chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My daughter experienced body aches with headache and low grade fever for 24 hours. She also had mild nausea. She had a very sore right arm with lymphadenopathy and today, about a week later, she has a raised itchy bump at injection site which looks like a hive.
Severe swelling of feet and legs. Began early morning and has continued through the day. No treatment provided as of yet as I am seeing if it will calm down. If not will call health care professional. Swelling is so bad I can't even get socks nor shoes on. Painful to bear weight
Pain at the injection site; Feel fatigued; Tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  As per client, MO error in DOB capture
FEVER SWEATS; FULL BODY ACHES; JOINT ACHES; HEADACHE; 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 and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced full body aches, joint aches, headache, and fever sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, joint aches, headache, and fever sweats. This report was non-serious.
1. New onset change of body odor - strong onion-like more pronounced under left axilla as compared to right axilla - no treatment outcome remains unchanged 2. Pain discomfort to left breast with palpable changes matrix of breast tissue and discomfort pain voiced upon examination of left breast as compared to right breast. Treatment monitor for three months with Mammogram and ultrasound. Outcome pain and discomfort resolved on its own after three months with findings of normal diagnostic imaging. 3. New onset of Endometrial polyp with abnormal pathology upon polypectomy pre cancerous proliferation recommended laparoscopic partial hysterectomy - awaiting outcome.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.98 years. No concomitant medications were reported. Batch number 014M20A  underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and at 01:00 PM with temperature 26 degrees Fahrenheit. The vial was initially moved to the fridge on 24-Feb-2021 and proposed beyond use date was 26-Mar-2021. Product moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient with history of Crohn's and ulcerative colitis. She was seen in the ED on 12/12/22 with fever, shortness of breath, diarrhea, myalgias, headache, and abdominal pain. A COVID PCR test done in the ED resulted as positive. Ultimately, patient was admitted 12/12/22 - 12/14/22 for COVID-19 infection and hypokalemia. Patient remained on room air during hospitalization and did not require any oxygen or antiretrovirals.
My son was dx'd with Autism (after his MMR vaccination on 7/30/1998). He was 15 months old. He does not talk and he is 3 years old. He has violent tempers, eats inedible items. Follow up 10/18/2000: "Not known exact date/time.  Soon after the MMR vaccination."
pt recvd vax & had swelling & redness (6cm x5cm) w/ tenderness w/in 30 min of vax;
This is a spontaneous report from a non-contactable pharmacist. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at an unknown date, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to the vaccine on an unspecified date. The outcome of the event, allergic reaction was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Mother received phone call that dose of vaccine was undiluted and received 3 doses at one time. Received a phone call about 3-4 hours after the dose informing mother of the error. Since then about 12-18 hrs later pt is having fatigue, body aches, and chills. Arm soreness as well.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Screamed all day, off & on called MD; MD said to put on cold compresses on legs; had APAP cried 2AM next morning; legs sore to touch, red areas on legs fifty cents piece size;
pt recv vax & devel a rash p/being vaccinated w/Hep B vax; No further details were provided;
swine flu; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient relative).  This case is linked to case 2020SA313336 (same reporter).  This case involves an Adult female patient who had swine flu (h1n1 influenza), while she received vaccine INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown), the patient developed a non-serious swine flu (h1n1 influenza) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for h1n1 influenza.  There will be no information available on the batch number for this case.
erythema; pain; redness; heat; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On 21st February 2020, the patient experienced erythema. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the erythema was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient experienced pain, redness and heat at the injection site since receiving the vaccine.  On the day of reporting, the reporter noticed a line running down his arm from the injection site, extending a ways past the circle of redness.
Patient called to report that she "immediately started itching "- described as having a reaction to her first oral typhoid pill,
I started with fever, vomiting, bodily pain, bone/joint pain and head pain the early morning after my J&J vaccine which these symptoms lasted two days. There after I started to experience severe, constant headaches that come and go. My headaches are worse when bending down. I went to hospital and they performed lab work and told me it was a reaction to the vaccine. To this day my headaches come and go every day.
No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Flu like symptoms; Splitting headache; Muscles aches; Chills; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, headache, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, headache, muscle pain and chills were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. At the day of reporting, the patient had flu like symptoms, splitting headache, muscle aches and chills. The patient was inquiring if he could take Advil or something better to treat the events. The patient did not want to share any information.
Began having dermatography, itching, and hives roughly two weeks after booster (0.25ml) dose.  Also had other symptoms mimicking allergic reactions.  Alcohol consumption was causing head and neck flushing and itching, as well as esophageal tightness.  The esophageal symptoms mimicked previous reactions to mushroom consumption.  Not having those issues anymore, but the itchy skin and dermatography are still present.  Taking 2nd gen antihistamines twice daily seems to curb the symptoms, and they are slowly lessening in severity.  Can almost get away with only one 10mg cetirizine per day, but near the end of the 24 period, the itching flares up again.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thrombophilia" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: other medical history: ADHD. Date of last menstrual period: 27May2022. The patient was 14 weeks pregnant at the time of exposure to BNT162b2, BNT162b2 omi ba.4-5. The patient is expected to deliver a baby(s) on 03Mar2023. Concomitant medication(s) included: LOVENOX [LEVOFLOXACIN], start date: 29Jul2022. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Pediazole, reaction(s): "known allergies: pediazole", notes: known allergies: pediazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 29Dec2022 to 03Jan2023. The patient received other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
More than 20 minutes after vaccination, but within 24 hours, patient experienced throat restriction. He was hospitalized.
first shot made me sick; had flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain, pruritus and sleeplessness.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: first shot made me sick) and influenza (Verbatim: had flu). The outcome of the sickness and influenza were not reported.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR101938   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that the patient had shingles before vaccination. The patient stated that it was no joke, the burning and the pain and itching were all at the same time which made it hard to sleep.  The reporter reported that as soon as the shingles went away, he/she got vaccinated. The first shot made the patient sick like he/she had the flu plus his/her arm for it. The patient stated that, but it was worth it because if you do not get vaccinated, even if you had Shingles, you could get it again. For tolerance of 2nd dose, refer case US2023AMR101938. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR101938:same patient, 1st dose
tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1 , single and administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 02Mar2021, outcome "recovered" (2021), described as "tired"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovered" (2021), described as "Headache".  Additional Information: The patient explains that Pfizer employee reporting on the Covid 19 vaccine the booster shot, and who says she has a question. She was trying to find the information online but knows there isn't a ton out there especially about the booster shot. Caller is wondering if there is any information on having a delay in side effects. It is explained she had the booster on Saturday, 04Dec2021 and had a little headache on Sunday and Monday. Caller first states that her awareness date would be the day of the shot, that is actually when she had the headache: 04Dec2021. Later in the call, she states after the first dose she was tired and had a little bit of a headache that started and lasted just the next day; she was fine after that. Awareness date populated as 02Mar2022, the day after the first shot. Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks)  none. AE(s) following prior vaccinations: With the first 2 doses she was tired and had a little bit of a headache. The first dose was on 01Mar2021 and the second dose on 22Mar2021. Caller explains that the next day after the first dose she was tired and had the headache and that was it; after that she was fine. Please confirm the awareness date of 22Mar2022 was captured correctly. After listening to the call recording, the awareness date was provided as 02Mar2021.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101739611 similar report from same reporter
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe
Pt is a 61 yo female with PMH significant for aortic dissection, malignant hypertensive urgency, kidney transplant (2019) and MI . Received Pfizer COVID-19 vaccination dose #1 on 2/19/2021 and dose #2 on 3/19/2021. Pt is immunosuppresed on prednisone, mycophenolate, and tacrolimus. On 4/28, pt calls with symptoms of runny nose, fever, weakness and extreme fatigue. On 4/28/2021 pt undergoes COVID-19 testing and results positive. Pt meets criteria for Bamlanivimab/Etesevimab infusion and receives this medication on 4/29.
Injection site "red"-"itching immediately" after injection-to ED and received BENADRYL 50 mg IM.
Given Pneumovax on 12-21, pm.  Returned to clinic 12-22 approx 8:45, Left arm swollen, hot to touch, painful.  Seen by PAC, given Benadryl, left
4/10/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 1005. Alert and oriented and Anxious.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  VS 1005a- BP-143/114 P- 104, O2- 100% jiuce given as patient reports that she has had only apple, recheck VS - BP- 137/103, patient reports that she has HTN and has not taken her meds today.         Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/10/2021  9:54 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EW0162   NDC: 59267-1000-2
Pt. complains of Right arm pain,, flushing skin, right arm is hot to the touch.
17AUG93 mom called & stated 22JAN93 2 days p/vax pt had fever 104.5 given APAP;
Dermatographia on all parts of the body. There is a consistent trend in those who have pre-existing allergy conditions related to the skin or other parts of the body to develop severe skin reactions after receiving their 2nd or 3rd doses. My condition is best described by skin hypersensitivity. Regular clothing that used to cause no issues now irritates the skin, causing itching sensations, which leads to worsening of the condition if scratched. After scratching a location, wheals raise from the skin like hives and the itching gets worse. The severe sensations are tempered by taking daily allergy pills and using copious amounts of lotion and ointment. "Skin Writing" is the layman's term for Dermatographia, meaning that if I run my fingernail along my skin lightly, that contact points will redden and rise off the body as described above. The itching sensations come and go every 20-30 minutes in different places.
Pt developed fever, redness, warmth and tenderness within 24 hrs of injection.
I haven't received the 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.). On 29-Jul-2021, PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment and concomitant products information was not provided.
LOCAL RXN ON L LEG AT SITE OF DTP.  TEMP 103.4
Gave the injection on 11/5/18, rash started on the 6 and 7. Red patch rash about 3 inch by 2 inches with small watery looking bumps at injection site. Patient said the fluid inside the bump did not bust. Just a little itchy. She felt like a flu-like symptoms for 2 days.
Per client, arm of vaccinations was sore, swollen and pink on 10/31/15 so went to the ER, where she was prescribed antibitoics.