chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red welts developed followed by blistery rash. Was prescribed VALTREX followed by BACTRIM to help with inflammation.
I had to go to the bathroom at 2 am and felt like I was being pushed back into bed and then I tried it again and it did it again, finally my husband had to help me get to the bathroom. I'm pretty dependent so that was strange for me. I still feel dizzy, light headed like things are spinning. It's horrible, I sit there for a min or 2 then I can get up but at the beginning I couldn't even get up. Happens when I am laying down and sitting down to get up. And happens when I am standing. It come and goes. I called my doctor and he prescribe me some medicine (meclizine 25mg) until I can get in to see him. I have an appointment in about 2.5 weeks.
her fingertips were white; redness, burning and tingling in her toes; redness, burning and tingling in her toes; redness, burning and tingling in her toes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced redness, burning and tingling in her toes and patient noticed her fingertips were white. The patient still was experiencing, but she indicated that she was saw some improvement. The patient had seen her doctor about this (physician office visit). The outcome of the events was recovering.  No follow attempts were needed; information about lot/batch number could not be obtained.
Patient was instructed to wait 15 min seated in a chair and about 5 min later a patient sitting next to  him alerted the pharmacy staff that he said he wasn't feeling well.  Pharmacist went to check on him and he stated he had ringing in his ears, tingling in both hands, sweaty and felt like he was going pass out.  He appeared very pale (almost white) with white lips upon observation.  He was given some water.  A few minutes later the RPh took his BP in the consult room.  1st reading was 148/135 pulse 93, 2nd reading and 3rd readings were similar around 108/63 pulse 53-58.  Patient stated he felt like "he was coming back".  Patient did not want us to call anyone and stated his wife would pick him up.  He was walked out to his car by a pharmacist  to be picked up.  He had been in the observation area for at least 30 minutes or longer.
Pt recvd 2 doses Engerix 28FEB92 post 2nd dose exp itching, rash, hives, edema, swelling under both arms; nauseated; hand felt it was on fire; swelling & reddening; angioedema; felt bad, like going to throw up or pass out; SEE WORM MORE;
Post-Syncope Seizure, 30 seconds after receiving GARDASIL 0.5 ml left deltoid patient had vasovagal reaction - fainted eyes rolled back. Tongue protruded, full body jerking for 15 seconds, patient unresponsive during seizure activity, EMS notified.
Facial numbness and partial paralysis patient's right side from center forehead, extending around to level with right eye and back to mid skull.  Initially no feeling on skin surface ( similar to novocaine ).  After two months, feeling started to return.  Five months after initial present, feeling at skin surface but area above and to the upper corner of the right eye still has paralysis.  Patient experiences a "tugging" sensasion on the eye. Eye movement is not affected.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 14-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # J003806; expiry date: 03-JUL-2014). Concomitant therapies included ZYCLARA ("Pharmacy record showed that 2 months ago the patient was on ZYCLARA"). On 15-SEP-2013, the patient experienced at the injection site red raised area "the size of a half dollar piece". Approximately on 15-SEP-2013 (reported as "late last night or today"), the patient developed 1 small pustule at the injection site. The patient sought medical attention (visit to pharmacist) and was treated with TYLENOL, MOTRIN and cold compress. The outcome of the events was reported as not recovered/not resolved. No reporter causality was provided. Additional information has been requested.
increased weakness and general malaise. 10/13/21 presented to ED and subsequently hospitalized
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX. Concomitant products included simvastatin, carvedilol, hydrochlorothiazide and potassium gluconate. On 27th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache. The patient was treated with Aspirin and BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine at a local pharmacy. The batch number for SHINGRIX was not reported. The patient stated that after vaccination, she experienced injection site pain, injection site swelling to the size of a grapefruit, injection site warmth and injection site itching, which lasted for 9 days. Three days after the vaccination the patient experienced generalized joint pain. The patient took Aspirin and BENADRYL as treatment drugs, to treat the events. The patient reported that, there was no healthcare professional, who instructed to take the vaccine. The local pharmacist suggested her to take the vaccine. The agent instructed the patient to contact her healthcare professional. The patient had denied permission to contact her physician.
18FEB98 approx 30-45min p/vax & stated lt lip & cheek were red, swollen & numb;also stated the lt side of neck was also red;19FEB98 swelling, redness gone;doing well;
Severe immune system response.  High fever, chills, aches.  Set off atrial flutter and was admitted to emergency room/hospital for cardiac ablation
Report arm tingled across shoulder and down arm and was in pain.  Appointment made with care provider.
Pain down left arm has never gone away and now have weakness.  Vaccine has brought on my Lyme symptoms that I have not had any issues with in 10 years.
pt recv vax 6AUG98 & exp a temp, was cranky & leg was sore & sl swollen;tx included APAP & the use of a cold pack;
p/vax pt c/o feeling lightheaded;pt placed in wheelchair w/head between knees;cool cloth to neck vs P88, R24, BP 90/60;pt diaphoretic pt alert & oriented;vs R20, P76, BP 100/60;
MIGRAINE; BAD COLD UNCONTROLLABLE CHILLS; FEVER OF 101.7; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient never had a positive covid-19 test but the whole family was sick in JAN-2020 and had all the symptoms of covid-19.The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced migraine. On 13-MAY-2021, the subject experienced bad cold uncontrollable chills. On 13-MAY-2021, the subject experienced fever of 101.7. On 13-MAY-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from migraine, and fever of 101.7 on 15-MAY-2021, and the outcome of bad cold uncontrollable chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
About 5 to 7 minutes after receiving shot (while waiting her 15 minutes post vaccination) she came back up to pharmacy window and said she was getting hot and red all over and felt she was having allergic reaction.  I sat with her for about 30 to 40 minutes to make sure she was maintaining normal breathing.  She did take some oral Diphenhydramine as was very itchy and red. She did have friend with her and we instructed her to go to ER if got worse.  Next day 3/24/21 patient called and said she had a productive cough and was advised by staff pharmacist to go to Dr.  She called back and said did go to Dr. and was prescribed steroids and antihistamine (was on steroid at time of vaccination but we were unaware) and Dr told patient not to get 2nd vaccination. Patient was doing better but not completely recovered
bladder infection; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 13May2021, as a single dose for covid-19 immunization. The patient medical history included asthma. The patient's concomitant medications were not reported. The patient previously took penicillin for Lung stuff and experienced Anaphylaxis. On May2021, the patient experienced bladder infection. It was reported as received her first dose of the vaccine on 13May2021 and started taking antibiotics for a bladder infection on Monday. Her antibiotic regimen will last for 5 days. Reports her reaction to penicillin was a long time ago, she has asthma and was always treated with penicillin for lung stuff, but that was a long time ago. Caller states since then, she never took penicillin, even the pills, she tries to avoid that. Stated earlier she got the first dose of the vaccine and right now she was taking antibiotics and she was scheduled for the second dose on 03Jun2021. Transferring agent states the caller is wondering if that was okay if she can get the second dose. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
I noticed the stiffness getting worse in my hands about April 17th. I figured it was because I had gotten off my RA medication. When I got back on May 7, that first week of May (1st or 2nd) - my hands were waking my up 4-6 times a night because I couldn't used my right hand - had to use my other hand (my left hand doesn't have as much problem) to open up my hand - joints were stuck. I saw my doctor on May 18th and he prescribed me Prednisone for a week and a I did acupuncture for two weeks and I got back on the Methotrexate (I've only been back on it one week now) and now I can use my hands. I can sleep through the night without hand waking me up.
Intense itch and redness at injection site continues on day 8.  Headache is intense scoring 5/10 with no decrease when medication take.  Started 4-5 hours after injection.
Tender axillary lymph node in the right arm; Tiredness; Pain in her right arm where she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Tender axillary lymph node in the right arm), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine). On 10-Jan-2021, the patient experienced LYMPH NODE PAIN (Tender axillary lymph node in the right arm). On 08-Jan-2021, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine) had resolved. At the time of the report, LYMPH NODE PAIN (Tender axillary lymph node in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.
Fever lasting two days,  pain in the right arm.  Significant swelling in hands and feet making it impossible to grip things with hands. 10 days later, extreme paresthesias in the upper and lower extremities, face, and tongue lasted for two months.  The numbness in the tongue and hands continue.  Severe shortness of breath is continuing.  Respiratory disorder continues, unable to clear my lungs after several Dr. visits and ER visits.  Xray of the lungs, however, seems clear.
chest pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 7-year-old female patient received bnt162b2 (COMIRNATY) (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Complained of headache approx 20-30 min. after getting vaccines on 10/9/14. Checked with client 10/14/14 and there is no problem.
Both injections given too high on the deltoid, and too close to the shoulder joint. Left deltoid injection site with localized redness approx 2-3 inches in diameter. Patient c/o pain to both locations, and that injection site was too high.
Sore arm, general body ache, slight fever (99.3), accelerated heartbeat, grogginess
The pt developed a high fever and had a convulsion. He was rushed to the hospital and given test including a spinal tap. By the age of 2 1/2 he was dx with PDD.
patient reports HSV1 breakout at 3 days and again at 7 days post vaccination. (has had previous hsv1 breakouts)
Bruising noted 08/31/2001. Evaluated 09/01/01, platelet count 0. Diagnosed with idiopathic thrombocytopenic purpura. Hospitalized for IVIG infusion.
pain in left arm at injection site followed by severe headaches. Arm was sore for the next 2 days
Within 3 weeks of 2nd shot began to have low platelet counts, was sent to hematology and assured her platelets were high enough, greater than 100, platelet levels would fluctuate as bruisers on her abdomen would go away and come back.  Patient suffered a hemorrhagic stroke on June 23rd and passed on June 24th 2022 approximately 14 months after receiving 2nd Pfizer shot.
May have received three doses of Shingrix; This case was reported by a physician via sales rep and described the occurrence of extra dose administered in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2023, the patient received Shingrix. On 14th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Feb-2023 Reporter's comment:  Sales rep submitted report with possible AE related to the case.  An unknown amount of patients might have received three doses of Shingrix. There was no additional AE information available at this time.  See email to safety team regarding contact information for GSK sales rep. Additional supportive information:  The patients might have received three doses of Shingrix, which led to Extra dose administered.
JOINT PAIN; HEAVY MUSCLE ACHES; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced joint pain. On 13-APR-2021, the subject experienced heavy muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy muscle aches, and joint pain. This report was non-serious.
This case was reported by a consumer and described the occurrence of nausea in a male subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). It was reported that the vaccine was a combination of H1N1 shot. An unspecified amount of time after vaccination with Influenza vaccine, the subject experienced nausea, diarrhea and vomiting. At the time of reporting the events were resolved. This adverse event was reported during the course of follow-up with regard to a reaction to AVODART. The subject happened to mention that he received a combination H1N1 shot with the above adverse events reported. Refer to case number A0885456A for details surrounding vents with AVODART treatment.
so tired; head was hurting so bad; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (so tired) and HEADACHE (head was hurting so bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (so tired) and HEADACHE (head was hurting so bad). At the time of the report, FATIGUE (so tired) and HEADACHE (head was hurting so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs included no treatment drugs included
The patient inadvertently received pediatric dose (10mcg); The patient inadvertently received pediatric dose (10mcg); This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number N234J, expiry date 21st January 2022) for prophylaxis.   On 11th January 2022, the patient received the 3rd dose of Engerix B pediatric (intramuscular) 10 ug. On 11th January 2022, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter reported that, the patient inadvertently received pediatric dose (10mcg) of Engerix-B in the right arm, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
MMR II given IM.  Clinic guidelines state MMR II needs to be given SC.  No adverse event.
After pharmacist injected the flu shot, she noticed that the needle was shorter. She checked the needle and it was 5/8" in 1" box. She notified the patient and asked for her Doctor information so pharmacist can discuss if patient will need the 2nd dose of flu shot. Patient stated she will talk to Doctor herself. Also, pharmacist spoke to pharmacy manager who refilled the wrong needle size in 1in needle box. We will double check the size of needles before refilling as well as injecting to make sure the right size.
On 7/29/00 AM rash on left arm (size of quarter). On 7/29/00 PM, area of rash enlarged 2-5 X and itching, took Benadryl. On 7/30/00 AM, arm was swollen and red as well as hands and fingers. Could not remove ring. On 7/31/00 at 02:30 AM, complaining of pain and insomnia. Took Motrin 800 mg and Benadryl. On 7/31/00 at 11:00 am. Swelling decreased but complaining of weakness of arm and hands, with itching and tender to touch.
Medical called to evaluate patient 2nd  symptoms started approximately 10 mn after injection.  She states she felt a wave of tingling come over her chest, her heart starting racing. She then began to feel that she had a dry mouth/ and throat clearing.  12:26 epi pen given by rn prior to ems arrival  Pt moved over to observation tent.
Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Started with loud ringing in my left ear at 2pm, followed 2 hours later with complete hearing loss in left ear and then woke up the next morning  at 6:30am with severe vertigo (nausea and inability to walk).  Vertigo got better after lights turned on to the point that I had no nausea anymore, but needed to hold onto things while walking.  Ringing  Went to urgent care at 10am to get assessed and after speaking with an ENT they prescribed Prednisone and Meclizine.  Meclizine didn't help so only took for 2 days, was on Prednisone for 3 weeks .
Covid-19 Tested positive on July 16, 2022 4 days after I had a very mild  sore throat and i also experienced extreme fatigue. I was giving antibodies for treatment.
1 of 2 pts who devel a rash near site of Tetramune vax;also recvd MMR @ same visit;reporter could not recall pt's name;pt devel hive-like erythema multiforme lesions around the knee on leg vaxed w/Tetramune & on arms & trunk;