chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen vein on the side of his head; Gasping for air; Chills; Softball size knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Softball size knot), VEIN DISORDER (Swollen vein on the side of his head), DYSPNOEA (Gasping for air) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2L1A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE MASS (Softball size knot) and CHILLS (Chills). On 20-Mar-2021, the patient experienced DYSPNOEA (Gasping for air). On an unknown date, the patient experienced VEIN DISORDER (Swollen vein on the side of his head). At the time of the report, VACCINATION SITE MASS (Softball size knot), VEIN DISORDER (Swollen vein on the side of his head) and CHILLS (Chills) outcome was unknown and DYSPNOEA (Gasping for air) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-090449 (Patient Link).
Rash appeared on face on 6/1/03, rapidly spreading to trunk. Red, raised, blanching, maculo-papular. No vesicles, no pustules, no petechiae or purpura.
Sob, hives, vomiting, chest tightness, dizziness, lightheaded, diarrhea. Antihistamines and pepcid. Lasted 24 hours
A 14-year-old patient received a dose of FLUBLOK no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional (Reference number- 00802604) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 14-year-old female patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "Caller states that FLUBLOK has been administered to a patient under the age of 18; the patient is 14 years of age female; caller would like to know about adverse effects to look out for and if/when the proper flu vaccine can be administered"  No other 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 the 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.  There will be no information available on the batch number for this case.
Wheezing, Light headed, throat felt like tightening within 15 minutes of receiving vaccine.  Epi pen given, Benadryl 50 mgm.  Felt better after 10 minutes.   Patient requested to take Xanax .5 mgm.  NP approved.
Within one hour from vaccine child complained of stomach pain, crying nonstop, shaking, c/o difficulty breathing. Mom administered albuterol nebulizer treatment and 1 1/2 tsp BENADRYL. Child's symptoms resolved after both txmts.
My period was delayed by 22 days. I?m on the pill so it comes regularly each month, a light bleed.  After my second shot I should have gotten my period a week later, but it skipped with no bleeding at all.  When it finally did come it was one of the longest and heaviest periods since I had given birth 2 years prior.   Then when I started the pill after that period I continued to have breakthrough bleeding the entire month of that pill pack.  I?ve been on this pill since I was 15 and had never experienced this.
Patient felt unusual pain at time of administration which came back "2 weeks" after date of vaccination. Reported persistent deltoid muscle pain on 1-20-15.
Cardiac arrest at home Patient found down at home by son; son found patient drooling; initially thought she was sleeping but found her with her eyes open sitting in a recliner unresponsive at home. EMS arrived and CPR was initiated; patient was intubated and transferred to local hospital. CPR was performed approximately 10 minutes. Per family, patient was in normal state of health prior to incident
I had an extremely bad stuffy nose, bad sinuses, headache, body ache. I used a home COVID-19 test that came back positive. I called my doctor's and had a telehealth visit and was prescribed PAXLOVID. I started taking it immediately and by the next day my symptoms were gone. By the fifth day of my taking the medication I was completely COVID-19 free.
This spontaneous report from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 18-APR-2018 the patient was vaccinated with M-M-R II injection via the intramuscular route (dose, frequency, lot # and expiry date were not reported) for prophylaxis (incorrect route of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
This spontaneous report was received from a physician via a company representative concerning a 60 year old patient of unknown gender. It was reported that on an unknown date, the patient who was 60 year old was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information is not expected.
This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and feeling unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient experienced extreme fever, chills, and flu like symptoms for 3 days. The patient felt too sick to get out of bed for the 3 days. The reporter did not agree to follow up
immediate headache (mild) gone within a day, delayed onset of constant bilateral hip pain circa 10d post vaccine
Left shoulder pain, limited range of motion, and paresthesia to posterior shoulder starting the day of injection. Worse at night and upon waking this next morning. Symptoms have improved since onset.
Vaccine recipient developed shakiness and chills 15 minutes after receiving the vaccine on 1/6/2021. Did not go to the ED. The next day 1/7/2021, they developed fever and arm pain. She took Tylenol. On a follow-up call on 1/11/2021, she reported that she has recovered. Moderna COVID- 19 Vaccine EUA.
Approx. 9 hours after the vaccination, I began to feel achy in my neck, shoulders, and upper back. Within approx. 30 minutes, I was having extreme chills, some slight stomach cramping, and the neck/upper back aches became very intense. It felt like a case of the flu, but worse. I did not experience vomiting. I took 600mg of Ibuprofin at about 10:00pm Those symptoms ended at approx. 12:30am on 4/8/2021. I was quite exhausted all day on 4/8/2021. Throughout the day on 4/8/2021, I felt lightheaded and a bit dizzy. That symptom lasted for just that day only. I continued to feel tired through 4/9/2021. I now feel completely recovered.
Client was anxious about getting an injection. After injection client waiting to pay. She suddenly started to complain of chest and back pain, color pale, rapid breathing, slightly diaphoretic. Had client lay down monitored vital signs, encourage to slow deep breathing after 30 min. she felt better and was discharged home.
TENDON PAIN; BODY ACHES; COUGH; SWEATING; JOINT PAIN; MUSCLE ACHES; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 103. On 08-APR-2021, the subject experienced tendon pain. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tendon pain, sweating, joint pain, fever, and nausea on APR-2021, was recovering from muscle aches, and cough, had not recovered from headache, and the outcome of body aches was not reported. This report was non-serious.
This is a spontaneous report from a contactable consumer that reporter for his father and from the contactable wife's consumer. A 87 years old male patient received PREVNAR 13, intramuscular at 0.5ml single dose on 19Dec2014 around noon. The patient had history of pneumonia four times before and was being prepared for cataract surgery and had history of bypass 10-15 years ago and a surgery for skin cancer. At 7:00 that night, he said he was tired and didn't feel good so went to bed. At 10:00 PM, he got up to go to the bathroom and he stumbled to the door frame. He said he didn't have any power in his legs and he hard of hearing after the fall. At 3:00 AM on 20Dec2014 he had gotten up again and missed the bathroom door and fell down 3 steps to the landing. The wife noticed there was some confusion. At 7:30 AM the wife took him to the ER. He was there for 5-6 hours and they checked everything-blood tests, urine, EKGs and they also give him IV fluids. So then he went home as they couldn't find anything wrong. The rest of the day he pretty much slept away. Early on morning on 21Dec2014 he woke and got himself downstairs. Around 5:00 he just slumped to the floor. He did not have strength to help himself up and the wife couldn't get him up. The wife suggested he roll over to his stomach and maybe using arms and knees he could get up. He couldn't even roll over or didn't understand. About 6:30 an ambulance took him to the ER again. He again slept most of the day and didn't want to eat. The rest of the week, he napped a lot. Concomitant medications included COUMADIN, ZESTRIL, TOPROL, LIPITOR; CARDIZEM; Warfarin; aspirin 81 mg; multivitamin; Vitamin D and Fish Oil, all ongoing. The patient did not received any treatment for the events. Outcome for the events weakness, exhausted, hard of hearing and tired was reported as not recovered while the patient recovered from confusional state, fall, the outcome of the events somnolence, decreased appetite and feeling abnormal was unknown. Follow up (13Jan2015) Additional information reported from the contactable wife's consumer includes details on the clinical course of the patient. Lab data and events added.
Ptn reported to pharmacy on 4/21 complaining of cold chills and swollen arm. Patient seen at urgent care. Treatment and Outcome unknown.
low hemoglobin normocytic anemia ,Symptomatic Anemia +SOB and Tachycardia Hgb 6.6 fatigue with racing heart for the past  2 weeks and has been getting worse.
Tired; Feeling Unwell; Somewhat of a disoriented feeling; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 13Apr2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to penicillin (PCN) (MANUFACTURER UNKNOWN). Concomitant medications included acetylsalicylic acid (ASPIRIN), from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 14:00, the patient experienced tired, feeling unwell and somewhat of a disoriented feeling. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of reported events. The clinical outcomes of tired, feeling unwell and somewhat of a disoriented feeling were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Large red swell on left leg where vaccine was administered. Few days after the swell the child erupted in a severe skin reaction that spread from thigh to chest. A contact was made with the pediatric office that administered the vaccine. I was advised reaction is normal following vaccination. Child was taken to Emergency evaluation as the reaction persisted and continued to spread. Child was taken again to the pediatrician for evaluation on 8/30/14. Was advised the reaction was due to Dtap vaccine.
While driving on the freeway, the vision in my left eye began to fade out. Right before I was completely blind it came back. I went to the doctor and had CAT scans, MRI. They told me I had a Transient ischemic attack. It mimics a stroke. I was told a blood clot was in the back left side of my head. I was put on a heart monitor for 30 days. The event itself lasted for about 10 seconds. I was put into an observation room for 48 hours where they monitored me to see if the event would happen again.
Left office from vaccine adm. Started sneezing as soon as outside - 10-15 min dad noted eyes swelling. 30-40 seconds later back at office - eyes swollen shut - BENADRYL given. No other symptoms. Observed for 1 1/2 hrs improved - left office.
Patient had first Moderna Covid IMZ on 3/6 and had a stroke on 3/18.  His doctors do not believe this was related to the vaccine  and want him to get the second dose.
Information has been received from a registered nurse concerning a 27 year old patient who on 06 Feb 2007 was inadvertently vaccinated with a SC dose of Zostavax instead of a dose of Varivax. The event was a nursing error, not product confusion. No adverse experience was related to this event. A product quality complaint was not involved.   Additional information has been received from the registered nurse who reported that the event was not a product issue. The medical assistant who gave the vaccination did not validate what she was giving by checking with the physician. There was no adverse effect and the reported stated that "it was their own fault." The patient was told to stay away from pregnant women and people undergoing chemotherapy. Additional information has been requested.
pt recvd vax;severe inject site rxn p/ vax including erythema, swelling & pain;
Had cellulitis; This case was reported by a other health professional via other manufacturer and described the occurrence of cellulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and rheumatoid arthritis. Concomitant products included methotrexate.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Previously, the patient had shingles vaccine and experienced cellulitis. The patient was felt terrified and scared with rheumatoid arthritis.  The patient was receiving Xeljanz XR (11mg) for rheumatoid arthritis from 31st October 2020 and the therapy was ongoing.
I have had a sore arm for about two weeks now. It feels like  a pulled muscle. It has not limited my mobility in my right arm, but i continue to have an uncomfortable feeling of mild soreness, now 10 days after vaccination.
Information has been received from a physician concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 661008/1317X). Concomitant therapy included measles-mumps-rubella vaccine (MSD) (Lot# 660275/1255X). Patient experienced injection site swelling. The patient sought unspecified medical attention. Follow up information received on 03-Feb-2009 stated that a phone call was received from the medical assistant, he stated that the patient was given VARIVAX (Oka/Merck) (lot# 661008/1317X) and measles - mumps -rubella vaccine (lot # 660275/1255X) on the right thigh. It was also reported that the patient had localized reaction. Follow up information received on 05-MAR-2009 from a registered nurse stated that it was patient with an allergy to penicillin and no illness at time of vaccination, who on 08-Jan-2009 received the first dose of VARIVAX (Oka/Merck) (lot# 661008/1317X) in the right thigh, The patient also received a second dose of MMR II (lot # 66027/1255X) in the right thigh on 08-Jan-2009. On 20-Jan-2009 the patient experienced mild swelling of right thigh. No laboratories studies performed. It was reported that it was patient's first visit. This is one of 2 reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow up information was received from a registered nurse. It was reported that a second dose of VARIVAX (Merck) (route and lot number not reported), was given on the patient's left arm three months after the first dose, on 09-APR-2009. No reactions were noted. This is one of 2 reports from the same source. Additional information has been requested.
Tues Am vaccine given 11/11/02. Tues pm to following Mon: 11/11/02-11/18/02 sinus 11/11-11/25, headache 2 days fever, terrible body aches-6 days, diarrhea 2 days, confirmed to the bed most of time. Two weeks alter 11/25/02 still aching, no energy, sinus infection-began Zithromax Rx tonight by MD. Feel well after this flu shot. What is different this year. I'm on the same Rx as in previous years.
Approximately 12 hours after my 2nd dose - I had chills, fever and muscle aches, headache and itchy eyes which lasted for 24 hours and then 2 days after I had diarrhea and that wouldn't go away so I had to go see my regular doctor and she advised to do some laboratory tests and it came back that I have an inflammation of the GI track and it was recommended that I see a specialist. When I went to the specialist and there were several laboratory test performed again. She prescribed me with pills (Diphen-Atrop) and I took it for 10days 1 tab 3x/day. It did work when I was taking it but when I stopped the diarrhea came right back. Around the beginning of July is when I started to feel better.   When I got the booster shot (3rd dose - Moderna) last October 26, 2021 (017F21A) I had the same side effect which was diarrhea and lasted for about 2 and a half months approximately.
Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "extreme cramping in my stomach area"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "initially hot and cold"; MALAISE (non-serious), outcome "unknown", described as "I do not feel really well; do not feel 100%"; SPEECH DISORDER (non-serious), outcome "unknown", described as "I do not really feel like talking and answering lots of questions". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX), LEVOTHYROXINE SODIUM (SYNTHROID), MULTIVITAMIN FOR WOMEN, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PRESSURE + PAIN), MAGNESIUM, AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA) and CHOLINE, SILICON (BIOSIL) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form and MELATONIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report has been received from an office manager concerning a male patient over the age of 15 years old. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # L004014 (exp. date, strength, route of administration, and dose were not provided) (Inappropriate schedule of vaccine administered). No adverse events had been reported. Additional information has been requested.