chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic (Respiratory asthma Inhalation of toxic chemicals at work, burned eyes, nose & throat, ongoing) since 08-Jan-2016, Sleep apnea since 2014, Cancer (on 05-04-2020  Range of motion from proton radiation therapy - neck & spine.      14-09-2020 Neuropathy of hands and feet, toes from chemotherapy       26-01-2021 Lymphodemia - both arms and hands, lymph node removal,Double   mastectomy - range of motion, loss of upper body strength) since 14-Sep-2020 and Drug allergy (Zantac, Side Efftects to Anastrozole). Concomitant products included SALBUTAMOL (ALBUTEROL) and FLUTICASONE for Asthma chronic, EXEMESTANE from 23-May-2021 to an unknown date for Cancer, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Nasal discharge.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISION BLURRED (Blurred vision). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In April 2021, VISION BLURRED (Blurred vision) had resolved.            patient  have metal expanders in his chest.   This case was linked to MOD-2021-308096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: added patient address,patient demographics, medical conditions, vaccine facility information,     concomitant treatment and event outcome updated and narrative was generated accordingly.
pt was given a moderna booster. She is not over 18yo and should not have rec'd a moderna booster.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, doses of improperly stored VAQTA (dose, lot# and route were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Tinnitus in head - not specific to one ear. High-pitched "eeeeeee' going on two+ weeks. Mentioned the tinnitus to an ENT I visited on May 7, 2021 to make sure the swimmers ear in the right ear was gone and he said he had not seen anyone specifically about tinnitus tied to the vaccine but his colleague had seen several recently and mentioned it to him. He told me there was nothing to be done.
severe bleeding; Menstrual irregularity; very itchy rash after second vaccine at injection site for several days; severe bleeding/passing lots of large clots with heaviest bleeding than ever experienced in my life; This is a spontaneous report from a contactable consumer (patient). A 24-years-old (Pregnant: Unknown) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 24-years-old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included epilepsy from an unknown date and unknown if ongoing. The patient had known allergies from skin lotions. The patient concomitant medications included levetiracetam (KEPPRA [LEVETIRACETAM]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 10Aug2021 at 16:00 (at the age of 24-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced severe bleeding, menstrual irregularity, very itchy rash after second vaccine at injection site for several days, and severe bleeding/passing lots of large clots with heaviest bleeding than ever experienced in my life. The patient did not received treatment for the adverse events. Outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information was received from a consumer referring to her son, a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was vaccinated with M-M-R II (dose, frequency and route were not reported). On an unknown date the patient developed autism. The outcome was unknown. The causality was not reported. Upon internal review, autism was determined to be medically significant. Additional information is not expected since no contact information is provided.
Patient had severe muscle spasms in right leg the evening following vaccine administration which continued but decreased in severity. He had 5 cm circular area of redness on right inner thigh which started around the same time. Symptoms are decreasing in severity but continue 3 days later
DTaP given to 12-year-old should have been Tdap. No adverse event reported.
Started having left sided chest pain on 6/27 which progressively worsened over the next few days, called OB on 6/30 who instructed me to go to emergency department to be evaluated. Throughout the day the chest pain became progressively worse especially on inspiration also accompanied with difficulty to take a full breath. After testing done in emergency room I was admitted and diagnosed with pericarditis and said to be having an acute inflammatory response post covid vaccination. At time of adverse event I was 26 weeks pregnant with an uncomplicated pregnancy, estimated delivery date is 9/29
Injection received 2/19. On 2/27,  my left arm hurt when lifted above shoulder/head. I noticed this when @ the store reaching for an item on top shelf. Once home, I looked at the arm and noticed it was swollen, red, and hot to the touch. Under the skin was also hard. This was all near (estimated) the initial injection site. I circled the area and took 2 Benadryl. The swelling and hardness increased throughout the evening. Placed an ice pack on it and took 2 Tylenol. My temp was 97.7. Next morning (2/28) the swelling had gone down some, but area was still firm and warm to touch. Took 1 Benadryl and 2 Tylenol. Temp was 97.7 again. 3/1 the swelling and heat had greatly diminished but the area was still firm to touch. It also began to itch at this point. Called my PCP and appt. scheduled for  3/2. PCP indicated it was a delayed reaction to the Covid shot and encouraged me to complete this form. As of today, 3/2, the area is much better. Still some firmness but very minimal.
Shortness of breath; 7 days in hospital; 2 days in intensive care.
Feeling bad; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.  On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 14-Apr-2022, the patient experienced FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering) was resolving.     No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
MISSED TO TAKE FOURTH DOSE ON TIME; This spontaneous case report (PVX2019-2066) was received from a pharmacist on 09-Aug-2019. It described a female consumer who "missed to take fourth dose on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The female consumer took three doses of Vivotif on every other day, but missed to take fourth dose on time, which was due on 08-Aug-2019. The pharmacist was not sure if the fourth dose has already been taken.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose on time" was considered as not applicable.
It was very painful for a few days.  Suffered serious fatigue, headache, nausea for a few days after.  Had difficulty getting out of bed.  After a week, the injection site developed a rash that spread down my for a week.  Was hot and burned for the first day, itched after until it went away.
Joint pain/swelling, fatigue, pain in arms, legs, shoulder, feet, knees, hands, hip pain, pain all over arms, neck, stiffness in hands, neck, ankles and feet; symptoms are similar to rheumatoid arthritis and Lyme. 10/1/02 Per review of medical records a thyroid nodule was found on exam in 4/2002 and later determined by fine needle biopsy to be benign. The opinion of one specialist was that the patient had a reactive arthritis syndrome secondary to Lymerix vaccine in spite of the lack of genetic or inflammatory markers.
No adverse reaction IPV and Pediarix both given same day for total 2 doses IPV on same day.
Decreased movement R arm and leg 24 hrs after 1 vaccines in L leg,  2 vaccines in R leg (Hib, IPV, PCV).  Refusal to bear weight R leg.  Fully recovered within 48 h.  Pt had nl reflexes throughout.
pt devel laryngitis & a sore throat 2 days p/vax;pt had recovered as of the date of this report;this is one of four pt from this site to have an adverse exp p/flu vax;
late second dose of Shingrix / second dose 18 months later after the first dose; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follow: The patient received second dose of Shingrix 18 months later after the first dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. No further information was reported.
Narrative:  Patient reported a diagnosis of lupus which is not retrievable in CPRS. Unsure of where this dx was made. He attributes this to the COVID vaccine which he had received months earlier. The diagnosis was entered as angioedema which I can not see in the chart with the exception of the 1/27/22 PCP note which says "Contraindication: angioedema". In records the vaccine consent document is recorded and states there were no ADRs at the time of administration and upon the 15 minute observation.
Mother called the next day 3-28-08, stating that after daughter received the HPV vaccine that she was up all night throwing up.
RN witnessed Patient syncope - fell face down out of chair, landed on forehead/nose area, very brief tonic/clonic activity. Bloody nose, bleeding from cut on bridge of nose, abrasion above R eyebrow. Swelling on bridge of nose, appears that it may be broken. Patient conscious soon after syncopal episode and able to speak to RN and Medic. Patient notes history of syncopal episodes related to needles. Volunteer Medic applies pressure to cut and nose to stop bleeding. EMS called due to concern of patient hitting head during fall, possible broken nose. Patient hypotensive (90s/60s), blood sugar 76 - pt stated only black coffee to eat/drink today, slow to recover, dizzy, unable to sit up. EMS transferred to ED for assessment at ~1000.
Patient wasn't feel good; Felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish). On 12-Jan-2021, VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well.  The caller's friend said that her "smell was compromised"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Immunization.  The following information was reported: HYPOSMIA (non-serious), outcome "unknown", described as "a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well.  The caller's friend said that her "smell was compromised".  Additional Information: Questioned: Auto-Callback to a consumer who reports that about 3-4 days after her second dose of the Pfizer-Biontech Covid19 vaccine, she developed a "patter" in her ears that occurred when chewing or swallowing, and only lasts about 4-5 seconds at a time. She just wanted to report because it started happening after her dose of vaccine.  She also states that a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well. The caller's friend said that her "smell was compromised" but the caller doesn't think she's "lost it all together".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; SERTRALINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 31Jan2023 at 17:00, outcome "recovering"; FATIGUE (non-serious) with onset 31Jan2023 at 17:00, outcome "recovering". Therapeutic measures were taken as a result of headache, fatigue.  Additional information: No other vaccine in four weeks. Treatment included Ibuprofen. No COVID prior vaccination: No. Not tested for COVID tested post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 19FEB96 & 24MAY96 pt devel mild rash w/30-40 papules in different stages w/itching;presented to MD ofc & was treated w/med;
This spontaneous report has been received from a medical assistant referring to a 15 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
patient started with flu for 8 days; He suffered from constant lingering cough; chest ache; Back ache; both arm ache; His eyes started watering; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (patient started with flu for 8 days), COUGH (He suffered from constant lingering cough), CHEST PAIN (chest ache), BACK PAIN (Back ache) and PAIN IN EXTREMITY (both arm ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported Medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA (patient started with flu for 8 days), COUGH (He suffered from constant lingering cough), CHEST PAIN (chest ache), BACK PAIN (Back ache), PAIN IN EXTREMITY (both arm ache) and LACRIMATION INCREASED (His eyes started watering). At the time of the report, INFLUENZA (patient started with flu for 8 days), COUGH (He suffered from constant lingering cough), CHEST PAIN (chest ache), BACK PAIN (Back ache), PAIN IN EXTREMITY (both arm ache) and LACRIMATION INCREASED (His eyes started watering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: (Negative) Negative.         Action taken with Suspect product was Not Applicable.       Reporter did not allow further contact
10/8/12 8:30 A - Rec'd flu shot. 10/10/12 6:30 A Felt reaction starting. Sinuses blocked off and felt hot. Noticed some dizziness by afternoon. Wed. night Very bad headache and pain in neck and shoulders. 10/11/12 6:30 A Thursday pain, dizziness and grip problems w/ both arms and hands. Pencils and objects slipping from hands, stumbling. 10/12/12 5 AM Feeling normal w/ slight shoulder pain.
product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Coconut" (unspecified if ongoing). Concomitant medication(s) included: JUNEL; LEVOTHYROXINE. Past drug history included: Sulfa, reaction(s): "Known allergies: Sulfa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Got better, tested negative; (25Apr2022) Positive, notes: about 8 days after start of treatment got significantly worse and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient started Paxlovid on 16Apr2022 and treatment stopped on 20Apr2022 for the treatment of Covid-19. Other medication in 2weeks Junelle and Levoxy. Got better, tested negative, about 8 days after start of treatment got significantly worse and testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ADMITTED TO HOSPITAL  MORE THAN 2 WEEKS AFTER COMPLETION OF VACCINE SERIES   COVID + ON 3/18/21 ADMITTED 3/19 WITH ALTERED MENTAL STATUS, LETHARGY, AND COUGH   DISCHARGED ON 3/21
upon awakening in morning child had fever, congestion, cough & blisters on lip; mother states temp. ran between 38-40C took child to emergency room later that day-diagnosed as allergic reaction to varicella vaccine; follow-up with mom on 3/2/04 child still running fever, coughing, not eating much & vomiting
Chest pains that turned out to be blood clots in my lungs. I now have to take blood thinner medication.
Chills  Body aches - severe Sore throat  Headache   SOB - slight
shortly after receiving vaccine client began to have seizure, RN and MD responded to car, family stated this was a normal petit mal seizure for client, family attempted to give client ativan but was unable, EMS called, arrived, MD suggested glucose level, Seizure improving, starting to listen to mother, EMS took over patient, stable, and transported
Pt received her 2nd flu vaccine and broke out with hives. She then started swelling around the eyes and hands 2 days after flu shot.
Muscle aches, diarrhea, fever, chills, injection site is red, warm to touch swollen 2 lumps in area, rash 5cmx 3cm
Pt recvd vax 26AUG92 @ 1135AM & on 26AUG92 12 hrs post vax pt devel hives; treated w/DPH; 29AUG92 or 30AUG92 pt seen by MD & serum dickness dx'd;
Information has been received from a medical assistant concerning a male who on 01-AUG-2008, 01-OCT-2008 and 10-FEB-2009 was vaccinated with the first, second and third dose of ROTATEQ (lot number not reported) oral respectively.  The patient received the third dose at 9 months of age.  No adverse symptoms reported.  Additional information has been requested.