chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 28 month old female who on 31OCT2002 was vaccinated with a dose of varicella virus vaccine live. On 04MAR2004 it was reported that the pt "now" has atypical chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No further information has been requested.
Urinary inconsonance ; dehydration, left   neck lymph node swelling and pain, nausea, headache; ,fecal  incontinences. pain at vaccine site. muscle weakness; spasms of urethra
high fever, muscle and  body aches, headache,  fatigue, diarrhea
6cm x 7.5cm area induration left upper arm possibly early cellulitis. Starting Keflex and cool compress.
Pt vaccinated with Influenza vaccine developed temp 103; chills, Seen in ER that PM given Tylenol and labs done.
Full dose of 0.5ml was not given due to the needle or syringe leak; Full dose of 0.5ml was not given due to the needle or syringe leak; A spontaneous report was received from a physician. concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine, where full dose of 0.5ml was not given due to the needle or syringe leak.  There was no medical history provided. There were no concomitant medications provided.  On an unspecified date in Jan 2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan 2021 (last week), the patient did not get full dose of 0.5ml vaccine due to the needle or syringe leak. No further information was provided at the time of this report. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for event, full dose of 0.5ml was not given due to the needle or syringe leak was resolved on an unspecified date in Jan-2021.; Reporter's Comments: This report refers to a case of underdose and syringe issue (full dose of 0.5ml was not given due to the needle or syringe leak) for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of underdose and syringe issue. The reported event is unlisted and company causality was assessed s not applicable.
tested positive for Covid 19 - cough, shortness of breath, no smell, sinus pressure, back ache, very tired
rt deltoid area swollen w/inc heat;rx w/warm compress & amoxil;good results;
PT RECEIVED VACCINE ON 6/9/2021. PT STATES THAT SHE DEVELOPED A STIFF NECK ON 6/20/21 AFTER DRIVING SEVERAL HOURS TO HER VACATION DESTINATION. SHE HAD TO TAKE NSAIDS AND USE A HEATING PAD OVER THE COURSE OF 2 & 1/2 WEEKS TO GET IT TO RESOLVE. STIFF NECK OCCURRED ON THE SAME SIDE AS INJECTION SITE.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "recovered" (30Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received the Paxlovid treatment from 21Sep2023 to 25Sep2023. Patient Tested negative for Covid on 30Sep, 10 days after Covid symptoms began and after finishing 5 days of paxlovid 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-202300316749 same patient, different event/drug;
I have underlying Afib which has been controlled on Sotolol for the last five years with occasional episodes of arrhythmia but my heart rate stayed controlled.  After the vaccine my heart rate shot up to nearly 300 while I was driving home and it eventually came down but I stayed in Afib for nearly 2 months afterwards.  I upped my dose to 400 mg daily from 320 mg of sotolol and eventually got some control of the Afib but now goes out of rhythm more frequently and when it goes out I am not rate controlled.
Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and route were unknown; lot number L029631 with expiration date 14-AUG-2017 and lot number M000442 with expiration date 31-MAR-2018). No adverse effects reported. This is one of the two reports that received from the same source. Additional information has been requested.
Information has been received from a physician concerning an 8 year old male who on 21-Aug-1998 was vaccinated with a dose of Varivax. Subsequently on 24-Apr-2006 the patient experienced a "mild" case of breakthrough varicella rash. Unspecified medical attention was sought. No further information is available. There was no product quality complaint involved. Additional information received indicated that there was no further information available. No additional information is expected.
Significant fatigue. Mild tinnitus in both ears. Mild ear fullness in both ears. Intermittent, mild headache.
Erythema and edema of large area around site of injections.  (+) tenderness (+) hyperthermia
about 5hrs p/vax pt was noted to be extremely pale;mom couldn't tell it was breathing @ first & picked pt up to shake pt;pt was conscious & took about 2oz formula p/crying but was a little pale & limp for another hr
injection site is red and painful; injection site is red; injection site is red and painful; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via the Pharmaceuticals company.  This case involves a female patient (age not reported) who experienced injection site is red and painful (vaccination site inflammation, vaccination site erythema and vaccination site pain), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via an unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection site is red and painful (vaccination site inflammation, vaccination site erythema and vaccination site pain) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of this report, event outcome was not reported.  There will be no information available on the lot number for this case.
Recieved the shot 11/02/2007 at 12:30pm, by 3:30pm I was very dizzy and weak, Idid not call the Doctor I went and laid down the rest of the evening, I was also nauseated and aches till Sunday 11/04/2007, I had to stay in bed because I couldn't walk a straight line because of dizziness.
Next day dizziness, aching all over, in bed for 2 days, then 3 days later blacked out with seizure-like symptoms.  Ended up in hospital ER with face lacerations.  Diagnosis of possible sudden onset of migraines.  Continue to have weakness in legs, arms - lightheaded - trouble swallowing at times. 3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.  3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.Discharged home from ED.
Fatigue; arm pain at shot site; muscle aches; nausea; fever; basic flu symptoms; This is a spontaneous report from a non-contactable other HCP (Patient). A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital.  Medical history included asthma, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Dec2020 09:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at time of 06:30 PM, the patient experienced fatigue, arm pain at shot site, muscle aches, nausea, fever, basic flu symptoms. No treatment received for the events. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Here for Synagis injection mother called my attention to lumps in both legs about 2 mm knot in each leg palpated. No redness or tenderness. No fever, consoles easily.
hey had symptoms and that was why they tested; they had symptoms and that was why they tested; This is a spontaneous report from a contactable other health care professional. Caller is reporting on two patients and this report is for patient 2. A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 14Apr2021 (at the age of 33-year-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 26Mar2021 (at the age of 33-year-old) as dose 1, single both for covid-19 immunisation. Caller said that the doses had the same lot numbers and expiry dates. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced tested positive for covid and had received their covid vaccines. Caller said that the patients reported to her because they had to if they were sick on site or have COVID symptoms and that all had to go through her. She did not test them, but they had both tested outside and they have sent her the positive reports. They had symptoms and that was why they tested and they had family events a week prior to this. She received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test with result positive on 02Aug2021 (yesterday) report was from a nurse who had a patient that tested positive for COVID. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in narrative, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. Linked Report(s): US-PFIZER INC-202100994257 same reporter, drug AE, different patient.
patient husband called on 9/25 and said patients arm was red, swollen and her bottom lip had started swelling up.  I told him he should contact her primary care doctor about the swollen lip.  Patients husband came to pharmacy on 9/26 and said her top lip had started swelling today.  He had contacted the doctor on 9/25 and he advised pt to take Benadryl, Pepcid and to not get the second dose of Shingrix
I was diagnosed with Bell's Palsy.  The symptoms began on Monday, May 3, 2021.  I went to the ED of Hospital.
A report has been received from a Pharmacist concerning a 15 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 10-Jan-2015. It was reported that the expired FLUMIST quadrivalent administered to two patients which started on 10-Jan-2015. The outcome of the event of expired FLUMIST quadrivalent administered to two patients is unknown. The report was considered to be non-serious.
shingles on my eardrum; dizziness; head hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 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 HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting). At the time of the report, HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
This is a spontaneous report by a contactable nurse. This is first of the three reports. This nurse reported that a patient received PREVNAR 13 on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date after vaccine administration, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment regimen was not reported. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
This spontaneous report as received from an 80 year old female patient with no pertinent medical history and no known drug reactions or allergies refers to herself. On 31-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper left arm for recommended vaccine from a Pharmacy. Concomitant therapies included ATENOLOL and PAXALL. On 02-JUN-2013, the patient began having joint elbow pain along with swelling. The patient contacted pharmacy to seek medical attention. The patient was treated with ALEVE (dosage unspecified). No lab diagnostics studies were performed. The patient was still feeling discomfort and was planning to contact her physician on 04-JUN-2013. The outcome of events was reported as not recovered. Additional information has been requested.
Local erythema 4.5x6.5 cm about injection site, tenderness, mild swelling & itching.
Local reaction at injection site at left upper 5.5cm erythematous, indurated reaction at injection site, no pain, temp 99.0, BP 82/51, pulse 112, RR 23, P ox 99%.
I got my vaccine and was ok (normal mild side effects). I went to bed and awoke around 2:20 a.m. with tinnitus. I have had it in the past but never more than a few hours. It's ongoing and I am concerned after reading prolonged tinnitus can cause hearing loss. I also found an online group of others having this issue (worse and louder than me) from all 3 Covid-19 vaccines). I have no pain, no itching, just the high pitched ringing and it seems to be "louder" or felt as louder in my right ear. All the mild symptoms are resolved and I'm left with this. My other concern is should I take the 2nd shot? Some on the group board skipped it.
liquid started dripping into patient's arm; A spontaneous report was received from a consumer concerning a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "liquid started dripping into patient's arm".  The patient's medical history, as provided by the reporter included migraine, weight loss and cholesterol. No concomitant medications were reported.  On 01 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number 012M204) for prophylaxis of COVID-19 infection.   The patient stated that while she was receiving her dose, the syringe broke while the nurse was pushing the needle into her arm.  The liquid started dripping into her arm and made a puddle on the table.  The nurse first told her that she administered half of the dose.  The nurse called Moderna to ask if what occurred was fine, and she was told to send the patient home. Treatments of this event are unknown.  Action taken with mRNA-1273 in response to the event was not reported.  The event "liquid started dripping into patient's arm" considered as resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Have a stuffy nose and a cough; Have a stuffy nose and a cough; I have been dealing with my sinusitis; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history included ongoing sinusitis (this happens with her every year). The patient concomitant medications were not reported. On an unspecified date in 2021, the patent experienced have a stuffy nose and a cough, I have been dealing with my sinusitis. Patient stated, I received my first dose of Pfizer (Unspecified Medication) on April 15, and I am scheduled to receive my second dose this evening but for the past week I have been dealing with my sinusitis. I have a stuffy nose and a cough So; I didn't know if I can still get the vaccine today. Patient stated, yes but this happened due to my sinusitis, this happens with me every year around this time (Further clarification was unknown). At the time of this report, outcome of all the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Myalgia Chills Prostration Injection site tenderness  Took Tylenol as advised but not much help Could not go to work location this morning, having difficulty doing much
The patient became lightheaded and dizzy 4 hours post vax. The patient experienced nausea and vomiting during the night, which abated by the next morning.
Injection area and about 4 inches around area- felt as if it were on fire, it was raised and it itched terribly for approx 6 hrs
On the 21st, about a week after- I rubbed my arm and it hurt. It was very red and hurt to touch and warm. I called my PCP and they said it was cellulitis. They marked the area and if it grew bigger to let them know. They gave me antibiotics. On the 27th, I noticed the red spread further than the mark they drew. I went to the Dr. and they told me it was a allergic reaction and call me a steroid, it wasn't hot and didn't hurt.
Headache on 6/24/2021 and temp of 99.0 on 6/25/2021.
Joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Few minutes after patient received vaccine the technician heard her say "I'm not feeling very good" and rushed to her side. She was looking very pale and we proceeded to check her blood pressure and lean her back in the chair. The patient noted feeling nauseated but did not vomit. BP was 103/80 ~4:05p and then 123/90 ~4:25p. An Epipen was retrieved but was not used since patient was alert. Talked to the patient continually. Asked colleague to call 911. Team leaders were assisting within a few minutes. Patient's Mom arrived within 30 minutes. EMS took over an hour to arrive. By the time Mom had arrived, patient was already feeling better. We gave her ice water and a Pepsi. Patient had only had chips and some candy for food today. Patient ultimately felt okay when she left. She walked out on her own.
Information has been received  from a licensed practitioner nurse concerning an unknown number of patients of unknown age and gender. Since 19-MAR-2015, the patients were vaccinated with doses of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016 (dose and route not reported), which underwent supported temperature excursions. This is one of several reports received from the same source. Additional information has been requested.
Initial report received from a health care professional on 01 Sep 2010: On 01 Sep 2010, this patient inadvertently received intramuscular dose of lyophilized A powder reconstituted with liquid from HEP B vaccine MENVEO (batch number 023011, expiry date 20 Apr 2010). The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. The outcome of the event was not reported. Follow up report received from a health care professional on 28 Sep 2010. The outcome of the event was reported as complete recovery.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 29-OCT-2012 14:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.