chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reported information from patient: I had a severe reaction to the COVID-19 vaccine.  Met with Dr. and did a series of skin testing for PEG allergy.  All were negative and progressed to a microdose of the vaccine.  Continued to have no reaction so remaining dose was administered.  I waited 2 hours in clinic and experienced some mild pruritic symptoms.  Took 2 zytrtec and went home.  the next day experienced some throat swelling with shortness of breath.  Took additional allergy medication and contacted Dr.  He prescribed prednisone and up to 4 allergy tabs a day.  I developed increased shortness of breath, hives on my tongue which developed into ulcerations.  The waves of throat swelling would come every 4 hours or so.  Was able to manage with oral agents, did not administer the prescribed epi-pen.  These symptoms started on that Tuesday and were severe enough to keep me home from work until Feb 15th (I work Monday/Wednesday).  Throat swelling and coughing persists but it markedly improved.   Now understand I have a non-IGE mediated allergy to PEG.   Patient wanted to receive the COVID vaccine so was seen by an allergist given previous history of possible polyethylene glycol allergy.  Following review and discussion of risks patient was scheduled to receive a test dose.  Provider notes as follows:  She has had several occasions where she has developed shortness of breath and "generally not feeling well," within 1 to 2 hours of taking MiraLAX.  She has not had any reactions to any prior injectable medications or vaccinations.  Due to this MiraLAX potential allergy there is a contraindication to receiving the Pfizer or my during a Covid vaccine.  What I have recommended since she would like to be vaccinated is to have her to return to clinic at which time we will do skin testing with skin prick and intradermal to polyethylene glycol as well as polysorbate 20 and polysorbate 80.  If the allergy testing to polyethylene clean glycol is negative we will then give her graded dosing of the COVID-19 vaccine and monitor her in clinic.  If the polyethylene glycol is positive but the polysorbate testing are negative she may be a candidate for receiving one of the newer vaccines which are yet to be on the market.     The patient was seen today for a new problem which is polyethylene glycol allergy and the need for COVID-19 vaccination.  She will return for testing to the vaccine components and then intramuscular graded challenge if necessary.     Prior to the graded challenge skin prick testing to MiraLAX was completed which was negative.  Skin prick testing and intradermal testing was also completed for Solu-Medrol, Depo-Medrol and triamcinolone.  The Depo-Medrol contains polyethylene glycol, the triamcinolone contains polysorbate 80 and the Solu-Medrol functions as a control without any polyethylene glycol or polysorbate.  All skin prick and intradermal testing was negative.  An ~10% dose of the COVID-19 vaccine was given and the patient was monitored for 30 minutes. The remaining ~90% of the COVID-19 vaccine was then given  and the patient was monitored for an additional 90 minutes. The patient received pre-medications with: Zyrtec and Tylenol
This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included the patient has one kidney, and seafood allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A,) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bumpy rash on back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bumpy rash on back was not reported. This report was non-serious.
PATIENT'S PARENT AND PATIENT MISREPRESENTED PATIENT'S AGE AND DATE OF BIRTH TO OBTAIN A COVID-19 VACCINATION.  TOLD PHARMACY IT WAS FIRST DOSE - UNSURE IF THAT STATEMENT WAS TRUE.  DISCOVERED DISCREPANCY LATER WHEN INSURANCE PLAN WAS CONTACTED.  ATTEMPTED SEVERAL TIMES TO CONTACT PARENT, WHO EVENTUALLY CALLED BACK ON JULY 7TH AND ADMITTED TO FALSIFYING PATIENT'S DATE OF BIRTH TO GET A COVID-19 VACCINE.  PARENT  ALSO SAID THE PATIENT HAD NOT EXPERIENED ANY ADVERSE REACTIONS SINCE THE VACCINE WAS ADMINISTERED.
3" x 1½" oval, red, itchy swelling.  Firm/hard feeling to inflamed area.  Extends down arm from injection sight.  No symptoms until suddenly itchy and inflammation discovered at that time. Still ongoing 1st March 2013.
Information has been received from a medical assistant concerning an 18 month old male patient with no pertinent medical history and no drug reactions or allergies who on 04-NOV-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 667490/0784Z, expire date 15-JUL-2012, 0.5 ml, subcutaneously in the left thigh. Suspect therapy administered on the same day included MMR II (Lot #, expire date and route not reported), in the left thigh. Concomitant therapy included DTaP, in the right thigh, and FLUZONE, in the right thigh, both administered on the same day. Medical assistant stated that on 09-FEB-2011, child presented to doctor office and was not able to walk. When child's pant leg was pulled up he had lesions on left leg at thigh; child had shingles. Child was treated with acyclovir. Medical assistant mentioned that on follow up visit on 17-FEB-2011, the lesions were all dried up. Medical assistant stated that "it looked awesome, child totally recovered". There were no laboratory diagnostics studies performed. Additional information has been requested.
Dizziness and tingling in arms/legs initially, abated within two hours.  Fatigue, headache, burning eyes and slight disorientation for 12 hours after first dose of Moderna.  No prior reaction/side effects from any vaccination.
Within three minutes of getting the injection, I felt a surge, like adrenaline, going through my body, then my heart started pounding rapidly. I also had shallow breathing, like panting.  I drank water and it gradually subsided. As it subsided, I felt a tingling in the left corner of my mouth. It then went entirely numb. After ten minutes, my heartbeat went back to normal.  Also, although I had urinated at 6:10 p.m., I had to urinate again at 6:30. This was not due to drinking the water,  since I only drank about four ounces of water.
The day after I received the COVID vaccine, I woke up the next morning with a "full" feeling in my right ear.  I also developed a muffled sound/decreased hearing and intermittent tinnitus in the right ear-- this persisted for weeks.  I was finally able to get in to see ENT on 12/23/2021-- they started me on high dose prednisone (60mg daily). My hearing , tinnitus, and "full" feeling started improving within 24 hours of starting the prednisone. I did NOT have any dizziness, increased headaches, vertigo or other symptoms-- just the hearing loss, "full" feeling and high-pitched tinnitus of the right ear. I have not had any symptoms in my left ear.
Palpitations, sweats, nausea/vomiting, chest pain. Transported by EMS to hospital, found to be having massive MI requiring emergent open heart surgery.
suspected autoimmune disorder; achiness under the eyes; one inch itchy area; fever of 101.7 / The 2nd day / she had a 107 fever; chills; Didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of suspected autoimmune disorder in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included conjunctivitis. Previously administered products included tdap vaccine with an associated reaction of pain (received number of years ago from the reporting date, reference case US2021AMR060204), Shingrix with an associated reaction of pruritus genital (1st dose received on 17th July 2020, reference case US2021059714) and hydrocortisone ointment. Concurrent medical conditions included pre-diabetic, house dust mite allergy and allergy to animal dander. Concomitant products included cetirizine hydrochloride (Zyrtec) and famotidine (Pepcid).   On 16th December 2020, the patient received the 2nd dose of Shingrix. On 18th December 2020, 2 days after receiving Shingrix, the patient experienced fever, chills and feeling unwell. On an unknown date, the patient experienced autoimmune disorder (serious criteria GSK medically significant), eye pain and localized itching. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the autoimmune disorder and feeling unwell were unknown and the outcome of the fever, chills and eye pain were recovered/resolved and the outcome of the localized itching was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, feeling unwell and localized itching to be related to Shingrix. The reporter considered the fever, chills and eye pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 61 or 62 years. In November 2020, the patient was prescribed with Zyrtec and Pepcid and ointment for genital itching and asked to use it for 2 weeks but still the itching was not over, she used them for 2 more weeks prior to getting 2nd dose of Shingrix. The patient experienced a fever of 101.7 and 107, chills, did not feel well and achiness under the eyes, 2nd day after receiving the second dose of Shingrix. The patient took Tylenol and was better. The patient was still getting genital itching sometimes but only on one side, it was slowly going away. The patient had a one inch itchy area on one side of her stomach and she had pictures to share. The patient asked her doctor if her itchy symptoms could be autoimmune, doctor replied that they could be.  The patient asked doctor if her itchy symptoms could be cancer and doctor replied that he did not think so. The patient was not sure if itching symptoms were related to Shingrix or not which was why she was calling. The consent to follow-up was requested.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021059714:Same reporter, Shingrix 1st dose US-GLAXOSMITHKLINE-US2021AMR060204:Same reporter, Tdap vaccine US-GLAXOSMITHKLINE-US2021AMR061311:Same reporter. Invalid Hearsay case.
Day after vaccine given -wheezing/allergy like symptoms -10 days later horrible cough fever, runny nose, body aches, diarrhea for about 4 days.
- Swollen arm - Pain at the site oF injection  - Arm is warm. - Entire arm hurts.
This spontaneous report as received from a health worker, the reporter reported that RECOMBIVAX HB (lot#, dose, route, indication not reported) was exposed to 24.5 F for 8 hours and could not be supported, she didn't know whether any doses were administered to patients. SR# provided to follow up if any patients were administered unsupported doses. No adverse effects reported. Additional information is not expected.
Extreme drowsiness 2 days after vaccine.   "Covid Arm" at the injection area 8 days later. Red circular area on upper arm where vaccine injection was given. Minimal swelling in red area, but slight itchy irritation.
Patient lips got numb in 5 minutes; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes). At the time of the report, HYPOAESTHESIA ORAL (Patient lips got numb in 5 minutes) outcome was unknown.            No medical history information was reported.  No treatment medication was provided.   This case was linked to MOD-2022-661777 (E2B Linked Report). This case was linked to MOD-2022-662000 (Patient Link).; Sender's Comments:  MOD-2022-661777:MOD22-027301 (Same reporter)
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine underdose).    No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received included non-significant information.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Right heel was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right heel was hurting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right heel was hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Right heel was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Head is pounding (migraine); Jaw hurting; Neck is stiff; Can't sleep (haven't slept); This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. In Jan2021, the patient's head was pounding (migraine); jaw was hurting; neck was stiff; and she could not sleep (have not slept). The outcome of the events, 'head was pounding', 'jaw was hurting', 'neck was stiff' and 'could not sleep', was unknown.  Information on the lot/batch number has been requested.
3MAY pt ran a fever of 104 for 2 days & had fever blisters;pt fever today 100 & had MD appt 6MAY98;MD office feels fever is unrelated to immun;
UNCONTROLLABLE MUSCLE MOVEMENTS, JERKING, FEVER OF 101.5 TEMPORAL WITH CHILDREN'S TYLENOL. UNCONTROLLED MUSCLE MOVEMENTS LASTING 3 DAYS.
Administered Hep A GARDASIL 9 vaccine. Within minutes patient became flushed. After about 45 seconds said felt dizzy and then passed out. Ammonia used. Patient was stabilized in chair she was in. Eye lids began to flutter and twitch rapidly. Patient then urinated large quantity onto floor. Postured and appeared to be seizing. B/P 88/ palp.  Lowered patient to floor and laid on side. Patient came to after ammonia used. Said she couldn't feel her body. Was able to tell me her name. After 3-4 minutes said feeling was back. within 5-6 min after start of reaction color improved. Mom sais "Well, she does pass out when has blood drawn, but never has with vaccines" mom says has never seen her have such a severe reaction. 911 called Squad responded. Assessed her and upon patient and moms agreement transported to ER. Patient was alert at time of transport.
Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine; Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 11:00 (Batch/Lot number: unknown) as dose 2, single 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 immunisation, reaction(s): "no reaction". The following information was reported: NAUSEA (non-serious), VOMITING (non-serious) all with onset 30Mar2021, outcome "unknown" and all described as "Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine".  Additional Context: After second vaccine patient has been nauseous and throwing up every 15 minutes since she received the vaccine. This started 15 minutes after the vaccine which was given at 11:00 on 30Mar2021. Reporter states there were no reactions after the first vaccine and does not know of anything she was allergic to.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received SHINGRIX (batch number EK279,expiry date 31st March 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient developed goose egg at the site of injection after receiving the SHINGRIX vaccine. The health care professional was no sure when the reaction started but the patient contacted them the next day to report the event. The goose egg on the arm was bout the size of a 50 cent piece.
Rash, headache, body ache, fever, sweats, diarrhea, dizziness, blurred vision
Vaccine use by 12/12/2021, vaccine given 12/13/2021
Inflamed, raised rash of about 5 cm in diameter at injection site (left arm).
Patient had appointment for Janssen vaccine.  He presented with passport and no Data was found. When checking out patient, I reviewed that this was the first COVID vaccine the patient has had. He stated he had not gotten a vaccine for COVID before. After vaccination, the patient was asking about Janssen after having had the vaccine series.  The patient then made us aware that he received this vaccine with last dosing sometime in September 2021.  He had no documentation to show this. I suggested he report all of his vaccines to the agency program and contact his provider with any other concerns.
About 8 minutes into the 15 min time, I felt a wave go across my stomach and about 2 min later, I felt another wave go across my stomach. When my 15 min was up, I told the RN I didn't feel good. I told her I felt like I was going to pass out and I needed to use the bathroom. She pushed me forward and back. I pulled myself back to try and keep from passing out. The RN was taking my pulse, said it was Bradicardic. Then they got more people, I saw them running in and I remember hearing a CODE going over the speaker. I remember them saying check my blood sugar and keep the pulse ox on my finger if I didn't have oxgen on. When I came to, my vision was blurry and kinda in a fog.  I remember saying I took a nap. When they put me on the stretcher, I had riggers and remember thinking, " put a coat on me!"  After some tests, I was discharged.
Persistent but improving pain to site of injection. Still has pain after 10/17/08 administration. Pain increases with adduction motion. No other complaints.
Within 5 minutes of vaccine patient felt dizzy, lightheaded, heart racing, and sick to her stomach. We had patient lay down on the bleachers, where she was sitting. She did deep breathing and heart rate was normal. We provided her with water. She laid on the bleachers for 10-15 minutes. She improved during this time. Patient felt well and walked her to the car. Explained if any symptoms get worse go to ER.
Information has been received from a physician concerning a 14 year old female who was vaccinated with two previous doses of Gardasil on unspecified dates (lot number, site and route not reported).  On approximately 22-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot number, site and route not reported).  Subsequently, after the third dose, the patient had a "seizure" according to the physician's office.  The patient had her head slumped in her hands and she was "rigid".  The patient became disoriented and did not know the time and date.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No further information was provided.  Upon internal review seizure was considered to be an other important medical event.  Additional information has been requested.
T102 to 104, stiffness in neck, irritable, soft spot in head swollen, neg for meningitis;
No additional AE/PQC reported; HCP reported that an expired PNEUMOVAX 23 vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W021636 has been verified to be a valid lot number, expiration date reported and validated as 01-OCT-2023) (expired product administered) for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided). No additional adverse event/PQC was reported.
Pt recvd vax on 18DEC91 pt devel fever of 103; also had runny nose & cough; mom did not call;