chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer (patient) and described the occurrence neuropathy in a 26-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to sulfa drugs. Concurrent vaccination included typhoid vaccine (non-gsk);non-GSK manufacturer;unknown;unknown given on 26 September 2008. On 26 September 2008 the subject received 1st dose of TWINRIX (unknown route, route arm) and on unspecified dates the subject received 2nd dose and 3rd dose of TWINRIX (details unknown) and experienced poor quality vaccine administered with the 1st dose. The subject believed that his symptoms might be caused by his vaccine not being refrigerated properly because an internet search turned up a recall for the reported lot number by an agency in his state. On 26 September 2008, about 1 month after vaccination with TWINRIX 1st dose, at an unspecified time after vaccination with TWINRIX 2nd dose and 3rd dose, the subject experienced paresthesia, neuropathy "that felt like his nerves were on fire", memory problem, "irrational" anger/rage, "relapsing fever where he would feel feverish" and exhausted. He explained the fever would go away and recur. While he was hospitalized for these symptoms, but "they did not know the cause". Everyone in his family and at work noticed that "something was wrong because he acted very differently from before the vaccination" (acted as a different person). The subject was seeing a neurologist for these symptoms. The subject reported that the first and second vaccination doses were received at the same office and the third dose was received at a different office, but did not know the exact dates. It could not be determined if the events got worse from subsequent TWINRIX doses or if the problem, was just progressing, thus all doses were considered suspect. The subject was hospitalised. At the time of reporting the paresthesia and "relapsing fever where he would fell feverish" and exhausted were unresolved and the neuropathy "that felt like his nerves were on fire, memory problem and "irrational" anger/rage were worse. The outcome for acted as a different person was unknown. The subject reported an event for his father. See case A0984842A for details.
Shortness of breath; Swollen stomach; Upset stomach, still feels sick after they eat; Had to lay on the floor after a bath because they were afraid they couldn't move; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Patient came in today to report local swelling, sore arm, warm red skin around vaccinated area which appeared day following immunization.
Full 0.5 mL given instead of booster dose of 0.25 mL; no adverse reactions reported by patient at time of phone call to report error which was 1145AM 12/29/21
No adverse symptoms reported. came back after having received Pfizer vaccine.  had not communicated that this was his second dose prior to vaccination and had noticed that the vaccine he received was not the same one listed on his vaccine card. Apparently,  had received Moderna vaccine on 3/4/2021.  were concerned, so came back to clinic. No symptoms reported from time vaccine received.
Tingling in tongue, feet, fingers approx 5-10 immediately  after injection. The day after injection. Feelings of Adrenaline rush, increase heart rate. Waking many times at night with same episodes. PCP Prescribed Predisone and Benadryl . some symptoms  still remain 3 weeks out.
developed severe abdominal pain; multiple CT scans of abdomen, treated with abx no better, originally had diarrhea then constipation original felt to have diverticulitis labs normal  sigmoidoscopy - swollen sigmoid  hospitalized, symptoms resolved
Pfizer-bioNTech COVID-19 vaccine EUA  red severely itching rash on neck
Pain and swelling at injection site. Excess bleeding at injection site. Injection safe adhesive barrier strip used for injection filled with blood that spilled out all over my arm and floor during removal. The adhesive was removed approximately 45 minutes after injection. Cleaned the injection site with antiseptic wipes, took 2 Tylenol, and put ice pack on the area. Treatment still in progress, so outcomes unclear.
Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.
Systemic: Dizziness / Lightheadedness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt felt lighted & turned pale shortly after administration. Clinic had pt lay flat for a while & he recovered thereafter.
Fever, chills, body shakes, shortness of breath, headache, arm pain, nausea, exhaustion
fever; lost appetite; COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), DECREASED APPETITE (lost appetite) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PYREXIA (fever) and DECREASED APPETITE (lost appetite).   At the time of the report, PYREXIA (fever), DECREASED APPETITE (lost appetite) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Cold sweats been going on for 12 hours now. My bed is soaked in my sweat, but I?m freezing.  Headache/migraine feel like someone is stabbing me in the forehead repeatedly. I cannot breath and I keep having muscles spasms. Several in my legs but the main area is the muscle between my right shoulder and head keeps spasming. I had covid in May and it was terrible, however the symptoms I am getting from this vaccine are much worse than when I actually had covid
AFTER TAKING THE VACCINE IN THE AFTERNOON, THE NEXT DAY I HAD A HEADACHE AND MY NOSE STARTED DRIPPING, SO  I WENT TO THE BATHROOM. IMMEDIATELY WHEN I STOOD UP, I FELT FAINT AND NAUSEOUS.  CONSTANT SYMPTOMS THAT HAVE DISSIPATED : SHORTNESS OF BREATH (I FIND MYSELF WAKING UP B/C I LOSE MY BREATH IN THE NIGHT WHEN I SLEEP AND/OR WHEN AWAKE, I'M HAVING TROUBLE BREATHING) I'VE BEEN TERRIFIED TO SLEEP, NOT KNOWING IF I'LL WAKE UP THE NEXT DAY. MY PARTNER STAYS ON THE PHONE WITH ME AND CALLS ME IF HE DOESN'T HEAR ME BREATHING/SNORING.  I ALSO HAVE A  PAINFUL SORE THROAT (PHARYNX) .  BOTH ISSUES I AM STRUGGLING WITH FOR THE PAST THREE WEEKS WITHOUT RELIEF.  I'VE TRIED TAKING A VITAMIN FOR THE SORE THROAT, BUT IT HAS NOT HELPED SINCE.
Diagnosed with rare autoimmune disease called birdshot chorioretinitis. My vision within weeks from the vaccine got really bad. After seeing a specialist I have macular edema requiring steroid injections in both eyes, retinal detachment in both eyes,
Shortness of breath, back pain, stayed up all night, headache. Still has headache and shortness of breath.
Case number PHEH2014US025036, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 33-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
On 8/18/99 and 9/20/99, the pt received her 1st and 2nd dose of Lymerix. Following the 2nd dose, in January, 2000, she experienced pain at the bilateral bases of thumbs and wrists. The pt reported no swollen joints, but she had warmth at the base of her thumbs. The pt believed she might have carpal tunnel syndrome. She stated that she did not perform repetitive tasks. The physician stated that the pt's symptoms clearly are related to overuse from moving. She did not feel that they had any relationship to Lymerix. The pt was treated with Celebrex and her symptoms were mild as of 10/2/00. The most recent information received on 10/2/00, reports the outcome of the events as resolved.
This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: This case is reported by the consumer who was inquiring about getting vaccinated her husband with SHINGRIX 2nd dose. While doing inquiry the reporter had provided an information about 2 patients who had experienced pericarditis after receiving SHINGRIX. The patient age at vaccination was not reported. On an unknown date the patient got pericarditis after the vaccination. The patient had already filed the report with centers for disease control and prevention (CDC). The reporters husband has underwent stem cell transplant and they wanted him to get shingles vaccine at 2 months. This case has been linked to the case US2018GSK224235, reported by the same reporter.
Pt experienced nausea, shortness of breath, chest tightness and anxiety and then lost consciousness.  Vitals were obtained several times during the medical intervention. Respirations were within normal limits throughout, BP was 135/89 initially, then rose to 210/110, then declined to 180s/? prior to EMS assuming care. Heart rate was 47 initially, then rose to normal limits. Treated with epinephrine, Benadryl and ammonia smelling salts and transported by ambulance to hospital.
Patient was on the schedule for dose, her birthday was the day before and should have gotten adult dose. Smaller dose was given in error.
PATIENT RECEIVED FLU VACCINE, APPROXIMATELY 3 MINUTES FOLLOWING ADMINISTRATION PATIENT STOOD UP AND REPORTED FEELING DIZZY.  THE PATIENT WAS RESEATED.  PATIENT AGAIN REPORTED DIZZINESS AND FAINTED.  PATIENT WAS LAID DOWN ON THE GROUND AND HIS FEET WERE ELEVATED AT WHICH POINT HE BECAME RESPONSIVE.  EMT SERVICES HAD BEEN INITIATED AND PATIENTS VITALS WERE TAKEN UPON THEIR ARRIVAL.  VITALS WERE UNREMARKABLE AND WITHIN NORMAL LIMITS.  PATIENT DECLINED ANY ADDITIONAL SERVICES INCLUDING TRANSPORT TO HOSPITAL AND WAS ABLE TO TRAVEL HOME SAFELY WITHOUT ADDITIONAL ASSISTANCE.
No adverse event, patient received a 3rd shingrix shot after already receiving 2 shots course
Patient complained of pain of extremities and presented with ataxia and absent reflexes. Diagnosed with Guillian-Barre Syndrome. Received IVIG and physical therapy. No lumbar tap (parents refused).  Nurse follow up on 07/27/04 states: "diarrhea."  Per annual report- have not seen patient in the office since 4-15-04.  Have not spoken to family since 4-19-04.
Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported for a female patient (wife) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 1:30pm at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced headache from unspecified date, and the consumer was asking if patient can take Excedrin for pain killer. The outcome of event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Patient approached me at 1721 stating that he feels dizzy, and felt like his heart was racing. Patient ask to sit in chair and vitals were taken. BP 177/89, HR 86. Pt is feeling very anxious. Bottle of water given. Rechecked at 1739 BP 163/105 and HR 94. Pt asked to relax and deep breathe. Rechecked at 1748. BP 154/124, HR 87. Pt felt more relaxed and stated that he feels much better. BP 143/98, HR 86 at 1757. Pt educated to follow up with care provider. Patient left facility.
Chicken pox- mild case over trunk and L lateral knee - developed w/in 12 hours of admin of varicella vaccine no. 2.
Pt states are injection cause her to get a fever over 102F with her arm swollen and red painful, could not move arm. Took advil, tylenol to help with fever, had to ice her injection site to bring the inflammation down,  pt was bedridden for 3 days.
Tiredness; headache; fever and temperature of 100.8; chills; swollen lymph nodes; muscle pain; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8932) via unspecified route of administration in left arm on 23Mar2021 (at the age of 70-year-old) at 14:45 as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient also took other unspecified medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The past drug history of the patient included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN62600) via unspecified route of administration on an unspecified date in left arm for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced tiredness, headache, fever & chills, swollen lymph nodes, muscle pain, temperature 100.8(unspecified units) on 24Mar2021 at 04: 00. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tiredness, headache, fever & chills, swollen lymph nodes, muscle pain, temperature 100.8(unspecified units) was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Extremely sore arm post vaccination which left me unable to work for one day. Side effects abated and then reoccurred 9 days after injection. Been 2 days of pain with certain arm rotations. Unable to lift arm above my head without pain. Ibuprofen helps but pain inhibits driving, sleeping, getting dressed, exercising, etc.
This is a spontaneous report from a contactable reporter who reported on the behalf of a physician for a patient. This is first of the two reports reported by the same reporter. A 2-month-old female patient received PREVNAR 13 (Lot #G92622 and Expiration date: 12/2014), intramuscularly on left anterolateral thigh at a dose of 0.5ml on 07Jun2013 at 11:30 am. Relevant medical history was none. Concomitant medications included PENTACEL [Manufactured by Sanofi Pasteur], (Lot # C4484AA) intramuscularly on left anterolateral thigh on 07Jun2013 and ROTATEQ [Manufactured by Merck] (Lot # J003951) orally on 07Jun2013. The patient experienced fever and was fussy, both on 07Jun2013 at 9:30pm. Therapeutic measures taken in response to the reported event fever was TYLENOL in Jun2013 at a dose of 40mg in every 4 hours. The patient did not visit the emergency room or the doctor in response to the reported events, the patient was not hospitalized. The patient was recovered from the event fever since an unknown date in Jun2013 and clinical outcome of the reported event fussy was unknown at the time of the report. Follow-up (20-JUL-2013): Follow-up attempts completed. No further information expected.
The patient received 1st moderna dose (mono)  on 12.5.21 at store, patient received 2nd moderna dose (bivalent) 10.20.22 at store. patient received pfizer dose on 7.22.23. No adverse events happened at any time. Patient circle that they have chronic health conditions and seizure disorders which what would at the time though would satisfy getting the 3rd dose. Not documented in notes however pharmacist at the time spoke to the patient and decision was made. No one can tell a patient they are not moderate or severely immunocompromised.
Patient  experienced a "stroke like" event within 5 min after receiving immunization. Ambulance summoned-arrival within 10-15 min-taken to hospital--unknown outcome at this time.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator 14Jan2022. The vaccine was administered on 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.  No treatment medication information was provided.
Infant was delivered prematurely but was big enough that we would give hepatitis B.  There was an order placed for it to be given at birth.  Usually when a baby is on CPAP, it is delayed.  A second order set was placed when the infant was in the special care unit for hepatitis B vaccine to be given at 48 hours.  It was not recognized by pharmacy or nursing that the infant already had a dose, and he received a second dose.  It was not discovered until the infant went to the pediatrician's office.  She saw that 2 doses had been given.  The hospital pediatrician will call the family to let them know about the second dose.  The second dose was given 8/4/23 at 1059. All the vaccine information was the same as the first dose.
Right after I gave the shot to the patient. Patient got dizzy and have to help her to sit down. She said she is about to fall, cannot see anything and her head is spinning. I Immediately grab water from our shelf.  5minutes after drinking, pt wasn't getting better. She requested to lie down on the floor.  She  claims that she haven't eat that much so she took a chololate bar.  I stayed and watched the patient for 15 to 20 minites.  Patient tried to stand up and right after she stand up she got dizzy again, have to assist her to sit down. Wait another 15minutes and she said she is felling better. I observed her when she stood up and walked her to her car. I gave her an epipen just in case she would need it. She said she is feeling better and just live 2 blocks away.
Immediately after the shot, I had moderate to severe pain in the injection site and my entire arm was in a lot of pain. A couple hours later, I felt extremely fatigued, sore, had chills and a headache. 6 hours after the shot, I developed a low-grade fever of 99.9 degrees. 8 hours later, I had a 102.2 fever and severe chills, a headache, severe body aches, nausea, and severe fatigue.
3/5/2009 - Telephonce call from school nurse to report that child came to her office in the AM with c/o severe itching, left upper arm, after recieveing vaccination on 3/4/2009.  Area appeared red, swollen, quarter sized with 4 small blistered areas n center.  Ice pack was applied.  Mother called who reported child had c/o early in the morning of itchy arm.  Mother to give benadryl in the PM, call pediatrician.
Immunization was Administered incorrectly. Should have been given subcutaneously but was given intramuscularly.