chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring a 12-year-old patient of unknown gender who on 02-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all available information has been obtained.
5 hours after receiving injection, I had severe arm pain from shoulder to elbow on side shot was given, woke up next morning with brain fog, extreme fatigue, and feverish feeling, but no temp.  Concerned because of my autoimmune disease. Worried about second shot in four weeks.
TWO DAYS AFTER VACCINATION SITE BECAME RED WARM, ITCHY. It worsened over 3 days then began to resolve. Came to MD office for first time since shot on 10/09 for eval. Left arm with 6x4 red area. Pt states it is getting better.
Information has been received from a pharmacist referring to a 48 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-FEB-2017 the patient was vaccinated with a dose of ZOSTAVAX VIAL 19400 PFU subcutaneous injection (lot # M035693, expiration date 07-NOV-2017, dose and site of administration were not reported) subcutaneously for prophylaxis. This was outside of the prescribing information recommendation (inappropriate schedule of drug administration). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected because there is no consent to contact the reporter.
Redness and swelling 8cm in size at site of immunization began night of immunization.
This case was reported by a nurse via call center representative and described the occurrence of welts in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 15th March 2019, the patient received SHINGRIX. On 16th March 2019, 1 days after receiving SHINGRIX, the patient experienced welts and skin red. On an unknown date, the outcome of the welts and skin red were not recovered/not resolved. It was unknown if the reporter considered the welts and skin red to be related to SHINGRIX. Additional information were reported as follows: This case is reported by the nurse for herself. The patient developed a big red hard welp. At the time of reporting, the event was ongoing. Lot number and expiry date was unknown.
Had dentist yesterday and had 2 teeth pulled/dental extraction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction) in a 55-year-old female patient 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 TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction). The patient was treated with PROCAINE (NOVOCAINE [PROCAINE]) for Adverse event, at a dose of Unknown. At the time of the report, TOOTH EXTRACTION (Had dentist yesterday and had 2 teeth pulled/dental extraction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Patient had visited dentist and had her 2 teeth pulled. She didn't receive her 2nd shot of the Moderna COVID 19 Vaccine.
bitten by fire ants (about 12 bites); vomiting; impeding sense of doom; panic; hypotension; allergic response; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: EW0150) at the age of 61 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "Mood disorder" (ongoing); "Nonsmoker" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "depression" (ongoing). Concomitant medication(s) included: LISINOPRIL; MICARDIS oral taken for hypertension (ongoing); LUVOX [FLUVOXAMINE MALEATE] oral taken for depression (ongoing); LAMICTAL taken for affective disorder (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Site: "Arm". Route: Intramuscular, Lot number: EN6207.), administration date: 15Mar2021, for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "allergic response"; ARTHROPOD BITE (medically significant) with onset Jun2021, outcome "unknown", described as "bitten by fire ants (about 12 bites)"; HYPOTENSION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021); ANXIETY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "impeding sense of doom"; PANIC REACTION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "panic"; VOMITING (non-serious) with onset Jun2021, outcome "recovered" (Jun2021). The events "vomiting", "impeding sense of doom", "panic", "hypotension" and "allergic response" required emergency room visit. The event "bitten by fire ants (about 12 bites)" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthropod bite included Weekly fire ant venom shots. Clinical courses: In June 2021 was bitten by fire ants (about 12 bites) and needed to call 911 (vomiting, impeding sense of doom, panic, hypotension, allergic response). Recovered within an hour or two. Subsequently, sent to allergist who started fire ant venom immunotherapy.; Sender's Comments: Reported event of "Arthropod bite" is assessed as unrelated to bnt162b2 vaccine. It was reported that the patient was "bitten by fire ants (about 12 bites)".  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300318617 Same patient, different vaccine dose/events.;
Dull, steady pain from shoulder to fingertips in the arm where the injection was given.
The dose spilled from the syringe and pour down from the arm; A spontaneous report was received from a physician, concerning a patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and the dose spilled from the syringe and poured down from the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 03L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient reported that while receiving the Moderna vaccine, the dose spilled from the syringe and poured down from their arm. The patient said it came down from the side of the needle. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event was considered resolved on 05 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.
Swelling in right eye, fluid all around the eye, , couldn?t open my eye , traces of fluid , faces started getting bigger, was getting harder to breathe, had to take Benadryl, had to see virtual urgent care and had to get rx for steroid eye drops and a dose of steroids , but took a while for the fluid in the eye to go away
Redness and swelling at injection sites. Topical Calamine, oral Benadryl PRN.
Information has been received from a consumer concerning her son (DOB 1/20/01) with no known allergies and a history of ear infection who on an unspecified date was vaccinated with a single dose of MMRII. The day after vaccination, her son experienced a seizure. She brought her son to the ER. She was provided azithromycin (Zithromax) after the ER visit. Her son then developed a rash all over his body and diarrhea. Upon internal review, seizure was determined to be an "Other Important Medical Event". Additional information has been requested.
09/16/2022 01:45 I received Dose 5 of Moderna, approximately 6 hours later I had fever, body aches, joints hurt, and had nausea and nose bleed with blood clots.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot # M027884, expiration date 19-APR-201; lot # M027883, expiration date: 15-APR-2019; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006072: US-009507513-1702USA006073: US-009507513-1701USA012827.
it felt like my knee was hyperextended; Left kneecap was very painful; soreness at the injection site; slept more than usual; dry cough; tickle in my throat; unable to walk; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified date in left arm on 09Apr2021 08:00 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient medical history included Relapsing Remitting Multiple Sclerosis(RRMS), high cholesterol, high triglycerides, high LDL, depression, (acute PTSD 21Dec2013). Patient was known allergies included rash due to sulfa drugs, ear bleed due to nickel. The concomitant medications included atorvastatin; citalopram; calcium, ergocalciferol (VITAMIN D2 + CALCIUM [CALCIUM; ERGOCALCIFEROL]) at a dose of 5000 iU, ongoing ocrelizumab (OCREVUS) taken for relapsing-remitting multiple sclerosis (RRMS). On 09Apr2021 patient received her first dose of the Pfizer COVID-19 vaccine in left arm. On 10Apr2021 she experienced soreness at the injection site & slept more than usual. On 11Apr2021, when extending her left leg on her ottoman, it felt like her knee was hyperextended. Left kneecap was very painful and she had to use a pillow under that knee routinely for a few weeks. She woke up between 2:30-3:00 am for a few weeks with dry cough and tickle in her throat. This had since resolved.  She was unable to walk without a limp after her first Pfizer dose due to pain in left knee. The reported serious of the events was serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 28Apr2021 as dose 2, single for COVID-19 immunization. After her second Pfizer COVID-19 vaccine on 28Apr2021, her left knee became very swollen, stiff, and painful. On 22May2021 she had a full blown flair of whatever that was. Both knees and thumbs were inflamed, cracking, stiff, painful. She thought she had arthritis. She had RRMS for 27+ years & she was on Ocrevus. Her B-cells were now zero. She believed the Pfizer vaccine had triggered an inflammatory arthritic response in her body. On 26May2021, patient was being tested for COVID-19, since the vaccination. Covid test type post vaccination was reported as Blood test. Covid test name post vaccination was Sars Cov-2 AB (IGG) Spike, SemiQN with the test result as positive. She saw a rheumatologist on 02Jul2021. On an unspecified date in 2021, the outcome of the events dry cough and tickle in her throat was resolved while that of the other events was not recovered.
earache; Migraine; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the right arm on 02Apr2021 at 16:45 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune inner ear disease, multiple sclerosis and shellfish allergy. The patient did not receive any medication within two weeks of vaccination. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the first day, the patient experienced headache and progressed to migraine on the second day (on 04Apr2021), then went away. On 07Apr2021, after 5 days of vaccination, the patient experienced earache. The adverse events headache, earache and migraine resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event headache and migraine was resolved on an unknown date in Apr2021 while that of the event earache was not resolved.   No follow-up attempts are needed. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding concurrent conditions, medical history, and concomitant medications was not provided. On or around 21-JUN-2017, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for prevention of shingles (dose, route, anatomical location, lot number, and expiration date were not provided). Shortly thereafter (estimated to be in 2017), the patient suffered a severe rash. Approximately on 24-JUN-2017, three days later, the physician diagnosed shingles. The symptom resulted in physical limitations, not present before vaccination. The patient was also experiencing mental and emotional distress due to result of physical limitations and seriousness of her condition.  The patient sustained severe and permanent personal injuries. The outcome of shingles was considered not resolved.  The reporter considered shingles to be related to zoster vaccine live( ZOSTAVAX).  The reporter considered shingles to be disabling.
flu; sore arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis and Dermatitis (The current event is unspecified dermatitis). Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided by the reporter.  The case is an medication error spontaneous case.
3 separate skin rashes, different days, different locations over the past 3-4 days. Red, raised, swollen, slightly itchy. Applied cortisone cream. Each  Rash disappeared within a day. Not at injection site. Locations: right inner wrist, right buttock, left elbow/forearm area.
Tennis ball size allergic reaction at site of injection. Warm to touch, itchy, very painful, red. Started day after the receiving the vaccine. Taking ibuprofen and Benadryl to help, but it is continuing to get bigger.
Symptoms: Light headed, fever, chills, joint swelling, muscle pain, headache, tiredness, diarrhea   Most of these were severe for 3 days then were off and on for another 10+ days. A lot of rest was needed.  Still having moments of slight fever and chills once a day.
Elevated temperature 101.6, lethargy, low pulse oximeter identified at 0407 this morning.  Fever has continued throughout
Inappropriate schedule of vaccine administered; swelling on arm from the second dose,; both ankles are swelling up,feet swollen up pretty bad in the ankles; dizziness; sick stomach; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL, AMLODIPINE and DILTIAZEM for Blood pressure abnormal, TRAMADOL for Pain, PANTOPRAZOLE for Stomach discomfort, PRAVASTATIN for an unknown indication.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PERIPHERAL SWELLING (swelling on arm from the second dose,), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved and JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-307512 (Patient Link).
Under arm pain so bad cannot lift arm; Temperature of 102 Fahrenheit; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 18:15 (at the age of 70-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior to vaccination. The patient previously took first dose of bnt162b2 on 09Feb2021 at 18:15 in the right arm for covid-19 immunization. The patient experienced under arm pain so bad cannot lift arm and temperature of 102 Fahrenheit on 02Mar2021. No treatment was given in response to the event. The patient was not tested for covid post vaccination. The patient had not recovered from both events at the time of the report.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
I got sick 6/11/22 so the whole day I had symptoms and went to work and was weak, headache, and I was feeling very bad and told my supervisor and they gave me permission to go home by 2330 I went to the hospital and my temp was very high and at 0200 the hospital they gave me something and I don't know what the name of it was. They did a COVID-19 test that was positive. I was sick the whole week and they started me on PAXLOVID and my symptoms got better but the whole week I was weak. After one week I was better.
Body aches; Nausea; Vomiting; Low grade fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever). On 03-Jan-2021, PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatments of these events were 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; 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
Diarrhea several times throughout the day. No other symptoms. (Usually suffer from chronic constipation.) Nine days later continue with diarrhea, (regardless of diet) stools have been very different, ie. color, odor, consistency. Plan to go to doctor if not better by Monday, which will be almost 2 weeks. Also injection site bruised and very sore.
Redness, warmth and mild pruritis from the vaccine site on skin overlying triceps to the elbow almost circumferentially, left arm affected. Reaction on left arm, at site of Hep A vaccination.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with improperly stored ROTATEQ. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.