chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED Note: At 1650, patient was observed following another nurse to the observation area, when he began swaying from side to side,  lost consciousness and landed on his right side.  This nurse approached the patient while other co-workers were assisting him to a chair.  The patient was regaining consciousness.  The patient's vital signs were as followed:  112/96, pulse ox 99%, pulse 46.  This nurse gave the patient water and the patient was alert and oriented X 3.  The patient c/o left knee pain but denied any other symptoms.  This nurse again checked his vital signs at 1655:  85/52, pulse ox 100%, pulse 86.  At this point, rapid response was called and report was given.  This nurse moved the patient to a wheelchair to prepare for transport to the E.R.  The patient denied any further symptoms at this time except pain in his left knee.  This nurse checked his vital signs at 1658:  102/64, pulse ox 100%, pulse 59.  Rapid response arrived and this nurse gave report to them.  Patient was transported to the E.R. via stretcher.  No further issues noted at this time.    Pt reports he has a history of getting nervous and "passing out" when getting blood drawn or getting a shot.  Pt stated that when he stood up after getting his covid vaccine he felt lightheaded and passed out.  ED staff responded to vaccine clinic  At 1658 where pt's VS were as follows: 102/64 HR: 59 Sats 100%   At present time, pt reports feeling "totally normal" and does not feel that he needs to stay to be seen in ED.  Pt comfortable with being monitored by RN for 10 min. Pt still does not want to be seen in ED, wants to leave.  Pt ambulated out of ED without difficulty.
Injection site pain; This is a spontaneous report from a contactable consumer (patient) A 42-years-old female not pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:30 (Batch/Lot Number: 5318) as single dose or covid-19 immunisation  .  Medical history included crohn's disease from 1985 and ongoing (Father and brother have Crohn's disease)  The patient's concomitant medications were not reported.  The patient experienced injection site pain  (non-serious) on 03Feb2021 with outcome of recovered in feb2021. No treatment received for the event  Information about Lot/Batch number is obtained. Additional information has been requested
Within 12 hours of receiving vaccine pt was feeling ill: nausea, vomiting, severe headache. On 01/07/12 pt developed pain and swelling on underside of right arm, on right side of body, right breast and into the neck. Pt states she felt extremely fatigued and feverish. Today, 1/12/12 swelling is resolving as well as nausea and headache but still experiencing fatigue.
About 13 minutes after the vaccine was given, patient started complaining of chest tightness and trouble breathing. Pt has had multiple severe anaphylatic events due to medications, injections and foods. Patient was immediately escorted over to our ED department for further treatment which is connected to the hospital.
After the injection, she turned pale and passed out for a short period time (less than 30 seconds).
10 minutes after vaccine administration, pt. reported chest pain, abdominal pain, and throat swelling. On exam, she was mildly agitated but in no respiratory distress. Exam revealed slight wheezes (B) & urticaria on her abdomen. O2 sats NL. She received EPI-PEN JR. EMS brought her to medical center where pt. had clinically improved, so no further tx was necessary. Pt. recovered well.
Covid arm 7 days after each dose/Localized allergic reaction; Very hot; Red; Throbbing; Localized allergic reaction; A little bit lightheaded; Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing) and ALLERGY TO VACCINE (Localized allergic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), ALLERGY TO VACCINE (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash). The patient was treated with Manual therapy for Pain. At the time of the report, VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), ALLERGY TO VACCINE (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash) 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 did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-288404 (Patient Link).
We had achy deltoids for a day or so; This is a spontaneous report from contactable consumer or other non-health care professional (patient). This consumer reported similar events for 2 patients. This report is for 1st of 2 patients. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EM9809) dose 2 via an unspecified route of administration on 08Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration on 18Jan2021 as dose 1, single for Covid-19 immunisation. It was reported that after 2 dose of vaccine administration, on an unspecified date in 2021, the patient had achy deltoids for a day or so, otherwise they had no adverse reactions. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284066 Same reporter/drug/event, different patient
Pt said she had been passing out recently and hoped she didn't today, but she did, over a period of 15 minutes passed in and out 3 times, felt weak, drank some juice and relaxed, then felt better and left with her husaband.
Throwing up; vomited 4 times; Chills; Headache; Fever; highest temperature was 101.4 degrees; low-grade temperature; Nausea; Stomach was not feeling right; upset stomach; This is a spontaneous report from a contactable consumer (patient's mother who is a caregiver). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in right arm, on 26Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included birth control pill. The patient's concomitant medication included ethinylestradiol/ norgestrel (CRYSELLE) from 26Jan2021 as birth control pill. The patient previously took the first dose of BNT162B2 on 05Jan2021 at 08:00 AM for COVID-19 immunization (in right arm). The vaccine was administered in a hospital facility. The patient was a certified nursing assistant (CNA) at a hospital. The patient and her mother both work at the same hospital that administered their COVID-19 vaccines, both received the first and second COVID-19 vaccines at the same date and time. The patient received her second COVID-19 vaccine dose yesterday (26Jan2021). Since 26Jan2021 around 09:00 PM, the patient was experiencing symptoms of chills, headache, fever, and nausea. The patient had a fever, clarifying that the highest temperature was 101.4 degrees, and also has chills and headache. Last night (26Jan2021 at 09:00 PM), the patient's stomach was not feeling right, had a low-grade temperature, and chills. On this morning (27Jan2021), the patient was throwing up. The patient didn't throw up until this morning and has vomited 4 times today. The patient has not sought medical treatment from an emergency room or doctor yet. The patient has been throwing up today. If the patient continues throwing up, and becomes dehydrated, she may need to go the emergency room. It was also reported that the patient started ethinylestradiol/ norgestrel last night. The patient's mother thought that the patient's initial stomach upset may have been caused by the ethinylestradiol/ norgestrel. Therapeutic measures were taken as a result of headache and fever including ibuprofen and acetaminophen; the patient isn't taking anything for nausea at this time. The patient's mother wanted to see if anyone else had been reporting these side effects the patient has been experiencing since receiving her second COVID-19 vaccine dose. The patient had not recovered from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
This is a spontaneous report from a contactable other hcp. Pfizer Sponsored Program. A contactable Other healthcare professional and contactable female consumer (patient) reported that: A 62-years-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown single dose for COVID-19 immunization. Tofacitinib citrate (XELJANZ XR), oral from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 11 mg, 1x/day for rheumatoid arthritis.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble with allergies and dry eyes, and patient missed doses. Patient reported that, she started xeljanz in February 2021 with samples from doctor and after start of therapy states she got covid and then subsequently got COVID-19 vaccine and was off Xeljanz (dates unknown of missed doses)and restarted Xeljanz last Monday (03May2021 to ongoing). md aware. patient reported currently has "trouble with allergies and dry eyes" and eye doctor prescribed erythromycin ointment and steroid drops for eyes, reports primary care doctor prescribed antibiotic for possible sinus infection with congestion, "sore throat due to drainage". encouraged to notify rheumatologist. Outcome of the events were unknown. No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a patient who was vaccinated with a first dose of VARIVAX (Oka/Merck). Concomitant therapy included MMR II. "Two weeks after receiving the vaccinations the patient was admitted to the hospital and was diagnosed with ITP". The physician reported that at the hospital the patient was given IV treatments. No further adverse event information. It was noted that the adverse event was considered to be life threatening. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
- Day of vaccination, fatigue that required a nap.  Was fine by evening - Next day, delt muscle was sore to the point that I winced when lifting my arm (but I could still lift it) - 3rd day, I could move my arm fine, but site of injection was sore to the touch - Days 4-7 fine - Day 8 (March 10) I woke up with a sore arm (not as sore as before, but very noticeable), and the injection site is swollen, sore, and hot.  My left eye is also very swollen, my throat is sore, and I'm feeling under the weather
pt mom said pt was sick p/the vax & had convuls & high fever which resulted in brain damage & learning disability;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:53, the patient was vaccinated with improperly stored zoster vaccine live (ZOSTAVAX) injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000505: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-AUG-2016, the patient was vaccinated with incorrectly stored dose M-M-R II lot # L029266 (dose and route of administration were not reported). Additional information has been requested.
Patient's eyes rolled in the back of her head, she was drenched in sweat, clammy, and unresponsive. I tried to check to see if she was breathing it was very shallow breaths and I couldn't locate a heart beat, so I administered a dose of Epipen. We called 911 at the same time and layed her down on her back and was monitoring her. She slowly began gaining consciousness and color returned back to her face.  Paramedics arrived and checked her vitals all seemed good but they took her to the hospital to continue monitoring her. Father returned to the pharmacy after several hours and reported that patient was fine.
presented to ER 1040PM parents stated pt inconsolably crying since vax in afternoon-@ time of triage pt asleep-afeb, inj site unremarkable; crying during exam but sleeping afterward, rx w/APAP & discharged home;
Moderna COVID-19 Vaccine EUA Saturday, Feb. 6 (one week after vaccination), in the early afternoon the injection site started itching. By Sunday evening, Feb 7, the injection site was red and swollen(approximately the size of a baseball). It has continued to swell to about the size of a softball during the day on Monday, Feb 8. I have been applying ice packs, applying anti-itch cream and plan to take some oral benadryl after consulting the nurse line at my clinic.
Daily minor nosebleeds. Nightly nasal congestion. Difficulty falling asleep. All minor.
Client loss consciousness for approximately 2 minutes following vaccination. Client did not fall, no other injury. Client assisted to wheelchair, taken to EMS OBS area, Vitals monitored, client recovered, vitals with in normal limits. Client left site with mother in stable condition.
Information has been received from a 71 yr old female with high cholesterol who on 10Nov05 was vaccinated IM in the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included simvastatin, latanoprost (Xalatan), antihistamine, acetaminophen/oxycodone hydrochloride (Percocet) and naproxen. On 10Nov05 the pt experienced transient pain on the medial aspect of the injection arm from arm pit to elbow with erythema, warmth, nausea, and difficulty sleeping. The pt was seen in the ER. At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Information received the same day from the RN indicated that the pt was vaccinated at another location on 10Nov05. The RN reported that on 13Nov05 the pt experienced swelling, redness and pain in the right deltoid. The pt told the nurse that she was given an antihistamine after being examined at a clinic. Additional information has been requested.
This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 27-year-old male presented with sudden, new onset, sharp, severe left chest pain radiating to his left arm that woke him from sleep. Because the pain lasted for a few hours, he was seen by an on-staff physician and given ibuprofen, which temporarily relieved the chest pain. He continued to have intermittent chest pain throughout the day and was given at a local emergency department (ED) overnight. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with diffuse ST segment elevations in most of the leads with a troponin of 4.87 ng/ml and creatinine kinase of 511 units/L. He had received ACAM2000 (lot number not reported) 2 weeks prior to presentation. Two days prior, he also was diagnosed with vaccination-site cellulitis and was started on BACTRIM, which was later switched to clindamycin. Thereafter, he developed a facial rash and recurrent chest pain, prompting him to visit the local ED. After myopericarditis was considered likely, the patient was transferred to another facility for further evaluation and treatments. The patient did not have any past cardiac problems. He was a nonsmoker and did not consume alcohol or reactional drugs. His family history was negative for cardiovascular diseases. Clinical examination revealed a facial rash, 1 cm-eschar at vaccination site with 0.75 cm-area of surrounding erythema without any active discharge that developed on left upper extremity 2 days post vaccination. He had regular heart sounds with a rub and no murmur. The rest of his clinical examination was unremarkable. The patient was seen by cardiology, who advised that he continued on ibuprofen for presumed myocarditis. He was started on "cephalexin" for arm cellulitis. A transthoracic echocardiogram obtained the following day revealed normal left ventricular size and function, absence of regional wall motion abnormalities, pericardial thickening, and a tiny posterior pericardial effusion. The patient was monitored for 2 days on telemetry floor, where he remained asymptomatic and had resolution of his electrocardiographic changes. He was discharged home with ibuprofen. He continued to stay asymptomatic with no activity limitations and had a normal echocardiogram (ECHO) at a 4-week cardiology clinic follow-up visit." The reporter for this case is the same as for case number 2012-00937. Documents held by sender: None.
rash - two pink itchy spots on neck and lower jaw - no other rash - present for several days without spread at time of evaluation
This spontaneous report was received from a licensed vocational nurse via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 30-MAY-2017 (reported as "today"), the patient was vaccinated with an expired dose of VAQTA 50 U/1.0 ml, injection (lot # M040421, expiration date: 26-MAY-2017; exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015651:
BOOSTRIX vaccine administered incorrectly. It was give subcutaneously, rather than IM. Estimate about 75% of dose was given before I recognized the error. Followed with a new complete dose IM in the same arm. (Pt also received ZOSTAVAX in other arm).
Stomach cramps, extreme nausea (throwing up), extreme chills and shakiness, body aches, headache and dizziness and diarrhea. These symptoms were extreme enough to prevent sleep and lasted for approximately 20 hours.
There was NO adverse event. The parent was not truthful about her son's age and told us he was 11 multiple times. She insisted we show her the Pfizer kid's vaccine vial. The patient turned out to be 12. He was given the wrong shot. We were advised by VAERS customer service to report this anyway.
shingles; rash; Itching; Hives on back/Itching hives; Swelling below the injection site; Bruise; injection site is sensitive; This case was reported by a consumer via call center representative and described the occurrence of hives in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 2nd dose of Shingrix. On 9th June 2019, less than a day after receiving Shingrix, the patient experienced hives, local swelling and pruritus. In June 2019, the patient experienced contusion and injection site hypersensitivity. On an unknown date, the outcome of the hives, contusion, injection site hypersensitivity and pruritus were not recovered/not resolved and the outcome of the local swelling was unknown.   It was unknown if the reporter considered the hives, local swelling, contusion, injection site hypersensitivity and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced swelling below the injection site that started within an hour of receiving the vaccination. The patient developed hives covering his back, on the same day. The hives itch. The hives were unchanged at the time of reporting.  At the time of reporting, less than a week after vaccination, the patient had a bruise below the injection site and the injection site was sensitive. This case has been linked to US2019106865, reported by the same reporter.   Follow up information received from consumer on 19th June 2019: On 13th June 2019, the patient went to the emergency room and was diagnosed as having a rash.  On 19th June 2019 at the reporting date, the patient was seen by his Primary Care Physician (PCP) and was diagnosed as having shingles. The VAERS information updated.
Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-). At the time of the report, COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-) outcome was unknown. Not Provided          No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-046434, US-MODERNATX, INC.-MOD-2021-046649 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: document updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046434:cosslinked US-MODERNATX, INC.-MOD-2021-046649:cosslinked
Urticaria 3-4 hours after vaccine (IPV, PREVNAR and Hep A) No respiratory prob - no vomiting; no pallor. BENADRYL oral give office ->outpatient.
raised, hardened, reddened area @ site of inject lt thigh; 19AUg94;