chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Five days after his shots, he broke out with hives alll over his body. His legs were the worst. They were swollen. Underneath his eyes, they turned black. We brought him to the ER. We were given an Epi Pen and to give him Benadryl. We did for 2 weeks.
Patient had redness, swelling and tender to touch. Patient advised to ice area and take Advil for soreness.
(L) thigh with approximately 10cm diameter redness-area very warm and tender. Area slightly itchy. Pt will be taking BENADRYL and AMOXICILLIN.
This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of oral herpes (1st dose received in March or April 2018, for tolerance, refer case US2019GSK052324). In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced PSA increased. On an unknown date, the patient experienced fever blister and generalized rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever blister and generalized rash were not recovered/not resolved and the outcome of the PSA increased was unknown. It was unknown if the reporter considered the fever blister, generalized rash and PSA increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient could be around 69 years old at the time of vaccination. After receiving the 2nd dose of SHINGRIX, the fever blisters on his lips returned 2 weeks after the dose. They were worse in appearance and size than after dose number 1. The patient reported spots on his body, but most prevalent around the neck. In October 2018, the PSA (prostatic specific antigen) of the patient were increased from 1.7 to 2.9. Follow up contact was consented. Permission to send letter for MD information was granted on an unspecified date (date not known by the reporter).
My throat was hurting in the morning. During the day felt like I was getting ill. By Monday I was very ill. I had a telemedicine appointment with a physicians assistance. I tested negative on Tuesday using a test. Wednesday I remained ill so I tested again using a different type of home test. I was able to meet with the doctor on the same day and she told me to take Mucinex and she prescribed an albuterol inhaler. I was feverish and had chills that would come and go. I just felt fatigued and had muscle aches similar to flu but more severe than what I had experienced in the past. I took ibuprofen and Tylenol alternatively. The fever was gone on that Thursday morning. I developed a dry cough that I am still experiencing. I do think that I have recovered. It took several days to get my energy back. I had sinus an lung congestion as well. All the symptoms have gone away outside of the lingering. During the process I also lost my sense of taste and smell.
Flu like symptoms:  chills, muscle and joint aches 28 hours after vaccination.  No temperature
Patient seen by PCP on 2/11/22 and reported the PCP that he as been experiencing PIPO and MCPO joint aching starting 3 months after 2nd Moderna shot and then recurring 1 week after Moderna booster and now persisting.
Chills Headache Extreme fatigue  Nausea Rash Pain, swelling, redness at injection site
1. The day of the vaccination the following side effects surfaced:  a. Soreness, redness, swelling and heat at the injection site which lasted 4 days. b. Left forearm cramp and muscle bulge which lasted 3 days. c. Left arm weakness and pain in forearm/wrist which lasted 4 days. 2. The day after the vaccination (7 October, 2021) the following side effects surfaced: a. Flushing and redness of face and neck, nut no fever which lasted 4 days. b. Dry cough (vs. productive cough prior to shot) which lasted 2 days. c. Headaches and tingling in back left side of head which lasted 4 days. d. General fatigue especially after any exertion which lasted 4 to 5 days. e. Aches and pain in joints and muscles which lasted 3 to 4 day 3. Two days after the vaccination (8 October, 2021) the following side effects surfaced: a. Red rash upper body scars which lasted 7 to 8 days. 4. Three days after the vaccination (9 October, 2021) the following side effects surfaced: a. Swollen Lymph nodes to include the following locations i. Tenderness in Tonsils (with funky taste) which lasted 6 to 7 days. ii. Left Collarbone location, swollen with no tenderness which lasted 10 days. iii. Under both armpits, swollen with tenderness which lasted over two weeks. iv. Left inner thigh near groin, swollen w/tenderness lasting over two weeks.
Pain and tingling in mouth. Pain in arm for days. Weakness for 13 days. Changes to menstrual cycle. Headache. Depression/irritability dizziness/lightheaded
Severe sickness - like illness with fever, joint pain, ankle swelling, urticarial/erythema multiform type rash.
I have a rash..looks like psoriasis patch size of half dollar.  No treatment..still there 7/24/2014 at site of injection..reported to nurse. Permanent rash.
temperature raised to 100.06; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature raised to 100.06) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (temperature raised to 100.06). At the time of the report, PYREXIA (temperature raised to 100.06) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.06 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age." No relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received PENTACEL, PCV13 and ROTATEQ 12/04/15. Mother called 12/07/15 stating that pt developed "pimples" on the (L) leg the night of 12/04/15. Rash became red 12/06 and 12/07 and had spread to the (R) leg, abdomen, arms and chin. Pt seen in office 12/07, referred to ED where pt was treated with BENADRYL. Pt saw allergy 12/16/15, negative skin testing - hives resolved 12/09/15.
10-1-15 pt noticed 0.5 inch red circular area to (L). Upper arm's warm to touch - not at injection site.
Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 77-year-old male patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2023, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 3rd January 2023, unknown after receiving Engerix B adult and Engerix B 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: 05 JAN 2023 Reporters comment: The nurse practitioner reported that the patient received an adult dose of Engerix B on 3rd January 2023 and the dose had expired on 2nd January 2023. The reporter wanted to know should re vaccinate. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information. As patient administered expired vaccine which led to expired vaccine used. Reporter did not consent to follow up as no contact details were available.
11 hours after injection: fever (100.4), headache, joint pain.  22 hours after injection: fever (103.4), severe headache, joint paint, fatigue, body aches Treated with Tylenol and ibuprofen
On May 17th 1999 three weeks post vax, the pt developed mild chickenpox rash. There were about twenty lesions and some of the lesions were filled with fluid. It was noted that no treatment needed. The patients MD noted in follow-up that the patient's rash faded and drying of vesicles resolved by May 25th 1999.
Breakthrough case admission after two vaccines Moderna 4/3/21 Lot# 032H20A;  Moderna 5/11/21 Lot# 044B21A
Client c/o onset of exhaustion, body aches fever 104 degrees by 5-12-07; by 5-14-07 developed hives at "body pressure points", took tylenol and benadryl for symptoms; by 5-16-07 developed chest pain , went to ER; unknown test were done; Denies any redness or swelling at site of injection.
I woke up with acute pain at the injection site and radiating from the shoulder to elbow. It was extremely painful to use my arm or even touch it. My left arm, where the injection site took place, was nearly immobilized by the pain. I went to an urgent care facility and was prescribed hi-dose naproxen and to use a cold compress. After 24 hours the pain lessened, but was still severe. I returned to my primary care doctor, who prescribed antibiotics in case of infection, which were not effective. Over time the pain gradually subsided, but I still have daily pain (to a much lesser degree) at the injection site 4 months later.
Information has been received from the mother of a male child with no known allergies and no medical history who was vaccinated with MMRII a few years ago. There was no concomitant medication. Subsequently, the pt experienced "seizures from the medication" that lasted through the entire evening. The mother noted the child had not been the same since and was a little slow in learning things. It was reported that the child sought unspecified medical attention. Additional information has been requested. Upon internal review, seizure and learning impairment were determined to be "Other Medical Events".
Patient stated she woke up this morning with both hands are swollen to the point she needs to take off her rings.  Also she states she has "tingling' between each finger but it does affect her grip.  No discoloration noted.
experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; ache all the way around his waist; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration in the left arm on 08Feb2021 14:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient experienced ache all the way around his waist from his front to around to his back and it is pretty intense. After receiving first dose, the next day on 09Feb2021, he experienced pain on hips, trunk, lower stomach and back. He saw on the article not to take ibuprofen, tylenol or advil. He spoke to his Dr. and said never heard about such an article. He wants to check with someone if he can take tylenol because of pain. The reported events were considered as non-serious by the health authority. The outcome of the events ache all the way around his waist was not recovered, for experienced pain on hips, trunk, lower stomach and back was unknown.  Information on Lot/Batch number has been requested.
On Tuesday 5/11/10 patient was given DTAP-IPV which is a pediatric dose of TETANUS and POLIO.  I called patient immediately after realizing this was given.  Patient had no questions at the time and did not complain of any problems.
Pleural effusion, pneumonia, pleurisy, shortness of breath, tachycardia, chest tube placement,.
About two hours following vaccine administration feels hot, dizzy, faint, confuseddenies SOB
HEAVY CHEST FEELING; ANXIETY; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pain, non-smoker, alcohol use, and sulfonamide allergy. The patient was previously treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 10:00 on left arm for prophylactic vaccination. Concomitant medications included buprenorphine hydrochloride/naloxone hydrochloride for pain.  On 25-MAR-2021, the subject experienced chest heaviness. On 25-MAR-2021, the subject experienced anxiety. On 25-MAR-2021, the subject experienced high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest heaviness, anxiety, and high blood pressure. This report was non-serious.
seemed like a roller coaster ride with his taste buds and appetite; seemed like a roller coaster ride with his taste buds and appetite; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself that:  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient second dose for Pfizer COVID-19 vaccine was on Thursday in (withheld). Patient had first dose on 04Feb2021 and does not had breakfast the morning first shot he had and wondering if any precautions need to be taken in the morning of getting second shot. After first shot patient seem like roller coaster ride with taste buds and appetite in Feb2021. The clinical outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician and a health care professional concerning a 15 year old female who on 15-MAR-2007 at 11:00 AM was vaccinated in the left arm with a second dose of GARDASIL lot #65605/0244U. On 15-MAR-2007, the patient received her second dose and experienced generalized hives which the physician described as a migratory rash. The patient sought unspecified medical attention. The patient tolerated her first dose well. In follow-up it was indicated that on 17-MAR-2007 patient had painful, itchy rash raised, on right arm, face, left fore arm. She was advised to give 25 milligram BENADRYL every 6 hours until no hives for 24 hours. Subsequently, on 04-APR-2007 the patient recovered from generalized hives and migratory rash. Additional information is not expected.
On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).
Fever, chills, full body aches, nausea, migraine for over 18 Hours so far
Pt received routine vaccines 6/27/17 at 11yo physical in office. Following administration Pt. with multiple hives to upper (RT) arm distally. Area with positive warmth; no induration; no resp. S/S or N/V. Gave PO BENADRYL and monitored status x30 min. plus. Improved 6/28/17 per mom=all S/S have resolved.
This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient recently had a SHINGRIX shot, and the patient was experiencing some muscular pain. She asked if it was safe to have aspirin and EXCEDERIN for the event.
No adverse event; Dose administered after manufacture expiry date; This spontaneous case was reported by a nursing assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2022 at 10:50 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) to have an unknown relationship.    Vaccine did not undergo and temperature excursion issue.  No concomitant product reported by reporter.  Event did not caused patient to seek medical care.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-635425, US-MODERNATX, INC.-MOD-2022-630555 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635425:76 year old female US-MODERNATX, INC.-MOD-2022-630555:88 year old male
Beginning evening after given, upper extremity became very red & warm - 48 hrs later - redness decreased ice was placed.
Information has been received from a licensed practical nurse concerning a 4-month-old patient who on 06-JUN-2007 was vaccinated PO with a dose of Rotateq. Concomitant therapy that day included a dose of DTaP (+) tetanus toxoid, a dose of Prevnar, a dose of Hib (manufacturer unknown), and a dose of poliovirus vaccine. On 06-JUN-2007, several minutes after vaccination, the patient vomited. No other symptoms were noted. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
About 1.5 weeks after receiving 1st dose of vaccine client reported getting shingles rash. Went to MD and was treated.
Local redness, tenderness, induration, morbilliform rash, dependent edema from mid-triceps to elbow.
2 1/2 hrs after Imm. child had a look of fear in face, grasping, swollen and purple color from waist down. Called 911 - went to ER given BENADRYL and observed.
10 days post vax devel chickenpox bumps first on head then face & remaining body (trunk);
Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Bad fever, severe chills, nausea and vomiting, diarrhea, dizziness, fatigue, rapid heartbeat, and ongoing diarrhea since the vaccine.
pt sibling recv vax 21JUN96 & 6JUL96 pt dx w/chickenpox w/greater than 50 lesions;PCR analysis of specimen from pt lesions revealed wild-type varicella;no vaccine assoc adverse event occurred;MD felt pt may have exp secondary transmission
Patient developed 1 week of headache, had CT head which showed venous sinus thrombosis. She was admitted to ICU for anticoagulation and Q1h neuro checks. Required full stroke workup and
Within 1 hr of vaccines being given pt became irritable, facial flushing, hives diffusely esp on trunk/back but also on extremities.  Mild swelling of eyelids.  Zero resp probs/wheeze NL O2 Given BENADLYL + steroids with improvement
Initial report received from a nurse in the USA on 20-OCT-2005. A 60-year-old female patient developed a severe headache, stomach pains with diarrhea and a fever of 101 degrees Fahrenheit shortly after receiving the injection of Fluzone in the left deltoid on 18-OCT-2005. Treatment received not reported. At the time of this report, which is two days post immunization, the patient "feels okay." The patient has received the influenza vaccination many times with no reactions. Follow-up information received on 27-JAN-2006 from a healthcare provider. The adverse event onset was one hour post-vaccination. The patient also experienced constipation. The patient has a history of asthma for which she takes Advair. The symptoms subsided 24-48 hours post-vaccination.
Syncope/vasovagal after vaccine administration (Pfizer EW0167). Patient lowered to floor; responsive after 10-15 seconds. Taken to medical tent and monitored. Patient's mother felt transport not needed after symptoms resolved.
Right axillary lymph node swelling and tenderness with normal injection site right deltoit; redness and induration at injection site left arm.
Swelling, redness and soreness at injection site several days later.  Palm of both hands itchy.
Five minutes after receiving vaccine patient felt light headed and dizzy and black out for approximately 15 seconds.  He had self-described heart palpitations and 911 was called.
Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 2, single, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose."; bnt162b2 (Dose 1, single, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose.". The following information was reported: TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist at (Withheld). MRI ordered, no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient, same event, different drug dose;
Muscle Aches, Runny Nose, Sore Throat, Loss of Taste & Smell, Headache, Fatigue, Cough, Chest Pain.