chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spontaneous report received, 10/30/00, from the son of a pt who experienced an adverse event possibly coincidental with receipt of Fluvirin. Additional information was obtained in a phone call to son on 10/31/00. This 74 year old male received his vaccination on 10/11/00. On 10/12/00, he was noted to be unable to raise his left arm. His PCP referred him to an orthopedic physician, who dx'd atrophy of the shoulder and neck. Pt has been referred to a neurologist; appointment has not yet been confirmed.
a red rash, around the injection area; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE RASH (a red rash, around the injection area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Graves' disease and Arthritis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (a red rash, around the injection area). At the time of the report, VACCINATION SITE RASH (a red rash, around the injection area) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
rash; This is a spontaneous report from a contactable male consumer(patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced rash. The patient stated that he had what he suspect was rash from Pfizer Vaccine and his current dermatologist said only that it was unusual then left me hanging for the next month without any explanation for the numerous lab reports that were all inconclusive his lack of concern was unacceptable. Fortunately, the rash was finally went away, outcome appears resolved on its own. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
He had the shingles shot on 08april2020 had fever,and body aches that night. The following day he was nauseous, chills, fever, sweating and head ache. these sympoms lasted  until sat. He is doing fine today.
Spontaneous and chronic Urticaria suspected. Full body itching and associated rash/hives. Have been treating with daily 10mg Cetirizine. Itching/rash returns within 24-28 hours of previous dose. Condition has persisted since 2 weeks after Moderna Covid vaccine, for 1 month so far. Untreated, leads to sleep disruption and strong urge to scratch. Upon scratching, skin responds with raised red marks. Can write letters on skin with nails. This is despite having had 3-4 previous Moderna Shots/boosters in previous years.
The next day after the vaccine, I started with a headache and it kept getting worse. I started aching all over and getting a low grade fever and chills and flu like symptoms. The following day, I had extreme fatigue, sweating, weak and tired. I stayed home and in bed for 5 days and could not do normal daily activities. I started getting better however I am still suffering from extreme chronic fatigue every day to some degree. I get brain fog, muscle and joint pain, extremely tired, trouble sleeping, trouble concentrating and unable to complete daily task.
burning sensation in my armpit; small rash around injection site; Hard lump under injection site; other pains in my arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 23Aug2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021 the patient experienced a severe burning sensation in his armpit on the same arm he got the shot. He also had a small rash around injection site and had a hard lump under injection site. The patient also mentioned It was also causing him other pains in his arm not near the injection site. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. Follow-up received from a registered nurse. The reported stated that the lot# and expiration date for VAQTA was J002347, expiration date 04-SEP-2013. A 12-month old patient, gender unspecified was vaccinated on an unknown date. This is one of the several reports from the seam source. Additional information has been requested.
pt recv vax; pt cried 10-12 hr straight, unconsolable; T 101; apap given q 4 hr;MD notified by RN on 2MAY95;
12 1/2 mo. old presented to me on 7/5/07 after receiving Hib vaccine 7/12/07. He had redness (approx 1 1/2 in x 1 1/2 in) around injection site. Seen and Keflex prescribed but parents did not start it till 7/16/07 in AM. They reported that area "seems faded somewhat, not as red, about the same size".
patient called health system call center. pt c/o generalized body pain,feling tired started 5/1/2021(saturday) midnight after she got ist dose covid vaccine on 05/01 morning time. Pt denies emergency sx at this time. Noted temp 100.7F stated by pt. Also c/o slight dry cough,runny nose,sore throat and loss of taste. Scheduled earliest available UC MD telephone appt  for further consult and evaluation. told pt to go to nearest ED/call 911 if any medical emergency arises,pt verbalized understanding.
He got his vaccine, his leg from his knee to his ankle got bloated. Then he had a real bad rash on the back of his calf muscle.  He told the nurse about it and she thought it was a blood clot . He had an U/S which they found out it was not a blood clot, and was given antibiotics for 10 days for what was thought to be an infection.  He then had bloating of his hand from his hand to his elbow.  Then he had another symptom that was weird, he had a terrible itch that wouldn't go away which was al over his body.  They gave him another antibiotic for 7 days, the swelling went down, and then it migrated into his left arm from the elbow to his hand.  The antibiotics did not seem to work and would just migrate.  He was sent to the ER and he stayed in the hospital for about 2 days and was given intravenous antibiotics.  It then happened again, went down and migrated again.  He went to the hospital for 4 times and they continued to give him IV antibiotics.  They did a lot of tests and could not pinpoint what was causing it.  The doctor said that he had not seen anything like that before.  He eventually saw an infectious disease doctor and the swelling went down, and did not have any FU with them.  It slowed it down, but it was trying to come back, the swelling in his legs.  The itch always remained and he still has it as of today, all over his body which he takes medicine for.  It goes from his fingers all over his body.  When he takes the pills (hydroxyzine) and it stays away for a few days and then it comes back.    He was not in good terms with those people over at the hospital and considered a trouble maker, and as soon as he took the vaccine is when he started feeling bad, and feels they may have done something to the vaccine to cause this reaction.    He kept going back and forth to the hospital and stayed for about 2 days each time about 4 times.    He is now walking normally and it is bloated at the knee, and the left leg is not 100%, it is about 70%, he walks with a limp.  He really believes it stems from the vaccine.  It is painful to walk at times, but it was worse than it is now when it first started out.
Patient developed frequent headaches starting a day after receiving first dose of vaccine.  Patient then developed daily headaches after he got the second dose.  Patient was hospitalized for his headaches and had to be started on medication.
Hard to breathe; Blisters in mouth; Blisters in mouth lips; below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth; burn really bad in mouth and going down throat; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA6780), administered in arm right, on 25Jul2020 at 11:30 (at the age of 56-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine, lisinopril, cetirizine, aspirin (acetylsalicylic acid), omeprazole (OMEPRAZ); all reported as medications that patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021 at 05:00 AM, the patient experienced blisters in mouth, lips and below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth and going down throat. Since COVID, he had always rinsed mouth with mouthwash before bed and when he got up. Currently it was unbearable to do because it burned. Hard to breathe. No treatment was received for the events. The patient had not recovered from the events.   Follow-up attempts are completed. No further information is expected.
I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
I have had a low grade fever, chills, fatigue, and body aches for two weeks now (on going as of 4/13)   fever spiked and I broke out in hives the night of 4/12
Patient received a Td vaccine 7/23/02 in her left deltoid. She noticed a welt 7/25/02 in the PM. On // she presented to our office with a 10mm induration that was red and warm at injection site. There was a large erythematous area distal to injection site. This patch was measured 100mmx70mm.
Patient Received vaccines on 4/11/22 beginning 4/12/22 patient had quarter size redness, pain,  hot to touch  and itching around area surrounding vaccine sites, seen by pediatrician 04/13/22 area marked, and given steroid cream to be applied to site
Headache, chest and head congestion; coughing; fatigue and low grade fever 99.7 x 3 days.
arm soreness; hard at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hashimoto's thyroiditis. The patient was allergic to sulfa and erythromycin. Concomitant medications included thyroid (ARMOUR THYROID), fluoxetine (MANUFACTURER UNKNOWN), both taken for an unknown indication and received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 01:00, the patient had arm soreness that started one week after the injection. No rash, but also experienced hard at the injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of arm soreness and hard at the injection site was resolving at the time of this report.  No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
No adverse effects reported; A medical assistant states that on 01/21/2020 GARDASIL 9 was administered to a 5 monfu old child; This spontaneous report has been received from a medical assistant, referring to a patient of 5 months old. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided.  On 21-JAN-2020, the patient was vaccinated (product administered to patient of inappropriate age) with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, lot number 1621929 and expiration date 06-DEC-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported). No adverse effects reported.
Information has been received from a physician concerning a 24 year old female patient who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot#660557/0072X), 0.5ml. On 27-OCT-2008 the patient was vaccinated with the second dose of GARDASIL (Lot#660557/0072X), 0.5ml, and on 21-MAY-2009 the patient was vaccinated with the third dose of GARDASIL (Lot#661953/1130X), 0.5ml. MENACTRA (Lot#U2877AA) was administered during the same visit. There was no other concomitant medication. On 21-MAY-2009, 5 minutes after receiving her third dose of GARDASIL, the patient fainted and fell on the floor. She was now experiencing severe headache and she also had a "busted lip" and her upper tooth was loose. The patient was not recovered now and she had sought medical. Additional information was received from a medical assistant that the patient was admitted to a hospital on 21-May-2009. The admitting diagnoses were reported as syncope, head trauma, severe headache, reaction to vaccine, contusion to mouth, and laceration to lower lip. It was also noted that the patient's two front teeth were loose. When the patient was discharged and the patient's recovery status were both unknown. The patient was not scheduled for a follow-up visit with the physician. Additional information has been requested.   7/8/09 Received PCP & vaccine records.  Patient was seated during injection of vaccines and after 5 min, fell onto the floor sustaining facial injuries.  Observed in office 40 min.  BP prior ro vaccines 110/80; after fall 8/40; then returned to 110/70.  Stable & d/c to home w/parents.  Phone contact w/parent that evening revealed patient c/o HA, toothache & dizziness.  Admitted to hospital for 23 hr observation.  Remained stable & d/c to home.  Seen again in PCP office for cellulitis/abscess left thigh/hip.  No further problems.  6/9/09 Hospital records received DOS 5/21/09. Admitting diagnosis: syncope, head trauma, headache, reaction to immunizations.
Redness at site of injection-onset 6 days later. Lethargy since date of injection-till present (6/4/15-6/10/15).
Influenza vaccine administered and injection site seemed lower than what had experienced in the past.  Site was sore and achy night of administration and over the next few days she developed shooting pain up the side of her left arm associated with the site and pain with raising arm overhead. Patient was seen by provider 1 week after injection. At the end of October Patient was referred to Ortho and received steroids with significant improvement in pain. She has needed no further f/u and reports symptoms have resolved at this time.
2mo p/vax pt devel ITP-first dx 22MAR99 bruising, dec platelets
Student reported to health room (after clinic had broken down). Per the school nurse, she was not feeling well and had a temp. of 101.1F. Was reportedly feeling fine before receiving inactivated vaccine. Student was sent home with mother. She was also abesent from school on 1/21. The school nurse followed up with student's mom--child was feeling better; had no temp; did not go to MD.
After the dose was administered, the daughter of the patient contacted the pharmacist and informed that the patient had received an unknown brand flu vaccine 3 days prior with no reported adverse event; Initial information was received on 09-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 87 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after the dose, the daughter of the patient contacted the pharmacist and informed that the patient had received an unknown brand flu vaccine 3 days prior with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 09-Nov-2023, the patient received a  0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT8111CA and expiry 30-06-24) (formulation, strength: unknown) that the patient had received an unknown brand flu vaccine 3 days prior with no reported adverse event (extra dose administered) via unknown route in unknown administration site for prophylactic vaccination (immunization).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1/31/07 tc from mother-states patient had HPV vaccine 1/19/07 on 1/20/07 c/o achy arms.  Developed headache that comes and goes and blurred vision the comes and goes.  On 1/26/07 c/o weakness-couldn't move-went to hosp ER-was in ER for 8 hours. No convulsion for use of symptoms.  Able to move now but has charge of sensation of left side. Mom states had been sleeping a lot.  2/21/07-Return call from mom. Completed form with available info, lasted 6 days-numbness/tingling. 03/30/07-records received from reporter. PE:WNL Pain when walking able to walk with some poor effort on examination but grossly normal musculoskeletal exam. Dehydration, musculoskeletal pain. Orthostatic blood pressure mostly likely due to poor oral intake. Sore throat and nasal congestion. Numbness in toes and feel and intermittent blurring of vision and seemed confused. Tired. Mother concerned about possible bipolar disorder. Multiple stressors in home life. Recommended mental health care provider
Pain in all extremities, toes, fingers, joint, lower back, in rib cage front and back
On day of vaccine administered at about 1100 patient started with headache.  At 1300 he began to have body aches and headache increased.  Fell asleep.  At 1900 his heart rate went to 147/min, fever of 103 F, cough, increased body aches, headaches, O2 sats 97% on RA.  Went to ER by squad.  Was given tylenol, robitussin by mouth.  Given 1 L of IVF, and IV Toradol.  Was told by ER doctor to quarantine for 14 days and that the vaccine "work up the COVID-19".
Pt 1 of 9 from total of 191 pts who completed series of 3 vax & failed to achieve immunity.Pt did not seroconvert.
PT WAS GIVEN FIRST DOSE OF COVID 19 VACCINE (PFIZER). DURING 15MIN OBSERVATION PERIOD, SHE STARTED FEELING DIZZY, LIGHT HEADEDNESS AND BLURRED VISION (FELT LIKE FAITING). PARAMEDICS WERE CALLED. WHEN PARAMEDICS WERE ARRIVED, HER VITALS BECAME NORMAL. SHE STATED THAT SHE FEELS A LOT BETTER AND SHE WAS ABLE TO GO HOME WITHOUT FURTHER EVALUATION.  INFORMED DR OFFICE FOR THE ADVERSE EVENT. SHE'LL DOCUMENT IT ON PT'S CHART FOR REFERENCE.
I got a pain in my right armpit. I read online that it probably is a swollen lymph node on the same side as I received the Moderna booster. I just want you to have this report so that if the incidence of this side effect is higher than previously reported, you will have the data.
Patient began to complain of itching all over body, numbness & tingling of lips.  Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED.  Upon arrival to ED, patient began to cough.
6 months after receiving my 5th dose. I contracted COVID-19 infection the symptoms started on 10/10/2022 in the morning. I had fever, runny nose and feeing unwell. I used a home test on 10/12/2022 which was positive. I called my  doctor's office and they called me back saying the you tested positive we can't do anything about it. They also said to call back if my symptoms worsened. It was a very mild case.  My symptoms subsided slowly  so I didn't need to call back.   I probably took Tylenol. I took  a COVID-19  test on 10/20/2022 which was negative.
PT VACCINATED WITH DTP DEVELOPED HIGH PITCHED CRY FOR MORE THAN 3 HRS.
One day later employee broke out in a rash that spread throughout her whole body.  She stated that the rash caused extreme itching. She had to take Benadryl.  Employee will make an appointment to see her doctor. Do not know of the outcome as of now.
I started to have breast pain and felt a lump. Doctor couldn't determine cause. Did a mammogram and found nothing significant. Doctor found enlarge lymph nodes but no reason why.