chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late in the same evening I received the shot, I had bone/body aches, which started on my left side. Then I had slight chills. By the  middle of the night, I had a throbbing headache. The next morning, the headache continued, to the point I could not get out of bed. I had two extra strength Tylenol, which helped ease the pain. I was also extremely tired the night of the shot and the next day.
10/18/21 pt seen at Pharmacy received 2nd COVID W/I 1 hour c/o back pain & developed fist size node under L axilla. 10/20/21 pt contacted our office lymph node decrese in size, back pain improved remains afebrile I
MISSED THE THIRD DOSE; A spontaneous case report was received from a nurse on 20-May-2019 for two consumers.  Based on the information obtained from a nurse, two individual case safety reports PVX201905-000399 (PVX2019-1263; first child) and PVX201905-000400 (PVX2019-1264, second child) were created and cross-linked in the database.  This case describes a male child consumer who "missed the third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif, but missed to take the third dose, which was due on Friday as he went to another location and his mother forgot to carry medication with her.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000399:
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, sweating and weakness. On an unknown date, the outcome of the muscle pain, sweating and weakness were unknown. It was unknown if the reporter considered the muscle pain, sweating and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received first dose of SHINGRIX and experienced muscle pain, weakness and sweating. The reporter was a pharmacist at call center who did not have access to patient information or vaccine information. The reporting pharmacist was not the administering health care professional and did not work at the administering medical office. No information was available other than the documented side effects.
pt recv vax 26AUG97 approx 730PM that evening;later that noc approx 230AM pt woke up w/wheals on eyebrow area, back & legs, swollen ears & hands;pt took DPH;
upper right arm has been extremely sore/Lifting my arm brings the sore feeling; I can still lift or pull things but it is a little difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Patient did not other vaccine received in four weeks. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 30-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Right), administration date: 10Feb2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 22Jun2022, outcome "not recovered", described as "I can still lift or pull things but it is a little difficult"; PAIN IN EXTREMITY (non-serious) with onset 22Jun2022, outcome "not recovered", described as "upper right arm has been extremely sore/Lifting my arm brings the sore feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, movement disorder.  Additional information: Patient had no known allergies. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with covid-19 prior vaccination. Case was reported as non-serious. Adverse event For the last few weeks, my upper right arm has been extremely sore. I can still lift or pull things but it is a little difficult (it is my dominant arm). Lifting my arm brings the sore feeling as well.
Leg pain, shooting pains, fever, headache, nausea, fatigue, painful rash.
7 yo immediately after injection left deltoid, said "I don't feel good", lost consciousness in a parent's arms, eyes rolled up , arms/legs spasmed/ 5 seconds, then awoke, alert able to answer questions.
only the liquid component /was given; only the liquid component /was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 31st October 2022) for prophylaxis.   On 4th August 2021, the patient received Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provide are as follows: The office manager reported that only the liquid component of Menveo was given to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Day 3 after second dose had heart palpitations for approximately 8 hours, then very low blood pressure, and passed out.  Went to urgent care, refered to ER.
Information has been received from a manufacturer and was assigned manufacturer number INF 2002029 concerning an 11 year old female (conflicting information also indicated male) who was vaccinated at 19 months of age with a third dose of MMR (second generation)(lot # not reported) on 10/7/92. The child had received the first dose (lot # not reported) in July 1991, the second dose (lot # not reported) in September 1991 and the fourth dose (lot # 613247/0210B) on 9/21/95. Additional suspect therapies included vaccination with a first, second, third and fourth dose of HIB conjugate vaccine (HIBTITER) (lot # not reported for first, second, and third doses, but a lot number of 428036 was reported for the fourth dose) in May 1991, July 1991, September 1991 and on 9/21.95; vaccination with a first, second, third, fourth and fifth dose of diphtheria toxoid/pertussis vaccine/teta (ACELIMUNE) (lot # not reported for first, second, third and fourth doses, but a lot # of 428036 was reported for the fifth dose) in May 1991, July 1991, September 1991, October 1992 and on 9/21/95; and vaccination with a first, second, third, and fourth dose of poliovirus vaccine (manufacturer unknown) (lot # not reported for first, second, and third doses, but a lot # of 394927 was reported for the fourth dose) in May 1991, July 1991, March 1993 and on 9/21/95. When the child was 4 years old, in approximately 1995, she was diagnosed with autism. It was noted that the father thinks there may be a potential link between her autism diagnosis and administration of vaccines. Unspecified medical attention was sought. Upon internal review, autism was determined to be an other important medical event (OMIC). This was originally reported by a consumer, the patient's father. Additional information has been requested.
1 x 1.5 inch rash right under the injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm right on 25Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included norgestimate, ethinyl estradiol (Ortho tri-cyclen). Relevant past drug history was provided as not that the patient knows of. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 the patient experienced 1 x 1.5-inch rash right under the injection site (vaccination site rash). The clinical outcome of the event vaccination site rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vomiting, headache, dehydration, diarrhea, fever, chills
This spontaneous report as received from a pharmacist via representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, route, dose and lot number (unknown). On an unknown date, the patient experienced burning, and nerve pain, in the vaccinated arm, post vaccination with the PNEUMOVAX 23. In addition to the burning sensation and nerve pain the patient had limited limb mobility for about one week after getting vaccinated. Unspecified treatment was given for adverse event. The patient was reported as recovered/resolved. Upon internal review, the event limited limb mobility for about one week after getting vaccinated was considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
JOINTS AND MUSCLE ACHES; HIGH BLOOD PRESSURE; HIGH CHOLESTEROL IN BLOOD; DIABETES MELLITUS; IMPOTENCE; NUMBNESS AND TINGLING FINGERS; NUMBNESS LEGS; HEADACHES; FATIGUE; BACK PAIN; LEGS PAIN; VISION BLURRED; HAIR LOSS; POOR TOLERANCE FOR LOUD NOISES; RUNNY NOSE; VISION PROBLEMS.  11/16/06 Received medical records from VAMC which reveal patient experienced chronic low back pain, adhesive capsulitis of right shoulder, intervertebral disk displacement L5-S1 with dural sac compression, overweight, cervical spondylosis w/myelopathy, high cholesterole, NIDDM, hyperlipidemia, cervical radiculopathy s/p 3-4-5-6l fusion with wound infection, resolved.
Started runny nose, cough day after vaccines. Then turned blue, had seizure. Went to ER. 1-year-oild male presents following a generalized seizure. Mom states that the child was well yesterday and went for a routine checkup. He had his 12 month vaccinations. This morning he had a runny nose which mom states he has had for most of is life. She states he developed a cough and decreased appetite that were new symptoms today. No rash. No vomiting or diarrhea. No ill contacts. Mom states that he was sitting and suddenly developed a clenched jaw and blue discoloration around his mouth, he then "stopped breathing" and started shaking all over. Mom states she ran over to her neighbor's house with him and they blew into his nose and mouth and he then started crying and breathing. She states that while he was shaking his body seemed very stiff but then after he started crying his body seemed limp. She reports that she did not notice a fever until after it was checked here. He has never had a seizure before. There is a strong family history of seizures. Mom states that multiple children in the family have had seizures. She is unsure if they were febrile seizures. No treated Temp 101.9.
Information has been received from a health professional concerning a 16-year old female with no allergies or medical conditions and a history of being exposed to chicken pox at a younger age who on 18-Jun-2003 was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live (lot 640552/0798M). Concomitant therapy included a dose of tuberculin purified protein derivative (Tubersol) (lot C1616AA). "About three weeks later", on approximately 09-Jul-2003 the patient experienced a fever of 102 F and general tiredness. In September 2003 a titer drawn had a negative result. Unspecified medical attention was sought. No product quality complaint was involved. It was reported that the AE abated. No other information was available. Follow-up information indicated that 21 days post vaccination, on 09-Jul-2003, the patient developed flu like symptoms, a fever of 102, no rash, no nausea or vomiting, no diarrhea. On 08-Sep-2003 a varicella zoster IgG was negative. It was reported that the patient was going to schedule an appointment. Additional information is not expected.
Vaginal bleeding /  bleeding felt like menstrual period; Cramping; Cravings; Womb hurting like contractions; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding /  bleeding felt like menstrual period), MUSCLE SPASMS (Cramping), FOOD CRAVING (Cravings) and UTERINE CONTRACTIONS ABNORMAL (Womb hurting like contractions) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) for Blood pressure, ATORVASTATIN for Cholesterol, METFORMIN, Glipezide and SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes mellitus.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding /  bleeding felt like menstrual period), MUSCLE SPASMS (Cramping), FOOD CRAVING (Cravings) and UTERINE CONTRACTIONS ABNORMAL (Womb hurting like contractions). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. On 09-Jun-2021, VAGINAL HAEMORRHAGE (Vaginal bleeding /  bleeding felt like menstrual period), MUSCLE SPASMS (Cramping), FOOD CRAVING (Cravings) and UTERINE CONTRACTIONS ABNORMAL (Womb hurting like contractions) had resolved.
1/13 vaccination 3 days later, I got blurred vision. It got worse. 1/15 got worse with vision. Stayed at home. Had to stop driving, double vision.  1/18 really started to get bad with vision.  Been like this ever since. I have been working from home for 3 weeks now.  PCP; She gave me medicine to get sugar down;  Jarviance 1/21 Blood sugar went up to 495; went to ER.Opthamologist;  He told me nothing he could do for me. He told me I had vision reversed due to sugar being so high. He told me he couldn't give me any glasses as when sugar decreases, the vision will go back to normal.
left hand fingers went to sleep for about 7-8 hours; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181 and expiration date was not reported), first dose via an unspecified route of administration, administered in the left arm on 29Jun2021 (at the age of 62-year-old) as single for covid-19 immunization. The patient's medical history included drug hypersensitivity for septra and bactrim. The patient's concomitant medications were not reported. Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On unspecified date in 2021, the patient experienced left hand fingers went to sleep for about 7-8 hours. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Moderna given to 17 y/o- out of age date for manufacture. No adverse reaction noted at this time.
WOKE WITH T.100 ON 10/27/2006.LETHARGIC ALL DAY. T. WENT AS HIGH AS 101.5. THAT NIGHT MOM NOTICED AN AREA ON HER LEFT ARM WHICH WAS RED, HOT AND RAISED, ABOUT THE SIZE OF A TENNIS BALL. NO ITCHING. ARM WAS SOMEWHAT SORE WHEN SHE LIFTED IT.
substantial headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (substantial headache) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (substantial headache). On 17-Jan-2021, HEADACHE (substantial headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This was my booster, so I picked dose # 3 above.   I experienced the following adverse events for 36 hours after the injection: - Nausea (I vomited 18-20 times during a period of 24 hours), I could not keep anything in my stomach, not even water - Strong Headache (unable to take medication due to vomiting) - Fatigue - Chills - 'Blinking lights' sensation even when I had my eyes closed
CHIEF COMPLAINT:   pt. sent in for AMS. recently diagnosed with covid. and PNA.  hx. of CVA, DM, non-verbal, arrives with snoring respirations with PEG tube in place. all four extremiteis stiff, pt. responds to painful stimuli which is in WNL, pt. lethargic per caregiver.             PROBLEM LIST/PAST MEDICAL HISTORY:   Ongoing  Anemia  Diabetes mellitus  Diabetes mellitus type 2 in obese  Gastrostomy tube dysfunction  H/O: stroke  Hyperlipidemia  Hypertension  Left-sided weakness  Paralysis  Pressure sore of hip  Right hemiplegia  S/P percutaneous endoscopic gastrostomy (PEG) tube placement  Stool incontinence  Urine incontinence  Historical  No qualifying data
Patient states arm soreness never went away after shot. She went to Dr's office yesterday 10/14 and was told that the flu shot potentially hit a nerve from being injected too deep in the arm which resulted in a radiated pain in the upper shoulder. There was no sign of the flu shot being administered into the bursae around the shoulder, it was the Dr's opinion that it was administered too deeply into the arm.
September the 5th she began coughing and she thought she had  sinus infection under was a fever on 8th of September of under 100, tested positive on September 8th 2021,  initial vaccination was March 31, 2021.  Was advise to take tylernol  and musinex and delcim for the caught.  Lost sense smell 09/07/2021 still recovering from sense of smell.
6x3 inch knot on arm, joints and upper body hurt all weekend fever Saturday night, sweating more than usual, and chest tightness since Friday night..
developed progressive LLLR after AVA. #6 AVV given in split dosing and in subdeltoid area and still developed significant swelling from shoulder to wrist. Sx subsided in a week with po prednisone.
Muscle soreness at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 21Jul2021at 11:30 as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication included supplements (unspecified). The patient's history of known allergies was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Jul2021, the patient had muscle soreness at injection site. Therapeutic measures were not taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle soreness at injection site was recovering at the time of this report.
head-to-toe rash with hives; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00752389) and transmitted to Sanofi on 02-Sep-2021.  This case involves an unknown age and gender patient who experienced head-to-toe rash with hives (urticaria) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious head-to-toe rash with hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The caller does not have patient specifics regarding the event. She says she assumes that her business partner would have reported the event at the time. The patient was tested for allergies after the event and the only allergy that came back positive was to thimerosal."  It was not reported if the patient received any corrective treatment for the event.  On an unknown date, the patient recovered from the event.  There will be no information available on batch number for this case.
redness, swelling of the front arm, swelling at the elbow. patient states felling warm and painful.  there?s also pimple like that appear 2 days after injection.
Conjunctivitis in left eye the morning of 11/12/2021 (5 days after 1st dose of Covid 19 vaccine). treated with Zatidor anti-allergy eye drops and Benadryl.  Treatment worked within the hour to reduce redness and irritation.
MODERNA COVID-19 Vaccine EUA I took the vaccine on Monday Jan 4 at around 9 AM. During the day only pain in the left arm. On Tuesday I felt tired all day long. At 7 PM, I took a Coke inside the fridge and I noticed and told my husband I was not feeling well. I put the coke in the glass, after I took the glass in my hand and then I fainted. Never in my life I have fainted before. I hit my head in the floor. Now I have some bruise in my face, mainly around my left eye. Feeling a little dizzy,  I am in quarantine I and my husband are staying home all the time. I have my doctor scheduled for next Thursday.
bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 008C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, AMLODIPINE, LOSARTAN, MONTELUKAST, HYDROCODONE, METOPROLOL, LINAGLIPTIN (TRADJENTA) and CLONIDINE for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering), MYALGIA (Muscle pain) and HEADACHE (Headache). On 13-May-2021, CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering) had resolved. At the time of the report, MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-127970 (Patient Link).