chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; muslce pain; headache; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness) in a male 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 INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not provided by the reporter.   This case was linked to MOD-2021-032128 (E2B Linked Report).; Sender's Comments:  MOD-2021-032128:Source: MOD21-042382
One day after the injection I got a (abnormal for me) extremely heavy period bleeding start with painful low back cramps. Took 800 mg Advil for cramps. Previous period had just ended 5 days prior.  Heavy bleeding lasted 3 days, then regular bleeding for one day then stopped abruptly.  Only other effect from injection was mild soreness at injection site for a couple days.
Said patient mentioned she had a phobia of needles and was also on her menstrual cycle. post vaccination she sat in the observation area then proceeded to lay on the floor. attending to her aid was  (paramedic),  (Registered nurse) and myself,  Lead supervising Registered nurse. Vitals were as such: BP 113/71, P: 63, O2: 98. patient was alert and oriented, answered all questions appropriately and expressed in quote "I am okay, this happens when i receive vaccines". Sais pt proceeded to get off the floor and sat in another chair.
Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever.  Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts.  I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive.  I am a little worried about the second dose.
Information has been received from a physician concerning a 24 month female twin with a history of premature birth, minor resolved intraventricular hemorrhage, resolved retinopathy of prematurity, and patent ductus arteriosus resolved with indomethacin who on 12-JAN-2007 was vaccinated IM with a 0.5 mL dose of hepatitis A virus vaccine inactivated. Illness at the time of vaccination included an ear infection. On 19-JAN-2007, the patient experienced a papular vesicular rash. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. It was noted that the patient's twin was vaccinated at the same time and did not developed a rash. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient came into her office on 26-JAN-2007 with complaints of a rash. The rash was trunk-sparing affecting the arms, legs, neck, and face. It was red, papulo-vesicular and crusting. There was minimal to no pruritus and was possibly tender. The patient had also been amoxicillin for otitis, started on 12-JAN-2007. The patient's twin was vaccinated the same day and lives in the same household without a rash. There were no contacts with any similar rashes. The working diagnosis was Gianotti-Crosti disease. No diagnostic laboratory tests were performed. No further information is expected.
pt recv vax & lab eval revealed an IgG ELISA of 0.76 which indicated pt failed to seroconvert;
Had them after the vacation/Suspected vaccination failure; Had them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them after he/she took the vaccination. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever & convuls day p/vax recvd; Hospitalized workup neg, include CBC, serum, urine, CIE, Blood Culture, CXR, spinal;
Headache, body aches, fever, chills,  Hand Cramps.  Started about 10 to 12 hours after shot and lasted for around 16 hours after starting.
Patient experienced vasovagal syncope approximately 3 minutes after vaccination completed. Appeared to have seizure-like dystonia reaction, then slumped over in chair. Pharmacist moved her to the floor to prevent her from falling. Upon awakening she vomited multiple times. Patient BP recorded at 87/50, HR 42, SpO2 97% on room air. Patient noted on pre-vaccination checklist that she has fainted after previous vaccinations. Mother was present with her and was not concerned as she explained "this happens every time". Patient recovered and was transported out of pharmacy by her mother.
lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  Concurrent medical conditions included Sulfonamide allergy and Lyme disease.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-Dec-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series). At the time of the report, BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) had not resolved.        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 concomitant medications were reported by the reporter.
Sore area on back near spinal cord; Just an unusual feeling and uncomfortable when sat back; This is a spontaneous report from a contactable nurse, the patient. An 89-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 14:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and arthritis. The patient had no known allergies to food, medications or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) and hydrochorize; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 09Feb2021 at 15:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, at 19:00 the patient experienced sore area on back near spinal cord; no marks, redness, or itchy. It was not a sharp pain, just an unusual feeling and uncomfortable when the patient sat back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore area on back near spinal cord and just an unusual feeling and uncomfortable when sat back were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information was received from a registered nurse concerning an 81 year old male patient with a penicillin allergy who on 15 FEB 2005 at 11:00 was vaccinated with a second dose of PPV in the left deltoid.  There was no illness at the time of vaccination.  On 15 FEB 2005 at 6:00pm the patient experienced "local reaction, plus fever, aching, sweating, headache, left arm swelling, red from injection site to elbow".  There were no relevant diagnostic tests or laboratory data.  The patient recovered on 22 FEB 2005.    It was also reported that another patient had an adverse event after being vaccinated with PPV.    No further information is available.
Fever, chills, vomiting, severe headache, swollen lymph nodes and fatigue.
Got the shingles shot. Then got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received the Shingles shot and then got shingles. The reporter stated no extra stress. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
pt had vax 2PM on 27MAY93 in office; did not have a physical just shots; mom did not note any problems in the afternoon; put pt to bed; 2AM 27MAY93 checked on pt; asystolic, apneic; t105;
patient said she felt faint  and nauseous- no treatment done. offered to call ambulance, patient refused
Flu vaccine given 9-15-11. Patient reports difficulty with swallowing that night. Woke up in morning with swollen tongue & swelling in throat.
"Patient" noticed site tenderness, posterior left upper arm region (where sq yellow fever was administered) on 3/16/08 and then visualized redness about 1 1/2 "diameter, warmth. On 3/20 still w/erythema. No induration, fever. Will see again if not improved or resolved by 3/25.
The patient registered for Moderna COVID-19 Bivalent Vaccine (18+ yrs Booster). She was given Moderna Covid Vaccine (Lot # ar9236b 0.5 ml) designed for age 6 M-5 year old by mistake.  Patient was informed about this incident, and was suggested to monitored signs and symptoms, as well as contact information with the vaccinated clinic in case any adverse events happen. Pt. was followed up on Monday, 10/24/2022. No adverse event was noted in the past few days.
Sore and swollen arm at injection site, headache, fatigue, fever, chills
Moderna vaccine (NDC 80777-0273-48) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
two hives to right upper  arm with itching and 2 hives on left upper arm with itching, pt given 25mg IM pt waited extra 30 minutes, hives resolved, VSS =88HR, RR=20,BP=108/74, sats=98%
Swelling of arm about injection site, pain. Benadryl taken. Transient hypotension (87/56) the following morning, resolved by afternoon, with improvement in swelling.
1.) Cold Sore started to form 36 hours after injection hadn't had a cold sore in 1.5 years after starting Acidophilus probiotic 2.) Gout outbreak in Left Big toe / foot began 42 hours after injection.  1st ever gout attack. Foot still swollen as of 1/25/2021 3.) Psoriasis outbreak, Psoriasis had been controlled.  Outbreak mostly on forehead started to dissipate by 01/20/2021
Death  1 week after 2nd dose of Phizer COVID vaccine, this person developed shortness of breath and was found passed away by his roomate.
13 year old female with history of exercise-induced asthma received injectable 10/24/2010 in left arm. Three hours after vaccination patient experienced hives starting on lower abdomen and lower back. Pt complained of severe itching and back pain. Hives also spread to legs and arms, but were less coalesced on extremities. Mother took patient to ED, where she was treated with BENADRYL and given a 6-day Rx of steroids. The ED physician could not conclusively attribute symptoms to flu shot as hives began shortly after pt. ate a sushi dinner; however, patient had eaten the exact sushi meal over couple of months for the past few years. Symptoms have largely resolved. Pt is going to be allergy tested for sushi and eggs.
FLU AND PNEUMOVAS WAS ADMINISTERED IN THE LEFT ARM AS REQUESTED BY PT. PT STATES HE COULD NOT USE THE RIGHT ARM BECAUSE HE WAS HAVING PHYSICAL THERAPY ON THAT ARM. PT STATES DAY AFTER INJ HIS LEFT ARM WAS SWOLLEN AND HURT SO HE WENT TO THE LOCAL ER. PT RECEIVED AN RX FOR HYDROCODONE/APAP 5/325 AND KETORALAC 10 MG.
Patient came it with redness and a bruising like rash at the joint of her left elbow. When the rash first appeared with was itchy and the redness was larger than when she came in on 10/6/16. On 10/6/16 the rash was circular about the size of a baseball. It was light red to dark red in color and about a foot from the administration site. The rash was noticed on 10/5 in the morning, which was 2 days after the immunization. When the patient came in on 10/6 the rash was no longer itchy and the size was subsiding. We advised her to get Benadryl and keep an eye on it to make sure it continues to go away.
Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, chills, weakness Narrative:  PT REPORTED THE FOLLOWING ADR POST 1ST DOSE OF COVID VACCINE: nausea, myalgia, fatigue, chills, arthralgia, weakness, feverish. PT WAS SELF MEDICATED WITH IBUPROFEN
Full body rash that itched and spread. Required an urgent care visit, prescription of prednisone, and over the counter medications to subside the itch, and several days of missed work.   Since this adverse event, each time I have gotten a cold or other viral illness, I have had the same full-body rash that required urgent care visits and prednisone prescriptions. I have reached out to my allergist to determine how to move forward.
Day of-Within 5 minutes I went unconscious. I was sweating profusely and my vision began blurring I could feel my heart rate and had haggard breathing. After I came by to I had extreme light sensitivity and nausea. After 1 week-Still experience fever, chills, muscle ache, headaches, nausea, fatigue, winded easily, and hot flashes. 2 weeks- Still experience excessive fatigue, nausea, hot flashes,  persistent mild to moderate headaches with occasional overwhelming migraine, light-headed, dizzy, loss of coordination and balance. 3 weeks-Same as 2 weeks out.
Myalgia, Fever Decreased movement, pain, dizziness Used OTC tylenol
I'm not 100% sure that this is related to the shot, as it developed 5 days after the shot.  That said, i've never had an allergic reaction to anything and have not changed anything in my diet or hygiene habits.  Beginning yesterday around 5 pm, both of my arms became splotchy and itchy.  As the evening progressed, the rash was all over my body.  The "splotchiness" eased after a few hours, but I remained "itchy" throughout the night.  This morning it's better, but I'm still slightly "itchy" in my extremities, particularly around my ankles and hands.  I have not contacted a Dr, as it appears to be getting significantly better on its own.   Just thought I would let you know in case it's something that others are experiencing.
Information has been received from a registered nurse referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored MMR II (lot # J013431, expiration date 24-OCT-2015, second dose in the series; dose, strength and route of administration were not reported). There was no concomitant medication reported. No adverse effects were reported and the patient declined revaccination. This is one of two reports received from the same reporter. Additional information has been requested.
Immediately after the injection pulse increased. Came in waves and went up to 150. stabilized around 100 until taking Benadryl, which reduced it to 80. Lasted 2-3 hours. Monitored in case it comes again.
Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134437, US2022134438 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134437:Same reporter US-GSK-US2022134438:Same reporter US-GSK-US2022134440:Same reporter
Vaccinated with H1N1 nasal spray - reports stomachache, body aches, fever of 104F (on 12/5/09, fever subsided to 102F) - symptoms have been going on as of 12/5/09. has used tylenol and advil for symptoms.
Chills, body aches, headache, fever (101) approximately 4 hours after vaccine. Felt better next day, but took 1/2 of next day to feel "normal" again.
Tenderness; Soreness; Lump; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump). At the time of the report, TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
It was reported that a pt (5 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.
Immediate onset headache; 35 minutes later developed chest tightness and sensation of being "squeezed around the ribs"/chest area. Arrived to walk-in clinic at 03:50 p.m. for evaluation. Tx: self monitor. Outcome(s): condition continued at patient discharge to home
Admitted about one month after full vaccination with dyspnea, hypoxemia and COVID-19 +.  Chest x-ray did shoe bilateral infiltrates.
I had heart attack about 2 weeks after the 1st dose. I was almost lost my life. Doctor still could not diagnose the cause because I am a healthy women; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), dose 1 via an unspecified route of administration at the age of 38-years, administered in arm left on 14Mar2021 15:15 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had heart attack about 2 weeks after the 1st dose (25Mar2021 09:00). I was almost lost my life. Doctor still could not diagnose the cause because I am a healthy women. I will provide more detail if you need them for research. The patient did not receive other vaccine in four weeks, did not receive other medications in twoweeks, she received treatment (Emergency room, hospitalized, cardiac procedure) for the event. The patient did not received Covid prior vaccination, she tested Covid post vaccination (Covid-19 PCR test) via Nasal Swab on 28Mar2021, Covid test result was negative. There is no known allergies. The outcome of the event was unknown.