chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
Fatigue started 3 hours after shot. Woke up with bad fatigue the next morning, muscle aches, and headache. Headache has persisted. Treating with Ibuprofen
60 mm round area of erythema surrounding injection site, warm to touch, and tender to palpation. No drainage or lesions noted, no fever.
Expired ANTHRAX administered. Lot FAV231, Exp date 4Oct10. Given 15 Oct 10. No adverse reaction noted.
Mother of child states 11/15 size of a dime large lump with redness developed on R arm at injection site. It continued to increase in size on 11/16 became very warm to touch 3 large half dollar size blotches were present. 11/17 began to resolve and now completely gone without further complications.
The day following vaccination I began to have abdominal pains with nausea, and diarrhea. I have been very tired only able to stay up approx. 3 hours then must lay down. Diarrhea quit after 4 days but am still nauseated and feel cold all over.  No fever, no vomiting. Very shaky. I have been keeping hydrated by drinking ginger tea, green tea, ginger snaps.  I am hungry and can eat small amounts which makes me feel better for a couple of hours but then back comes the abdomen discomfort. I am a cardiac patient and a diabetic.
Onset of local reaction in AM of 10/26/00. At time of exam, had 7cm X 9cm area of erythema and induration on left anterior thigh. Treated with Benadryl.
Swollen red hot left arm where flu shot was given (from shoulder almost to elbow). Swollen red (L) arm. Rx. cold compress - No BENADRYL.
medication leaked out from syringe; most of dose ended up on patient's thigh; most of dose ended up on patient's thigh; syringe issue; pharmaceuutic product complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-month-old female patient who received Hib (Hiberix) (batch number BA975, expiry date unknown) for prophylaxis.   On 1st August 2022, the patient received Hiberix .5 ml. On 1st August 2022, unknown after receiving Hiberix, the patient experienced incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint were unknown.   Linked case(s) involving the same patient:  US2022115404   Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's Comments: The reporter calling about Hiberix.  A patient was to receive dose and when giving the dose the medication leaked out from the syringe out of the hub of the needle that was connected to the syringe.  So, there must had been a defect in the connection and most of the dose ended up on the patient's outside of the thigh versus inside of the thigh. The syringe might have a defect and that was the reason of the leaking. The reporter informed that he/she could be reached between the hours of 8:30 and 5. Health care professional (HCP) did not provide any patient details, date of birth, lot number, or expiration date of product.   HCP provided contact for follow-up. Additional Supportive Information: Hiberix was administered incompletely since the syringe leaked, which led to incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022115404:FU2 - Deleted
This spontaneous report as received from a Nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 04-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX. Concomitant medications were not reported. On 04-JUN-2014, the patient was inadvertently administered with (Oka/Merck) VARIVAX that was incorrectly stored. No adverse effects were reported. The outcome of administered with (Oka/Merck) VARIVAX that was incorrectly stored and no adverse effects was unknown. Additional information has been requested.
Hives on arms-extremely itchy and raised.  After several days started taking Benadryl and Pepcid. Still itchy and it has been almost 2 weeks.
This spontaneous report as received from a consumer refers to a his male friend of unknown age with CLL (Chronic lymphocytic leukaemia). On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot, dose and route not provided). On an unknown date, the patient experienced died. On an unspecified date, the patient sought medical attention by doctor's visit. The patient cause of death was not provided. The reporter considered this report as life threatening. Additional information has been requested.
Information has been received from a physician concerning a female who on 03-JUL-2008 was vaccinated with the first 0.5mL dose of GARDASIL (Lot # 0250X) IM into the right deltoid. After receiving the first dose of GARDASIL, the patient experienced rash behind one of the ears. The patient sought medical attention, spoke to the physician. At the time of the reporting, the outcome of the patient was unknown. Additional information has been requested.
Patient presented to pharmacy with swollen and red injection site. She was referred to emergency department and was diagnosed with cellulitis and was prescribed clindamycin 300mg three times daily for 10 days.
Painful itchy raised Rash on bend of right arm 1x1 inch in size. Smaller in size on the fore left arm. Still present after 10 days
Pt complained of sore throat immediately after vaccinations. AFter two hours pt could not be calmed due to painful swelling of tongue and throat. Drooling. Unwilling to swallow, eat or drink. No breathing impairment. Negative strep test (two). Pt in perfect health prior to injection. Benadryl given by MD. Rash on back next day. ER supervision in case of breathing impairment.
Covid arm. Upper left arm with itchy raised rash in the outline of a deck of cards.  Used benadryl and hydrocortisone cream
5 x 5 cm urticarial rash around injection site started 30 minutes after injection. Was given 5 ml of BENADRYL with improvement of itching and redness. Observed x 30 minutes with no worsening of symptoms.
Pt states that when he left work at aproximately 5pm he felt worn out.  When he got home later that evening he started running a fever of 102. He continued running a fever the following day and when he came in to the clinic on the 11th of July his temp was 100.5 orally.  At this time it was noticed that he had sores in the inside of his mouth.  Pt seen by DR to evaluate. Pt given Motrin and told to follow up as needed. There was no difficulty breathing at any time. Pt was given his first Hep B and was also given typhoid but he has received this before.  A PPD was also placed.
Redness & swelling at injection site; Redness & swelling at injection site; Dizziness; Hot & cold sweats; Hot & cold sweats; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 30Mar2021 (at the age of 86-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On the second or third day after receiving the vaccine, the patient experienced redness and swelling at injection site, dizziness, hot and cold sweats. The event were reported as non-serious. The outcomes of redness and swelling at injection site, dizziness, hot and cold sweats were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia, swollen glands, fatigue, injection site itching, discomfort Narrative:
On 7/9/21 at approximately 11 or 11:30 AM , I injected patient with Janssen COVID 19 .  This afternoon, I realized that the vial had been punctured the previous day 7/8/21 @ 11AM. I contacted my regional manager and then contacted Janssen for stability and sterility information. The drug company was unable to provide me with any information. I contacted the patient and explained to him what had happened. He stated that he was fine and that he would contact me if any issues arose.
Received DTAP injection on 2/18/03 and returned on 2/21/03 with erythema with itching 11cm X 15cm area. Dx'd with cellulitis and put on Keflex X 7 days and Benadryl.
8aug91 21 days /p vax;hip pain;pain/swelling of fingers&knees cont;23aug91 RF test+(40);ANA neg;Next 2yrs polyarthritis was dx as rheumatoid arthritis by MD tx extensively;serum rubella antibody pos & RF neg on 10jan94;
Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient has history of PAT (tachycardia) and heart palpitations and is history of Verapamil per patient. He was not feeling well after the shot and we observed him and had the minute clinic nurses come to take his blood pressure and heart rate. He was feeling heart palpitations after the shot. After the nurse took the blood pressure he felt better and his palpitations slowed down so we had him sit again. He had palpitations again nurse call 911 paramedics took pt to hospital
Complete numbness of right leg (below knee) and foot.; I also had some pain in back of right knee; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 13Oct2021 at 16:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, controlled high blood pressure and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glipizide/metformin hydrochloride (GLIPIZIDE/METFORMIN), carvedilol (MANUFACTURER UNKNOWN), amlodipine besilate (AMLODIPINE) and olmesartan medoxomil (OLMESAN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 24Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient received other unspecified vaccines within four weeks prior to the COVID-19 vaccine. On 15Oct2021 at 10:15, the patient experienced complete numbness of right leg (below knee) and foot and also had some pain in back of right knee. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events complete numbness of right leg (below knee) and foot and also had some pain in back of right knee was resolved on an unknown date in Oct2021.
misrepresented himself by altering his name, address, or phone number on 2 occasions to receive $100 vaccine incentives. 1st COVID vaccine was given on 09/03/21 Janssen (#204A21A); 2nd COVID vaccine was given on 09/10 Janssen (#204A21A); and 3rd COVID vaccine was given on 09/17 Pfizer (#EW0181).  lied on his intake form regarding if he had received the COVID vaccine before. He also lied when the nurse verbally asked him if he had received a COVID vaccine before.
Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), LISINOPRIL, OMEPRAZOLE, AMLODIPINE and BUDESONIDE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (Nauseous). On 14-Mar-2021, DIZZINESS (Dizzy) and NAUSEA (Nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Medication was available.
The vaccine that was given was expired past the 30-day recommendations. At this time there have been no s/s of any adverse events.
DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Narrative: A 41yo female with no immunization information in the facility system On June 23, 2021 at 15:53 NP reported the patient had a historical ADR of Covid-19 vaccine induced Anaphylaxis The report included breathing difficulty occurred 15 minutes after receiving the Johnson & Johnson Covid-19vaccine and staff administered Epi-Pen
Roughly a month after the vaccine, had shortness of breath, low oxygen level, disabling fatigue, bad headache, coughing up blood. Symptoms worsened over 3 weeks. Considered asthma, then pneumonia (with antibiotics), conditions worsened, so referred to a pulmonologist.
Only one menstrual cycle since April when had first dose; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose). At the time of the report, MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided. Treatment information does not provided. The patient had only one menstrual cycle since April when had first dose.   This case was linked to MOD-2021-372632 (Parent-Child Link).   See case MOD-2021-372632 for details regarding the child case.
After the second covid shot I immediately started having having lower back pain.  Since I've had this before, I knew it was  caused by Inflammation.  All I took for it was Acetaminophen. Some days none, some days 1.  Never more than 1. Yesterday 5-24-21 it completely quit.  I was amazed.  Thought you should know. Thank you for your time.
tested positive for covid19 after receiving vaccine; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications. On an unknown date, the patient tested positive for covid19 after receiving vaccine, coughing and did not feel super well. It was reported that when mentioning contacts, reporter stated his boss had friends over, she got her vaccine last Friday, but she was in contact with someone. It was a huge house and people were all around and they did not have waiters because caller had nobody to serve them. reporter was very conscious, he added that maybe her boss went out and got contact with someone. Reporter's boss did not tell him or anything and added that his boss obviously got the virus on the Monday night, she did not feel super well and on Tuesday, his boss was coughing a little bit and she went to go get the test and tested positive. She tested positive on Monday morning. They did PCR test and she was positive. Reporter does not want to report on his boss, she will probably do it on her own. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pain in arm; skin reaction on arm red; skin reaction on arm swollen; skin reaction on arm itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm), VACCINATION SITE ERYTHEMA (skin reaction on arm red), VACCINATION SITE SWELLING (skin reaction on arm swollen) and VACCINATION SITE PRURITUS (skin reaction on arm itch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm), VACCINATION SITE ERYTHEMA (skin reaction on arm red), VACCINATION SITE SWELLING (skin reaction on arm swollen) and VACCINATION SITE PRURITUS (skin reaction on arm itch). At the time of the report, VACCINATION SITE PAIN (pain in arm), VACCINATION SITE ERYTHEMA (skin reaction on arm red), VACCINATION SITE SWELLING (skin reaction on arm swollen) and VACCINATION SITE PRURITUS (skin reaction on arm itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Day 1: Fever 100.5 after ibuprofen and Tylenol. Chills, Severe muscle aches, headache, and ear/jaw pain. Abdominal pain. Stiffness. Day 2: Diarrhea, abdominal pain, leg pain/restless leg
Initially ( on the night of 2-26-2021 while taking a shower), I noticed a lump under my left armpit. It was slightly swollen and sore/painful to the touch...after about 3 to 4 days this subsided. On Monday ( March 1, 20201) until the present I have had intense pain at the nap on my neck -it is a stiffness and tightness. It is intermittent and can only be relieved with ibuprofen
Here?s what happened to me to far, starting on my walk home from the rec center and monitored at home by myself using my oximeter:  Starting 40 minutes after injection: -oxygen rate went down to 94% -heart rate went up to 140 -Numbness in the right side of body, especially my right leg and arm. Currently feels like there is a block or something in my right leg. Massaging it now.  -Hard to swallow/ swelling on right side of throat (I think my thyroid nodules are inflamed). Caused me to feel like my throat is closing. But I?m able to breathe fine when I don?t panic and concentrate on my breathing.  -Sense of impending doom, which relaxes when I focus on my breathing  -tingling right foot  2.5 hours after injection: left arm is starting to feel numb as well. Other symptoms persist, though oxygen levels are back to  98% and bpm is down to 88-90
Headache, Myalgia, Arthralgia, Fever, fatigue, arm soreness Narrative: Headache, fever 100.4, myalgia, arthralgia, fatigue, arm soreness. Recovered 96 hours with exception of sill being lethargic, currently being treated. for possible pneumonia, also swabbed for COVID 2/2/21. Second set of s/s started 2/1.
I had a major headache the first couple of days and my blood pressure was extremely high. 200/100.. i have the headache under control some but my bp is still high is 178/95 pulse is 68..
Fever to 101 degrees F, chills, malaise, muscle and joint pain, fatigue, abdominal pain, nausea, anorexia, lightheadedness, diarrhea. Fever lasted 4 days, all symptoms resolved in one week.
Right arm red and swollen, hot to touch. Redness midway down arm. Marked redness, Benadryl PO TID pack.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 02-MAR-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # R013129, expiration date 03-FEB-2019, intramuscular (dose and anatomical location was not provided) for prophylaxis. No adverse effects were reported.
Headache  fatigue  Narrative:  Per nursing report: "reported adverse symptoms after her 2nd COVID 19 vaccine this morning [5/3]. Employee complains of headache and fatigue"