chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOW GRADE FEVER; ACHES AND PAINS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had history of taking other medications for other ailments.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced low grade fever. On 13-MAR-2021, the subject experienced aches and pains. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, and aches and pains. This report was non-serious..
No Adverse Event. Patient received Prevnar 13 when Prevnar 20 was soon available
48 hours lymph nodes swollen and painful; 48 hours lymph nodes swollen and painful; Jaw ached; within 24  hours, chills aches and fatigued.; Aches; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 00:00, within 24 hours, the patient experienced chills aches and fatigued, on 01Mar2021, 48 hours lymph nodes swollen and painful and jaw ached. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills aches and fatigued, 48 hours lymph nodes swollen and painful and jaw ached was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Reports  itching, redness and warmth at site 10/28/2008.  Blister formed 10/29/2008. Today reddened area measure 120 mm x 100mm.  Blister 45mm x52mm.  Area still appears red at FU
Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: uterine cramping/spotting-Severe, Systemic: Nausea-Medium, Additional Details: patient was 15 weeks pregnant and experienced severe uterine cramping and spotting. After 1 week is still experiencing cramping
Pt received vaccines on 3/19/02 and on 3/21/02,  presents with fever, induration, swelling and warmth at the injection site, consistent with cellulitis. Got DTAP and IPV on right arm at injection site.
two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15-JUN-2023, the patient received the 2nd dose of Boostrix. On 07-JUN-2023, the patient received the 1st dose of Boostrix. On 07-JUN-2023, not applicable after receiving Boostrix and an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023). On 15-JUN-2023, the patient experienced expired vaccine used (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023) and drug dose administration interval too short (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023). The outcome of the expired vaccine used, drug dose administration interval too short and expired vaccine used were 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: 26-JUL-2023 The Medical assistant reported that two doses of expired Boostrix were administered.  The reporter opted out of follow-up and providing additional information. The reporter did not consent to follow-up. The patient received 2 expired doses of Boostrix, which led to expired vaccine used. The patient received 2nd dose of Boostrix earlier than recommended interval, which led to shortening of vaccination schedule.
PAIN; MUSCLE ACHE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced pain, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and pain was not reported. This report was non-serious.
Acute pancreatitis, 2 weeks of chronic non-stop pain under left rib. Subsided and now is occasionally happening once or twice a day for 30 min - a few hours.
Nausea, vomiting, diarrhea, joint aches, muscle cramps, fever, chills
Mother to a 33 month old who still breastfeeds; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds) in a 33-month-old child of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Maternal exposure during breast feeding.     No Medical History information was reported.    On 24-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2021, the child was diagnosed with EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds). At the time of the report, EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not provided.   This case was linked to MOD-2021-105429 (Parent-Child Link).   See case MOD-2021-105429 for details regarding the Parent case.
pt recv vax lt arm 26MAR area became red 2 days p/vax by 2APR the swelling, itching & redness;had travelled down arm almost to elbow;
Modera covid-19 vaccine eua  Dizziness, sore, loss of appetite, minor sweating
Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone.      -took advil, increase fluids and went to bed to sleep ~ 7 hours
Felt a pop after giving a flu shot. Pain in arm. Swelling. Rx for ibuprofen given by nurse practitioner.
Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 28-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 08-FEB-2023 Reporter's Comment: The nurse reported that a patient received an expired dose of Havrix. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N015136, expiration date 16-FEB-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 Fahrenheit degrees (°F) to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007812: US-009507513-1802USA007492.
Less than 5 minutes after giving vaccines, pts mom reported pt had a rash, upon entering the room with NP, red scattered rash all over, no difficulty breathing, alert and crying , Benadryl 5 ml po given at 11:57, rash still spreading, decadron 4 mg  given at 12.07, rash has spread , pulse ox 98%, pt now scratching at rash.   At 12:15 I checked pt,   he drank some water, alert and whining, conts pulse ox on, Pulse ox 100 % and pulse 153.  tb,lpn  , AS PATIENT WAS LEAVING THE EXAM ROOM, MOM WALKED UP TO ME AND ASKED IF THE RASH HE WAS DEVELOPING ON HIS LEFT ARM WAS NORMAL. PATEINT HAD DEVELOPED WHELPS ON LEFT ARM WHERE MMR HAD BEEN INJECTED.  I HAD THE PATIENT GO BACK INTO THE EXAM ROOM.  INSTRUCTED NURSE TO GIVE 4 ML OF ORAL BENADRYL.  I WENT AND SPOKE WITH DR. AND AS I RETURNED TO EXAM ROOM THE RASH HAD SPREAD TO HEAD, SCALP,FACE, AND TORSO.  LUNGS SOUNDS CTA, NO WHEEZES, NO STRIDOR.  ORDERED NURSE TO INJECT 4 MG DECADRON IM.  PATIENT STAYED IN EXAM ROOM FOR OBSERVATION FOR A TOTAL OF 1 HR AFTER INJECTIONS.  UPON LEAVING OFFICE I NOTED HIS PULSE OX WAS STILL 100%, LUNGS CTA, PATIENT WAS ACTIVE AND ALERT, NORMAL RESPIRATIONS AND HEART SOUNDS.    TL,FNP-C
Fine 1st day. Went to doctor had pain in left deltoid. Dr. felt nerve was hit when given shot.  Still have pain and stiffness.
This spontaneous report was received from a radiology technician concerning a 13 month old child patient of unknown gender. Pertinent medical history, concurrent conditions, allergies or concomitant medications were reported. On 25-APR-2018, the patient was vaccinated with a dose of PROQUAD lot # N016113, expiry date 21-NOV-2018 for prophylaxis (strength, dose, dosage schedule and route were not provided) and a dose of VARIVAX for prophylaxis (strength, dose, dosage schedule, route, indication of use, lot # and expiry date were not provided). (overdose). No adverse effects were reported.
As somewhat described in paperwork given after administration, I experienced all of the side effects that have been reported in clinical trials and to a very strong degree on all accounts.  Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm, pit and neck.  General side effects: fatigue, headache, muscle pain, joint pain, chills (extreme) nausea including vomiting, fever ***(extreme hot sweats and drenching of sheets while at the same time freezing cold. Then periods of only chills and repeated drenching phases. Serious sweating!!!
Itchy patch on neck Thursday, by Friday afternoon, upper body covered with itchy rash / Rash gone by Monday evening; No blisters, just raised areas; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Nov2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received nitrofurantoin (MACRODANTIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 05Mar2021 at 12:00 (at the age of 72-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 18:00 (Thursday), after the third shot on 08Nov2021 (Monday), the patient experienced itchy patch on neck, by 12Nov2021 (Friday) afternoon, her upper body was covered with itchy rash. There were no blisters, just raised areas. The rash was gone by 15Nov2021 (Monday) evening. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy patch on neck, upper body covered with itchy rash and no blisters, just raised areas was resolved on 15Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) (seriousness criterion medically significant). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) 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 concomitant information was provided by the reporter.  The pharmacist reported that they had 5 refrigerated vials that went the beyond use date of 08JUL2021. Out of them 1 vial was used for 4 patients on 09JUL2021 and that was beyond the use date.   The pharmacist also reported that those vials were refrigerated on 08JUN2021and are not supposed to be given after its BUD of 08JUL2021.   The other 4 vials are still sealed, unused and kept for disposal.  No treatment information was provided by the reporter.  Company comment: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received does not contain any new information (NNI); Sender's Comments: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria.
soreness in left arm; flu-like sx's; mild temp; headaches; gained 8 lbs of presumed water weight; enlarged lymph nodes; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   On 17th August 2022, the patient received Shingrix. On an unknown date, the patient received Influenza vaccine and COVID 19 BOOSTER. In August 2022, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Influenza vaccine.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix into left arm and co-administered with Flu vaccine and Covid Booster (Pfizer) into right arm and patient experienced soreness in left arm, flu-like sx's, mild temperature, headaches, gained 8 Pound-Mass of presumed water weight and enlarged lymph nodes. The symptoms were gone by 36 hours (mid day Friday) post vaccination. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, fever, headache, fluid retention and enlargement of lymph nodes to be related to COVID 19 Booster.
Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   Previously administered products included Havrix (received 1st dose in 2017).   On 16-JAN-2023, the patient received the 2nd dose of Havrix. On 16-JAN-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter reported that a patient received their second dose of Havrix 6 years apart and wanted to know if they had to restart the series. Information about the patient, vaccine and vaccination was collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Havrix later than the recommended schedule, which led to lengthening of vaccination schedule.
body aches; Low grade fever; swelling of upper lip/recurrent swelling of the upper lip; This is a spontaneous report from a contactable physician. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included morniflumate (FLOMAX [MORNIFLUMATE]) for benign prostatic hyperplasia. It was also reported that patient was not on an ACE inhibitor. The physician reported that the patient received the second dose of the Pfizer COVID 19 vaccine two weeks ago today (unspecified date). Eleven to thirteen hours later, the patient had the typical symptoms including body aches and low grade fever. Patient also experienced swelling of the upper lip. All of these effects resolved within 24 hours and the patient had recovered completely. Then 14 days later, the patient had recurrent swelling of the upper lip again. It was stated that the events were not serious.  Outcome of the events 'body aches' and 'low grade fever' was recovered; outcome of the event 'swelling of upper lip/recurrent swelling of the upper lip' was not recovered.  Information on the lot/ batch number has been requested.