chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .
Left arm numbness and tingling, redness and raised bump from Anthrax vaccination/swelling in left arm.
No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 23-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S004548, which has been verified to be valid, expiration date reported and validated as 12-AUG-2020) (product storage error). No additional adverse event information provided.  The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
Fever, Dizzy, Fatigue, Swollen Left Arm, Vaccination site hot to touch and visibly swollen and red.  left Arm, left armpit, left torso lymph swollen. painful to lower left arm fully, panful to raise/ use left arm. Soar throat, labored breathing,
Tinnitus in left ear. Persistent ringing as well as distortion of hearing. Symptoms first appeared 4 days after injection.; Tinnitus in left ear. Persistent ringing as well as distortion of hearing. Symptoms first appeared 4 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo153) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tinnitus in left ear. Persistent ringing as well as distortion of hearing. Symptoms first appeared on 14Apr2021 at 08:00, four days after injection. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus in left ear, persistent ringing as well as distortion of hearing and included treatment with Prednisone 60milligram daily. The clinical outcome of the events tinnitus in left ear, persistent ringing as well as distortion of hearing was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Nauseous; laying down on couch, then on bed, sitting on toilet, had bowel movements.; Then VOMITING started.14 times at HOME, 3 more times in ER.; This is a spontaneous report from a contactable nurse.   A 84-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Exp6202), dose 1 intramuscular, administered in LEFT ARM ON 24FEB2021 AT 13:30 AS SINGLE DOSE FOR COVID-19 immunisation.  Medical history included arthritis, sciatica, sinusitis, allergic sinusitis, surgery. The patient's concomitant medications were not reported.  No other vaccine in four weeks. No covid tested prior and post vaccination. 25Feb2021 01:00 PM, she had nauseous, laying down on couch, then on bed, sitting on toilet, had bowel movements. then vomiting started. 14 times at home, 3 more times in ER. The event assessed as non-serious. Therapeutic measures of GI Cocktail with Lidocaine, Carafate. RX: Ondansetron HCL 4 MG were taken for all events. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 21-JUL-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K003604, expiration date: 20-MAR-2015, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Nausea, chills, body aches, headaches, soreness, fatigue all lasted two days Treated with ibuprofen
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out.  Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low.  Called 911.  Put oxygen on me, gave me Epipen, and checked sugar levels.  Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up.  Gave me water and orange juice.  Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers.  I was still trying to feel back to  myself after a half hour to 45 minutes.  My doctor says not to get 2nd dose in which I'm due on 2/21/2021.  I started to feel back to myself around an hour later.  I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing.  No fever.   I called  my physician on 2-1-2021 to let her know what happened.
rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rashes). At the time of the report, RASH (rashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
We mis-calculated the expiration date wrong. Instead of it being expired at day 70, we calculated to be expired at day 77th. Patient received the pfizer gray top dose at day 77th of expiration date.  The pfizer vaccine was kept in the refrigerator in a range of 36-46 Fahrenheit without any temperature excursion. We called Pfizer company on 04/11/2022 which is the date when we discovered this incident. They recommended following guideline which is repeating dose immediately. We reached out to the mother of the patient to let her know the incident. No Adverse Events from the patient was reported. We told patient's mother the dose needed to be repeated immediately.
She had flulike symptoms a few hours after the vaccine was administered.  She progressively "got worse" and went to her private physician after a few days.  He prescribed her antibiotics, which she has been taking.  She now has a respiratory infection.
This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-FEB-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot and expiration were not reported). Co-suspect and concomitant therapies were not reported. On 19-FEB-2014, the patient was given a prescription for methotrexate (manufacturer unknown) for an unspecified condition, started in approximately February 2014. At the time of the report outcome was unknown. Additional information has been requested.
Vaccine given to patient outside of approved age group (17 years, 9 months at time of vaccination)
Fever of 103 Degrees, Severe pain in vaccine inject under arm/inflammed gland in under arm. Adverse reaction in injection site, raised and sore. Back spasm and seizures in muscles of back. Disorientation and incoherant speech. Headaches and eye pressure. Treated with Ice and cold compressess to effected injection site and under arm glands to reduce pain and lymphnodes. Fever and back pain being treated with Ibuprofe and cold compresses.
Patient describes headache and waves of nausea since vaccine, with arm pain from vaccine site down to wrist. Today (the next day) has shoulder pain. Last night had chills followed by fever of 104 today. Feels fatigued.
pt tx w/keflex & on 19JUL93 cellulitis vs hypersensitivity to vax was resolving; 17JUL pt had 7x7 cm erythema (2) upper arm);
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional) from product quality. The reporter is the patient. A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 74 years, in left arm for covid-19 immunisation, Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "AFIB" (unspecified if ongoing), "hypertension" (unspecified if ongoing), "high cholesterol" (unspecified if ongoing), "low thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are needed. No further information is expected.
Pt was given 1/2 dose of MedImmune .2ml Nasal Spray when nurse realized that the baby should have gotten a shot or injection. She stopped giving nasal spray. Instructed mother to watch for sign or symptoms.
On 12/21/2022, I woke up with a cough. I had just spent the day before doing a serious cleaning in my basement, so I thought I was reacting to dust. I had family coming for the holiday though, so on 12/22/2022, when I still had a cough and a slight fever, I took an at home COVID-19 test and it was positive. I took some TYLENOL to treat the fever and called my doctor who prescribe PAXLOVID. I started taking that the same night. By the next morning, I was already feeling better. The PAXLOIVD made me feel sicker that the COVID-19. By 12/25/2022, I tested again, and it was negative. Overall, it was a very mild case.
Right sided facial droop diagnosed in ER as Bell's Palsy on 3/31/2021.   Took several weeks to resolve but did eventually resolve.  No other potential inciting factors other than COVID-19 vaccine 11 days prior to onset.   Workup otherwise unremarkable.
All day 1 day post vaccination:Fatigue, mild headache, joint and muscle pain, fever 100.4, warmth at injection site, pain at injection site
SORE ARM, FEVER, WEAKNESS, HEADACHE, SHIVERING AND UPSET STOMACH
received Moderna vaccine on 1/6/21 tested positive for Covid-19 on 1/13/21 sent to Hosp. on 1/19/21 2/5/21-Incubated 2/19/21-Trach & PEG placement Currently a patient at hospital inpatient for 46 days
3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose .   This lasted till 2/20 until around 5:30 pm
RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY  EASILY; ACHING PAIN IN LEGS; FEELING TIRED; THROBBING; TINGLING OF BODY AND TINGLING IN LEGS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced throbbing. On 23-MAR-2021, the subject experienced tingling of body and tingling in legs. On 23-MAR-2021, the subject experienced aching pain in legs. On 23-MAR-2021, the subject experienced feeling tired. On 24-MAR-2021, the subject experienced restless legs. On 24-MAR-2021, the subject experienced feeling weird. On 24-MAR-2021, the subject experienced super emotional and cried very easily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing, tingling of body and tingling in legs, restless legs, feeling weird, super emotional and cried very easily, aching pain in legs, and feeling tired on 30-MAR-2021. This report was non-serious.  Additional information received from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Outcome of the events updated.
The day of it was red, mother put cold packs on and give her TYLENOL. The next day it look green like a bruise couldn't move arm. Patient got better after 2 days just had a little arm pain. Mother told us this morning 09/11/2017 that patient is doing better now. Left arm.
Narrative: Moderna dose#2 received in the morning of 2/18/2021. Admitted later that day for syncope. Patient with seizure history, unclear if vasovagal vs seizure. Patient undergoing work up with neurology service and continues on home valproic acid at this time.
Pt received Influenza vaccine at 8:30AM. began itching @ 9AM. Notified RN @ 10:15AM. Benadryl 50mg IM @ 10:18. C/O itching, rash around neck, dry mouth, Itching in throat. No difficulty breathing at this time  Pulse 60, Resp. 18. patient pale. Repeat VS Pulse 100, Resp 24 @ 10:25AM. EMS on scene at 10:27AM. Transported patient to ER.   Taken to Emergency Room by EMS.
Information has been received from a 25 year old female patient with an allergy to ALLEGRA and CLARITIN who on 03-AUG-2007 was vaccinated in the left arm with a first dose of GARDASIL. Post vaccination immediately the patient experienced extreme pain at the injection site, and felt dizzy. Also some slight swelling at the injections site on the first day. The patient stated she still has pain at the injections site and surrounding area. When she raises her left arm it felt painful in the muscle and when she tried to grab things it hurt and it was worrying her. She stated that her left arm had never been the same since the injection. She called the physician's office. No treatment prescribed by the physician. The patient scheduled to have her second vaccination on 01-Oct-2007, and was unknown whether she will continue. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submittedon 10/12/2007. No additional information is expected.
C/O headache and extreme night sweats, that required a change of bedding and chills. Began evening of vacination, much better the next day.
Headache; malaise; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek5730), intramuscular on the right arm on 19Dec2020 16:15 at a single dose for covid-19 immunization. The patient's medical history included reflux and anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), spironolactone, loratadine (CLARITIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), vitamin d3, and famotidine (PEPCID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced headache, malaise, and diarrhea on Dec2020 (reported as 18Dec2020 19:00, pending clarification). No treatment was received for the adverse events. Outcome of the events was recovered on Dec2020.
No adverse effects; Patient received improperly stored PROQUAD on 6/6/2019.; This spontaneous report was received from a medical assistance concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 06-JUN-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  for prophylaxis, lot # R026721 and expiration date: 17-MAR-2020 (strength, dose, route of administration and frequency were no reported), it was reported that a sterile diluent properly stored was used to reconstituted the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD). The administered dose of the vaccine experienced a temperature of 6 to 14 Fahrenheit for 20 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Pt. had fever up to 102 degree last night. Woke up with red, puffy, itchy eyes. Has a red/pink circle around injection site.
4-days post immunization, patient developed stroke symptoms while exercising at the gym. He was given immediate care by the reporter (off duty healthcare provider) and transported by ambulance to  hospital and later transferred to  for further treatment.
Pt developed body aches, myalgias on 5/29/09. The next day, she was much better.
Muscle Pain in Deltoid Muscle; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site). On 15-Mar-2021, MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant drug reported. No treatment reported.
Muscle Soreness and Shivering through part of the night, symptoms had gone away by morning.
Chills, low grade fever, soreness Enlarged and painful lymph node in the left axilla (size of large egg or baseball); enlarged lymph nodes in the clavicle area
Received 1st dose of Twinrix on 11/08/2005 in left arm. On 11/10/2005 started having pain in both knees and thighs. That evening developed a razor burn type rash from mid calves to her ankles that was itchy after on 12/11/2005 every joint in her body from the neck down was swollen and painful. Saw MD on 11/11/2005 instructed to take ibuprofen and is slowly getting better. Denies any swelling or discoloration at injection site.
Localized swelling, redness, pain, and tingling/loss of sensation in hand/fingers for 3 days
Vaccine given 1/30/22.  On 1/31/22, he developed chills and nausea and fatigue.  That night, he developed profuse night sweats.  Felt tired 2/1/22 and had night sweats again that night.  On 2/1/22, he developed right medial ankle redness and swelling and pruritis (itchiness there), which improved some by the next day.  On 2/2/22 as his right ankle was improving, he developed left thumb arthritis (swelling, redness, stiffness), which started improving by the next day.  On 2/3/22, he developed right ear (pinna) swelling, redness and warmth, which started improving by the next day.  On 2/4/22, he developed left ear (pinna) swelling, redness and warmth, which started improving by the next day.  He started taking naproxen about 1-2 tabs (220 mg each) about 1-2 times a day starting around 2/1/22 and continued through Friday 2/4/22.  He was feeling overall better by 2/5/22.
Fever, shivers, hard breathing, back ache, headache.  Shivers & hard breathing lasted 10  - 15 minutes Fever peaked at 101
Severe hair loss after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe hair loss after vaccination) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Severe hair loss after vaccination). At the time of the report, ALOPECIA (Severe hair loss after vaccination) outcome was unknown.            No treatment information is provided. No concomitant information is provided.
Initial misuse report received from a healthcare professional on 13 January 2014. Some patients (no information was provided regarding patients) had received a dose of Tetanus Toxoid Adsorbed on an unspecified date. It was reported that expired vaccine was administered. No adverse event was reported. List of documents held by sender: none.