chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shooting pain in my neck; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 04Feb2021 (age at vaccination: 31-years-old) as dose number unknown, single for COVID-19 immunization (Workplace clinic). The patient medical history and concomitant medications were not reported. The patient had no allergies. On 04Feb2021, the patient had experienced shooting pain in my neck. The patient had not received any other vaccine within 4 weeks. The patient not received other medications in two weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
RED, NON RAISED, NON PAINFUL AREA APPROX. 3 INCHES BY 2 INCHES SURROUNDING THE INJECTION SITE.
This was my booster shot. After receiving the shot, 2 days later I started my period. My normal period is on the lighter side and typically lasts 4 days. I had severe bleeding. Wearing overnight pads the entire time and changing them hourly. This lasted almost 8 days with some unbearable cramps. As a very strong female, I had never been in such pain since child birth.
Patient received PREVNAR 13 10/27/15. On 10/29/15 patient returned to clinic. Pt developed a localized welt (4cm x 5cm) raised, warm, and painful to touch. This appeared 2 days after administration.
Upon completion of administration, patients eye were closed and stated she felt faint. Patient became pale and breathing shallow and vomited once. Patient received an ice pack on back of neck and remained sitting with legs elevated on another chair. 911 was called and patient was taken by EMS.
No adverse event; Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart).    Concomitant medication was not provided.  Pharmacist stated that they have a patient who got their 1st 2 doses of the Moderna Covid-19 vaccine 21 days apart last year. They want to know if they should give them a 2nd primary dose or the bivalent booster. No further information was provided.  Treatment information was not provided.
sore arm at injection area -day of vaccination & next day very tired - 9 hours after vaccination  lower fever and body pain & sweating - around 13 or 14 hours after vaccination  pain in ovaries - day of vaccination & the following days
(R) upper ext. visual lesion: macule red, oval, isolated, localized where Varicella #2 was given. Tx: OTC BENADRYL and local ice packs, schedule f/u visit if not improved in 2 days.
I got my 1st SHINGRIX shot at pharmacy on Friday, March 1st. On Saturday I awoke feeling very weak, cold, and achy. The injection site was painful. My legs hurt. I vomited that afternoon and had a urgent bowel movement. My skin was warm but I felt cold. I pretty much stayed in bed all day. I feel fine today Sunday, so I suspect it was a reaction to the SHINGRIX. I hesitate to complete the 2-shot series.
Information has been received from a medical assistant concerning a 66 year old male pt with hyperlipidemia, benign prostatic hypertrophy, hypothyroidism, and a history of coronary artery bypass graft (CABG), who on 06/06/03 at approximately 10:00AM was vaccinated IM in the right deltoid with a 0.5mL, first dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M). Concomitant medications include doxazosin mesylate (Cardura), hydrochlorothiazide (+) lisinopril (Zestoretic), sildenafil citrate (Viagra), simvastatin, potassium chloride, and levethyroxine sodium (Synthroid). It was noted the pt was well, and did not have any illness at the time of vaccine was administered. It was noted that the pt's medical record indicated he then "felt ill" that evening (06/06/03), and developed a sore arm at the injection site. The pt was seen in the physician's office on 06/12/03, and reported that he had a blister that had ulcerated on his arm at the area of the pneumococcal vaccine 23 polyvalent injection. The medical assistant reporter that on 06/12/03, the physician had noted in the record, that the pt had a 5 cm area of erythema with an indurated area of necrosis of surface skin on his right deltoid. The physician also noted in the record that it "looked like a second degree burn" (also reported by a MA as necrotic area size of a nickel in right upper arm at injection site). The pt was treated with mupirocin (Bactroban)2x/day. The MA noted he was unsure if the pt had recovered. The MA noted the pt had not yet been seen again in the office. A product quality complaint was not reported.  Follow up information received from the physician reported that the pt's arm became sore on 06/06/03 at 16:30 and by the next morning the pt's arm was red, swollen and erythematous. The physician noted the pt then had an area of necrosis of the skin over the injection site. When the pt was seen on 06/12/03 he had a 5cm area of erythema with a 4cm area of skin slough/necrosis within it. The physician reported the pt recovered on 07/11/03.  No further information is expected.
secondary bronchitis infection; COVID symptoms (very mild)/tested positive; COVID symptoms (very mild)/tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "COVID symptoms (very mild)/tested positive"; BRONCHITIS (non-serious), outcome "unknown", described as "secondary bronchitis infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were taken as a result of bronchitis. Clinical course: The patient has all 3 shots and tested positive on 04Jan2022. COVID symptoms (very mild) started on 27Dec2021. Vaccines worked by experience. The patient got better but then did get secondary bronchitis infection responding with antibiotics (unspecified date). The reporter further described the vaccine as god sent.  The lot number for bnt162b2 was not provided and will be requested during follow up.
immediately post administration patient complained of scratchy burning throat. breathing signs were monitored and no changes in breathing occurred. pt was given benadryl solution and monitored for 15 minutes for any progression of symptoms. pt felt normal and scratchy burning throat sensation went away
Pt recv vax on 11/19/98; on 11/21/98 pt exp red, hot, painful area, fever (101), lethargic & dec energy
macular rash devel below inject site day of immun; progressed down to wrist then to other arm; seen by PP 4OCT93 dx as react to flu vax; given topicort cream & DPH; rash resolved;
Started achy feeling, rash (golf ball size), red, swelling, warm sensation, but more pain now.
warm to touch; Little bit itchy; Arm swollen; Arm still hurting; Red with half a dollar coin size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
rheumatoid arthritis breakthrough; mild achiness; fatigue; breakthrough pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308908-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "rheumatoid arthritis breakthrough"; PAIN (non-serious), outcome "unknown", described as "mild achiness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; BREAKTHROUGH PAIN (non-serious), outcome "unknown", described as "breakthrough pain". The action taken for upadacitinib was dosage permanently withdrawn.  Clinical course: The patient stated that her doctor was doing a trial of being off of Rinvoq and she experienced a breakthrough. Prior to that she had been experiencing breakthrough pain. She had mild achiness and fatigue following covid-19 vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant Drugs Not Reported  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of rheumatoid arthritis breakthrough, achiness and fatigue was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): The reporter's causality for the event(s) of ache and fatigue was possible. The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and 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.
A non-serious spontaneous report of inadvertent administration of FLUMIST to a 9-year-old with asthma was received from a registered nurse. The patient's medical history included asthma. Concomitant medications included the Flu Shot given 22-Sep-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient report of lightheadedness and nausea post COVID vaccination; states this is a chronic complaint x 16 years and frequently will have syncopal episodes; upcoming OV with neurology for complaint. Last fall reported 3.9.21 Water intake 8-10 ounces today Denies any dietary intake r/t decreased appetite; RN offered snack - patient declined   Vitals taken 1201: BP 135/85 HR 76 SpO2 96 %   Patient observed for additional 15 minutes :   Repeat BP taken at 1217 prior to D/C from COVID clinic - 135/83   Patient reports of feeling "fine" and able to ambulate on own and departs facility with wife   No further action necessary
p/vax pt exp a local rxn w/a nickel sized area of redness & a scab @ the inj site;there was also to be some warmth to the touch but no fever or other lesions noted;pt sought unspecified med attention;
tingling and numbness and some tension in arms, hands, legs and face. Events are strongest and persistent in the right arm and hand. No visible swelling.
Phone call from mom 10/10/13, stating pt. began with left leg pain and unable to bear weight since 10/9/13 evening sent to ER 10/10/13 pt diagnosed "transient synovitis of left hip" given ibuprofen. Phone call to parent 10/11/13 pt improved less pain and increased mobility and able to bear weight. Vaccines given 10/1/13.
Intense shoulder pain felt immediately (more so than on prior flu shots). Pain did decrease some but has continued and it is now almost 3 weeks later. Pain is felt mostly when lifting shirts above my head.
my brother got a vaccine for shingles and has had it twice, had to be hospitalized for 7 days/ suspected vaccination failure; had it twice, on the right side of his face around his eye and forehead, had to be hospitalized for 7 days; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister. The age at vaccination was not reported. The reporter stated that, her brother got a vaccine for shingles and has had it twice. The reporter stated hat, her husband's nurse stated that, we all have it in us, it was just dormant. The patient had it on the right side of his face around his eye and forhead. The patient He had to be hospitalized for 7 days. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Thursday night approx 48 hours I had a body wide rash as well as erythemic areas on trunk, and what appeared to be blood blisters (?).  Rash and reddened areas were somewhat pruritic.
Localized pain, redness and swelling at injection site lasting 2 weeks. Presently still experiencing discomfort in the affected arm upon exertion. Using ibuprofen, cool compresses and avoiding muscle strain to minimize inflammation.
Pt was on gestational week 37w4d when she presented to Labor and Delivery Triage for leaking of fluid. She was not ruptured on exam and her cervix was FT/T/P. However, on arrival to triage, she was saturating 92-95% on room air. She was positive for COVID-19 on 1/5. She was admitted for oxygen management and treatment of COVID-19 symptoms. She was started on 4L oxygen via nasal cannula to maintain saturations >95%. She was started on Remdesivir, Decadron, and vitamins. She was switched from Lovenox to Heparin. While in the hospital, she was on 0 to 4L NC in order to maintain her saturations. On 1/8, she was noted to maintaining her oxygen saturations >95% on room air and was feeling better. She was reassessed at that time and was stable for discharge home. She  scheduled induction of labor on 1/14/2022.
I was able to smell and taste the vaccine. My BP was relatively high. I had flu like symptoms. I have a chronic crick in my neck my neck. I also have chronic diarrhea/ abdominal issues now.  Damage done to my liver.I live with the crick in my neck occasionally I get a massage or chiropractor to ease the pain.The diarrhea/ abdominal issues I just treat the symptoms as the come? which is about two weeks out of the month. Very aggravating. Nothing can be done about the liver damage. I just have to keep it from getting worse.
Patient had received DPT and Prevnar in right thigh and developed wheal and flare reaction; appx.  4 x 5 cm. patients had no other c/o or problems.
Myalgia, Arthralgia & Fever Narrative: Fever 100.3, myalgia, arthralgia; took tylenol.  Other Relevant History:
Very soar arm at injection site, joint pains, muscle pain, diarrhea, nausea fatigue, chills and headache
I did not have an adverse reaction to the vaccine. I exposed to COVID-19 at my child's day care center. I tested positive for COVID-19 on 09/29/2022. I did not contact my doctor and my symptoms were very mild. My doctor's office requires her patients to come to the office to get the prescription for PAXLOVID. I did not want to do that. I took over the counter medication to help with my symptoms. As of today, my thyroid and cholesterol levels have changed.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot K025766, expiry date 08-JUN-2015. This one of the several reports received from the same reporter. Additional information has been requested.
Fatigue, Nausea, dehydration, Headache (2-3 days), Vertigo (long lasting), swollen lymph nodes (long lasting)  Given Meclizine, made patient numb, switched to Valium Lasting effects still stand
Monovalent covid vaccine order instead of bivalent. staff administered monovalent covid vaccine as ordered. When counting the covid vaccines, RN discovered event. MD notified. No side effects reported in chart.
new onset of Hypertenion started 04/03/2021.  severe Headache  no history of any BP issues
0200 6/14 Temp 102.2. Vaccine given 10:00 6/13. Redness L upper arm c/o dizziness/weakness sore. Swelling +2 edema (injection site).
This spontaneous report was received from a healthcare professional regarding unspecified number of patients of unknown age and gender. On an unknown dates the patients received improperly stored doses of VARIVAX (lot# M019643, expiry: 20-APR-2018 and lot# M009767, expiry: 23-FEB-2018) (data digital logger). No adverse effects were reported. The vaccines were exposed to a temperature of 5.4 degree C for 3 hours and 53 minutes. There was no previous exposure reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
rash on neck; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and RASH (rash on neck) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to lactose and sucrose).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). On 19-Jan-2021, the patient experienced RASH (rash on neck). On 21-Jan-2021, RASH (rash on neck) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety
Tested positive for COVID-19; This is a spontaneous report from a contactable consumer.  A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8737), dose 1 intramuscular, administered in deltoid left on 07Apr2021 at 14:15 as single dose for covid-19 immunisation. Medical history included seasonal allergy and drug hypersensitivity (allergic to Codeine and Soma, like the heavier pain medications). The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 08Apr2021, the patient had allergies and he went to a walk-in clinic. He was given a rapid test and he was tested positive for COVID-19. He went to the doctor thinking it was just his allergies kicking in because it was that time of the year- it was Spring time and pollen starts popping up. He normally gets his seasonal allergies twice a year- Spring time and Fall. However, he found out it was COVID-19. The event considered as medically significant with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Chest pains which were eventually diagnosed as a result of Pericardial effusion. Sternotomy was performed to remove fluid.
Approximately 18 hours after the injection, noticed a red, raised rash on left arm around the injection site. Rash has grown larger and spread down the arm towards the elbow. Rash is hot to the touch and swollen. It does not itch but is uncomfortable.
Patient woke up in the middle of the night crying and saying that his heart was hurting. We immediately took him to the emergency room at Medical Center.
Patient was received undiluted vaccine, which made the dose to be close to adult dose. Patient experienced side effects extreme tiredness type of side effects. Unable to have an appetite.