chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 year old accidentally received Moderna vaccine; Regular chills; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Regular chills), MYALGIA (Body aches) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHILLS (Regular chills) and MYALGIA (Body aches). On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine) had resolved. At the time of the report, CHILLS (Regular chills) and MYALGIA (Body aches) outcome was unknown.        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.   Concomitant product use was not provided.   Treatment information was not provided.
after 45 minutes she felt itchy; Her face swelled up; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, after 45 minutes of first dose the patient felt itchy, and her face swelled up. She was put on Predisone 2 mg and Zyrtec. She wanted to know since she was on a steroid if that would cause the Covid vaccine to be less effective and she won't have any antibodies. She stated that her allergist thinks the irritant might be polyglycol and they will be testing her next week. She stated the lot number was EL9262. She wanted to know if she would be able to take (Company name), relayed that she would have to check with them to see what was in their vaccine. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events (itchy, swelling of face).  Follow-up attempts are completed. No further information is expected.
2 mins after vaccination, pt was caught by RN while falling to the floor. Observed for 15 mins, finished a water bottle and ate some crackers. Pt rested and became ambulatory.  Pt stable and released from vaccination site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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 drug ineffective, covid-19. Patient received treatment with Paxlovid (24Jul2023 to 28Jul2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265882 same patient, different drug/event;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2022 at 12:00 as dose 4 (booster), single (Lot number: Fk9895), in left arm 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: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: bee stings" (unspecified if ongoing). There were no concomitant medications within two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid  No follow-up attempts are possible. No further information is expected.
Within 5 minutes of receiving the vaccine, the patient became pale white, lips became numb, tingling in fingers, blurred vision, and sweating profusely. 911 was called and all tests performed by the EMTs came back within normal limits. The patient then was taken to the hospital by his mom. The hospital diagnosed the event as vasovagal syncope.
Vaccine site redness, itching, bump, feels warm to touch. Also left shoulder, and torso pain, as well as back pain.
10/9/04: left arm (pneumonia vaccine injection arm) , itchy , red, hot, swollen. Benadryl 25mg taken. Redness heat, swelling and itching is not at injection site, but 2 inches away. Supervisor felt that VAERS form should be submitted.
Patient received the Flu shot at her place of employment yesterday. She was seen today at clinic reporting severe right arm pain affecting mobility. She is instructed to schedule Ibuprofen Q8H for next day or 2 taking Tylenol PRN. Frequent Icing and keep moving as tolerated. She is asked to return to clinic if she is not better enough to return to work on Friday.
Pt was given Flumist and was pregnant. Pt did not tell me she was prior to vaccination.
Three weeks post vax the pt developed a rash. The most recent information received reports the condition of the pt is unknown.
Patient experienced profuse rash and possible hives on the injected arm, trunk, groin, flank, and legs in addition to soreness at the injection site starting within 3 days of vaccination and continuing for the past month. The rash is still unresolved but has gotten better.
The pt experienced urticaria 2 weeks post vax. Has had chronic urticaria since then.
swelling, induration, musclar soreness locally in lt deltoid 7-8cm. Onset within 25-48 hrs, duration 4-5 days /w resolution
Fever and chills arose at 3 am the day following the shot and lasted until about 11 am on 4/28. It was at that time I noticed a large raised welt at the injection site, the size of a softball. It was firm and hot and very sore. It's now 4/30 and I still have a smaller version of the welt on my arm that has begun to itch but is not nearly as sore. It looks more like a bruise now with different coloring vs the fully red lump it was on 4/28 and 4/29.
About 4 hours after receiving the dose I started experiencing piercing, stabbing headache on the left side of my head. Sitting through my temple, eye, cheek, jaw and even my nose and top of my head. It is now 11am the next morning and still in pain only slightly more dull.
Patient's arm was sore and began swelling on 6/15/18 after BEXSERO and MENACTRA was given. Patient was seen at 2:00 pm for a F/U and given 25 mg of BENADRYL.
pt recv vax 15JUN95 & 13DEC95 devel scattered lesions on trunk, chin & extremities that numbered fourteen on 14DEC95;MD indicated that the rashes were considered to represent break through chicken pox & not causally related to the varicella
High fever (102-104), severe chills, pain and achieness not responsive to ibuprofen for 2 days, arm pain at site of injection ongoing at 9 days post injection, swollen and painful lymph node in neck near collar bone on going at 9 days post injection, swollen lymph node in underarm for 2 days.
Within less than 10 minutes of receiving the vaccine I began to feel a tingling sensation inside my mouth. That moved to my lips within the following 10 minutes and my pulse increased. I received benadryl at the triage area of the vaccination clinic and monitored. My BP was unusually high (140/90). In the days that followed, the injection side was swollen and raised, the muscle around it knotted, and incredibly painful. I had some slight symptoms such as headache and nausea. Those all subsided by Friday, 1/22/2021.  One week later (today, 1/26/2021) the injection sight is suddenly reinflammed; the knot has returned and is larger than before, the skin is raised and red and hot to the touch, and it is extremely itchy.  I was advised at the vaccination clinic that I would be able to receive the second dose, but that I should take benadryl prior to receiving it. Now I'm wondering if I should receive it at all. Why should it be reinflammed, a week later?
Uncontrollable shivering early in the morning (6:00 - 6:30 am), slightly elevated temp (99.9 at 7:00 am, down to 99.6 at 8:30 am, dizziness when moving my head as if ears are plugged, upset stomach.
Patient received Tdap vaccination to left deltoid then patient received HPV vaccination to right deltoid after vaccination given pt had syncopal episode.
This report describes the occurrence of "severe" muscle pain in a pt who was vaccinated with hepatitis A activated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was rec'd from the pt and has not been verified by a physician or other healthcare professional. The pt reportedly had no relevant medical history, allergies, adverse experiences following previous immunizations, or concurrent medications. The pt stated that she rec'd her first injection of Twinrix at the end of 8/02. within 1 week after receiving the injection, she experienced muscle pain in her arm. The pain persisted at the time that she rec'd her 2nd injection of Twinrix, at the end of 10/02. the pt reported that the pain had "continued to worsen with time" and that she was unable to pick up anything heavy. The pt stated she was uncertain if the pain was related to Twinrix or a pulled muscle. She had contacted her physician's office but, as of 2/6/03, had not been evaluated by her physician.
Severe pain at injection site, headache, chills, very low energy in bed for 3 days
Cellutitis to injection site in right glute noticied redness that keeps increasing and swelling to lymph nodes in pelvic area prescribed antibiotic 3 days post antibiotic and continues to have increasing redness
cutaneous lymphoid hyperplasia; Fatigue; This is a literature report.  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,Single), for COVID-19 immunization. The following information was reported: PSEUDOLYMPHOMA (medically significant), outcome "recovered", described as "cutaneous lymphoid hyperplasia"; FATIGUE (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy: Unknown result; CD30 expression: Positive; CD4/CD8 ratio: 3:1, notes: Unknown unit; Histology: Performed; SARS-CoV-2 test: Unknown result; T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, fatigue.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Initial information regarding this serious valid case received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111446 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 70 years old male patient who experienced anaphylactic reaction, while he received vaccine INFLUENZA VACCINE (TRIVALENT). Patient had a medical history of chronic obstructive pulmonary disease and coronary artery disease but no hypersensitivities. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with breathing difficult (Dyspnoea) and cardiopulmonary arrest (Cardio-respiratory arrest) 258 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. (outcome fatal). It was unknown if an autopsy was done. The documented cause of death was reported as anaphylactic reaction. Document held by the sender: none.; Sender's Comments: This case concerns a 70-year old male infant who died due to  anaphylactic reaction with symptoms like difficulty in breathing and cardiopulmonary arrest, 258 minutes after vaccination with INFLUENZA TRIVALENT VACCINE. It was further reported that the most probable cause of death could be anaphylactic reaction. Notably, a history of chronic obstructive pulmonary disease and coronary artery disease, can increase the likelihood of a severe or even fatal episode of anaphylaxis, however no conclusion on the cause of death can be made at this point, as no autopsy results are available. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.
no adverse event; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.Names of vaccines involved PROQUAD X013909 11/10/2024 Temperature 8.1°F Time frame 3 hours 0 min; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 29-SEP-2023, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) rHA injection, (lot # X013909 has been verified to be valid, expiration date: 10-NOV-2024), administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (product storage error). The administered dose underwent a temperature excursion of 8.1 degrees Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse events reported.
Case number PHEH2014US016598, is an initial spontaneous report received from a pharmacist on 18 Aug 2014. This report refers to a 12-year-old male patient. Past medical history was not provided. Concomitant vaccination included TDAP. The patient only received the CYW-125 liquid component of MENVEO (batch number: M14024) intramuscularly on 29 Jul 2014. No adverse reaction reported following this administration error.
PT fainted and pale and bradycardia around 15 mins post vax. PT was stimulated and came out of it.  Given cookie ? she said she was hungry. She hasn't eaten for at least 19 hrs before.
fever to 101.8, arthralgia, myalgia, cellulitis, lt arm local swelling, redness, warmth & bruising;
MOTHER STATES PATIENT HAD A HEADACHE, THROAT PAIN, PAIN, ITCHING, STOMACH WEAKNESS. PATIENT CAME TO ER AFTER LEAVING THE CLINIC.
At approx 24 hours after the injection, I had extreme chills, fatigue , body aches, headache, nausea and temp of 101. This lasted  approx. 15 hours. The nausea and headache lasted another 24 hours. Sore arm lasted about 4 days. Did not contact PCP.
This patient is a 59 year old female with a history of hypertension, hypercholesterolemia, mitral valve prolapse, prior breast cancer, migraine headaches and apparently an MI in 1994.  Her medications include atenolol, Zocor, Vasotec, and Lexapro.  She had been on HCTZ in the past. The patient received smallpox vaccination on 3-11-03.  On 3-28-03, while at her job she developed chest tightness, and felt faint although she did not pass out.  Co-workers laid her on the floor and took her blood pressure, which was reported in her physician's note to have been 210/105. She was apparently checked in the ER of the hospital and released.  I do not have that portion of the record, although I do have the EKG that was done.  It shows QS waves in leads V1 and V2 which appear to be old, and not acute. The patient is normally on Vasotec and hydrochlorothiazide, and her doctor apparently adjusted these meds when he checked her.  On 4-1-03, she was rechecked at her doctor's office and was doing fine.  Her blood pressure was down to 100/60. A basic metabolic panel done at the doctor's office showed a mildly elevated BUN and creatinine (30 and 1.5 respectively) but no other abnormalities.  The doctor's office note indicates she was in no distress and had a normal exam except for perhaps some mild lower extremity edema. On 4-13-03 she was seen in the ER again, with a complaint of mid-sternal chest pressure, after having become symptomatic while at work.  This was accompanied by nausea, one episode of vomiting, but no shortness of breath.  It apparently came on during light activity at work.  Again, her colleagues apparently checked her BP and found it to be 151/119, so they sent her down to the ER.  Her vitals were BP 112/73, P 66, R 18, T 97.2 and she was not orthostatic.  Pulse ox was 95%.  She was given some sublingual nitroglycerin, apparently with complete resolution of her symptoms.  Her exam was unremarkable and her EKG on this occasion was completely normal, not even showing the small QS deflection in V2 that had been present on the earlier tracing.  Her cardiac enzymes (CK, troponin, cardiac index and myoglogin) were normal.  Her other labs were also unremarkable except once again for a minimally elevated BUN/Creatinine. For reasons that are not clear from the record, the patient also had a renal artery MRA which was normal, witn no stenosis.  She also had MRA of the carotid arteries which was unremarkable, and an MRI of the brain, which showed possible areas of small vessel disease in the paraventricular areas, but nothing definite.  A Circle of Willis MRA was also done, and was normal. It is not clear to me why the patient received these tests when her presenting complaint was chest pain. As of 4-22-03, the patient was reported to be doing very well, with no further complaints.
Slight fever; Bad headache; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (Lot number: EL3247), at the age of 48-years-old, as a single dose for COVID-19 immunisation. Medical history was reported as none. No allergies to medications, food, or other products. Concomitant medication included with fish oil (OMEGA-3 FISH OIL) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 48-years-old) at 14:15, as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced slight fever and headache on 24Mar2021 at 02:00 am (after getting the vaccine at 14:00 the day before) and progressively getting worse throughout the day. Symptoms started to decrease around 18:00. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Two days after the vaccine shot, patient had no symptoms. The clinical outcome of slight fever and headache were resolved on 25Mar2021.   No follow-up attempts are needed. No further information is expected.
patient will not receive second dose until after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient will not receive second dose until after 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient will not receive second dose until after 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient will not receive second dose until after 42 days) had resolved. Not Provided          Action taken with vaccine was not applicable. No concomitant medication was reported. No treatment information was provided.
Patient developed what mom believed to be insect bites on site where varicella vaccine was administered. Was taken to an urgent care facility where the physician agreed that they could be insect bits and patient was treated with a steroid injection and BENADRYL by mouth. Mom contacted our office today as symptoms had not resolved. On exam all three vesicles had drained clear fluid per mom's recollection and are now crusted with minimal inflammation.
Severe pain (constant) originating from the intercostal nerves (left side).  Vaccine was administered in left deltoid.  Pain was exacerbated when respirating.  I applied BENGAY ointment and took extra strength TYLENOL with very little reduction in pain level.  Pain resolved by 9 PM on 13 December 2015.
Day 1: soreness at the site of injection (left arm) Day 2: extreme fatigue, whole body muscle aches, whole body joint aches, chills, fever (100.3), headache Day 3: none Day 4: headache and nausea Day5: symptoms have resolved
pt recv vax & exp local pain & local swelling to lt triceps;seen in ER where had an ice bag applied & was given motrin & a sling;