chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site is warm to the touch; Injection site itching; injection site reddness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is experiencing redness swelling itching and injection site is warm to the touch 2 weeks after initial injection. Concomitant and treatment information not provided
EMOTIONALLY DOWN; BACK PAIN; STOMACH PAIN; ANXIETY; DEPRESSED; NO MOTIVATION TO DO ANYTHING; LEG PAIN; WEAK; HEADACHE; TIRED; BAD BODY PAIN; HIGH FEVER; QUEASY; This spontaneous report received from a patient concerned a 24 year old female. 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: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 09:35 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body pain. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced queasy. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 09-APR-2021, the subject experienced emotionally down. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced stomach pain. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced depressed. On 09-APR-2021, the subject experienced no motivation to do anything. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced weak. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body pain, high fever, and queasy on 08-APR-2021, had not recovered from weak, headache, depressed, anxiety, stomach pain, leg pain, and back pain, and the outcome of tired, emotionally down and no motivation to do anything was not reported. This report was non-serious.
At 1059 patient reported to RNs that he was feeling dizzy following administration of Janssen vaccine at 1053. RNs assisted patient to cot where VS were taken, and juice given. 1101 BP 94/60, HR 72, SPO2 96% while patient was supine on cot. Pt reported he had not eaten prior to vaccine visit and that he has had this reaction with all vaccines due to his fear of needles. Patient reported improvement of symptoms @ 1103. Patient sat at bedside without further symptoms. At 1110 patient able to stand and ambulate without residual symptoms and at 1115 left clinic independently.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known Allergies: latex, nickel alloys" (unspecified if ongoing), notes: known Allergies: latex, nickel alloys; "hypoglycemia" (unspecified if ongoing); "handful of autoimmune diseases" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known Allergies: latex, nickel alloys" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL PM, start date: Jan2015, stop date: Jul2022; ACETAMINOPHEN, start date: Jan2015, stop date: Jul2022; D3, start date: Jan2019, stop date: Jul2022; PROGESTERONE, start date: 26Apr2022, stop date: 18Jul2022; LIOTHYRONINE, start date: 27May2022, stop date: 18Jul2022; LOSARTAN, start date: 18Jun2022, stop date: 18Jul2022; LEVOTHYROXINE, start date: 24Apr2022, stop date: 18Jul2022; AMLODIPINE, start date: 17Jun2022, stop date: 18Jul2022; ROSUVASTATIN, start date: 03Jun2022, stop date: 18Jul2022.The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient has been taken other medication within two weeks. The patient has been treated with Paxlovid, (batch no. 1917017A) from 07Jul2022 to 11Jul2022 for event COVID-19.Metallic taste/ awful/ more like hairspray. Complete relapse 2 days after getting well + negative test; started completely over again, this time worse symptoms, testing positive.  No follow up attempt possible: No further information expected.
Severe Parosmia/smell changed drastically; taste and smell changed drastically, all foods tasted and smelled of rotting meat and garbage; Fast food still tastes very chemically and onion are still rotten; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) as dose 2, single at the age of 23 years old for COVID-19 immunisation. No medical history. No known allergies. Concomitant medications were not reported. Historic vaccine was first dose of bnt162b2 (lot number: EN6199) administered in right arm received on 10Mar2021 11:00 as dose 1, single at the age of 23 years old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced severe parosmia, taste and smell changed drastically, all foods tasted and smelled of rotting meat and garbage, fast food still tasted very chemically and onion were still rotten on 10Apr2021. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment received. No Covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab BinaxNOW: negative on 10Sep2021. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Red, hot, warm, swollen and itchy upper arm at injection site. Requiring antibiotic.
Red rash appeared on my face about day 7 or 8 after the injection. Also on the top of my left hand.    I cleared most of it up with OTC salves but it was quite red, raised and itchy.  Now it is on my chest, neck and under my chin.  Some postules and bumps, also very itchy on top of right hand.  My second injection is today.  On Monday I will make an appt. to see my Dermatologist.
inflammation in her brain; burning; stinging, pinching; spike in blood pressures; joint pain, extreme pain in hips when walking; ill/sick; Seriousness criteria- Medically significant.  Initial information was received on 14-Sep-2020 regarding an unsolicited valid serious case from a consumer.  This case involves a 67 years old female patient who experienced inflammation in her brain (non-infective encephalitis), burning (burning sensation), stinging, pinching  (pain), spike in blood pressures (blood pressure increased), joint pain, extreme pain in hips when walking (arthralgia), extreme pain in hips when walking and ill/sick (malaise), while she received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number UJ25388 and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient became ill/sick (malaise) on 28-Sep-2019 (in same month) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  On an unknown date, the patient developed a serious inflammation in her brain (noninfective encephalitis), burning (burning sensation), stinging, pinching (pain), spike in blood pressures (blood pressure increased) and joint pain, extreme pain in hips when walking (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from any of the event.; Sender's Comments: This case involves a 67 years old female patient who experienced noninfective encephalitis, burning sensation, pain, arthralgia and malaise after vaccination with FLUZONE. The time to onset is unknown. Additional information patient's medical history, medical condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Waking up around midnight the night after getting the vaccine, I experienced what I found to be palinopsia. The light was medium to dim and as I got up and moved around I kept seeing white/silvery lines moving with me. I thought I had a web or string on me. As I tried to brush them off, I realized that they were actually image trails of my hands as I moved them. I would see my hand/arm moving and fading sort of in a stop motion through space. I have never experienced anything like this before. The images were very strong for about 15 minutes and left me dizzy then they faded but never left completely. It has been 4 days since my vaccination and I still have palinopsia usually first thing in the morning, fainter, and lasting only a minute or two. The dizziness is a little better too. I can catch an extra image now and again especially against a dark back ground in low light but don't notice anything else during the day.   The only other side effect I had along with this was fatigue and dizziness.
At 1412 , patient was vaccinated in anti-gravity chair. At 1427, patient reported dizziness to EMT. Patient reported dizziness after her first dose. Patient reported she did not alert EMTs on site and dizziness went away when she got home. Patient reported not following up with primary care provider for her first dose reaction. At 1427, EMT assessed patient vitals: blood pressure 130/89 mmHg and pulse 82 beats/minute. RN assessed patient. Patient denied itchiness, rashes, hives, difficulty swallowing, and difficulty breathing. Patient advised to drink water. Patient offered water. Patient drank water. At 1432, EMT assessed patient vitals: blood pressure 124/94 mmHg and pulse 88 beats/minute. Patient reported feeling less dizziness. At 1441, EMT reassessed patient vital signs: blood pressure 133/87 mmHg and pulse 84 beats/minute. Patient reported feeling less dizziness and stated she was "feeling better". At 1451, EMT reassessed patient vital signs: blood pressure 128/88 mmHg and pulse 88 beats/minute. Patient reported feeling less dizziness. Patient reported she can drive herself home and stated "I'm okay". RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider and to register with v-safe. At approximately 1257, patient left facility with unlabored respirations and steady gait.
Swelling of face; Slight rash on face; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 01Apr2021 (age at vaccination was 21 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 22Apr2021 at 12:00 PM (age at vaccination was 21 years) as DOSE 2, SINGLE for covid-19 immunisation at other facility. The patient was not pregnant at the time of vaccination. Medical history was none. No known allergies reported. Concomitant medications were not reported. No other vaccines were received within four weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 22Apr2021 at 09:00 PM, the patient experienced swelling of face and slight rash on face. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures taken as a result of the events included treatment with Benadryl 25mg every 6 hours. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovering.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Patient states her arm was red and has a lump where her vaccines were given. She states she got a headache that resolved. She states that almost 2 weeks later she developed a painful rash on her backside, a headache, and has trouble sleeping.
Right thigh - proximal anterior 9 x 10cm - Erythema, tender. Aventis Lot# C60699 Exp 3-15-09
Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore left shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Sore left shoulder). At the time of the report, ARTHRALGIA (Sore left shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Computerised tomogram: unknown (Inconclusive) Cat scan done using IV contrast and iodine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful.
Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date; Vaccine was stored in refrigerator and administered beyond 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022 and had been stored in the refrigerator since then and stored longer than 30 days prior to administration.  The vial did not undergo any temperature excursions.  Full vial was not administered.  It was reported that site of administration of the vaccine was deltoid.  No treatment medication information was provided.
Very painful arm that radiates to hand, chest, and back; Very painful arm that radiates to hand, chest, and back; Very painful arm that radiates to hand, chest, and back; Very painful arm that radiates to hand, chest, and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 12:00 (Lot number: FHS020) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; METFORMIN; SPIROLACTONE; CYMBALTA. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product=COVID 19, Prev dose brand= Pfizer, Prev dose brand unknown=False, Prev dose lot number= ER8730, Prev dose lot unknown=False, Prev dose administration date=30Mar2021, Prev dose number=2), administration date: 30Mar2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, Prev dose brand= Pfizer, Prev dose brand unknown=False, Prev dose lot number= EN6205, Prev dose lot unknown=False, Prev dose administration date=09Mar2021, Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 09Mar2021, when the patient was 32 years old, for Covid-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 25Oct2021 16:00 PM, outcome "not recovered" and all described as "Very painful arm that radiates to hand, chest, and back". Therapeutic measures were not taken as a result of pain in extremity, pain, chest pain, back pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not received treatment.  Follow-Up (02Nov2021): Follow-up attempts are completed. No further information is expected.
Booster; Off label use; Fever; Headache; Shingles; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FV3181) via an unspecified route of administration in the left arm on 30Aug2021 at 00:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney transplant in 1998. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included prednisone (MANUFACTURER UNKNOWN), ciclosporin (NEORAL), atorvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK8734) via an unspecified route of administration in the left arm on 05Apr2021 at 00:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 30Apr2021 at 00:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021 (also reported as 21Oct2021 at 16:00), the patient experienced fever, headache and shingles that appeared 2 months after third dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events fever, headache and shingles that appeared 2 months after third dose were not resolved at the time of this report.
Patient reports left side facial drooping, weakness, headache.  Patient states symptoms have resolved.  Patient referred to her PCP to discuss whether she should get her second dose.
pt devel unconsolable crying 26 hrs p/shot w/o redness, swelling, heat or tenderness of leg w/low grade fever of 100; crying stopped w/in 2 hrs-1 hr p/APAP given;
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 24-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis.  A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001719: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001714: US-009507513-1706USA001728: US-009507513-1706USA001729: