chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report.  No follow-up attempts are needed. No further information is expected.
Pt broke out in hives & began running fever @ 630PM on 26AUG92; pt started on DPH & APAP; outbreaks of hives & fever up to 102 cont on 27AUG92; completely resolved by 28AUG92;
pain in the arm; Headache; eye pain; Shortness of breath; Cough; Chills; Flu-like symptoms; Fatigue; Body aches; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 21st December 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 21st December 2021, 8 hrs after receiving Shingrix, the patient experienced fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms. On 26th December 2021, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the fatigue, general body pain, headache, eye pain, shortness of breath, cough, chills, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by consumer itself. The patient reported that received second dose of Shingrix  on his right arm. On 26th December 2021, 5 days after vaccination the patient experienced headache. The reporter consented to follow up. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264178:same reporter
"Received 2nd shot 2/9/21. 101.2 temp the next day and fatigued. Last night felt better. Today still fatigued and sore throat. Temp is 98 now."
Woke up the next morning with numbness in injection arm from shoulder to elbow. Lasted about an hour after waking up. (Till about noon) Painful to move arm about two days after injection. (Note, I did have COVID-19 in January)
Vomiting/lethargy 11-3-07 to 11-4-07.  Also with fever.  No treatment.  Parents spoke to on call doctor regarding symptoms.
Fingers on both hands are blue and are painful.; Fingers on both hands are blue and are painful; Left leg swollen; Fingers on both hands are blue and are painful. No feeling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 10Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV). The patient had no known allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced fingers on both hands were blue and were painful, no feeling and left leg was swollen. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fingers on both hands were blue and were painful, no feeling and left leg was swollen was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache about 2 hours post vaccine administration, lasted over 24 hours as Tylenol wore off. Diarrhea began 3am following the vaccine, was accompanied by nausea. Mild sore throat began about 18 hours post vaccine. Low grade fever 99.1 began 20 hours post vaccine. Mild Muscle and joint discomfort began about 20 hours post vaccine. Arm was painful from about 12 hours post vaccine until about 5 days post vaccine. Itchiness began about 24 hours post vaccine, and a horizontal welt became raised around the same time itchiness commenced.  Itchiness went downward to my elbow area. By about 36 hours post vaccine, symptoms, except for arm itchiness/pain, muscle and joint ache, had subsided. Muscles and joint ache subsided about 72 hours post vaccine. Itchiness and pain on injection site subsided about 120 hours post vaccine administration. No medical results or outcomes experienced in ?Item 21?  as of time of this submission.
Starting 12 hours after vaccine I felt cold and needed a sweatshirt and 3  blankets to stay warm?no fever.  8am woke up, still cold, no chills or fever, moderate headache.  By noon (24 hrs after vaccine) I had low grade fever-100.2 with moderate to severe headache. I?ve always had migraines, this was not a migraine? By 3 pm fever spiked to 102.7, stayed there until 6 pm. Took 1000 mg of Tylenol, by 8:30 fever was gone.  Arm around injection side slightly painful.   It is now 10 pm. Still have moderate headache no fever, no other symptoms except soreness around injection site.
stomach ache; disoriented; dizzy; very itchy arm lasted for quite; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and ABDOMINAL PAIN UPPER (stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy). At the time of the report, PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, COVID-19: negative negative (Negative) negative.         no concomitant medication given no treatment provided   This case was linked to MOD21-046612, MOD21-036754, US-MODERNATX, INC.-MOD-2021-022796 (E2B Linked Report).; Sender's Comments:  MOD21-046612: MOD21-036754:
Blood pressure dropped, vision blurred, ringing in ears, difficulty breathing, then nausea, vomiting, diarrhea, fell against sink and bruised leg/hip, severe dehydration followed.
Pt presented to the clinic on 8/13/07 with 1 week history of diplopia, ataxia, and weakness of extremities R>L. Pt was admitted to hospital on 8/14 and dx with acute disseminated encephalomyelitis and azotemia. Pt was treated with a 5 day course of Solumedrol and Prednisone taper started with improvement in all sx's except diplopia.  12/26/2007 MR received for DOS 8/14-24/2007.  No formal D/C DX noted but following diagnostic studies DX of ADEM is proposed.  Child presented to ER with 6 day hx of double vision, 4 day hx of unsteady gait, extremity weakness (R>L) and abnormal eye movements noted by dad. Pt began running into things and falling while walking.  Weakness, pain and unsteady gait have worsened. PE (+) for decreased strength upper & lower extremities, 1 beat clonus bilat, CN III palsy, R exotropia. Neurologic sequelae:  Pt became more encephalopathic during admission (ataxia and III CN palsy) so transfered to PICU.  Pt developed deteriorating renal function/azotemia which worsened after CT contrast. Txd with IV and po steroids.  Discharged on day 10 in stable condition with aspiration precautions. 12/28/2007 Spoke with reporter who states only sequelae at this time is some occasional double vision when pt gets tired. Other sx such as ataxia, dysphagia and renal function are now resolved.
Chills, fever, severe headache, neck and shoulder muscle pain, dizziness and almost passed out.
I was vaccinated by vaccinator (don't have his name) at the Center on 2/9/21.  My appointment time was 1:45 pm, I was injected at 1:25 pm into the Left shoulder (instead of intramuscular of the arm).   The location of the injection was placed too high and into the shoulder joint.  At 4:25 pm a sudden onset of acute pain began in the Left Shoulder,  limited range of motion, limited to no ability to lift the arm without intense pain.
Got shot 7:15p Went to bed at 10 P with very sore injection site Woke up at 1a with head spinning, vertigo type symptoms feeling very nauseous.  Stumbled to bathroom, sat for30 minutes, never vomited  Went to bed at 1:30A. Tossed with feeling nauseous until 6:30 A wake-up.  Still mildly nauseous with slight lightheaded ness Generally feeling better but not feeling100%  Around 2p, felt profound weakness, very tired. Went to bed and slept until 6p. Took temperatures -98.8.  Feels like flu type of fatigue without chillls, fever or muscle aches.  Infection site still very sore after 24 hrs.  Nauseous has subsided but still slightly lightheaded 24 hrs after injection.
had shingles 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the single shingle shot in 2018 and experienced had shingles. The patient asked if he/she could get the shingles shot For 2nd occurrence refer case US2021AMR227089.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227089:same reporter same patient
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had no drug abuse or illicit drug usage. It was not reported if the patient consumed alcohol or smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported.  The patient donated blood 2 weeks ago, so 7 weeks after vaccination on  27-MAY-2021, the antibody test showed negative (coded as confirmed immunological vaccine failure). The retested today (as reported) on 01-JUN-2021, and was again negative. The patient was curious if she would get a different vaccine product or booster. The patient's daughter did not want her to visit as the patient have not seen granddaughter in over a year, since her daughter felt that the patient was unprotected.  On 27-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. On 01-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC).; Sender's Comments: V0: 20210602347-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever of 100.3° F on 4/6/2021 at 8:43 a.m. Headache Patient says that his symptoms began 4/5/2021 at about 6:00 p.m.
Vaccine given in Right upper arm SQ. 1 minute later noted area of swelling, raised welt, below injection site. Swelling measured 1/2 inch long by 1/4 inch wide. No other symptoms noted. Given oral BENADRYL and monitored in office. No further reactions noted.
Pt recvd a series of 5 hep B Recombivax & titer levels drawn failed to show seroconversion.  Pt recv booster w/ Engerix b.  Specimen drawn indicated "positive protection against hepatitis."
pt recv vax 25JUL94 & 28JUL devel a rash over body,arms,ankles & inj site;rash lasted approx 24hrs;
About 5-6 days after getting the vaccine, developed knot under the skin at the site of the vaccine, then developed redness and itching with slightly increased swelling. Seems to be slightly improving (9 days after vaccine and about 3 days after reaction started).
red arm; fever, temperaures; very nauseated; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache). At the time of the report, PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
pt recv vax 12JUN97 & 17JUN97 pt devel temp of 101;19JUN97 pt devel chickenpox;pt recovered;
HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 77 year old female. The patient's height, and weight were not reported. The patient had medical history of high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, acetylsalicylic acid, ergocalciferol, ibuprofen, magnesium, vitamins nos, and zinc.  On 12-APR-2021, the patient experienced high blood pressure, which had increased over 2 days. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 177/93 mmHg at 3:00, 172/86 mmHg before bed, 159/95 mmHg yesterday, and highest reading of 201/104 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427613- COVID-19 VACCINE AD26.COV2.S- High Blood Pressure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Starting at 48 hours after the shot, I began having severe flu symptoms - fever, sore throat, congestion, painful cough. Then, starting at 1 week after the shot, a severe rash started. I have red, raised, hive-like rash all over my body. It started in both arms and has spread to my back, stomach, chest, legs. It has gotten worse each of the last 3 days (including today). It is a bit painful and fairly itchy.
Her fiance who has been tested positive; Her fiance who has been tested positive; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 31Jan2021 this case now contains all required information to be considered valid:   This is a spontaneous report from a non-contactable consumer (Patient's fiance) and a contactable consumer (Patient). An elderly male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Dec2020 at single dose, second dose via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history included back pain before receiving the vaccine; later described as a Spinal pain. The patient's concomitant medications were not reported. Caller said she got the 1st dose of Covid vaccine on the 18Dec. But she is living with her fiance who has been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine. Caller stated receiving the first dose of the COVID-19 vaccine yesterday (18Dec2020), And receiving a drug prescription for "Medol" today. He explained that his appointment with the doctor was scheduled a month ago, due to his "back pain", which he later described as a "Spinal pain". He specified that "everything is fine" and that his pain is not due to the inoculation. He asked if the Medol would interact with the vaccine. patients second dose was scheduled for Wednesday and he got a call on Saturday saying the spot was not available now. They want me to get his second dose tomorrow instead. he had heart problems and he was over 65 years old. he was thinking perhaps he should wait because he wanted the maximum beneficial effect of the inoculation. Will he get as much protection if he got the vaccine at 19 days instead of 21 days, patient questioned. Reporter said (patients fiance) she got the 1st dose of Covid vaccine on the 18Dec2020. But she was living with her fiance who had been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine she questioned. The relevant laboratory tests includes SARS-CoV-2 Antibody test with result was positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
FOR 3/2/2010 I GAVE THE PNEUMOCOCCAL VACCINE TO LEFT THIGH.  ON 3/3/2010 CHILD RETURNED FOR READING TB TEST AND FAMILY INFORMED ME ABOUT REDNESS ON LEFT THIGH.  NOTICED 3 BY 4 INCHES INDURATION, REDNESS, SWELLING.  PRESCRIBE KEFLEX AND INFORM MOTHER BY PHONE AT 12:30 AM ON SAME DAY MAY BE A REACTION TO PNEUMOCOCCAL VACCINE OR INFECTION.  ADVISE TO RETURN THE NEXT DAY BUT PATIENT NEVER RETURNED.
(Nausea 2days) Chills 2 days  (left arm soreness and rash  10 days, 1 week)
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with RECOMBIVAX HB which had been improperly stored (lot#, expiration date, frequency, dose and route were unknown). And no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
2 hrs after injection pt experienced sharp stabbing pain at injection site, partially relieved by TYLENOL. Woke up 4/25/18 with redness around injection sie extending down arm just above elbow.
Uncontrollable sobbing for no apparent reason. Started morning after shot and there are no triggers whatsoever.  Crying and sobbing at anything.
Local reaction only.  Redness, hives near where vaccine administered, onset the following day,  which then faded to small bumps-to-flat rash in 12-24hrs..  No systemic symptoms.
I had my booster vaccine October 5 and on October 6, I couldn't lift my left hand, grab anything, or close my left hand. I also started having pain in my left hand and that is what made me go to the doctor. My doctor put me in a hand brace, but it made the pain worse. I eventually saw an orthopedic doctor who put me in a wrist brace and gave me some meds. I was told that he has seen this in patients after booster vaccines, and it does seem to be getting a little better.