chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration in the right arm on 29Jan2021 09:45 at a single dose for COVID-19 immunization. Medical history included herpes simplex virus from an unknown date. For the concomitant products, the patient mention she only takes vitamins and minerals and no other medications. The patient had her first dose on the 29Jan2021 at 09:45AM and 2 days later on 31Jan2021 had a herpes simplex virus (HSV) outbreak on leg where she have had in the past. She had it there before and doesn't get it very often but that is the usual location of the HSV outbreak. She is scheduled to receive the second dose of the vaccine on 20Feb2021. Outcome of the event was not recovered. The event did not require a visit to physician or ER. There were no prior vaccinations (within 4 weeks).
Extreme exhaustion, heart palpitations, early start of menstrual cycle, diarrhea, vomiting
got shingles from the shingles vaccine / Suspected Vaccination Failure; got shingles from the shingles vaccine; arm is truly compromised for life; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (patient had Chickenpox as a child).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles from the shingles vaccine / Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles from the shingles vaccine) and arm discomfort (Verbatim: arm is truly compromised for life). The outcome of the vaccination failure, shingles and arm discomfort were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.  The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that the shingles shot contains shingles as a serum. The patient received the shot when he/she did not had shingles. The shot gave it (shingles) to him/her and now arm was truly compromised for life and could not sue anyone. The patient stated that they use the shingles virus as an antidote in the vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
not received second dose; Felt a little tired; Felt a little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not received second dose), FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not received second dose), FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received Moderna covid 19 vaccine, but has not received second dose. The patient reported felt a little tired and a little sore after receiving first injection.   No concomitant medications and treatment were provided by the reporter.  Treatment information was not provided.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 30-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Fatigue, body aches, low grade fever (peaked at 101.5). Peaked after about 24 hours with severe chills for 3 hours.
lung issues; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A 62 years old patient of unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) when 61 years old, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lung issues on an unspecified date with outcome of unknown. It was not clear if the lung issues were before the pneumococcal 13-val conj vac (dipht crm197 protein). The reporter said the patient has lung issues and the doctor reordered for the patient to get the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine again and the caller thought the patient should get the Pneumococcal 23.  Information on the batch number has been requested.
bodyache; stiff arm; urinating every hour; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Postnasal drip from 28-Dec-2020 to 11-Jan-2021.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills). The patient was treated with IBUPROFEN on 28-Jan-2021 for General body pain and Stiffness, at an unspecified dose and frequency. On 29-Jan-2021, PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills) had resolved.            No concomitant medications reported.   This case was linked to MOD-2021-002281 (Patient Link).
Breast pain; Menstrual spotting, This is not the normal time of the month for my female cycle to begin.; Menstrual spotting, This is not the normal time of the month for my female cycle to begin.; Fever; Chills; Body aches; Pain in left underarm area; Swollen lymph node in left underarm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 23Mar2021 at 15:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ); both from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 15:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation and took AUGMENTIN and SEPTRA; both on an unknown date for an unspecified indication and experienced drug allergy. Prior to 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 23Mar2021 at 18:30 the patient experienced pain in left underarm area and swollen lymph node in left underarm beginning day of shot. Symptoms lasted about a week. On 24Mar2021, the day following shot, the patient experienced Fever, chills and body aches and continued for about 36 hours. On an unknown date in Apr2021 the patient experienced Breast pain began about two weeks following shot and menstrual spotting began approximately 2-3 days after breast pain began. This is not the normal time of the month for my female cycle to begin. 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. The clinical outcome of the pain in left underarm area and swollen lymph node in left underarm was resolved on unknown date and of the fever, chills and body aches was resolved on unknown date in Mar2021 and of the breast pain, menstrual spotting and irregular period was not resolved, at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax 23AUG96 & 18MAR97 pt devel chickenpox which consisted of approx nine lesions described as red swollen bumps that were not itchy;poss few varicella zoster type lesions, small erythematous papules that crusted over on back;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on an unknown date). Concomitant products included ADACEL. On 4th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site warmth. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site warmth and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling and injection site warmth to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 26th May 2018, the patient received 1st dose of ADACEL on the left arm. The patient received 2nd dose of SHINGRIX on the left arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
A report has been received from a Health professional via medical representative concerning a female patient. It was reported that the patient might be having reactive airway before taking FLUMIST. On an unknown date, the patient (Healthcare professional) started taking FLUMIST (intranasal) every year (0.2 mL, every hour, Nasal). The patient had Pneumonia three days after taking FLUMIST between October to December 2015 on an unknown date. FLUMIST quadrivalent was continued. The outcome of the event of pneumonia was unknown. The company physician assessed the event of pneumonia to be serious due to important medical event.
Booster was given to a patient less than 18yo. No adverse event was reports by the patient.
Patient called and stated that her arm is red, swollen, and hot down by the elbow. The patient reports that this is 6 inches below the injection site on the left arm. Patient unsure if this was caused by her flu shot. Patient is going to check with her physician if this gets worse or does not improve.
Information has been received from a RN concerning a 69 yr old female who on 01Nov04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot647655/0869N). On 02Nov04 the pt called and reported that she developed a red, swollen, and painful arm. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00945 through 0411USA00947).
Case number PHEH2012US021294 is an initial spontaneous report received from a physician on 21 Oct 2012. This report refers to a 19-years-old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 19 Oct 2012. Later on that night she experienced muscle pain in her back and neck as well as nausea and vomiting. The events were still ongoing at the time of reporting. No further information about causality and seriousness was provided.
In opposite arm (not the injection site) she awoke on the second day after immunization with hives, rash and swelling of entire right arm, into her neck and on one side of her face. She went to urgent care quickly where she received a steroid injection. She was given a Rx for oral steroids, but has not taken them as the injection has affected her blood pressure and heart rate, and has made her "feel funny" so she is scared to take the oral medication. The rash is currently resolved, but now she is worried about her reaction to the treatment.
Patient felt faint, almost fell down, pharmacist went out to check on patient took blood pressure and gave water. Asked patient to stay to be monitored about 30 minutes and her mom came to pick her up
Moderna COVID-19 Vaccine EUA Had  the normal side effects on 2-20-21, chills, fever, body aches, but on 2-21-21 I woke up with a rash all over torso and arms, sneezing, scratchiness in throat and a spot under the vaccine that is a knot and red, very itchy.  Today, the 23, there is still some sign of the rash and the place on my arm is still there.
cold, clammy skin, lightheaded, shaking forcefully, bp:160/90, p: 76 Denied chest pain, or resp distress
Hives within 24 hours of immunizations (just made aware that brother who also received DTAP, IPV from same lot #'s also had brief case of hives).
Sick; received her first TRUMENBA dose in Jun2018; she did not come back for her second dose; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration in Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The healthcare professional asked if they need to restart the two-dose series. The patient received her first meningococcal group b rlp2086 dose in Jun2018. She did not come back for her second dose, which was due in Dec2018. The patient is in the office for sick visit on 20Aug2019. Outcome of the event sick was unknown.   Information on the batch number has been requested.
Vaccine was given 7 days past beyond use date. The data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Inconsolable crying, swelling of involved leg, Treatment - Benadryl (not used though) cool compress.
Arm sore for 3-4 days (woke her at night when she rolled onto it), also felt "icky & woozy".  Now swollen, itchy and warm.  Dr. feels it is a localized allergic reaction.
Same thing happened after the second dose,More redder than the first dose; itching more than 1st dose; reaction is little more than the reaction with 1st shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot). At the time of the report, ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) outcome was unknown.        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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
10:45 AM - Vaccine (Moderna Bivalent Booster 0.5mL) injected IM to pt's right deltoid 10:46 AM - Pt reports feeling "dizzy and lightheaded", staff assist pt to sit in chair next to vaccination area and within sight of medical/pharmacy staff 10:47 - Pharmacy nurses observe pt exhibiting signs of seizure-like activity while sitting in chair (Pt was convulsing and thrusting her head and upper body back and forth, her body was very stiff, fixed pupils, non-responsive - appeared to be a tonic seizure that lasted approximately 1 minute. BP: 218/79, P93). Facility staff were notified and EMS called.  10:49 - Pt still unresponsive to sternal rub and orientation questions, then started to exhibit signs of another seizure-like episode and facility staff provided pharmacy nurses with pt's medical record where it listed pt having an allergy to "latex" (pt had previously supplied pharmacy nurse who administered the vaccine with her consent which the pt did not indicate that she had any allergies as she had checked "No" to this question and a band aid that has latex in it was placed to the injection site per administration protocol). Band-aid from pt's right deltoid injection site was immediately removed and EPI Single Dose Auto Injector 0.3mg administered to pt's left thigh x 1 dose. BP: 190/83, P90.  10: 50 - Seizure activity ceased and pt appeared to become alert, pupils reactive and able to follow pharmacy staff movement, muscles relaxed, however she was still verbally non-responsive. Bilateral upper grips improved.  10: 55 - EMS arrived on scene, pharmacy nurse provided thorough report, along with facility LPN who assisted with pt's medical history 11:00 - Pt left on stretcher with EMS to local hospital, pharmacy nurses obtained pt's information in order to report to VAERS.
Pt came to office 10/13/2005 due to rash mainly on legs and arms, DX with chicken pox.
The employee received both Pfizer covid vaccines (12/17/20 - R deltoid and 1/7/21  -L deltoid per report).  The employee reports taking only OTC Claritin the day of vaccination for both covid vaccines per employee report. The employee offers no other recent illness, no new medication regimen, nor change in overall health.  The employee reports two small "hive" spots noticed on her  R buttock on 1/12/21, 5 days after the second covid vaccine. Since 1/12/21, the employee has a described flat, red, non-itching rash extending from her R buttock to her R groin and flank, extending to the R breast. The redness has extended across her abdomen and now includes involvement on the left, from the L axillae to the L groin. Newest spots per employee include now her left wrist and two spots on her left upper arm.
PT was in observation period and came up to the consultation window asking if a numb arm was a normal side effect of the vaccines. At further inspection I noticed that he was having a rash . I had a sit for a few more minutes then his mom came up and we noticed that his arm started to swell. We gave him 2 capsules Benadryl 25mg and instructed him to go to urgent care. Called for a follow up later in the evening and found that urgent care send him to the ER. The rash was spread all over and well as the swelling. He swelled all the way to his toes. He also tuned white and became very lightheaded at the ER. They gave him IV Benadryl and dexamethasone and was sent home. It has been recommended by the ER doctors to not get the 2nd dose.
received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 22nd April 2022, the patient received Shingrix. On 22nd April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: Registered nurse reported that the patient received only liquid portion of Shingrix, without being reconstituted and wanted to know if they have to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. Healthcare professional did not have any demographic details from patient since she send them over to the manager. Healthcare professional was not sure if lot number was for liquid portion or lot number from the box. She was not sure and did not have any further details. The reporter consented to follow up. Additional Supportive Information: The patient received only liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 7 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter