chrisvoncsefalvay/vaers-outcomes huggingface dataset:
J&J covid19 vaccine, about 20 or 30 min. after when in car going home terrible excruciating pain from injection site down left arm to hand. Ongoing of and on, thought I was having a heart attack, husband said it was "anxiety", got worse during the nite, breathing, dizzy, husband again said "anxiety" took tylenol. Hurt for about a week, talked with a friend who is a physician asst. and she said just a sore muscle should get better in a week or so. Ended up continuing off and on depending on what I was doing, hard shampooing hair, brushing, etc. when trying to raise left arm, then the spasms started from left arm up into my head, very debilitating. Hard to walk started about April, by May issues going up and down steps, hard to lift legs, heavy, shooting pains/tingling especially at night down into my toes, arm injection site jabbing pain wakes me up at nite, dry mouth with tongue sticking on roof of mouth, conjunctivitis issue in right eye, painful, red, irritates eye dr. can't figure it out, balance issues, GI issue wiht right knee and boths legs hard to walk, FATIGUED. AND IT'S GOING ON A WHOLE YEAR. PT ARM, SHOULDER, PT RIGHT KNEE. NECK SPASMS ONGOING debilitating. quality of life changed. used to be able to watch grandchildren 4 days a week, got to the point where I was using furniture to lean on to get around, now only able to watch 1 day a week with toddle grandchildren able to help me now, get things, help me up when needed, was falling asleep, fatigued, bloating, gi issues, eye issue walking issues, dizzy. I put on like 20 pounds in just one week! I have always walked 2 miles per day, now I have trouble getting up a short road across from my house, very unsure of myself. mood changes, depression. NO HELP! FINALLY FOUND a primary that took all fo my issues seriously, only blood work issue found was high ferritin blood serum., scans showed, liver steanosis, nodules in both lungs, calcifcation in my heart arteries, no autoimmune diseases found, eye dr still can't figure out my right eye pain/distress, gastroentologist can't figure out my GI distress. Rashes on arms, like purple colored not raised, under skin. that's finally stopped, CAN'T SLEEP. I get dizzy, hard to breathe sometimes, headaches sometimes. just got a brain scan neurologist report, says white matter and a venous leak in brain? Going on to have nerve testing done and get complete report of brain scan.
Sharp shooting pain from neck to head which resulted in loss of consciousness. 10 hours after incident head and neck pain continues, is less in severity.
Treatment of COVID-19; Treatment of COVID-19; Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 10:00 as dose 1, single (Lot number: el9261), in left arm, on 17Feb2021 at 15:45 as dose 2, single (Lot number: en6201), in left arm and on 26Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 30135BA) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2022 at 13:15 as dose 4 (booster), single (Lot number: 04bl21a), in left arm and on 09Sep2022 at 11:30 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 27Sep2022 to 02Oct2022.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
She feels like its neuropathy; Tingling feeling like pins and needles in both feet; Numbness particularly in her left foot; Eye infection; Arm was redder/spread was bigger at the injection site; A larger pinkness to the arm; Low grade temperature; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (she feels like its neuropathy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE for GERD, CALCIUM, MAGNESIUM, COPPER, ZINC, VITAMIN D NOS, OMEGA-3 FATTY ACIDS and MENAQUINONE-7 (K2) for an unknown indication.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm), VACCINATION SITE PAIN )pain at the injection site), and PYREXIA (low grade temperature). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (she feels like its neuropathy) (seriousness criterion medically significant), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection) and VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 01-Jun-2021, PYREXIA (low grade temperature) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (she feels like its neuropathy), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection), VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site), VACCINATION SITE PAIN )pain at the injection site),  and VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm) outcome was unknown.            Concomitant medication included  Probiotic used for unknown indication. Reported  treatment information included  amox/clav for 10 days and  steroid eye drop.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The neuropathy was considered as non-serious due to medical judgement.
On 1/22/2021: Today patient reported red spot (about 6 inches in diameter) at the injection site appearing about 3-4 days ago. Patient stated there was not pain, no hardness on touch. Symptom has been becoming worse since it started
Case number PHEH2015US003147 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 30 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error.
This spontaneous report as received from a healthcare worker (a pharmacy buyer) refers to a patient of unknown age and gender. On 07-NOV-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J001729, expiration date: 20-OCT-2013, 0.65 ml, subcutaneously). No symptoms were reported. Additional information is not expected.
102.2 degree fever. Tremors and shaking for hours and hours. Insomnia. Diarrhea. Nerve pain. Joint swelling. Loss of taste
Pt got 3rd SHIGRIX dose by mistake (L Arm); R arm Pt had an adverse reaction. Pt calls Pharmacy 7/23/2020 stating that she is experiencing an adverse reaction in her "R arm with huge red reaised reaction, hot to touch, red, itchy, fever through the night 100.5 & 101 degree Fahrenheit fever, nauseous, chills, shaking." She stated she had taken TYLENOL already, I advised her to also try applying a cool compress to the area, and diphenhydramine, in addition to continuing the APAP. Also stated if not improving or seems to get worse to seek medical attention.
The event onset began 48 hours after injection. Symptoms include inhibited range of motion (left shoulder) causing extreme bursts of pain throughout upper arm.  It is especially painful when I am trying to dress, lift objects and/or execute general daily functions requiring use of my left arm. Ten days from injection, the pain has spread to my elbow area. Initially after injection, I applied cold presses to relieve pain but it did not help. I also administered Tylenol, but again, this did not provide relief.
Pt developed dizziness and nearly passed out after injection. BP 100/60, HR 64, SPo2 99%. Symptoms improved without intervention. PT's wife drove him home.
Pt vax w/ 2nd dose of Hep B on 13Jul91 the next day following vax devel weakness & malaise. At time of the report pt's condition was worsening & remained under tx.
waves of heat in hands, arms, chest up into head . 3x per day. feel tired and naesous afterwards. still happening after one week
Admitted to ED, with headache, hyperventilation, panic state, adm temp 97.3F, repeat tem 100.3; awaiting blood work results.
1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea 1/12 afternoon-headache and jaw ache continues, nausea, low grade fever (99.9) and chills 1/12 night-headache and jaw ache 1/13 AM and afternoon-headache and jaw ache
This spontaneous report as received from a physician via field representative refers to a 65 year old male patient. Pertinent medical history and drug reactions/allergies were unknown. On 23-OCT-2015 (FRIDAY), the patient was vaccinated with ZOSTAVAX, subcutaneous. Approximately on 24-OCT-2015 (reported as "over the weekend"), the patient felt very sweaty, and had body aches. The patient stated he just generally did not feel well over the course of the weekend. Outcome of the events was unknown. The patient did not seek medical attention. No product complaint was involved. Additional information has been vaccinated.
Arthralgia, SOB, palpitations, chest pain, migrating arthritis, erythema and swelling distal to site.
Brain fog; Mental fatigue; Lack of concentration; Mild tremors in hands; Anxiety; Depression; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 31-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune symptoms which subsided before vaccination. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced brain fog, mental fatigue, lack of concentration, mild tremors in hands, anxiety and depression. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events brain fog, mental fatigue, lack of concentration, mild tremors in hands, anxiety and depression were not resolved at the time of report.
This spontaneous report was received from a pharmacist refers to a 67 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2018 (also reported as last year), the patient was vaccinated with PNEUMOVAX 23 (dosing details, strength, route, frequency were unknown) for an unknown indication and again yesterday instead of receiving PREVNAR 13 (wrong product administered)(Interchange of vaccine products).
PATIENT DEVELOPED FULL BODY RASH/BLISTERS 36 HOURS AFTER RECEIVING INJECTION. DURATION LASTED 3 WEEKS AND HAS COMPLETLY RESOLVED SINCE THEN. PATIENT STATES BLISTERS WERE ITCHY AND INFLAMMED
"Moderna COVID-19 Vaccine EUA";  patient reported jaw and throat area felt numb  approximately 30 min following vaccine. Patient vital signs were taken and patient was monitored the entire time: BP and heart rate readings: 140/89, HR 64; 126/85, HR 73; 136/99, HR 69;  139/94, HR 68; 100% pulse oximetry all readings, each approximately every 10 min. Patient stated she was not getting better, but able to speak. EMS was called and arrived; patient was taken to hospital.
As I began to vaccinate the patient in the L deltoid, the plunger depressed normally and then stopped. I removed the needle from the patient? arm and  saw that I had given 0.12 mL of the vaccine. The plunger would not depress once removed from her arm, either. I then gave 0.2 mL of the vaccine from a different syringe in the same arm. I reported the incident to the supervising physician and sent the faulty syringe back to the pharmacy, where both syringes had been pre-filled. I communicated what I was doing to the patient throughout the process and answered all questions. The patient felt well throughout, had no concerns, and continued to the observation area as usual. I reported the incident to the supervising nurse and to the supervising physician.
Site's a little sore; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced site's a little sore after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), risk factor and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed site's a little sore (tenderness) (unknown latency) following the administration of Influenza Vaccine.  It was reported "Got mine yesterday! Got the COVID BIOS update, too. Site's a little sore but I'm rubbing dirt on it and telling myself to grow a pair. And Motrin."  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Severe headache at 12h post vaccine.  Headache, body aches, chills, joint pain at 24h post vaccine.
pt recv vax 6JUL98 & pt devel spotted rash 2 1/2inches diameter, hot to touch & photophobia;MD visit 8JUL98 AM identified as allergic rxn;no further tx ordered;
1st pregnancy, estimated delivery 09/27/2021. Have bleeding was hospitalized and monitored for 30 hours. Concerned about early delivery such as 25 weeks.
@1035Pt was in the observation room, with head down looking pale. Approached patient. Pt stated that she is feeling dizzy and nauseated. Pt is looking pale. Placed on a gurney, supine position. Pt's color started to come back. Pt had a similar episode during the first vaccine, which resolved in few minutes. Fluids provided.    @1055 Pt progressing well. Color is going back to normal. Slowly repositioning to high fowler's/ sitting position. Tolerating well. Pt finished all water and juices. Denies any nausea. Dizziness is resolved.    @1110 Placed on sitting position. Tol well. Denies any symptoms. No sob noted. No s/sx of distress noted. Resp even and unlabored. VS 143/97 (112) 65 98%RA 16RR.    @1120 Pt is feeling better. Pt felt comfortable and confident going home. Ambulated. Gait stable. Denies any symptoms. Tol well. ED precautions provided. Instructed to follow up with PMD. Pt verbalized understanding. Made DOD, Dr aware and agreed with the plan.
Tingling and vibration in left calf and foot.  This has been going on for 5 weeks so far.  Symptoms started 2 days after J&J Shot.
expired vaccine applied; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was recovered/resolved.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional stated they gave a patient an expired vaccine.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Twinrix which was already expired which led to expired vaccine used.
pain on arm; discomfort on arm; He has a swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on arm), LIMB DISCOMFORT (discomfort on arm) and VACCINATION SITE SWELLING (He has a swollen arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on arm), LIMB DISCOMFORT (discomfort on arm) and VACCINATION SITE SWELLING (He has a swollen arm). At the time of the report, VACCINATION SITE PAIN (pain on arm), LIMB DISCOMFORT (discomfort on arm) and VACCINATION SITE SWELLING (He has a swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a nurse to a 68 year old female patient with anxiety, irritable bowel, osteoporosis and allergic rhinitis. The patient's drug reactions included codeine allergy, penicillin allergy and sulfa allergy. On 02-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j005011, expiration date 04-DEC-2014, 0.5 ml, intramuscular). Concomitant therapies included Estradiol (manufacturer unknown), Hydrochlorothiazide (manufacturer unknown), Levothyroxine sodium (manufacturer unknown), Neurontin, Aspirin, Omega-3 marine triglycerides (reported as fish oil), Alprazolam and Vitamins (unspecified) (reported as multivitamin). The "next day" after receiving PNEUMOVAX23), on 03-JUN-2014, the patient developed arm swelling, pain, and redness from the "shoulder area to the mid forearm". The nurse stated that the patient went to an unspecified emergency room on 03-JUN-2014 and was given an injection of Dexamethasone. She also stated that the patient was sent from the emergency room with prescriptions for Prednisone and Keflex and was told to also take over the counter Benadryl. The nurse reported that the patient was seen by the nurse practitioner on 04-JUN-2014. No lab diagnostics studies were performed. Outcome of the events was reported as recovered on 07-JUN-2014. This is one of several reports received from the same reporter. Additional information has been requested.
horrible rash on her back and torso, not on her arm, close to her hind legs; Arm turned red and stayed red for 4 days; Arm was painful; Arm was swelled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red and stayed red for 4 days), PAIN IN EXTREMITY (Arm was painful), PERIPHERAL SWELLING (Arm was swelled) and RASH (horrible rash on her back and torso, not on her arm, close to her hind legs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 036D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ERYTHEMA (Arm turned red and stayed red for 4 days). 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful) and PERIPHERAL SWELLING (Arm was swelled). On an unknown date, the patient experienced RASH (horrible rash on her back and torso, not on her arm, close to her hind legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-May-2021, ERYTHEMA (Arm turned red and stayed red for 4 days), PAIN IN EXTREMITY (Arm was painful) and PERIPHERAL SWELLING (Arm was swelled) had resolved. At the time of the report, RASH (horrible rash on her back and torso, not on her arm, close to her hind legs) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information also included cream.   This case was linked to MOD-2021-162214 (Patient Link).
Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15  hours did not feel well.  The next morning (Sunday 3/21) woke up nauseous and had trouble breathing.  Went outside for cold air and breathing  was OK.
PATIENT RECEIVED MODERNA VACCINE AT AGE 15. SHOULD HAVE RECEIVED PFIZER VACCINE. PER CDC, DOSE DOESN'T NEED TO BE REPEATED.
5 minutes after administration of nasal monovalent H1N1, developed imbalance gait, tachycardia, increased BP, decreased PO2 (90-92%), tightening of throat, decreased ability to speak. RX in ER-IV BENADRYL, ranitidine, PREDNISONE PO.  10/27/09 Dermatology consult (includes dermatology ER visit) received service dates 1/1/94 to 10/27/09. Assessment: Allergic to Nasal H1N1 flu vaccine. Anaphylaxis. Sinusitis. Patient c/o throat tightness, lost balance, anxious. Tightness in shoulders, vomited.  10/29/09 ED records received service date 10/21/09. Assessment: Allergic to Nasal H1N1 flu vaccine. Anaphylaxis. Sinusitis. Patient presents with shortness of breath and chest tightness which began within 10 minutes of vaccination.