chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 08 November 2013. A 76 year old female received dose of FLUZONE HD (lot # U4784AA) at left deltoid on 17 October 2013. Patient reported that it hurts when needle went in and patient had pain in her left arm. Patient reported that post weekend she had limited range motion in the left arm. Event outcome was unknown at the time report. List of documents held by sender: none
SWEATS; FEELING VERY SICK; WEAK AND MOVING VERY SLOWLY; LOW GRADE FEVER (100.7 DEGREES F); BODY ACHES; HEADACHE; NAUSEA; CHILLS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to plants, dust mite allergy, tree and grass allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient has medical history. the patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced low grade fever (100.7 degrees f). On an unspecified date, the subject experienced sweats, feeling very sick, and weak and moving very slowly. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F, 96 F, 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever (100.7 degrees f), had not recovered from headache, nausea, body aches, chills, and sweats, and the outcome of feeling very sick and weak and moving very slowly was not reported. This report was non-serious.
I did not have an adverse reaction to the vaccine. I had a sore throat and slight fever prior to test positive to COVID-19 on 03/20/2023. I contacted the doctor and got a prescription for Paxlovid that I am taking now. I am tolerating the medication without any complications. I have congestion, cough and a runny nose.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant medication was reported. No treatment medications were reported.
Immediate metallic taste in my mouth, followed by itchiness all over. The next day, my tongue felt scorched, pain in my right side, lower back and hip, which cause me to limp, itchiness and taste continued. I started having headaches and pains in my jaw on both side and severe abdominal pain, shortness of breath and it felt like a lump in my throat. My symptoms continued to get worse. I've been to the urgent care, doctor's offices and the hospital 4 times. I started having seizure/uncontrollable spasms, shortness of breath, racing heartbeat, loss of consciousness, sensation of my throat closing, chest pain and the list goes on. Each day my symptoms either gets worse or I form new ones. It's been over a week and I am still not well. Was advised to follow up with multiple specialists for treatment. Scheduled upcoming appointments.  I've been administered steroids, pain meds and muscle relaxers. I've been given little to no relief and my symptoms are continuing even after the meds.
Local papular rash on both lateral thighs, no systemic symptoms. Happened at 2 and 4 month visits too, bilaterally.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in right 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's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA, start date: 01Jan2015. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient recived Paxlovid from 05Sep2023 to 10Sep2023 as COVID-19 treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303408 same patient, different drug/event;
A physician reported that a 52-year-old female patient received a dose of FLUMIST (2003-2004 Formula) on 05-NOV-2003 and experienced a respiratory infection which led to pneumonia.  On 07-Nov-2003, the patient developed a respiratory infection  which progressed to pneumonia . The patient was treated with intramuscular LEVAQUIN. The patient has not recovered. No additional information was available at the time of this report.
None. However patient was older than 65 year of age. Physician should have given injection rather than RN doing so; per protocol-however MD did not check age.
This spontaneous report as received from a pharmacist via a company representative refers to a 65 year old female patient. Concomitant medication and pertinent medical history were not provided. On approximately 18-JUN-2014 (about one week ago) the patient was vaccinated with ZOSTAVAX (19400 unit 1 standard package vial of 1, lot #, dose, route and frequency were not provided). On an unspecified date of June 2014 patient developed localized reaction at injection site, further described as round lump which was red and warm. Patient didn't seek for medical attention. Patient was directed by unspecified person to take BENADRYL for the adverse events. Events remained on going and the patient was not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Starting 24 hours after the injection, extreme fatigue for about 48 hours. Also, very slight soreness at the injection site. Starting the 7th day, injection site swelled, became firm, warm to the touch, and started itching.
Immediate extreme muscle weakness and fatigue. Has not improved and possibly worse 6 months later.  So weak went from an active person painting my deck to not being able to climb ladder. Extreme difficult to climb stairs.   Strength is just gone overnight. Second issue is that I am having mensural bleeding which hasn't occurred in 23 years.
01/10/21 received vaccine sore arm for 1 week.  01/17/21 lump developed in R Auxilla with pain, swelling throughout arm, numbness and pins in needles throughout right arm.
Febrile seizure lasting approx. 2 minutes. Sudden spike in fever while napping.
Lingering, chronic nausea.  Continuing. It comes and goes.  Recently had a COVID lab test and it was negative.
LITTLE SORE ARM; CHILLS; 102 TEMPERATURE; MUSCLE ACHES; FELT KIND OF TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be request for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little sore arm, chills, 102 temperature, muscle aches, and felt kind of tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, 102 temperature, muscle aches, and felt kind of tired, and had not recovered from little sore arm. This report was non-serious.
A few hours after receiving the flu vaccine in the left shoulder I started having a burning itching rash that started on the left side of neck and chest, spreading to upper back and upper chest over to the right shoulder. Rash got worse for the next two days until I contacted my primary physician and he prescribed me a Medrol pack to alleviate rash and itching. Rash went away quickly with treatment with steroid.
Fatigue; Cut on finger became infected; elevated liver lab values; Alanine aminotransferase 100; This is a spontaneous report from a contactable pharmacist.  A 27-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fatigue, cut on finger became infected, elevated liver lab values and Alanine aminotransferase 100 on an unspecified date. The patient stated that he got his  first dose 3 weeks ago and went to the doctor after he  had cut in his finger and it got infected. the patient stated that he had also become quite fatigued which was unusual for him. They did labs and his ALT come back elevated. They informed him if he had any reports of altered liver values from the vaccine. The patient stated that he had no information on elevated liver lab values after vaccination. The physician ordered lab work because the patient had not had blood work done in a while as well as a Covid test. The patient's Covid-19 test was negative and patient's blood work came back normal except for his ALT which was 100. The patient stated that he was due for his second dose tomorrow. He enquired if it is contraindicated for him to get the second dose?. The patient was prescribed Keflex for the infected cut on his finger. Caller stated that he doesn't think that there is any interaction between Keflex and the Covid-19 vaccine and inquired if that was true. Caller stated that he can't imagine why Keflex would be contraindi-cated with the Covid-19 vaccine for one thing. Caller inquired if there were any reports of any al-tered liver values from the Covid-19 vaccine in original studies. Caller reported that he couldn't find anything online and stated that he would imagine that it had looked at liver studies. The patient underwent lab tests and procedures which included alanine aminotransferase increased: 100 on unspecified date Elevated , covid-19: negative  on unspecified date, blood work: normal on un-specified date.  Therapeutic measures were taken as a result of cut on finger became infected (lo-calised infection). The patient was given Kelflex.
On 9/7/2019  pain began in left  shoulder and moved towards left side of face and increased in severity , patient visited pcp on 9/11/2019 and was diagnosed as trigeminal neuralgia.
Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181109 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in right deltoid on 16 Sep 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, following the vaccination, the patient developed redness, swelling and tenderness, firmness, and the skin darkened at the injection site of the right deltoid. It was reported that this was a person of color. It was also reported that symptoms progressed to the shoulder, neck and left arm also lips had become swollen. patient required emergency room or doctor visit. Laboratory investigations were not provided. It was reported that patient had been on steriod for 24 hours. The patient was not recovered from events (it was reported that it was unknown at this time if there had been any improvement). List of documents held by sender: none.
Patient received their first Moderna COVID-19 vaccine dose on 4/24/2021. Second dose was administered on 5/15/2021 (7 days prior to scheduled 2nd dose). No adverse reactions were observed during the 15 minute monitoring period.
Dose 1 given 2/15/2021 Lot #015M20A Moderna. Patient died at  on 1/28/2022 of worsening lung mass, respiratory failure.
A report from a Health Professional concerns a 6 year old male. No information regarding relevant medical history, concomitant medication was provided. The patient received FLUMIST (intranasal) on 27-Nov-2013. The health professional reported that the patient received FLUMIST QUAD nine days ago on 27-Nov-2013 and developed hives seven days ago, and was tested positive for the flu with fever and congestion which started on 04-Dec-2013. He was seen at the doctor's office on 04-Dec-13 and prescribed ORAPRED 49 ML for three days. The patient was taking a dose of 8.2 ML of ORAPRED three times a day. He came back to the physician's office on 06-Dec-2013 as his condition worsened and was prescribed ORAPRED of 50 ML again for three days for his symptoms. Patient had erythema multiforme, possible virus infection, bruising, joint swelling, angioedema, and possible hypersensitivity reaction. Patient was treated with prednisone, BENADRYL and ZYRTEC. The outcome of erythema multiforme, angioedema, tested positive for flu, fever, congestion, bruising and joint swelling was unknown, the patient recovered from the hypersensitivity reaction or viral infection on an unspecified date, and at the time of reporting, the hives were ongoing. The reporter assessed the events of tested positive for flu, hypersensitivity reaction vs viral infection, fever, congestion, and hives to be non-serious. The company physician identified erythema multiforme from the source document and added it as a serious adverse event (seriousness criterion of important medical event) while bruising, angioedema, and joint swelling were judged non-serious. Follow-up information received by AstraZeneca/MedImmune on 21-Jan-2014 from a health professional upgraded this case to globally expedited: Serious event of erythema multiforme was added. Non-serious events of hypersensitivity reaction vs. viral infection, joint swelling, angioedema, and bruising were added. Lab details added.
Rash from elbow to armpit all the way to the back; Vertigo; Nausea/vomiting; Tired/ could not make 2 steps; Nausea, vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash from elbow to armpit all the way to the back) and VERTIGO (Vertigo) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash from elbow to armpit all the way to the back) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting). At the time of the report, RASH (Rash from elbow to armpit all the way to the back), VERTIGO (Vertigo), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patent stated that 6 to 10 days after the administration of the second vaccine the patient started to develop a rash from his elbow to his armpit, then the next day the rash was all the way to his back. Patient also experienced nausea, vomiting and vertigo. The patient went to the emergency room on 21-APR-2021 and was prescribed prednisone, ibuprofen, loratadine.  Company comment: 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.; Sender'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.
pt recvd vax; had immed crushing pain in rt hand;w/in 15 min began to feel "really weird", felt woozy, strange odd;T 100-101, hives on face & neck; LOC fro 16 hrs;woke w/ fever, congestion; felt like the flu; still feels weird;
12/29/2022 I started having cold symptoms and body aches. I tested positive for COVID-19 on 12/29/2022. I contacted my PCP and was advised against taking PAXLOVID and letting it run its course. Symptoms lasted 10 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of PNEUMOVAX 23 (Lot # 666558/0449Z, expired on 08-OCT-2012, route not reported) on 24-SEP-2012. No adverse effect reported. It was not known if the patient sought for medical attention. Additional information has been requested.
PATIENT DEVELOP RED BUMPS (HIVES) AND HER LEFT SIDE OF FACE ( SIDE OF THE LEFT LIP -DROOPING).  PATIENT TAKE CLARITIN FOR 3-5 DAYS ALONG WITH CONTINUOUSLY MASSAGE HER FACE.  PATIENT RETURN TO PHARMACY THE FOLLOWING WEEK TO INFORM THE PHARMACY ABOUT THE REACTION.
This spontaneous report as received from a physician from a nurse via company representative refers to a 14 year old female patient. On 13-MAY-2013 (also reported as "13-MAY-2014", "first dose on May 2013"), the patient was vaccinated with the first dose of GARDASIL, in June 2013, the patient was vaccinated with the second dose of GARDASIL and in December 2013, dose 3 of GARDASIL (lot# and dose unspecified). On 11-APR-2014 the patient developed facial hair after completing three doses of GARDASIL. The outcome of the event was unknown. The mother of the patient called in to seek medical attention. No treatment was given for the event. Additional information has been requested.
loss of hearing in right ear after first shot and loss of hearing in left ear after second shot. two other males in our small community have same issue that I know of
Information has been received from a RN concerning a 21 yr old female pt who on 09Aug05 at 10:15AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499989/0579P), IM in the left arm. On 09Aug05 the pt developed severe pain and swelling in left arm, then developed febrile illness with decreased WBC and increased alk phosphate. The pt recovered. It was also reported that another adult pt had an adverse experience after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0508USA03390). No further information is expected.
No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided) (Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs).
Did not experience any symptoms; inadvertantly administered one dose of MMR II on 27NOV2019, that has expired on 03NOV2019; This spontaneous report was received from a nurse prescriber refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-NOV-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (therapy type: recombinant Human albumin (rHA)) of lot # N031005 with an expiry date of 03-NOV-2019 for prophylaxis (strength and route of administration was not reported) (expired product administered). The patient did not experience any symptoms (no adverse event). The outcome of expired product administered was unknown.