chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in his legs/feet; stiffness, lost flexibility, stiffness in arm and leg; face was flushed and he was red; could not remember how to take Tylenol; could not move arm and leg, could not lift arm; muscle pain; Urinary incontinence; very very weak; confused; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet) and MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis and COVID-19 (Tested positive for COVID-19 last year). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (very very weak) and CONFUSIONAL STATE (confused). On 21-Apr-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol), HYPOKINESIA (could not move arm and leg, could not lift arm) and MYALGIA (muscle pain). On 22-Apr-2021, HYPOKINESIA (could not move arm and leg, could not lift arm) had resolved. At the time of the report, URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol) and MYALGIA (muscle pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degrees Fahrenheit and 101 (High) 101 degrees Fahrenheit. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 last year.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment drug included as IV hydration infusion.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: reporter contact details were added, route of administration for suspect drug is added, concomitant medication is added, Event was added.Dechallenge Results, Rechallenge Results was updated.
Diarrhea; nausea; This is a spontaneous report from a contactable other hcp.   A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular from 28Dec2020 09:00 to 28Dec2020 09:00 single dose for COVID-19 immunisation.  Medical history included haemochromatosis from an unknown date, rubber sensitivity from an unknown date. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), trazodone, quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT). Vaccine location was arm left. The patient experienced diarrhea on 29Dec2020 10:00, nausea on 29Dec2020 10:00.  The action taken in response to the events for BNT162B2 was not applicable. Events outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a 2 week old patient. On 21-OCT-2018 the patient was vaccinated with M-M-R II for prophylaxis. On 21-OCT-2018, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not assessed to M-M-R II.
I have a cyst developed on my arm; Injection site is very swollen and very painful; Injection site is very swollen and very painful; redness on my forearm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration from 02Jan2021 in the morning (yesterday of 03Jan2021) at single dose for covid-19 immunization. Vaccine location was upper arm and it was the first dose. None medical history. The patient's concomitant medications were not reported. The patient start to develop some redness on her forearm, injecting site is in her upper arm. Patient have a cyst developed on her arm. The cyst, it is on the same arm but on the forearm, it (cyst) was very small like pen tip right now it is like a 2 mm or like 4 mm. She was not sure if it is going to get dissolve or not but it is not recovering for now and it had some yellowish fluid inside the cyst. Patient also stated the injection site was very swollen and very painful. Patient stated she took one Tylenol 400 mg last night and took another one this morning. Patient think she had the lab test for Covid, PCR test within two weeks. The outcome of event "cyst on arm" was not recovered, the other events was unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 13-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
She did experience flu like symptoms after the vaccine. Then, approximately one month after the vaccine she started experiencing chest pain. Then it progressed more and more chest pains. On 6/18/2022, she went to the ER. While at ER she had EKG, blood work, chest x-ray, stress test, and electrocardiogram. The echocardiogram notated something. Then on 6/28/2022, she had a heart cath performed. There was a minor blockage that shouldn't cause the chest pain. The doctor was not for sure why she is having these issues.
About 40 minutes after receiving vaccine I began to feel as though I had a lump in my throat and my coworkers said I looked very red. I immediately went to a store and purchased fexofenadine. I took one and within an hour I did not feel the lump anymore. I had a similar reaction once, to allergy shots, and the fexofenadine stopped the reaction.
mom states golfball size area of red raised bumps, tender but w/o itching @ vax site;noticed secondary post vax;pt would not allow mom to touch, move arm
9/10/19: Seen and diagnosed with local reaction 9/11/19: (+) extension of area with fever dx'd with cellulitis
her arm where she had the injection under her armpits was swollen by her lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 11Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202), administration date: 22Mar2021, when the patient was 63-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2593), administration date: 29Oct2021, when the patient was 64-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6207; Date of administration: 13Jun2021 or 13Apr2021- Patient can not tell if the month is a 4 or 6), administration date: 2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Jul2022, outcome "not recovered", described as "her arm where she had the injection under her armpits was swollen by her lymph nodes".  Additional information: Patient was fine on 11Jul2022 and 12Jul2022 but woke up on 13Jul2022 morning and her arm where she had the injection under her armpits was swollen by her lymph nodes. This was not hurting but was still swollen in morning. She thought that swelling was the same but clarifies yesterday (as reported) was a little more puffy. The swelling had improved just a tad but was still there. She could still feel the swelling and saw the difference when she raised her hands and looked at both arms. Her armpit was visibly swollen. She just took her regular medications that her primary care prescribed and did not provide her medications. Indication as reported by the primary source or Indication for use in the case also reported as Diabetic. Additional vaccines administered on same date of the Pfizer suspect reported as no. Prior Vaccinations (within 4 weeks) were also reported as no. Adverse events following prior vaccinations mentioned as none.
Mom reports child had 1st seizure 6-3-09 at 2030 lasting approx. 1 min. taken directly to hospital ER. CT of head and CXR done.  Ativan and Tylenol supp. given.  Temp 101.7 CT and CXR WNL. Sent to Hosp per parents request.  Had 3 min. seizure in ambulance to hosp.  EEG done, normal.  Child is allegic to PCN.  Was given Omnicef by PCP on 5-27 for ear infection.  Mom stopped giving medication on 6-3. Discharged child with RX of Cefdinir 125mg 2.8ml bid x 10d. Child was afebrile at time of vaccine administration.  Parent agreed no temp prior to.
Info has been received from a woman in a physician's office concerning a 73 year old male pt with no past medical history and no known allergies, who on 10/18/2002 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included moexipril hydrochloride (UNIVASC) and morniflumate (FLOMAX). It was reported that 24 hours after receiving the vaccination, on approx 10/19/2002, the pt developed a swollen right arm. It was also reported that the pt developed redness, and an unspecified site was hot to touch. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. Additional info has been requested.
PER PT DAUGHTER. RECEIVED VACCINE AND HAD NORMAL SORENESS OF SITE. AFTER 5 DAYS, HAD SEVERE PAIN IN LOWER EXTREMITIES AND HAD TO GO TO HOSPITAL  ER 3/5/21. WAS GIVEN STEROIDS AND NSAID AS WELL AS PAIN SHOT DURING VISIT BUT DIDN'T HELP PAIN MUCH. FELT A LITTLE BETTER NEXT DAY BUT WENT TO PRIMARY CARE AND WAS TOLD TO STOP MEDICATIONS FROM HOSPITAL. NOW WAITING FOR ULTRASOUND. DURING THE COURSE HAS EXPERIENCED SEVERE PAIN, SWELLING, HOT FLASHES, NAUSEA, AND LOSS OF APPETITE.
This spontaneous report as received from a registered nurse refers to a 12 years and 11 months old female patient. The patient was vaccinated with dose 1, dose 2 and dose 3 of LIQUID PEDVAXHIB in 2000 (lot #, dose and route not reported). On 03-JUL-2012 the patient was inadvertently vaccinated intramuscularly with a fourth 0.5 ml dose of LIQUID PEDVAXHIB, instead of GARDASIL. At the time of the report no adverse effects were reported. Additional information has been requested.
Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium
An 85 year old female patient refers to a headache after receiving the first booster of the Moderna vaccine.
About 0400 hours became extremely hot, dizzy, and nauseated.  Threw up and then became short-of-breath.  Felt hot and fever went up to 102.6 (oral).  Charge nurse was notified and the house supervisor.  Was sent home and told to fill out this form.
Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in the right arm on 16Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included asthma/allergies and eggplant/zucchini sensitivity. The patient's concomitant medications were not reported. The patient experienced sore at injection site (felt like bruise) on 17Jan2021 that lasted approximately 36 hrs. The patient was okay by 18Jan2021 afternoon. Outcome of the events was reported as recovered on 18Jan2021. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior vaccination and has not tested for COVID-19 post vaccination.
Information has been received from a physician for the merck pregnancy registry concerning a 16 year old female with no previous medical history or no drug allergies, who on 18-MAR-2008 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. On 14-Apr-2008 the patient found out that she was 7 weeks pregnant. The patient also experienced soreness at the injection site. Unknown medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Redness, mild swelling with blisters on left arm where vaccine was given 1 week ago.
Redness in face, colicky, would not eat, could not sleep for more than an hour. Back arching every time we picked him up.  eyes squinting, holding his head, generally uncomfortable in his body.  Could not comfort him.
Itching on the midsection of the body; Broke out on both legs/Broke out all around on the waist/Breaking out on the face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the midsection of the body) and RASH (Broke out on both legs/Broke out all around on the waist/Breaking out on the face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itching on the midsection of the body) and RASH (Broke out on both legs/Broke out all around on the waist/Breaking out on the face). The patient was treated with PREDNISONE for Adverse event, at a dose of 40 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on the midsection of the body) and RASH (Broke out on both legs/Broke out all around on the waist/Breaking out on the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received on 07 Aug 2021 and outcome was updated from unknown to Resolved.Correction made from initial version: Reporter's contact detail and Product indication was updated/corrected. All the three events Broke out on both legs, Broke out all around on the waist, Breaking out on the face, were merged into one.
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were provided. It was reported that patient did not take pfizer/biontech vaccine, instead took moderna vaccines. No treatment information provided.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a dose of mRNA-1273.222  vaccine administration. No diagnostic result or treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
As reported by patient's son, extreme throbbing pain in arm after vaccination.  Went to ER that same night (1/23/20) and received morphine for pain, which resulted in widespread itching.  Saw urgent care the next day (1/24/20), received Zpak, Benadryl, Hydrocodone.  No swelling or bruising at injection site.
Information has been received from a Registered Nurse concerning an unknown number of patients, of unspecified ages and genders.  The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (lot # M045204, expiration date: 11-NOV-2018; lot# M042495, expiration date: 19-OCT-2017; lot# M041081, expiration date: 06-OCT-2018) (dose, frequency and route of administration were not reported). No adverse effect was reported in any of the patients. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 8.6 Farentheit degrees for 45 minutes. A prior temperature excursion was not reported. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1705USA009998:
COVID Toe like symptom (purple toes on left foot); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 (Lot number: FL3198) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "Heart rhythm issue" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: some antibiotics" (unspecified if ongoing); "Known allergies: some sea food" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0175, Location of injection: Arm Left), administration date: 28Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Low blood platelets count", "Liver enzyme number increase"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Low blood platelets count", "Liver enzyme number increase". The following information was reported: BLUE TOE SYNDROME (non-serious) with onset 26Feb2022 22:00, outcome "unknown", described as "COVID Toe like symptom (purple toes on left foot)". It was unknown if therapeutic measures were taken as a result of blue toe syndrome.  Additional Information: If other vaccine in four weeks: No. Other medications in two weeks: None. Covid prior vaccination: No. Covid tested post vaccination: No. Patient sated that pictures were taken to be showed to primary doctor for seeking medical treatment/advice.  No follow-up attempts are possible. No further information is expected.
Adacel vaccine was given to a 72 year old patient in error with no adverse event; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist via agency (reference number: 00326385).  This case involved a 72 years old patient (gender unknown) who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site, in error, for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration. (Latency: on the same day of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
She fell down in the afternoon on same day; she got hurt; Patient started with headache on same day after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (She fell down in the afternoon on same day), PAIN (she got hurt) and HEADACHE (Patient started with headache on same day after receiving 1st dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ESCITALOPRAM, AMLODIPINE and HCTZ for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced FALL (She fell down in the afternoon on same day), PAIN (she got hurt) and HEADACHE (Patient started with headache on same day after receiving 1st dose). The patient was treated with NAPROXEN at an unspecified dose and frequency and CYCLOBENZAPRINE at an unspecified dose and frequency. At the time of the report, FALL (She fell down in the afternoon on same day), PAIN (she got hurt) and HEADACHE (Patient started with headache on same day after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080001 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080001:Cross-Linked case