chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 04May05 from a literature report regarding an adverse event, it was reported that a 35 year old male pt received multiple immunization as part of preparation for deployment. The vaccinations consisted of Diphtheria and tetanus, tuberculin PPD, Typhoid vaccine, oral polio, hep A, MMR. The trade names, manf, lot numbers, routes and sites of admin were not reported. The vaccines were all administered on a single occasion on an unspecified date. Several days post immunization, the pt started to feel ill with fatigue, malaise, and general flu-like symptoms that progressed over several days. One week later, he presented to his primary care physician. The pt had no significant surgical history or prior transfusions. The pt was currently taking a beta blocker and diuretic for hypertension. He denied any recent ingestion of over the counter supplements. The pt denied any family history of liver disorders or autoimmune diseases. He denied a smoking history and his alcohol intake was infrequent small quantities. The pt denied any allergies to medications or food. Physical exam was unremarkable. At presentation, the pt's lab tests were significant for elevated liver associated enzymes with an aspartate aminotransferase (AST) level of 1361U/L, alanine aminotransferase (ALT) of 2656U/L, and alkaline phosphatase of 152u/L. Total bilirubin was 4.8mg/dL, with a direct bilirubin component of 3.1mg/dl. Additional lab tests included total protein of 7.8mg/dl, albumin of 4.2mg/dl, and y-glutamyl transpeptidase biopsy performed one month after initial presentation showed severe chronic hepatitis with widespread parenchymal injury, chronic portal inflammation, numerous plasma cells, and piecemeal necrosis. These findings were suggestive of AIH. Steroid therapy was initiated, and after two months of therapy, the liver enzymes responded well, with AST decreasing to 46u/L and ALT to 73u/L. Azathioprine was added to the medical regimen at two months post steroid therapy and the liver enzymes increased, AST to 895u/L and ALT to 1922u/L, after seven weeks of therapy. Repeat autoimmune markers showed ASMA of 1;80 and negative ANA, with IgG elevated, at 1590mg/dl. Endoscopic retrograde cholangiopancreatography was normal. Azathioprine was discontinued, steroids were increased, and tacrolimus was initiated. The medical regimen over the next five years consisted of prednisone, 10-20mg daily, and tacrolimus, 1mg twice a day. Attempts to taper the prednisone lower than 10 mg caused significant elevations in AST and ALT. A repeat biopsy performed five years following presentation showed moderate inflammatory activity consisting of plasma cells with mild periportal fibrosis. It was not reported whether this pt recovered from these events.
Blanching non-raised red patches - 12 > 1 cm developed immediately after administration of vaccines on Lt shoulder. First time receiving flu vaccine, received other vaccines previously. BENADRYL 7.5 mg liquid administered and observed in office 30 minutes.
and treatment, if any:     Headache    Narrative: I have flu like symptoms and migraine possibly  reaction from the vaccine yesterday. Adding staff for  protocol.
pt recv vax & devel vomiting occasionally & felt warm to touch (no temp checked);given APAP;while in car seat parents noted child to have head arched backwards & eyes rolled back in head-unresponsive for 2min;
Information has been received from a physician concerning a 18 year old patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number unspecified). The physician reported that the patient broke out with the chicken pox within the last few weeks (as recent as 12-APR-2010). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
After vaccines given (within minutes) patient slumped into chair slightly shaken of body, appeared pale in color, eyes staring upward vs. outward into space.  Patient placed on exam table, given O2 via face mask, BP 108/36, accucheck 87, Hbg 12, EMS called.  Patient was responsive within 5 minutes.  Before leaving awake, alert, no respiratory distress.  Refer to ER.
swelling over entire deltoid area w/redness, itching;pt had poss saliva exposure from raccoon;
got a flu shot I almost died.; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu shot and experinced almost died.
Feb 2 - the site of the injection was swollen and hard Feb 4th through 5th - the site of the injection was red and itchy
experienced extreme shortness of breath a day or two after receiving 2nd COVID-19 vaccine. Breathing became worse at night, more so in reclined position than upright. Thinking it was a vaccine side effect waited for it to subside, when it did not sought medical attention. Doctors determined to be acute congestive heart failure exacerbation. Treated with diuretics and blood pressure medications. Hospitalized from 3/14/2021 to 3/19/2021.
Pt arm red and swollen 3" by 6". Mother noticed at 1600 11/07/2001. Child playing as usual without complaint.
Woke up with mild slurred speech on Nov 7. Progressed to dysphasia, difficulty mobilizing secretions, difficulty chewing and swallowing, difficulty walking, and  hypersensitive gag.
post herpetic neuralgia; The pt was diagnosed with herpes zoster; Herpes Zoster; painful blistering rash on her arms, back and stomach; painful blistering rash on her arms, back and stomach; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On an unknown date, a healthcare provider administered the zoster vaccine live (ZOSTAVAX) to the patient (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. After receiving the vaccination, pt suffered a painful blistering rash on her arms, back and stomach. As a result of these symptoms, pt presented to her medical provider and she was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, the pt had continued to suffer the effects of herpes zoster and postherpetic neuralgia and she would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Causality assessment between zoster vaccine live (ZOSTAVAX) and the events was considered to be related.  Additional information has been requested.
I awoke during the early hours of 10/08/2021 for a bathroom break and found myself with serious vertigo. I was able to complete the bathroom break; upon arising in the morning, the vertigo was almost gone. I went on with the day. In the very early hours of 10/19/2021, I awoke for a bathroom break.  I felt "off" and checked my BP. The readings were much higher than normal (100-110/60/65-70) for me. Over the remainder of the "morning", the readings were 25-50 points over my usual for the Systolic; 10-30 points, diastolic and normal for the Pulse. I contact my medical groups office when it opened and was told to go to the emergency room.
DTaP placed in L forearm on 3/18/03, Mom called 3/19/03 @ 11am to report marked swelling, redness, heat on upper arm and guarding by pt since this am. Advised to use cold compress Q 10 min on 30 min off and children's motrin.
ANTIBODIES FOR COVID-19 WERE TOO LOW; This spontaneous report received from a patient concerned a 91 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included dialysis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient had too low antibodies for Covid-19 (therapy partial responder). Laboratory data included: COVID-19 antibody test (NR: not provided) was 3.8 on a scale of 4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibodies for Covid-19 were too low was not reported. This report was serious (Other Medically Important Condition). This report associated with product complaint number: 90000187784.; Sender's Comments: V0: 20210760822-Covid-19 vaccine ad26.cov2.S- Antibodies for Covid-19 were too low. 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
Patient has experienced very intense pain in her left arm since receiving both vaccines in the same arm. She reports it being sharp and constant, radiating up her neck and down the back of her arm.
I had body aches and I didn't have a fever. I had a headache.  Three days later, I had a runny nose. That weekend, I did get a fever but it only lasted a day. I saw my dermatologist (regular visit) on January 14th and she put me on Prednisone - (which I'm still taking now since the 14th - the dose is 20 mg once a day) and she also put me on Doxycycline - On the 18th, I tested positive for COVID.  Two weeks before the vaccine, I had quarantined away for 14 days  - after my fiancé tested positive for COVID on December 30th.and I tested negative both time and went back to work on 8th of January and I got the vaccine on the 11th. After my positive test, I quarantined on the 18th and went back to work on 1st of February. On the 25th of January, I did do a televisit with doctor because I was still having symptoms - and by that point I had a cough and a wheeze.  Dr had me use my albuterol as needed every 4-6 hours. I didn't get better from the symptoms until about the 30th or so of January.
Patient called. She stated she had vaccine yesterday and last evening startted to get the chills. She stated she has a temperature of 100.8 this morning and headache.She asked what medication she could take. RN staaed she can take Acetaminophen or Ibuprofen. She asked if she could take Acetaminophen and RN stated yes. She stated she heard if her temperature does not go down in three hours she can take another dose. RN stated do not do that and to follow the directions on the bottle. Reviewed increasing hydration, monitoring tempersture. RN advised to call her provider if her fever does not go down or if increases. RN reviewed to call 911 if any SOB or chest pain. She stated understanding.
Severe nausea, headaches, sinus congestion, arm soreness, arm feeling "heavy" or "numb"
At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.
Information has been received from a physician concerning a 30 year old female who in March 2001 and April 2001 was vaccinated with first and second dose of varicella vaccine. In June 2001, a titer was done and came out negative. The pt sought unspecified medical attention. Additional info has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (Lot, number, dose and route not reported) in 2011, a year ago. The patient received dose 2 GARDASIL (Lot number, dose and route not reported) on 11-JUL-2012, which would be late. No other co-suspects were reported. No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
MEMBER RECEIVED MODERNA-COV-2 VACCINE ON 11 FEB 2021, APPROXIMATELY ONE DAY LATER DEVELOPED FEVER, HEADACHE, MYALGIA, AND ARTHRALGIA LASTING BETWEEN 5 TO 7 DAYS. PATIENT NOTED THAT THE HEADACHE WAS WORSE BETWEEN DAY TWO AND DAY THREE.
Numb/tingly  left hand immediately after shot given.  Following day hand is achy and weak.
This case was reported by a healthcare professional and described the occurrence of night terrors in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline).  Concurrent medications included ZITHROMAX.  The subject has a history of reactive airway disease/asthma and AMOXICILLIN allergy.  The subject had sinusitis just prior to 1st vaccination with HAVRIX and the 1st night terror.  On 22 February 2007 at 10:00 the subject received 1st dose of HAVRIX at 0.5 ml in the left arm.  That night, on 22 February 2007, less than one day after vaccination with HAVRIX, the subject experienced night terror which resolved the same day.  On 27 February 2008 at 10:00 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm.  That night, on 27 February 2008, less than one day after vaccination with 2nd dose of HAVRIX, the subject experienced night terror and a fever of 103.6 degrees F.  The subject was given TYLENOL and the fever resolved the next morning on 28 February 2008.  The night of 28 February 2008, the subject experienced a 2nd night terror.  They then resolved.  Follow-up information was received on 04 April 2008 from the nurse.  Diagnosis was vaccine reaction.  The vaccine reaction, night terrors, and fever resolved on 29 February 2008.  The nurse considered the events were possibly related to vaccination with HAVRIX.  The nurse did not believe the events could have been associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medicinal product, or any other unspecified reason.
Approximately 8  hours after receiving first dose of Hepatitis B vaccine baby developed fever of 101.3 temporally.  Temperature rechecked rectally and was 100.8. Baby was also fussy when laid down . Due to baby's age and onset of new fever, baby was sent to ED for evaluation and full sepsis work-up.  Hospitalized
Initial report was received from a consumer on 24 May 2013. This is a cluster of 2 unidentified  patients who experienced cellulitis following administration of ADACEL, lot number C4418BA. This case is invalid (no patient identifiers). Two unidentified patients (gender, date of birth and ages not reported) had received an injection of ADACEL, lot number C4418BA (route, site and date of administration not reported) and an unspecified amount of time later developed cellulitis. Treatment included antibiotics. Outcome was unknown. Documents held by sender: None.
PATIENT said she had egg allergy. we administered the flublok to her. she said the day after she got redness and itching at her arm.
Infant developed hives approximately 16-24 hrs after receving 4 mos vaccines
muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) 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) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.     No concomitants were reported. No treatment was reported.
Redness and swelling where I got the shot, tired, muscle pain, a headache, shivering, fever, and stomach pain
Morning the day after injection after severe flu like symptoms; body aches, lethargy, head aches, etc. All these symptoms were gone 24 hours later. Morning after injection and lasting through time of report - swollen lymph node on injection side.  Swollen, painful, and limited range of motion in my shoulder.  4 days after injection and lasting through report - severe rash and itchiness. Most of the rash is limited to extremities like hands and feet. Rash caused pretty significant swelling in hands as well. Had trouble removing a metal wedding band.
This spontaneous report as received from a 66 year old female patient, referring to herself. The patient's concurrent conditions included penicillin allergy, unspecified skin conditions and fibromyalgia. Her concomitant therapies included Lisinopril (manufacturer unknown) and estradiol. The patient's medical history included shingles twice before. On 08-DEC-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided) for prophylaxis. On 09-DEC-2017 (24 hours later), she experienced a "rash and redness at the injection site, the rash and redness was approximately 2 1/2 inches long and the shape was oblong. At the time of the report, "the rash and redness was two circles, smaller in size and they were next to each other". The outcome of injection site erythema and injection site rash was reported as not recovered. The causal relationship between the above mentioned events and ZOSTAVAX was not provided.
Vomiting for 2 days after vaccine, Migraine first 2 days then headache that continues to date, Chills, Fever highest was 101.5, body aches, diarrhea on 2nd day.  Tylenol every 6 hours, Brain Fog still to date.
Systemic: Fainting/Unresponsive-Mild, Additional Details: Patient fainted few minutes after vaccination. He was responsive after a few seconds. EMT called, but patient declined care.
weird adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weird adverse reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (weird adverse reactions). At the time of the report, VACCINATION COMPLICATION (weird adverse reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
I just got a funny feeling; I am getting lot of chills; Blood pressure is keeps going up (160, 170; was 185 over 90); Nervous; does not feel good; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, when the patient was watching television, they just got a funny feeling, got lot of chills, blood pressure kept going up, was nervous and does not feel good. It was reported that during the night the patient was like 160, 170 and when the patient took it (reported as now), it was 185 over 90, that they don't feel. It was reported that the patient was worried about the side effects. The outcome of the events was unknown.  No follow-up attempts are needed, information on the lot/batch number cannot be obtained. No further information is expected.
Patient described  arm as red and swollen. States the muscle is tight. It is now red from injection site and traveled to elbow. Stated starting to feel side effects within a few hours of vaccine.
Right thigh w/ erythema under injection site.  Approx area of induration 3cm x 3c,
Shortness of breath & cough, tachycardia (104). RR = 28 BP = 146/96; oral temp 98.4; SaO2 = 97% normal breath sounds; cap refill < 2 sec., skin w/d. Treatment - O2 at 2L; IV BENADRYL 50mg; Prednisone 40mg taper dose x 3 days.
Right leg burning, red, swollen. Doppler showed XL blood clot and numerous small clots in right leg. Put in Eliquis for2-3 wk. brought to hospital on 5.6.21 with worse swelling, red, and right foot very painful. CT showed clots in legs and in lungs. Still in hospital as of 5.8.21
Patient was 17 years old + 4 months and accidently given the new Bivalent Moderna Booster dose (not needed until 18 years old). She could have received  the Pfizer for her current age group  - but at this time a booster was not indicated. Patient and Parent traveling - they were getting Booster doses for travel preparation.  Called the patient and informed them of the error - the patient has had no known adverse reactions and has no further questions.
A report has been received from a pharmacist a 52 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 04-Nov-2014. 52 year old received FLUMIST QUADRIVALENT which started on 04-Nov-2014. The outcome of the event of 52 year old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Pt recv vax on 12/23/98; on 12/24/98 pt exp hives; on 12/25/98 pt exp muscle &joint pain w/ weakness, unable to walk; on 12/30/98 pt exp vomiting, diarrhea, fever x 4 days; tx=Benadryl &Prelone
Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: 1/20/2021 Achy, low grade fever, diarrhea, headache. 1/21/2021 Achy, low grade fever, diarrhea, headache. 1//2/2021 Diarrhea, vomited 1/23/2021 Symptoms resolved.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M003659 for prophylaxis. Concomitant therapies included BEXSERO. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507:
Initial report received from a non healthcare professional on 31 October 2013. A 21-month-old male patient who received second dose of DT pediatric vaccine DECAVAC (batch number: C4161AA, intramuscularly in the right deltoid) on 08 August 2013. The patient's medical history was not reported and had no illness at the time of vaccination. On 08 August 2013, the injection site became red. 3 days later, patient's arm was more red and swollen from top of arm to his elbow. On an unspecified date, the patient recovered. Lab investigations and treatment medications were not reported. The company causality of this case was unclassified. List of document held by sender: none.
Subacute progressive (now moderately severe) polyneuropathy-mainly motor- assoc with highly elevated GM1 antibody, IgM of 172 IV (normal <50) in previously extremely healthy 72 y.o. male. Disease is still progressive.