chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP stated it was administered to 31-year-old patient who needed for school on 8/31/2023. No other AE reported. No PQC repo; HCP stated it was administered to 31-year-old patient who needed for school on 8/31/2023. No other AE reported. No PQC repo; This spontaneous report was received from a pharmacist referring to a 31-year-old patient of unknown gender. The patient0s concurrent conditions, medical history or concomitant therapy were not reported.  On 31-AUG-2023, the patient was vaccinated with a dose of measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, lot# X012186, expiry date 16-JUL-2024, recombinant Human albumin (rHA) (dose and route of administration were not provided) (product administered to patient of inappropriate age).  Lot No. X012186 has been verified to be a valid lot number for measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, expiration date reported as 19-JUL-2024, but upon internal validation established as 16-JUL-2024.  No other adverse events reported. The pharmacist also inquired if measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) could be given Intramuscular or Subcutaneous.
Cough; Phlegm; Hoarse voice; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine allergy) and Iodine allergy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice). At the time of the report, COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Received TCR form: Outcome updated.
Received MMR 4/30/2008 3 days after, developed rubella like rash
Day 1 (day of vaccine): Red and swollen point of injection. GI distress Day 2: Red, swollen, hot point of injection. Swollen and painful through the arm. GI distress. Exhaustion and lighted headed. Full-body joint pain. Swollen glands in the throat. Day 3: Red, swollen, hot point of injection. Swollen and painful through the arm and collarbone. GI distress.
MY LIPS AND MOUTH ON THE RIGHT SIDE OF MY FACE WENT NUMB WITHIN 8 MINUTES OF VACCINATION.  THE NUMBNESS THEN SPREAD TO MY RIGHT CHEEK TOWARDS MY EYE.  THE NUMBNESS LASTED APPROXIMATELY 6 HOURS THEN WENT AWAY.  I REPORTED IT TO THE PHARMACIST WHO TOLD ME I WAS PROBABLY GETTING A COLD SORE.  I DO NOT GET COLD SORES.
Ipol was administered inadvertently instead of Tubersol/No AE; Ipol was administered by intradermal route/No AE; Initial information received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old female patient who was inadvertently vaccinated with vaccine IPV (VERO) [IPOL] (lot P1F541M and expiry date 07-Dec-2020) via intradermal route in the right forearm instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 23-Jun-2020 (wrong product administered and incorrect route of product administration).   The patient's medical history, past medical treatment(s), vaccination(s) and  family history were not provided. No concomitant medications  were reported.   It was an actual medication error case due to wrong vaccine administered and inappropriate route 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 holders 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
22 minutes after receiving Vaccine I started feeling brain fog, feeling pain in entire body, pain in left arm and chest. My husband drove me to the ER, and I collapsed. Gave me pain medication for pain. Slept for about 2 weeks. Out of work for three weeks.
Ringing in left ear, which began abruptly about 30 hours after vaccine was administered.  Manifests as a soft, high-pitched, slightly oscillating tone.  Has persisted ever since (almost 8 days so far).   It does not interfere with my hearing ability (as far as I can tell) but is noticeable and distracting.
Patient received Moderna Booster. C/O redness on upper extremeties, with blanching on palpation. Pt assessed by RN and RN. No SOB, itching, or warmth reported by patient. Airway patent. Pt states baseline BP is at 150 systolic. Upon assessment VS were BP 198/80, 02 sat 99%, HR 62. Pt advised to be under observation for 40 min. VS stabilized at BP 154/86, HR 60, o2 98%. No warmth, swelling in oral area, itching, or SOB reported at time of discharge. Spoke with husband on phone for update. Pt advised to call Urgent Care, emergency, or ER of symptoms worsen. Incident occured on 3/11/21, report submitted on 3/17/21.
Numbness, tingling, slight burning sensation, and weakness starting with my feet worked its way up into legs and then from the hands into arms. The severity persisted through the night along with body tremors, which was thought to have been due to nervousness. The next morning symptoms of tingling and weakness in arms and legs remained, and have since been present with back pain, heart palpitations, rapid heart beat, and swollen lymph nodes. Some days it is more pronounced than others.
Patient developed tingling throughout her left arm and hand shortly after injection. She denied any strength or sensation deficits.  She reported that the symptoms were relatively minor but were not improving. She was encouraged to follow up with her PCP.
t102 ax 4 days; nose & throat swelling w/rattling breath; bright red rash, blister & peeling of penis (day 9 of rash) Seen by MD & told it was MMR rxn; pt given DPH;
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of M-M-R II (lot # H017433, expiration date: 20-SEP-2014; dose and route not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Post vax, the pt's left deltoid became sore; it comes and goes and feels like a strong punch in the arm. Pt takes acetaminophen for the pain.
Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RIGHT LEG, ERYTHEMATOUS RASH, 3 CM, NONBLANCHING (SITE OF INJECTION)  BLISTERS ON HANDS, ERYTHEMA WITH SKIN PEELING NO DISCHARGE AND NO STREAKING.
swollen red hands, feet, face - esp rt side of body w/rt facial nerve weakness; (bell's palsy);
On 05/28/2022 I had my 4th vaccination with Pfizer for COVID-19. On 06/17/2022 I woke up congested and felt different then allergies. I developed cough. On Saturday I had really bad body aches and had a COVID-19 positive result. I slept on and off for 24 hours. By Monday I felt just fine and took another COVID-19 test which was negative.
Approximately 9 months post vax, the pt experienced pain in both knees, lower back, and on the plantar surface of her left foot. The pt added that she has gone to many physicians all of whom have determined that she has a severe condition of arthritis. She was started on Vioxx by a neurologist but it was discontinued due to anemia and suspected but unconfirmed gastrointestinal bleeding. The pt noted the pain is increasing, she is having difficulty walking and she is in bad pain most of the time.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/2/2021 and 3/24/2021.  Presented to ED on 10/22/2021 for evaluation of weakness that resulted in falls yesterday and today with associated upper back and neck pain. Pt is unable to give a complete ROS. States that he got COVID from his wife but does not know when his symptoms started, endorses a cough with green sputum for "a long time", weakness, and upper back and neck pain from fall. He states that he is so weak he is unable to stand up. Denies n/v, diarrhea, CP, SOB, ABD pain, ROS otherwise limited. PT extremely HOH. EMS reported O2 sat 90% on RA at home. Patient started on dexamethasone and remdesivir. Further history from patient indicated his prior diagnosis of bacterial of PNA was done over the phone. His imaging findings were consistent with bacterial PNA, he had no WBC and a relatively unimpressive procal, bacterial PNA was unlikely so abx were stopped. The following day patient became agitated and confused. He was alert only to himself but still attempted to converse and answer questions, he had no focal neurological signs. This was thought to be delirium from COVID-19, his UA was negative and his CXR was negative for aspiration and he did not show signs of sepsis. The following morning patient was obtunded and would not respond to sternal rub, he had nonreactive pupils. A stat CT head was ordered which revealed a massive extra-cranial bleed with 5 cm midline shift and subfalcine as well as uncal herniation. The bleed was most likely epidural or subdural in origin.  Family elected to make patient comfort care and patient expired on 10/26/2021.
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 56-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.    The patient's medical history was not reported. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 56-year-old patient . The patient's medical history was not reported. The patient experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day the patient  received the first dose of mRNA-1273 (Lot number: 041L20A) at an unspecified time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient with high blood pressure. The patient's past medical history was unknown (other relevant medical history was also reported as "none"). On 26-APR-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# M040145, expiry date 26-DEC-2017). On 22-APR-2017, the patient was vaccinated subcutaneously with another 0.65 ml dose of ZOSTAVAX (lot# M040145, expiry date 26-DEC-2017). On the same day, she received PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported). The patient's concomitant medications included  hydrochlorothiazide and levothyroxine sodium (manufacturer unknown). The patient did not experience any adverse effect and no laboratory tests were performed. The patient planned to follow up with her physician. Additional information has been requested.
Started to sweat for no reason, muscle and joint soreness. Next Day Sinus congestion Third Day more congestion & drainage, No fever.  Fourth day congestion/aching all over and itchy patches on body.
Severe shoulder pain began approximately 3-4 weeks following vaccine, which I believe was administered too high. Pain continued without improvement for 6 months. Finally improved after 2 months of physical therapy.
There was no adverse event,  Patient received 2 doses of Shingrix.  We looked, no vaccines reported. Patient stated he received one dose on Shingrix in October of 2021, thus are dose was his third.
In about January of 2022 I noticed that I was having pain my hands. In the beginning it felt like tingling in my fingers, discomfort and pain. It was hard to stir batter and open jars. I had trouble holding a knife to cut vegetables. It was painful when my husband held my hand. I was told by the doctor that I lost muscle in my right hand.  Osteoporosis was diagnosed.  In late May the pain got a lot worse and this was after my second booster.  (details below)  In June 2022 I had a flare up of pain in my right hand with burning pain.  The pain began in my left hand began after my second booster in May.  Now my fingers and thumb are misshapen and curved on my left hand two fingers and on my right hand my thumb and two other fingers.  The pain is bone pain, swelling, burning and joint pain.  My neck is also bothering me as of the past couple of weeks.  The pain is like sharp pain and was told I had trouble with vertebrae 5, 6 and 7.   I began having tingling in my feet began after the first booster (dose 3) last Fall. Dose 4, Pfizer FM9992.
Basic symptoms two days after second dose. On the third day (May 3rd) was experiencing chest pain. Hospitalized for two nights. Had echocardiogram and MRI imaging done. Diagnosed with myocarditis.
shortness of breath on exertion; diarrhea; body aches; muscle ache; rash at the injection site; felt tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache) and VACCINATION SITE RASH (rash at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Type-2 diabetes).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache) outcome was unknown.            the action taken with response to drug is not applicable
c/o numbness/ tingling around mouth and SOB chest pain x 2 minutes after vaccine. No swelling or facial flushing noted.rash not on patient not typical of patient . Patient felt numbness and tingling resolved but not chest pain/ SOB. 121/85,83,98% o2 RA . Patient transported to ED for unresolved chest pain and rash. Transported to hospital
Heavy flow with large blood clot size of golf ball; Menstrual cycle has lasted 14 days and still going.; Extreme tiredness; loss of appetite; clenching of jaw at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing). Concomitant medication(s) included: IRON; VITAMIN C [ASCORBIC ACID]. The following information was reported: FATIGUE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Extreme tiredness"; INTERMENSTRUAL BLEEDING (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Heavy flow with large blood clot size of golf ball"; MENSTRUAL DISORDER (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Menstrual cycle has lasted 14 days and still going."; MUSCLE TIGHTNESS (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "clenching of jaw at night"; DECREASED APPETITE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of intermenstrual bleeding, menstrual disorder, fatigue, decreased appetite, muscle tightness.  Patient not been took any vaccination within four weeks. Patient not had COVID prior to vaccination. Patient tested COVID positive post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fine red rash devel 15AUG93 face & trunk APAP & DPH PRN;
A spontaneous report was received from a healthcare professional concerning a group of 6 patients under 18 years of age, of unknown gender, who were given COVID -19 Vaccine product administered to patient of inappropriate age. Each patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, each patient received their first of two planned doses of the prophylaxis of Covid-19 infection. On an unknown date, 6 patients under 18 years of age were given COVID-19 Vaccine. They were all 17 and a half or older. No treatment information was provided. Action taken with the second dose in response to the event was not reported. The event, 6 patients under 18 years of age were given COVID-19 vaccine, was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age with no associated AEs.
Moderate swelling of the left arm and shoulder area. First reported approx. 22 hours later. Treated with outpatient course of prednisone, methocarbamol, and hydrocodone/APAP approx 46 hours later. Needed to have a ring on finger removed due to swelling.
On awakening at 4:30 am on 4/19 left arm was sore and muscles in upper body and back were sore like when recently exercised - worsened all day.  Started to have fever about 2:30 with chills. Took temp. at 6pm was 100.6 degrees.  Felt so cold and muscles in legs, feet, hands were sore and stiff.  Hips hurt so she could not lie down.  Unable to sleep at night. Started to take Advil every 4 hours, at 6pm on 4/19/06.  Highest temp was 100.8 degrees on 4/20/06.  Advil 4 tabs every 4 hours during the day took edge off body discomfort.  Took advil before sleep with ambian and slept thru the night 4/20/06. Returned to work 4/21/06 with less soreness but 2.5cm x 3cm red swollen area on left deltoid.
After administrating vaccine PFIZER. We sat down to wait 15 minutes in the chairs located next to the place where the vaccine was administer. 10 minutes after, a red spot appeared on his neck, immediately I notified the nurses who were in charge, they took his temperature, pulse, oxygen, and checked his heart and everything came out with normal range. He was itchy on his face, and his eyes became small and itchy, they administered two tablets of BENADRYL in 15 to 20 minutes later the itching went away he had water and GATORADE we waited about 40.
Patient developed bright red rash on torso after receiving 4 month immunizations. The rash persisted for about 5 minutes prior to starting to resolve. Patient was in office for about 10 minutes and although rash was still present, it appeared to going away, No facial involvement or difficulty breathing
This spontaneous report as received from a registered nurse refers to a 6 month old patient (gender unknown). Medical history and concurrent conditions were not reported. On 13-JAN-2014, ROTATEQ was stored outside the recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside the recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 24-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014. Concomitant therapy was not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
The patient received a minor irritation in his injection site arm after each dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.) in an 87-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.). At the time of the report, VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-546141, MOD-2022-546147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Followup received contains no new information.