chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like she has the flu; woke up horribly; Muscle pain; joint pain; headache; arm hurt a little; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has the flu), SLEEP DISORDER (woke up horribly), VACCINATION SITE PAIN (arm hurt a little), MYALGIA (Muscle pain) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    Concomitant products included Centrum vitamins and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm hurt a little). On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu), SLEEP DISORDER (woke up horribly), MYALGIA (Muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has the flu), SLEEP DISORDER (woke up horribly), VACCINATION SITE PAIN (arm hurt a little), MYALGIA (Muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Platelets dropped to 6.  Oncologist stated not to proceed with second dose.  treated, and plt count at 22  as of report.
Extreme pain at injection site; Large red itch welt 18 hours later; Large red itch welt 18 hours later; Fatigue; Stuffy nose; Blurry eyes; Tightness throat; Hoarseness; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26May2021 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. Medical history included migraine and polycystic ovarian syndrome (PCOS). The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 05:00, the patient experienced extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat was not recovered at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Dry Mouth, Chest Pain, SOB. Transported to Emergency room/department or urgent care.
Patient called 1-15-2021 reporting delayed reaction from her Moderna vaccine given 1-04-2021. She reported soreness, redness, warmth, swelling and a lump 2"x2" at the injection site. The message was sent to me and I have tried to call the patient with no answer. I have left a voicemail for her to return my call. Date for onset of side effects is unknow at this time.
slight fever of 99.8; nauseated; not feeling well; achy; threw up twice; This is a spontaneous report from a contactable consumer or other non-hcp. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EL3302) via an unspecified route of administration (age at vaccination 38-year) in Right Arm on 23Feb2021 at 04:00 PM as dose 1, single for COVID-19 immunization. Medical history included Special needs, CP, MR, behaviors from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No known allergies were reported. The patient received other Pfizer vaccine 4weeks (lot number= EL0140) in right arm on 02Feb2021. No COVID prior vaccination was reported, the patient not tested COVID post vaccination. On 23Feb2021 at 07:00 PM the patient experienced slight fever of 99.8, nauseated, not feeling well, achy, threw up twice. The patient underwent lab tests and procedures which included pyrexia: 99.8 (fever went back up to 99.8) on an unspecified date. Therapeutic measures were taken as a result of the adverse events, the patient took ibuprofen 2/24 as AE treatment. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Patient seen at the health department immunization clinic to receive vaccines needed for permanent residency on 05/04/2023. She did not have a record of previous vaccinations. Prior to vaccination, she was screened for contraindications, including pregnancy. All screening questions were answered "No".  Patient received MMR, Varicella, IPV, Hep B and Tdap vaccines. Patient returned to health department on 05/15/2023, stating she was pregnant. LMP 04/08/2023. Vaccine contraindications/recommendations described in the literature, for all vaccines received, reviewed with patient.  She was instructed to seek prenatal care as soon as possible and to tell the health care provider she received live virus vaccines while pregnant.
Breakthrough case admission after 2 vaccines Pfizer 7/27/21 lot# FA7484;  Pfizer 8/26/21 lot# FF2588
Shingles; Pain; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in Novemebr 2019 and did not experience side effects).   On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th March 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain and pruritus. The patient was treated with antihistamine. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain and pruritus were unknown.   The reporter considered the shingles, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The following day after receiving Shingrix, the patient had pain and itching.  She said that she went to her doctor they told her that she has Shingles.  She said that her doctor gave her Antihistamines and a topical solution.  The patient stated that she never had shingles before and that she believes that the shingles vaccine vaccine caused the shingles. The patient was very frustrated that GSK would not compensate/reimburse for the Shingles vaccine and the cost of her medical bills.
Pain in right  leg from hip area such that I was unable to  put weight on right leg and had to walk with support and cane. This lasted for 3 days along with random muscle aches and dizziness at times. The pain gradually wore off and I can walk normally. I took Tylenol for the pain but it did not seem to help.
Case previously recorded as MA2009-5413. Case received on 23 NOV 2009 via MedCom from a healthcare professional the following information: A 12-month-old male patient was vaccinated i.m. with FLUVIRIN H1N1, batch no. 102125P1 (off label use), on 23 NOV 2009. No adverse events were reported. MedCom no: NA09-008745.
29 yo male diagnosed with acute pericarditis. Pt well enough for outpt tx. Hx notable for recent vaccinations: 29 in October 2021 and Covid 19 Moderna vaccination #2 on 27 August 2021.
light bruise right arm below injection site; sore right arm; fatigue; little hard right arm (injection site); muscle aches full body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (light bruise right arm below injection site), MYALGIA (muscle aches full body), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (muscle aches full body). On 01-May-2021, the patient experienced VACCINATION SITE BRUISING (light bruise right arm below injection site), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)). At the time of the report, VACCINATION SITE BRUISING (light bruise right arm below injection site), MYALGIA (muscle aches full body), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were provided by reporter.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 23-APR-2007 was vaccinated, intramuscularly, with a 0.5 ml first dose Gardasil (lot #653736/0014U). There were no concomitant medication. On 23-APR-2007, while attempting to leave the physician's office, the patient "appeared to have a seizure" and lost consciousness. It was reported that the incident lasted only a few seconds. When the patient regained consciousness it was discovered that her blood pressure was low. On 23-APR-2007, the patient recovered and was able to leave the physician's office with her mother. Upon internal review, "appeared to have a seizure" was considered to be an other important medical event. Additional information has been requested.
Injection in Bursa resulting in enlarged/swollen Bursa as confirmed by an xray examination by orthopedic surgeon as of 5/10/21; painful to reach or pick up items with left arm/hand; painful to move arm; bicep around lipomas in left upper arm painful however, that pain has subsided after about 6 weeks and is now tolerable (I was considering surgery to have the small lipomas removed thinking they were causing the pain after the inoculation).  Orthopedic surgeon prescribed Meloxicam 15 mg tab to be taken daily for 3 weeks plus 6 weeks of physical therapy .
Had HPV#2 on 6/1/2015 17 days later had GTC seizure. Had HPV #3 on 7/29/2015 1 day later had GTC seizure and had another GTC seizure today 8/3/2015.
Patient states the next day after the COVID vaccine he felt a bit fatigued and same has been going on since then.
SWEAT; HEADACHE; COLD; BACKSIDE OF INJECTION ARM STARTED TO GET NUMB/BACKSIDE OF ARM DOWN THROUGH THE ELBOW TO PINKY & RING FINGER/20-30 MIN AFTER THAT JAW/CHEEK WAS SLIGHTLY NUMB FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 13-APR-2021 13:45, the subject experienced backside of injection arm started to get numb/backside of arm down through the elbow to pinky & ring finger/20-30 min after that jaw/cheek was slightly numb feeling. On 13-APR-2021 20:00, the subject experienced cold. On 13-APR-2021 23:00, the subject experienced sweat. On 13-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from backside of injection arm started to get numb/backside of arm down through the elbow to pinky & ring finger/20-30 min after that jaw/cheek was slightly numb feeling on 13-APR-2021, and sweat, and headache on APR-2021, and the outcome of cold was not reported. This report was non-serious.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself. A 59-year-old female patient of an unspecified race received pneumococcal 13-val conj vac (dipht crm197 protein) for immunization on unknown date at single dose via an unspecified route of administration. Relevant medical history and concomitant medication were not reported. On unknown date the patient experienced an allergic reaction. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Pt with hx of smallpox immunization in approx 2nd wk of Jan (unable to recall exact date). Notes onset approx 25 Jan. Denies prodromal symptoms, but reports that individual lesions are severely pruritic and admits to excoriation of affected areas. Reports that he has kept smallpox vaccine site covered with bandage and gauze/tape and used gloves to change bandage. Reports that he has not kept lesion open to air, has been covered with bandage the entire time. Reports that he was asked at time of immunization about hx of rashes. Denies fever, cough, mucosal lesions, headaches, or any other constitutional OS systemic complaints.
I had aching muscles, headaches, diarrhea, nausea, pain in my arms and legs and vomitting.
pt recv vax & devel fever, gen malaise, muscle weakness in the legs;all resolved w/o sequelae;
6 hours after vaccination patient began having progressive severe b/l upper extremity neuropathy from forearms to fingertips
A report was received from a health care professional concerning three vaccinees of unknown demography who experienced pain at the injection site an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003, three vaccinees experienced pain at the injection site that radiated up to the shoulder and neck after receiving Fluvirin.  The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment.  Update1, 11/10/2003: Further information received from a health care professional on 11/10/2003 indicated that 3 to 4 vaccinees experienced pain in their deltoid radiation into the trapezius 1 to 2 days after receiving Fluvirin on 10/03/03. No follow up pending. Cross reference with PJP-2003-00790.
Case number PHEH2014US018207 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to an elderly male patient of unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) intramuscularly  at a dose of 0.5 ml on an unspecified date. IT was reported that FLUVIRIN was stored at temperature of 32 degree F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
Patient was in the observation area and approximately 10 minutes after injection she developed a rash up her right arm. She felt fine otherwise. She reports she never gets an vaccines and was getting nervous. Paramedics responded patient sat for a long time and the rash disappeared, her vitals were received and she refused further treatment.
Sore arms, extreme fatigue, hunger, dry mouth/thirst. Symptoms persisted for about 2 to 3 days.
My daughter was 17 and accidentally was administered the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) in a 17-year-old female patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) had resolved.            No concomitant medications were provided.
Not feeling very well; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling very well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling very well). At the time of the report, VACCINATION COMPLICATION (Not feeling very well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment medication was reported.
Information has been received from a physician concerning a 12 month old patient who on 3/9/2005 was vaccinated with a dose of varicella virus vaccine live (lot 648753/0449P). On 3/17/2005 the patient developed breakthrough varicella with 250-500 lesions. The patient had a fever of 102 degrees F that lasted 2 days. There were no complications. The patient had no prior history of chickenpox. The patients varicella was not lab confirmed. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Pt c/o dizziness and feeling shaky, denied SOB, felt like heart was racing, BP: 114/78, pulse 65, resp 12, Temp 97.6. Given a glass of water and asked to wait 10 more minutes.  Continued to state not feeling well, A & O x3.  Shaking increased and c/o chills. Stated the only meds taken were Verapamil and Topamax last night. Called EMS and continued to monitor vital signs.  At 10:08, BP 135/90, pulse 90.  At 10:15, 134/86, pulse 102.  EMS arrived, gave O2, and encouraged her in deep breathing.  Patient refused EMS transport to ER. Called patients father who agreed to come and take her to ER. EMS and father escorted patient to vehicle for transport to ER. Patient walked with assistance.  Father texted at 2:15 to state patient was greatly improved, had lunch, and was going home to rest.
Eyesight was excellent with a slight degradation in ability to focus which I will concede was probably related to age. Started noticing a mark change in vision after 3rd vax in series. Then again after the 4th. I can read the letters but for a lack of a better description, they seem blurred with a dark halo around them. Doctor stated that she is experiencing a decrease in near vision coincidentally occurring while receiving Anthrax.
2 days after receiving Menactra, had numbness, tightness, and stiffness of fingers on right hand.  The night before had headache, sacral pain, hip and neck pain.
Outbreak of shingles Post Vaccine Rash, pain R jaw.  Saw MD Tx Famvir 500mg TID x 7 days.
t102-103 on 30APR96;vomiting @ 3AM 1MAY96 & cont throughout day;no vomit or fever on 2MAY96;c/o diarrhea over the weekend;afeb & feeling better 6MAY96;this was not felt to be a true adverse rxn but actually an incubating viral infect
3 cm X 4 cm indurated erythematous lumps at all 3 injection sites to bilateral thighs found by mom on the evening of 5/8/23.  Mom also found her to be feverish and more lethargic on the evening of 5/8/23.  Mom medicated her with infant's Tylenol at home and then brought her into see her pediatrician on 5/9/23.
Starting 10/19/2022, I felt hazy and off. As the week went on, I became more disoriented. I couldn't follow the normal instructions in aerobics class. On Saturday, I was about to start celebrating my birthday and my daughter noticed that the right side of my face began to droop a little. My speech became slurred and I was taken by ambulance to the hospital. They did 2 CAT scans, an MRI and did lots of blood work. I was discharged with a diagnosis of TIA and told to see my cardiologist, GP, a neurologist and a vascular surgeon. On 10/26/2022, Plavix was discontinued and on 10/27/2022 Brilinta was added. I just started Baclofen 11/6/2022. I am feeling fine today but I am still scheduled to see the vascular surgeon on 11/9/2022 and wear a 30 day heart monitor. They want to watch me because I am at a higher risk for a full stroke.
diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, their first dose, via an unspecified route of administration on an unspecified date; both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with a covid-19 infection on an unspecified date (2 days after the second dose of the Pfizer's COVID-19 vaccine). The reporter inquired if the patient could be administrated with a monoclonal antibody infusion for the management of mild COVID-19 symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient received dose #1 of Pfizer vaccine on 6/10/2021 @ Vaccination site and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 7/31/2021 as recommended. No adverse reactions identified on site.
Pain at injection site, chills/shivers, high fever, headache, stomach ache. Given Ibuprofen, Tylenol, cold compress, rest, Epsom salt bath
Pt developed hives on R side of body 12 hours after receiving vaccine (red and itchy). Resolved after taking 1 dose of benadryl.
Patient received two doses of COVID-19 Moderna vaccines and subsequently was diagnosed with COVID-19 at our institution on 11/8/2021
Migraine, nausea started 2pm 2-8-21 Hot/cold flashes started 9pm 2-8-21 Full body aches, extreme tiredness started 9am 2-9-21 Chest pain/heart palpitations, balance/depth perception started 11am 2-9-21 Vision sensitive, muscle weakness, metallic taste started 2:15pm 2-9-21 Skin irritation, blurred vison started 7pm 2-9-21