chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 07-APR-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Report 200035528-1 describes an unspecified infection in a 52 year old male who received hepatitis B vaccine.  Medical history is significant for type II diabetes meelitus, chronic renal insufficiency secondary to diabetes mellitus and requiring hemodialysis, peripheral neuropathy, hypertension and 6-vessel coronary artery bypass grafting. Concurrent medications included insulin 70/30 40 units twice daily, benazepril, rosiglitazone, amlodipine, furosemide, dialysis/stress vitamin supplement, aspirin, calcium carbonate, and vitamin E. This reporter stated that family history is significant for arthritis-like symptoms, numbness in feet, and carpal tunnel syndrome in this patient's daughter following injection receipt of the hepatitis b vaccine (see case 2000035544-1). The patient received his first injection of hepatitis-b vaccine on 15 October 2000. At some later date  (not specified), he experienced weakness in his lower extremities. The weakness continued to worsen.  The patient then developed an unspecified infection.   The patient received his second injection of hepatitis b vaccine on 22 November 2000. At  some later date (not specified), the patient experienced weakness and numbness in his arms. The reporting health care professional, who is also the patient's wife, stated that the patient "was fine until the second injection". She stated that the only reason for his rapid deterioration of health is the hepatitis-b vaccine. As of 12/06/2000, the infection, leg weakness, arm weakness, and arm numbness persisted.
patient received vaccine and was light headed and fell twice. had patient sit and have oral glucose gel and her color came back and after 20 minutes patient seemed okay and left with mother
FLU-LIKE SYMPTOMS; GENERALIZED ACHING; COLDNESS; FATIGUE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immense pain/dull ache in bones and joint, bad time walking, psoriatic arthritis, and breathing was hurting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced flu-like symptoms, generalized aching, coldness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from flu-like symptoms, generalized aching, coldness, and fatigue. This report was non-serious.
Maculopapular red rash generalized on face, anterior and posterior stomach, extremities and appeared 15 minutes after receiving vaccines - txed with prelone and benadryl. Completely resolved 20 minutes later.
Nausea, arm began to swell, fever,  severe headache, chills, faint feeling. Was prescribed Prednisone by healthcare provider. Has began to itch over entire body, pain in eyes.
Headache began  3 days after the booster shot.  I had NO reaction to the 1st or 2nd shot.  Only to the booster. The headache felt like a sinus infection and lasted 5 days!  Ranged from mild to severe.
First COVID vaccine Pfizer  Second COVID vaccine Moderna. EUA does not permit interchange of vaccine manufacturers.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Extreme weakness. Walking was at a shuffle (24 hours)  Sleeplessness. Hyper but couldn?t sleep for 3 days. All resolved with no lasting effect.  Please note - this was 2d dose. First was 6 weeks prior.
mom reported pt devel swelling & redness @ inject site which later turned colors down to the knee & behind the calf eventually developing lines down to the ankle; seen by MD dx blood poisoning;
This was a flu shot but don't know which type of flu shot was used.   Within seconds the area of injection started itching.  Within 24 hours it was very sore, very hot to the touch and had a red rash surrounding the injection area and outlying area of the upper arm.  Now on day 3 with the same symptoms.  Will take a Zyrtec or Benadryl to try and calm down the itchy and redness.
Shortly after injection right hand finger tips presented with peripheral neuropathy. Patient believed this would shortly go away and didn't report it. Following day neuropathy had spread down fingers. Currently fourth day, numbness has continues in fingers and into palm of right hand.  Patient has been living with peripheral neuropathy in his feet for over 15 years is well versed with neuropathy and its symptoms. This is new. Very similar to allergic reaction to Ciprofloxacin which according to CDC can cause permanent damage to the CNS after one dose.
Some numbness and tingling in arm and fingers. Not constant but noticed in certain positions. Numbness in tip of index finger. Symptoms are improving but have not yet completely resolved. believes "a nerve was nicked" and expects it to heal slowly. She has not reached out to a doctor or clinic; I recommended that she call her health care provider.
ACHY ALL OVER; GOOSEBUMPS; COLD SHAKES; FEVER; BAD HEADACHE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. 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, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 26-MAR-2021, the subject experienced achy all over. On 26-MAR-2021, the subject experienced goosebumps. On 26-MAR-2021, the subject experienced cold shakes. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold shakes, bad headache, achy all over and goosebumps was not reported. This report was non-serious.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
Here for Covid 19 vaccine at 0850 observed for 30 minutes prior to going home at 0930. Complain of throat tightness-able to speak in full sentences, able to swallow-report history of throat swelling in the past from codiene and limbs swelling with PCN
Developed severe headache the morning of 1/15/21 called for help found unconscious in bed room floor regained consciousness taken to Hospital became unresponsive shortly there after. Result of hemorrhaging on the brain. Died 1/17/21.
Patient stated that after her first vaccine she has had some vision loss and does not want the second dose.
Broke out in hives on chest. Hives lasted 7 days. Treated with Benadryl and topical Caladryl.   This is the same reaction I have when I take steriods, either oral pills or injected in joints.
Pt states "I received my second covid vaccine 01/21/2021 at 2:30pm and approx 2 hours after the vaccine, I began to have a fatigue, fever and I started chilling. When I got home around 4:30pm, my temp  was approx 99.8. Day 3,4, and 5 after vaccine my temperature stayed around 102. I took tylenol around the clock. I had severe fatigue, fever up to 102.9, chills, headache, nausea, and diarrhea. On day 4 I began to have severe stomach cramps. I could barely walk myself to the bathroom. I went 01/27/2021 and received 1 bag of IV fluids."
Approximately 48 hours a flu vaccine administered. Pt developed a 1 1/2" diameter red circle on inner part of arm, warm and red, also itchy and note itch was not where the shot was given. Dr. gave BENADRYL spray and circled spot to watch for cellulitis.
receive a corticoid steroid shot in her knees; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 as 1st dose for COVID-19 immunisation. The patient experienced "receive a corticoid steroid shot in her knees". Treatment was provided for the event. The patient reported that she had received her third dose of the Pfizer COVID-19 vaccine on 14Aug2021 but on 02Aug2021 she did receive a corticoid steroid shot in her knees and she was now reading on the internet that it should not have been taken. She stated she has called the CDC, they had no information and was told to try Pfizer. She reported that before getting a corticoid steroid should wait 2 weeks and then get the booster, she got it on the 13th day not the 14th day. She wanted information about the efficacy of the booster dose after receiving that but also receiving the steroid around that time and asked if that can effect the efficacy and if so would she need another dose in 6 months because of that. She received two steroid injections in her knee on 02Aug. Then on 14Aug she received her COVID vaccine booster. She was wondering if the efficacy of the Covid booster be affected by the steroids. Relayed PMI information and transferred to (name). Faxed PSCC for AE as she needed cortisone injections after taking 1st 2 doses of Covid vaccine. Outcome of the event was unknown.  Follow-up (18Aug2021): This is a follow-up spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for herself included clinical information.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Mom report pt had t106 w/convuls approx 2 wks p/vax; Taken to ER; t108 dx UTI IVs & ATB given; Rash appeared the following day; No apparent effect; ER reports states "fever seizure";
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. In approximately 2010 the patient was vaccianted with PNEUMOVAX23 (dose, route of administrtion and lot number were not reported) concomitatly with Meningococcal vaccine (unspecified). In approximately 2010, the patient developed a temperature 104 degrees after receiving PNEUMOVAX23. The putcome of event was unknown. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
17Feb98 pt recv 1 dose vax. 03Mar98 pt exp increased white blood cell count (22,000 cells/mm3).
Information has been received from a nurse concerning a 21 year old female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced a lump on her neck after receiving the vaccine. A CT scan was performed to check the lump but no results were available. No further details were provided.
no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 5th of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:Master
Drying excoriated 1/2-1cm patches scattered on lower legs c/o insect bites. Eryth papular lesions scattered on trunk esp. right flank about 20-30 total.
Redness and swelling from the vaccine site down the right arm. No fever. Patient was prescribed Cephalexin antibiotic medication.
Slight fever achy after first shot; Slight fever achy after first shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Slight fever achy after first shot) and PYREXIA (Slight fever achy after first shot) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (She has caught Covid twice.).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight fever achy after first shot) and PYREXIA (Slight fever achy after first shot). At the time of the report, PAIN (Slight fever achy after first shot) outcome was unknown and PYREXIA (Slight fever achy after first shot) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported that she has had all of her Moderna shots, and she had caught Covid twice. She blames this on the medications they gave her for Covid-19 and not the Moderna Covid-19 vaccine. Patient had to leave the telephone call and could not provide much information about her previous Moderna Covid-19 vaccines however she reported slight fever achy after first shot they said that this was what one usually gets.   Treatment information was not reported.
had COVID-19 in October; had a stroke; has been receiving therapy, physical therapy; Chills/it throw him in a hard loop of chills.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Stroke in 2020. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills/it throw him in a hard loop of chills.). On an unknown date, the patient experienced COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant) and PHYSIOTHERAPY (has been receiving therapy, physical therapy). On 26-Jan-2021, CHILLS (Chills/it throw him in a hard loop of chills.) had resolved. At the time of the report, COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) and PHYSIOTHERAPY (has been receiving therapy, physical therapy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events itching on fingers and arm, sore throat, swollen lips, warm to the touch at the injection site. Consent for follow-up given. Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching on fingers and arm, sore throat, swollen lips, warm to the touch at the injection site were unknown.
chills; body aches; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported that a 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 23Dec2020 at 03:00 PM ((at the age of 54 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 10:00PM, the patient experienced chills, body aches, fatigue. The report was reported as non-serious. The patient was not treated for chills, body aches, fatigue. The clinical outcome chills, body aches, fatigue was recovered on an unknown date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine Saturday. Sunday knot and sore arm. Passed  out Monday, May 8th @ 3am & 5am went to hospital. Treated for passing out but hospital never really acknowledged shot. Bruising down arm of shot and a bruise on thigh left side.
3" Hive at injection site.  Swollen lymph node left arm pit and neck/throat which has still not resolved after 4 month's.
Severe Rash starting on abdomen and slowly continuing over entire body over the course of 1 month. The rash did not itch until skin started to slough off. Last of sloughing ended around ankles about 2 weeks ago. After my research on vaccine, I found out that neomycin was in the family of NEOSPORIN. Years ago, I had a suspected reaction to NEOSPORIN cream and have never used it since. In previous years, I have received flu shots w/no adverse events.