chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer and refers to a 26 year old non-pregnant female patient. The patient's pertinent medical history included abnormal pap smears. She had no drug reactions or allergies. On 09-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, site, route of administration, lot # and expiry date were not specified) for prevention of human papilloma virus (HPV). Concomitant therapies included unknown birth control medication. On 09-FEB-2017, after GARDASIL 9 vaccination, the patient experienced twitch in her eye. The patient did not call her physician and no treatment was given due to the event. After an unknown number of weeks in 2017, the twitching stopped (also reported as "Did AE Improve: No"). The patient did not decide if she was going to receive the additional doses of GARDASIL 9. Product quality complaint (PQC) was not involved. The reporter did not provide the causality assessment between the event and GARDASIL 9.    Additional information is not expected as there was no consent to contact a healthcare provider.
Large red welts on upper arm starting 8 days after injection.  Warm and itchy, not raised...
12/19/2022 I was still on a cruise and I developed minor symptoms at this time. When we got back home, on 12/21/2022, I had the left over test available at my mother's home so I took that test. I also had a virtual visit and I was positive for COVID-19. I was prescribed PAXLOVID and took that and improved some. I returned home on 12/24/2022. The following Monday, I was getting worse and had to do constant nebulizers. I had some left over steroids and other medications to take. I tested positive twice when I was first sick. On 01/02/2023, I took another COVID-19 test and it was negative and I returned to work. I was still having frequent coughing and asthma attacks for a month and I would say it took about 2 months before getting back to base line. I would still need an inhaler a few times a week. I decided to see a pulmonologist back in January but was finally able to see her on 03/09/2023. I had a pulmonary function test and was formally diagnosed with asthma and started on medication. The pulmonologist also noted a new heart murmur that had not been noted before. I am scheduled for an upcoming echocardiogram on 04/19/2023.
Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, SIMVASTATIN and QUINAPRIL for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-083847 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-083847:Case for dose 2
Headache severe injection arm pain, chills, fatigue, insomnia, Narrative:    Other Relevant History:
Information has been received from a nurse practitioner concerning a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. In approximately 2011 (reported as 4 years ago), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route not reported). In approximately 2013 (reported as 2 years later), the second dose (lot#, expiration date dose and route not reported) and the third dose (lot#, expiration date dose and route not reported) were administered. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
patient had syncopal episode, resulting in fall from chair and hitting his head. Patient quickly regained consciousness when laid supine and was alert and oriented x 3
56 inch diameter red and swollen area. Warm and tender to touch. 1 inch diameter faint black and blue mark at area of injection. Area was on leg. Treated with Tylenol and cold compresses.
Patient was given a expired (BUD) vaccination. Patient informed and advised to have another vaccination ASAP.
Fever 103.8F.  Given Tylenol and Ibuprofen at emergency room.
After first dose, arm soreness lasting 3 days, headache lasting an hour. After around 5 days, I thought it was stress related, but I started to have itchiness on the roof of my mouth at the back. There is a kind of rashy area in the back of my mouth, mostly on the roof. It itches a lot and it makes my throat hurt when I attempt to scratch it. I have had to use chloraseptic spray and numbing cough drops to ease the itch and pain. Also, I have been experiencing shortness of breath. I attributed it to Chronic Bronchitis, but it feels different and is not constant. I didn't make the connection of mild allergic reaction until I received my second dose. I received my second dose on 01/29/2021. I was experiencing flu-like symptoms on 1/30, and am not experiencing the same symptoms as of 1/31. I am, however, still experiencing the mouth rash and itching, and mild shortness of breath.
This hospital employee received a dose of flu vaccine.  She then presented to our ED with shortness of breath, tingling, coughing, and difficulty breathing.  She received steroids and epi x2 doses.  She was transferred to an adult hospital ICU and placed on BIPAP.     PMH: asthma
On April 11, 2021, patient passed a sizeable blood clot and has experienced labored breathing.
In 8/99, the pt became covered in lesions and missed school for 7  - 10 days. She also experienced a fever, decreased activity, decreased diet and was miserable. Ten days after onset, the pt recovered. No further information is available.
This spontaneous report as received from a pharmacist via a company representative refers to a 61 years old female patient without any drug reaction/allergy. At the beginning of April 2016 the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not reported), 0.65 ml, subcutaneous. The patient was on unspecified concomitant medications. On the next day of vaccination, the patient developed redness and swelling around the injection site. The patient reported the events to the reporter on the phone on an unknown date in 2016. The patient recovered on an unknown date in 2016 (reported as within a week). The causality was not reported. Additional information has been requested.
Severe chills; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 08Jan2021 08:00 (Lot number: EK9231) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild seasonal type allergies" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose lot/batch no = EN9899, Anatomical location: Deltoid left, Date: 19Dec2020), administration date: 19Dec2020, when the patient was 49 years old, for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious) with onset 08Jan2021 22:30, outcome "recovered" (2021), described as "Severe chills"; PAIN (non-serious) with onset 08Jan2021 22:30, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of chills, pain. Additional information: The patient received the vaccine at hospital.  No follow-up attempts are possible. No further information is expected.
sore arm; received moderna vaccination as a 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021 at 3:53 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 3:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information was reported.
In less than a week and a half after the second dose, I started experiencing eye irritation - which was recently diagnosed as Conjunctival Chalasis.   Extreme eye irritation and occasional cystic swelling of conjuntiva in my right eye.    My eye was been treated with steriod drops, and am now being treated with Prolensa.  I can no longer wear a contact in my right eye.
arthritic joint pain exacerbated, migraine, fatigue, lethargy, decrease in appetite, teeth became extremely sensitive to pressure (chewing) and temperature. inability to maintain thermoregulation independently. lethargy and pain began in a few hours, tooth pain by evening. symptoms ramped up from injection to 24 hours, with peak pain/ problems 48-72 hours, lasting about a week before the symptoms started tp subside. lack of appetite continued for months. odd tooth pain intermittent
Heart pounding similar to if I had performed physical activity, but I am sedentary.  I am also very lethargic and can barely make it through the workday without needing caffeine or a nap.
10 months late for 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments:  This case was reported by consumer via interactive digital media. The patient was 10 months late for 2nd Shingrix shot and asked was it too late. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
myocarditis; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 27Jun2021 as dose 2, single (Lot number: EW0196) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Strength: 30 ug, Lot Number: EW0180), administration date: Jun2021, for Covid-19 Immunisation, reaction(s): "She mentioned since receiving the vaccination, her son has been dealing with myocarditis and pericarditis", "She mentioned since receiving the vaccination, her son has been dealing with myocarditis and pericarditis". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown". The events "myocarditis" and "pericarditis" required physician office visit. Clinical course: Caller was calling on behalf of his 26-year old son who received two doses of the Pfizer Biontech COVID 19 vaccine on Jun2021. Additionally, caller mentioned she had been sending documentation for Pfizer since April, May and Jun about her son who was not supposed to receive the same shot, but had not received a clear answer. She mentioned since receiving the vaccination, her son had been dealing with myocarditis and pericarditis, and that she had been told by nurses that their sons had been getting sick too after receiving the vaccinations, and also a bunch of young people because of the proteins in the vaccine. Caller mentioned she had previously spoken to someone at PMI who advised her the timing between doses of the Purple Cap was 2 months and not 3 weeks and that we were lying to her. She called earlier and spoke with a nurse and documented her sons side effects to the COVID vaccine. She switched her to the medical department. They were going back through lot numbers of the two pfizer shots he got. She confirmed the two BioNtech COVID shots her son received. The agent said he was only supposed to receive 1 because Pfizer switched to a different covid shot. He went to get COVID shots in Jun and got two COVID vaccines back to back. He had severe side effects including health problems and pericarditis. The medical information agent was supposed to send something that shows the lot numbers and where his vaccines were administered at. The emails she got from Medical information were not that. The only information on the card was lot numbers and the healthcare professionals. It only had the numbers where it was administered in the pharmacy. Her son received two shots. The agent said he should had only got one. Why wouldn't the pharmacy know that. Her son was at the cardiology center. She was talking to them, and they said young people are coming in with diagnose pericarditis after covid shot.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263295 Same patient/product, different dose/events (Dose 1);
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the nineteenth of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
high pain level at injection site; exhaustion/fatigue; This is a spontaneous report from a contactable consumer.  A 65-year-old male patient received bnt162b2 (BNT162B2, lot/batch number and expiry date were unknown), via an unspecified route of administration on unknown Dec2020 (last week) at single dose for Covid-19 immunisation. Medical history included obese by medical standards, has heart rhythm issues and diverticulosis. He also was tested positive for COVID and had symptoms over two weeks in the summer of 2020. The patient's concomitant medications were not reported. On unknown date in Dec2020, he experienced the exhaustion and fatigue that he experienced when he had COVID. It lasted about a week and he took two days of sick time. He also reported 12 hours of high pain level at injection site following the shot. He described it as a higher level of pain than he had experienced with other vaccines or injuries. Events took place after use of product. The outcome of events was recovered.  The following information on the batch number has been requested.
About 2 weeks after the first dose, my lymph nodes on the left side of my neck and behind my earlobe were very swollen and it was hard to turn my head. Also had a terrible headache. The swelling lasted 5 days and has gone down now. The headache lasted 2 days. I had a slight fever and body aches and tiredness for about 5 days after the vaccine.
REDNESS AT INJECTION SITE THAT EXPANDED TO SIZE OF AN ORANGE.  CHILLS AND FEVER ON DAY 2 TO 3. ALL SYMPTOMS RESOLVED BY DAY 4.
itching; shortness of breath; Allergic reaction to booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itching), DYSPNOEA (shortness of breath) and ALLERGY TO VACCINE (Allergic reaction to booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), DYSPNOEA (shortness of breath) and ALLERGY TO VACCINE (Allergic reaction to booster dose). At the time of the report, PRURITUS (itching) and DYSPNOEA (shortness of breath) outcome was unknown and ALLERGY TO VACCINE (Allergic reaction to booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Breakthrough case admission after 3 vaccines Moderna 1/14/21 Lot# 012L20A;  Moderna 2/11/21 Lot# 010M20A;  Moderna 4/21/22 Lot# 048L21A
This case was reported by a physician via sales representative and described the occurrence of limb swelling from the injection site to the elbow in an unspecified number of subjects of unspecified age and gender who were vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. It was reported that lately, the physician's office had been noticing that with the majority of the 5th doses that have been given with Infanrix, the children have had swelling from the injection site to the elbow. The subjects had received Tripedia or Daptacel for their first four doses of the series. At the time of reporting the outcome of the events were was unspecified.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020. On 14th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 15th March 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: No other vaccines were administered to this patient in the last 4 weeks from this pharmacy. The patient was administered SHINGRIX in the left arm. The patient reported to her health care professional and to the pharmacy. The patient stated the rash on shoulder started the next day after the injection. The patient's health care professional instructed the patient to not get the remainder of the SHINGRIX series. The pharmacy did not have additional information pertaining to this adverse event. No QA was reported.
Information has been received from a Licensed Practical Nurse concerning a 35 day old patient who in December 2011, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported), PO. No adverse effects were reported. No further information is available.
-there was no adverse event. this form is being filled out because the patient lost his vaccine card and informed us that he previously took the pfizer vaccine a long time ago and the vaccine is overdue to get the second dose. I asked if he received pfizer , he said yes so i proceeded to administer the second dose. After - I went to bill the vaccine and received a rejection stating that there was a vaccine already billed so I called to find out what was going on. They informed me august 20th the patient received a moderna vaccine, not pfizer. Patient received moderna on 08/20 and pfizer on 10/04.
Flu vaccine and Tdap administered day 1 9/29/2015. Day 2 - body aches and low grade fever - Tmax 99.2 also eye lid pain. Day 3 - woke up - puffy, red and painful eye lids, continued body aches and low grade fever through Day 6. Approximately Day 5, red raised macule-papular and painful rash to upper chest, upper back, bilateral arms and legs. This lasted through Day 11. Joint pain and edema began approx day 10 and continued currently.
pt recvd MMR vax 12MAY92 & onset of fever & fussiness;  became inc fussy w/persistent crying; devel ataxia 3 days p/vax; had CT Scan, LP hospitalized for observation; pt neuro consult dx MMR rxn w/poss cerebellitis;
I woke up in extreme pain in my right shoulder. I couldn't lift my arm without the help of my other arm.  Raising it and lowering were extremely painful.  I couldn't raise it above my waist. This lasted for about 8 hours. I took 800 mg Ibuprofen and I could finally move my arm to chest level but it still ached, even when just laying at my side so I had to hold it to my chest. After 4 days, it felt better but there was still pain when raising my arm over my head. It felt like I had ripped something in my shoulder at the rotator cuff. 4 days later, the pain came back and I had to once again hold my arm at chest level for 2 days. Yesterday, January 28th, I went to my doctor and received a steroid injection in my shoulder and they also put in MRI orders.
Patient received J+J COVID vaccine on 5/23/2021 and received Pfizer vaccine on 8/10/2021 as documented on this report.
Difficulty breathing, fever, hive like rashes. Currently being assessed for Autism spectrum, speech loss, occupational therapy, etc.
20FEB96 PM vomiting (2X) p/eating;21FEB96 AM vomiting (1X) after eating suspended feeding;21FEB96 PM diarrhea (several times); 21FEB96 PM fever (101-103);22FEB96 fever 101;23FEB96 PM rash over stomach & lower back;