chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of her upper lip; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Swelling of her upper lip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  Two Cases of Well Controlled Chronic Spontaneous Urticaria Triggered by the Moderna COVID-19 Vaccine. Allergy and Rhinology.. 2021;12:1-3     The patient's past medical history included Allergic rhinitis, Chronic spontaneous urticaria (Her last known flare was in 1973.) and Angioedema (For multiple years until her symptoms became controlled with a first generation H1 antihistamine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGIOEDEMA (Swelling of her upper lip) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Swelling of her upper lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Swelling of her upper lip) to be possibly related.    No concomitant medication was reported. Past medication included first generation H1 antihistamine to control Chronic spontaneous urticaria (CSU).  The patient's CSU symptoms included angioedema of the upper lip. Her last known flare was in 1973. The patient had spontaneous angioedema for multiple years until her symptoms became controlled with a first generation H1 antihistamine. When the patient received her first Moderna Covid-19 vaccine, she experienced the same swelling of her upper lip that she had last experienced in the 1970's. The edema appeared 30 minutes after injection and resolved within 30 minutes without pharmacological intervention.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-256134 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt reports ~3 hours post-vaccination her left arm was sore and painful, and her legs felt weak. She reports that she felt like she was not able to breathe bc her whole mouth and throat got dry, and it felt like her tongue was getting large (but it did not look big, just felt big). She reports that her throat felt ticklish. Pt reports she hyperventilated and had heart palpitations; she had a lot of anxiety and could not sleep for three days. Pt reports she experienced these symptoms for 3 days and all subsided. Pt reports she took Advil Allergy formulation which helped relieve her left shoulder pain only. She also went to the  Hospital when she was experiencing these symptom and she was checked out and was told no abnormal findings and was recommend to follow up with MD, pt. states she does not have a PCP.
4/6/18 Hoarseness and a knot like obstruction on left side of throat, within about 15 to 20 minutes of receiving shot. Went back into the office took two BENADRYL and notified the nurses and Dr. Remained at office until BENADRYL took affect. The knot went down and hoarseness subsided. Dr. kept check on breathing, heart rate, and pulse. Took about 30 to 45 minutes.  Later in day arm began to stiffen, swell, and be warm. Ice made stiffness worse. Had very little range of motion. 4/7/18 Redness began along with more swelling. Swelling was to the point that had light bruising on arm when swelling went down.  Redness and swelling migrated down arm to elbow over the course of several days. Have photos of what the arm looked like. Still have issues with arm on 4/17/18. On set of weakness in muscle.  Tingling and pain if arm bent in use for prolonged periods. Must rest on pillow at times, even when driving or riding in a vehicle. Took series of Steroid over 7 days.
Red hot patch 4 x 2 inches on L arm Arm soreness for a week
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021 patient did an antibody test for covid-19 antibodies, no antibodies were found. On 16-APR-2021, patient did the examination again, however no antibodies were found second time. The patient experienced confirmed immunological vaccine failure. On 25-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies found (units unspecified). On 16-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies found (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436395. This report was associated with product quality complaint: 90000176773.; Sender's Comments: V0-20210435716-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
The shot was administered in my left arm and I have had limited motion in left shoulder every since.  I am not able to sleep on my left shoulder because of the pain.
pt recvd vax;3 days later,exp eye redness,blurred vision,rash,achy joints,stiff neck;has been told that her visions stem from vax,damage to lower lt field of eye & blurred vision is permanent;further vax seems doubtful;
I woke up on the 4/13/2021 with hives all over my body I did not know what it was I had no pain at injection site I felt fine I went about my business the next day I felt like there were ants crawling under my skin by Thursday the feeling of heat kept rising in my skin i would look and it would be hives the following the bloody noses began every three days i get nose bleeds. the hives has gotten worse I am now taking 6 Benadryl's a day just to avoid itching my skin off I went to medical facility where i received 2 steroid injections. The dr does not know what to do, I had to go to the hospital to cauterize the inside of my nose they could not figure out the cause. I had a stroke back in Oct and I thought maybe something was going on but the Dr said it was not associated. Ever since I received the shot I have not been the same. Right before the hives appear, it feels like the stinging burning feeling right after someone slaps your skin. This lasts for 30 seconds. My skin is dark but my skin turns red with the hives. They gave me Zofran for the nausea, they also gave me a nose pincher thing that I use when I have nosebleeds. Also, I thought it was allergies but I have congestion that have no diagnosis. It is hard to breathe. I feel like I have Covid but I do not. The doctors say I have insomnia, I have headaches due to the congestion. I also feel tired. I have dizziness that feels like I am on a merry go round that I can't get off. Walking up stairs exhausts me which is unusual because I am a physically fit individual. I have had to take a lot of days off from work due to these side effects. Taking as many Benadryl's as I do causes drowsiness and I am a single mother of 4, I cannot be drowsy.
A non-serious spontaneous report of head cold, runny nose and muscle aches all over the body has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 10-Nov-2010, the patient received FLUMIST. On 11-Nov-2010, the patient experienced symptoms of cold; head cold, runny nose and muscle aches all over the body. The outcome of the events head cold, runny nose and muscle aches all over the body was not resolved.
Case number PHEH2014US025318, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 72 year old female patient. Historical conditions were not reported.  No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) 0.5 intramuscular into left deltoid that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes on 27 Oct 2014. No adverse event was reported. No further information was provided.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L032181, expiration date 25-AUG-2017; L043702, expired date 03-NOV-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Case number PHEH2014US004025 is an initial spontaneous report received from a physician on 24 FEB 2014. This report refers to a 07 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported), at dose of 0.5 ml intramuscularly on an unknown date. No adverse event was reported following this administration error.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
14 year-old girl, who came for a covid-19 booster shot at health center was given a Pediatric Pfizer vaccine, at 4pm on 1/31/2022. The  Covid testing staff who checked in the patient after COVID testing directed the patient to the pediatric side and MA  just administered the pediatric vaccine assuming that's what she was here for.
pt recv vax 1998 & pt devel numbing in rt arm;also has had drop foot & numbness in both legs & arms;has had numb arm the whole time;pt exp tingling in legs & has has trouble walking;
At about 18 hours after the vaccine started with a terrible headache, took Motrin with no effect. Headache continued for about 30 hours after the vaccine.  At 22 hours started with chills and a fever of 103. Alternating Tylenol and Motrin by 30hours fever broke.  Sore arm almost immediately after vaccine continues to be sore at 36 hours post vaccine.
Had soreness in arm for several days, but that had gone away. This morning, it was not only tender again, but swollen and red at injection site.
Racing heart. My heart used to average 60 beats per minute and now is up to around 90 even up to 100 per minute. I?ve been having to take Propranalol to slow it down. It?s horrible. I don?t know what to do.
Urticarial rash onset 8/2/04, within 72 hours of receiveing Hib vaccine.
Stomach sickness; red rash on the back of her left arm; red rash on the back of her left arm; a bit swollen, a bit red, and very hot that she could feel it through her shirt.; left arm was very swollen and red; sick all that night; vomiting and diarrhea; vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), RASH (red rash on the back of her left arm) and ERYTHEMA (red rash on the back of her left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness). The patient was treated with PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) for Stomach sickness, at an unspecified dose and frequency. On 03-Feb-2021, DIARRHOEA (vomiting and diarrhea) had resolved. At the time of the report, ILLNESS (sick all that night), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red), VOMITING (vomiting and diarrhea), RASH (red rash on the back of her left arm), ERYTHEMA (red rash on the back of her left arm) and ABDOMINAL DISCOMFORT (Stomach sickness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Phenergan for stomach sickness.
7 days after vaccination, patient developed facial swelling, itching, redness, sciatica, and mental change that lasted approximately 2 weeks. The only treatment used was Benadryl.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
- Sore throat  - Non-recurrent acute suppurative otitis media of right ear without spontaneous rupture of tympanic membrane
Immediately after receiving the dose, I developed lightheadedness, nausea, sweating. This worsened for 15 minutes, then slowly subsided over several hours. The next day, I was a little fatigued, but returned to baseline by the evening. On the 2nd day after vaccination, I developed uncontrollable violent rigors and PACs, along with fatigue and vertigo. These symptoms improved on days 3-5 after the vaccine, but returned on day 9 with worsening rigors and PACs. I also developed substernal chest pain on day 5. Now, day 9 post vaccination, and I'm feeling unwell. Main symptoms are chest pain, PACs, intermittent rigors,  vertigo.
Myalgia, Chills, Fever (100.2), and swollen lymph nodes above collar bone.  The lymph nodes became swollen from the first dose and had been getting smaller, but they became larger within 24 hours of the second dose.  I first took Tylenol for the pain and felt no relief.  At 7:00 am on the 3/16 I took Ibuprofen and felt relief from pain and fever within a couple of hours.  I took two more doses of Ibuprofen that day.  All symptoms but swollen lymph nodes have resolved on 3/17.
A one year old infant experienced fever after vaccination with RabAvert for post exposure prophylaxis. The dose, route, and frequency of the RabAvert was unspecified. He received his last RabAvert 07/17/04. His past medical history and concomitant medications were also unspecified. On 07/17/04, the patient developed a fever of 100.8 degrees Fahrenheit after his third vaccination with RabAvert. He was treated with Motrin with fever resolution within 12 hours time that same day.
got the Booster dose, and three hours later, she got a fuzzy tongue; and prickly lips; thinks this was an allergic; This spontaneous case was reported by a patient and describes the occurrence of TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic). At the time of the report, TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Positive COVID PCR. Lives in LTCF and had exposure in the house.  Only with Diarrhea no other symptoms.
Patient describes experiencing tinnitus after second dose of Pfizer in April. He also mentioned that he went to his PCP regarding this matter and they "shrugged" it off. When asked, the patient stated they did not examine his ear and has no other pre-existing conditions.
Started with arm pain that got more and more painful and radiated to fingers and chest. She went into the ER on 1/3/16 in the morning to get chest pain checked out and was admitted to hospital for a day until the following evening to rule out heart attack which was negative.
Severe pain, unable to lift arm. Have had two steroid injections, physical therapy and to this day still have pain.
pain/sore at injection site, myalgia, headache X2  days   Narrative:
Pt stated she had some bruising immediately and pain after administration (6/25/2019).  Pt presented today and stated she still had some soreness and bruising, but it appeared to be getting better(7/3/2019).
Patient presented with anaphylactic symptoms 5 minutes after vaccine.  Patient stated she had tingling in her face, lips and throat.  She stated she was becoming short of breath and her voice was changing and becoming raspy.  I administered an epipen and recorded the time at 11:27AM.  I called 911 at 11:30AM.  The patient said she felt much better after the epipen.  The emergency medical team arrived quickly and took over treatment.
Pfizer vaccine was administered outside of the source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- R29.810 LEFT FACIAL MUSCLE WEAKNESS 4/17/2023 CAD W STABLE ANGINA
Rash on arm close to the shot. About  3 in long by 1.5 in wide
Spotting between periods.   Hasn?t happened in many years.  Had the vaccine on day 6 of my period and was pretty much done but then continued to have my period  two more days after the vaccine to ending 4/1 at night.  Then on then on 4/ 6th break though spotting.  I don?t spot between periods and my period normally ends on day 5 or 6.
Redness, swelling and itching. Pt took Benadryl told pt to see MD.
Intractable Nausea and vomiting. Severe headache--pt transferred to ED via EMS
Swollen left occipital lymph node accompanied by small itchy bumps that come and go.
Information has been received from an officer manager referring to an unspecified number of patients. On unknown dates the patients were vaccinated with M-M-R II (lot # M015931, expiration date 30-MAR-2018) which was improperly stored at 48.9 F for 48 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever, chills, and myalgia not controlled by 600 mg ibuprofen q6h developing around 11 hours after vaccination and peaking around 15 hours after vaccination, resolving overnight without need for ibuprofen upon awakening.
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Starting about 5 hours after my shot, I got the most intense migraine headache I have ever experienced.  Hands on my head, fetal position pain.  Paired with Nausea, Body Aches & Fatigue.  Lasted 8 hours straight!  Then my body took another 24 hours just to recover.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 28-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Right after adminstration patient felt dizzy, then went into a quick seizure where she lost conciousness for a brief time. After coming back to concious patient felt nauseated and vomited.
Received immunization on 04/27/05. RTO on 5/4/05 c/o knots/redness of legs. Per MD exam 2 cm SC nodules on lateral aspects of both thighs.
Nausea, lightheaded, dizzy, feels foggy or high about 10 minutes after the vaccine.  BP and other VS were within normal limits. No chest pain, palpitations, changes in vision, diaphoresis or rash
Since july, over 6 months I have had calf, thigh and arm muscle pain and aches. had all kinds of tests done. all normal.Pain still persists every day.
for 2 days severe muscle aching and fatigue , some pain at the site . Pt stated "very sick". improved on the 3rd day and then onset of sore throat and anterior neck pain, stuffy nose  , followed by extremely severe headache , unlike her usual migraines but identical to the headache she had with Covid infection ( January 2021)
Pain, discomfort at injection site - feels like punched hard in the arm. Numbness, tingling below the wrist on the injection arm (lasted about an hour or so). Worst side effect was the "brain fogginess" - that lingered for almost 4-5 hours. Felt very odd, out of sorts.
Pt received TD rather than PPD intrathecally into LFA. Some moderate swelling, induration, redness, warmth noted the next day lasting approx 1 week.
Tongue tingling, lips tingling , tongue twitching, tongue and lips numb.   Tingling of tongue and numbness of tongue still lasting 8 weeks after shot.   Did not take second one because of this