chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-OCT-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 DF reported as: 19400 PFU intramuscularly in error, on the right deltoid (expiration date, dose and lot number were not provided). At the same date, on 16-OCT-2016, reported as immediately, the patient developed a big knot at the injection site. No treatment was given for the adverse event. At the time of the report, the outcome of injection site nodule was unknown. There was no product quality complaint involved. The causal relationship between ZOSTAVAX and injection site nodule was unknown by the reporter. Additional information has been requested.
Very sleepy; Sick with the flu; Sick with the flu; This case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sleepiness, sickness and influenza. On an unknown date, the outcome of the sleepiness, sickness and influenza were recovered/resolved.   It was unknown if the reporter considered the sleepiness, sickness and influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 08-FEB-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient got the vaccine with the insurance that she/he had. The reaction was the next day and it made her/him very sleepy and sick with the flu. It lasted one day and with redacted blood covering her/him. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
pain at injection site; joint pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 11th September 2019, refer case US2019222769 ).   On 15th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain and joint pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the joint pain was unknown.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and continued to experience joint pain and pain at the injection site.The patient reported that she was going to physical therapy for the joint pain all over her body. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up. Furthermore, the patient reported that she was aware of people that had the injection and experienced pain at the injection site, but no further information was provided.
Information has been received from a woman concerning a 5 year old black male with food allergies and eczema who on 04/10/2000 was vaccinated  SQ in his left thigh with the first dose of varicella virus vaccine live. there was no illness at the time of vaccination. On 01/12/2005 the pt developed vesicular eruptions was seen by the MD and was dx with chicken pox. Subsequently, the pt recovered form the chicken pox. Additional information is not expected.
Client reported feeling nausea to father and alerted RN. The client sat in the anti-gravity chair in a high-folwer's position. The client reported nausea, blurry vision, ringing in her ears. The client was provided an emesis bag and vomited into it. Vitals obtained at 6:46 PM were as follows: BP 120/39, HR 80, O2 99%. The client reported current ringing in her ears. She last ate at 4PM. At 6:49PM the client stated the ringing in her ears had resolved.  Vitals obtained at 6:54 PM were as follows: BP 95/60, HR 73, O2 99%. The client reported a history of "needle phobia." The client was provided juice and saltine crackers and began drinking the juice and eating the crackers.  Vitals obtained at 7:05PM PM were as follows: BP 98/64, HR 74, O2 99%. RN provided education to the client and her father regarding signs and symptoms of anaphylaxis, when to seek EMS, and V-safe. The client and her father voiced understanding of this education. Vitals obtained at 7:15 PM were as follows: BP 97/67, HR 80, O2 99%. The client ambulated unassisted with a steady gait out of the vaccination site at 7:17 PM.
Debilitating effects from vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: having Covid in 2020. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Debilitating effects from vaccine and booster".  Additional information: Patient will not get any further vaccinations due to horrible effects from having Covid in 2020 & then with each vaccine & booster the debilitating effects lasted for 2-3 weeks (original Covid lasted 2 months for me).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath upon standing or walking after 2nd dose; drop in blood pressure; Chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m20a and 048a21a) for an unknown indication.     The patient's past medical history included COPD.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-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 DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose). At the time of the report, DYSPNOEA (Shortness of breath upon standing or walking after 2nd dose), BLOOD PRESSURE DECREASED (drop in blood pressure) and CHILLS (Chills after 2nd dose) outcome was unknown.
Received second Hep B on 6/22/06.  Began to have dizziness and ataxia on approximately 7/27/06.  Also received varivax on 6/22/06. 10/26/06-seen in ER discharged from ER on 7/28/06 records do not indicate a hospitalization DX: headache, dizziness and giddiness and tension headache. Presented to ER with c/o headache, dizzy in morning. Seen in ER at 15:30. Felt good prior to presenting at ER.
1 am - woke with chills, achy joints, migrane-type headache. This continued throughout the night and in to the next day. Nausea and dry heaves. Very weak, needing assistance to get out of bed. Slept off and on. By late afternoon (4pm) feeling better. By 6 pm, just tired. And hungry!
Patient assumes vaccine was given too low, had a rash, and has experienced pain 25 days past injection date
Pt received FLUZONE HD and PNEUMOVAX 23 in Left Deltoid IM at 2PM on 9/2/10. On 9/3 - pt had lower backache and dizziness. On 9/4 at 8AM he noticed redness & tenderness. He came to see me approx 10AM. (L) anterolateral arm was red & warm from shoulder to elbow. Referred to urgent care. Received Cephalexin 500mg qid & sx resolved by 9/9.
Woke up with Chills and body aches at 3am, measured temp at the time was 97.5F by IR forehead thermometer.  By 7am temperature was up to 101.7F.  Tylenol taken and fever began to break within an hour.  Lots of fatigue for the rest of the day.
Administered Pfizer Bivalent for primary series second dose. Client needed monovalent vaccine to complete primary series and was given Bivalent Pfizer booster. No adverse effects noted within 15 minutes at clinic. Followed up with the father of the client on 11/10/22 after vaccine error administration and informed that the dose and formulation that was given counts as second dose in primary series and that the client is eligible for the booster dose in two months. Voicemail left on father's answering machine, no response or call back from father.
This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 11 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA006915: Original Case : 1804USA006915 US-009507513-1809USA013793: Original Case : 1809USA013793 US-009507513-1809USA013795: Original Case : 1809USA013793.
10 days after starting paxlovid (same day as positive covid test); 10 days after starting paxlovid (same day as positive covid test); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 31Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "10 days after starting paxlovid (same day as positive covid test)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not received any other medication within 2 weeks prior vaccination. The patient received treatment from 05Jun2022 to 06Jun2022 as a treatment for the events. It was reported that, the 10 days after starting paxlovid (same day as positive COVID-19 test), the patient had rebound symptoms of runny nose, cough, chills, fatigue. which were worse than original symptoms. The patient had no known allergies. The patient had no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-07-05 Onset of pain near left eye, vision blurring. 10-10-05 Saw primary care Dr. Dx was ophthalmic migraine. 10-12-05 Saw optometrist Dr was optic Neuritis. 10-20-05 Saw neurologist Dr. was optic neurotics. She wanted to admit me for IV steroid therapy. 10-20-05 Saw retinal specialist for 2nd opinion.
body aches; 98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit; headache; hand was numb for 6 hours; migraine; dizzy; administered downward in her left arm; wrist felt like some one was squeezing it; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm) and ARTHRALGIA (wrist felt like some one was squeezing it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 148A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Factor V Leiden thrombophilia (blood clot in left arm 3 years ago). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it) and HEADACHE (headache). On 01-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 01-Apr-2021, HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit) had resolved. Not Provided          This case was linked to US-irms-MOD21-097869 (E2B Linked Report). This case was linked to MOD-2021-090673 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received; adverse events and vaccination facility details were added.; Sender's Comments:  US-irms-MOD21-097869:irms
Monkey Pox vaccine given 9/24/22. 2 days later he started having headaches. Not severe but persistent going going on for 11 days.  No other neurological concerns No viral illesses  Seems related to vaccine but seemed to have lasted longer than expected
Throat tightness happened on 2/1. This lasted about 10 seconds. Then I became very dizzy. This lasted about 2 hours. Went to clinic. Everything checked out. COVID tested and sent home. Labs normal. Felt better 2/2, then on 2/3; had sharp stomach discomfort with severe nausea. No vomiting. Had EGD and colonoscopy on 2/9. All normal. Had abdominal ultrasound on 2/18. All normal. Still having mild to severe nausea every few days.
Unsure if this is just coincidental, but small sore bump/knot below clavicle. Skin does not appear to be red or swollen. Just bothersome. No fever or any other symptoms listed on information sheet.
Three hours after vaccination, client crying, vomiting, T 102ax, LE bilaterally warm and tender to touch with R>L.  All symptoms continued throughout the night.  Tylenol given with noted relief lasting 3 hours, ice applied to site with little relief.  Family physician notified by mother--recommended Tylenol and ice.  Mother states child is less restless 01/10/2006, LE remain tender to touch, denies redness, less crying noted this morning.
hives chest/stomach/back; severe bodyaches; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives chest/stomach/back), MYALGIA (severe bodyaches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives chest/stomach/back), MYALGIA (severe bodyaches) and PYREXIA (fever). At the time of the report, URTICARIA (hives chest/stomach/back), MYALGIA (severe bodyaches) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No relevant concomitant medications were provided. No treatment was received by the patient.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month. No treatment medication was reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Subsequently post vax, the pt experienced a rash and ten occipital nodes as seen with German measles.
Patient called to report about swelling on her arm one day after receiving COVID-19 vaccine (Administration date 4/18/21). Patient also mentioned having itching all over her arm and the injection site is warm to touch. She used cold compress, Benadryl and Tylenol for 2 days with no improvement in symptoms. Patient will be contacting her PCP tomorrow on 4/22/21 to be seen. We will follow up with patient tomorrow after her doctor's visit.
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm.  Vital signs within normal limits.  Patient improved.
PFIZER COVID 19 VACCINE GIVEN INADVERTANTLY INSTEAD OF MODERNA COVID 19 VACCINE
Left arm soreness; sharp pain radiating from left armpit to bottom of back ribcage; persistent orthostatic hypotension; sitting to standing dizziness/vertigo; headache; chills; sore neck and soreness at right armpit radiating to fingertips.
dizziness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 28- years-old) at 16:15 as a single dose for COVID-19 immunisation. Medical history was not reported. There were no known allergies to medications, food, or other products. The patient did not receive any medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19, since the vaccination. On 21Mar2021, the patient experienced dizziness at 16:30. It was unknown if the patient received any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness was not recovered at the time of report.  Information about batch number cannot be obtained. No further information is expected.
Pt presented to doctor's office after complaining to pharmacy about tender/red skin near site of injection that traveled down her arm. Redness start away from site of injection further down her arm.
Patient was administered original primary series covid vaccine instead of bivalent booster. Patient does not report any adverse events at this time.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tachycardia-Mild, Additional Details: pt heart rate increased to 140 for a few minutes, then returned to normal
This case was reported by a pharmacist and described the occurrence of swelling injection site in a female subject of unspecified age who was inadvertently vaccinated with Engerix-B for prophylaxis. The pharmacist reported that, on 16 August 2006, "a nurse accidentally administered (the 1st dose of) Engerix-B to a patient subcutaneously thinking the vaccine was a tuberculosis vaccine." The recommended route of administration of Engerix-B is intramuscular. On either 16 August 2006 or 17 August 2006, less than one week after vaccination with Engerix-B, the subject experienced swelling injectiong site and injection site redness. The subject was seen at a physician's office. The vaccination course with Engerix-B was discontinued. The outcome of the events was not reported.
Breakthrough COVID case: "Admit Date: 8/16/2021  Discharge Date: 8/24/2021 Reason for Hospitalization:  72 y.o. male with history of multiple myeloma on treatment and covid vaccine, admitted for covid 19 pneumonia.    Hospital Course by Problem List:  #COVID-19 pneumonia #acute hypoxemic respiratory failure ?Likely contracted virus approximately week PTA, COVID VACCINATED ?Recovered in ICU, then transferred to floor  ?Started Covid protocol -Decadron, Remdesivir ?Low suspicion at present time for secondary pneumonia ?Pro-Cal, lactate noted -Pulm followed -patient eager to obtain covid booster vaccine -RT eval- 4LPM oxygen   #Multiple myeloma ?Status post bone marrow transplant  ?Follows with Dr.  ?Oncology aware   #Bacteruria -without symptoms   #Hypocalcemia -replete prn  "
This spontaneous report as received from a nurse practitioner refers to a 18 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 09-JAN-2015 the patient was vaccinated with M-M-R II (lot number: K008814 with expiry date of 19-JUN-2016), (0.5 ml, once) and VARIVAX (Merck) (lot number: K010438 with expiry date of 22-JUL-2016) (0.5 ml, once), both subcutaneously. Concomitant medications were not reported. On 11-JAN-2015, 3 days after onset of therapy the patient experienced pink maculopapular rash from the groin to the abdomen and an ear infection. No treatment was given for the adverse events. The patient sought medical attention by visiting to the office. The outcome of rash maculopapular and ear infection was reported as not recovered/not resolved. The causality of the events with VARIVAX (Merck) and M-M-R II was not reported. Additional information has been requested.
Dizziness, then syncopal episode. Syncopal episode lasted for <30 seconds. Recovered fully within25 mins with just water and snacks.