chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a second dose of the COVID vaccine at facility on December 2, 2021, woke up with a temp of 102.3F at 5a and was dosed with ibuprofen.   At 12:15p, he vomited and upon getting into the shower to rinse off his puke, turned blue in the face and began shivering uncontrollably, his temperature was taken and recorded at 102F, a pulse ox read in the 70s and ambulance were called at 12:21p in case there was a need for oxygen.   Fire department evaluated upon arrival, no temperature taken due to a broken thermometer, but his pulse ox was up to 92-95 O2 saturation, but he was still clammy and purple in the lips.   Ambulance arrived about 20 mins later, took his blood pressure (110/60), temp (102F) and glucose (131) and his O2 saturation went from 95-98. Paramedics recommended dosing with Tylenol for temperature and to monitor at home and reaction was likely in response to COVID vaccine one day prior. Paramedics noted he was tachy with an elevated heart rate of 160bpm.
Pt devel "a hive-like rxn" immediately p/vax. No further info.
Felt stiffness and pain radiating from injection site right deltoid to trap muscle and up neck and down through chest.  Felt heaviness in chest, felt achy with joint pain.
Pt received the pneumococcal polysaccharide vaccine and was asked to remain in pharmacy for 15 min. She left immediately and ended up having a rxn requiring her to seek medical treatment. Pt said she rec'd an epipen and 3 other vaccines. She returned to pharmacy to fill RX for medical dose. PT is ok.
Mother called stating small Red dot on stomach and back; Told to give tylenol and call if symptoms change.
Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massive headache; This is a spontaneous report from a contactable physician. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:00 (age at the vaccination 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation at Doctor's office/urgent care. Medical history included prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0185), via an intramuscular, administered in Arm Left on 15May2021 12:00 PM date as 1st dose, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath on 05Jun2021 12:45, daily severe headaches /massive headache on 05Jun2021 12:45, upper and lower gi side effects on 05Jun2021 12:45, slowed mentation on 05Jun2021 12:45. Every afternoon patient had massive headache which patient had never before, shortness of breath and had digestive problems every night, digestive problem like patient can have days of digestive problems upper GI and Lower GI. Adverse event (AE) required visit to the Physician Office. It was getting worst. Therapeutic measures were taken as a result of daily severe headaches/massive headache. Patient took Motrin for headache. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Dyspnea cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Confusion, headache, myalgia, anaphylaxis and sweating, photophobic, shortness of breath, red face, flushing. Diphenhydramine 25 mg once, prednisone 60 mg once, ranitidine 50 mg once.
Pfizer vaccine was diluted with 0.9mls of 0.9% of Sodium  Chloride instead of1.8mls
Pain at injection site; Itching injection site; Reddish circle; Warm injection site; Intense Headache; Red injection site; Chills; Left sided headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Left sided headache). On 12-Feb-2021, the patient experienced CHILLS (Chills). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm injection site), INJECTION SITE ERYTHEMA (Red injection site) and HEADACHE (Intense Headache). On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching injection site) and ERYTHEMA (Reddish circle). On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache), CHILLS (Chills), INJECTION SITE ERYTHEMA (Red injection site), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Intense Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
Severe pain at the injection site immediately after the shot. Cont. for 1 night & 1 day after that. Took MOTRIN not relieved.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Dose-1) on 21-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter reported that that they had temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on four dates. The impacted vaccines were administered to 40 patients. No patients have reported any adverse events to date.   The storage condition at the time of the excursion was refrigerator. The lot number was 059H21A with expiration date 27-Mar-2022. The maximum or minimum temperatures reached on 28-Jan-2022 temp range was positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range was positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range was positive 35.2F to positive 41.7F for 12 hours. The date the vial moved from freezer to refrigerator was not available. It was also reported that all the vaccines were administered. All 4 vials were administered, they were thawed because they were in the refrigerator. The proposed desired Use by Date was 0 not applicable. The vial was thawed on 28-Jan-2022.  No treatment information was provided.
The day after the vaccine patient woke up with dizziness and vertigo. developed fast heart rate, nausea, vomiting, lightheadedness. seen by me on 3/13/21 and was noted to have irregular rhythm on auscultation. EKG showed frequent PVCs, every 3rd beat, with rate of 87. She has no h/o prior arrhythmia. obtaining monitor and labs to assess but unclear whether she should get the second shot or whether current sx are related to COVID vaccine.
Extreme & Acute Head & Neck Pain. Thumb knuckle would not perform properly (continuous pain and swelling). A lot of very deep coughing. All beginning within 2 days of side effect onset.
Information has been received from a patient of unknown age and gender referring to himself/herself. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX(strength, dose, lot # and expiration date were not reported) subcutaneously for prophylaxis. On an unknown date (in December 2016), the patient had injection site reactions after receiving the ZOSTAVAX. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was unknown. Additional information is not expected as no contact details were provided.
One week after IM injection pain redness and swelling noted at site of injection. Applied ice on 20 min and off 20 min for 1 hour, took 600mg of ibuprofen with noted increased swelling, redness, and warmth at injection site. Called  clinic and received prescription for Bactrim to treat cellulitis with instructions to follow up with PCP in 2 days if symptoms do not improve.
Had tenderness in local region 18MAR thru 22MAR; 23MAR noted erythema & swelling lt arm deltoid; 23MAR fatigue, chilling; seen in ER placed on Dicloxicillin; pt adm to hosp w/impression cellulitis lt arm;
1-2 minutes, post vax, the child broke out in hives (generalized), ears turned red and had stomach pain. She was treated by the doctor with Benadryl. All symptoms resolved within 3 hours.
Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
My COVID-19 symptoms started on 04/02/2023 in the morning before going to the church. I woke up in the morning with a sore throat. I thought it was a cold but throughout the day I had sinus and fever 3 days for 101.00. I took ADVIL because of the fever I had. I took the COVID-19 later in the evening which was positive. The next morning I called my doctor's office but no one called. I called at the end of the the day again to my doctor's office. They provided me with a number to call and I called and did a telehealth with a doctor. They prescribed PAXLOVID for 5 days. I also continued to take ADVIL along with it for fever.
Sore arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient mentioned he got the 1st dose of Shingrix and had a sore arm. Consent to follow up was denied.
Patient complained of tiredness and exhaustion. Also low grade temp, slight shortness of breath, post nasal drip and s/s of GERD. Patient also complained of right foot pain between 3 and 4th toes.
Patient called to inform staff she had localized reaction and had to be seen on 11/15/2017 due to arm swelling and redness radiating down arm. States MD reports of adverse event with cellulitis and treated with KEFLEX.
small blood clot in brain; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Type two diabetes b, covid prior vaccination in 2021, blood clot in lung. Concomitant medication included exenatide (BYETTA). The patient previously received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced small blood clot in brain on 09Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received the treatment Heparin for event. Covid test post vaccination (Blood test) was negative on 12Apr2021. The outcome of the event was not recovered.  Information on Lot/Batch number has been requested.
generalized weakness to the point of being unable to walk, cold/flu symptoms, nasal congestion, cough, chest discomfort
Joints Pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRALGIA (Joints Pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ARTHRALGIA (Joints Pain). At the time of the report, ARTHRALGIA (Joints Pain) had not resolved.            No treatment was administered for event.   No concomitant medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old male patient who received SHINGRIX (batch number 3NY5G, expiry date 31st March 2019) for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. On an unknown date, the patient developed a rash, described as not blistered, which spread 5-6 inches from the injection site. The healthcare professional (HCP) reported that the rash was improved but not yet resolved.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 12-year-old female patient received the first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, headache and severe arm soreness for 3 days on an unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
football sized black and blue right arm; Pain shot up arm to neck; fibromyalgia; enlarged knuckles; burning legs / burning feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs / burning feet), PERIPHERAL SWELLING (football sized black and blue right arm) and PAIN IN EXTREMITY (Pain shot up arm to neck) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass. Concurrent medical conditions included Spinal stenosis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles) and BURNING SENSATION (burning legs / burning feet). On an unknown date, the patient experienced PERIPHERAL SWELLING (football sized black and blue right arm) and PAIN IN EXTREMITY (Pain shot up arm to neck). At the time of the report, FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles) and BURNING SENSATION (burning legs / burning feet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient consulted two HCP and was prescribed steroids for treatment and was also recommended TYLENOL 2 STIXS, three times per day.  No concomitant medication was provided by the reporter.   This case was linked to MOD-2021-259143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16-JUL-2021 , Containing No Significant Information
swelling in wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in wrist) in a 65-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling in wrist). At the time of the report, JOINT SWELLING (swelling in wrist) outcome was unknown.            Concomitant medications were not provided.  Treatment information included unknown medication for swelling of wrist.
2/1/22 pt fell at home and was brought to the hospital with a left humeral and left pelvic fracture; non-operative management recommended by orthopedics and trauma doctors; 2/7/22 pt had a positive COVID test; O2 saturations good on RA; no Decadron needed; dc'd to home on 2/10/22 and he passed away at home on 3/7//22
1/31 Nauseous, Achy, tired, almost passed out, stayed in bed & slept entire day. 2/1 Sick all day 2/2 Still tired but began feeling better I took Advil & Tylenol to relieve body aches.  The 1st dose of Shingrix caused similar but much less severe symptoms. *I have never had any side effects from vaccines except local pain on any other vaccines
Very painful, red rash on right upper arm MD suspected shingles. Prescribed FAMVIR, NEURONTIN rash & pain still present.
Red arm ("Covid Arm") and rash on arm, thighs, and trunk. Pictures available on request.
Pt experienced swollen neck glands, joint pain and 102 temperature 4 hours post vax.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805421 was crossed linked to original case 201804863 due to same reporter.
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
High fever 103 F. Lethargic. Gave Motrin and later Tylenol.
Started with hand joint and muscle pain. Extreme fatigue. Moved to knee and toes (joint pain). Lost appetite, dizzy, went to MD 2 weeks later. Blood work done. MD diagnosed it as reaction to vaccine.
Started to be come anxious, led to  harm OCD episodes never before experienced. Depersonalization episodes, extreme panic.  Seeking treatment from psychiatrist/LPC- - ongoing treatment with medications and therapy.
This spontaneous report was received from a pharmacist referring to a 73 years old male patient. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies. On 24-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in an unspecified arm for prophylaxis (indication reported as doctor recommended) (lot #: R017900, expire date: 26-MAR-2020, dose and strength were not reported). On the same day after the vaccination, the patient developed swelling and itching in the arm where he was vaccinated. And reported the swelling and itching extended from the deltoid down to the bend of the patient's arm. No treatment was given and no lab diagnostics/studies were performed for the events. The patient had sought medical attention by contacting the pharmacist. The outcome of the events were reported as not recovered at the time of this report. The causality assessment was not provided.