chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016, lot # K007264, expiration date 02-MAR-2017) (dose, route and site of administration were not reported) post vaccine excursion. No adverse effects were noted. Additional information has been requested. This is one of several reports from the same reporter.
pt stated her left arm started hurting.  It was hot and it started swelling and developed red streaks underneath her arm going up around the injection site.   It was very painful so she went to her Doctor and was diagnosed with cellulitis.  She was prescribed Keflex 2000mg for 10 days.  This helped with her infection.   She developed shingles on 1/2/22 but has never had chicken pox.  It was spreading around her left side of her face, neck and hairline.  She had one spot on her right cheek.  She was treated with antiviral Valtrex 2gm and steroid pack medication.   She no longer has these symptoms.
High prolonged fever. Severe chills. Headache, body aches. Can't get warm.
diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer's father received the first dose of Pfizer's vaccine yesterday (02Feb2021). He had diarrhea since last night (02Feb2021). The consumer asked if it was due to the vaccine and how long it will last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
patient inadvertently received the Pfizer covid19 vaccine indicated for patients 12 and older at the age of ten. patient has not reported any adverse events.
Swelling of cheeks, tongue, and lips (not severe-patient was able to still breath and talk properly). Stated that the areas just felt tight/tingly/itchy
Patient has a recent history of breast cancer on chemo and radiation. After 1st dose had allergic reaction was given epi and transported to ED. Patient pre medicated prior to arrival today, 40mg PO prednisone yesterday then 40mg PO prednisone & 50mg PO Benadryl today. Approx 7 mins after injection #2 tonight patient complained of shortness of breath, coughing with laryngeal spasm, flushed face. Vitals Bp 239/129 HR 126 Sats 96 RR26 MD on site requested to administer 0.3mg Epi IM and transfer to ED.  Patient took own albuterol. At approximately 1721, administered IM EPI 0.3mg. Patient transported to ED at 1735.
flushing; rapid heart rate; elevated blood pressure; This is a spontaneous report from a contactable consumer. A non-pregnant female(Age: 72, Unit: Unknown) patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265), via an unspecified route of administration on arm Left on 16Feb2021 09:00 AM at single dose for COVID-19 immunization. The patient medical history included Asthma, high cholesterol. The patient had allergies to PCN, Ativan, Zofran, Prednisone. 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 had not received any other vaccines in four weeks. The patient Concomitant medications included Rosuvastatin, Cetirizine Hydrochloride, Albuterol inh. On 16Feb2021 09:00 AM, Five minutes after injection, the patient experienced some flushing, rapid heart rate, elevated blood pressure. The events resulted in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Right Deltoid, red, swollen, slight rash on upper 1/3 of arm.
Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, esp L shoulder, L upper back, L neck, L jaw) Joint aches (whole body, esp L shoulder, L jaw) Fatigue Sharp, intermittent shooting pain in shoulder Headache  Effects most pronounced night of and day after vaccine, but persisting to lesser degree still on day 3 (today)
I received my first covid shot at about 2 in the afternoon, within about 2 hours my arm was sore, and almost hungover? I don't have a better description. I went into work (graveshift) because I felt alright, but by about 1am I felt like I was getting sick, the chills and slight nausea I was expecting. The soreness in my chest I was not. I've been progressively worse each day being congested, in my sinuses as well as my lungs, Mucinex has helped some. It's Monday and I still can't breathe right, taste anything or go more than 20 minutes without my box of tissues.
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
Patient received Pfizer dose as patient needed to receive Pfizer 12+. No Adverse reaction occurred.
45 hours after injection felt dizzy.  Slightly at first and it progressed to room spinning.; 45 hours after injection felt dizzy.  Slightly at first and it progressed to room spinning.; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 19Feb2021 at 15:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hay fever, arthritis, GERD and allergy to shellfish and adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included many supplements, loratadine (CLARITIN) and omeprazole (PRILOSEC); all for unknown indication from unknown date and unknown if ongoing. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021 at 10:30, 45 hours after vaccination, the patient felt dizzy, slightly at first and it progressed to room spinning. Took to bed and took a nap and awoke 3 hours later and felt fine and no more dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt dizzy, slightly at first and it progressed to room spinning was recovered on 21Feb2021.  No follow-up attempts are needed. No further information is expected.
pt recvd vax;exp flu like sx w/ fever & difficulty breathing;seen in er;
Shortly after, pt got home and began with a generalized seizure which lasted about 15 minutes. Called 911 and transported to ER. Temperature was up to 104F but no longer seizing at the time of arrival.
She received Moderna lot 033B21A dose 1 on May 29.  On May 31st she started to develop significant intermittent dizzy spells.  By June 2 she had started having additionally diffuse joint pains and focal left heel pains that then started to spread up from the heel to the knees bilaterally, constant fatigue, and tingling sensations in the bilateral hands and bilateral lower legs.  Her joint pains have started to improve in general and her heel pain finally started to ease up as of June 16.  Her dizzy spells remain intermittent and impactful.  She has been on work from home status out of precaution.  She has not seen any improvement in the tingling sensations for the past 2 weeks.
pt recvd vax & exp exacerbationof MS, foot drop, altered sensations in the lt foot, facial weakness, dysarthria, flu-like illness; weak rt leg & reduced sensation inlt leg; rt leg weakness; brisk deep tendon; reduced pain; difficulty speak
Continuous  Lt. arm shoulder ache/pain sometimes radiating  down arm to hand.  This is  the 3rd week since symptoms started.
A spontaneous, non-serious report of administration of expired product was received from a nurse concerning an adult female patient.  On 20-Jan-2009, the patient received expired FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009 that included the results of an investigation for a medication error.
pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolved then on the left then resolved.  She also felt like her lungs were feeling weird.  This gradually improved over the course of an hour.
On 6/18/21 heart transitioned to AFIB state. Prior occurrences have all occurred due to ingest of caffeine and ended between 6 and 24 hours after start.  No caffeine is known to have been ingested since September 2019 (last accidental ingestion).  I have not sough medical assistance yet.
patient complained of dizziness on vaccine floor. patient brought to observation area. upon arrival patient reports dizziness, sweating, "hard to hear", and shakiness. Vitals taken HR-71, RR-18, BP- 100/63, Pulse ox- 98%. Patient drank water bottle and apple juice cup. Vitals taken Q5min while under observation. 1455- HR-89, RR-18, BP- 117/75, Pulse ox- 100%, 1500-HR-72, RR-18, BP- 128/78, Pulse ox- 100%, 1505-HR-72, RR-18, BP- 123/77, Pulse ox- 99%, 1510 (while sitting upright)- HR-65, RR-18, BP- 116/72, Pulse ox- 99%, 1515 (while standing)- HR-79, RR-18, BP- 138/80, Pulse ox-100%. Patient reports feeling better and would like to leave.
This spontaneous report as received from a Medical Assistant concerned a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-JUL-2017 the patient was inadvertently administered an expired dose of VARIVAX, (lot # L019127, expiration date 27-MAY-2017), (route unknown) for prophylaxis. This was the patient's first dose. The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (Reported Lot# L024102, expiration date 31-MAR-2018). No adverse event was reported. Additional information has been requested.
coma for a day / doesn't remember getting out of bed; not feeling well; sick; lethargic; Sleep excessive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) (seriousness criterion medically significant), MALAISE (not feeling well), ILLNESS (sick), LETHARGY (lethargic) and HYPERSOMNIA (Sleep excessive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed), MALAISE (not feeling well), ILLNESS (sick) and LETHARGY (lethargic) was resolving and HYPERSOMNIA (Sleep excessive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Lab data was not provided. Treatment product was not provided by the reporter.  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 and therefore, causality for the events is assessed as possibly related. No further information will be requested. Patient niece was a doctor, and told him that the batch may have been exposed to high humidity.; 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 and therefore, causality for the events is assessed as possibly related. No further information will be requested.
Patient presented to the ED and was subsequently hospitalized with NSTEMI within 6 weeks of receiving COVID vaccination.
Narrative: 7/26- reports SOB, fever, cough, loss of taste/smell, chills, myalgias, runny nose, diarrhea 8/5- most sx resolved, occasional dry cough and sore throat
Redness at injection site and sore shoulder all the way up the neck starting a couple of days after administration of vaccine.
This spontaneous report was received from a physician, via a company representative, and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In November 2010, reported as "7 years ago", the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included sterile diluent (MRK) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). On approximately 24-OCT-2017, reported as "2 weeks ago", the patient developed shingles in an unspecified area. The outcome of herpes zoster was unknown. The causality between herpes zoster and ZOSTAVAX was not reported.
This spontaneous report as received from a Registered Nurse concerning a 9 weeks old patient who on 13-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Lost his appetite; Feels tightness on his chest; Felt tired; Sore arm; A spontaneous report was received from a physician concerning a 59-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, felt tired/fatigue, lost his appetite/ appetite decreased, feels tightness in his chest/chest discomfort.  The patient's medical history included testing positive for COVID-19 on Mar 2020 which took about 6 months to get over. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.   On the same day, after vaccination, the patient experienced a sore arm that lasted for 4 days. On 28 Dec 2020, he felt tired and lost his appetite. The patient reported that he got tested for COVID-19 three times between 28 Dec 2020 and 07 Jan 2021, which were all negative. At the time of report, on 07 Jan 2021, the patient had tiredness, appetite was not great and felt tightness in his chest.   Treatment for the event included dexamethasone for couple of days..   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, sore arm was considered resolved on 27 Dec 2020. The outcome of the events felt tired, lost his appetite, feels tightness in his chest, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient said her arm was swollen and had a red spot initially.  The redness had gone away but it was still swollen.  She had not tried to put anything on it or take anything.  She said it did itch sometimes.  I suggested she try some Benadryl and call her primary care doctor.
Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Inflammatory bowel disease (Taking Linzess to treat this illness.) since 2018 and Drug allergy (Allergy to Lactose). Concomitant products included LINACLOTIDE (LINZESS) for Inflammatory bowel disease.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine). At the time of the report, COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         It had been stated that Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  reported as Unknown. It had been reported that after second dose of the Moderna Covid 19 vaccine Paitent did not experienced any symptoms. No Treatment medication reported.  Company comment: This spontaneous case concerns a 21-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The patient received 2 doses of mRNA 1273 COVID-19 vaccine with 34 days interval. The patient tested positive for SARS-COV-2 test 6 months and 15 days after the second dose of mRNA 1273 vaccine. No further details were provided regarding patient symptoms, course of disease and treatment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-486076, MOD-2022-486108 (Patient Link).; Sender's Comments: This spontaneous case concerns a 21-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The patient received 2 doses of mRNA 1273 COVID-19 vaccine with 34 days interval. The patient tested positive for SARS-COV-2 test 6 months and 15 days after the second dose of mRNA 1273 vaccine. No further details were provided regarding patient symptoms, course of disease and treatment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
The patient had pain during injection that progressed into (L) arm pain radiating to chest & back. That then progressed and pt developed a redline of erythema that extended down to left breast and left axilla and began to swell. This lasted 2-3 days and resolved. Pt recovered fully.
Local, injection site reaction resulting in a 3-4 inch bruise surrounding injection site beginning night of vaccination. No allergic reaction reported. No other adverse effects  reported and hospitalization was not necessary.
Noticed lump approx at site of injection morning after immunization. Area swelled/worsened, became erythematous & firm, warm. At time of exam approx 54 hours from time of injection, approx 2/3 of diameter of (L) upper arm 1/2 of length of (L) upper arm involved. Pt denied systemic signs/symptoms. Treated with Prednisone & SEPTRA (started 4-30-11).
A report was received from a health care professional on 10 November 2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301040. Update 1, 06 January 2004. A follow up report was received form a health care professional indicating that no adverse effects were experienced by the vaccine at the time of the follow up report. No follow up pending.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-MAY-2023, the patient received Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   The reporter considered the pain in arm to be possibly related to Shingrix.     The company considered the pain in arm to be possibly related to Shingrix.   Additional Information: GSK receipt date: 25-May-2023 This case was reported by a patient via interactive digital media. The patient received the shingles vaccine the day before the reporting. The patient reported that felt fine except for a slightly sore arm. The reporter said that of course it might be the follow up shot in a month that affects her/him. The reporter's senator apparently got shingles and would retire, so it was not joke. The follow up would not possible, as no contact, details were available.
Pruritus and urticaria within 1-2 hours of receiving vaccine dose #1
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (incorrect product storage) (lot # L027733, expiry date 13-SEP-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIHAX HB was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA005893 and 1603USA006320 via same reporter link. Additional information has been requested.