelling, itchiness,sensitive and warm to touch. Also, client states of feeling "queasy". On 9-24-07, clients is able to function but still feel queasy, arm is somewhat inflamed, swelling has decreased, but arm remains itchy.
I started getting a headache that turned into a migraine. I went to the hospital. They did blood work and a CT scan. They did not know what was causing the migraines. They did find 2 aneurysms in my brain. They were both bleeding. They transported me to another hospital for surgery to stop the bleeding. They could only stop one aneurysm. The other they put in a PICC line from my brain to my stomach to drain it. I went into a coma for about 6 weeks. When I woke up, I could not walk, and it affected my thoughts and speech.
I was pregnant in my first trimester with perfectly rising Hcgs every 48 hours. I needed to be boosted for work and 2 days post booster my Hcg stopped rising appropriately.
Got 2 shots then ended up with them again/Suspected vaccination failure; then ended up with them again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 2 shots then ended up with them again/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: then ended up with them again).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she had shingles. The patient got two shingles shots then ended up with shingles again.  The reporter stated that the last time was the worsened. 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. Follow-up would not possible as no contact details were available.
low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years 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: PYREXIA (non-serious) with onset Aug2023, outcome "unknown", described as "low grade fever". It was unknown if therapeutic measures were taken as a result of pyrexia. Additional information: the patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 8 week old patient who was vaccinated on 05-DEC-2022 with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023, orally (PO). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Two weeks after my 2nd Moderna vaccine I started to feel very dizzy all day long when getting up from laying or a sitting position..  This has been going on now for 3 weeks.   I have no other medical problems & the only thing  different is I had the vaccine & never had problems with being dizzy before.   Also the day after the vaccine I started with back pain that still has not gone away.
Information has been received from a physician's assistant concerning an approximately 66 year old female consumer with "sensitivity to vaccines" and no pertinent medical history who in approximately March 2008, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lovastatin. It was reported that the patient received the vaccine and later felt fatigue.
Ocular black zig zig lines; paraesthesia; mild enlargement nodular heterogeneity of the bilateral lingual tonsils; Headaches; Chills; Slight feeling of not quite right; Swelling on face; Swelling of lips; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right) and PARAESTHESIA (paraesthesia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, the patient experienced SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), HEADACHE (Headaches) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils) and VISUAL IMPAIRMENT (Ocular black zig zig lines). At the time of the report, SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils), VISUAL IMPAIRMENT (Ocular black zig zig lines), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details include Tylenol , MRI and CT scan.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: No specific follow-up information recorded.
Major swelling in both feet, ankles, and calves. Swelling subsided after a few days, but there is still pain in the toes and ankles whenever I sit down
Legs and arms started shaking uncontrollably and I passed out or had a seizure for several minutes. I woke/came to and my husband helped me to bed. He said I was all sweaty. I slept for about an hour and got up. I fed my dogs, made tea, sat down and fell asleep. After waking I got up and continued my day with extreme fatigue, nausea, and a headache.
On 01-27-2011 patient presented to a Health Department Drive-thru flu clinic. Immunization administered by SN participating in event. On 01-28-2011, pt presented to Health Department stating she had a reaction to the vaccine. Left arm had diffuse redness over entire deltoid. Pt went to Urgent Care - told reaction was normal for type of vaccine given.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of VARIVAX (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 66 year old male with acid reflux, asthma and a balance problem associated with the inner ear, ringing in his ears and no known drug reactions/reactions who two years ago in November 2005, was vaccinated with an unspecified pneumonia vaccine (manufacturer unknown). Concomitant therapy included atenolol, an unspecified acid reflux medication and unspecified asthma medication. Two years ago in November 2005, after receiving the vaccine, the patient developed cellulitis which began on his arm and traveled to his feet which turned black and blue. He was hospitalized for three weeks. On an unspecified date the patient recovered from the events. At the time of this report (13-NOV-2007) the patient was suffering from neuropathy in both ankles due to his cellulitis. Additional information has been requested.
2 days after vaccination patient experiencing chills and sweats without fever, diffuse pain. No trouble at injection site, no respiratory symptoms. Reported to pharmacy today; directed patient to reach out to primary care doctor, waiting to hear back from them.
6.5cm x 7 cm, round, red & hard area at injection site. DTAP rxn vs cellulitis. Keflex 250mg/5ml 8ml pox1 then 5 ml po tid. Benadryl/5 ml po qid.
My son died on Sunday evening after getting shots on friday afternoon. He was in perfect health prior to his shots and death.  Nurse follow up on 07/26/04 states: "Complete."
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Prior to administration, patient reported history of allergy to fentanyl, and itchiness for 1st dose. Patient reported itchiness and redness 2nd dose. It started to develop 5-10 minutes after administration. 2 Benadryl tablets was ingested. Patient start to have increased redness/itchiness around the body, and neck. 40-50 minutes later, patient reported the symptom had subsided and she mention she felt fine. She mentioned she was prone to this type of reaction in the past and had taken benadryl.
Patient received pneumovax 23 on 2/21/21.  She experienced pain and swelling the same night she received the vaccine.  The next morning 2/22, she noticed a patch of redness that looked like cellulitis and was hot/warm to the touch and her doctor prescribed cephalexin to treat the suspected infection. She is going to follow up with pcp on 2/24.
Patient received Pfizer COVID vaccine on 2/4/21 (lot # EL9264), 2/25/21 (lot # EL9266), and 11/11/21 (lot # 33026BD). On 10/31/22, patient admitted to our inpatient facility (med/surg unit) with COVID-19 infection, failure to thrive (generalized weakness), and chronic cough. As of today (11/7/22), patient is still admitted in the med/surg unit.
Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headaches, fatigue