chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after second dose, COVID arm reaction; red circle around the injection site; slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (after second dose, COVID arm reaction), VACCINATION SITE ERYTHEMA (red circle around the injection site) and VACCINATION SITE PRURITUS (slightly itchy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE REACTION (after second dose, COVID arm reaction), VACCINATION SITE ERYTHEMA (red circle around the injection site) and VACCINATION SITE PRURITUS (slightly itchy). At the time of the report, VACCINATION SITE REACTION (after second dose, COVID arm reaction), VACCINATION SITE ERYTHEMA (red circle around the injection site) and VACCINATION SITE PRURITUS (slightly itchy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-406282 (Patient Link).
This spontaneous report was received from a registered pharmacist concerning an approximately 72 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J005721 and 29-AUG-2014 respectively), subcutaneously. Concomitant therapy included FLUZONE (lot number, expiry date, dose and route unspecified) administered on 23-OCT-2013. On 23-OCT-2013, the patient experienced intense itching on her trunk and legs later that day. Approximately on an unknown date in 2013 (reproted as after a few days), the patient developed raised bumps on her trunk and legs that looked like chickenpox. The patient did not seek any medical attention. The patient was treated with over the counter (OTC) BENADRYL. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. VZVIP packet was declined by pharmacist. Additional information has been requested.
Rash at vaccine site started proximately eight days after injection. Size of a tennis ball, bumpy and warm to touch for 2 days then bumps subsided. Remained very itchy and red for  a week. Now 29 days later red circumference still  visible and slightly itchy.
At the time I was going to inject the vaccine into the patient's arm, he moved and subsequently got punctured by the needle.  The vaccine had to be re-administered shortly thereafter.
From initial information received on 1/18/05 from a health clinic regarding an adverse event, it was reported that a 24 year old male patient received his first dose of JE-VAX, lot number EJN213A, administered in the left deltoid, and his first dose of PNEUMOVAX, lot number 0513P, on 1/11/05 at 10:00 AM. The route of administration was not reported for either product. Twelve hours after receiving the vaccines, the patient developed chest tightness and was unable to sleep. The events lasted 20 minutes and then resolved. The patient was hospitalized and recovered from these events.
Severe rash 9 days after injection.  Extreme itching. Rash is subsiding after 9 days but still active.
Prior to getting the vaccine, I have a history of hypertension and cardiac EF of 50%-55%.   After the 2nd dose vaccine, I started to notice increased shortness of breath upon exertion and at rest, chronic fatigue, chest pains, lightheadness, weakness in arms and legs and difficulty breathing when bending over .  I had these symptoms for about 2 weeks. On May 6, 2021 , I had chest pains that would not go away and went to the ER.   They ran a bunch of tests, EKG, blood work, and  X-ray.  They were going to admit me to the hospital, I asked to be transferred to a different Hospital since my cardiologist is at that hospital.  I was admitted to Hospital and did a left heart catherization they next day.  I did an ECHO that measured my EF to be 30%.   I was discharged on 5/7/2021 and to follow up with my cardiologist with a diagnosis with non-obstructive coronary artery disease.  The symptoms continued to worsen and I did see my cardiologist at the end of May 26, 2021  who changed my medication from labetalol to carvedilol.  On June 30, 2021, my doctor added Spironlactione to help decrease my blood pressure.  On July 12, 2021,   I did go back to the ER since I was having symptoms  of lightheadness, dizziness, chest pressure, nausea  and difficulty walking and balance issues.  I was diagnosed with hyponatremia (low sodium).   I did get another ECHO on 7/13/2021 that measured my EF to be 35%.  Since then, I have had episodes of low blood pressure and my neurologist have ordered a pulmonary function test.
Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine.  Clinically suspicious for ITP.
Information has been received from a registered nurse concerning a patient who was vaccinated IM with Recombivax HB (manufacturer unknown).  Subsequently the patient had negative hepatitis B virus (HBV) antibody titers/had not seroconverted.  The patient's outcome was not reported.  Follow up information indicated that the patient did not seroconvert following vaccination.  There was no patient information to provide.  No additional information is expected.  This is one of several reports received from the same source.
headache; sinus disorder; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), SINUS DISORDER (sinus disorder) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced HEADACHE (headache) and SINUS DISORDER (sinus disorder). At the time of the report, HEADACHE (headache), SINUS DISORDER (sinus disorder) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068687 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068687:
High fever of 103.4, fatigue, body aches, headache, vomiting
Mother phoned stated daughter received MENVEO on 4/16 and c/o arm itching when walking to car. Mother noticed this A.M. that arm was swollen size of softball.
experienced headache, chills and body sore; experienced headache, chills and body sore; experienced headache, chills and body sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) 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: HEADACHE (non-serious), CHILLS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "experienced headache, chills and body sore".  Additional Information: Got the first dose last 23Apr and the second dose is on 18May. After the first dose he experienced headache, chills and body sore. He was asking if it is okay to take Tylenol for the pain reliever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in 2015, the patient was vaccinated with ZOSTAVAX (dosing details not known) by subcutaneous route. On an unknown date in 2016, the patient was diagnosed with shingles (herpes zoster). The patient contacted physician assistant and sought medical attention. The patient received treatment for the event. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Patient was noted to be unresponsive. Eyes were glazed over, looking up. No cyanosis or apnea. Denies generalized shaking/jerking. Lasted about ?5 mins. Seen in the ER. Normal labs and head CT. Observed overnight. No fever.
Pt was given HPV vaccine around 1317. At 1322 I was notified that the patient had "passed out." When I got to the patient he was very pale and diaphoretic. Pt was responding.  Mom states, "He passed out twice. When he woke up the second time he said he was hurting all over." Pt also complained of vison problems. Vitals at 1322 blood pressure 95/59, pulse 46 and o2 sat 95% on room air.  Oxygen applied at 2L/min by nasal cannula at 1323. Vital signs at 1324 blood pressure 104/58, pulse 55, o2 sat 97% on 2L/min.  Pt denies hurting all over at this time. 1325 o2 sat 99% on 2 L/min and pulse 60. 1326 blood pressure 100/65, pulse 58, o2 sat 99% on 2L/min. 1329 blood pressure 130/83, pulse 66, and o2 sat 99% on 2L/min. Pt states he feels much better at this time.
chills; muscle aches; This is a spontaneous report from a contactable consumer(patient). This 43-Year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247; Expiry date: Unknown) in the left arm as a single dose for COVID-19 immunization on 25Feb2021 at 09:00 AM. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247; Expiry date: Unknown) in the left arm as a single dose for COVID-19 immunization on 03Feb2021at 09:30 AM. The patient did not have any known allergies. The patient reported that she did not have any other vaccines in four weeks. The patient did not have any other medications in two weeks. The patient did not have COVID prior to vaccination and was not tested for COVID prior to vaccination. On 25Feb2021 at 9:00PM, the patient experienced chills and muscle aches. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Extreme dizziness,  dry heaves, nauseous, chills, achiness, no appetite and extremely fatigued. Went to the ER  on 4/18/21  all tests and blood work came out OK; got a pill for dizziness which did not help at all. It took at least 2 weeks for me to feel better but the light-headedness continued for about a month. I still have bouts of light headedness and slight vertigo from time to time 5 months later.
After the second dose, I felt general lethargy. July 2021, I woke up with headaches, lightheadedness, dizziness, nausea, upset stomach, fever, chills, diarrhea. Diarrhea stopped the beginning of August. I saw my COVID-19 doctor on the 15th - she tested me for COVID-19, Influenza and Strep throat - negative results. Daily headaches, light and sound sensitivity, diarrhea, fatigue, migraines with auras, which I found out were migraines from neurologists, chest palpitations randomly at rest, elevated heart rate while doing very mild physical activity - going from bed to desk or standing up from chair (my heart would race); brain fog; memory loss; inability to recall words; Headaches and migraines got worse. From August to October - I had severe exhaustion - any kind of physical activity would exhaust me: get out of bed, do laundry or make lunch would cause exhaustion where I would have to sleep for 2 - 6 hours.  Exercise intolerance - if I tried to walk it would cause a wave of exhaustion where I'd be bedridden the rest of the day. Migraines continued. Looking at TV or computer screens would exacerbate headaches and also cause sensation of nausea. I was experiencing TMJ lockjaw, as well. Also, I had a tingling down my right leg which was not often but just intermittent. In September, I started developing eye pressure behind my left eye and also a pounding, stabbing sensation behind my left eye. I had a sensation of imbalance. As a result of that, I had a fall and hit my head and had a concussion. Still dealing with all the other symptoms plus a concussion. I went to a Cardiologist; Urologist; Concussion specialist; infectious disease doctor and we've been trying different meds. The med that finally seemed to relieve Migraines - Emgality medication. I also during this time had insomnia and ability to fall asleep and or staying asleep. I was prescribed Gabapentin for sleep (in Sept) and then after that was prescribed the Emgality for Migraines with Cardiologist. I also had a syncope in July - one episode. I am also scheduled for a COGNITIVE Psychiatric evaluation as the result of this. I am contacting the doctor's office to try to get an earlier appt then the one scheduled. Sumatriptan - this medication is also helping me abort the migraine attack. I'm still undergoing to see doctors for this. My primary doctor, however, is clearing me to go back to work.  I still have headaches, joint pain, dizziness and lightheadedness and head pressure, fatigue and exhaustion but not to a debilitating degree. I had COVID-19 in January 2020 and early February 2020.
Pt was taken to the ED on 6/1/2019 after she developed itchy red rash on bilat cheeks that started the night before. Some swelling in hands also noted at the ED- No resp. distress. Pt received Diphenhydramine 12.5 mg 15 ml, 5 ml p.o discharged in stable condition.
Pain in arm from (deltoid to elbow) started in the night of vaccine has lasted two weeks
Patient received V AXELIS after it experienced a temperature excursion of 8.5°C for 30 min.; This non-serious spontaneous safety report with Agency reference# 02080038 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021.  Due to the nature of the event, the causality between Vaxelis and the reported event of Temperature excursion' was not applicable.  For reference purposes this case is linked to MCM-002954, MCM-002953, MCM-002957 due to same reporter.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded to Agency on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable.  No further information is expected.
After 2-3 days developed redness to arm where the vaccine was given, appears to have a blister at injection site. Saw NP and was given hydrocortisone to apply to area, area still noted to be reddened, no pain noted at this time.
pt recv vax & exp vertigo & felt, in general, just bad; later that noc the pt exp severe cramps & devel a fever, violent vomiting & diarrhea;  approx 24 to 48 hr p/vax still feeling bad;
pt recvd vax; 4 hrs after vax, pt exp pruritus; 24 hrs after vax, pt devel urticaria; 48 hrs after vax, pt exp vague tightness in his chest w/ burning in his throat;
got little symptoms like high fever; muscle pain; Joint pain; Little nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC number and UPC number was unknown), via an unspecified route of administration on 16Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 (today), patient got little symptoms like high fever, muscle pain, joint pain and little nausea. Patient asked if it was that normal and wanted to know why it happened like this. Patient also asked that do he/she need to go for COVID test or do he/she need to do that. The outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My daughter received her vaccination and in August she started showing symptoms.  Her limbs were becoming numb.  She was loosing feeling in different parts of her body.  At the end of August, she was diagnosed with the auto-immune disease Juvenile Rheumatoid Arthritis.
Patient Fainted but was conscious in observation station.  Patient was resting comfortably slowly sipping on water.  Was able to ask patient if she was having any trouble breathing her response was no.  Also asked if she had fainted before any other vaccinations also said no.  Had her remain in observation station for an additional 30 minutes.   After 30 minutes symptoms did not improve and we called the paramedics.  Her Mother and Husband were present.  The paramedics noted low blood pressure, started IV fluids and took her to the hospital for continued care.
Gave varicella vaccine at approximately 10 AM.  Client had immediate redness, warmth, two to three papules, and itching to injection site.  No difficulty breathing or any other S/S of anaphylaxis present.  Gave 7.5 ml of liquid Benadryl per package instructions.  After approximately 10 minutes the redness and bumps had disappeared and the itching had subsided as well.  Was still slightly pink at injection site.  Instructed father to continue with Benadryl at home if needed.
10 days after receiving second shot, had occasional shooting pain in left ear. 13 days after second vaccine, developed ringing in left ear. Approximately one month after second vaccine, ringing has not subsided and now sound seems muffled in left ear. Physician changed blood pressure medication to Diovan to see if symptoms will improve. No improvement after a few days. Had I known tinnitus was a potential side effect of the vaccine, I don't know if I would've gone through with getting it. Quality of life has diminished as a result.
Patient called later on the evening he received vaccination. Stated that his arm was very painful and red at injection site. Told him to ice it and call me back next day to let me know if any worse. He called next day and said pain was diminished but he had experienced chills and nausea that did go away but his arm was swelled up down to elbow and skin was very saggy. Told him if no improvement by next day or if worse to go to ER/doctor to have it checked out.
Client was given 0.2mL from the Moderna 6 months to 5 years dark pink cap and yellow label border when they should have received 0.25 mL of the Moderna 6 months to 5 years from the blue cap and gray label border vial.
Hot feeling at the injection site; Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at the injection site, soreness at the injection site, and a hot feeling at the injection site The reporter did not consent to follow up. This case has been linked with case US2020167493, US2020167496 and US2020167490, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167493:Wife influenza's case US-GLAXOSMITHKLINE-US2020167496:Mother in law's case US-GLAXOSMITHKLINE-US2020167490:Wife shingrix's case
Whole body muscle aches; headache; fatigue; This is a spontaneous report  received from a contactable other health professional. A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3247 and expiration date was not reported) via an unspecified route of administration in left arm  on 10Feb2021 at 11:00 AM (42 years at the age vaccination time) as a 2nd single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was never diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and expiry date was not reported) via an unspecified route of administration in left arm  on 20Jan2021 at 11 AM as a 1st single dose for covid-19 immunisation. The patient's concomitant medications included diazepam 5 mg on 08Feb2021, (pseudoephedrine hydrochloride) SUDAFED 30 mg on 06Feb2021 (received within 2 weeks of vaccination). On 11Feb2021 at 02:00 AM, the patient experienced whole body muscle aches, headache and fatigue. The events were lasted for approximately 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected. .
After getting his 2nd dose, he mentioned that his right eye was twitching on and off for 7 days after his first dose then it just stopped.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX (batch number 2AH5M, expiry date 31st May 2021) for prophylaxis. On 29th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, stomach pain, headache, general body pain and rash. On an unknown date, the outcome of the fever, stomach pain, headache, general body pain and rash were recovered/resolved.  It was unknown if the reporter considered the fever, stomach pain, headache, general body pain and rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever, stomach ache, headache, body ache and arm rash for 2 days.