chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up for work at 3:45 am . Just didn't feel good. Went back to bed and then went down hill. Felt like I got hit by a freight train and a sever headache. Could not open my eyes it hurt so bad. Tried to sleep for the next 12 hours. Headache had let up some body felt sore. Was up for about 2 hours and went back to bed till the next morning.  Felt much better but was wore out from the day before. By the 2nd day evening felt back to normal.
w/in 24 hrs sneezing, nasal congestion, felt bad next 48 hrs; 18OCT93 generalized body rash, hoarseness & throat constriction;
Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date.    The following information on the lot/batch number has been requested.
This 9 year old patient was given a dose of Moderna after 2 doses of Pfizer in the past.  The Mom thought her daughter should get a booster.  The Med Tech saw "Booster" on the Moderna bottle and gave the dose.  He realized immediately.  The patient was observed carefully after the vaccine and had no untoward reaction.
12 hours post vaccine nausea body aches headaches 101.3 fever chills lasting 24 hours followed by more nausea and diarrhea
Started as skin rash - went to doc - provided antivral for -- I had Shingrix shot in Summer 2018
vasovagal- lightheadedness, nausea, dizzy, headache. Patient placed in a flat position, cool cloth to head, and vital signs monitored and within normal limits. Declined EMS
PATIENT JUST TURNED 12 AND WEIGHTED 65 LBS. PEDIATRIC PFIZER WAS GIVIEN INSTEAD OF REGULAR PFIZER.
RAPID HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-OCT-2021, the patient experienced rapid heart rate. On 16-OCT-2021, the patient experienced dizziness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rapid heart rate, and dizziness. This report was non-serious.
sore arm; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; feeling of heaviness/heaviness in my head; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, administered in left arm on 01Mar2021 at 13:00 (at the age of 51-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included hypothyroidism and autoimmune disorders. Patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) at a dose of 112 mg daily, calcium and vitamin supplement. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 at 13:15, minutes after vaccination when the patient was sitting in the waiting/observation area the patient experienced headache and dizziness as if the patient had hit her head or got aneathesia and was about to go out and had feeling of heaviness/heaviness in her head. Patient stayed a bit longer when she thought she could leave 15-20 minutes after the feeling started to subside and but when she tried to walk and go upstairs dizziness and feeling of heaviness was persisted, got better with lots of water. Overall, about 2 hours later around 3- 3.30 pm she was feeling better and went home. That evening around 8 pm, she felt ok without the dizziness or heaviness in her head. She only had a sore arm and was ok the next day. No treatment was received to the patient for the events. The outcome of event sore arm was recovering, rest of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
entire body rash. started on forearm as a vesicular rash on erythematous base. no improvement with topical steroids.  quickly spread to upper right arm as sand paper rash the size of a softball to inner upper arm.  Then large erythematous firm purple tinged almost bruise like on right flank.  another on right inner lower leg.  all rashes of slightly different appearance and inconsistent.  itching, painful, warm.  spares hands and feet and face.  worse with heat, better with cold. no relief with oral or topical meds/steroids.  injection on right arm and all rash symptoms on right side of body.  no other constitutional symptoms.  present for 4 weeks with minimal improvemnt.       pt had previous reaction to HPV vaccine with several weeks of hives and therefore didn't complete the series.  was trying to avoid covid vaccine for fear of hives again but was forced to get vaccinated at place of employment.  first vaccine no reaction, second dose caused the rash
Leg is also swollen; Bump at the injection site. Bump is hard; This spontaneous safety report, with reference number 2022SA261502, was received on 21-JUL-2022, from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events: "Bump at the injection site. Bump is hard" and "Leg is also swollen".  Further information is expected.  For reference purposes the case is linked to MCM-003723 (parent case/ same reporter).
On the day after the shot, I started developing a rash on my forearms and lower legs and ankles. It's a mild red in appearance but very itchy. Have been treating with Triamcinolone ointment and just started taking an antihistamine (Claritin). Went to a walk-in clinic this morning because it was so itchy. Advice was to take an antihistamine and see my primary care physician if it persists more than another week.
Pt received ORIMUNE and experienced fever on 17-JUL-89, 2 wks aft immunization.  29-JUN-89 infant had diffues hypotonia which progressed to flaccid weakness in both legs, weakness primarily affected lt leg paralysis possibly due to polio.
No adverse event; a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a 72-year-old patient received expired Bivalent 4th dose of Moderna COVID-19 vaccine on 02JUN2023).    No concomitant medication information was reported.  Individual vials vial size was reported as 0.4 mL, 0.5 mL, 2.5 mL, or 5.5 mL, 2.5 ml. The vial was initially stored in the refrigerator on 01JUN023 The vial did not undergo any temperature excursions. No treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Live Significant follow up appended.
Subsequently, in addition to experiencing unspecified adverse events, she experienced deteriorating eyesight(NOS) and was losing her mental capacities.
Developed Vestibular Neuritis 3 days after first Pfizer shot.  This is still a problem 3 months later.  I did receive the second shot with no change in symptoms.
Patient received an expired dose of Pfizer 0.3ml. Dose expired on 1/6/22 and was administered 1/7/22. Patient monitored, no side effects noted. Patient's mother notified.
This pain is interfering with my daily activities. The pain is from the injection to just above my elbow. I cannot lift my arm or sleep on my arm. Sanofi told me they had never heard of this complaint. This is day 18
ARM SORENESS IN THE SAME ARM AS THE INJECTION; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included hypercholesterolemia, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 11-MAR-2021. This report was non-serious.
This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 42 year old female patient with unspecified blood disorder and penicillin allergy. The patient became pregnant with last menstrual period (LMP) of 15-APR-2014 and estimated delivery date (EDD) of 20-JAN-2015. On 09-DEC-2014 the patient was vaccinated in error with GARDASIL dose 1 (dose, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included LOVENOX. Initial exposure to GARDASIL was at 34 weeks (third trimester of pregnancy). The pregnancy outcome was pending. No adverse symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Blurred vision, dizziness, redness and swelling and pain at injection site, headache, fast-heart beat, chills, very tired.
03/11/21 - slight headache rest of Day after shot. OK 04/04/21 - Same as above, OK NEXT DAY after shot. 12/16/21 - Same as above. 06/06/22 - Same as above.  *See Next page for last shot - issues. 01/04/2023 - 3rd Booster shot. After morning shot, headache in afternoon. Gone by evening. Arm sore. 01/06/2023 - Morning wake up with bad nausea. This lasted all day.  Barely ate anything all day, chills. Repeated diarrhea all day, along with severe tiredness. Joint pain. Rested all day. this was all gone by Next day. Arm sore.  01/10/2023 - Woke up with diarrhea and intestonal gas. Gone buy next day. 01/18/2023 - Woke up with left eye blurred vision. This was gone next day. 01/19/2023 - Woke up with nausea and intestonal gas. Texted my Doctor about this repeat issue. Advised virtually that the latest Covid Booster is causing this. Told to treat with over the counter remedies. Symptoms gone next day. 01/20/2023 - Feeling well again.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 53-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included prasugrel, Montelukast, CRESTOR, KOMBIGLYZE XR, MYRBETRIQ, TRULICITY, cyclobenzaprine, glipizide, lisinopril and metoprolol succinate. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th May 2018, 1 hr after receiving SHINGRIX, the patient experienced nausea (serious criteria disability) and vomiting (serious criteria disability). On an unknown date, the outcome of the nausea and vomiting were not recovered/not resolved. The reporter considered the nausea and vomiting to be possibly related to SHINGRIX. Additional information was received as follows: The patient visited Healthcare Professional office for a regular visit earlier morning of 11th May 2018, and received SHINGRIX on left deltoid afterwards at 12:30. The patient was not sick at the time of vaccination. The vomiting was severe enough that the patient would stop to vomit while speaking with the pharmacist on the phone.
Arm pain night of second shot. Severe body pain that isn?t being alleviated by aspirin, Advil, or tramadol lasting, so far, from around  3-9pm. Chills for about 30 minutes, tired, rapid heart beat
Pressure headache. Ibuprofen and Tylenol did not help alleviate the  symptoms. Symptoms continued for 48 hours with no relief. Most of the pressure was to bilateral temple area.
pt recvd vax & 6 hrs p/inject exp flu-like sx, stomach cramps, dry heaves, diarrhea, h/a;
1) Very painful swelling in left armpit gland. Started on 9/27 and still have it as of 9/29. Has not went away yet. 2) Drenched in sweat on the evening of 9/27 but went away after about 2 hours.
Dose was not diluted and resulted in higher than dose recommended.  Unsure if any adverse effects were experienced by the patient.
Breakthrough case admission after 2 vaccines Pfizer 2/25/21 Lot# EN6202;  Pfizer 3/18/21 Lot# EN6207
Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated .  With great difficulty she was able to communicate that she had a headache and was slightly dizzy.  Failed FAST and does have a history of CVAs.  EMS called and patient was taken to ER where they admitted her for observation post Stroke.    Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.
This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with VAQTA (dose, route of administration anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medication were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
rash/redness at injection site measuring 2"x2", tender to the touch - noticed 3/2/22 at 8am  rash on forearm measuring 2"x3", itchy, noticed 3/2/22 at 11am
patient's vaccination card was scanned-- this copy only showed only first two doses that were administered (both in March 2021). when the 3rd dose was given, she handed in the actual vaccination card for me to write on and at the back of the card, was the 3rd dose she had in October. I asked her if she already received her 3rd dose and she denied receiving it. I checked immunet and discovered she did receive her 3rd dose.
Trouble breathing. Chest tightness, hives, redness,  started at 10:08 and it was called as a code at 10:15 and they administered epi
Received vaccination at work in a Hospital at approximately 9am on Monday, November 6, 2006 in my right upper arm.  Awakened at 3:30am the next morning, Tuesday, November 7, 2006 with severe tingling and numbness in BOTH hands.  I am left handed.  I have had NO history of numbness or tingling in either arm.  Was concerned about possible stroke or MI symptoms.  Took B/P at home and it registered 188/110.  Took 2 ASA and rechecked B/P several times.  Numbness and tingling and swelling in both hands did not subside.  Went to hospital OR (where I am employed) and rechecked by B/P there.  It was still 180/98.  Numbness and tingling persisted, so I presented at  Emergency Room and was seen by MD.  I was especially concerned about the left hand numbness as it was my dominant hand.  I have never had ANY problems with prior symptoms such as these before.  He examined me, drew lab work, and monitored my elevated B/P.  The digits involved in my hands were thumbs, index fingers, middle fingers, and the inner aspect of the ring fingers.  He diagnosed the problem as carpal tunnel and I was discharged with a left arm splint as this was my dominant hand.  I reported these symptoms to EOHS on Thursday morning, Novmeber 9th to see if any other prior reactions had been reported.  She called MD and there had been some report of Carpal Tunnel in the immunized side, but none bilaterally.  I, at no time, lost no time at work throughout this ordeal.  There was a time lapse between the immunization reporting and this document, because I had a conference for 10 days, then the day I returned, my Mother died and I had another week off for funeral arrangements and support for my Father.  I only mention this to explain the time lapses and delays between the occurrence and consultation with physicians.  The symptoms continued and still are present.  I tried Ibuprofin, but it provided no relief.  My internist at a Clinic was unavailable and I saw his colleague on Friday, December 8th @ 3:20pm (the soonest appointment available).  He confirmed the diagnosis of bilateral carpal tunnel and said I didn't need an EMG as the diagnosis was definitive to him.  They set up an appointment with a Hand Surgeon on Wednesday, December 27th @ 3:30pm which was the soonest I could see him also.  I await the visit and remedy and have seen the EOHS nurses several times for consultation.  I continue to wear bilateral hand splints and this seems to help some of the numbness, but it is still VERY present in the same 4 1/2 digits on both hands.  An employee incident was completed as requested by EOHS on December 6, 2006.  Note that I am due for my second dose of Rubella vaccine for employment, but it is suggested that I defer than until after this situation is resolved.
Driving home after vaccine injection, lips started tingling.  When I arrived home, cheeks started to swell.  I immediately took 2 Benadryl (otc) by mouth and applied ice to the swelling on my face.  When Benadryl wore off, swelling began again, so I took 2 tablets of Benadryl, had to repeat two more times.   As of April 30th at 8 a.m.,  I am not taking Benadryl.  Face is still slightly swollen.  If the swelling starts increasing, will take Benadryl.
Patient is reporting a dry mouth, coughing, eyes being swollen, dizziness. Patient had to call a family member to help take care of her.
This spontaneous report as received from a medical assistant refers to a 11 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reproted. On 13-JUN-2014 the paitent was vaccinted with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # H020002, expiry date: 08-AUG-2015 which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Patient states she began having right arm pain and swelling once she was home after receiving PCV-20 vaccine on 05/08/23. Patient complains of being unable to work and eat since vaccine administered.
The evening after receiving the vaccinations, mom states the baby began watery stools and cottage cheese like appearance, with blood in the stools. Mom states baby has been arching his back and very fussy, acting like his stomach hurts.
Pt had mild itching and redness on both arms from elbow up about 3-4 inches. The reaction started about 20 minutes after the injection and continued for about 30-45 min. There was no redness around the injection site. The patient also reported mild nausea. I recommended a cold compress and that helped with redness. Nausea resolved on its own.
fever, headaches, chills, sweats, arm stiffness/sore, light headed, nauseous, blurry vision, tired
This is in follow-up to report(s) previously submitted on 12/23/2008.  Information has been received from a registered pharmacist concerning a female with allergies to AVELOX  and it was also reported that the patient was "allergic to everything", who on 03-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 663195/1416X, route, dose not reported).  The patient experienced a large red rash at the injection site where ZOSTAVAX (Merck) was given.  The patient states the area is "really red".  The patient sought unspecified medical attention.  No lab was reported.  The patient's large red rash was not recovered.  Follow up information was received which reported:  The 62 year old female with no illness at the time of vaccination on 03-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 663195/1416X) via subcutaneous at 3:00pm.  The pharmacist reported that on 04-NOV-2008 the site of the injection was real red about double quarter size next to each other.  There was no pustule present, just real red and itchy.  No lab tests or diagnosis were performed.  On an unspecified date, the patient recovered from the events.  Follow-up information received from the pharmacist indicated that the patient was a banker.  the patient recovered on 10-NOV-2008.  No further information is available.