chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"golf ball" size swollen gland under her arm; swollen arm; headache; fatigue; injection site pain and swelling; injection site pain and swelling; 1st dose 14May2021 & 2nd dose received 07Aug2021; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Aug2021 17:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included had a child with COVID on top of her for 2 days and she didn't catch it on an unspecified date. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks other than bnt162b2. No relevant tests. The patient previously received the first dose of bnt162b2 on 14May2021 at 50 years old in the Arm Left for COVID-19 immunization. On 09Aug2021, the patient experienced a "golf ball" size swollen gland under her arm and was asking if this something that is normal or that she should be concerned about. The patient also experienced other "typical" reactions which include swollen arm, headache, fatigue, injection site pain and swelling on 08Aug2021. The events were treated with Advil and the patient will be consulting with her physician on the phone. The patient received the 1st dose 14May2021 and 2nd dose on 07Aug2021. The outcome of the event "golf ball" size swollen gland was not recovered, for the events headache and fatigue were recovered on an unspecified date in Aug2021 while for the other events was unknown.     The lot number for BNT162B2, was not provided and will be requested during follow up.
Patient appeared to get light headed and had sweating.   Had to move from chair to floor and elevated feet.   Patient was given water and some sugar/protein.  Ice pack on back of neck as well.  Regained to normal in 10-15 mins.
Patient is 35 weeks pregnant.  Patient visited local ER department on 10/19/22 for a bite on her hand and was given a TDAP Boostrix lot number 34FR4.  Patient presented to prenatal appt on October 24th and was given another TDAP Boostrix at her appointment.  Patient was 35weeks 3 days pregnant at her appt on October 24th when she was given her second Boostrix 5 days apart. LMP 02/01/2022.
Dose administered greater than 12 hours after initial vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 50 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
sick for 1 week also; 3rd dose: worst headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 1 week also) and HEADACHE (3rd dose: worst headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, RIVAROXABAN (XARELTO) for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 1 week also) and HEADACHE (3rd dose: worst headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick for 1 week also) outcome was unknown and HEADACHE (3rd dose: worst headache) had not resolved.            This case was linked to MOD-2021-317581, MOD-2021-317412 (Patient Link).
lymphadenopathy at her bilateral axilla.; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the first report out of 2 patients. Only this case is serious, medically significant.  A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date: 31Mar2021, NDC number: 59267-1000-1), intramuscular in the left deltoid on 21Dec2020 17:32 at 0.3ml single, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced lymphadenopathy at her bilateral axilla and got worse on 07Jan2021. She reported that it was painful and swollen. The events was reported as serious medically significant. She wanted to know if she should have the 2nd dose of the vaccine. The outcome of the event was not recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lymphadenopathy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : 2021025446 same reporter and drug/similar event/different patients
8,5 hours after getting the vaccine, I had been on the floor wrapping gifts all afternoon.  I stood up and suddenly realized all my muscles and joints hurt like a sudden flu and my left arm hurt to move it.  Symptoms until next Sunday night:  Sore throat, copious rhinorrhea, headache, myalgias, arthralgias, severe fatigue, fever, and cough.  Sunday night, I blew out a massive amount of yellow drainage from L nostril and felt like I was getting better (very typical reaction to Covid vaccine for me).  Monday morning the next morning, I got up at 6:30 AM and suddenly started having uncontrollable bilious vomiting, watery diarrhea, dizziness, severe fatigue and muscle weakness, and subsequently developed severe muscle cramping.  Emergency Phenergan suppositories at 2:30 PM and Gatorade hydration kept from an ER visit/hospitalization.
Within 5 minutes post-vax, the patient developed 2 hives on her upper right arm. One 15mm hive measured adjacent to the Varicella vaccine site and one 10mm hive measured adjacent to the MMR vaccine site. The patient was treated with Benadryl and advised to report this to her pediatrician.
Numb legs; Mild nausea; headache; Wobbly legs, legs could not hold me up; Diarrhea; Stomach ache; Arm hurting, pain in thigh; Jaw pain; neck pain; Pain in Back; Shortness Of Breath; difficulty breathing; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced mild nausea/nausea, diarrhea, stomach ache/abdominal pain upper, mild headache/headache, arm and thigh hurting/pain in extremity, jaw pain, neck pain, wobbly leg and legs could not hold her up/ gait disturbance, back pain, short of breath/dyspnea, and numb legs/hypoaethesia.    The patient's medical history included chronic obstructed pulmonary disease and arthritis. Concomitant product use was not provided.   On 24-Feb-2021, approximately hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24-FEB-2021 the patient had mild nausea, diarrhea, stomachache, mild headache, arm hurting, pain in the jaw to neck, wobbly legs, pain in thigh, back pain, shortness of breath, left lung was paralyzed for 20 minutes and then right lung. Then on 27-FEB-2021 the patient had severe headache, violent nausea. The patient described it as fireworks inside her, wobbly legs, and numb legs.   Treatment information included acetaminophen.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) were considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tenderness at injection site after a few hours that went away after a few days / Achy muscles and joints after a couple days (ongoing) / After nearly 2 weeks, a red patch about 2 inches in diameter appeared at the injection site causing concern but no real discomfort (ongoing).
Narrative: Patient reported arm and joint pain the opposite arm of the injection following administration of 1st dose of Pfizer Covid Vaccine. Patient states it started 1 day post vaccination and continued for several days.
sore arm; have body aches; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was health care professional. The patient received second Shingrix shot and had body aches and a sore arm all Day. The patient asked how long the patient would experience ache.
Within two weeks of receiving the second dose of the Moderno vaccine, I had developed a extremely severe bouts of inflammation in both of my forearms. It had gotten to the point where I was unable to drive, cook for myself, or even turn on the shower. I felt intense pain when holding anything or using my hands in any way.   It has been 3 1/2 months, and I am still far from healed. Though it has gotten better, I cannot do anything without using braces on both of my arms to support and protect me. This injury has been debilitating to me in most ways. It has been frightening, confusing, frustrating and persistent. I will try anything to just play guitar again.
Information has been received from a certified nurse practitioner concerning a 25 year old female patient with no previous medical history and no known drug allergies reported, who on 15-AUG-2008, was vaccinated with a dose of GARDASIL (Lot # 0530U) IM, 0.5 mL in the left deltoid. A couple days after vaccination, in August 2008 the patient developed severs arm pain. On 25-AUG-2008, the patient called to reported that she experienced a persistent injection site soreness. On 26-AUG-2008, the patient was seen by her family physician and the site was, without redness and warmth. The patient was referred to an orthopedist who referred her to physical therapist. She had physical therapy for four weeks but continued to have arm pain, the physical therapy was completed; and was treated with anti inflammatory. In October 2008, a magnetic resonance imaging was performed, which result showed negative for tearing. The patient had been taking oral antiinflammatories (NAPROXEN) for her symptoms and had recheck for two months. At the time of the reporting the patient was recovering. The patient did not had illness at time of vaccination. The persistent injection site soreness was considered to be disability by the physician. Follow up information has been received from the certified nurse practitioner, who stated that the patient had followed up with an orthopedic physician and she confirmed that the patient was never hospitalized. The nurse also reported that the patient reported that "everyday after the injection, the injection site pain became more painful." Additional information is expected.
Pt developed rash about 2 days after vaccines were given. Described as red bumps, that did respond to BENADRYL. Parents also report low grade fever at time of rash. Also had new detergent.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA288342 (same reporter). This case involves 2 patient of a 4 years old (gender was unknown) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT instead of 0.5 ml in the right arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccine were used. On 13-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259KA via intramuscular route in the right arm. It was case of actual medication error due to Vaccine under dose. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
After receiving my second dose, I started having unusual bleeding. I thought it may be that I needed my Nexplanon replaced, so I had it replaced. My bleeding lasted for about 10 days. I started bleeding for a longer period of time from July 11th until August 29th. I went to my GYN and she did a full work up. She checked for infection as well. I have had Nexplanon from 2016 until recently and I did not have to purchase any feminine products, but recently I have gone through two boxes of tampons since my lasting cycle. She referred me for an ultrasound on 09/09, which they noticed that I had the cyst. It was defined as a well-defined simple cyst. My doctor proactively prescribed me hormonal birth control (Estradiol tablets) plus my Nexplanon. I am on this regimen for another 2 1/2 weeks. After I complete taking this medication, I will go back to see the doctor if I start bleeding again or the pain becomes worse.
This non-serious medically confirmed report (initial receipt 10-Oct-2014) concerns a male patient. On the 10-Oct-2014, the patient received AFLURIA (batch number R56508) 0.5mL annually via the intramuscular route for the prevention of influenza. The vaccine was expired on the 30-Jun-2014. It was believed that the patient was fine and had left the facility. Outcome was not reported.
Donor stated approximately one hour post Hep B immunization, he began to experience a metallic taste which caused intermittent nausea. Donor stated that a headache type pain then began and persisted. No additional symptoms were noted. No redness or inflammation noted at injection site.
Pain and excessive swelling at and near the site of administration. Seen in ER at Hospital. Ultrasound consistent with cellulitis. Pt was admitted x 24 hrs and tx with IV Ancef. Discharged with po Keflex. Signs and symptoms have progressively improved.  8/15/2008 Reviewed hospital medical records of 5/1-5/2/2008. FINAL DX: LUE cellulitis secondary to tetanus shot Records reveal patient experienced increasing inflammation, fever, erythema & pain in LUE x 1 week along w/lymphadenopathy.  Tx w/IV antibiotics
No further AE details provided; VARIVAX was administered after a TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JUN-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route of administration and anatomical location of administration were not reported), in combination with a sterile diluent.  The administered dose underwent a temperature excursion via digital data logger of 12.84 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported. No further adverse event details provided.   Follow-up information has been received from the nurse on 25-JUL-2023. This case has been become valid as concerns to a 7-month-old male patient. On 22-MAY-2023, the freezer door was opened for scraping ice off-sides, but the door was left open too long. Then, temperature excursion occurred and was improperly stored. Consequently, it was confirmed that the 7-month-old child was vaccinated on 14-JUN-2023, with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 with expiration date 09-SEP-2023) administered subcutaneously in the left tight for prophylaxis. The vaccine was used according to the instruction leaflet. It was reported that the patient was given the vaccinate without reporting to the manufacturer to verify if the vaccine was safe to use. On 11-JUL-2023, the vaccine was properly reported to the manufacturer with temperature excursion; however. The vaccine was no available for return/evaluation. Manufacturer reported that the vaccine was safe to use. The child received the last dose of the vaccine in stock at that time and no other stock was administered. The patient had not had medical events occurred due to the administered vaccine. This temperature excursion did not occur as a result of a reading from a digital data logger.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002154: US-009507513-2308USA001000:
Patient had received an expired COVID 19 vaccine.  Vaccine was drawn up on 4/21/22 at 12:00pm for a patient  & the vial was put back into the refrigerator.    At the end of the day, vial wasn't wasted  & it also wasn't dated.   Next day around 1630, pt received his 1st dosage of COVID 19 as ordered by Dr.  Staff then realized that the vial wasn't labeled & it was from 4/21/22.  Dr. called the parents up on 4/21/22 to check on patient at the end of the day.   Parents stated that pt was fine.  No symptoms noted.  Patient was brought back to the office on 5/2/2022 to received a dose of COVID 19.
High fever and body aches after 2 days. I felt pain in my lower rib and that was really painful. It lasted for at least 3  4 days. I had some blood tests and x-ray of my chest, and everything was okay. The doctors said I have inflammation around my lungs, and they didn't give me any medicine and told me to just take the Tylenol. I dealt with the pain, and it resolved.
Red rash; Red rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE RASH (Red rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031620A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE RASH (Red rash on injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE RASH (Red rash on injection site) had resolved.     No concomitant medication was reported.  The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event outcome was updated to resolved.
Pt reported swelling (now improving) of her cosmetic fillers. This has been reported with Moderna's vaccine but not yet with Pfizer's to my knowledge.
Influenza vaccine H1N1 in Rt thigh. Influenza vaccine T I V in Lt thigh. Broke out in hives especially Rt leg then spread to the face - itching no edema of extremity or face. No resp distress - resolved with BENADRYL 48 hrs.
Pfizer COVID Vaccine EUA: Adverse Drug Reaction of Pancreatitis Patient received Pfizer Vaccine on 3/22/22. Pt presented to ED with severe abdominal pain with associated vomiting. Pt was recently restarted on ozempic 6 weeks ago and has no other new medications besides her regular metformin. Upon admission, Glu 155, SGOT 75, SGPT 58,lipase of >9k, all other labs wnl. Admitted for acute pancreatitis without gallstones or necrosis. Ozempic was d/c. As of 3/31/22 acute pancreatitis has resolved.
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Coronary artery disease (CAD with stent), Hypertension (HTN), Polymyalgia rheumatica, Gout, GERD, Irritable bowel syndrome (IBS) and Blood cholesterol abnormal (Cholesterol). Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Coronary artery disease, METFORMIN HYDROCHLORIDE (METFORMIN ER) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANTOPRAZOLE for GERD, LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension, CHOLESTYRAMINE and NORTRIPTYLINE for IBD, METOPROLOL for an unknown indication.    On 14-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 9:00 AM, the patient experienced DIZZINESS (Dizzy). On 17-Feb-2021, DIZZINESS (Dizzy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided   This case was linked to MOD-2021-370410, MOD-2021-376997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant Follow up received: Added additional reporter, HCP details,patient demographic details , medical history, concomitants, events information and narrative was updated accordingly. On 08-Nov-2021: Non significant follow up received on 08 NOV 2021