chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event; vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 90 years old male patient and reporter reported Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: U8162BA) (Expiry date: 30-Jun-2024) (Strength: High dose) (Frequency: once) (with an unknown formulation) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation).  On 16-Oct-2023, reporter reported Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event (product storage error, latency: unknown) (poor quality product administered, latency: same day).  It was reported, Supervisor called in because they received a shipment of FLUZONE HIGH DOSE QUADRIVALENT on 16Oct2023 that was shipped out on 12Oct2023, and the facility received a notice from VAXSERVE that the vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine out of stability. Caller was asking about what to do next if the vaccines should be repeated. This inquiry was submitted to PV since it was not supported by the extended stability information post excursion and the dose was given to a patient.  Action taken: not applicable.  Outcome: Unknown    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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
No adverse effect; administration of an expired ROTATEQ vaccine; This spontaneous report was received from a medical assistant concerning to a 2 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 03-OCT-2019 at 16:30, the patient was seen for a well-child check and weighed 12 pounds, 6 ounces. On that day, he was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) per oral route (dose unspecified) lot# R002806 expiration date 29-SEP-2019 for prophylaxis. Later on the same date, the medical assistant realized that the vaccine given had expired days ago. No adverse effect was reported.
Narrative: patient reported continued muscle fatigue and body aches continued after receiving his 2nd dose of vaccine. Also had some bilateral rash to legs.
Sick for two days; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; batch/lot number was not reported), via an unspecified route of administration on 09Mar2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the second shot and was sick for two days on an unspecified date. The outcome of the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
He actually got his first round of: Hep B, Polio, Varicella, Meningicoccal, MMR and TDAp on the first day because our right to religious freedom was stripped from us. prior to 8/23/2019, he never had any...on 8/30/2019 his neck started to feel very stiff and his ran a high temperature, felt nauseated and couldn't eat. He slept for 48 hours getting up only to go to the restroom and drink some water
had a nose bleed; Severe Arm Soreness; Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (had a nose bleed), PAIN IN EXTREMITY (Severe Arm Soreness) and OROPHARYNGEAL DISCOMFORT (Scratchy throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Scratchy throat). On an unknown date, the patient experienced EPISTAXIS (had a nose bleed) and PAIN IN EXTREMITY (Severe Arm Soreness). At the time of the report, EPISTAXIS (had a nose bleed), PAIN IN EXTREMITY (Severe Arm Soreness) and OROPHARYNGEAL DISCOMFORT (Scratchy throat) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, second dose details updated
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant information received.
This is a spontaneous report from a non-contactable consumer reporting on behalf of her mother via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced paralysis of the legs on an unspecified date with unknown outcome.
This spontaneous report was received from a physician, via a company representative, concerning to a patient (Encounter key # 296945) of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. on 01-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had six temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 256 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 288 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 552 hours, and 1.11 Celsius Degrees (34 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
HIVE LOOKING RED RAISED , HOT TO TOUCH WHERE INJECTION SITE IS ON RIGHT ARM. WENT TO EMPLOYEE HEALTH , THEY SUGGESTED TO REPORT IT.
Patient could not take the second dose / on time / not able to go to the facility; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not applicable for this report. The pharmacist reported that the patient could not take the 2nd dose of Shingrix on time due to the patient was not able to go to the facility, which led to incomplete course of vaccination. The healthcare professional declined provide more information. The reporter did not consent to follow up.
S/S Patient reported having the chills and a fever. Pt. went to PMD on 5/14/2013 when noticing red lines running down his arm and a continued fever. PMD Rx'd Bactrim for 5 days.
After receiving the vaccine on 12/30 the only side effect at that time was arm soreness at the injection site. A day later some chills and fatigue but no other side effects after. I noticed starting on 1/4 pain started on injection arm from shoulder down lower to extremities on left arm. Pain very excruciating but comes and goes. Joint pain and muscular pain throughout entire arm and even in right arm. After couple days of this,  contacted family physician regarding this.  Was seen by physician on 1/6. Discuss concerned and he ordered X-rays on both arms and ultrasound droplet on entire left arm (injection site- from shoulder in down). MD also I formed me to take Advil/Aleve twice a day as needed for pain/soreness along with heat/cool compressions as needed as well as shoulder exercises. Today is 1/9 and pain isn?t as bad. Can still feel discomfort here and there but not as excruciating. Numbness from time to time also. Is this normal after receiving the Moderna vaccine? Is it normal to experience this a week after receiving the vaccine?
On 11/06/10 severe chest pain mostly right upper backside under rib area and shortness of breath at school around 1:00 PM. Picked up at school 2:00 Pm and brought to Dr's office. He sent us to ER where they took chest xray and EKG. Gave her Motrin at 4:00 pm. Nothing significant showed. They diagnosed chondochostritis ? but she had no fall or hit to the chest. She did have her last Gardasil shot 11/02/10.
Patient came into the Pharmacy for a walk-in 2nd dose booster of Janssen/J&J COVID vaccine. Her form did not state the fact that she has had vaccine reactions in the past.  Allergies and medical conditions were listed as "NONE". Pharmacist administered the dose and counseled regarding the risk factors and patient acknowledged that she was in the high risk group for thrombosis. She was advised to remain in the pharmacy for 15  minutes after vaccination. Pharmacist returned to the Pharmacy to obtain the dose of vaccine for the next patient. When Pharmacist returned, perhaps 2-5 minutes later, she approached patient, who was sitting in the immunizer's chair. Pharmacist sat down across from patient to check on her and patient fell onto pharmacist. Patient was sweating, her skin was pale and clammy, her hands and mouth were shaking. The patient was non-responsive and her eyes were rolling back. Pharmacist expressed to the team to call 911. Shortly after,  the Fire Dept responded. and patient was monitored by the Fire Dept paramedics who monitored her BP at 80/40 and BP progressed to 92/76 a half hour later.  Patient remained in the pharmacy for at least an hour after the incident until her BP attained 110/78.  She came to the Pharmacy alone and stated that she was able to drive home.
STARTED WITH LOW GRADE FEVER, CHILLS SORE ARM, PROGRESSED TO ACHINESS IN ALL JOINTS AND STIFF NECK, PAINFUL TO WALK.  APPLIED HEAT TO NECK  AND TOOK BOTH EXTRA STRENGTH TYLENOL AND MELOXICAM.  SLEPT ALL DAY , FELT BETTER IN THE EVENING ARM STILL VERY SORE AND TENDER AND STILL ACHY, FEVER GONE.  EARLY  WED AM STARTED ITCHING ON LEFT ARM AND BUTTOCKS, AT FIRST THOUGHT IT WAS JUST DRY SKIN.  BY LATE AFTERNOON/EVENING HAD HIVES OVER TRUNK OF BODY STARTING ON BACKSIDE OF BOTH ARMS, TO SIDES AND BACK OF TRUNK AND THEN LEGS, IN MY NOSE, EARS, SCALP  AND INTENSLY ON UPPER THIGH AND LOWER LEGS .  I TOOK BENADRYL 2X 25MG, FAMOTIDINE 40MG,  CETERIZINE 10MG.  IAM A PHARMACIST AND ALSO THE PATIENT.  I  SELF MEDICATED OVERNIGHT SO I COULD COME TO WORK TODAY.  I AM LEAVING  WORK EARLY  TO GO TO  URGENT CARE FOR A STEROID BECAUSE AS THE BENADRYL  DISSIPATES, THE HIVES COME BACK INTENSELY
Fever 101.2 for 12 hr Red swollen arm hot to touch > 48 hrs Headache for 36hrs
The patient started experiencing a burning sensation throughout the body, itching and pain in the left arm, and developed a bump at the injection site.  The symptoms commenced on the next day after the patient received the vaccine.  The bump gradually diminished, but the pain in the left arm and a burning sensation persist (as of 10/17/21, it is 10 days after the vaccination).
swelling of the arm; tired; gland swelling under her arm; runny nose; having to clear her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization. T  he following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the arm"; FATIGUE (non-serious), outcome "unknown", described as "tired"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "gland swelling under her arm"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; THROAT CLEARING (non-serious), outcome "unknown", described as "having to clear her throat".  Additional information: The patient and her mother took the second dose of Covid vaccine last Thursday. They both experienced swelling of the arm but her mother's was hotter, redder and hard. She had gland swelling under her arm and they are both tired. Now developing a runny nose and is having to clear her throat. She wondering if this is side effect from Covid vaccine as her mother in in her 90's and wants to make sure mother is ok.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 9 year old female with no know drug allergies who at 11 AM on 24-JUN-2008 was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #660277/1893U) in her right deltoid. There was no illness at time of vaccination. In the morning of 25-JUN-2008 the patient experienced local reaction, red area 10 cm times 12 cm in right arm which was diagnosed as cellulitis. KEFLEX was given. At the time of report, the patient's outcome was unknown. Additional information has been requested.
very sore arm; a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy. Concomitant products included CARVEDILOL (CARVEDIOL) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark). On 06-Jan-2021, PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication also include statin (low dose). Action taken with mRNA-1273 in response to the event was not applicable.
Approximately 10-15 minutes post vaccine -> 3 cm in diameter area of redness and mild swelling around puncture site. No wheezing or dyspnea. Dexamethasone given IM in rt deltoid. Approximately 30 minutes later, returned to office with redness around injection site for Dexamethasone = 5 cm in diameter. Complained also of headache and coughing. Vital signs were stable except for respiratory rate (30-40 per minute range). Treated with Albuterol via nebulization and counting slowly (to relieve anxiety and hyperventilatory symptoms) EMS arrived approximately 20-30 minutes into treatment. Most of symptoms had subsided. Redness of the injection sites was less. She was taken to the ER for observation and discharged after several hours.
Cramps and diarrhea 2 hours after 3rd dose of Oral typhoid vaccine.
Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HOV positive." It was reported that the patient had a normal pap result prior to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.
On day 9 following the 1st dose of Moderna Vaccine, an itchy, red and splotchy rash developed slightly below the injection site.  It grew pretty much across the top of the arm and down in a meandering way for at least 4 inches.
Experiencing pulsing headache, extreme fatigue, diarrhea, stomach cramps x6 days at this point.
physician was misinformed and sent in a prescription for a third dose of Shingrix; third dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number Kj937, expiry date 11th June 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th August 2019) and Shingrix (2nd dose received on 18th November 2019).   On 14th July 2022, the patient received the 3rd dose of Shingrix. On 14th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced drug prescribing error. On an unknown date, the outcome of the extra dose administered and drug prescribing error were unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The reporter reported that a physician was misinformed and sent in a prescription for a third dose of Shingrix. The third dose was administered. It was unknown whether the patient was immunocompromised. The patient just had chronic health condition in their health history. The reporter did not consent to follow-up.  Additional supportive information: The patient received the 3rd dose of Shingrix which led to extra dose administered. This case has been linked to the case US2022AMR046791 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR046791:Same reporter
Rash/Eczema on my face especially around eyes, which comes with strong itchiness and irritation that lasted about 1-2 months.
Shoulder area of injection is moderately sore; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Feb2021, the patient's shoulder area of injection was moderately sore. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shoulder area of injection is moderately sore was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash on lower back; heart rate elevated; tongue was itchy; cough; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate elevated), TONGUE PRURITUS (tongue was itchy), COUGH (cough) and RASH (rash on lower back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     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, the patient experienced HEART RATE INCREASED (heart rate elevated), TONGUE PRURITUS (tongue was itchy) and COUGH (cough).   On 08-Apr-2021, the patient experienced RASH (rash on lower back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   On 07-Apr-2021, HEART RATE INCREASED (heart rate elevated) had resolved. On 14-Apr-2021, TONGUE PRURITUS (tongue was itchy) and COUGH (cough) had resolved. At the time of the report, RASH (rash on lower back) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It is reported that patient's doctor recommended to get the second dose, but patient declines to get second dose due to these side effects experienced. Concomitant product use was not provided by the reporter.
Pt claims that the flu shot was given too high up on her arm, and that it caused shoulder pain.  She has been given 4 cortisone shots, 1 x-ray, 1 MRI, and 12 OT sessions