chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client in to OHC today for MD f/u physical. Client reports "I felt like I was having the flu". Client reports feeling "tired" and "fatigued", low back pain, and periorbital swelling; left greater than the right. Client reported low back pain, and fatigue were resolved Saturday morning.
back and neck pain; back and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "back and neck pain".  Additional information: Reporter stated he was calling on behalf of his wife. Reporter confirms he was calling about the Pfizer Covid 19 vaccine. Reporter stated his wife had her first vaccine dose on 12Apr2021. Reporter stated she was scheduled today for her second dose of vaccine on 03May2021. Reporter stated that last week, his wife developed back and neck pain. Reporter stated her doctor prescribed her a muscle relaxer, unspecified, and the medication Prednisone. The reporter stated his wife took Prednisone for 3 days, on Sunday, Monday and Tuesday and then she stopped. Reporter stated the Prednisone made her feel sick and she gained 5 pounds. Reporter stated she had not taken the Prednisone for 6 days. Reporter said he read the side effects of Prednisone, and she stopped the medication. Reporter stated that his wife had pain in her back and neck before she had the Covid vaccine and declines a safety report. Reporter stated that she continues to take the muscle relaxer and feels better. Reporter stated the Prednisone was in a pharmacy bottle and does not have an NDC, Lot number or expiration date to provide. Reporter stated that when she was reading the screening form for the vaccine, the form asks if Cortisone, Prednisone, steroids or any anti-inflammatory medications have been taken. Reporter stated his wife took Prednisone for 3 days last week. Reporter states he wants to know if there was a problem with taking Prednisone, with the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at the injection site; swelling at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-303065 (Patient Link).
Covid arm on day 4 - swollen, red, hot, extended down to the elbow on top and inner arm
About 1 hr after vaccines administered, patient became lethargic and developed fever, 100-102 degrees F overnight. For the following 8 days, He was treated with ibuprofen at recommended dose for his size, as well as POWERADE. He had no appetite, mild watery nasal discharge. Dime sized knot under skin at injection site as well as some blood at injection site - developed about 10 days post injection. (L) leg (no lesion on right leg although had one vaccine in each.).
pt recvd vax & devel swelling at inject site; inc in size each day;
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. ROTATEQ was administered to a 6 month old patient. ROTATEQ lot number J008725 with expiration 04-MAR-2015. This is cases 4 of 4 patients. This case was linked to cases: 1403USA007267, 1404USA014641, 1404USA014642. Additional information has been requested, all scheduled correspondence was scheduled.
Patient presented to the ED on 1/21/21, 2/2/21, 2/4/21 and 2/12/21. He was admitted from the ED on 2/4 and 2/12. These visit were within 6 weeks of receiving COVID vaccination.
This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (one single shot, injection, dose, units, route of administration, anatomical location, and lot number was not reported). Concomitant medications were not reported. On and unknown date, the patient developed injection site reaction after receiving ZOSTAVAX. The reporter stated that the nurse gave this vaccine and it was sitting out on the counter and went through a temperature excursion, the office knew about this and administered it anyway. The patient was not happy about this. The outcome of injection site reaction after receiving ZOSTAVAX was not reported. The relatedness between reported events and ZOSTAVAX was not reported. Additional information is not expected.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 04-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T010313 has been verified to be valid, expiration date reported and established as 24-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. It was reported that the vaccine was exposed to the following previous temperature excursions: 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 F) for 1 hour, 14 Fahrenheit degrees to 46 Fahrenheit degrees (32.36 F) for 1 hour and 14 Fahrenheit degrees to 46 Fahrenheit degrees (21.38 F) for 37 minutes. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006642: US-009507513-2108USA006643: US-009507513-2108USA006644: US-009507513-2108USA006645: US-009507513-2108USA006646: US-009507513-2108USA006647: US-009507513-2108USA006641: US-009507513-2108USA006640: US-009507513-2108USA006639: US-009507513-2108USA006638: US-009507513-2108USA006637:
patient did not show any signs or symptoms, but she did not want the moderna vaccine, she was given the vaccine in error
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of swelling in the feet in an adult female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  There were no concurrent medications.  On 31 October 2008, at 09:00, the subject received a dose of FLUARIX at 0.5 ml.  On 31 October 2008, at 17:00 (8 hours after FLUARIX administration), the subject experienced swelling in the feet and hives on the trunk.  The subject was seen by an internal physician at the hospital and was treated with unknown medications.  The events resolved.  The pharmacist considered the events possibly related to vaccination with FLUARIX.
Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 25 year old female patient with no known drug allergies, who on 26-APR-2008 was vaccinated with her first dose of GARDASIL (lot# 654272/0073X), on 30-JUN-2008 with the second dose of GARDASIL (lot# 0250X) and on 30-OCT-2008 with the third dose of GARDASIL (lot# 660620/0571X). There was no concomitant medication. On 05-OCT-2008, the patient had her LMP and had an elective termination of pregnancy in December 2008. At the time of reporting the outcome of the patient was unknown. The patient experienced an elective termination in May 2008 after the first vaccination with GARDASIL (MSD, WAES: 0903USA03061). Upon internal review elective termination was considered as an Other Important Medical Event. Additional information has been requested.
Patient said they started developing welts on injection arm the night of the day of vaccination. She said  that her arm swelled up, the skin was "hot" and it hurt to lie down on her left side. She said she took ibuprofen and it helped a bit. I told her that I would call her Dr to see what they recommend for her to do. Her dr suggested that she apply cold compresses to the arm. I followed up with her every other day. In a few days, patient reported that the swelling on her arm had gone down and the pain was almost gone.
This spontaneous report as received from a Licensed Practical Nurse refers to a 61 year old patient of unknown gender. On 13-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (0.5 ml, Lot # and expiration date not reported). No concomitant medications and no other relevant medical history were reported. The reporter stated that the patient was intended to receive ZOSTAVAX, however, on 13-MAY-2014 was inadvertently administered with (Oka/Merck) VARIVAX. No adverse effects were reported. No further medical information was provided. Additional information has been requested.
I woke up on Nov 9, 2021 and I was unable to walk. The right side of my body was completely numb and I was rushed to the hospital. After about 4 hours in the emergency room, i was numb from my chest down to my feet on both sides. After 1 week in the hospital and 2 weeks in inpatient rehab, I am still unable to walk without the assistance of a cane and I still have numbness on the right side of my body with no explanation as to why this has happened from neurologist. I have had MRI's and a spinal tap and no one can explain what has happened to me. It has been suggested that this could be a result of the vaccine.
Parents noted red nose on client 11/12/15 next AM client c/o itching and redness of Rt thigh, penis and between Lt fingers. Sx increased to include hives and taken to urgent care 11/15/15 Dx as allergy probable flu vaccine with Rx for BENADRYL and prednisone.
I think it was a couple days after receiving it, I started getting heart palpitations, then they got more intense.  It felt like there was a cell phone in my shirt, chest pocket constantly going off on vibrate mode.  Some time later, I went to the Doctor and they told me I had PVC (preventricular heart contractions).  I also had chest pains.  It took many months for it to go away.
covid-19; covid-19; covid-19 Recurrence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), on 04Oct2021 as dose 3 (booster), single (Lot number: EW0173) and on 20May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; CARVEDILOL; FUROSEMIDE; GLIMEPIRIDE; JANUVIA; JARDIANCE; LOSARTAN; METFORMIN; RIVAROXABAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "covid-19"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "not recovered", described as "covid-19 Recurrence". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (11Jul2022) Negative; (17Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. The patient received Paxlovid for COVID 19 Treatment from 05Jul2022 to 10Jul2022. Patient took the Paxlovid for 5 days. On 11Jul2022, patient tested negative for Covid. Patient felt very tired starting yesterday, took Covid test and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966972 same reporter/pt, different drug/event;
Difficulty breathing; chills; sore arm at injection site; Aches; fever; Sore Throat; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), DYSPNOEA (Difficulty breathing), MYALGIA (Aches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E12D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Swab) on 08-Jan-2021. Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Darvocet), Drug allergy (Dilaudid), Drug allergy (Compasine), Drug allergy (Ambian) and Asthma (Wheezing, breathing difficulties). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 08-Jan-2020 to an unknown date and MONTELUKAST SODIUM (SINGULAIR) from 08-Jan-2020 to an unknown date for Asthma, CEFIXIME (FLEXERIL [CEFIXIME]) from 02-Jan-2001 to an unknown date for Muscle ache, GABAPENTIN (GABA [GABAPENTIN]) from 02-Jan-2004 to an unknown date for Pain, ROPINIROLE HYDROCHLORIDE (RAPINEROL) from 03-Jan-2011 to an unknown date for Restless legs.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches) and PYREXIA (fever). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated reporter information. updated patient demographics, added other relevant history. Added concomitant and treatment medication. Added new events.
Significant decrease in well established breast milk supply. Have been breastfeeding with no issues for 4.5 months. After the second vaccine, supply dramatically decreased.
Presented to MD office on 9-27-10 with weakness in legs x 3 days. Flu shot received about 7-10 days ago. Admitted to hospital on 9-27-10.
pt recv vax 19AUG96 & pt ached all over especially in back;also had a runny nose & noted that pt felt like was coming down w/something;pt attributed sx to vax;
Started to get an upper respitory infection that slowly moved down into lungs. was given anti biotic. This condition may not have anything to do with the vaccine. Infection may have been transmitted although I do wear a mask most of the time when in public. I don't think it had anything to do with the vaccine (s). It lasted approx. 2 weeks from first discomfort to full recovery.
Mild to medium headache. Not particularly quick onset, Felt more like tension headache than like migraine type. Accompanied by stiff neck/shoulders. Took no medication - headache and stiffness continued into evening at mild level.  Home thermometer showed 98.7 around 8:00 pm ( I am usually 96.5 to 97.5 ) No problem sleeping that night and headache and 'fever' was gone upon awakening.  Similar symptoms ( no fever) developing late afternoon of 1/26/2021 - will input another report if different outcome.
Patient received flu shot on right deltoid muscle on 1/20/17. Approximately 1 week later, he came down with flu symptoms (fever, body aches). The flu resolved, but he continues to have pain, soreness and tenderness in his Right arm (underneath the shoulder) and radiates to his right upper back. He has also noticed a scan on his right upper back. Recommended TYELNOL or ADVIL for the pain and if it doesn't resolve in 3-5 days, he should follow up with his primary care provider.
the patient was two weeks pregnant when she received her final shot of the 3 dose of GARDASIL; This spontaneous retrospective pregnancy report was received from an approximately 24 years old female patient referring to herself. The patients' concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.      On an unknown date in January 2010, the patient was vaccinated with her final shot of the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. The patient reported she was two weeks pregnant when she received the vaccine (maternal exposure during pregnancy).
This spontaneous report was received from a nurse via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed burning and stinging pain in pelvis and pubic regions one hour after receiving a dose of ZOSTAVAX at a local pharmacy. On an unknown date, the patient developed small blister like bumps at the belt line the next morning. The patient sought medical attention (called the nurse). The patient was possibly prescribed with VALTREX. No lab tests were performed. The outcome of all the events was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's drug reactions/allergies included amoxicillin hypersensitivity. Concurrent conditions were not provided. On unspecified date in 2002, the patient was vaccinated with VARIVAX (Merck), first dose, (frequency was not provided). Concomitant therapies were not reported. Afterward the vaccination, the registered nurse stated that the patient was treated with amoxicillin for an unknown reason, later, on an unknown date, the patient was diagnosed with "strep throat", and after the event, the patient had an anaphylactic reaction. At the time of the report the outcome of the events was unknown. The relatedness between pharyngitis streptococcal and suspect therapy was unknown. Additional information has been requested.
Severe swelling, redness, edema, and itching at injection site spreading over two days up arm and onto anterior chest. Treated with ice compress and oral antihistamine.
01/02/2022  History of Present Illness  The patient presents with contractions.  Uterine contractions are 5  minutes apart.  Patient is gravida 1, para 0.
14th Jan-lump left-groin-lymph node, he feels it, body aches,  15th Jan-feeling better-slept-all day 16th Jan-lay in bed 15 & 16th Jan till noon-holiday week-end 17th Jan-lay in bed 18th Jan-lay in bed 19th Jan- lump in left neck-lymph node he says-enlarged-he feels it-hoarse like sound in his voice 20th today-Jan-better today-feels like he is getting to FLU-nose runny
Right arm pain to fingers - very difficult to move right arm. Felt heavy. BP 152/88 (pulse 68).
Edema & red ring around injection site. Tender to touch. Ice to area prn. Also ADVIL prn.
Sudden severe itching in both ears/eustachian tubes.  Took ibuprofen for it and itching went away within an hour.  left ear is now itches and feels painful periodically.  Tinnitus in left ear now.
C/o neck pain, body aches, lo grade temp 24 hours post immunization.
12 hours after shot, shaking and cold.  Leg cramps. Little sleep. However, I went throughout my day with no issues and symptoms ended around 6pm the next day.
Approximately 3 months after the vaccine, my defibrillator went off and would not stop. Called paramedics and they resuscitate him and sent to hospital. While at hospital observations were done. Was put on Lidocaine drip and Amiodarone medication. Was in the hospital overnight. Medicines were changed and felt good after that.
A 68 year old male pt was treated with OncoTICE. After 4 instillations, on 25Jun04 he presented dysuria and an area of induration on the dorsal side of the penis with edema on the skin of his penis. Treatment with Ciprofloxacin was started but on 29June04 the events had not yet abated.
This spontaneous report as received from a licensed piratical nurse (LPR) refers to unspecified group of patients of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (dose, frequency, indication and lot # were not provided, route of administration default to oral) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Did not want to get shot.  Ask mother to stand near, vaccine given.  approx 5 min later at the check out area, she was found lying flat on back.  Had bump on back of head size of golf ball.  Is lying flat-got up and c/o nausia, H/A and dizzyness. Lay pt back down with feet up, no better, called 911. 7/28/03 spoke with sister, child sent home and is OK.  Mother to call me back.