chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy at injection site 4 days later; Extreme swelling, redness (bigger than 1/2 dollar) ITCHY at injection site 4 days later; Extreme swelling, redness (bigger than 1/2 dollar) ITCHY at injection site 4 days later; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. On 21Apr2021, the patient experienced extreme swelling, redness (bigger than 1/2 dollar) at injection site. On 24Apr2021, 4 days after vaccination, the patient experienced itchy at injection site. 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 extreme swelling, redness (bigger than 1/2 dollar) and itchy at injection site were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
I got the chills on that same day, I had chest pain and body aches. I took the quick dissolve Tylenol. I had nausea and dizziness.  I couldn't go to church on Sunday and my body was in pain for that weekend. and all week.
menstral flooding (clots, more than 2 super max tampons in 3 hours)
Client received the 1st  dose (Pfizer, Lot# FJ6369) at 10:39 am. EMT reported to Co-Lead Nurse at 11:00 am that client stated she is feeling well right now, but noted during the 15 minute observation she experienced some dizziness that lasted a few seconds. Co-Lead Nurs responded. Client standing in no apparent distress and skin appeared appropriate for ethnicity without any sweating, redness or swelling. Client reported to Co-Lead Nurse that she also experienced feeling hot which lasted a few seconds about 5 minutes after receiving the vaccine and reports "I don't know if it is just my anxiety." At this time, client reports she is feeling well. Client admits to history of panic attacks and reports waiting to receive any COVID 19 vaccine due to anxiety related to adverse effects of vaccine. Vital signs were taken at 11:03 am and were as follows BP 124/78, Pulse 110, 02 saturation 99% room air, RR 18.  Client reports she did not eat breakfast this morning and was provided with a juice.  Client denies experiencing shortness of breath, chest tightness, dizziness, palpitations, nausea, or itchiness of face, head, legs, arms and palms. Clients medical history includes anxiety, panic attacks, and depression. Client denies known allergies or taking medications at home. At 11:20 am vital signs were as follows BP 110/76, Pulse: 90, RR16, O2 saturation 98% room air. At 11:27 am, Co-Lead Nurse educated client on ER precautions, how to sign up for V-safe, and when to follow up with PCP. Client verbalized understanding. At 11:30 am the client left the vaccine site with a steady and symmetrical gait.
Person became lightheaded, c/o nausea, had syncope.  Awakened and felt better in a few minutes without intervention.  Mother refused transport or other care.
So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I also had cramping and pain in the back of my legs as well. I went to the DR and she put me on antibiotics, Cipro and something else I cannot remember. I went to the DR on Wednesday the 30th of June. The GI problems have been happening for about 2 weeks. I also saw my cardiologist on 4/8/2021 and he saw I was ok, the pulmonary DR also said my lungs looked fine on 4/26/2021.
This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 25-MAY-2016, the patient was vaccinated with an expired 0.5 mL dose of PROQUAD (lot # K021548; expiration date: 06-MAY-2016), intramuscularly. Concomitant therapies were not reported.  No adverse effects were reported. Additional information is not expected as reporter did not want to be contacted for follow up.
In January my blood pressure after years of creeping up final stayed and would not come down. I went to my primary care physician to see what we could do. We tried adding a diuretic with lisinopril but the lisinopril gave me a dry cough that I needed to be taken off of. I have been changed to better combination of Losartan and hydrochlorothiazide that has helped tremendously.
Shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender, who had an artificial limb. The patient's medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. The vaccine was not actually administered into the artificial limb. On an unknown date, after receiving the vaccine, the patient experienced severe swelling and possible infection around injection site. The outcome of the events was unknown. Causality was not provided. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA004402.
Janssen vaccine given after pt. received first dose of  Astrazeneca in another country.  Primary care physician requested second dose of COVID -19 be given in this country. No adverse reactions noted in observation.
looking to receive her second dose of the monovalent vaccine in her primary series; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient reported no disease state and no medication history .   No concomitant medications were reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The Patient does not report any other adverse reactions. It was reported that it was more than 35 days between the patients first and second dose of the Moderna Covid-19 primary vaccination series. No treatment information was provided.
Initial report received from a healthcare professional on 10 September 2013. A male patient (demographic details were not provided), whose medical history and concomitant medications were not reported, received FLUZONE HD (Lot number, route and site of vaccine administration were not reported) on 10 September 2013. It was reported, that the patient had experience muscle cramping on an unspecified date. Laboratory investigations and corrective treatments were not reported. The patient's outcome was unknown. List of documents held by sender: None
patient received an expired dose; Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU vaccine. Past adverse reactions to the above products included No adverse event with FLU vaccine.    On 20-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) and PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022).    53-year-old patient received an expired dose of Moderna COVID-19 vaccine on 20DEC2022. Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022 ( Lot# 043H22A & MFG Exp. Date: 08JUN2023). Dose administered after 30-day Use By Date: Product. Bivalent 4th Shot Lot number: ( Lot# 043H22A & MFG Exp. Date: 08JUN2023) Individual vials or intact cartons: Inside Carton Vial size: 0.4 mL, 2.5 mL or 5.5 mL: 2.5 ml.  No concomitant medication was provided. No treatment medication was provided.
Vomiting, Diarrhea  Nausea,  Started Tuesday 4:00am effects still lingering Friday at 10:30
Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Heart palpitations, heart fluttering; Heart palpitations, heart fluttering; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), single dose, dose 1 via an unspecified route of administration, administered in the right arm on 31Mar2021 at 09:30 (at the age of 66  ears-old) for COVID-19 vaccination. Medical history included hip arthroplasty from 21Nov2020 to an unknown date. Historical vaccine included felt like she had the flu and was down for a few days after she got the flu vaccine. Family Medical History Relevant to the adverse events included her aunt passed away from taking penicillin years ago but does not specify that she has an allergy herself. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On There were no additional vaccines administered on the same date of the Pfizer suspect. The patient experienced heart palpitations, heart fluttering on 31Mar2021, reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin on 04Apr2021. She felt was down for a few daysThe events did not require an emergency room or physician's office visit. The patient used moisturizer and Vitamin E oil for the rash. The clinical outcome of heart palpitations and heart fluttering was not recovered and recovering for rash and dry skin.                                                     .      .
Burning and itching at injection site; tingling and numbness of entire arms; dizziness; redness and slight swelling around eyes. All symptoms resided within an hour or two then I became very tired for the rest of the day and normal vaccine reactions occurred(low grade fever, chills, body ache, etc).
Shortly after receiving MMR immunization, left upper arm began hurting. Body aches and fever of 102, and chills. Later in the day, seen at neighborhood health center.
Developed a fever suddenly and then had a seizure which lasted about 5 minutes and was tonic-clonic.
Started out normal: Day 2 (01/12) developed body aches, chills, fatigue. Day 3-5 (01/13-01/15) also had low-grade fevers with excessively swollen lymph nodes (w/ drooling and severe throat pain). Negative home COVID test on 01/16. Side effects persist though. Last fever 01/18, reduced lymph node size, overall improved that day but started a dry cough. Very swollen, painful lymph nodes (arm pit), headache, body aches, upper respiratory congestion through 01/18-present. Negative rapid COVID test 01/18. Awaiting PCR results. Not allowed to work until PCR comes back and side effects fade.
heart was shocked back into rhythm; a-flutter; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL9264 on 28Jan2021 12:00 in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications in two weeks. Medical history included diabetic, heart disease. The patient experienced heart was shocked back into rhythm, a-flutter on 10Mar2021 13:00 with outcome of recovering.  The patient was hospitalized for the events from 12Mar2021 to 16Mar2021, the events were also reported as life-threatening. Events resulted in Emergency room/department or urgent care. The patient did not have COVID tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Mar2021.  Events treatment was reported as yes, Heart shocked back into rhythm.
Next day after 2nd dose of Vaccine  ,I passed out,fainted. I havd never fainted in my life till that day. I hit my head and suffered an injury to my hip,a cut. I also got a cut on my back from the fall.  I have had a herniated disc prior the fall and so my back/spine hurts.
Client complained of dizziness. He reported to have eaten an apple pie before getting vaccinated.  He stated that he forgot to take his Xanax this morning.   BP at 2:40p 144/106 pulse 108, encouraged to rest. BP repeated at 03:05 136/99 pulse 103 . Client felt better.  Encouraged to rest at home and contact PCP in case of adverse reactions.
pt recv vax 7JUL98 & 8JUL98 PM began to break out in hives;devel hives on arms/legs/few on neck & back;no fever; acted self;consulted by phone & f/u w/MD;took OTC DPH;rx for atarax;
Narrative: 56 y.o. male who presents for evaluation of chest tightness and dyspnea of 6 days duration. He received the first dose of the moderna vaccine and then the first dose of the pfizer vaccine. After this second dose he developed chest pain and shortness of breath. He is still able to exercise without significant limitations. He has no personal history of lung disease or heart disease. ECG without ischemic changes and troponin negative. CXR without acute findings. No leukocytosis or other significant lab abnormality. D dimer was mildly elevated and CTA significant for no PE.
COVID-19; COVID-19; Vaccine brand other Moderna/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 11:30 as dose 5 (booster), single (Lot number: GJ6665) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 at 14:00 as dose 1, single (Lot number: EN6208), in left arm and on 07Apr2021 at 14:00 as dose 2, single (Lot number: EN6208), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 026P21A), in left arm and on 13Jun2022 at 17:30 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "Osteoporosis" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccine brand other Moderna/ vaccine brand=Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19".  Therapeutic measures taken as a result of drug ineffective, covid-19 included PAXLOVID from 16Mar2023 to 21Mar2023.
Light-headed dizziness some pains in my chest shortness of breath chills diarrhea feeling out of myself like weird
PATIENT IS COMPLAINING OF RIGHT ARM PAIN. SAYS THAT THE DR HAS DETERMINED THAT HE HAS A TEAR IN HIS RIGHT ROTATOR CUFF
Red area below injection site about 5 cm x 5 cm, warm to touch and itchy - patient to apply ice and use Benadryl prn.
Within 5 min I had hives and facial swelling.  I was given Benadryl and 20 min later I had body shaking/tremors
Day 6 post vaccine developed soreness in right arm, inferior to injection site. Over the next 48 hours pain worsened to the point where I could not move my right arm. Pain was constant, not responsive to OTC analgesics, not able to sleep due to pain. Unrelenting pain lasted 3 days, then reduced over the next 3 days. Significant improvement of ROM & pain after that. Soreness persists (mild) & ROM nearly normal.
Moderna  Covid-19 EUA  Later the second night - I had very sharp pain in my left breast and upper back for 2 days,  excessive sleeping, no energy.
Redness,  swelling, pain at injection site.  Fever, chills, shaking
This case was reported by a physician (also the subject and a GSK employee) and described the occurrence of influenza like illness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 October 2011 the subject received a dose of FLUARIX (details unknown). On 23 February 2012, 4 months after vaccination with FLUARIX, the subject experienced influenza like illness, not feeling well, fever, myalgia, fatigue, nausea and decreased appetite and on 26 February 2012, the subject experienced cough, sneezing and "slight" rhinorrhea. At the time of the report, the physician reported having "3 days of fever to 100". At the time of reporting the outcome of the events was unspecified. Follow up received from the physician, also the subject and GSK employee, on 03 April 2012. The physician reported that the events were resolved and noted that they were not serious. The physician stated that the events could have been associated with a lack of efficacy. According to the physician, he was diagnosed with influenza, but the diagnosis was not laboratory confirmed so he could not be certain (possible influenza). The physician stated that if it was influenza, he did not know the strain. This case was assessed as medically serious by GlaxoSmithKline due to the vaccination failure.
approximately 2 weeks after receiving the injection began experiencing very itchy skin and then out break of small red bumps.  Bumps are not filled with fluid but appear very similar to  what I with a mild outbreak of shingles  18 months ago.  when bumps break leave a nasty long lasting scarred area that takes weeks to  heel.  Spots continue to break out, sometime with short  periods of calm but more or less continuously since initial outbreak.  worst area is groin and front of thighs followed by arms and recently small bumps on hands and fingers.  Steroid shot and topical steroid prescription foam seem to help slow but process continues and itching goes up and down the scale.  Scars are very ugly to look at and itching is unpleasant.  Beginning to affect mood  negatively.
not even 1 minute after admin patient leaned forward and passed out. Woke up about 1 min later.
10 inches from injection site some rash; 10 inches from injection site some redness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (10 inches from injection site some rash) and VACCINATION SITE ERYTHEMA (10 inches from injection site some redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (10 inches from injection site some rash) and VACCINATION SITE ERYTHEMA (10 inches from injection site some redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (10 inches from injection site some rash) and VACCINATION SITE ERYTHEMA (10 inches from injection site some redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Patient had Covid in late November/early December.  Same side effects as then. Severe migraine like stabbing headache, fever, chills , body ache  and nausea.