chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of eyelids and cheekbones; Swelling of eyelids and cheekbones; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in right arm on 05Apr2021 10:00 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included diabettes from an unknown date and unknown if ongoing and known allergies to chicken, cigarette and smoke from an unknown date and unknown if ongoing. Allergies to medications, food, or other products: Alergia pollo, humo de cigarro. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 06:00, the patient experienced swelling of eyelids and cheekbones. No treatment received for the adverse event. Outcome of the event was not recovered at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Acute ischemic left MCA stroke - passed away. This visit was within 6 weeks of receiving the COVID vaccine.
10:15 - PT was given 3 vaccines: HPV in (R) thigh, and MCV and hepatitis A in (L) thigh. She was in supine position. Afterwards Pt stood up and became dizzy and pale. Sat down with water, voiced concerns of vomiting, and then said she felt better. 10:25 - MD was brought into room, talked to PT. MD said common s/e of HPV are dizziness, paleness. Pt soon then bent over and vomited twice. Pt was helped onto exam table. 10:30 - PT was given a cold cloth for her forehead, and immediately voiced, "I feel better." Vitals were monitored. Pt remained in office x 10 minutes for observation. She was slowly brought into standing position again. MD asked father to keep PT's activities "light for the day." Father agreed, and Pt left clinic with father.
20 minutes after tetanus vaccine, developed severe headache, vomited twice.  Red, flat rash developed within 1-2 hours after immunization.  Developed slight shortness of breath within 1 hour after immunization.  Symptoms resolved after 4 days.
Pt arrives after having a fall last ngiht. pt is in long term facility after having a car accident when he was 4 years old. Pt is always somewhat unsteady to gait. Pt fell getting into bed last night, he was found half on and half off the bed. pt was noted to be more unsteady this morning by staff. pt has a brain shunt. pt is Alert and oriented at his baseline. Pt does not complain of headache but has persistently complained of back pain. Pt has no rib pains to palpation. Pt has midline back pain thoracic and lumbar. Pt is on Plavix and aspirin. pt does not seem to have had loss of consciousness. Pt is here with group home caretaker.  Associated Symptoms: back pain, fall, injury
pt recv vax 23AUG96 & pt felt ill & exp a fever for 2 days;pt devel nausea & a fever for 1 wk followed by an eczematous lt arm, trunk & face;rash persisted most of the school yr & lt scars;
Day 1: mild flu-like symptoms Day 6: Pain from head (tooth ache) to toe (ingrown toenail) and places in between that had experienced some type of pain in the last year or so.  Specifically, arthritic knee pain (which had not been a problem prior), sciatica, heartburn, hashimoto itch.  I had great difficulty walking, going up or down stairs, getting out of a chair, etc.  The day before I had been to the gym and was increasing the levels of weights on my routine, but the next day I felt like a cripple, especially when I tried to exercise.  Most of the pain has ceased except in my legs.    I tire easily.  The Hashimotos itch re-occurs frequently, which makes me wonder if the vaccine didn't mess up my thyroid more.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:case (1 of 56 patient)
Moderna COVID-19 Vaccine EUA Fatigue and then rash appearing like pityriasis rosea on chest and legs, continuing to spread over weeks.
Injection site red and swollen day of injection and for 3-4 days following, then tingling in lower arm.
pt recv vax & lab eval revealed varicella zoster IgG AB=0.22;
This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031945, expiration date 27-DEC-2017 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 6°Fahrenheit (F) and 14°F (11.2F), for a time frame of 8 hours. There was no previous temperature excursion and no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
11/14/2021 I began to have a sore throat and little bit of a cough. 11/15/2021 I felt the cough in my chest and having nasal congestion. I took a home test on this day and it was negative.  11/16/2021 cough became much worse, chest felt full, and unable to sleep, nasal congestion was much worse. 11/17/2021 I was much sicker, all same symptoms but much worse, I coughed all night long. 11/18/2021 I did a home test again and it was positive.  I did a telehealth visit with my doctor. on 11/18/2021.  I still have fatigue, slight cough and waves of dizziness, and brain fog.
Patient may have received slightly less than the recommended 0.3 mls due to the equipment used. One pharmacist had drawn up the vaccine with a 25 G 1 inch needle. A different administering pharmacist switched the needle out with a 23G 1 and 1/2 inch needle due to patient weight. However due to the difference in needle sizes and the differences in needle dead space between the two needles, it is possible that the patient may have received slightly less than the recommended 0.3 mls. Per CDC recommendations in deviations from protocol, patient will come in on 10/12 for a repeat dose.
patient received shingrix vaccination on 7/9 and developed the side effects the next day.  Patient came back to pharmacy on 7/12 to show us the area.  It was red and swelling about 2-2.5inches in diameter
Moderna Covid-19 Vaccine EUA Pain at injection site including shoulder and jaw (couldn't raise arm), general body aches, headache, fatigue and metallic taste in mouth. Acetaminophen has helped with the aches.
Fatigue; swelling at injection site; light hives on lower legs and upper arms; tension headache; slight swelling of hands, ankles and feet. Warm all over but no fever.
No adverse event.  Patient was administered Covid-19 vaccine on 6/8/2022 and it expired on 6/3/2022.  Scheduled for revaccination.
There was no adverse event at all reported. Vaccine was administered to an 11 year old minor who was not eligible  to receive the vaccine under pharmacy protocol/standing order guidelines. Wrong birthday was provided by the parents intentionally to get the vaccine sooner than his actual age. Wrong birth year of 2009 was given instead of his actual birth year of 2010. Month and date wad give correctly.  Pfizer vaccine is currently approved for 12 years and older.
Pt seen for well visit in the AM on 8/11.  Brought to ER on 8/12 at about 2AM.  Not breathing - CPR performed - pt died.
I had muscle pain & in my arm and assumed it was from the injection.  After a couple days, it was obvious the pain wasn't from the injection because it wasn't located at the injection site.  The pain/weakness is located approximately from the area of mid-upper arm (6 inches above elbow) to approximately 3-4 inches below the elbow on my right arm (injection arm).  There is constant ache and with any pressure (lifting even a few ounces like a glass of water) there is an immediate onset of achy pain and weakness to the point where I must stop lifting.  Movement is not an issue other than the constant "ache".  The biggest problem is the sharper pain and immediate weakness upon use of the arm.
Patient originally had sore throat and coughing. Throat itchiness and discomfort disappeared after injection. Injection needle was a bit hard to pull out and caused slight bleeding.
I noticed a lump in my neck on 5/3/21 I scheduled an appointment to see healthcare provider for 5/12/21. Healthcare provider said to wait and see if lump would go down; was told to schedule a follow up appointment. I scheduled a follow up appointment for 6/3/21 at that time lump was still prominent so an ultrasound was ordered. I went to ultrasound on 6/7/21 at that time they were able to determine that I had 2 swollen lymph nodes in my neck but due to receiving the 2nd dose of Covid vaccine on 5/20/21 they want to do a follow up in July if swelling continues.
Patient called complaining of general malaise and shivering/chill episodes. Denied Fever. Said it resolved by that afternoon.
Chills, malaise, nausea, vomiting, diarrhea, currently at a total of 44 hours from symptom onset without significant improvement
Pt called stating on 3-26-21. She woke up with 102 fever. Had been taking Tylenol since received vaccine   Twice that night and continued the next day. Later that day puts husband who is an md said she experienced a seizure for about 10 seconds and wanted to report the adverse effect to someone. The patient did not go to er or md office. Did not call her regular md. She stated she was fine and had no other ill effects
Pt states she woke up in the middle of the night with body aches and a sore arm. She said arm was tender to touch. She looked  the mirror and noted swelling into her neck and shoulder. She went on to feel feverish, chills, severe headache and nausea on Saturday 8/22. She took her migraine medication and Tylenol and symptoms improved. She felt better Sunday and almost normal today but tired.
11-1130AM pt was shaking, pale, surface blood vessels markedly visible, said was hurting, was drowsy, felt hot to touch; went to ER shortly p/noon, dx'd w/ear infect tx w/Trimax & advil; pt appeared well w/no c/o prior vax appt;
Employee had FLUZONE injection 10/13 - reports increased temperature 101.5, body aches & drowsiness occur same day as injection.
Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS) and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer
I have been getting tumors on my face. I currently have them all along the bottom of my face. It is extremely stressful and depressing and I am glad to be wearing a mask. The doctors identified them as being granulomas that happen when multiple  vaccines are given at the same time. I had the shingles vaccine a month in November after receiving the COVID vaccine and flu vaccine on  the same date. I began getting these raised bumps upon my face at the end of November. I had second shingles shot on January 24, 2022. I went to see a specialist in granulomas today who advised me not to wear a mask and to not get the 2nd booster. He indicated that we would need to wait a few months to see if it goes away and if that does not work, we could try a steroid injection. The doctors advised me that they have been seeing this type of reaction with individuals that have had more than 1 vaccine on the same day. I have seen multiple immunologist, dentist, rheumatologist, dermatologist (4 in total), ENT specialist, and oral surgeon. I also went to my rheumatologist to rule out lupus. This whole thing is a nightmare. I am a journalist and this has had a huge impact on my life in general. I have been advised not to get the 2nd booster.
Rcv'd vax 11/22/99. 1 hr post vax, L arm became red and swollen, no hives, no itching. Symptoms dec after 2 days.
Patient's EHR showed that he was due for a bivalent covid vaccine, and even after the state vaccine database, no records showed until after the vaccine had been given. In other words, patient received an errant bivalent booster, as he had already had a bivalent booster in October. Patient also did not remember receiving one in October. Patient was notified of the error and it was documented in EHR appropriately. No adverse event reported for patient.
This spontaneous (non-serious) report received from a consumer, concerned a male of unspecified age. The patient's height and weight not reported. No past medical history, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# and expiry: unknown), route of admin and dose not reported, administered Apr 2021, for immunization. On an unspecified date, patient experienced headache; with outcome of not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Per procedure, no follow-up will be requested for this case. This case, from the same reporter is linked to 20210946745.
Left arm vaccine area is swollen, red, a little itchy, and hard.  Also the area is hot.  The vaccine was given to me on 08/5/08.  Patient directed to use warm compress.  See doctor if worsens.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Demerol, reaction(s): "Known allergies: demerol". Patient received PAXLOVID for COVID-19 treatment in Sep2023. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
feel malaise on her nose; feel malaise on her nose and developed congestion and sneezing; feel malaise on her nose and developed congestion and sneezing; pain in the injection site; This is a spontaneous report from a contactable female consumer. A female patient of an unspecified age received second dose of BNT162B2 (solution for injection) via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in the injection site and which last for 2.5 days, started to feel malaise on her nose and developed congestion and sneezing and still present on the day of reporting. On Saturday was able to go to work but presented pain in the injection site, she started to feel malaise on her nose and developed congestion and sneezing, these later to are still present today, patient feels better now. She believes that these side effects are a reaction to the vaccine as she was feeling prior to the vaccination  The outcome of the events pain in the injection site was resolved while the outcome of the events malaise, nasal congestion, sneezing were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a RN concerning an adult male who on approx 07Feb05 earlier this week was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). On 10Feb05, the pt was seen again in the office due to injection site reactions including redness, swelling, local heat and low grade fever. It was reported that the pt is recovering. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P) and experienced adverse events (WAES0502USA01620).
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of GARDASIL (lot# L040460 and expiration date 27-MAY-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
(R) arm deltoid pain/weakness/decreased ROM. No injection abnormalities supportive care (Ibuprofen or naproxen) ice. No change-no worsening or improvement. Also with B/L hip clicking x1 week.
VAERS INCIDENT (adverse drug reaction) with Jassen COVID vaccine at off-site UH clinic. Pt blacked out 5 mins after the shot and he fell out of seat into the floor. Pt did not require immediate treatment, EMS was not called and wasn't hospitalized.
Patient 11 y/o, 113.6 lbs was vaccinated at 9:15.  He received his first dose of HPV9 and MCV4. Both vaccines were administered and during the 15-minute monitoring time he experienced a vasovagal syncope while sitting. The syncope episode lasted about 30 seconds and then gained consciousness. His skin appeared pale, moist and clammy but was fanned while nurse took vitals. Temp 98.5F, blood pressure 117/69, pulse 70, oxygen 97%. No oxygen was needed. He stated that he felt nauseous and vision was blurry. He was advised to remain seated for an additional 10 minutes. Nurse asked if he would like a cold juice to soothe his stomach and he agreed. He was given a juice and skin color returned to normal color and vision slowly returned. Education was given to mother to monitor for any additional adverse symptoms and advised to go to the emergency room if needed. Patient's mother verbalized understanding and had no further questions.