chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. presented to nurse to receive H1N1 vaccination in the conference room of her place of employment.   She denied allergy to eggs and stated that she was feeling well that day.  She received Novartis Influenza A (H1N1) 2009 Monovalent Vaccine 50 mg Intramuscularly in Right Deltoid.  She left conference room in no apparent distress.   She returned approximately twenty minutes after receiving injection stating that she felt "itchy", and that her right upper arm was swollen.   This area appeared slightly swollen, slightly reddened and warm to touch.  An ice pack was applied to the injection site with some acknowledged relief.    Her BP was 110/60 which she stated was her "usual"  blood pressure reading.   Breathing appeared normal.  Pulse was 86.    The nurse stayed with patient for approximately twenty minutes.  It appeared that patient was having a localized reaction to the vaccine.  Pt. was encouraged to seek medical attention if she felt that she needed further treatment.   Pt. was working in a facility with a substance abuse detoxification program on another floor and therefore there was medical personnel available in the building.  That evening the nurse tried to contact the patient at her home telephone number.   There was no answer and a message for her to call the nurse was left.   Pt. did not return telephone call.
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF INCORRECTLY STORED VACCINE; This spontaneous report received from a physician concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of incorrectly stored vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of incorrectly stored vaccine and incorrect product storage was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558436, 20220558475, 20220558482 and 20220558498.
Chills started about 10 hours after vaccine but minimal.  Extreme chills started about 11 hours after vaccine and lasted about 1 hour or so.  Layered with clothes and blankets to get under control.  I have had many vaccines over the years and never experienced any adverse affect.  Next day a bit cloudy and headache but subsided after about 27 hours after vaccine
Neurological concerns with parsons turner syndrome; sharp pain down middle of shoulder blade; difficulty snapping fingers; pain; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves male patient (age unknown) who experienced neurological concerns with parsons turner syndrome (neuralgic amyotrophy), sharp pain down middle of shoulder blade (arthralgia),difficulty snapping fingers (musculoskeletal stiffness) and pain, after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (clarifying with patient prefilled syringes or MDV- Multidose vial), lot number and expiration not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious neurological concerns with parsons turner syndrome (neuralgic amyotrophy), sharp pain down middle of shoulder blade (arthralgia), difficulty snapping fingers (musculoskeletal stiffness) and pain, few weeks after receiving INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  Patient had to start steroids.  At the time of reporting, the outcome was unknown for all the events.  Reporter was investigating more on vaccine to see what strains it covers, had no way of knowing if cause or effect from vaccine.  There will be no information on the batch number for this case.
This 13-year-old patient inadvertently received a pediatric dose of Pfizer (10 mcg/0.2 mL) which is approved for ages 5-11.  Patient was observed for the recommended 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 20Jan2021 01:15 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure (abnormal) from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food or other products. The patient experienced dizziness, vertigo, falling on 20Jan2021 02:30. Treatment was not received. Outcome of the event was recovered with sequelae on an unspecified date. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.
severe anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe anaphylactic reaction. The reporter wanted to know if she could get the ingredients of the COVID-19 vaccine and if the regulatory authority has approved the COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19 January 2023 Reporters comment: The nurse informed that Twinrix was administered to a patient, but such vaccine had expired on 1st January 2023. The Vaccine Administration Facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As patient received the expired vaccine, which led to expired vaccine used.
Child received FluMist as prescribed in each nostril mom stated about 15 minutes later she started complaining of a headache.  They had not left the Health Department so the mom brought her back in to see the nurse.  The child stated her head still hurt but was doing better.  Mom was advised to give Tylenol like after any other vaccine and if symptoms get worse to see her medical provider.
patient given Vaqta 0.5 ml in left Vastus Lateralis this was #2 in series. upon waiting 15 minutes after vaccine I went to release patient to go and mom stated "I think she's having a reaction" brought patient to room she had bilateral redness and mild swelling to back of both arm, mild facial flushing and some redness to hands, temp went up  to 99.8. Provider alerted, ice packs applied to bilateral arm, Benadryl given. vital signs monitored Provider noted some tachycardia, patient stable and transported via ambulance to Hospital.
Hep A - Only vaccine she has ever had. Had yesterday prophylactic from Berry mix she had eaten with family. Today came into clinic with brother because he couldn't come yesterday. Hives under (L) arm in armpit and half way down chest. # 8 hives. Mom doesn't know of any other changes other than the vaccine.
A consumer report from another company was received on 12 May 2010. This is a case of misuse where FLUZONE was administered in a divided dose (1 hour apart). A 4-year-old male patient had received a divided dose (1 hour apart) of FLUZONE SV on 03 November 2009 at the allergist's office. The lot number, route and site of administration was not reported. On 17 November 2009, i.e., 14 days post-vaccination, the patient did not eat his dinner and the following morning the mother found the patient shaking like he had a fever/seizure and he was "lifeless for 3 hours." He was taken to the emergency department where his blood sugar was noted to be low (exact reading not provided). Treatment included intravenous fluids and the patient was admitted for observation. Diagnostic tests included CAT scan and sleep deprived EEG; however results of these tests were not provided. It was reported that another incident occurred 5 days later, where the patient was in a trance and "laying there." He would not eat, was irritable, "sleeping", and had projectile vomiting after taking orange juice. After that he was able to eat chicken nuggets without any further vomiting. The patient had no history of prior episodes, but did also have medical history of allergy to wheat, soy, dairy, eggs and nuts which causes eczema. The patient also had history of RSV one year prior to 03 November 2009 that was treated with PULMICORT and prednisone. Per the mother, the patient was diagnosed with ketotic hypoglycemia and required the right amounts of carbohydrates and proteins. She reported that her son will be tested for suspected tumor or cyst on the pancreas which may be interfering with processing of insulin. The mother feels that the patient's reaction may be the result of his allergies and not from the flu vaccine injection. At the time of this report, the patient had not recovered. Documents held by sender: None.
Got vx 2 yrs ago got mild outbreak /Suspected vaccination failure; Recovering from mild outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. In September 2021, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received shingles vaccine 2 years ago and got bad case all over one side of face, near eye 2 years ago.  The reporter stated that, just recovered 2 weeks ago from the date of reporting from a mild outbreak. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR196905, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196905:Same reporter
LARGE RED INJECTION SITE THAT HAS GOTTEN LARGER AND MORE PAINFUL LASTING 4 DAYS SO FAR! SEVERE HEADACHES AND FATIGUE LASTING 4 DAYS SO FAR! SWOLLEN LYMPH NODES UNDER LEFT ARM! VERY ITCHY INJECTION SITE! LARGE KNOT IN THE RED AREA OF INJECTION SITE THAT HAS GOTTEN LARGER SINCE INJECTION LASTING 4 DAYS SO FAR!!
3 days p/vax pt had runny nose, cough, irritable, devel rash on chest & diaper area & then became reddened spots by 10/6/99;
puked; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 8-year-old male patient received bnt162b2 (BNT162B2) (Lot number: FK5127) at the age of 8 years as dose 1 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "puked". Therapeutic measures were not taken as a result of vomiting. Additional information: The reporter ("a pharmaceutical rep") stated, "I just want to report an adverse event that happen to my 8-year-old one (consumer), an hour after he got his first Pfizer dose." The reporter stated, "one hour after he got the vaccine, he puked just randomly."  No follow-up attempts are possible. No further information is expected.
On September 18th I was hospitalized with sudden onset symptoms of acute pericarditis. I spent 2 days in the hospital and was released. Follow up tests have shown little to no improvement. Placed off work until October 25th (5 weeks total) until assessment can be completed by cardiologist. Still feeling pressure/discomfort around the heart. No previous heart conditions and no known causes of pericarditis would be applicable to me, aside from receiving the vaccine.
Pfizer/BioNTech COVID 19 Vaccines Rec'd: 1) 1/23/2021 Lot# EL9262 2) 2/19/21 Lot# EM9808 3) Boost 1 10/15/21 Lot# FF8841 4) Boost 2 5/6/22 Lot# FM7553. Symptom onset 5/31/2022. Negative COVID at-home test 6/1/2022. Positive COVID at-home test and Positive PCR test 6/2/22. Symptoms: chills, sore throat, cough, wheezing, short of breath with any activity, bilateral ear pain, nausea, fatigue, rash on trunk, loss of taste and smell. Telehealth visit with provider 6/7/22 due to worsening symptoms after beginning to improve. Unable to work, perform activities of daily living 6/2/22 to 6/10/22.
First time episode of wheezing requiring medical attention, albuterol and systemic steroids.
Breakthrough case admission 5/25/21 Moderna Lot# 033B21A 6/22/21 Moderna Lot# 026D21A 2/8/22 Moderna Lot# 042J21A
I received the Moderna vaccine at 11:50am.  When I went to bed that evening, around 9pm, I noticed a constant buzz in my ears.   I'd call it "ringing of the ears", but it not like a ringing noise. It's a constant buzz.    It is now 4/19 and it still hasn't resolved.  It's a constant buzz that is always noticeable when it's quiet.
Vaccine given on 2/2/00-on return 2/3/00 c/o facial myalgia.  Returned on 2/4/00 c/o L/side facial weakness.  (Dx: L/Bell's Palsy) Also had corneal abrasion.
After first dose-Numbness and tingling that started in the left jaw area, moved into era and throat, then moved up to the scalp on the left side only.  (I thought I was getting shingles)  Pricking sensation in left arm. After second dose tingling and numbing in different parts of the body with pricking at different time ALL over my body randomly.  Sometime feeling of cold and other times the feeling of heat.  It takes 1-3 day to subside and as it subside I get an itchy feeling.  Comes back what seems to be every 2 weeks.   It is like my nerves are "firing off", again, all over and randomly.
adult patient was accidentally given a pediatric dose of Engerix-B; adult patient was accidentally given a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 24-JUL-2023, the patient received Engerix B pediatric. On 24-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-B). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-JUL-2023 They did not have information about the patient nor vaccine but did allow for follow-up, preferably via e-mail. The Vaccine Administration Facility was the same as Primary Reporter. The reporter called to report that an adult patient was accidentally given a pediatric dose of Engerix-B, which led to accidental underdose and adult use of a child product.
Fever, extreme body aches, fatigue ; lasted  5 days; two days OK; 6th day lethargy, aches, unsteady, vomited. 7th day: lethargy, unsteady
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated at a clinic and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Mother called clinic to notify us of swelling and redness to the left thigh. Mother states child woke on 4-4-23 with redness and swelling to the left thigh. Mother gave 24 hours of  watching for any improvement. mother called on 4-5-2023 at 8 Am to notify us of the swelling, redness and warm to the touch. Denied any SOB, raspatory distress mother was advised to head to the clinic and have child evaluated for  symptoms. Provider confirmed adverse reaction to the site. child had 3 x 3 1/2 of redness and swelling on the LT thigh. child was advised to give a dose of Benadryl and notify clinic of any extreme changes.
Dizziness, headaches, blurry vision and vestibular disturbance which began about 12 hours following administration of the vaccine and persisted for 8 months.  Symptoms did not respond to treatment but dissipated gradually with time.
states had joint pain in arms & legs, rash over body, & a sore throat;temp ranged from 100 to 102;this lasted for more than a week;went to ER on 15DEC96 & then saw MD on 19DEC96;
Child complained of sore leg. I thought this was because of injection site, but later complained both legs and arms were sore. Child has fever of 102 degrees F currently. Child broke out in hives this afternoon around face and is sleeping before usual nap time.
Pt had nausea/sick to stomach with chill at 2:30AM, temp of 103.6. Neck/head bothering, sore throat, chest tightness (sharp pain). Tylenol/Motrin given for temp. Spoke with representative. Benadryl 25mg, Compazine 5 PO q 5 as needed. Call to mom 07/14/05, Back to normal.
Itchy rash, whole body, in .5-1.0 cm, mostly in the torso, legs, it started as a patch, well demarcated, hyperpigmented, thought it was  tinea corporis, but failed topical antifungals. Steroids slightly improved condition after anti-fungals failed, but more lesions developed. After the second dose, the lesions became even more numerous almost a day after the 2nd vaccination. The lesions itched severely, limited sleep, improved with 20mg prednisone daily, but that limited sleep, and had to use a 1st gen anti-histamine to sleep, but was very drowsy in the morning. I cannot win here.
Redness, warmth, and itching at injection site. About inch and half in diameter.
Received the  Johnson and Johnson  first; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received the  Johnson and Johnson  first) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received the  Johnson and Johnson  first). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received the  Johnson and Johnson  first) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    Reporter did not allow further contact
Pt reported that he start sweating and could not understand what TV saying - he was very confused.  He is living alone. He called 911 and 911 came to his home and checked him.  Once they arrived at his home, he started feeling better. His blood pressure was normal per patient. He thinks they didn't check his temp.  He told me once I asked him if he has any heart problem. He has 4 stents and he thinks he had similar problems  about 4 months ago.
pt states when he woke up that he felt like he had fever but when he checked his temp on forehead it was 99 and when he checked his temp around the ear it was 101.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for the vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
I got sick a few days later, tested Positive for COVID-19.  I had a bad cold, fatigue, muscle ache, shortness of breath, lost taste & smell. I was fatigue for two weeks, since then, I repeat get bronquitis and get tired.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced lightheadedness, feeling faint, sweating. 2 minutes post vaccine, BP was 108/70, P-64, O2 100% RA. Patient was easily aroused, stated he hadn't eaten or had hydration for > 12 hours and "needles make him nervous."  Crackers and orange juice provided. After extended observation patient stated he felt better and symptoms were relieved.