chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediarix and Pentacel administered on same day (overdose of DTap and IPV); This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis.   Previously administered products included Pediarix (received 1st dose on an unknown date ).   On 06-OCT-2023, the patient received the 2nd dose of Pediarix and PENTACEL. On 06-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Pediarix and Pentacel administered on same day (overdose of DTap and IPV)).  The outcome of the overdose was unknown.   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 6 Oct 2023 Director stated that a CMA administered Pediarix and Pentacel to a patient on the day of reporting. The patient initially started the Pediarix series and this is the 2nd dose administered today along with the Pentacel, which led to overdose of DTaP and IPV. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication information was provided. No concomitant medication information was provided.
Pt in today 3/9/05 for TD shot because of puncture wound in buttocks. Pt states she did not go to her Dr or hospital. Call back today 3/14/05 with complaint of swollen jaw and ear ache. Pt state she saw a nurse practitioner today, who gave her Rx for earache. Pt states Dr advised her to get tetanus shot and take Benadryl before shot, and she did, because of local reaction in 1993. Pt states she had Td shot in 1993 and had a local reaction to shot, with itching, redness, hot to touch. When she presented to Health Dept with injury, she stated she called her IM (internal med). Dr to see if she should get the shot. Her Dr told her to get the shot but take Benadryl before she took it and 6-8 hrs after shot she started to have a headache on left side, jaw began to tighten and this lasted from the day of the shot until 5 days later on the following Monday when she went to see she had an left ear infection and prescribed meds for her to take, her gynecologist says she believes it was from the TD shot. Pt was advised to see family Dr (Internal med) several times.
Tc from client today states arm is swollen the size of a baseball and very red, improving redness today. Also states had severe back pain yesterday "worse than after surgery" and extreme fatigue. Advised to monitor if redness and swelling were increasing and follow up with pc to discuss if should get second dose. Enc ice to site as needed. States back pain has improved but enc to follow up if recurs.
Small area (6? round) of itchy rash on stomach which resolved after a few hours.  Tingling of itchiness on various locations of body.
had developed shingles; red itchy rash on her back; I was in so much pain, nerve pain; can't sleep at night and it is torture; red; left arm was very sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain) and INSOMNIA (can't sleep at night and it is torture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm was very sore for a couple of days), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red). On 30-Jan-2021, the patient experienced PRURITUS (red itchy rash on her back) and NEURALGIA (I was in so much pain, nerve pain). On 04-Feb-2021, the patient experienced HERPES ZOSTER (had developed shingles). At the time of the report, HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red) 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.   Patient was treated with gabapentin (Neurontin), Valtrex and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: No specific follow-up information recorded.
On 2/22/2021- Very fast pulse, Teeth chattering, chills from 8:00 p.m. to 10:00 p.m. (These same adverse side effects occurred for 4 hours on the 4th day after first vaccine received on 2/1/21).
Fever of 104+ (5/8/2021 at 11pm. Tylenol did not help much. Showering helped bring fever down to 102.5. Fever lasted until 3am 5/10 when it broke. Has been low grade 100.5 from 3am 5/10 until now 10pm 5/10 Shortness of breath, chills, uncontrollable shaking - from (5/9/2021 at 1:30am- 10am :Tylenol was taken with no effect) Swelling, redness, heat, sensitive to touch at injection site. Approximately 3 inches by 3 inches.
After not menstruating for 9 months,  the day after my vaccine I got a very heavy period with significant cramping
20 yo patient inadvertently received Fluzone High-Dose on 22Oct2019/ No AE; 20 yo patient inadvertently received Fluzone High-Dose on 22Oct2019/ no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 20 years old patient who inadvertently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) via unknown route and site of administration on 22oct2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to the product administered to patient of inappropriate age and overdose. It was reported that patient inadvertently received Fluzone High-Dose on 22Oct2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number was requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, reporter reiterates that because the facility was unable to download the digital data logger and reporter also stated that they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State. Reporter did not stated that no adverse reactions were reported by any Patient.  No treatment medication was provided.
Two weeks after second vaccination shot I started experiencing pain in the knuckles in my fingers. Soon this spread to other joints. Toes, shoulders, neck, left elbow, wrists and knees have all been affected. Currently I experience weak grip strength, difficulty walking due to right knee/leg, general chronic pain in right wrist, and pain throughout my fingers. New Year's eve 2020 I ran 10 miles. Today I can barely walk in the morning.
Headache, Myalgia, Fever, FATIGUE, SORE ARM  Narrative:   Other Relevant History:
1 hr following FLUZONE .5 ml immunization patient developed fever, chills, nausea, increased fatigue, nasty headache and body aches.
Approximately 10 hours after receiving vaccine I felt chills and had a low grade fever. By the next morning I had a headache and felt nauseous. Had to take off from work. Felt tired and had no appetite. Fever was gone, but general malaise persisted until evening time.
The next day, could not go to work, completely exhausted and had vision problems. Did not go to the doctor. Also got flu shot the same time. Does not have information on flu vaccine.
On next 2 days :   Bruised upper arm, sore arm, red swollen large area on arm,   Fatigue & nausea.  On Day 4:  Fatigue, headache, nausea, so took 1 Advil.  I hour later; Burning, itching hives over entire body.   Most intense in ears and side of face.   Took 2 Zyrtec and put cortisone cream on itching spots.   Day 5:  went to Dr.  she prescribed Zyrtec and Pepsid, twice a day for 5 days.  Symptoms are subsiding.
hospitalized for pneumonia; He did not get dose 2 of SHINGRIX yet; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.     Additional Information: GSK receipt date: 31-JAN-2023 Reporter comment:  The patient reported that, he had received first dose of Shingrix in the left arm via intramuscular route. He stated that in late July (2022), he was hospitalized for pneumonia.  He did not get second dose of Shingrix yet at the time of reporting. The reporter did not consent to follow-up. Additional supportive information: Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination. Since, it was not clear from the response received from the agency that due to hospitalization the patient had not taken the second dose as it also said that he forgot and hence incomplete course of vaccination was coded conservatively.
Received 1st dose of Pfizer vaccine at 1:50 pm and verbalized no discomfort.  At 2:10pm complained of slight tightening in her throat that was not there before the vaccine was given.  Oxygen Saturation = 98% on room air.  Vitals were: BP 110/76, HR 86.  Given 2.0L oxygen via nasal cannula.  Oxygen Saturation = 99%.  Pt. denied any complaint of difficulty breathing or chest pain.  NP assessed patient and ordered Diphenhydramine 25mg IM stat.  Order given via right arm.  Patient continuously monitored.  At  2:20 pm vitals were:  BP 107/67, HR 82.  Patient verbalized relief of symptoms.  At 2:45pm, vitals were: BP 104/67, HR 79 and 134/89, HR 92.  Patient remained asymptomatic.  Patient was discharged to home ambulatory alert and oriented x 3 and MD was informed of event.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Joint Pain-Severe, Additional Details: his left shoulder intermittently has pain when raising his arm, site is still swollen
received a quarter dose for booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (received a quarter dose for booster) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034FZ1A) for COVID-19 vaccination. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a quarter dose for booster). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (received a quarter dose for booster) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Redness at the injection arm; Swelling that is getting bigger at the injection arm; Hardness at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced Pain in arm, Redness, headache.     The patient's medical history was vocal cord dysfunction, asthma and allergies. Concomitant medication albuterol were reported.     28-Dec-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.     On 25-Jan-2021, The patient experienced swelling, redness and hardness at the injection site, that isgetting bigger. No Laboratory details provided.  The patient was given Benadryl  for the symptoms.     Action taken with mRNA-1273 in response to the events was fatigue, chills, headache, muscle aches and pains, other pain  reported.   At the time of this report, the outcome of the events injection site erythema, injection site rash, injection site inflammation is known.
Immediately after administration all the above vaccine she became limp then stiff - eyes rolled up - fainted - helped to the floor within a minute she recovered fully - vitals signs normal. No treatment given - paramedics came - no medications given - stable.
Muscle ache, fatigue, brain fog, joint pain, sensitive to touch, chills, all over weakness, nausea, loss of appetite,
A MINOR ITCHINESS; RASH ON BOTH ARMS FROM ELBOW DOWN; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, overweight, alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced a minor itchiness. On 06-APR-2021, the subject experienced rash on both arms from elbow down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms from elbow down, and a minor itchiness. This report was non-serious.
Pt developed diffuse blotchy erythema and pruritis 4-5 days post vaccination. Also c/o chest pain and SOB. Ruled out myopericarditis. Diagnosed with mild case of erythema multiforme. Treated with anti histamines.
Severely swollen lymph node in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 08:00 (Lot number: FF2593) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillins" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El9266), administration date: 17Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Oct2021, outcome "recovering", described as "Severely swollen lymph node in left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was diagnosed with COVID-19 was unknown, Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
currently lactating; currently lactating; Two swollen lymph nodes above left clavicle; This is a spontaneous report from a contactable other health professional.  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, from 21Dec2020 08:45 at a SINGLE DOSE for covid-19 immunization. Medical history included currently lactating and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included fish oil, calcium and lecithin. The patient experienced two swollen lymph nodes above left clavicle on 26Dec2020. The patient underwent lab tests and procedures on 08Jan2021 which included nasal swab test with negative result. The outcome of event "two swollen lymph nodes above left clavicle" was not recovered whereas the outcome of other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027508 baby case