chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8732), in left arm and on 26Apr2021 as dose 2, single (Lot number: EW0172) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HAILEY 24 FE taken for contraception, start date: Jan2020, stop date: 02Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (09Jul2022) negative, notes: tested negative for COVID-19 on 09Jul2022; (12Jul2022) positive, notes: On 12Jul2022 (three days after my final dose of Paxlovid) I tested positive for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details: Paxlovid for COVID 19 Treatment (Treatment start date: 03Jul2022 and Treatment stop date: 08Jul2022). Indication: Treatment of COVID-19. I was prescribed and began taking Paxlovid on the afternoon of 03Jul2022 and completed the course as directed on the morning of 08Jul2022. I experienced a resolution of COVID-19 symptoms (fever, aches, congestion) on 06Jul2022 and tested negative for COVID-19 on 09Jul2022. On 12Jul2022 (three days after my final dose of Paxlovid) I tested positive for COVID-19. I had not been in close contact with any other individual, so my presumption was that this was a rebound of my COVID-19 illness. I experienced symptoms, including aches, congestion, and fever that were worse than during my initial illness, through 17Jul2022. Other medications in 2 weeks product (Hailey 24 Fe): Birth control and Statin (Brand: Rosuvastatin), start date: Sep2021 and stop date: 02Jul2022. No known allergies. No other medical history.
Fever up to 102 degree F for aprox 12-13 hours. Alternating Acetaminophen/Ibuprofen-fluids rest.
Pt reports throat feels tight. Reports h/o "rxn" after GARDASIL. Taken BENADRYL 50 mg x 1.  Observed x 45 min. Vitals stable. Pt returned home. Called pt 2 hours later - doing better. No resp/skin issues. Sister vaccinated (latex allergy as well) without incident.
Light redness on arms/back. No swelling or itching. Does not appear to have gotten any worse since appearing 11/4/16 morning.
(R) upper arm swollen, tender, erythemic AUGMENTIN 1 po Q 18 hours x 7 days given with relief.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (13.9 degree centigrade for 17 hours) doses of PEDVAXHIB (lot # L014429, expiration date: 15-MAR-2018 and Lot# L028501 with expiration date: 16-AUG-2018, dose was unknown). No adverse effects were reported. No previous temperature was excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: about 100, which lasted for about the hours.   No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for RINVOQ(UPADACITINIB) was not provided No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-642636 (Patient Link).
A report has been received from a health professional concerning a 2 year old male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 20-Dec-2013. The reporter mentioned that patient was administered expired dose of FLUMIST (preferred term: expired drug administered) on 20-Dec-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium
Chills at 9 pm following injection. Insomnia, woke up at 1 am day following injection, could not sleep. Moderate to severe fatigue with sore arm entire day following injection with loss of appetite. 100.4 fever, chills, sweats at 4 pm day after injection. Took ibuprofen then at 6 pm day following injection, appetite returned. Sleep returned to normal and no fatigue or other symptoms 2nd day following injection.
ADEM 3 weeks after vaccine administered. Treated with IV SOLUMEDROL and PEX (x5).
The primary reporter is the physician. Dr. reported a one month old patient received VARIVAX. No adverse symptoms reported. No further information provided.
Approx. a month after getting the first booster of Pfizer Covid vaccine, patient began experiencing floaters in her vision, which became very severe in both eyes.  Floaters eventually moved to periphery.  Vision loss began to become noticeable.  About 2 weeks after second booster on 4/21/2022 vision loss became worse in left eye and patient has been declared legally blind in left eye.
After receiving vaccination, the  staff reported "cold sweats." He went home sick after receiving vaccination.
11/22/04 onset severe arthralgia, fever, unrelieved by Motrin 400mg every 4-6 hours symptoms increase with T 102 F on 11/23/04. No relief with Motrin 600mg every 4 hours. c/o pharyngitis, headache, continued joint pain. Saw physician on 11/24/04. Received Dx of possible viral illness. Symptoms completely resolved by 11/28/04, returned to normal activity.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient. Medical history was not provided. On 01-APR-2013 the patient was vaccinated with ZOSTAVAX. In APR-2013, on an unspecified date after administration of ZOSTAVAX patient experienced muscle spasms. As treatment, patient was prescribed MEDROL dose pack. The outcome of muscle spasms was reported as not recovered. The relatedness for muscle spasms was not reported for ZOSTAVAX. Additional information has been requested.
My wife experienced extreme fatigue, requiring 2 full days in bed, mostly sleeping plus severe pain at injection site. Also got PREVENAR 13 in rgt. arm - no problems.
Diabetic foot infection (left) with osteomyelitis. MRI was not definitive for osteo but infection did not improve on IV antibiotics so he was taken to OR for I&D and amputations. He did very well post op and was discharged home with cane. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 05Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid to treat drug ineffective, covid-19. Treatment start date: 10May2022, treatment stop date: 16May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Patient complained of itching and redness at LAC site. She believed it may be from the blouse she is wearing. Her blood pressure was slightly elevated. Heart rate, oxygen saturation, and temperature were normal. Patient reported improvement with clothing sensitivity. No medications given. Patient drank two 8 fluid ounces of water.
I started to breakout in hives and welts. I was itchy. They thought I had a seizure. My heart rate was high. The following day I went back to the ER they thought I had another seizure. Two days later I went back to the ER for abdominal pain.
Patient stated that their arm swelled up with red marks at the sites of injection. They also experienced some discomfort.
2 Hours after getting Vax he got a severe headache and it has never gone away. After 2nd vax  on 04/13/2021. after 73 days
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a medical assistant refers to a unspecified multiple patients. The medical history of unspecified number of patient was unknown. Approximately in June 2014 (last month), unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (dose unit, route, lot# and expiry date unknown) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of (Oka/Merck) VARIVAX was stored improperly and were administered to unspecified number of patients and no adverse effects reported was unknown. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
26cm x 18cm reddened warm area noted to right upper arm, RT upper arm remains red, swollen, and warm to touch
soreness in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Dec2021, for COVID-19 immunization, reaction(s): "soreness in arm", "contracted COVID-19", "fever", "chills", "runny nose", "cough". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Flu shot on 10/27/12 and noticed pain in shoulder shortly following administration. Patient called today to inquire since pain still exists and may be getting worse with difficulty raising arm - no rash present.
On 3/15/2021 Moderna COVID19 Vaccine Vial Lot #014M20A was punctured at 10:45A, vaccine was given at 5:20P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to Moderna same evening, received response from Medical Affairs 3/18/2021.  Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
Pain in the injection site,fever ,chills for 3 days,throat pain,lymphadenopathies in the neck today
loose bowel movements, and watery stools; loose bowel movements, and watery stools; This spontaneous case was reported by a physician and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (loose bowel movements, and watery stools) and DIARRHOEA (loose bowel movements, and watery stools) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included ALPRAZOLAM, OMEPRAZOLE, SODIUM BICARBONATE (URAL [SODIUM BICARBONATE]), POLYCARBOPHIL CALCIUM (FIBER), PROBIOTICS NOS, FISH OIL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (loose bowel movements, and watery stools) and DIARRHOEA (loose bowel movements, and watery stools). At the time of the report, BOWEL MOVEMENT IRREGULARITY (loose bowel movements, and watery stools) and DIARRHOEA (loose bowel movements, and watery stools) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include, anti-diarrhea medication (unspecified).  Treatment information was not provided.
Information has been received from a physician, via a company representative, concerning a female patient (age not reported) with an allergy to aluminum, who on an unknown date was vaccinated with the first dose of GARDASIL (lot # not reported). Within 24 hours, she developed hives. The patient called the physician, and was instructed to take BENADRYL. Subsequently, the patient recovered (duration not specified). Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008.  Initial and follow up information has been received from a physician via a company representative and from doctor's office, concerning a 20 year old female nursing student with an allergy to aluminum, who on 13-MAR-2008 at 01:13 PM was vaccinated IM into left deltoid with a second dose of GARDASIL (Lot # 655849/0263U).  The reporter reported that within 24 hours, she developed itching and hives.  The patient called the physician, and was instructed to take BENADRYL.  Subsequently, the patient recovered (duration not specified).  It was reported that patient would not get another dose of GARDASIL.  Additional information is not expected.
We unintentionally gave a 17 year old a Moderna vaccine, she verbally said that she was 18. The consent form was not looked over by the provider or MA before administering. The patient had no adverse reactions.
Patient complained of sore left arm for last two months. Complaint is ongoing, sounds like a muscle ache type pain. Patient has been to doctor but has had no treatment to date.
Hives on (R) arm (same side as vaccine) within 10 min; felt hot, flushed, weak; "palpitations", HR 90, BP 122/72, O2 sat 99; lungs CTA; 25 mg BENADRYL p.o.; symptoms resolved within 30 min; d/c'ed in stable condition. Fever, chills during night, not feeling well.
The evening patient received the vaccine started feeling feverish, tired, anxious, and experienced shortness of breath with the feeling of "throat closing"  This resolved on its own, patient did not seek any medical care and patient was fine at the time of reporting to the pharmacy (5/20/21)
pt recv vax & devel numbness of the feet & hands;13 days post vax pt hosp & treating MD dx GBS, although diagnostic eval is not complete;pt is currently in ICU for resp precautions;
POTS; dizziness; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS) and dizziness. Reported date of injury was unspecified date in 2008. The outcome of the event was not reported. The causality assessment was considered as related by the lawyer.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Pains in my legs severe joint pain in knees, ankles, and muscles. I ended up going to doctor first. The primary care doctor about a week after the vaccine on a Thursday he gave me Prednisone to try to get the swelling down. It kind of worked for a time. As soon as the Prednisone stopped, I couldn't walk. I was at work and they sent me home from work. I ended up in the ER and that was on 4/19/2021. They gave me shot of pain killer and a couple of prednisone again. That helped me to walk for a few days. Then I ended up back in the hospital on 5/6/2021 for the same thing. They did bloodwork and x-rays again and gave me pain killers. No prednisone at that time. Then I got in touch with a Rheumatoid Doctor, and she ordered tons of bloodwork on 5/21/2021. All of that was normal as well. If I try to walk at work, I have to go home within three days because of the pain and legs swell up so badly. I work as a teacher's aide. I have fallen a couple of times when the legs swell up. My doctor doesn't know what kind of treatment to give me until when I see the Pulmonologist except for pain killers Tramadol 50mg as needed. Try to just take one or two a day if that. I try not to take anything but I'm at the point where I can't sleep at night because of the pain ice it at night even just to stop the pain. Can't walk my dog and help take care of my mother. I would use to hit 12,000 steps by noon at work. Meth prednisone 5 pills a day at 4mgs to keep swelling just at a minimum. Still, if I try to go food shopping by 03:00 pm I am in excruciating pain for being on my legs too much. If I do laundry, I'm okay for a bit but then it's just exhaustion for the day and then I'm done for the day and that's just not me. I've lived with these autoimmune diseases my entire life and I've never had my joints swell up like they have or have been in this much pain ever.
5 days after injection, patient started getting and itch, swelling, redness, and rash at injection site/arm.
Systemic: Headache-Medium, Systemic: Dizziness accompanied by elevated blood pressure (175/111), blood pressure dropped within 10 minutes, most likely induced by anxiety-Severe
10 days post vaccine, broke out in rash, blistered, itchy. Rash lasted about 2 weeks. No PCP visit or tx. Patient had 2nd Varivax on 2/21/01. No reaction as of 2/28/01.
Sore throat, sore neck, body aches, fever, chills, itching, cough, itchy eyes.
Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and was seen by Dr.  He was concerned so that he insisted that I go to the hospital to be admitted on Tuesday 4/6/21.  Was admitted and blood work was done and ct abdomen and car which was negative. More lab work was done on 4/7/21 which showed a elevated d-diner. At that time a ultrasound of legs done which showed a clot in my right leg. Then a ct chest was scheduled and done 4/8/21 which showed a clot in my right lung.
feeling funny; weak; temperature fluctuating between 100.4F; shivering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling funny), ASTHENIA (weak), PYREXIA (temperature fluctuating between 100.4F) and CHILLS (shivering) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELOXICAM, FINASTERIDE, TAMSULOSIN, LEFLUNOMIDE and OMEPRAZOLE for an unknown indication, DULOXETINE.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (feeling funny), ASTHENIA (weak), PYREXIA (temperature fluctuating between 100.4F) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling funny), ASTHENIA (weak), PYREXIA (temperature fluctuating between 100.4F) and CHILLS (shivering) outcome was unknown.
Patient developed fever, myalgia, arthralgia, and serum sickness. Discharge summary states hyperglycemia, hypocalemia, hypokalemia, dehydration. msv Medical records states cough, anemia. msv
Patient was injected 2nd time due to not being able to provide 1st injection when needle removed patient developed hardening of skin about dime size, Checked on patient 10/02/09 and hardening was gone.
Left deltoid injection site. Soreness for first day, ROM pain days following for 2 weeks. Injection site has no redness, swollen, or pain.
2-3 hours after injection, sore and stiff arm. Another 2 hours and I began to feel extremely fatigued in the muscles, like they weren't attached to my bones. Very difficult to move. Felt extremely tired and weak. This continued for 15 hours. 6 hours after injection and I also began feeling very cold. Fever at 101.6 F. These chills lasted approximately 6 hours. 8 hours after injection I began experiencing extreme lower back pain. This was nearly unbearable. It hurt close to the spine and radiated laterally. Heat seemed to help slightly. The pain made it impossible to sleep. This lasted approximately 12 hours, at which time I took a Tylenol and the pain subsided slightly. 17 hours after injection I experienced a headache behind my eyebrows that moved from side to side for 2 hours until I took a Tylenol.  A lesser version of the headache and chills returned 48 hours after injection and lasted for 3 hours at time of this report.
RASH TO RIGHT LEG IT IS SMALL.  LEFT LEG IS WORSE STARTED SMALL RED SPOT 2X2 BUT IT  DID SPREAD AND NOW COVERS MOST OF THE THIGH  WARM, SWELLING AND MILD PAINFUL. SUSPECTED LEFT SIDE HAS INFECTION