chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm in deltoid region is painful, redness, swollen, and hardness with warmness to touch.
After having the second Pfizer COVID 19 shot on 2/13 I noticed about a 1 inch swollen left cervical (neck) lymph node. It wasn?t overly tender to the touch but it was mildly sensitive. I took a picture of it and contacted my OBGYN who thought since it was on the side my vaccine was given (left arm) and appeared one day after vaccination that it was likely due to the vaccine and to keep an eye on it, she was not concerned. I kept track of it for several days and the size started to decrease over the next 2-3 weeks approximately. It is now essentially gone. There may be very very small swelling noted if I side bend my head to the right to make the lymph node on the left side of my neck pop out but it is extremely mild. I?ve had no pain or issue in the area. At the time of the vaccine I was 21 weeks pregnant. My due date is approaching.
Case number PHEH2013US025146 is an initial report received from a pharmacist on 02 DEC 2013. This report refers to a 60-year-old female patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307701; expiry date: not reported) intramuscularly on 02 DEC 2013. She only received half of the recommended dose because half of the dose escaped from the needle. No adverse event was reported followed by this administration error. The event outcome, seriousness and causality were not reported.
Shivering Slight Fever Headache Sore Arm (around injection site)
Pt recvd 3 doses of Engerix-B 4FEB91, 4MAR91 & 12AUG91 & it was determined that pt did not respond; 4th Engerix-B dose was administered 18OCT91 & it was determined that p/this dose pt responded; also pt takes 1 Motrin tab po for back pain;
Fever, chills, diarrhea, swollen armpit on side shot was given, swollen in a where shot was given.
Starting 1 day after the second dose of Pfizer vaccine, pt developed behind her ears spread across the scalp and down the neck.  The rash spread to bilaterally to the shoulders, forearms, thighs, calves and ankles.  The rash is pruritic and is painful upon palpation/scratching.  Blisters developed in the area of the rash and burst after scratching.  It's been approximately 2 months since the first appearance of the rash, and pt was prescribed 2 courses of abx which have not improved symptoms.
Pt developed a varicella infection. The pt was hospitalized with a hospital course complicated by multiple pulmonary issues.
Patient said reaction began day after vaccine administered - large hives back of legs, itching, trouble sleeping due to itch.  She took Benadryl PO and topical last night, but did not help.  Reaction getting worse.  No difficulty breathing.
Body aches; Dry cough; Fatigue; tested positive for covid after being fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated) in a female patient of an unknown age 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 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. In September 2021, the patient experienced PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated). At the time of the report, PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported.  Treatment medications included Quetitin  for COVID.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected event of Covid-19.  The event occurred following an unspecified time after the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing times and details were not disclosed. Causality for the reported event was not provided by the reporter. Based on biological implausible and etiology, the event is considered not applicable. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events assessed as non-serious per regulatory authority reporting.  However, Covid-19 is an adverse event of special interest
Death; This spontaneous report was received from a consumer, via Sanofi, and refers to an infant patient of unknown age and gender who was a participant in one of the reported "2 studies". No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unknown date, the patient was vaccinated with diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (PENTACEL) and hepatitis b vaccine (Recombinant) (RECOMBIVAX HB) (strengths, number of dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number and expiration date were not provided).  On an unspecified day, the infant patient was reported death. The cause of death was not provided. It was unknown if an autopsy was performed.  The causality assessment between the suspect vaccines and the patient's death was reported as not related. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the RECOMBIVAX vaccine and the reported event of "Death" cannot be established. Missing information includes: subject´s demographic information, complete medical history, concurrent conditions, dates of RECOMBIVAX administration and other concomitant vaccines, detailed clinical course, diagnostic workup results (if any performed), treatment details (if any provided), and primary cause of death (as per death certificate).   Company Comment- No changes to the RECOMBIVAX vaccine product safety information are warranted at this time.  Merck and Co., Inc. also known as MSD, continues to monitor the safety profile of the product.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 21-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Previously healthy 17 year male with acute pancreatitis 4 days following his first dose of GARDASIL HPV vaccine. Symptoms included sudden onset vomiting and epigastric/LUQ abdominal pain. Treated with intravenous antiemetics, analgesics, hydration.
This spontaneous report as received form a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of GARDASIL injection (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
7/10/2021 COVID-19 Positive Breakthrough Case >14-Days Post Vaccination Series Completion Narrative: 7/10/2021 COVID-19 Positive Breakthrough Case >14-Days Post Vaccination Series Completion
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient has taken 0.25 mL, since dose number is not provided, it is presumed to be booster.  No adverse events were reported.
Experienced muscular pain in entire arm x 1 week c/o dull ache and soreness in elbow currently. This does effect her ability to lift ie mild jug. Instructed to use NSAID's x 7 days and to see PMD PRN.
Information has been received from an investigator via agency concerning a patient who on an unspecified date was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date the patient was vaccinated with a dose of RECOMBIVAX HB. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (manufacturer unknown). It was reported that 1 week post vaccination the patient experienced erythema and skin induration. The reporting investigator felt that erythema was possibly related to RECOMBIVAX HB and to PNEUMOVAX 23 (manufacturer unknown). Skin induration was definitely related to RECOMBIVAX and to PNEUMOVAX 23 (manufacturer unknown). Erythema and skin induration were considered to be other important medical events. No further information is available.
Since 17 December she has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body and typically occur at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. She reports eyelid and lip swelling but denies generalized laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 7 December, 10 days prior to onset of symptoms. She has used oral antihistamines with limited control of symptoms. She denies constitutional symptoms. score today is 3 (0, 0, 0 ,0, 0, 2, 0, 1).
started the migraines, kicking it into overdrive; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included she is immunocompromised and is suffering from heart problems (both ongoing), had a hysterotomy 2 months before an unspecified date, ongoing auto-immune issues. Concomitant medications included had botulinum toxin type a (BOTOX) injections 2 weeks prior to her first injection; golimumab (SIMPONI) for auto-immune issues. Patient reported that she already had the injections of golimumab done. After receiving the first dose of Pfizer's COVID vaccine, it kicked her migraines to overdrive on an unspecified date. After her 1st injection, it started the migraines, kicking it into overdrive. Her migraine doctor started another medication and started another side medication on top of that. And she was still having migraines. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediately after the vaccine was injected, I felt like I got slugged in the arm. I also had a momentary hot flash. Then, I went to go sit in the waiting area, and I continued to get warmer and warmer. After 5 minutes, I went up to the front desk, and told them I didn?t feel well and that I felt like I was overheating. They put me in a wheelchair, and I immediately passed out and hallucinated for a minute or two. I felt incredibly weak, and I had sweat completely through my shirt. A paramedic came and put me in a stretcher in a cornered off area of the clinic. After 30 minutes or so, I started feeling better, but I got several spirts of cold flashes. All of my vitals came back normal.
Subsequent to receiving either Tetanus and Diphtheria Toxoids Adsorbed or Tetanus Toxoid Adsorbed an inmate developed a local reaction.
pt recv vax 8AUG95 & 27APR(7 pt exp full blown chickenpox w/approx 90 lesions, fever, runny nose & itchiness;
Patient up to date on COVID vaccines who admitted to hospital with positive COVID test (initially ""not detected"" then test on 08/21/22 resulted ""detected". "Provider d/c note: "73 year old male with a history of hypothyroidism, paroxysmal AFib, Granulomatosis with Polyangiitis, and hyperlipidemia who presented to the hospital on 8/4/22 at the direction of his rheumatologist for evaluation of abnormal labwork and increasing shortness of breath. Upon admission to the hospital, an extensive workup for his worsening respiratory status began. Initially thought to a pulmonary emboli, a pulmonary CT scan was ordered. No PE was identified, though it did reveal worsening ground glass opacities bilaterally suggestive of a possible infectious process. He was started on broad spectrum antibiotics and bronchoscopy was performed. While his initial COVID test was negative, the Bronchoscopy came back positive for COVID, Pseudomonas aeruginosa and Klebsiella pneumonia. His respiratory status continued to worsen despite being on appropriate antibiotic coverage and receiving high dose steroid, eventually requiring NIPPV and extensive stay  prior to transfer to floors. Respiratory status showing minimal/slow improvement, palliative care was consulted for a goals of care discussion. Around that time, patient decided that he no longer wanted to proceed with treatment in the face of a prolonged/difficulty recovery and LTAC placement. He wanted to be made comfortable. Comfort measures were put in place and supplemental oxygen was slowly weaned off. He passed away on 9/2/22 at 12:49 AM".
Achy; Fever; This case was reported by a consumer via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the fever was recovered/resolved.   The reporter considered the pain and fever to be possibly related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced fever and achy. The events got better within 24 hours but still achy. The reporter consented to follow up.
Fever; Chills; Nausea; Vomiting; Iitching all over body; Soft stool, not liquid; Weakness; Tired; Light headedness; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tooth abscess (about a month and was taking Amoxicillin 3 times per day), post-traumatic stress disorder, benign prostatic hypertrophy, eosinophilic esophagitis and hypertension. Concomitant products included amoxicillin.   On 13-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 14-MAR-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), pruritus (Verbatim: Iitching all over body) and soft stools (Verbatim: Soft stool, not liquid). In MAR-2023, the patient experienced weakness (Verbatim: Weakness), tiredness (Verbatim: Tired), light headedness (Verbatim: Light headedness) and appetite lost (Verbatim: Loss of appetite). The outcome of the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting and pruritus were recovered/resolved and the outcome of the soft stools was unknown.   The reporter considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.     The company considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.   Additional Information: GSK receipt date:15-MAR-2023,16-MAR-2023 The patient reported that hours later having shingrix vaccine, he experienced weakness and being tired, light headedness, and loss of appetite. The next day he experienced fever, chills, nausea/vomiting, itching all over body and states his stool was soft but not liquid.  He said that he was taking shingrix vaccine has he was getting ready to take anothermedication Dupixent. He spoke to nurse because he had been ill the last couple of days with possible side effect. The nurse was very professional extremely kind, she gave helpful information from a nursing point of view pointing him to product information advising him to contact physician due to the issue.The patient was extremely impressed with her. He got the second round of these Shingrix shots and just because he was taking Dupixent. The reporter did not consent to follow up.
Weakness in the muscle where flu shot was given: could not lift left arm and felt sore while lifting. It took more than 3 weeks to resolve.
She got her vaccine, she went home and seemed to have slept a lot with both vaccines.   She also had lack of appetite and did not want to come down to the table to eat, just wanted to sleep.   If her mother could get her down to eat, she would take 2 bites of food and go back to bed, which mother feels the vaccine may have lowered her threshold for seizures.   About 15 days after the vaccine she came to her door and she was banging in the hallway and was hollering help me.  Her mother felt that she was having a seizure which she has not had any in about 2 1/2 years, and she was into one that her mother stopped with the cannabis oil.  They have been controlled with the cannabis oil for the last 2 1/2 years but she was having multiple daily seizures prior to the cannabis oil.  Her mother went downstairs and got her cannabis capsules and the MCT oil which she gave sublingually and she started to subside from the screaming and then moaned for 30 minutes.  She then started to have involuntary neck movements and her head would swing back as she is walking, and she has been tapping her head on items and on her mother, which her mother thinks she is trying to tell her that something is wrong.   She was not doing this prior to the 2nd vaccine.  Her days and nights also seemed to be out of sorts since the vaccine as well.  She is very limited in communication and does not speak much, but has so  more since she started the cannabis oils.
Earrs: Swollen Eustachian tubes in both ears:   distorted hearing, amplified sound, equilibrium off.  Eyes: both eyes had irritation, then Left eye pain, inflammation and redness on the outer edge of eyeball.
Extreme dizziness - could not stand or walk.  High fever off and on,  body aches and pains.  Arm ached constantly even without movement near injection point.  Last for a few hours and now I'm fine.  Arm is still sore but not as bad.
1 X 3 cm area of erythema but no induration, (R) thigh
Acute onset 2 days after vaccination of global pounding daily headaches that progressively became worse.  Had to be treated with narcotics after persisting for 3 wks. Saw neurologist who put her on Decadron 4mg  qid for 4 days.  No other f/u at this time No history of headaches
"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 .  She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered "
The customer had Bell's Palsy the day after the pneumonia vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable pharmacist. A 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Lot number was not reported) as unknown dose number, single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had a reaction with the pneumonia vaccine which was not specified. The patient had Bell's Palsy the day after the pneumonia vaccine on an unspecified date. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) (pneumonia vaccine) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) (pneumonia vaccine) has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's Palsy with pneumococcal 13-valent conjugate vaccine can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swelling and redness no fever no discharge. Given Cephalexin 500mg capsule 2 times daily x 14 days. Given Keflex 500 BID x 14 days.