chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN; SWOLLEN RED ARM DESCRIBED AS COVID ARM; SLEPT FOR 30 HOURS ONLY WAKING UP FOR WATER AND BATHROOM; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient never experienced any pain or discomfort (Dose number in series 1).  On an unspecified date the patient received non-company suspect vaccine included: covid-19 vaccine (unspecified manufacturer, not J and J) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced pain, swollen red arm described as Covid arm and slept for 30 hours only waking up for water and bathroom (Dose number in series 2).  As per the reporter, "Johnson & Johnson I also had Both my vaccines never experienced any pain or discomfort. But when I got the booster (not J and J) supposedly compatible I had Pain and swollen Red Arm described as Covid Arm. I slept for 30 hours only waking up for water and bathroom. Not sure anyone knows the true story of how this affects us". The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with covid-19 vaccine was not reported. The outcome of the pain, swollen red arm described as covid arm, slept for 30 hours only waking up for water and bathroom and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Shingrix only adjuvant; received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number H755H, expiry date 9th June 2023) for prophylaxis.   On 5th August 2022, the patient received Shingrix. On 5th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 05-AUG-2022 Reporters comment: The patient received only the adjuvant AS01B of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 12th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter.
Pt reported chills the evening of vaccination, upon applying blankets to warm up, pt reported sweating. Temperature was not taken to verify/rule out fever. Next morning pt reported weakness.
Drowsiness and chills started at nighttime. The next day the chills continued along with headache and weakness in the body. Fever symptoms all day. Random bursts of pain in legs and arms. Subsided around 8 on the day after the vaccine was administered.
COVID arm: rash on arm of injection site. Red and raised. Not painful. Slight itching. No treatment
Patient was in post observation and reported to post observation RN dizziness. While Pt was speaking with RN, he had "full body convulsions/twitching and his eyes rolled back". The post observation RN reported this event happened 2 times and was done in less than 2 min. EMT's called to scene. Pt reported ringing in ears, and was diaphoretic after the event. Pt was immediately able to speak, and drank water. Pt was not postictal. Pt became pale after vaccine administration. No PMH, No Allergies, No meds taken daily or given at site. VSS throughout. EMTs took over care of Pt and stayed with Pt until wife came and picked him up.  VS: BP: 118/78 HR: 68 RR:22 O2 sat: 99% on RA
Mild covid arm (rash, swelling, redness,itchy) Diarrhea  Fever Chills Shakes  Body pain Headache  Dizziness  Sore throat  Swollen lymph nodes Sweats  Lethargy  Nausea  Started 3 hrs after injection , on day 3, still occurring with symptoms getting milder
A report was received from a healthcare professional on 10/09/2003 concerning a group of 8 vaccinees aged less than 4 years of age, who were inadvertently administered Fluvirin vaccine between 10/06/2003 to 10/08/2003. During 10/06/2003 to 10/08/2003, a group of 8 vaccinees aged less than 4 years of age received Fluvirin vaccine.  No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
sore arm; This is a spontaneous report from a contactable consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was and concomitant medications were not reported.  The patient experienced sore arm on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406291 same patient, different  event in seperate vaccine
Information has been received from a female consumer who was vaccinated with ZOSTAVAX (Oka/Merck). The consumer reported my physician did not believe that my symptoms were a result of the ZOSTAVAX (Oka/Merck). There was a "nasty stomach bug" going around at the time of my vaccination, so it was concluded that my symptoms were related to that. The consumer was fine at the report time. This is one of several reports from the same source. Additional information has been requested.
Patient explained she was feeling soreness in the tissue that connects from under her breast to her left armpit; causing her to not be able to raise her arm. She is also experiencing body aches, headaches, and a sore throat. There is a red ring around the bottom injection site.
Large localized reaction at injection site--bright red, painful spot expanding to over 8 cm in diameter by day 2. Arm extremely sore for 4 days. Fever of 100.2 on Day 2, including body aches. 8 days after injection, pale reddish brown spot 8 cm in diameter is still visible.
2/10/99 surgery for dyspnea, paranasal swelling;dx:rt nasal vestibule obstruction & swelling, fx maxillary boneplates. 3/12 &16 eval for hyperlipidemia, taking Lopid, wt gain, hands swollen, bilateral hand pain
COVID 19; COVID 19; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013l20a), in right arm and on 12Feb2021 as dose 2, single (Lot number: 039k20a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "benign enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Nov2021, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19. Clinical course: Treatment for COVID 19 included Paxlovid from 06Oct2023 to 10Oct2023. The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Numbness in extremities.  Primarily in legs and fee.  Also rapid heart rate.  Lasted for a few weeks.  Some periodic numbness still
Patient is 13 yr old child who received a Moderna booster dose on 01/11/2022.  Mother reported that kiddo had a fever ?between 100 and 101 for a few days and was fatigued for about a week?.
She tested positive for COVID in Jun2022/as her symptoms just felt like a cold; She tested positive for COVID in Jun2022/as her symptoms just felt like a cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6202), in 2021 as dose 2, single (Lot number: EN6207) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications, she just takes her regular medications that her primary care prescribed. Caller did not provide her medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "She tested positive for COVID in Jun2022/as her symptoms just felt like a cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Unit: Not Provided. Clinical information includes the patient did not have prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No AE(s) following prior vaccinations. Family medical history relevant to AE(s) was unknown. No relevant tests. Description of complaint: She tested positive for COVID in Jun2022. Her primary care didn't call anything in, as her symptoms just felt like a cold and after 6 days she felt better. It was reported that the patient did not tell properly that received date for 2nd dose was 13Jun2021 or 13Apr2021, as She can't tell if the month was a 4 or 6.
Appetite decreased; lost 11 pounds; food does not go down; Little Vomiting, he upchucked; He felt warm like feverish that was only for a couple of hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Throat cancer (cancer survivor), Esophageal cancer (cancer survivor) and Pacemaker insertion (cardiac). Concurrent medical conditions included Atrial fibrillation and Hypoglycemia. Concomitant products included LEVOTHYROXINE, APIXABAN (ELIQUIS), METOPROLOL, COLECALCIFEROL (VITAMINE D3), BETACAROTENE (BETA CAROTENE), OMEPRAZOLE, TAMSULOSIN, DIGOXIN, FAMOTIDINE, ACYCLOVIR [ACICLOVIR], ROSUVASTATIN, ERYTHROMYCIN and SUCRALFATE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds), DYSPHAGIA (food does not go down), VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours). At the time of the report, DECREASED APPETITE (Appetite decreased), WEIGHT DECREASED (lost 11 pounds) and DYSPHAGIA (food does not go down) outcome was unknown and VOMITING (Little Vomiting, he upchucked) and PYREXIA (He felt warm like feverish that was only for a couple of hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) no cancer found. On an unknown date, Sigmoidoscopy: normal (normal) no cancer found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included centrum silver, stool softner two per day and iron pill three times a week.  Treatment details was not reported by the reporter.  Reporter stated that doctor suggested for her husband to get tested for Covid   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received contains no new information
This spontaneous report as received from a physician via a company representative refers to a 6 month old patient of unknown gender. The patients medical history was unknown. On 19-JUN-2013 the patient was vaccinated with ROTATEQ, oral solution. On an unknown date, after the administration of ROTATEQ, the patient experienced blood in the stool. The patient was taken to the emergency room because of the event. The event resolved on an unknown date. The physician did not rate the causality between ROTATEQ and blood in stool. Additional information has been requested.
Initial report was received 11 April 2011 from a consumer, who is also the patient.  A 57-year-old female patient who had a history of Hashimoto's disease and hyperparathyroidism, had received a right deltoid intramuscular injection of ADACEL, lot number C3828AA on 25 March 2011 and two days later, she developed an intense burning from the injection site to her shoulder.  She also experienced pain shooting down her arm and pain in the back of her arm.  The event required an emergency room visit and doctor's visit.  The patient was seen by a neurologist and diagnosed with brachial neuritis.  Corrective treatments consisted of Tramadol for pain.  The patient had no illness and no known allergies at the time of vaccination.  Concomitant therapies consisted of Levoxyl 100 mg.  The patient had not received any other vaccines within four weeks of ADACEL and she denied any history of adverse events following prior vaccinations.  Outcome was not recovered.  Documents held by sender: None.
Gums are so sensitive to temperature; Barely eat; This case was reported by a consumer via call center representative and described the occurrence of sensitivity of gums in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sensitivity of gums and decreased appetite. On an unknown date, the outcome of the sensitivity of gums and decreased appetite were unknown.   It was unknown if the reporter considered the sensitivity of gums and decreased appetite to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that after vaccination the gums were so sensitive to temperature and can barely eat. The patient asked if there is a known reaction to teeth and gums after a shingrix shot. The patient stated that this could be a coincidence and asked have heard of this problem before.
High fever (102-103), sever headache, body and joint aches, vomiting
Student became nauseated immediately after receiving IM injection of H1N1. No vomiting occurred. Student was taken to the school health room and assessed by the school nurse. School nurse informed staff that the student had had this occur in the past with other immunizations. Student ate something afterward and recovered completely.
Vial was shaken before administration; A spontaneous report was received from a consumer concerning a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the vial being shaken before administration/product dispensing issue.  The patient's medical history was not provided.  Concomitant medications were not provided.  On an unknown date, the patient received her dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient's daughter called stating that the vial was shaken before being administrated.  Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, the vial being shaken before administration/product dispensing issue was recovered.; Reporter's Comments: This reports refers to a case of Product dispensing issue for mRNA-1273 (lot number unknown) with no associated AEs. Causality for the event is not applicable
p/vax pt exp sharp pain up & down arm, feeling nausea & lightheaded;pt sought unspecified medical attention;
The day after she got the vaccines she started developing symptoms such as the arm being hot, swollen, and tender to touch.  She has experienced headache, hot/cold flashes, muscle aches, stomach aches, and a fever of 103 degrees that started two days after receiving the vaccines.
Pt exp dizziness & nausea following 1st Hep B vax; sx resolved spontaneously w/in 24 hrs; pt subsequently recvd 2nd inject & did not exp any problems;
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Had bilat. leg pain and refusal to walk 48 hrs after 5 yr vaccines given in legs. Lasted several hours without parents being able to see redness, tenderness or swelling. Also had fever 101 degrees.
Within hours: - blisters on hands and feet - Migraines - Severe joint pain - Chest pain - Chest pressure (crushing) & tightness - SOB - Pain radiating into jaw - Swollen hands & feet - Eyes red, swollen, heavy like lead - Increased sweating - Electrical shocks and bee sting pains all over like being shocked with a cattle prodder - Muscles weak (can?t lift) & tight (can?t relax) - Lost grip & function of hands - Swollen lymph nodes - Smell like chemicals/plastic - Fatigue - Pulsatile tinnitus - Sunburned skin feeling - Brain fog - Difficulty swallowing  - frequent infections (toes, eye, ear) - New allergic reactions to multiple antibiotics  - Muscle pain & weakness - Neuromyotonia/muscle spasm in upper abdomen/ribcage/chest (went to er for possible aneurysm) - Lichen nitidis (raised bumps) all over chest (5/17)
Temp 100.8 next day, took Motrin and all issues resolved Outcome: Resolved and fine
Mother very concerned about bilateral 1" bruising with quarter sized knots noted on thighs where vaccines were given. Instructed to see PMD ASAP. Child was seen by MD same day. Meds administered and child fully recovered.
Fever 101.9, chills, mild body aches, nausea for 6 hours, then low grade fever, slight headache, tired.  Still have symptoms.
About 45 days after receiving the 3rd dose of the vaccine I started to experience double vision. I went to see a Neurologist and was diagnosed with ocular myasthenia gravis. I was prescribed Mestinon 90mg 3 times daily, prednisone for 4 days, Mycophenolic 500 mg 2 times daily.
Pt was administered Tdap Vaccine on 19NOV13 after it expired on 20OCT13. Pt educated no signs or symptoms. Vaccine readministered.
Patient contacted pharmacy the day after receiving immunization stating he could not move his arm.  Patient contacted physician's office on the following Monday. By that time and after us contacting patient his pain and immobility had gotten much better and his physician was informed.
Client in clinic requesting first dose of Pfizer Covid vaccine. Client upon interview denies prior Covid 19 vaccines. Client given Pfizer Covid 19 vaccine. Upon placing vaccine in state vaccine registry, discovered client had prior janssen covid 19 vaccine in April 2021. Advised client of possible side effects and advised that client that I was made aware of prior vaccine . Client admits that he with held the janssen vaccine because he wanted the additional vaccine due to media reports that Janssen less effective on delta variant.Advised client that the CDC does not recommend receiving two different brands of Covid19 vaccineand that he is not to seek a second dose of Pfizer, unless CDC recommendations change.Client voiced understanding.
Client complained of itchy rash, to f/u with doctor and allergist.  07/29/04 Vaccination given, 08/01/04 hives, itching, 08/04/04 dr. visit, medrol pak x 4 days.
Child had fever in L arm, swollen and red on Wednesday patient receiving shots.  While family member  was at her medical provider, Dr. stated looked like the child had a reaction to the vaccines.
Cellulitis, vomiting, diarrhea, high fever, dizziness, lethargy, loss of appetite.
Interstitial Lung Disease, Lung scaring , Reduced to 57% capacity - April 2021 through October 2021