chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling on left side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling on left side of face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PARAESTHESIA (tingling on left side of face). At the time of the report, PARAESTHESIA (tingling on left side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was  provided by the reporter. No concomitant medications was reported by the reporter.
a rash yesterday 17Apr2022 on the right side of his body, shoulder, joint where arm bends, and on stomach; a few spots on his left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (3rd Dose/Booster, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: MACULE (non-serious) with onset 17Apr2022, outcome "unknown", described as "a few spots on his left leg"; RASH (non-serious) with onset 17Apr2022, outcome "unknown", described as "a rash yesterday 17Apr2022 on the right side of his body, shoulder, joint where arm bends, and on stomach". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He started with a Migraine headache, loss of appetite, weakness, vomiting, and he had cold sweats and body tremors. He has had a little of dizziness and loss of balance.
Patient went to the Urgent Care two days  after receiving the Shingrix vaccine with shingles like symptoms.  She was diagnosed with shingles presenting with a painful, burning rash.  She was given rx for Valtrex 500mg
Patient received HIB #4, MMR #1, flu shot, and Prevnar. On 12/20/04, rash developed. 12/29, fevers off and on over last few days.
Flu symptoms the day after the shot. Pain bad redness in the shot arm, increasing two days after the shot. Itchy and painful at touch
Swelling and pain in deltoid muscle, Headache, nausea, vomiting. Got HPV9 vaccine yesterday morning at about 10:20 am when she came in for left ankle pain. Later that evening about 19:00 hrs she started feeling pain in her arm, fever chills, headache and nausea with vomiting. Vommited twice last night, and still feels nauseous on exam today. In addition, has frontal throbbing headache denies photo/phonophobia and no pmhx of migraine headaches.
Pt reports altered mental status, hallucinations, shortness of breath and anxiety...reports frozen left shoulder in addition to flu symptoms.
Her Rheumatoid Arthritis feels so much better; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Lot number: EN6206) as dose 1, single and administered in arm left, administration date 27Mar2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid Arthritis; "Liver Enzyme" (unspecified if ongoing), notes: Methotrexate: Dosage is now 3 tablets a week as of today due to her liver enzymes. Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis (ongoing); PREDNISONE taken for rheumatoid arthritis (ongoing); FOLIC ACID taken for rheumatoid arthritis (ongoing); NAPRELAN taken for rheumatoid arthritis (ongoing); REMICADE taken for rheumatoid arthritis (ongoing). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "Her Rheumatoid Arthritis feels so much better".  Additional Context: Calling about the Covid 19 Vaccine. Stated that she would like to report a good thing about her vaccine. Stated that she has severe Rheumatoid arthritis and after receiving the vaccine she feels so much better. States that she almost doesn't even need her other medications. She wanted to call and report this in case Pfizer wants to look into it. Stated that she takes Methotrexate, and her liver enzymes were up so they had to decrease her dosage. The last time this happened her rheumatoid arthritis flared up, but this time she hasn't really even noticed that her dose has changed. Caller does not have the full contact information to provide for the prescribing physician. Stated that she has an appointment with her Rheumatologist on the 17Dec2021. Stated that she never had any of the muscle aches and headaches that everyone else seemed to be reporting; she was feeling good after getting her vaccine, then after the 2nd dose she felt even better, so she was excited to get the booster shot. Booster received on 07Sep2021. Lot: FE3592, Expiry: Unknown. Stated that she received all 3 doses in her left arm. Caller stated that the last time she saw her Rheumatologist she asked him to just prescribe her the vaccine every 3 months instead of the Remicade because it helped her so much. Concomitant medications: Stated that she has missed a dose of her Remicade, but that she still isn't feeling anything which was good. Clarified that she had to take antibiotics for a sinus infection recently, so she had to stop the Remicade and the methotrexate, but still has had no problems with her Rheumatoid arthritis. No further details provided. No prior Vaccinations within 4 weeks, has not had any other vaccines since childhood. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician referring to a female patient between "13 or 14 years old". The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On approximately 09-OCT-2017 (reported as "about 2 weeks ago"), the patient was vaccinated with GARDASIL 9 first dose, intramuscularly (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. Immediately following the vaccine administration, the patient experienced headache, then "passed out, fell, and hit her head and had a gash on her head. Patient was observed in the office where she recovered completely without any treatment. Subsequently, the patient was brought back in for a follow-up visit on an unknown date (reported as "a week later") she was still "doing fine." The physician did not mention the causality assessment between the events of headache, loss of consciousness and head injury and GARDASIL 9. Upon internal review, loss of consciousness was determined to be medically significant.
Thursday late night started have pain in both feet.  Friday pain getting worse.  Saturday could hardly walk. Saturday night was getting unbearable.  Temperature went from 97.6 to 100.3, then 100.8 and had chills and fever.  Extremely rare for me to have chills, etc.  Sunday could not walk on feet.  Used wheelchair to get to bathroom, etc.  Sunday night, I called the urgent care who recommended me to ER.  03/14 admitted to ER.  ER did xray of foot to eliminate break.  Concluded POSSIBLE cellulitis.  Treated with antibiotics.  kept overnight for observation.  Monday 03/15 pain was severe but could walk to bathroom.  Released Monday 03/15 at @ 5:00 pm.  Pain subsided after 4 days.
She received the shot walked a couple steps had a blank stare on face sat her in a chair where she sat for a couple seconds and just stared at me then head jerked and right hand curled and eyes rolled back into head. tried shaking her to respond she passed out .She came to opened eyes wasn't speaking but followed my command to spit out gum then again went limp with head shaking and hands twitching. Got her to the ground with help and called 911. She laid on ground then came to . She did not remember incident but was responding appropriately to questions. drank orange juice and placed ice bag under neck while laying. By the time paramedics arrived she was awake and appropriate.  Pulse ox, blood sugar and EKG normal.  Blood pressure was low but not unusual for her.  Prior to shot she was well hydrated and had eaten.  After being checked out by paramedics we denied need to go to hospital and she did walk out on her own.  Observed her closely over night and had no further symptoms.
Swollen arm, hot, red and tight. Fever and nausea. Went to ER, treated with rocephin and amox.
17-year-old patient was given the first dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patients' medical history was not provided. Concomitant product use was not provided.  On 17 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   The reporter was made aware of a 17-year-old that was given the first dose of the vaccine at his clinic.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, 17-year-old patient was given the first dose, was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 023M20A) with no associated AEs reported.; Sender's Comments:  MOD-2021-015022:different patient, different reporter (from same institution) US-MODERNATX, INC.-MOD-2021-015022:different patient, same reporter
Pentacel was expired when give.  Dose expired 10/11/2020, was given on 10/14/2020.
red blotchy rash, fever, runny nose, cough, lethary. Parents have administered tylenol, motrin and hydrocortisone for comfort.
Family, daughter, reports that patient felt "a little sick" on 2/24/21 and "sick" on 2/25/21. She reports that approximately 1 week later her father had weakness and and frequent falls, was evaluated in the E.D. and ultimately admitted to hospital (3/4-3/15) Patient was discharged to nursing home where he died on 3/16/21.
1 1/2" x 1 1/2" red and swelling at injection site with pain. Injection given 7/19/02 and her reaction 8/01/02. Started like a red bump then turned into a blister.
Approximately two weeks after second injection on December 5th developed ringing in ears.  Has not stopped and never had any tinnitus(or any health issues) previously.
No adverse event; The patient was supposed to received the new bivalent vaccine, there was a switch up and the patient received the monovalent vaccine as booster; patient received 0.5 ml of monovalent vaccine as booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient was supposed to received the new bivalent vaccine, there was a switch up and the patient received the monovalent vaccine as booster), INCORRECT DOSE ADMINISTERED (patient received 0.5 ml of monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053B22A, 076C21A, 010M20A and 010M20A) for COVID-19 vaccination.     Patient had no allergies to (medications, food and other products). It was unknown that patient has ever had COVID + test or diagnosis. It was unknown that patient received other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #).  Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient was supposed to received the new bivalent vaccine, there was a switch up and the patient received the monovalent vaccine as booster) and INCORRECT DOSE ADMINISTERED (patient received 0.5 ml of monovalent vaccine as booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient was supposed to received the new bivalent vaccine, there was a switch up and the patient received the monovalent vaccine as booster), INCORRECT DOSE ADMINISTERED (patient received 0.5 ml of monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (The patient was supposed to received the new bivalent vaccine, there was a switch up and the patient received the monovalent vaccine as booster) and INCORRECT DOSE ADMINISTERED (patient received 0.5 ml of monovalent vaccine as booster).    No concomitant medications was reported.  Patient was taking other medication. Patient's HCP was aware of the incident.  No treatment medication was reported.   This case was linked to MOD-2022-655840 (Patient Link).
"Pimples" that are itchy appeared on patient's lower back approx. 1 week after flu shot. Also has redness/dryness around injection site. He is seeing his doctor later this week to be evaluated.
person who gave the shot gave it way too high with no adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from via other health professional (under reference number: US-SA-SAC20211001000464).  This case involves Adult and unknown gender patient who was administered  INFLUENZA VACCINE (product administration error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It is unknown if the patient experienced any additional symptoms/ event.   It is unknown if there were lab data/results available.  It was case of an actual medication error due to product administration error (latency: same day).  At the time of reporting, no adverse event was reported.  There will be no further information on the lot number for this case.  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 the 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.
I estimate the date reaction began. But around that time I began having high blood pressure even though I was on 10mg of Lisinopril. Still ongoing now even though my doctor doubled the lisinopril, and last week changed med to Losarton 50 mg. Now this week this  is doubled to 100 mg. I never had this much high bp before. Maybe it was the Moderna. I do not know what has caused it.
Patients First dose 01/13/2021 and second dose of Moderna Covid 19 vaccine was administered on February 11th.  Patient developed pulmonary embolism in both lungs and hospitalized February 25th.    Patient later developed PCP Pneumonia and died March 23rd.
Became hypotensive, fell & broke ankle at home, evening, after receiving flu vaccine at 11:30 that morning.
Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and DIARRHOEA (Diarrhea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (Vomiting) and DIARRHOEA (Diarrhea). At the time of the report, VOMITING (Vomiting) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Diabetes medications.  Treatment medications was not given.
Erythema and induration of entire lateral surface of (R) upper arm; tender on palpation of erythematous area.
Large patches of a red rash only on left side of face with significant swelling in left eye.  Slight itching, no pain.  Swelling of left eye lid much worse 36 hours later.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269); via an unspecified route of administration in the left arm on 19Feb2021 at 01:00 PM (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient received second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN); via an unspecified route of administration in the left arm on 12Mar2021(Lot Number: EN6202) as a single dose. The patient reported allergies to SULPHA DRUGS (MANUFACTURER UNKNOWN). Concomitant medications included Synthroid (MANUFACTURER UNKNOWN) for an unknown indication and unknown date and Triamterene (MANUFACTURER UNKNOWN) for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 19Feb2021, the patient experienced diarrhea. It was unclear if the patient received any treatment for the event. The clinical outcome of diarrhea was not recovered. No follow-up attempts are possible. No further information is expected.
Covid 19 booster vaccine; Fever of 100.5 after booster; Feels weak after booster; Feels overheated after booster; Chills after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid 19 booster vaccine"; PYREXIA (non-serious), outcome "unknown", described as "Fever of 100.5 after booster"; ASTHENIA (non-serious), outcome "unknown", described as "Feels weak after booster"; FEELING HOT (non-serious), outcome "unknown", described as "Feels overheated after booster"; CHILLS (non-serious), outcome "unknown", described as "Chills after booster". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.   Additional information:  Caller asks what should she do for that, maybe besides taking a Tylenol for the fever Caller does not states that she has taken Tylenol as of yet.  Caller states the vaccine instructions that she received are confusing and they do not instruct about the booster. Caller asks how will she feel. Caller declines to complete a safety report. Caller states she is starting to have chills. Caller states she woke up in the morning feeling this way.
HEADACHE, BODY ACHES, FATIGUE, PAIN AT THE INJECTION SITES. ADVICED PATIENT TO TAKE TYLENOL FOR ALLEVIATING THE PAIN.
macular neuroretinopathy type symptoms in the right eye only, resulting in persistent palinopsia/photopsia-like symptoms for approximately 6 weeks duration.  Symptoms gradually resolved over 6 weeks, and caused severe anxiety due to concern that the symptoms could be permanent and result in permanent visual disturbance.
Onset was within 1 hour of vaccination. Child could not walk. It was not numbness of limbs - it was the inability to ambulate - paralysis.
Rash across right side of chest, under arm pit around rib cage under shoulder blade up right side of spine to just below neck. Got shot on Fri 6th at 9:56 dr gave me acyclovir 800 mg. I still have red rash on right shoulder blade 4/3/2015.
Headache, chills, weakness, Extremely sore left arm, muscle aches throughout the rest of the body, fatigue, lack of concentration began on 11/6/2018 at approximately 6 pm and continued to 11/8/2018 at approximately 8 am or sometime during the evening while sleeping. I still feel some weakness this morning and some muscle pain and a very slight headache, but I will be able to go to work today which was impossible yesterday.