chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED HALF DOSE FOR HER BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned two 28 years old female patients of unknown race and ethnicity. No past medical history or concurrent conditions were reported. The patients received vaccination with covid-19 vaccine ad26. cov2.s (Series 1) (suspension for injection, route of administration was not reported, batch number: Unknown expiry: Unknown) dose was not reported, start therapy date were not reported, for prophylactic vaccination. No adverse events were reported following vaccination. (dose number in series 1) The patients received covid-19 vaccine ad26.cov2.s (Series 2) (suspension for injection, route of administration not reported, batch number: was either 1822809 or 211A21A expiry: UNKNOWN) dose was not reported, 01 total, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient received half dose for her booster dose, off label use. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for her booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202371, 20211202199 and 20211202469.
Expanding swelling, redness, heat, itching left arm beginning 01/07/21
This spontaneous report as received from a Registered Nurse refers to a 29 years old male inmate without pertinent medical history and drug reactions/allergies. The inmate was vaccinated with PNEUMOVAX23 (0.5ml, SQ right arm, lot# 1947AA, expiration date 20-OCT-2013) for hepatitis C on 25-JUL-2012 and On 26-JUL-2012 in the right upper arm it was red, swollen and painful. No other co-suspects were reported. Concomitant medications included MOTRIN and TYLENOL. Shot of TYLENOL for the treatment of the AE. The outcome of right upper arm red, swollen and painful was reported as recovering/resolving. No lab diagnostics studies performed. The inmate sought medical attention via sick calling to nurse in the prison yard. Report 2 of 3. See SRs 1-5406566483 (MARRS Case # 1208USA001635) and 1-5406566843. Additional information has been requested.
Erythema multiforme and urticaria 8 days post vaccination. Treated with BENADRYL and oral steroids.
Soreness in right shoulder and wrist night of injection, swelling of right wrist overnight 12/28. Symptoms resolved by mid-day 12/19. Soreness in shoulder and wrist returned evening of 1/6 and persisted through daytime 1/7. Have not yet resolved.
Presented with SOB/fever/productive cough/body aches; began with + Covid test 2 weeks prior to arrival; Had zpack/steroids/Vit D & C/plaquenil PTA; dx Covid PNA; tx with remdesivir/Vit C /Vit D/Zinc/steroids/antibiotics/supplemental O2; discharged home with O2
Chills and Anxiety from Sunday 03/21/2021 to Wednesday 03/24/2021
Phone call from MD's office, states L arm is warm, swollen and has decrease mobility at shoulder joint. Pt is being adm to the med center (known sickle cell pt).
Patient called pharmacy on 8/16 complaining of a sore red arm. She said it was more painful than the tetanus vaccine she received previously. We advised the patient to apply a cold compress to the area. She was visiting her primary care this afternoon for an annual visit and was going to have him look at the site as well. Patient will contact us if situation worsens.
Vaccine Clinic at middle School. Patient was vaccinated at 1724 by RN. After vaccination patient went to observation area with mother and siblings. At 1730, patient's mother notified Site Manager that "my daughter isn't acting right." The site manager notified myself, APRN and another RN. The nurse and myself assessed the patient who was diaphoretic, lethargic. At time of assessment it 1731  was noted  that patient was tachycardic, had thready radial pulse and the nurse observed her eyes roll back in her head and would not respond to verbal stimuli. 911 was called. Patient regained full consciousness  and was moved out of the Cafeteria area to a calmer location. Mother stated that child had not eaten recently and was given a bottle of orange juice. After consuming the orange juice, child seemed to "perk back up" and stated that she felt a little better.  Ambulance squad arrived and transported child
Vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (experienced zests several years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was over 50 years old at the time of reporting. The patient received both the doses of Shingrix. At the time of reporting, the patient came down with shingles, months after receiving 2nd dose of Shingrix.
pain at the injection site; fatigue; muscle/joint pain; muscle/joint pain; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. Medical history included fibromyalgia, depression, anxiety, migraines, gastrooesophageal reflux disease (GERD), menopause, allergy to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications within 2 weeks of vaccination. The patient experienced pain at the injection site, fatigue, muscle/joint pain, chills and headache on 22Dec2020 14:00 with outcome of recovered on an unspecified date.  No treatment received for the adverse events. The patient received the second dose of BNT162B2 (lot number: EK9231) at left arm on 10Jan2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Lump on the outside of her Left Elbow (Fluids in the lump); This spontaneous case was reported by a pharmacist and describes the occurrence of MASS (Lump on the outside of her Left Elbow (Fluids in the lump)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    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 MASS (Lump on the outside of her Left Elbow (Fluids in the lump)). At the time of the report, MASS (Lump on the outside of her Left Elbow (Fluids in the lump)) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. It is reported that the lump was not related to Moderna vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Events outcome updated.
large area of erythema-warm to touch generalized body aches x 2 days febrile x 1 day
Pt developed severe pain in b/l heels with erythema and adema. Pain progressed up legs. She then developed bilaterally axillary lymphadenopathy. ESR and CRP elevated.
Case number PHEH2014US025105, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 82-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pt developed a 3 x 2 cm area of redness, warmth, tenderness and induration on right deltoid.
Moderna vaccine was administered outside of office - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- R09.02 HYPOXIA 12/20/2022 ASPIRATION PNEUMONIA
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002690 (Novavax). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), FACIAL PAIN (non-serious), outcome "unknown" and all described as "The patient experienced numbing and pain in the face, numbness of arms"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart beating really fast". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On 20Jul2022, it was reported that a patient started treatment on an unreported date with Pfizer Biontech COVID-19 Vaccine at unreported dose and frequency for an unreported indication. The patient experienced numbing and pain in the face, numbness of arms and heart beating really fast. No further follow-up is anticipated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FLU LIKE SYMPTOMS/ACHINESS/BODY PAIN; SLEEPY FEELING; This spontaneous report received from a consumer concerned an adult male. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms/achiness/body pain, and sleepy feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms/achiness/body pain and sleepy feeling was not reported. This report was non-serious.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever of 100.2ºF) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 5, 2021, patient experienced pyrexia (fever of 100.2ºF). At the time of the report, pyrexia (fever of 100.2ºF) outcome: unknown. Diagnostic results: On Aug 5, 2021, body temperature: 100.2°F (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Information has been received from a nurse practitioner via a field representative referring to her daughter, who was currently 11 years old. Medical history and drug allergy were not reported. On an unknown date the patient was vaccinated with her first dose of GARDASIL, 1 vial. (dose and strength were not reported, lot # was reported as HOZO90L and expiration date was reported as 05-JUL-2015) intramuscularly in the deltoid in the right arm by the nurse practitioner reporter. The patient simultaneously received 2 other vaccines in her left arm, diptheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). The next day her entire right arm swelled all the way down to her right hand. There was no reaction in her left arm. The patient was treated with an unspecified dosage of BENADRYL. The swelling subsided in three days. No lab tests were performed. The patient was not going to receive any more vaccines in the GARDASIL series. The patient did not seek medical attention. At the time of reporting, the causality was not reported. Additional information has been requested.
Onset midday on 6-19-12 with low back pain above the waist radiating to middle of back to shoulder blade area with soreness in right shoulder. Denies any fever, nor headache or nausea. Took 200 mg Ibuprofen only once which seemed to help. Received HPV in right arm. The NP was contacted with her recommendation of NSAID every 6-8 to see if this helps and to contact clinic is symptoms increase or worsen. If not better will do testing. 7-3-12 patient doing fine.
received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   In September 2022, the patient received Menveo. In September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent. The patients received Menveo powder reconstituted with saline diluent. After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022137202:Same reporter US-GSK-US2022AMR137841:Same reporter US-GSK-US2022AMR137842:Same reporter
The injection sight was hot and firm. I had a low grade temp of 99.2. I was VERY achy, I had difficulty sitting, standing, any movement, VERY tired and a little dizzy.
INNER LEFT ANKLE FELT HOT TO TOUCH; LEFT LEG PAIN; BULGING VEIN ON LEFT LEG; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced bulging vein on left leg. On 16-MAY-2021, the subject experienced left leg pain. On 19-MAY-2021, the subject experienced inner left ankle felt hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg pain, bulging vein on left leg, and inner left ankle felt hot to touch. This report was non-serious.
Severe chills with involuntary shaking over entire body, lasting about 5-6 hours.  Moderately severe headache, still exists 22 hours after vaccination.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. Dose, route, Lot number and expiration date were not reported. The physician reported that improperly stored VAQTA was administered to unspecified patients on unspecified dates. No adverse effect reported. It was also reported that tetanus and diphtheria vaccine had been improperly stored. This is one of  two reports from the same source (other case # 1407USA003778). Additional information has been requested.
pt recv vax in DEC96 & lab eval in 1997 revealed a lack of seroconversion;
Patient received dose 2 of Pfizer vaccine.  While sitting in chair during 15 minute observation period patient informed Mom light leaded and then lost conciousness.  Mom stated she assited her to floor but patients lip hit the floor.   Patient reponsed to mom within 15 seconds after fall.
One week starting on May 11th - I had a sore throat and then it went to a fever. I had about 100 degrees or close to 101. I was taking Tylenol though. I had a headache and fatigue. I may have had a cough over the week. Typical flu but also things that can be associated with COVID. I got tested for COVID about May 13th - negative result. I talked to my doctor after about 5 days. She said that my symptoms were not strong enough to need any treatment. She said at the time that she was seeing a lot of COVID patients at that time so she had suspicion that it may be a mild case of COVID.
Pt c/o fever after receiving injection. LD is indurated to touch and warm with redness painful all upper arm. Pt was send via ambulance to hospital.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: Wag12325), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: Ew0150), in right arm, on 23Apr2021 as dose 2, single (Lot number: Ew0176), in right arm, on 17Nov2021 as dose 3 (booster), single (Lot number: Fj1620), in right arm and on 18Apr2022 as dose 4 (booster), single (Lot number: Cus374), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hemophilia A (mild)" (unspecified if ongoing); "Known allergies: Contraindicated for aspirin and all products with aspirin" (unspecified if ongoing), notes: Contraindicated for aspirin and all products with aspirin. Concomitant medication(s) included: SIMVASTATIN oral, start date: 01Oct2021, stop date: 07Oct2023; C 1000 oral, start date: 01Jun2020, stop date: 07Oct2023; MULTIVITAMIN 6 oral, start date: 01Jan2021, stop date: 07Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 08Oct2023.
This spontaneous report as received from a pharmacist refers to a 69 years old male patient with hypothyroidism. The patient did not have any drug reactions/allergies. The patient was vaccinated with PNEUMOVAX23 (0.5 ml, lot # H014283, expiration date 17-APR-2014) intramuscularly in left arm on 04-JAN-2013. No other co-suspects were reported. Concomitant medications included benazepril hydrochloride and SYNTHROID. On 04-JAN-2013 the patient experienced extreme pain described as muscular, a fever of 100F lasting for 2 hours, and nausea and vomiting. The patient reported that he took ibuprofen and acetaminophen, PERCOCET (manufacturer unspecified) and it did not relieve the pain. He was seen by physician at unspecified date, and reported that the fever, nausea and vomiting had resolved, but the pain and difficulty using his arms remains, although it had improved slightly. Patient was now taking ibuprofen to manage discomfort. The relatedness for event was unknown for PNEUMOVAX23. Additional information has been requested.
Patient: MRN: Age:77 y.o. DOB: Admit Date:  7/30/2022 Discharge Date:  8/2/2022      Principal Diagnoses:  Principal Problem:   Weakness Active Problems:   COVID-19 virus infection   Hyponatremia   HTN (hypertension)   OSA on CPAP     Discharge Diagnosis:  Weakness, COVID-19   Hospital Course:  Patient is a 77 YO man who was admitted to a HCF on 07/30/22 for concern of weakness due to COVID-19 infection and hyponatremia which have now resolved.  While admitted PT/OT/SW were involved in the care of this patient for concern he would need rehab stay however he declined and family was in agreement.  Reports today he is feeling much better and weakness has resolved.  He is eager and agreeable for discharge.    Disposition:  home   Discharge Condition:  fair
This patient's mom states patient has redness, swelling, small red red bumps, and complains of itching to the site where the Hep A shot was given. Treated with Hydrocortisone cream.
Tinnitus (ringing in the ears), not sure if it comes and goes or just when occupied I do not hear it. Only other symptom was sore arm after each injection. Was only tired after the second shot.
Arm soreness, warmth, swelling, nausea, vomiting, started on 10/15/2003.  Treatment Tylenol, Ice packs and ibuprofen.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K001716, 24-NOV-2015, doses, frequency, site of administration were not reported) oral route of administration. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
he is not feeling well earlier; This is a spontaneous report received from a Sponsored Program. A non-contactable male consumer (Patient) reported for himself that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated that his second dose appointment was scheduled today 09Mar2021 and he got his first dose appointment last 16Feb2021. He stated that he was not feeling well earlier that was why he decided not to take the second dose and he was trying to reschedule it on the system/online right now and during probing question he mentioned that he was feeling better now. He was looking forward in rescheduling the second dose on 11Mar2021. The outcome of the event was resolving.  Information on the lot/batch number has been requested.
Patient said shot was painful at time of administration. He said, in about 4 hours, he could not move his arm and was in extreme pain so he went to the emergency room. The doctor there told him that it looked as if the shot was given too high on the arm. He was prescribed an anti-inflammatory but is still complaining of pain today(monday 12/20)