chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not been able to move very well; thinking not very well; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unk dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: event outcome was updated
a week later contracted COVID from son; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son). At the time of the report, EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, COVID-19: (Positive) A week later (first week of may) he contracted COVID from his son.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that a week later (first week of May) he contracted COVID-19 from his son. He had mild case. He said he is three weeks past the onset of symptoms and is scheduled for the 2nd dose 20May2021.
Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines; Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines; Administered subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EN6204), on 23Mar2021 as dose 2, single (Lot number: EP6955), on 31Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 22Feb2022 as dose 4 (booster), single (Lot number: FR9729), all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "Diagnosed with DLBCL", start date: 2018 (unspecified if ongoing), notes: Was in remission at the time; "Had undergone CAR-T", start date: Nov2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Mar2021, outcome "unknown", described as "Administered subcutaneously"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" and all described as "Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines". Clinical course: The patient was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines. He has subsequently had a 5th jab on 28Oct2022.
Pt c/o "teacup size area which is very red, hard and sore to R/arm where Pneumonia shot was given".
Mild dizziness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Dizziness, Nausea and Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Nausea and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Mixed series. Patient is a  deployed to an environment.  Patient received Moderna vaccine on 21 April, was not available to receive second dose within required timeline due to mission requirements. Soldier then received Janssen vaccine on 21 May 2020.  Patient has had no adverse health effects.
This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 08 December 2009 an elevated Troponin, central laboratory level of 0.11 ng/ml. The subject had a rapid Troponin I level on 08 December 2009 that was within normal limits (negative). An ECG was performed on 11 December 2009 which was normal. A repeat Troponin on 11 December 2009 was < 0.10 ng/mL reported as normal. On study day 14, the subject had a left knee x-ray due to atraumatic pain that was within normal limits (WNL). The subject had no concomitant medications, no chest x-ray, no echo and no labs. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of elevated Troponin was considered an other important event and was possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
This solicited report has been received from a 61 years old male patient referring to himself, who was enrolled in a market research. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in December 2016, the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route not reported) as vaccine for shingles. On an unknown date in December 2016, the patient experienced an unspecified adverse event. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected as there was no consent to contact the reporter.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) at a healthcenter for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated at a hospital for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Dose 1 Moderna given subcutaneously in left arm. This patient has pain at the injection site. He reports no swelling, redness or decrease range of motion at this time.
Mother states patient has had diarrhea recently and wonders if this is related. No specific start date given. Waiting for call back from family
Extreme achiness, dizzy, weak. Missed 2 days of work. Recommended he see his physician.
Severe ache in upper arm for 1 month after vaccination. Then it subsided but could always feel a slight ache. Now recently over the past 6 months the ache has gooten worse to the point of limiting my range of motion. The ache is so bad it is effecting my sleep. I have photos of the vaccine record as well of my upper arm. The vaccine was given extremely high up on my arm.
sore throat; Hives all over; stuffed up nose; on and off fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Aneurysm cerebral since 2005 and Blood pressure.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever) outcome was unknown. Not Provided          Concomitant medication information was provided as Blood pressure medication.
It became difficult for me to swallow; my throat felt like it was burning.  I went directly to ER.
Erythematous wheal and flare pruritic. Prescribed Benadryl and Keflex.
This spontaneous report as received from a pharmacist refers to a unspecified patients of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored M-M-R II (lot, dose and route not reported). Concomitant medication was not reported. Additional information has been requested.
Client came in for TST reading and c/o (R) arm hurting it very  itchy. PHN observed arm to have big red area measuring 40mm by 35mm in size. Client also c/o that clothing touching arm hurt as well.
Patient developed redness, swelling and pain in left arm approximately 2 days after receiving vaccine.  Patient visited emergency room and was diagnosed with cellulitis.  Treated with Doxycycline.
Generalized bilateral rash affecting primarily the trunk, thighs and upper extremities. One lesion on (R) chin. Scattered discrete papular lesions with occasional excoriated vesicles. No treatment. No school until all lesions are dry & scabbed over.
Patient was given his 1st dose of HPV vaccine. Immediately after injection, his eyes rolled back. He was not responding to mom and medical assistant as if he could not hear or see them.  He laid down but it took about 2 minutes for him to become aware of his surroundings again. After recovering he recounted that he started seeing white spots in his vision and his hearing was muffled.  He also felt dizzy. After water, candy and laying down for 15-20 minutes, he felt better and had no further issues.
Reporting on the 2nd dose.  Had mild rash after first vaccine, but extended Rash on the front of my body - including my chest, stomach and underarms for 4 days after 2nd dose.
Major depression. I suffered through a false positive syphilis result from the covid vaccine. I tested positive for syphilis on Oct 12, 2021 . Reactive (STS) 1:16 DILS. Test result was reported to the health department on October 15, 2021. I was not informed of this lab result January 14, 2022 when I reported to the Department of Health to repeat the syphilis blood test. I had the blood test done on January 14, 2022 I had a FTA-ABs syphilis biological test done which gave a negative result: Non Reactive FTA-ABS. NON-Reactive. Test result was on January 20, 2022
Starting 04/21/2022, I lost my sense of taste and smell, then developed a fever and body aches. I tested my self that morning and was COVID positive. The fever went away at the end of the day. I had fatigue and brain fog, and felt very tired. I saw the doc on 04/22/2022 via a telehealth appointment. He prescribed Paxlovid and I started it that night. The same symptoms persisted at varying amounts until about 04/27/2022. I tested negative on 04/28/2022. I felt back to normal by 04/30/2022. I do not feel that the Paxlovid helped my symptoms but they did not get worse.
immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-571010, MOD-2022-570742, MOD-2022-571011 (Patient Link).
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
SEVERE Headache lasted 24 hrs; general malaise, severe leg cramps and pain, body/skin pain like with a Fibro Flare.  Could barely walk around house with the amount of pain.  Had exact reaction from Vax #1 only it all lasted longer.  Difficult to sleep due to pain.  1300 mg Tylonal 8 hr barely touched the headache etc pain.
This spontaneous report as received from medical assistant refers to patients of unknown age. On 25-JUL-2013 the patients were vaccinated with GARDASIL (lot # H020901, exp. 05-JUL-2015), 0.5 ml, subcutaneously. The vaccines were exposed to 79F for a maximum of 45 hours and were unspotted due to stability data not being available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
States she had large red area 3 x 2", painful arm lasted 5 days 10/6/16 - not much better, had fever, dizzy first 2 days. Took OTC meds. All resolved by 10 days.
Rash -  all over front torso - only discovered on my son at bedtime, although he said it was present in the early afternoon.  Will monitor, if still there in the morning will call pediatrician
I had a runny nose, cough, that continued for three or four days despite my having taken over the counter medication. I had taken two home COVID-19 test that came back negative. I went to a local clinic to try to find out what it was that I had. I was told that I had contracted a virus, I should take Mucinex, drink plenty of fluid and get rest.
had 1st bivalent in September and was infected with Covid last month; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had 1st bivalent in September and was infected with Covid last month) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (had 1st bivalent in September and was infected with Covid last month). At the time of the report, COVID-19 (had 1st bivalent in September and was infected with Covid last month) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by reporter. Suspect product dosage text was reported as initial booster. It was reported that patient had Paxlovid and had no symptoms. No treatment information was provided.   Reporter did not allow further contact
The patient was administered the monkeypox Jynneos vaccine intradermal of 0.1 mL, instead of receiving the CDC guidelines for individuals younger than 18 years of age which is 0.5 mL dosage with route of subcutaneous.
Patient received incorrect vaccine for COVID-19 booster. Patient was 16 years old at the time of vaccination and should have received Pfizer, not Moderna.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna vaccine (lot # 048C21A) was received at the pharmacy on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to another pharmacy where 20 doses were administered beyond use date.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient received treatment with anti viral drug paxlovid for covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Medicals conditions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Medicals conditions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Medicals conditions). At the time of the report, ADVERSE REACTION (Medicals conditions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
localized 5cm diameter erythema, skin temp hot @ site; no induration, no pain, moderate swelling, no systemic effects; 2cm diameter ecchymosis @ inject site, no other s&s;
Expired vaccine given, pt reports no adverse effects, pt states they will return to clinic for flu vaccination this month
Pt reports severe muscle aches, nausea and vomiting, dizziness, and weakness which persisted until today. Pt has given symptom management medications such as antivert, zofran and Acetaminophen.
Mother reported to nurse within 20-30 minutes after immunizations right arm swelling, hives, redness, slight itchy.  Child nervous, crying.  Ice pack applied to right arm at site of MMR injection.  Child complained of throat feeling funny.  Expectoratal white sputum.  No swelling of throat noted.  Treated with Benadryl, symptoms subsided within 30 minutes.
Body/muscle aches, joint pain/stiffness, dizziness, runny nose, fatigue.
Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side Effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side Effects). At the time of the report, VACCINATION COMPLICATION (Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.