chrisvoncsefalvay/vaers-outcomes huggingface dataset:
above his wrist had a black and blue mark, with some redish and a lump; above his wrist had a black and blue mark, with some redish and a lump; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump), MASS (above his wrist had a black and blue mark, with some redish and a lump) and CHILLS (Had chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (Had chills). On 27-Mar-2021, the patient experienced SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump) and MASS (above his wrist had a black and blue mark, with some redish and a lump). At the time of the report, SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump), MASS (above his wrist had a black and blue mark, with some redish and a lump) and CHILLS (Had chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Interval too short, patient came at week 2 but reported he was due. Patient received vaccine and wife corrected date after vaccination was given.
No adverse events reported.  Patient should have received the Fluzone Quad, but was accidentally given the Flublok instead.
On 6-26-2022, I started having a post nasal drip. On 6-27, I had nausea, a cough, chest congestion and tremendous back pain when coughing. On  6-28, I went to a drive thru Covid testing site Medical and they told me it was a positive result. I then went to a pharmacy and took a test at the pharmacy and it was positive as well. I called my doctor and had a telehealth visit and they called in a prescription for benzonatate pills. I was also taking mucinex D. The pharmacist at the CVS also called my doctor and got a prescription for Paxlovid. I am feeling alot better now. I am reporting a breakthru case of Covid.
i have chills now and have a light jacket on; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (i have chills now and have a light jacket on) 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 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (i have chills now and have a light jacket on). At the time of the report, CHILLS (i have chills now and have a light jacket on) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter
BRUISE ON LEFT LEG JUST ABOVE KNEE CAP CREASE AND RIGHT THIGH A COUPLE INCHES BELOW THE BUTT AROUND 2-3 INCHES IN SIZE, DARK-PURPLISH, RIGHT LEG MORE BLUE AND THE LEFT LEG MORE PURPLE THAT HURT LIKE A NORMAL BRUISE AND NOT SWOLLEN; RED DOTS ON LEFT LEG FROM UPPER THIGH TO JUST BEFORE THE KNEE CAP; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced red dots on left leg from upper thigh to just before the knee cap. Laboratory data included: Blood test (NR: not provided) Normal. On 16-MAY-2021, the subject experienced bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red dots on left leg from upper thigh to just before the knee cap on 14-MAY-2021, and had not recovered from bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. This report was non-serious.
Patient has been experiencing itching symptoms since receiving their booster of Moderna vaccine. Patient was treated with a steroid dose pack but that did not help. Based on the timing of the vaccine, patient's endocrinologist believes this is a reaction to the vaccine
25yo male patient fainted about 5min after receiving the vaccine while sitting in an observation chair. He fell to the side off his chair and hit head on the concrete floor, with his body still on the chair. Patient had convulsion-like movements. It was unclear if it was seizure-type activity or if his body was struggling to sit up from the supine position laying on the chair. Patient was attended to immediately by pharmacist  - he responded immediately to my talking to him and touching his shoulders. Patient was guided to an upright seated position, then helped to floor and asked to lie on floor with legs elevated. 911 was called and Seattle Fire Dept arrived about 5min later. Patient was fully aware of surroundings, his name, etc. Evaluated him and took multiple blood pressure readings with him laying on floor and eventually sitting up. His pressure was initially low but recovered to normal over 15-30 minutes. Ambulance was called but patient declined as his parents were on their way. Patient's blood pressure recovered to normal and he was able to sit and stand, was fully conversational throughout the episode. Patient left building of his own accord with his family to seek medical follow-up.
Patient c/o severe nausea. RN offered pt a seat near the bathroom. Pt sat down and waited until nausea decreased. RN gave pt a bottle of water and she drank about 60ml. After about 10 minutes, pt stated she was still nauseous but felt slightly better. RN ensured pt that she could stay as long as she needed to and until her symptoms subsided. Pt and family member agreed that they were comfortable enough to head home. RN instructed pt to notify healthcare worker of her episode of nausea before she received the second dose of the covid-19 vaccine.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00495 and expiry date: 14-APR-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Itching in left arm which spread to torso and other arm. No rash, no SOB, no chest pain. No swelling or hives. EMT started IV and administered 50mg IV Benadryl. Itching resolved but PT became dizzy and lightheaded without resolution. Taken to ED for observation.
Nasal congestion, sneezing, Itchy/red eyes, progressed into bronchitis which included significant unproductive cough. Used generic "Claratin" at first. 6 days after injection, began prescribed NEO-POLY-DEX eye drops, Fluticasone Prop 50 mcg nose spray, Albuterol inhalations.   8 days after injection got an Albuterol breathing treatment and began prescribed 5-day Prednisone 20 mg treatment. Using over the counter DM cough suppresant since 6 days after injection.  As of 10 days after injection, expect to start prescribed antibiotic (type yet unknown) and Tessalon Perles for cough. Note that I have "Hay Fever", but this event was notably more severe than have experienced in years.  Also tend toward bronchitis annually.
eye floaters; toes are tingling; Swollen legs and arms; throbbing pain; body is in pain from neck to toe; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (eye floaters), PARAESTHESIA (toes are tingling), SWELLING (Swollen legs and arms), PAIN (throbbing pain) and MYALGIA (body is in pain from neck to toe) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VITREOUS FLOATERS (eye floaters), PARAESTHESIA (toes are tingling), SWELLING (Swollen legs and arms), PAIN (throbbing pain) and MYALGIA (body is in pain from neck to toe). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VITREOUS FLOATERS (eye floaters), PARAESTHESIA (toes are tingling), SWELLING (Swollen legs and arms), PAIN (throbbing pain) and MYALGIA (body is in pain from neck to toe) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
pt recv vax & devel severe h/a w/dizziness, mild fever, pain in neck 7PM;joint pain, earache, speech stutter, soreness, neck gland feel like drawing up, itch, drowsy, hard to focus vision,stiffness;loss of appetite;
Slept a lot; Tired; Some coughing; Hiccups; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Oct2021 10:00 (Lot number: FC3184) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Time(24hr): 10, Site and route of injection: , Anatomical site if injection: Upper Right arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 13Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose: 02, Time(24hr): 14, Site and route of injection: , Anatomical site if injection: Upper Right arm, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 06Mar2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "developed Hiccups".  The following information was reported: HICCUPS (non-serious) with onset 2021, outcome "recovered" (08Feb2022), described as "Hiccups"; FATIGUE (non-serious) with onset 04Feb2022, outcome "unknown", described as "Tired"; COUGH (non-serious) with onset 04Feb2022, outcome "unknown", described as "Some coughing"; SOMNOLENCE (non-serious) with onset 05Feb2022, outcome "unknown", described as "Slept a lot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection for 3rd dose was upper arm right. Patient had no prior vaccinations (within 4 weeks). Patient had no medical history. On Fri 04Feb2022, Patient had symptoms of covid [Fatigue, cough, congestion, hiccups(!)]. on sat 05Feb2022 patient was tested + using a OTC test [Binax now]. Sat and sun the symptoms wear at their worst, but patient never had shortness of breath, or a fever. By Tuesday patient was almost fully recovered. With vaccine #2 and booster (#3)- patient developed hiccups that lasted over 2hrs at a time- gone the next a day. With my current covid infection- hiccups started on FRI. By sat and sunday (05Feb2022 and 06Feb2022) they could last 5 to 6 hours. But they tapered out on mon (07Feb2022) and were gone by Tuesday. Patient was started tested + [health] for covid on wed 09Feb2022.  No follow-up attempts are possible. No further information is expected.
I started having my period 2 days after my booster and I bled for  a month. This has never happened before.
Pt had local reaction over entire tricep. It's hard, welt, swelling, raised, warm. No blisters or other signs of anaphylaxis.
Patient is experiencing blurry vision, shaking blood pressure drop to 75-85/65-75, fever all seven days past  he injection
Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness
Patient received quadracel instead of pentacel with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via Medical Information (MI) (Reference number: 00812771) and transmitted to Sanofi on 14-Oct-2021.  This case involves a four-year-old male patient received quadracel instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 08-Oct-2021, the patient received a o.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml, Strength: standard except for Fluzone, dosage form: solution, lot UJ458AB, expiry date: 21-May-2022] via an intramuscular route in the right deltoid for Prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported  "medical assistant states pentacel was given to a patient accidently when quadracel was the vaccine they were trying to administer."   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Starting at 8pm experienced hoarseness, difficulty swallowing and dryness of throat. Over next 2hours more difficult swallowing, Numbness of mouth, swelling of tongue. Around 10:30 pm went to emergency room to receive treatment.
LITTLE DIZZY; LOW GRADE FEVER; IRRITABLE; SLEPT ALL AFTERNOON; HARD TIME EATING; STOMACH MESSED UP; LACK OF APPETITE CONSUMING FOOD DID HELP A BIT; STOMACH QUEASY; THREW UP TWICE REALLY BAD; SORE ARM FOR COUPLE OF DAYS; VERY LETHARGIC; DOES NOT FEEL HIMSELF; CAN NOT GO TO WORK; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 140 pounds, and height was 69 inches. The patient's past medical history included: anxiety, and concurrent conditions included: pmhx discoid lupus (dle), pre diabetic, early kidney stage, early stage copd, marijuana usage, alcohol user, and cigarettes smoker, and other pre-existing medical conditions included: The patient had experienced sulfamethoxazole screwed up really bad and made lupus get bad on his arms. The patient was previously treated with diazepam for anxiety; and experienced drug allergy when treated with sulfamethoxazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced very lethargic. On SEP-2021, the patient experienced does not feel himself. On SEP-2021, the patient experienced can not go to work. On SEP-2021, the patient experienced sore arm for couple of days. On 26-SEP-2021, the patient experienced slept all afternoon. On 26-SEP-2021, the patient experienced hard time eating. On 26-SEP-2021, the patient experienced stomach messed up. On 26-SEP-2021, the patient experienced lack of appetite consuming food did help a bit. On 26-SEP-2021, the patient experienced stomach queasy. On 26-SEP-2021, the patient experienced threw up twice really bad. On 27-SEP-2021, the patient experienced irritable. On 28-SEP-2021, the patient experienced little dizzy. On 28-SEP-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for couple of days on SEP-2021, had not recovered from very lethargic, irritable, little dizzy, hard time eating, stomach queasy, lack of appetite consuming food did help a bit, and stomach messed up, and the outcome of threw up twice really bad, slept all afternoon, does not feel himself, can not go to work and low grade fever was not reported. This report was non-serious.
pt recvd vax; devel an inject site rxn characterized by redness, swelling & pain;
1 hour after vaccine administration, headache while driving home requiring ambulance. Vitals normal and given motrin with improvement. Also had fever (102), fatigue and runny nose. Lasted approximately 1 week with headache and fatigue.
Pt received 2nd SHINGRIX at 11:45am on 6/7/18. He felt fine the rest of the day and went to sleep that evening. He woke at 3am on 6/8/18 and felt that he couldn't move muscles below his neck.  He was able to get out of bed and check his facial muscles in the mirror to rule out stroke. He determined all was well and went back to sleep. He then woke and took shower at 9am. He describes he "felt drunk." He then went to get a massage and at about noon on 6/8 felt better.
Immediately adverse reaction of menstruation.  Usually 5 days to one week and after 1st vaccination shot, menstruating 3 weeks at a time EVERY  MONTH.  Very heavy and erratic flow and staying heavy for nearly 3 weeks.  Started June 2021 and is still happening currently (nearly a year of adverse reactions from the vaccine).
Positive COVId-19 PCR test and hospital admission on 4/18/21 for Sob
Severe dizziness/cannot really lift my head or get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness/cannot really lift my head or get out of bed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Severe dizziness/cannot really lift my head or get out of bed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Severe dizziness/cannot really lift my head or get out of bed) outcome was unknown.            Concomitant medication included blood pressure medication, cholesterol medication and vitamins in the morning.
Popliteal DVT and suspected lateral calf hematoma, patient denies trauma to the leg but did fall
Acute shoulder and arm pain immediately following shot received on September 19th that never subsided and only worsened with time. Pain hindering mobility, painful to sleep on, hampered ability to complete daily tasks due to the pain that basic normal motions caused since receiving the shot. On 10/11/17 went to urgent care due to the acute pain. Assessment was that the vaccine was injected too high on my shoulder into the bursa creating inflammation of my shoulder bursa. I followed up the next day 10-12-17 with my GP, Dr. and he prescribed physical therapy. I have scheduled an upcoming appointment with an orthopedic specialist on 10/17/17  to fully asses the damage from the flu shot I received.
The patient reported today, October 29, 2020 that her arm pains her to lift it, for example lifting up bra strap on opposite arm or raising above her head. She stated that it really burnt at the time of injection and that is was high on her arm.  I had her show her arm to me today. There is no redness or swelling. She indicated that it is not as painful as it was and hopes it continues to resolve but wanted to report it due to her concern in the length of time it is bothering her.
n/v, chills, SOB, pulmonary embolism, pericardial effusion
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The patient was administered an expired dose of PNEUMOVAX 23 via intramuscular route (lot# reported as L041028, expiration date: 16-FEB-2017, dose was not reported) on 08-MAR-2017. No adverse effects were noted by the reporter. Additional information has been requested.
Information has been received from a nurse concerning a 24 year old female, who on 08-OCT-2008, was vaccinated intramuscularly in deltoid with the first dose of GARDASIL (lot# not reported). The patient was sitting in the chair, complained of pain and fainted within 2 minutes of receiving the vaccine. The patient recovered on 08-OCT-2008. Additional information has been requested.
After receiving all 3 shots in 2014 I had an abnormal pap smear.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 27-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sudden onset dizziness, hypotension, vomiting, diarrhea, myalgia, chills. Now, several hours later, myalgia, chills, nausea, diarrhea are persisting . Afebrile.