chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; The muscle is swollen; It's kind of heated up; Tired; Arm pain / Really bad; Kept her up at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain / Really bad), INSOMNIA (Kept her up at night), PAIN IN EXTREMITY (Sore arm), MUSCLE SWELLING (The muscle is swollen) and FEELING HOT (It's kind of heated up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain / Really bad), INSOMNIA (Kept her up at night) and FATIGUE (Tired). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCLE SWELLING (The muscle is swollen) and FEELING HOT (It's kind of heated up). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 12-Mar-2021, PAIN IN EXTREMITY (Arm pain / Really bad) and INSOMNIA (Kept her up at night) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCLE SWELLING (The muscle is swollen), FEELING HOT (It's kind of heated up) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include OTC allergy medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event Outcome: From unknown to recovered updated.
Cold like symptom, headache, chills, sore throat and sinus and chest congestion.
Pt has begun an unexplained Liver Failure.12/17/2009 Admission note and orders for 11/30/2009, increased bilirubin, LFT's 2-3x normal, c/o's extreme fatigue and diarrhea, MRI + for Hepatosplenomegaly, PE + for hepatomegaly. Will order GI consult, Morphine for pain.
Patient was due to receive COVID-19 Vaccine booster, but since monovalent primary series formulations are no longer acceptable for booster doses, the vaccine inventory was assessed. The product labeled "Moderna COVID-19 Vaccine - Booster Doses Only" was removed. There was no age listed on the package and it was clearly labeled as "Booster Doses Only" on the vial and package, so this product was administered to the patient. It was later discovered that this was product NDC 8077-0275-05 is actually indicated for Pediatric patients 6-11. No adverse effects were noted, this was an administration error of the incorrect vaccine product.
After receiving her dose of the Pfizer vaccine the pt seemed to be doing well conversing and reported she was feeling fine. The pt then stood up to leave the vaccination area and slouched to the ground. She went unconscious for about 4 seconds. When she came to she was awake, alert, and oriented. Paramedics were called to ensure the pt didn't suffer injury. After an evaluation by the paramedics the pt was released and her friends picked her up.
On 11/14/2010 received Hep A, PREVNAR & VARIVAX next day developed urticaria -> given Prednisone -> resolved.
Patient received Pfizer 12 years and older dosage instead of 5-11 years dosage.
3 days after his 2nd dose of the COVID-19 vaccine, patient had acute onset chest pain in the setting of 3 days of fever, headache and fatigue.  Was found to have elevated troponin level indicating myocarditis.  Was observed in the hospital overnight, troponin levels continued to down-trend and EKGs were normal, patient discharged home medically stable with close outpatient cardiology follow-up.  Total 1 night stay in the hospital
Low grade fever (99.7). Fatigue. Chills. Body ache. Soreness at injection site.
pt recvd vax & devel hives 4 hrs after vax; hive occured on & off x 2 days; pt was fussy & restless; tx w/ apap; recovered;
diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL9264 expiry date not reported) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient's medical history includes ongoing nausea and Not able to eat/ he can't drink or eat. Just thinking about eating makes him nauseated and threw up. Concomitant medications were not reported. The patient experienced whole body aches, he can't sleep and feels like crap on 31Jan2021. The patient also experienced diarrhea on 02Feb2021. The patient mentioned that on the morning of the vaccine, Sunday, he woke up, and tried to drink coffee and threw up. The Sunday morning he was nauseous before the shot. When he drank his coffee that morning. In the mornings, he can't drink or eat. Just thinking about eating makes him nauseated. His body aches started a little while after the shot. It was still Sunday when they started though. He can't sleep the body aches are so bad. Sunday evening is when he started to feel like crap. He has also had diarrhea. The outcome of the events whole body aches, feels like crap and diarrhea was not recovered. Outcome of the event He can't sleep was unknown.
Mom reports that later on that day shot was given on her left arm, deltoid area, where DTaP was given got pink, hard swollen to almost baseball size, pt didn't develop  fever or streaking from site. I checked the  site on 05/02/02 pink from almost baseball size doing good within Tylenol and ice packs on site per mom.
Feeling like coming down with flu. Did not take temperature, but arms felt very hot, hands very cold. Very weak - could not get out of bed all night and the next day. Fell when attempted to go to the bathroom. Left arm very red and blistered from wrist to mid-upper arm. Lips chapped. Did not eat for over 24 hours.
Patient experienced generalized rash to trunk, arms, and legs after receiving the vaccine on 03May2021. Patient still has rash three weeks later.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 07:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 29-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving her Pfizer mRNA COVID-19 vaccine.  Over the next 20 to 25 minutes she progressed to having a sensation of tongue swelling, then difficulty swallowing, then chest tightness.  Her vital signs were stable throughout the observation period (blood pressure 144/74 and 150/70, pulse in the high 80s to low 90s, and oxygen saturation 96-98% on room air) and she was able to speak in full sentences without any respiratory distress.  Her lungs were clear and she had no stridor.  She never had any pruritic symptoms or rash/hives.  Because of the progressive nature of her symptoms, however, I felt she needed emergency room evaluation for observation.  We never administered any medication while at the vaccine clinic including epinephrine or Benadryl.  After approximately 25 minutes, 911 was called and she was transported by ambulance to the emergency room in stable condition.
Fever of 101.8 - 102.3, rigors, severe headache, severe diffuse joint pain. Unable to get out of bed. Unable to perform normal ADLs.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient's wife called 7/22/21 saying they believe the 2nd covid vaccine caused her husband's vertigo. This occurs whenever he lays on his right side. She states it began exactly the day that he received the 2nd dose, on 5/4/21.
Gave first dose of Shingrix vaccine. Patient experienced swollen knees, extreme pain and could not work. Pain in muscles and down the legs a bit. Previously had no knee problmes but immediately noticed knee pain in the car on the way home after the shot.  Treated at Medical Clinic- Received prednisone shots .
Adacel that was administered to 3 year old instead of another vaccine daptacel, no AE; Adacel that was administered to 3 year old instead of another vaccine daptacel, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 3 year old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) instead of another vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via unknown route in the right thigh as prophylactic vaccination on 18-May-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration(for Adacel).   At the time of report, no 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 holders compliance with the requirements set out in 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 on the batch number for this case.
Developed reddened hard area that was tender to touch and had a large lump in right leg at injection site. Went to doctor and diagnosed an abscess. 1inx1in.
Patient is a 87-year-old female presented to Hospital on 12/9 with worsening of shortness of breath over 1 week and tested positive for Covid. Patient was initially admitted to cardiology for concern regarding acute heart failure with reduced ejection fraction exacerbation secondary to worsening aortic stenosis. Repeat echocardiogram did not reveal significant worsening of aortic stenosis. Patient was transferred to internal medicine for further care.  During the course of hospitalization patient was treated with dexamethasone for Covid. She was recommended to continue an additional 5 days course of dexamethasone after discharge. On day of discharge 6-minute walk test was performed by the nursing staff, patient required no oxygen while resting and up to 2 L of oxygen via nasal cannula with physical activity.  Imaging studies also suggested finding suggestive of pulmonary edema with small bilateral pleural effusion. Patient appears to be euvolemic on physical examination. During the hospitalization she was treated with IV Lasix followed by transition to oral Lasix. She was recommended to continue oral Lasix for additional 5 days after discharge. Follow-up with primary care provider for consideration of continuation/discontinuation/dose modification of Lasix as recommended. Hepatic lesions were seen on CT abdomen, outpatient follow-up with MRI abdomen is recommended. Her other chronic medical conditions remained stable during the course of the hospitalization.
This is a spontaneous report from a noncontactable male consumer (patient). A male patient, of unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On unspecified date, patient experienced nausea, chills, headache, fever with chills, he felt like he couldn't sleep and was frustrated continuously. The outcome of the events: unknown. No follow-up attempts possible. No further information expected.
Within 12 hours the pt experienced 5 seizures. The 1st two were blank stares lasting 10-20 seconds. The 3rd and 4th, the pt stopped breathing for 20 seconds. the 4th and 5th ones she became stiff and shook. She got worst with a rash and the last one was the longest lasting 1 minute and 15 seconds. They gave her Phenobarbital for her seizures. FU info states child was premedicated with Tylenol for the vaxs.
Subjective fever, and R breast pain 2-3 days after immunization. Breast pain continued about 10 days. No abscess or findings on exam.
Information has been received from a registered nurse concerning a 5 year old female with no past medical history who on 03/06/1997 was vaccinated with a first dose of varicella vaccine SC in the left arm. There were no illnesses at the time of vaccination. The nurse reported that on 10/11/2001, the pt developed chicken pox. The pt had only 2-3 lesions on her abdomen and none on her body. She did not develop a fever. Unspecified medical attention was sought and the pt was given Benadryl and subsequently recovered. The nurse reported that the pt's sister also developed varicella post vaccination with varicella vaccine. No additional info is expected.
I started having sweating, chills weakness at around 10:30 P.M. By 3:00 AM (11-5-2019), I was so weak and sick as if I had the flu. I could hardly make it from the bathroom back to bed. I specifically asked not to have the high dose and this reaction still occurred. Please check into this. I live alone and this was not a good experience. I had to cancel a Dr. appointment for 11/5/2019 as I was not feeling well. I am OK now (thank you God) but I am very leary about having a flu shot ever again. Thank you! This number is written on pharmacy print out that I received NDC 49281-0419-50 Qty. 0.5 ML.
This spontaneous report as received from a physician via company representative refers to a 60 year old female patient. In MAY-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. The physician saw the patient in June 2017 and she was still having injection site pain. The outcome of injection site pain was reported as not recovered/not resolved. Additional information has been requested.
Fever up to 104 for 12 hours; This is a spontaneous report from a contactable physician (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the left arm on 14Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included metoprolol, losartan and HCTZ. The patient previously received 1st dose of BNT162B2 on 24Dec2020 12:00 AM for COVID-19 immunization. The patient experienced Fever up to 104 for 12 hours on 15Jan2021 01:00 AM. Therapeutic measure was taken as a result of the event which included acetaminophen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
After getting the shot it was sore then around 830p.m. right arm started having pain took some Tylenol and at 200 a.m the pain still there cannot lift the arm and having the chill, headache, nausea then taking Tylenol and Motrin alternate to relieve the pain and still there cannot lift the arm still having headache continously and chills at night time. The headache and fever won't go away and not be able to lift the arm too painful and firm/swollen no redness warm to touch. Went to the DR yesterday and they order some blood work waiting for result. On the order it says meningococcal vaccine but she got pneumococcal vaccine. She is 19 years old and not smoking or had asthma. Not sure why she got pnemo vaccine instead of meningicoccal vaccine. She got pneumo vaccine and flu vaccine on her right arm the same time. The reaction is still the same for 3 days now, warm to touch not be able to lift the arm without help by other other arm and medication continously and continously bad headache and fever.
Pt received varicella vaccine 5/14/01 and 12/17/07. On 7/21/13 began with burning, itchy pain in dermatomal pattern (R) hemithorax. No rash erupted as of exam 7/24/13. Thought to have atypical herpes zoster and put on acyclovir x 5d and TYLENOL #3.
This case was reported by a physician and described the occurrence of not responding to therapy in a 36-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included positive ppd test. Concurrent medications included INH and Vitamin B6. On unspecified dates the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg) and on 4 November 2009 he received 3rd dose of ENGERIX B (20 mcg). The subject experienced not responding to therapy. The physician reported that the subject had received 3 doses of ENGERIX B. Last dose on 04 November 2009. No response with recent testing (date not provided).
On right arm only- patient developed hives on right arm and under the right arm the day after the vaccine. The hives itch and are warm.  Her arm is also tender and a bit swollen. The hives are continuing on Friday- 5 days post shot. Pt experienced a fever of 101 for 2 days post immunization and left very tired.
This initial report was received from a certified medical assistant concerning to seven (7) anonymous patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with the first dose of, at least, seven single-dose of MMR II 0.5 mL, intramuscular (lot # J007929, expire 28-JUL-2015). The reported also stated that no patients received any expired vaccine even though the unclear expire date in the carton was notice only the product had expired. The expired year in the carton was illegible in the way that the carton debussing was not clear whether the year was 2015 or 2016, but the product vials clearly showed the expired year as 2015, not 2016. No adverse effects were reported. Additional information has been requested.
I have taken both of the Pfizer BioNtech COVID vaccines, and surprisingly it made me feel better; This is a spontaneous report based on the information received by Pfizer from BioNTech (Reference #24877) and a contactable consumer (patient). A non-pregnant female patient of an unspecified age has received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified site of administration and unknown date at single dose for covid-19 immunization. Patient medical history included triple negative breast cancer, human papilloma virus infection (HPV) from 2004 and carcinoma in situ from 2004, chemotherapy and radiation therapy. Patient undergone chemo and radiation for breast cancer which she truly believe is a result of the HPV virus. Patients concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown) via an unspecified route of administration at single dose for covid-19 immunization. Patient reported that she was a patient with triple negative breast cancer with a history of HPV that was so severe in 2004 that It turned into carcinoma in situ. Patient have undergone chemo and radiation for breast cancer which she truly believes was a result of the HPV virus. It now appears that the cancer has recurred. Please note that she never drank, smoked, taken a single drug and had no genetic disposition to breast cancer, nor has any one in her family had breast cancer. That is why patient was convinced that her Breast Cancer was HPV driven, patient was fortunate to be treated by the world's foremost oncologist, but she was convinced that unless the HPV virus was taken into consideration in the medicine for my treatment, it will not work. She feels input from BioNtech could provide a ground-breaking dynamic to her treatment. Patient have taken both of the Pfizer BioNtech COVID vaccines, and surprisingly it made her feel better, her overall wellness related to cancer. This can be wishful thinking, but she doesn't think so. Patient read an article that you feel a Cancer Vaccine will be available in two years. She feels your research in regard to viruses is pivotal to managing cancer. She was the author of the Book which hit Best Seller list in 2005, and I am now working on the next version of the book. She collaborated with the world's most notable innovators who have changed the world including the co-creator of internet, so patient know how important innovation is especially to me now. Most importantly I have 3 children who need me. She was in the care of the best doctors in the world, but she truly believes that the HPV virus is a consideration in her health and treatment that must be controlled and is presently overlooked. This is the turning point for her, and she need help immediately. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a certified medical assistant concerning a 17 year old female who on 17-MAR-2009 was intramuscular vaccinated with the first 0.5ml GARDASIL vaccine (Lot # 661846/1312X). The patient has no medical history. There was no concomitant medication. Approximately 6 weeks after administration, the patient developed a "seizure-like activity" and "dizziness" when she was getting out of the bathtub. She saw a neurologist and had an MRI which was negative. The patient now has occasional vertigo. The patient was considered to be recovering at the time of the report. The patient has not received any additional doses yet. Follow up information has been received from this certified medical assistant. She reported that no other vaccines were administered at the time of GARDASIL dose. She could not confirm that the patient actually had a seizure (stating that "seizure-like activity" was what was reported by the patient's mother), and could not give a more definitive AE onset date. Upon internal review, "seizure-like activity" was determined to be an other important medical event. Additional information has been requested.