chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported dizziness and was moved into invertable chair, she described feeling weak and lightheaded.  Per allergic reaction protocol she was given 50mg of IV benadryl while her BP was checked every 5 minutes.  No decrease in BP during episode.  Dizziness/lightheadedness did not resolve, per MD and protocol 100mg IV solumedrol was administered while continuing to check BP every 5 minutes.  She did not feeling better and could not stand, 911 was called for ambulance to ED for assessment.
Swollen left arm size of small orange.; Arm burning feel like on fire; Painful; Large red rash; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. It was reported that the patient had known allergies to medications, food, or other products. Other medication within two weeks of vaccination was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:00, the patient experienced swollen left arm size of small orange. Arm was burning and felt like on fire. The patient also experienced large red rash. It was painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen left arm size of small orange, arm was burning and felt like on fire, large red rash, painful was not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Throat tightness, itchy throat after 2nd dose. Patient reported that with 1st COVID-19 vaccine developed itchy throat and mild tightness and received Benadryl. Patient denied shortness of breath and wheezing. Patient reports that she took her own Benadryl 25mg at 11:15 am, about 45 minutes after 2nd dose. Patient also reported that "this time is much better than 1st time" and may be related to anxiety. Stable. Released from vaccination site.
Patient described intense pain that started in her legs and moved up her back within 5 minutes of vaccine. She didn't not have swelling of the face, neck or tongue. She stated the pain made her short of breath. I, pharmacist, called 911 while sitting with the patient. She did not appear to be having an anaphylactic reaction but Epipen was next to me. EMTs arrived and took patient's vitals. By this time, about 25 minutes after initial symptoms, patient states the pain had subsided and declined going to the hospital.
Moderna vaccine given expired 10/24/2021-  monitoring- vitals stable, no complaints at 1400.
After I received my 1st dose i began to have shortness of breath on and off every once in a while; Had very very sore arm; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported  after I received my 1st dose I began to have shortness of breath on and off every once in a while and had very sore arm.  The outcome of events was unknow.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures).   Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented.    As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping.   He does not have any contraindications to receive 2nd dose of vaccine.
Pt recv vax & devel inj site rxn of swelling,redness,warmth & pain.This is 1 of 5 pts to devel inj site rxn w/this same lot #.
On 07/16 patient presented to pharmacy with a 2.5 to 3 inch wide and 4 inch long red area where she was given Zostavax on 7/13. She has had no other symptoms ot signs of illness. I refered her to her primary care. She was going to drive over after we talked, have not followed up with patient yet.
1 week after I felt welts on my arm around the injection site that we're itchy.  I took Benadryl and applied an ice pack.  The next day where the welts were my arm is now red and warm feeling.; Slightly itchy.  My arm has felt heavy like a swollen feeling although not swollen - as if my arm was asleep.
develop a rash; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but selected adult as per vaccine indication. The patient asked, if it was possible to develop rash after taking Shingrix shot. The patient did not consent to follow up.
Vaccine given beyond use date, incorrect BUD listed on vaccine. BUD: 2/27/2023. No adverse events were reports by the patient.
Arm swollen, large red area, itching, headache, general overall body aches.
14MAR91 pt in clinic w/arm red & swollen inc temp; Mom stated started then evening p/immun arm very swollen, child could not move arm- fever to 102;
Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); My wife who is a doctor has said is definitely shingles; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177, Expiry Date: not reported) via an unspecified route of administration, administered in arm left on 20May2021 at 18:00 (age at vaccination 39-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0175, Expiry date: not reported) via an unspecified route of administration, administered in arm left on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, patient had not been diagnosed with COVID-19 prior and had not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 at 19:00, the patient experienced pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base) that my wife who was a doctor has said is definitely shingles. The patient did not receive treatment for the adverse event. The patient was not hospitalised for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
I got my flue shot and today I have the flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for prophylactic vaccination.  On 31-DEC-2022 the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "I got my flue shot and today I have the flu".  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Arm pain at site of injection. Taking ibuprofen for pain. Applying ice and heat.
Patient called and claims after receiving the ZOSTAVAX vaccine on 10/18/12, she has bouts of shingles symptoms every year since. Per protocol and CDC recommendations, we needed a prescription from her PCP as she was not of age for a standing order from the pharmacy. Claims fatigue, pain persisting for 12 months every year.
Difficulty swallowing, took 25 mg Benadryl, had mom call the doctor's office, appt. made after talking to the doctor.  No respiratory problems.  Got to office stated her throat felt like it has in the past after having a cavity filled, kind of numb.
Flush; Body aches; Nausea; 99.5 is the highest temp; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) 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 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp). At the time of the report, FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 99.5 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Simple febrile seizure - temp up to 103, 13 days after vaccines. Other vaccines were given with this dose of MMRV: DTaP #4, PCV13#4, Hib #4, and Hep A #1 - as the child was behind on vaccines.
The following morning after receiving my first dose of the Pfizer COVID-19 vaccine I began my cycle early. It came about a week earlier than my normal cycle. I have a regular cycle towards the end of the month and have never been irregular. I also had painful cramping which is not normal during my cycle.
I experienced a little nausea and soreness into my left arm. I also had a headache.
chronic urticaria daily hives pruritic /dermatographia  ,neuropathic burning pain hives /frequent angioedema throat
BLOOD CLOTS IN LEG; This spontaneous report received from a patient via a company representative through social media (J and J Corporate account) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 6 months after second shot, the patient experienced blood clots in leg (dose number in series 2) and was on blood thinners. It was reported as, "6 months after my 2nd Johnson and Johnson shot I had blood clots in my leg. Now on blood thinners but does that even do anything for those covid blood clots. Wish I never took it or my kids. I trusted you." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210405- blood clots in leg . The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: lantus, reaction: "Known allergies: lantus"; Known allergies: amlodipine, reaction: "Known allergies: amlodipine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.
09/04/22 presents to ED for "chest pain and weakness". PMHx of "HIV/AIDS and hypertension"
Joint ache in hands and knees; Fever; Muscle ache in neck; Headache; Received the second dose one month and 10 days after getting the first dose; Nausea; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced nausea. On 22nd October 2019, the patient experienced arthralgia, fever, myalgia, headache and drug dose administration interval too short. On an unknown date, the outcome of the arthralgia, fever, myalgia, nausea, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the arthralgia, fever, myalgia, nausea and headache to be related to Shingrix.  The patient received Shingrix about 10 hours experiencing joint ache in hands and knees, fever, muscle ache in neck and headache. The fever and headache are improving. Patient also stated that he received the second dose one month and 10 days after getting the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up. No further details were provided.  The caller was reporting adverse event for himself and his wife.  This case is 1 of 2 cases, reported by same reporter.  From the case description it seems that US2019193745 is duplicate of US2019192798. As the case US2019192798 was reported earlier, it should be considered as case of record. Case US2019193745 would be deleted from system.
not feeling well for two days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) in a 36-year-old male patient 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 (not feeling well for two days after receiving vaccine). At the time of the report, VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.
Fevers, Tachycardia, Myalgias, Nausea, and Vomiting: requiring ED visit 2 L NS, 8 mg SL Zofran, Acetaminophen 500 mg,  and Toradol 15 mg.
This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K007824, expiration date: 04-NOV-2015, dose 0.5 ml) subcutaneously in the arm for immunization. On an unknown date the patient experienced redness and swelling on their arm at the injection site. The patients had sought for medical attention by making a phone call to office. The outcome of the events was unknown. The caller requested a lot check for PNEUMOVAX 23 lot # K007824 with expiration date: 04-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
twitching & jerking head to the rt side w/rt shoulder & arm movement 3-4x-4-5x/day; p/2 1/2 wks started to slowly go away; then started dropping chin to chest in a very quick motion 8-12x per day x 2 1/2 wks; pt cranky had disturbed sleep
Chest Pain that comes and goes, non radiating pain. No sign or symptoms of allergic reaction.
Shingles, rash, nerve pain, numbness and digestive upset. Started on 12/26/2021. Diagnosed by doctor on 12/29/2021. Symptoms still lingering to present date.
On 2/21/2021 approx. 5PM patient noticed some pain and swelling of right axilla. Described as if "someone punched me in the armpit." Symptoms worsened by the next morning, so on 2/22/2021 patient sought care at a local Urgent Care facility. Treating provider felt symptoms were most consistent with cellulitis of the right axilla. One week course of antibiotics (Bactrim 1 tab twice daily) was prescribed. Follow up with PCP was recommended for 2-3 days or sooner if symptoms worsened or additional symptoms presented. No laboratory testing or radiology procedures were performed. Patient filled prescription for antibiotics and started taking same day. On 2/25/2021 patient reported that symptoms were improving but not completely resolved.
Headache; shot site very sore; very tired; 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 HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired) outcome was unknown.            No concomitant and treatment drugs were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Dose given from vial opened/punctured on 09/09/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/15 from previously punctured vial.  Vial kept in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
Severe pancytopenia.  Bone marrow biopsy consistent with aplastic anemia, currently hospitalized.  Transfusion dependent for platelets currently and may be transferred soon to tertiary hospital for aplastic anemia treatment.
Patient experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 158/94  99% O2 room air HR 64. Patient Refused Evaluation/Care released against medical adive.
Woke at 7:00a, walked to the kitchen - was dizzy, sweaty, nauseous. Sat down with ice on my forehead. When I stood up, I fainted. I felt like I had the flu all day. I went to bed at 8:00p and woke up the next morning feeling good.
I broke out in hives about a week and half after my covid shot. Itchy and red skin all over my body.