chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Swelling and soreness in left armpit (the lump was the size of a golf ball and around 4 cm).
Patient was seen on Monday and by that night mother noted a redden area in right upper arm but did not give her any Tylenol at that time. It continued to enlarge and remain red and tender so mother brought her in on Wednesday. The child had a large area of inflammation at injection site: 15x20cm's, warm and firm. Child had no other signs of secondary infection; no fever, pustules or systemic symptoms. Benadryl was prescribed as well as Tylenol for the discomfort. The child had a return appointment which indicated the reaction was resolving without incidence.
Extreme oral herpes outbreak. I've gotten them occasionally my whole life,but I woke up with 4 sores in one morning. Usually just 1. Taking Valcyclovir (2 grams 2x a day) as prescribed.
Chills, body aches, fever, headache, dizziness, numbness in face
tested  positive for Covid 19  after being fully vaccinated. body aches, fever no more fever now, I just have terrible body aches, headaches and very congested and very tired.
Blood clot on right lung; soreness in arm; A spontaneous report was received from  a 72 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clot on right lung  (pulmonary embolism) and myalgia.  The patient's medical history was not provided. The patient had family history of blood clot (mother and brother). No concomitant product use was reported.  On 02-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient had soreness in the right arm which subsided couple of days later. The patient also experienced shortness of breath for a week after vaccine administration. On 17-Feb-2021, the patient went to the hospital and underwent COVID-19 virus test, the results of which were negative. On 17-Feb-2021, the computerized tomography scan on chest showed moderate size blood clot on right lung. On 18-Feb-2021, the patient was discharged from the hospital on recommendation to initiate and continue lifetime treatment with Eliquis (apixaban, 5mg every 12 hours). According to the physician, moderate size blood clot on right lung of the patient could be attributed to the genetic history (patient's mother and brother also had blood clot). The patient also followed up with primary care physician, who informed that it was genetic and not related to vaccine.  Action taken with mRNA-1273 was not reported.  The outcome of the events, pulmonary embolism was unknown. The outcome of the event, myalgia was considered as recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received influenza vaccination 10/16 around 7:38PM. She states that the following morning of Saturday, she woke up with the injection site being very stiff all the way up to her collarbone to the point she could not move her arm. On Sunday, 10/18, the injection site/arm was still stiff, however, not as severe at the day before.
Information has been received from a registered nurse (R.N.) concerning a 33-year-old white female with allergies to sulfa, erythromycin ethylsuccinate (E.E.S.), doxycycline, levofloxacin (LEVAQUIN), cefuroxime axetil (CEFTEIN), telithromycin (KETEK), and venlafaxine hydrochloride (Effexor), and no past medical history, who on 08-MAY-2006 at 15:45 was vaccinated intramuscularly in the left deltoid with 0.5 ml first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # "0553B"). There was no illness at the time of vaccination. It was reported that her arm hurt following vaccination. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information was received from th registered nurse indicated that the patient had severe pain and swelling, redness and pain at the injection site lasting "three to four days". No treatment was given and the patient on 12-MAY-2006. The immunization was not repeated. No additional information is expected.
After vaccine was administered, it was noted that the vial had a Beyond Use Date of 12/31/21.  Pfizer contacted to determine viability and no data could be provided to support viability after the Beyond Use Date.
Had onset of rash on 13AUG92; rash & fever progressed to t105.4 & diffuse rash that seemed to be either erythema multiforme or urticaria & angioedema; no mucus membrane involvement nor other sx to suggest URI or gastroenteritis;
30SEP92 t105 last noc-took to ER-blood drawn-all lab work nl; MD on Amoxil-dx vax rxn; 1OCT92 playing-not eating well-no fever; mom unable to talk while @ work; 8OCT92 recovered & back to school;
Within 5 minutes, I developed an intense migraine - it was an 8 or 9 our of ten. I felt nauseous and lethargic. I was given water and told to drink it and wait for 30 minutes. I lasted the whole day of work, but called out the next day.Body Aches chills within12 hours.   I had those symptoms about a week and a half. The night of the vaccine: About three in the morning, I developed achiness all over body. It was horrible. I was cold, lethargic, shivering. I used a heat pack. The migraine I had from the injection didn't go away for about a week which caused me to go to Urgent Care -  to get a shot - it may have been demoral but I'm not sure. It helped with the migraine - it went down from a 9 to a 5. The symptoms just slowly went away after the week and a half.
Tingling; Pain in the bones; Hands and feet numb; Not feeling well; Pain all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body). At the time of the report, PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
extremely weak; tired; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced extremely weak and tired after vaccine. The outcome of the events was recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/ drug, different patients/ events
had administered, 2 yo, a Quadracel vaccination of 0.5ml, in the left thigh; Initial information received on 12-Jul-2010 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that patient had administered, 2 yo, a Quadracel vaccination of 0.5ml, in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  On 11-Jul-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA and expiry date: 14-Nov-2019 via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  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 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.  List of documents held by sender: none.
No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender patient. The pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date on October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 11-OCT-2022, 13-OCT-2022, 14-OCT-2022, 18-OCT-2022, 20-OCT-2022, 24-OCT-2022) the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot number W009107 with expiration date 04-DEC-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   The administered vaccine experienced a temperature excursion of 47.5 degree fahrenheit (F) for 5 minutes. There was no previous temperature excursion. No additional adverse event reported.   This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
On 4/19 he received the first dose of Pfizer vaccine oh 4 PM.  Administration of vaccine was uneventful.  The next day he noticed sore shoulder at 3 PM on 4/20 he noted he had upper wrist pain that progressed to his right thumb as well as redness with a shiny quality that was consistent with previous gout flares so he took 2 doses of colchicine and 2 doses of Advil which did not relieve his symptoms.  A couple hours later he noted hand numbness and tingling as well as feet numbness and tingling bilaterally.  The numbness progressed to his extremities with the left arm more affected than the right arm (he received vaccine in his left arm).  He had accompanied pain of his extremities and wrists that was described as 10 out of 10.  He then felt 2 episodes of chest tightness and difficulty breathing prompting him to present to the strong ED.  In the ED his exam was notable for hypertension (240/90), tachycardia, wrist flexion in distress and yelling in pain.  His exam also showed bilateral hyperflexion of bilateral wrist with mild swelling and diminished sensation and motor function throughout.  He was administered IV hydromorphone, and Benadryl with dramatic improvement in his symptoms.  His labs are notable for abnormal electrolytes including magnesium, potassium, phosphorus, calcium and he was repleted with magnesium potassium and phosphorus.  He is admitted to ED OBS. overall felt his symptoms were most likely due to gout flare and hyperventilation, not likely related to vaccine.
Information has been received from a Licensed Practical Nurse, concerning a 5 year old female patient with asthma, Asperger's disorder, attention deficit disorder, migraine and reactive airways disease, with no allergies and with a history of remotion of tonsils and adenoids, who on 28-DEC-2005 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot number not reported). On 18-JAN-2010, the patient received subcutaneously a second dose of VARIVAX (Merck) (lot # 665007/1088Y). Concomitant therapy included montelukast sodium and VENTOLIN INHALER. On 26-JAN-2010, the patient was seen for a cold. The patient was given amoxicillin (unspecified), and cough medicine (unspecified). The patient was seen again on 30-JAN-2010, and the cough medicine was switched to MUCINEX cough syrup for pediatrics. On 10-FEB-2010, the patient developed a chickenpox rash. The patient was seen by a Nurse Practitioner on 11-FEB-2010. Lesions were noted on patient's anterior stomach, left arm, left flank and legs and were described as "moderate" in amount. At the time of the report, the patient was recovering from chickenpox rash and cold. An urine culture and an urinalysis were performed on 11-FEB-2010. The results were pending at the time of the report. Patient sought medical attention through an office visit. Follow-up information has been received from the Registered Nurse, concerning the 5 year old female patient, with recurrent urinary tract infections, who on 08-JAN-2010 at 4:00 PM, received subcutaneously in the right arm the second dose of VARIVAX (Merck). In the morning of 10-FEB-2010, the patient developed chickenpox rash, described as pruritic papules starting on abdomen, going to arms, neck and upper legs. Patient also experienced stomach ache and low grade temperature. On 17-FEB-2010, the patient recovered from the chickenpox rash. No further information is available.
CHEST PAIN/BURNING; FACE REDDENING; BLURRED VISION; SORE LEGS; HEADACHES; TROUBLE BREATHING AFTER DOING MANUAL LABOR/SHORTNESS OF BREATH; This spontaneous report received from a patient via a company representative concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and concurrent conditions included high blood pressure, and borderline diabetes, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing after doing manual labor/shortness of breath. On 10-APR-2021, the subject experienced face reddening. On 10-APR-2021, the subject experienced blurred vision. On 10-APR-2021, the subject experienced sore legs. On 10-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced chest pain/burning. Laboratory data included: EKG (NR: not provided) came out fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/burning on 13-APR-2021, and face reddening on 12-APR-2021, and was recovering from trouble breathing after doing manual labor/shortness of breath, headaches, sore legs, and blurred vision. This report was non-serious. This case is a duplicate. Additional information was received from patient on 15-APR-2021. It was determined that it was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt states that other than knot at injection site with shot 1 and 2, they were fine. The 3rd vax however was swollen at injection site, throbbing through left shoulder, arm.
This case was reported by a physician via other manufacturer and described the occurrence of generalized rash in a 5-week-old male patient who received ENGERIX B for prophylaxis. On 16th December 2018, the patient received Engerix B. On 24th December 2018, 8 days after receiving ENGERIX B, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B. Additional details were provided as follows: The patient developed rash all over his body. No further information was provided and was not associated with product quality compliant. The reporter declined to contact Merck for additional information and this information was not reported to FDA.
Pressure in chest(like something was sitting on my chest)lasted 4-5days post vaccine
77 yo female with a PMH of diabetes mellitus and hypertension who present our facility with COVID-19.   The patient been experiencing increased fatigue, fever, weakness, and cough.  This started approximately 10 days prior to arrival.  The patient indicated that this was significantly worse over the 2 days prior to admission.  The patient had mild shortness of breath but denied any current nausea, vomiting, diarrhea.  Patient had no loss of taste and no loss of appetite.  The patient had received both COVID-19 vaccines in the beginning of 2021.  The patient primarily presented due to her general malaise and weakness.   The patient was followed symptomatically.  The patient had no significant cardiopulmonary disease on chest x-ray.  The patient was initially started on dexamethasone and Tessalon Perles as well as IV fluids as she was felt to be dehydrated on admission.  The patient had a minimally elevated transaminitis.  The patient otherwise is well-appearing.  The patient had done well during the hospitalization and required no oxygen support.  The patient was discharged home in stable improved condition with home health care on 8/19/2021
Patient received monovalent Moderna 0.5ml blue cap purple label.  Patient was intended to receive Bivalant Moderna 0.5ml blue cap gray label.
Received MMR 12/4/2019. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Came in 1/16/2014 to report redness and warm to touch on upper part of arm, advised to see provider.
Patient received DTaP dose in (L) thigh. Developed redness at injection site earlier today. Following day developed urticaria at injection site, which progressed to generalized urticarial rash.
PTSD and anxiety; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, as a single dose, for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient reported that she has "PTSD and anxiety from getting this because now I definitely need a doctor, not an emergency room." The outcome of the event was not reported.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Patient received an undiluted dose of the Pfizer Covid vaccine which resulted in him receiving approximately four times the dose he was suppost to receive. Once the error was discovered we contacted the patient. We have been in contact with the patient since the incident. He has been in contact with his cardiologist.  He has been anxious and worried because he does not know what to expect. His arm was sore for a few days but at this time their are no lasting effects from the vaccination.
On the evening of Jan. 24, 2018, around 10 p.m, my son experienced severe chills, body aches, headache, nausea. No fever. He also found it hard to think clearly. He was given 100 mg of solu-cortef which is the emergency medication in cases of adrenal crises and EMT was called and vitals taken. He was given another 60mg of hydrocortisone by mouth a few hours later at 3 a.m. and ibuprofen. By Thursday at noon, he was able to eat something. Chills were reduced. He continued to feel some body aches for up to two weeks later. When he does physical activities at school, he gets winded easily and has to rest. His muscle aches also came back. He had no other illness at that time of the flu vaccine nor did he have any other sicknesses that day he experienced the adverse effects of the flu vaccine.
Thick congestion in back of nose and throat; pounding rapid irregular pulse; heavy breathing; no sleep that night. Next morning all symptoms rapidly disappeared. No further problems.
Pt reports that around 4:45 pm, after receiving the shingrix vaccine around 2, he started feeling clammy,  an increase in heart rate and "shaky".  He had his soon bring him to local ER.  Pt reports also had a cardiac evaluation a week later and all tests were wnl.
Multiple migraines per week, regular medicine taken does not help, at all.  Three to four days a week lost to fighting these migraines which are different from the ones I have sometimes due to the weather.
I found a lump in my left breast. After consulting with my doctor. I went in for an exam. By that time the lump had grown. I then scheduled a mammogram and ultrasound.  The lump has shrunk in that time but was still visible on imaging. Dr. then determined it was a cyst. No further treatment was recommended.
After 10 days, I began to get swelling in hands and feet, hot hands and feet, itching in extremities, hives on legs/face/arms. It is relieved with over the counter antihistamines taken once a day. It seems to be slowly getting better after one week of symptoms.
Redness, swelling at injection site;  Fever;  Joint pain in both hands starting within first day.  Fever and joint pain subsided within first couple days, area remains red and somewhat swollen 3 days later.
Sore arm starting a couple of hours after injection, starting at injection site, then slowly spreading to include entire upper arm. . Difficult to lift arm or do tasks (washing hair) the next day. Trouble sleeping, fatigued and achy the next day.