chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; her right leg started having muscle pain; she could only drag her leg (couldn't walk); This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 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 26Mar2021 at night, which was 48 hours after dose 2 of BNT162B2, the patient experienced right leg started having muscle pain to a point where she could only drag her leg; she couldn't walk. The patient was treated with an anti-inflammatory medication which took care of the worst of it but she had weakness on 27Mar2021 and some on 28Mar2021. The patient was fine by 29Mar2021 and the outcome of weakness was recovered. The outcomes of right leg started having muscle pain and she couldn't walk were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PYREXIA; Not feeling his best; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling his best), CHILLS (Bad chills) and PYREXIA (PYREXIA) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced CHILLS (Bad chills). On 19-Jan-2021, the patient experienced MALAISE (Not feeling his best). On 20-Jan-2021, the patient experienced PYREXIA (PYREXIA). On 19-Jan-2021, CHILLS (Bad chills) had resolved. On 20-Jan-2021, MALAISE (Not feeling his best) had resolved. At the time of the report, PYREXIA (PYREXIA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Rash and fever about 101 degrees F for 2 days. At 9 days post vaccination, light red, slightly raised dots on face and trunk. Fever down; rash still present but resolving.
pt called today at approx. 3 pm and states. "She" Received a flu shot on 10/17/14 (afternoon) in the right arm." She states her "Right arm was hot to the touch and aches, redness and swelling about a hands with." Fever of 99 degrees started that night." She also states she had nausea and a severe headache. She called the doctor office on 10/20/14 - they told her to take BENADRYL - She took BENADRYL for 2 days. She also states that she "had trouble breathing on Sunday morning (10/19/14) and Monday (10/20/14) till she took the BENADRYL". "The swelling in her arm went down Monday (10/20/14). She denied putting ice or heat on her arm. Patient called dr on 10/20/14 and reported the problems. Patient states the doctor told her she was allergic to the flu shot and to take BENADRYL. The patient denied going to the ER or doctor. Patient also states that she has received the flu shots every year since 2011 without incident.
Pt. developed bruise, hot to touch, redness following a few days after injection to site and near site.
A 10-year-old male patient was administered an adult dose of Pfizer instead of pediatric dose as recommended. He did not exhibit any acute reaction and kept under 30-minute observation. He remained stable. Assessment: Normocephalic, pupils equal and reactive, negative for abdominal discomfort and full range of motion to extremities x4. Mother advised to seek PCP consult if any symptoms developed and/or call 911 if needed. He left with his mother in no obvious distress.
swelling under her right eye; swelling to both upper and lower eyelids and upper and lower Iips; swelling to both upper and lower eyelids and upper and lower Iips; inflammation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 for covid-19 immunization, took tacrolimus for dermatitis atopic. Patient was a 36-year-old female who was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she was reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. She reported that she was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Had the Pfizer Covid 19 vaccination 1st dose 15Mar2021 and 2nd dose 07Apr2021. No other vaccines, illnesses, or dental procedures in the last 6-12 months. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Approximately 12 hours after the injections (about 3 a.m.) , i developed a severe headache - behind my ear, shivering, and of course site injection pain.   This continued for several hours even after ibuprofen.  By that night at 8:30 p.m. (approximately 29 hours after the injection), my face started to swell.  When I woke the next morning, my face was extremely swollen - around my eyes - and hot to the touch.   I reported to my physician.  Went to the physician.  Obviously an allergic reaction - had an injection of steriods, taking ibuprofen and antihistamines.  As I report this, approximately 72 hours after injection, my face and periorbital area is still extremely swollen and slightly painful and still a headache.
Redness and itching at the site about 4 days after two days following  a rash on face, hands and feet and lower back. Swelling of lips and face
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious anemia" (unspecified if ongoing); "history of prostate cancer" (unspecified if ongoing), notes: history of prostate cancer. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-OCT-2013 the patient was vaccinated with GARDASIL dose 1 for vaccination. No concomitant medications were reported. The nurse reported that the patient had come to office to receive the second dose of GARDASIL on 05-DEC-2013 but the dose was not administered at the time of all (reason unspecified). No adverse event was reported. Additional information is not expected.
vaccination site pain; Warm spot; itchy red rash; vaccination site pain; Vaccination site rash; lymph nodes under left armpit were noticeble swollen and tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (shooting pain/pain in left arm/armpit), VACCINATION SITE WARMTH (Warm spot), VACCINATION SITE PRURITUS (itchy red rash), VACCINATION SITE SWELLING (Swollen spot) and VACCINATION SITE ERYTHEMA (itchy red rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Cipro) and Drug allergy (Codeine).    On 06-Mar-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (shooting pain/pain in left arm/armpit), VACCINATION SITE WARMTH (Warm spot), VACCINATION SITE PRURITUS (itchy red rash), VACCINATION SITE SWELLING (Swollen spot), VACCINATION SITE ERYTHEMA (itchy red rash) and LYMPHADENOPATHY (lymph nodes under left armpit were noticeble swollen and tender). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 25-Mar-2021, PAIN IN EXTREMITY (shooting pain/pain in left arm/armpit), VACCINATION SITE WARMTH (Warm spot), VACCINATION SITE PRURITUS (itchy red rash), VACCINATION SITE SWELLING (Swollen spot), VACCINATION SITE ERYTHEMA (itchy red rash) and LYMPHADENOPATHY (lymph nodes under left armpit were noticeble swollen and tender) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. There was no recurrence of these symptoms with the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up information received provided patient details, suspect dosage details, event details and outcome.
Fever, Angioedema, Swollen and watery eyes in addition to 101 fever Narrative:
I HAD A LARGE RED SPOT(2 INCHES X3 INCHES)  AT THE INJECTION SITE (MODERNA) WHICH WAS TENDER  AS OF TODAY (TWO WEEKS) IT IS STILL THERE, BUT A BIT SMALLER AND NOW IT ITCHES; NOW IT HAS SPREAD OUT MORE I ALSO SPIKED A SMALL FEVER TONIGHT AND HAVE BEEN VERY TIRED FOR ABOUT 5 DAYS I ALSO NOTICED AT THE SAME TIME THAT I HAD NUMBNESS IN MY UPPER OUTSIDE THIGH ON LEFT LEG
One week AFTER ( with no symptoms prior) arm became sore.  Woke up to swelling, hives itching, redness in a uneven circumference bigger in size than my hand, deltoid muscle felt rock hard and hot.  Symptoms lasted several days with gradual reduction.
Extreme arm pain. Pain all the way down to the fingertips. Nerve-like pain in hand and fingertips. Cannot move arm without extreme pain.
Severe redness 4 inches/entire deltoid muscle. Swollen arm/deltoid, painful site, anorexia >3 meals. Over 3 day period, severe malaise and fatigue and anorexia. Rash on chest on fourth day. Not able to return to normal activities until day #5.
After the 1st dose vaccine, I had a little bit of a sore arm and mild flu like symptoms of low grade fever and headache.  On 5/2/2021,    I started to notice a pain in my leg and went to my normal routine physical and brought that to my doctor's attention. I was sent to get an ultrasound on 5/6/2021 and 2 blood clots were detected.  DVT thrombosis on my right calf and another behind my right knee.   My 2nd dose of vaccine was schedule for 5/7/2021 and my doctor approved me to go ahead to receive the vaccine (2nd dose Moderna lot #041B21A IM LA).  After getting the vaccine, I went to pick up my prescription (Rivaroxaban) for blood thinner for my blood clots.  I am going to be on that medication for 6 months.  I have also been on Androgel testosterone gel for 10 years which has a warning for blood clots.  My doctor have taken me off of the medication for now.
2 Oblong Rashes red in color with some swelling near injection site. Does not feel itchy but their is dull pain like a bruise like pain.
Afebrile localized reaction left upper arm - reddened, hot to touch, swollen - underside left arm. Checked 5 hours later and redness. Tylenol/Ice; doctor notified. Reaction subsided 11/10/06 with itching only.
Patient reports soreness in arm with limited range of motion for over 2 weeks. Also describes feeling of something still in arm. Pain when arm is raised.
Pfizer Vaccine. Patient received an extra dose more than he should have. He received his 3rd shot today.
There was a rash like on my arms and thighs roughly after 30 minutes. When I got home, I took Benadryl and Tylenol. After 30 minutes, I noticed that my rash started to go down. While at the same time, I started feeling abdominal pain and my throat closing. I started to feel fatigue and very sleepy.
With relating to the vaccine of anthrax a seen suffering of much sinusitis, problems to sleep, and runny nose.
Had hsv-1 flare up shortly after getting the covid vaccine. Unsure if related,has been more than 6 months since last flare up. Was diagnosed in 2015.
Extreme pain limiting mobility of left arm. Alternating ice packs and heat pad over the course of weeks with stretching in an attempt to regain mobility.
Arm began swelling @ Pneumococcal injection site, became feverish and discolored.  Had aching, fever (102degree) weakness and severe headache, lasting until 10/24/2010.
Skin and joint painful to any touch for 24 hours, lethargic, migraine for 2 days, shakiness, dropping things.  The worst is that the numbness and itch/tingling in my face started again as it was when I had shingles, but has grown worse and now has spread across my face from left to right.  Ear to ear across the lower half of my face.  It's an itch I can't get rid of or scratch enough.
Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; I have spots over different places in my entire upper torso, generally upper arms and my chest and my back, my stomach; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: EN6204) via an unspecified route of administration, administered in Arm on 20Mar2021 as single dose for COVID-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: was not reported) via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation.  On unknown date in Mar2021, The patient had developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection. It was surely after getting his/her second shot, he/she did not know exactly when it was, precisely 3 days or four days or a week. It had actually continued to grow 'not in' the armpits, that spot is not growing very much but now he/she had spots over different places in his/her entire upper torso, generally upper arms and chest and back, stomach, not that much but he/she had gotten them, so it seems like it was growing. His/her clinic dermatologist could not schedule anything for 2 months. The seriousness of events was non-serious. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Shots on Tuesday around 11 am.  Sore arm on Wednesday. By Thursday all 3 injections sites (all upper left arm) were swollen and red. The flu site was minor and the tdap was a bit more, but the shingles was red, hot, and swollen. Friday flu site is normal, tdap still a little hard, shingles still hot, swollen and red. I have more tenderness and a few red streaks heading toward my inner arm.
fever to 101, fatigue, blotchiness to injection site (denies hives)
Pt c/o pain/itching, edema at injection site (Right Deltoid)
LEFT DELTOID WITH PAIN, PRURITUS AND SWELLING FOR 1 TO 2 DAYS FOLLOWING VACCINE ADMINISTRATION. PRESCRIBED IBUPROFEN AND BENADRYL.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 57-year-old patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 57 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: Covid test name post vaccination=AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
LACERATION OF BLOOD VESSEL; FOGGY FEELING IN HEAD; NASAL DISCHARGE; EAR ACHES; RED BLOTCHES BOTH FOREARMS; COVID-19; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) frequency 1 total, dose was not reported, administered on 08-FEB-2021, and dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On 25-SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced laceration of blood vessel, foggy feeling in head, nasal discharge, ear aches, and red blotches both forearms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from abdominal pain on 2021, had not recovered from red blotches both forearms, and covid-19, and the outcome of laceration of blood vessel, foggy feeling in head, nasal discharge and ear aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20211050610.
pain in the right leg; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced pain in the right from the COVID-19 first shot. The outcome of the event was unknown.   The lot number was not provided. Information on lot number has been requested during follow up.
Pt rec'd. 12 mo. vaccines on 12-01-17 in office. Returned 12/14/17 for S/S = small, raised papulovesicular area (less than 1 cm) with surrounding petechiae (RT) arm. Afebrile (plus) redness at site (plus) runny nose. (Pt teething). TX - monitor and return if S/S worsen.
Rash 2 or 3 bumps onset 4/18/05 after applying different baby lotion. Diarrhea x 1.
Patient is 5 days past vaccine and has swelling in her collarbone, discomfort on her left side of body, and her hand/arm feel heavy
4JUL98 25 elongated papules noted;15JUL98 mom reported approx 50 scabbed areas noted all over body;
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX (dose and lot number was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is linked to MARRS # 1411USA013452 with the same reporter link. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 38 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2018, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M041508, Expiry date : 09-APR-2018), subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). On 24-MAR-2018, the patient had dose administered outside indications and usage from prescribing information (product use issue). There was no adverse event reported. There was no product quality complaint involved.