chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was very sore; In bed a lot, didn't feel like getting out of it; Lost 3 pounds because she hardly ate.; She hardly ate; Really bad headache that was different from any other she ever had/lower down headache; Had a temperature of 101° F for a good amount of time; Had very mild nausea, but hardly at all; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate) and HEADACHE (Really bad headache that was different from any other she ever had/lower down headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (ASPIRIN).   On 17-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all). In October 2021, PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101° F. On an unknown date, Weight: lost 3 pounds Lost 3 pounds.         No relevant concomitant medications were reported.  Patient started to experience approximately half a day after the second shot and the events persisted for a day and a half.  No treatment information was provided.   This case was linked to MOD-2022-533223 (Patient Link).   Reporter did not allow further contact
Received the H1N1 shot in office on 10-21-09. Several hours later around 6 PM she had onset of chest pain, SOB, and gasping for air. Felt like her throat was closing up. She was taken to Emergency Room and treated for allergic reaction. 11/17 and 11/20 medical records received for DOS 10/21/09-10/23/09 Final DX: Allergic reaction and URI, asthmatic bronchitis. 1 day S/P vaccine C/O diff breathing, sore throat, chest pain. Neb tx. Abx tx. Admit. CXR neg
Tinnitus, beginning two months after injection. As of this date (05/31/23) same or slightly worse, both ears.
Four days following the Gardasil vaccine, the patient developed a rash all over her body that was itchy and skin colored. It seemed to be worse on the arm of injections site. The patient received an antihistamine and cortisone creme.
Mother noticed reddened right arm 06/24/2003 evening.  Called 06/25/2003 and reported right arm swollen-hand-red-itching.  Doctor appointment on 06/26/2003.  Doctor not worried.  Treatment with antibiotics and benadryl.  no fever.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concurrent medical conditions included diabetes and multiple allergies. Concomitant products included glipizide. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included allergy pills containing pseudoephedrine and insulin. The pharmacist stated that, the patient received the SHINGRIX vaccine in left arm. A little over 1 month later in March 2018, the patient developed Shingles. The patient was planning to get the second dose.
orbital swelling; redness; itchy in her face; urticaria; prickly feeling; A spontaneous report was received from a consumer concerning a 77-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced started to feel itchy in her face (pruritis), orbital swelling (orbital oedema), urticaria (urticaria), redness (erythema) and prickly feeling (paraesthesia).  The patient's medical history was not reported. Current conditions included seasonal and environmental allergy and was allergic to ibuprofen and aspirin. Concomitant product use was not reported.  On 06 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Mar 2021, an hour after receiving vaccine, patient started to feel itchy in her face, orbital swelling,  urticaria, redness and prickly feeling. After taking diphenhydramine hydrochloride, symptoms were slowly abating.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, started to feel itchy in her face, orbital swelling, urticaria, redness and prickly feeling were considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Facial Angioedima after 2nd dose.  Mild rash - truncal after 1st dose
I underwent routine PAP test which came back abnormal for the first time in my life.  There was no lifestyle change that could have caused the abnormal results.  To further investigate the abnormal PAP test, I had to have an invasive colposcopy performed one month later, the results of which were normal.  I feel the Gardasil vaccine caused false positive PAP test results.
Severe pain in upper arm /shoulder which prevents from lifting arm and can only get elbow  inch away from body on Day 1 and 2. Day 3 still do not have full mobility of arm and can only move elbow 5inches away from body. Day 3 still do not have full mobility of arm and can only move elbow 10 inches away from body.
has had nerve pain radiating the neck to the finger on the right arm; has had difficulty sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, immediately after receiving Shingrix, the patient experienced nerve pain and difficulty sleeping. On an unknown date, the outcome of the nerve pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. Since the vaccination, the patient had nerve pain radiating from the neck to the finger on the right arm and difficulty sleeping due to the nerve pain. Till the time of reporting nerve pain and difficulty sleeping was ongoing. No further details were provided. The reporter did not consent to follow up. This case has been linked to US2020228544, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228544:Same Reporter
never received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male 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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter denied to provide patient's demographics. There were no additional information to provide. The information regarding consented to follow up was unknown.
Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Became extremely agitated, paranoid, showed symptoms of a Mood Disorder such as Bipolar 1 or 2. Family noticed a significant change in personality and mood. Also some hallucinations mostly at nights. This all occurred suddenly with no explanation
Swollen axillary gland; This non-serious case was reported by a other health professional via call center representative and described the occurrence of axillary lymph nodes enlarged in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis.  On 31-MAY-2023, the patient received the 1st dose of Bexsero (unknown arm) and HPV vaccine (unknown arm). On an unknown date, an unknown time after receiving Bexsero and HPV vaccine, the patient experienced axillary lymph nodes enlarged (Verbatim: Swollen axillary gland). The outcome of the axillary lymph nodes enlarged was resolving.  It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine.  It was unknown if the company considered the axillary lymph nodes enlarged to be related to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine.  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: 05-JUN-2023 Caller was a GlaxoSmithKline (GSK) representative reporting an Adverse event (AE) with limited information. She stated that, a nurse at one of her sites said they had a patient receive the Bexsero and HPV vaccine on the same day in unknown arms. The nurse reported that the mother of the patient called stating the patient got a swollen axillary gland after getting the vaccines. The rep does not know when the swelling occurred after the vaccines or if it has resolved.  The rep had not further information about the event, patient, or vaccines themselves. The reporter consented to follow-up.
Within 8 hrs of receiving Influenza vaccine developed severe headache, by next morning malaise and body aches, within 24 hours fever 103.  Resolved within 72 hours
Injection site  is tender, red & hard.  About 3 inches in diameter.  Applying heat and taking ibuprofen starting today 1/7/2021.  No fever or other symptoms.  contacted family physician.  I will call him tomorrow, 1/8/2021, if no improvement.
Generalized swelling (slight) left upper extremity with paresthesia, tenderness of biceps, triceps and forearm flexors. Reflexes and pulse intact. No local redness or purulence. Some tenderness over injection site. Symptoms started 11/6/00 and have worsened. Not yet recovered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Jun2022 at 13:00 as dose 3 (booster), single (Lot number: 058a22-2a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: patient received anti viral product for Treatment of COVID-19 from 26Jun2022 to 01Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer / BioNTech: Dose Number: 4; paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 4; paxlovid: 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 4; paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took Paxlovid as directed after a positive test; Negative, notes: Seven days and10 days later received negative test results; Negative, notes: Seven days and10 days later received negative test results; Positive, notes: Fifteen days later received a positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient received treatment with anti-viral "paxlovid" from 28Jun2022 to 05Jul2022 for COVID 19 Treatment. Other medication in 2weeks: Simvastatin. The patient took Paxlovid as directed after a positive test. Seven days and 10 days later received negative test results. Fifteen days later received a positive test result. Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Mother took child to ER with c/o pain in rt arm, rash after vaccination after taking DPT on 10/01/10. ER report states Lt deltoid with local (cutaneous) reaction, erythema w/some urticaria, alert and oriented, anxious, afebrile, lungs clear, no resp distress ER gave Benadryl 12.5 mg IM and Solu Medrol 10 mg IM.
Fever, chills, nausea, body ache, pain on all left arm including hand, tremors, headache and ear ache, light headed and blurry vision on the left eye, extreme fatigue , cough and pressure on diaphragm area .
Temperatures of 100.8 F nausea vomiting abdominal pain fatigue shaky chills  Left Arm pain
pt recv vax 20JUN97  1131AM & same day reports soreness to rt arm p/inj;reports approx 1PM that day noted stiffness to rt shoulder, neck & jaw;contacted MD & was seen in clinic shortly afterward for treatment;recv epi inj & DPH;
This spontaneous report was received from medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular) in the vaccination series and subsequently was possibly administered CERVARIX for her second dose in the vaccination series and on 11-APR-2013, the patient was vaccinated with third dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular) in the vaccination series. No adverse effect reported was unknown. Additional information has been requested.
localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; Myalgia; Malaise; Shivering; Nausea; Possibly fever; interfere with daily activities.; This case was reported by a consumer and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired. On an unknown date, the outcome of the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose 2 days ago from  the date of reporting. The reporter stated that after vaccination, the patient had localized reaction including erythema, edema and soreness. The patient also had systemic symptoms including myalgia, malaise, shivering, nausea and possibly fever. The reporter stated that the symptoms were severe enough to interfere with daily activities. The pharmacist reported to the patient that, most people had more side effects with the second dose, therefore the patient concerned about the reaction to the next suggested dose to complete the series.
Patient was in the process of receiving the peds Pfizer vaccination when she moved, the needle bent slightly and the vaccine fluid was observed by two witnesses and both parents in a 1-2 inch drip down her arm.  Per CDC guidelines, patient was revaccinated with Peds Pfizer lot # FK5127.
immunization event:   injected with an empty syringe that was brand new. apologized then drew up a syringe and administered in right arm deltoid. no adverse effects.
My arm was sore; I had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever). At the time of the report, PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever) outcome was unknown.            No concomitant medications were reported.  The patient had first 2 injections of moderna Covid-19 vaccine on an unknown date in Feb-2021 which went well. Patient received third dose on 13-Aug-2021 and experienced a  sore arm  and tiredness. Patient was scheduled for another dose, the 2nd one (Booster), which he wanted to get the scheduled 4th dose.  Treatment information was not provided.   This case was linked to MOD-2021-291170 (Patient Link).
Pain immediately upon injection and continuing for 5 days. Chills and hot flashes beginning 24 hours after injection, continued for several hours. General lethargy for 72 hours.
This spontaneous report was received from a medical assistant concerning a 3 month old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672:
Not sure if adverse or simply immune response or if a difference, but being as it didn?t present until a week later-i thought maybe i should report since it?s a new vaccine.   Delayed- one week post vaccine developed rash and redness at injection site that was Hard, swollen, hot to touch also.  Mild itchiness the next day on upper left side of body.  Redness continued spreading across my arm. I?ve had it three days and its only red now, all other symptoms related have subsided.   I also developed a swollen lymph node near my collar bone/neck Friday jan 29 on same side as injection.  (Two says after delayed redness appeared, 9 days post vaccine)   Currently, the lymph node is still swollen and hard about the size of a marble. Redness on arm remains.
The day after I received vaccination, I got a red painful welch (bump). I contacted  my PCP and he said it was an allergic reaction. I took Benadryl a couple of days after. I also experienced fever and chills which lasted about two days.  My skin also starting peeling a bit at the injection site.
Sore arm; Fatigue; Headache; Fever; Chills; hot/cold sweat; nausea; Menstrual cycle spotting; This is a spontaneous report from a non-contactable other health care professional.  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in left arm on 26Feb2021 at 08:30 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Medical history included goitre from an unknown date. The patient was not pregnant at the time of vaccination. The patient had no allergy. The patient concomitant medications were not reported. Patient received Oral contraceptives within 2 weeks of vaccination. No other vaccinations within four weeks prior. Patient was not tested Covid post vaccination. Patient not had Covid prior vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via intramuscular route, administered in right arm on 26Feb2021 at 11:15 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization. The patient experienced sore arm, fatigue, headache, fever, chills, hot/cold sweats, nausea and menstrual cycle spotting on 26Feb2021 at 21:00. Patient did not receive any treatment as a result of events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.