chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of mass in a 70-year-old female patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019) for prophylaxis. Co-suspect products included SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date 28th April 2020) for prophylaxis. On 26th April 2018, the patient received BOOSTRIX and the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 27th April 2018, 1 days after receiving BOOSTRIX and SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced mass. On an unknown date, the patient experienced sore throat and feeling unwell. On an unknown date, the outcome of the mass was recovered/resolved and the outcome of the sore throat and feeling unwell were unknown. It was unknown if the reporter considered the mass, sore throat and feeling unwell to be related to BOOSTRIX. It was unknown if the reporter considered the sore throat and feeling unwell to be related to SHINGRIX. Additional information reported as follows: The healthcare professional reported patient received BOOSTRIX on left deltoid and SHINGRIX on right deltoid on the same day. The arm in which the BOOSTRIX was given the patient developed big, huge lumps or bumps. The patient also felt sick for a while and had been experiencing a sore throat. The reported batch number BSEK2 for SHINGRIX did not exist and was updated to B5EK2 as per the sales database.
I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid; I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6206), on 07Apr2021 as dose 2, single (Lot number: ER8734) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: take Flonase which is nasal spray for allergy; "Type 1 diabetes mellitus" (unspecified if ongoing), notes: type 1 diabetic for 33 years; "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; IRBESARTAN taken for hypertension; FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity; PRAVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive for COVID. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Pharmacist told and doctor gave patient paxlovid, as tested positive for COVID. Patient had Pfizer all three shot. Pharmacist told stop taking it because patient was type 1 diabetic for 33 years. Patient took irbesartan and amlodipine for high blood pressure. Patient took Pravastatin, but did not feel good so, did not take it the night, on the Thursday night and the pharmacist told not to take the pravastatin because it was a statin drug so just do not take it, and other than that just take vitamins and also take Flonase which was nasal spray for allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore, stiff arm, couldn't move at all had to see urgent care for antibiotics and pain medication (Keflex, vicodin).
Patient a lot of pain in neck to head, dizziness couldn't move neck either way for 2 days Had a catsc& MRI of head & neck+ X-rays of the neck & blood work.
Mod to severe local reaction and redness, swelling. Fevers 101.4, nausea, HA, chills, body aches, fatigue lasting 24 hours.
Redness at reaction site, but her primary complaint was feeling like her head was in a fog and being mentally "gone" for 3 days post vaccination. Her family was concerned enough to check on her wellbeing several times daily for the duration of symptoms. She was well enough again by the next weekend to return to the pharmacy to report her symptoms and ask that her experience be reported on.
Patient may have received only the adjuvant; Patient may have received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2022, the patient received the 1st dose of Shingrix. On 18th June 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: 17-Aug-2022 Reporter's Comments: A pharmacist stated that they were about to administer the 2nd dose of Shingrix and realized that the patient might had received only the adjuvant portion of the vaccine for the 1st dose (two powder vials in box, no adjuvant).  The healthcare professional did not have the lot number or expiry date at the time of the call. The reporter consented to follow up. Additional Supportive Information: The patient received only the adjuvant portion of Shingrix, which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered.
Pain,swelling ,erythema on the right arm that started from next day acute last for about two weeks.Patient report to the pharmacy on November 23,2020 the adverse event  feeling pain but less severe during one month.Went to emergency room two days after Pneumovax 23 vaccine.Clinical impression celulitis.Received ketorolac injection Rocephin injection and Benadryl injection.She follow up with her primary care physician who prescribed prednisone 20mg for 10 days and instruct her to put ice over the area.
received 3 doses, second 19-JUL-2021, third 08-NOV-2021; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th May 2021) and Shingrix (2nd dose received on 19th July 2021).   On 8th November 2021, the patient received the 3rd dose of Shingrix. On 8th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: Registered Nurse reported that a patient received 3 doses of the Shingrix vaccine and wanted to know if that was ok.  The patient received the 3rd dose of vaccines on 8th November 2021 which led to extra dose administered. The reporter did not consent to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Hearing loss) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUDDEN HEARING LOSS (Hearing loss) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Arm hurt a bit). On 07-Apr-2021, SUDDEN HEARING LOSS (Hearing loss) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes many concomitant medications but details were not provided.   Patient took Tylenol (paracetamol) for her arm pain.  Reporter states that when experiencing the sudden hearing loss event, she couldn't hear a single thing. She also noted that the event had resolved before she went to bed that same day.  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.
sore muscles; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore muscles and fever on an unspecified date. The patient called to cancel and reschedule his second dose of Covid-19 vaccine scheduled on 05Mar2021, his first dose was given on 12Feb2021. Patient wants to reschedule to a date starting 15Mar2021 onwards after he comes back from his travel since he doesn't want to feel any of the reactions caused by the vaccine while he travels. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache- moderate intensity, lasting for about 6 hrs until 11PM.  No other symptoms.  No treatment taken; spontaneously resolved without sequelae.
light headed, clammy, fainted, nausea, diarrhea.  Passed out to the floor resulting in sore knee, bruised toe/foot, bumped head.  Saw family doctor next day
Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and armpit on vaccine side, chills, fever of 101.2 for 48 hours, severely painful joints, fatigue.  Hot flashes, feeling of chills improved but persists even 5 days after
Patient did not receive the 2nd dose between 25-35 of the1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) 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.   No relevant concomitant medications reported.  No treatment information was provided.
Patient received the COVID-19 vaccine at approximately 1300 on 3/18/21 without incident.  Patient woke from sleep at 0100 on 3/19/21 to find his top lip significantly swollen.  He was able to breath and talk.  He took Benadryl 50mg at home before coming to the ED.  He maintained his airway the entire encounter and the swelling was contained in his lips.  He received Depo-Medrol 80 mg IM x 1 and Zyrtec 20mg PO x 1 and was observed.  His swelling resolved and he was discharged with a prescription for Prednisone 10mg with a tapering dose over 4 days.  He was advised not receive the second dose of COVID vaccine at this time.
arm was swollen; dizzy; out of air; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for Pulmonary fibrosis.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired). On 28-Feb-2021, PERIPHERAL SWELLING (arm was swollen), DIZZINESS (dizzy), DYSPNOEA (out of air) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
This spontaneous report was received from a certified medical assistant, referring to a 17-year-old female patient. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not provided. On 03-JAN-2019, the patient was vaccinated with an expired dose of VAQTA 25/0.5 (units, dose and frequency were not provided), lot number N026997, expiration date 10-NOV-2018, intramuscular in the left arm, as prophylaxis. No adverse effects were reported.
Dose in series discrepancy. Patient received a 2nd dose in the single dose series. First dose was given on 5/5/23 and second dose was given on 6/6/23. No adverse reaction was reported by patient.
Low grade fever, malaise, n/v, anorexia for 14 plus days.
Janssen COVID-19 Vaccine EAU  Severe chills, uncontrollable shaking/tremors
pt recvd vax;became irritable for 6 hrs p/ getting the DTP-HIB on 16jan95;pt's thigh also became swollen despite apap & tepid bath;
RED RASH AT AND AROUND INJECTION SITE THAT WAS PAINFUL ON 06-03-2010 BUT NO PAIN TODAY. IMMUNIZATION WAS PREVNAR 13 AND GIVEN IN LEFT THIGH.
After patient was immunized,  realized that the vaccine was opened the day before. So the vaccine had been held in the refrigerator for about 19 1/2 hours before patient was vaccinated.   Patient had no side effects or events.
suspected vaccination failure; got the virus; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient thought, it helped him/her.  Through it a lot easier. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
1 day post vaccine knot on left collar bone. Palpable lump left axillary under clavicle, lobes soft and tender. Lymphadenopathy.
I21.4 ACUTE NON ST ELEVATION MI 4/12/2023 ESRD ON HEMODIALYSIS; I21.4 ACUTE NON ST ELEVATION MI 4/12/2023 AORTIC VALVE STENOSIS; I21.4 ACUTE NON ST ELEVATION MI 4/12/2023 CHRONIC OBSTRUCTIVE BRONCHITIS.
Persistent weakness, thirst, breathing problems, lips and rectum painful. Treatment: quit drinking coffee, cokes, and drink vast amounts of water.  Two doctor visits prescribed antibiotics but have not helped for long.  Docotor recommends doing extensive blood work and UA in additon to seeing Two specialist, !
With my regular exerting exercise (biking uphill): left chest pain radiates to back, shortness of breath, light-headedness, fatigue last few minutes. Requires immediate rest. Started this week 11/29/21 on Metropolol 25mg and baby Aspirin 81mg after having a Cardiac Stress test with same effects.
Information has been received from a physician concerning a 5 year old female with no history of drug reactions and no pertinent medical history who on 16-SEP-2002, was vaccinated with Varivax. Concomitant therapy included montelukast sodium (MSD). On 29-NOV-2006, the patient experienced full blown case of chickenpox. The child had 50 lesions and a temperature of 100.7F. She was treated with acyclovir (ZOVIRAX). Unspecified medical attention was sought. No lab studies were performed. As of 29-NOV-2006, the patient's full blown case of chickenpox persisted. Additional information has been requested.
Immediately after receiving the vaccine are was extremely painful and progressively got worse through the next few days. Had difficulty sleeping that night on 6/8/18 and unable to raise arm with out pain. Today mother reported still needed help getting dress this morning.
Fever; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, 24 hrs after receiving Pediarix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was resolved.   It was unknown if the reporter considered the fever to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the fever to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter reported that the patient received Pediarix vaccine and 24 hours after received vaccine patient experienced fever. The reporter stated that the fever had resolved now. The reporter did consent to follow up.
FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure.  On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a physician concerning a female who on 08-JAN-2007 was vaccinated IM with a dose of Gardasil (yeast). It was noted that the patient fainted during the administration of the vaccine, the patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Red arm rash size of baseball. Itching and pain at injection site, pain in lymp node under arm, body aches, fever and chills. Still not resolved after 4 days
Left leg and right leg at site of injection on upper thigh was red, swollen and warm to touch about the size of a fifty cent piece.