chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe metallic taste in mouth that maximized about 1.5-2hrs; Diarrhea over 2-3 days - soft then liquid; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: EL8982 Location of injection: Arm Left Vaccine Administration Time: 02:00 PM) on 19-Jan-2021 and Pfizer (Dose Number: 2 Batch/Lot No: EM9810 Location of injection: Arm Left Vaccine Administration Time: 02:00 PM) on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 08-Nov-2021 at 10:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid). On 10-May-2022, DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid) had resolved.            It was reported that patient had no allergy.  No Medical History information was reported.  Concomitant medication reported as Nature made started on 01-Mar-2022 and stop date reported as 20-May-2022.  The stop date was reported as 08-NOV-2021 for Moderna COVID-19 Vaccine.   It was reported that patient taking other medications/products within 2 weeks of starting COVID-19 treatment.   No treatment medications were reported.
Pain and tenderness in left shoulder, hurts to make certain movements, saw onsite nurse on 10/24/16, took over the counter Naproxen on and off through 11/14/16. Saw family physician on 11/15/16. Was prescribed topical anti-inflammatory for 10 days.
his arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (his arm was sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included METOPROLOL, AMLODIPINE and SIMVASTATIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (his arm was sore). At the time of the report, VACCINATION SITE PAIN (his arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: (High) started going up, it's been elevated ever since 160/170/180. On an unknown date, Blood pressure measurement: 190/90 (High) ER his pressure was 190/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided.   This case was linked to MOD-2021-052656, MOD-2021-052656 (Patient Link).
Severe pain unable to use left arm, extreme nausea, unable to eat or drink, fever and chills,  Disoriented with slurred speech and  Total incapacitation for over 24 hrs.
Starting on 9/3/22, 10 days after receiving the second dose of the pfizer covid vaccine, patient had conjunctivitis, congestion and slight cough.Also, there was a pontential covid exposure on 9/1/22 and a at home test was performed results were negative. Due to the holiday weekend of labor day we took patient in to be seen by his primary Doctor on 9/6/22. He was diagnosis with a double ear infection. His doctor prescibed a course of antibotic, augment. On 9/7/22 he developed a fever of 101, we have treated with tylenol. Unsure if this is a true adverse reaction to the vaccine, or simply a child who got sick.
Extreme itching and red, hive-like bumps on arms, back, shoulders, neck, sides of hips and groin area.  Woke up with scabbed scratch marks and small blood spots on my clothing and sheets.  Saw my doctor on 10/9/15, and she prescribed Fluocinonide (LIDEX / FLUEX) 0.05 % Top Crea, which has not helped.  After seeing her twice since then in January 2016, she prescribed hydrOXYzine Pamoate (VISTARIL) 25 mg Oral Cap (1 capsule orally at bedtime when needed for itching) and instructed me to purchase generic Zyrtec, which I did.  So far, neither product has helped the itching.  During my office visit on 1/8/16, she also ordered my regular series of lab tests that I believe were irrelevant to this problem.
COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (Lot Number: EL1284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID test/ tested positive on 29Dec2020, chills, body aches on 25Dec2020. She was supposed to get the second dose of the COVID Vaccine at the time of this report. She got the first dose on 23Dec2020 and after 2 days got chills and body aches. She took a COVID test swab on 29Dec2020. Then she tested positive on 31Dec2020. She was asymptomatic besides chills and body aches. She was in Isolation for 14 days and is done. She was wondering if she could take the second dose. Caller was a nursing assistant. The patient underwent lab tests and procedures which included COVID test swab: positive on 29Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID test swab positive) with BNT162b2 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.
Gurgling stomach all hours of day and night. Diaharea first thing in morning. Urgency to go and diahrea a few times a day for three days. Gurgling stomach still continuing through 7th day. INCREASED sense of smell and taste after first shot for about a week. Renewed after second shot, continues as of now.
his arm was a little red the first day; his is like a black purple bruise; he has seen how peoples' arms turn red, and his is purple and black after getting the shot/ it wasn't red or swollen, more like blood turning purple like when blood gets dry; This is a Spontaneous report from a contactable male consumer reported for himself. A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9587, Expiration date: unknown), via unspecified route, administered in right arm on 27Feb2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. The patient medical history includes sleep apnoea from 2006 and unknown ongoing, and have not had any other recent vaccinations or started any new medications.. On 27Feb2021, after the vaccination, the patient experienced redness initially and later on unspecified date in 2021, it turned to purple and black colour and it has been 4 days. He explained that he took the shot from his doctor. He says it could be just the colour of his arm, but while he was looking online most images, he had seen were red and swollen, and his is like a black, purple bruise. his arm was a little red the first day he said, but it wasn't like the pictures, it wasn't red or swollen, more like blood turning purple like when blood gets dry. The patient underwent with lab test and procedures which include unspecified tests on unspecified date with no abnormal results (reported as All good). The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Severe digestive problems, inflammation, swollen cervical nodes, chronic diarrhea, compromised immune system, waking up every 45 minutes at night from the night he received the shots for 10 months-then was given Zantac which temporarily helped him. Screaming, rolling around on the floor in abdominal pain at nighttime. Irritability in the day time. Restlessness, sensitive to certain foods. Liver/gall bladder dysfunction. Face swelling. Follow up states pt has not recovered. Digestive and immune problems. Sleep apnea. Restless and irritable. inflammation. Foos sensitivities. Loud mumbled speech. Difficulty processing information. High yeast. COMMENTS: i had a child who was in excellent health until the moment he received his 7 month old vaccinations. The combination of the shots was an overload to his system. It caused high yeast in his system which caused autism symptoms. The moment he received his shots he screamed for 1 hour and cried himself to sleep (passed out). He has never been the same since that day. Pervasive developmental disorder, attention deficit disorder, hyperactivity, speech delays, severe food allerges, sleep problems, abdominal pain.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE  5/23/2022,  10/9/2022,  12/17/2022  -- RECURRENCE OF SAME SYMPTOMS
15 minutes post injection pt recalls having "heart pain" She was fanning herself, "was hot and sweaty" she waited 15 minutes and then left without reporting any symptoms to the pharmacist. Pharmacist checked in with pt while she was waiting and pt told the rph she was feeling fine. When pt left she walked around store for 40 minutes after injections she said her heart pain lasted for 3 days at about 80-90% of the day. she called her dr. and they finally had a telephone conference Monday after the injections. She says over the next 3 weeks her heart pain decreased to about 10% of the day as of todays date.
Side Effects from 2nd dose of GSK SHINGRIX vac: temp. 100.4. No appetite. Cold chills + total body aches + Flu-like. Very sore arm. Very tired / on my back for 24 hrs. Flu-like. Night sweats on night 1 and 2. While these Side Effects are discussed as "possible" on GSK's SHINGRIX literature,  please note: (a)  I did not experience these effects from dose #1  after which I had sore arm + some body ache and tiredness (b) My general health & fitness is excellent (e.g. bike, walk, run daily).
Pt vaccinated with DTP developed temp of 104, MD started on antibiotic, Next day temp 106 given cool bath and tylenol, told to force liquids, child diarrhea was admitted to hospital on 8AUG90 with dx of pertussis. 9AUG90 temp back to normal
Presented to the ED due to shortness of breath that is worse on exertion and lying flat.  Per EMS patient had oxygen saturation 70 % on room air on their arrival.  Blood sugar elevated as well.  Patient reports testing positive for COVID.  States that his sister-in-law just recently died from COVID-19.  He is vaccinated against COVID x3 doses.  Reports getting outpatient COVID treatment including steroids however symptoms continue to worsen despite this.  Patient denies lower extremity edema, palpitations, chest pain, lightheadedness, dizziness, fever or chills.   - ED workup significant for HR 91, RR 22, increased anion gap 18.  ABG reveals 7.27/32.2/57.7/14.8.  Hyperglycemia present 643, with hyponatremia 125 BUN elevated 46 and serum creatinine elevated 2.53 (baseline 1.2-1.5) - COVID-19 positive - BNP elevated 4267.  Troponin not obtained in ED.  EKG reveals normal sinus rhythm without acute ST changes.  Chest x-ray reveals bilateral pneumonia and pulmonary edema however final radiology read pending at the time of admission.  Chest x-ray worse compared to 2 days prior. Hospitalized 1/15/22.  Discharged from hospital 1/27/2022.  Previously vaccinated Moderna 4/2/21 & 4/30/21.
pt recv vax 22OCT97 & 13JAN98 pt devel chickenpox several on lower legs & buttocks;
Client developed a vasovagal response, felt weak, dizzy, diaphoretic.  Laid down for about 10 minutes.  Was given sips of water, and juice.
Pt  was administered the Moderna vaccine on 7/26/2021 his mother contacted our clinic earlier in the week to report that "after my son received the vaccine we had to take him to the ER due to severe muscle spasms causing him not to be able to work for four days due to inability to walk."  Upon obtaining additional information regarding the event, we learned that  2 days after receiving the Moderna vaccine Pt assisted with moving an older couch.  Mom informed us that she took her son to the hospital and was seen by Dr. who diagnosed Pt with a severe back spasm. The mom then informed us that four days after ER visit Pt's gait "was unsteady and he was falling around".   Dr. was contacted with the description of events and instructed nurse to educate mom that  we will defer to his physician and reassess when his second dose is due.  Mom was contacted via phone with the follow up education and instruction. Mom continues to be unsure if she will follow up with 2nd vaccine for son, reports "I'll let him decide."
Rash grew largest, double in size - 6 inches diameter; Injection site that was a little itchy; Little pink mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site that was a little itchy), VACCINATION SITE ERYTHEMA (Little pink mark at the injection site) and VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID (VIT C) and FISH OIL for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site that was a little itchy) and VACCINATION SITE ERYTHEMA (Little pink mark at the injection site). On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Injection site that was a little itchy), VACCINATION SITE ERYTHEMA (Little pink mark at the injection site) and VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Patient reported on last page of ADR form "All is well". Outcome of the events updated.
Following vaccine administration, patient complained of feeling increased heart rate to observation nurse. Vital signs checked and initially her heart rate was 115 but decreased to 75 with next set of vitals. Patients BP was 140/78, pulse ox 98. No SOB, no signs of anaphylaxis. Patient has h/o of anxiety and felt this was related. Patient was monitored for 30 min and felt some intermittent tingling in her hands. Patient was transported to the ED for further evaluation as she was still not feeling well after she was offered a snack and a drink. Patient monitored in ED, workup included EKG and labwork. Symptoms resolved and patient discharged to home.
Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 hours. 6 days later, I experienced chills followed by hot flashes, nausea, dizziness, weakness (needed support to walk), headache and ringing in my ears. The chills, nausea, weakness, etc. came in waves for the next 6 days. The tinnitus and dizziness has stayed.
having trouble breathing and shortness of breath; Coughing and really struggling; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of unspecified age and gender received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 2, single via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.Patient also received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 1, single via an unspecified route of administration on an unspecified date for covid-19 immunisation.On an unknown date,  the patient who was vaccinated was experienced trouble breathing, coughing, all kinds of things happening, and reporter was inhaling and talking to the person. The patient received the Pfizer COVID vaccine yesterday, it was the second dose and  experienced these effects for the first time, shortness of breath and coughing and really struggling, and reporter suggested to the person go to the hospital. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Itchy lump under skin, then skin became red and hot around injection area and redness has spread down upper arm; symptoms including fatigue,  low grade temp.
fever (no thermometer), vomiting, lethargy; mom called clinic & was advised to contact MD; mom reports pt saw MD;
Large swollen itchy red rash at injection site along with pain and fever/nausea plus feeling weak and it?s been over a week of putting Benadryl cream on it and taking that and Tylenol
Clinician inadvertently gave monovalent covid vaccine when patient was due for and was expected the bivalent booster
This spontaneous report as received from a physician via company representative refers to a 4 year old male patient. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Lot number, expiry date, route and dose were not reported). Concomitantly the patient also received KINRIX at the same visit. On an unknown date, the patient developed very large localized swelling that required a second visit to the doctor. The outcome of the event localized swelling was unknown. This is one of the two assistant received from the same reporter. Additional information has been requested.
had pale episode, lifeless, eyes rolling, sleepy, feverish but temp not reported; started 30-45 mins p/receiving advil or pediaprofen & mom & grandma thought advil caused this so did not call office;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
I was sicker than I have ever been in my life. Fever, chills, body aches, general malaise, dizziness, nausea, vomiting, diarrhea, pain at injection site so severe as to cause involuntary moans when it was touched or moved. I honestly thought that I could be dying. 9 days later I still have significant loss of appetite.
(R) arm erythema from injection site to elbow (anterior aspect of (R) upper arm). Increased warmth. No pain, tenderness, pruritus, induration, swelling, or exudate. No fever or body aches. Had him take diphenhydramine 50mg; reports improved 6 hours later.
Rash on right lateral chest area under bra Bumps. Denied itching, fever or other symptoms.
On Monday, March 9th, I tested positive for the COVID antibodies and believe it was linked to an illness that I experienced last fall (COVID test was not administered at that time).  Approximately 16 hours after receiving the first injection of COVID-19 MODERNA I began to experience joint pain/stiffness, muscle soreness,  headaches, nausea, chills, sweats, malaise, heart racing, numbness to the fingers on my left hand, etc.  I became progressively worse until become bed ridden at 5:15 pm on Thursday, March 11th.  I remained bed ridden with symptoms becoming progressively worse until Friday evening, March 12th.  At that point, my condition began to improve.  I began to feel somewhat better by mid-morning on Saturday, March 13th.  My condition finally improved to ~90% by Monday, March 15th, with lingering muscle soreness and loss of feeling to the fingers on my left hand remaining.
Sore arm; This case was reported by a consumer via representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022142126   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's Comments: The consumer called and states that patient got her first dose and experienced a sore arm. The reporter consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022142126.; Sender's Comments:  US-GSK-US2022142126:Same reporter