chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant referring to an 83 year old female patient with no drug reactions or allergies. The patient's concurrent condition included hypertension, acid reflux and chronic obstructive pulmonary disease (COPD) (with oxygen). Concomitant therapies included aspirin(manufacturer unknown), atorvastatin, omeprazole, albuterol, tiotropium bromide (SPIRIVA), hydrochlorothiazide (HCTZ) and ipratropium bromide (ATROVENT).  On 18-APR-2017 the patient was vaccinated with a dose of PNEUMOVAX23 lot # M038359, expiration date 13-MAY-2018 (dose and frequency were not reported) intramuscularly in the left deltoid for prophylaxis. On 18-APR-2017  the patient contacted office that overnight she developed from injection site swelling, erythema, pain in her left arm, radiating pain to chest. The patient was being treated with sulfamethoxazole (+) trimethoprim (BACTRIM) "800/400" (unit unspecific) twice daily for 7 days. The outcome of the events was not recovered at the time of report. Causality between the events and PNEUMOVAX23 was not reported.The reporter stated another reaction she reported with same lot (same reporter link MARRS# 1704USA006512) and office did not plan to use further doses from this lot. Additional information has been requested; Sender's Comments:  US-009507513-1704USA006512:
I think the vaccine affect my Blood Pressure Pills. I take BP pills for several years, and the dose of LISIN/HCTZ 20-12.5mg daily for months. and worked very well. My BP usually 110-130/70-80 after daily medication. After vaccination, start the next day, my BP goes up to 130-160/80-95, and the highest is uaually at night. It seems my BP pills didn't work well since vaccination.
Onset 11/20/01 7 AM with stomach upset, cramping, chills, diarrhea times 24 degree.
Swelling in right armpit - initially swollen area was approximately 4 inches in diameter Diagnosed by an urgent care physician as a swollen lymph node Swelling has slowly decreased; still present today - swollen area now approximately 1 inch in diameter
1 of 2 pts were inadvertently given Tetramune instead of Hep B; The vax was administered SC instead of IM; pt called the office to report swelling @ the inject site; pts last tetanus booster was less than 10 years;
RUNNY NOSE; SORENESS IN THE INJECTION SITE; FEVER; NAUSEA; This spontaneous report received from a patient 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: 1855190 expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2022 for covid-19 prophylaxis. No concomitant medications were reported. On JUL-2022, the patient experienced nausea. On 07-JUL-2022, the patient experienced runny nose, soreness in the injection site, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, soreness in the injection site, and fever on 10-JUL-2022, and had not recovered from nausea. This report was non-serious.
started fibrillating; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the patient started fibrillating on an unspecified date. The patient got the vaccine and a couple hours later he started fibrillating and was still dealing with it. The consumer's seriousness assessment for started fibrillating was unspecified. The patient visited the doctor and the doctor adjusted his medications a bit, seems to be healing. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
After the vaccine I'm fine for 5 mins but when I reached my car I felt a weird taste it's not bitter but it tastes like the outside of an orange and I still taste it today 12/18/2020, it feels like I have sand in my throat and I keep drinking water but it is not helping, my arm is really sore and I have jaw pain,
Sore arm at injection site. Left arm  Hard lump, rash, arm hot at injection site, spot bigger than the size of my hand spread out, lasted more than a week. Stiff and sore neck, from shoulders up to the base of the skull. Rash lasted for most of a week, fatigue & muscle pain continues. 3-30-2021 Severe Itch with (3) large peas size lumps, below the injection site. Muscles sore in the arms. Severe pain when brushing my teeth, turning stern wheel in auto, trying to lift a small object, and other movements. When lying down my rib cage and the area around it is sore. General fatigue.  Reported to doctors office before receiving second shot. Injection on  4-19-2021 Moderna 2nd Dose - 047B21A Sore arm at injection site. Left arm again.  Hard lump, rash, arm hot at injection site, spot bigger than the size of my hand spread out, lasted more than a week.  Muscles sore in the arms even when I lay down at night. The arms hurt with no movements even when laying down. Severe pain in the arm continues when brushing my teeth, turning stern wheel in auto, trying to lift a small object, and other movements. When lying down my rib cage and the area around it is sore. Walking in the morning is difficult as the ankles and feet are sore when standing and walking. This continues a happens thru the day any time I stand up after sitting for an extended period, like two (2) hours.   I called the doctors office where I received the shots, and was given information to increase my fluid intake. This information was given to me on Friday (4-30-21), and to call back if this did not help by Monday (5-1-21). Drinking more fluid did not help. I did not call the doctors office back, because I felt like the information was less than adequate. I will be contacting my regular doctor instead.    I have used cold wet clothes & ice at the injection site, & warm heat pads. It feels good for a while, but this still does not make the pain in the arm muscles stop. Any movement and every time I try to use my arms I have pain. This continues even today (5-8-21). I also take Ibuprofen, Tylenol, & Midol several times a day to try and get relief.
Pain and swelling in calf. Unable to walk. Started on oral Xarelto. Improvement of symptoms noted, but not 100%.
Pt recv vax on 11/9/98; on 11/10/98 pt exp erythema/redness/fever at vax site x 1 wk
Second dose Pfizer Covid Vaccine-headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Cholesterol" (unspecified if ongoing); "Blood clots in legs" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol (ongoing); ELIQUIS taken for thrombosis (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Batch/lot number: EL3247 , Dosage text: administered in left upper arm), administration date: 03Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (Mar2021), described as "Second dose Pfizer Covid Vaccine-headache".  No follow-up attempts are possible. No further information is expected.
fever 100-104;started late in evening on 5OCT95;had myalgia, arthralgia, nausea & vomiting on 6OCT95;started having cellulitis in vax area on 7OCT;had trouble moving arm, chills, severe h/a, stiff neck by late 7OCT; went to ER
Attendee received first dose Moderna vaccine at 11:23 in the right arm.  Lot# 026C21A.   11:24 - Attendee slumped over in his chair where he was sitting to get the vaccination, the RN vaccinator assisted and he did not fall.  Attendee did not have a total loss of consciousness. Attendee's skin was warm with cold sweat. Pale. Attendee's respirations were not tachypneic or dyspneic. Alert and oriented.  11:25 - Attendee assisted to the cot and lied down on his side.  911 was called.  11:28  Attendee was speaking so much that staff was unable to get accurate respiratory rate. HR:  83   BP:  126/60   RR:  Unable to obtain   O2Sat%:  98
Patient had difficulty breathing and throat closing/swelling within 5 minutes of receiving vaccine. Patient initially didn't want emergency care sent nor Epipen but changed her mind quickly.  Pharmacist administered Epipen 0.3mg followed by 25mg oral diphenhydramine. 911 was called and EMS arrived shortly to take patient to hospital.
became severely depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 13:15 (Lot number: EM9808) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Mild arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "became severely depressed". Therapeutic measures were taken as a result of depression.  Additional information: currently patient was being treated for chronic migraine, panic disorder and major depressive disorder. Also have mild arthritis. After the first administration she became severely depressed, but this could have been a result of outside factors, had to change medications. There was no COVID prior to vaccination and COVID was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
titer levels were too low; This spontaneous report has been received from a pharmacist referring to a 16 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient had hepatitis B titers done and the titer levels did not meet criteria and were too low (hepatitis b surface antibody negative). At the reporting time, the outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not provided.
PATIENT PASSED OUT FOR ABOUT 15 SECONDS AFTER THE SECOND ATTEMPT OF INJECTION. PATIENT REVIVED WITHIN 30 SECONDS WITHOUT INTERVENTION. NO HOSPITALIZATION WAS INVOLVED, THE PATIENT WAS OBSERVED FOR 15 MINUTES AFTERWARDS AND THERE WAS NO FURTHER WORSENING OF THE SYMPTOMS.
Chills; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Severe headache; nausea; dry mouth; chills without fever; This is a spontaneous report from a contactable pharmacist. A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3246), intramuscular on 19Jan2021 on the right arm at a single dose for COVID-19 immunization.  The patient had no relevant medical history and no known allergies.  The patient's concomitant medications were not reported.  It was unknown if the patient had COVID-19 prior to vaccination. It was unknown if the patient had other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 post vaccination. It was reported that the patient experienced severe headache, nausea, dry mouth and chills without fever all on 20Jan2021. Treatment for the events was acetaminophen and diphenhydramine. The outcome of the events was recovering.
I just wanted to pass along my vaccine experience.  So, I got the first dose on 25 Jan.  Within a day or two I developed a cold sore.  I had not had one in years but it wasn't a big deal.  I just figured the foreign vaccine had triggered it from being dormant.  Well, I got my second dose on 16 Feb.  Within days my eyes started feeling weird...specifically my left eye.  It was achy all day, red when I woke up, watery, and it was difficult to focus when I first turned on the lights.  This morning I went to the eye doctor and he told me that I had developed a blister (like a cold sore) in my eye.  I had never ever ever experienced this.  But like the first cold sore on my lip, he said it was dormant in my body and the vaccine just triggered it.  There are only two eye drops that treat this and they are pretty expensive but he told me that if I had not come to see him, this virus would have just lingered in my eye.  Just thought I would share my experience.
Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no drug reactions or allergies who began the GARDASIL series around July of 2007 and finished the series in 2008 (lot # were not reported).  Concomitant therapy included MINOCYCLINE.  In approximately November 2008 the patient experiencing aching leg pain that began behind the back of her knees and then radiated to the front of her knees and thighs.  The patient also has been experiencing pain in her shoulders.  In January, the patient was seen by her physician for the pain.  The patient had not recovered.  Additional information has been requested.  4/2/09 MR received from PCP including vax recs.  15 yr WCC 7/24/08 with normal exam with exception of PMH rash/hyperpigmented skin. Returned 1/7/09 with c/o several  month hx of thigh/hamstring pain. PE (+) for decreased flexion.  Assess: Probable muscle strain.   F/u 2/12/09 with continued pain which has now spread to knees, elbows, wrists and fingers with low grade temp of 99'F.  Referred to rheum. 6/8/09 Rheumatology records received DOS 2/7/09 to 3/30/09. FINAL DIAGNOSIS: Juvenile Rheumatoid Arthritis, Poly. Presents with knee pain, hurts more when going up/down. At night/waking up. Arm pain, shoulder blade. Fever, energy level fair, chest pain, armpit rash. TMJ tenderness. Joint tenderness, limited ROM. Acne.
Erythema Multiforme minor (painful target lesions on palms and soles of feet)
Sudden onset of Vertigo.  First event within seven days of first vaccination.  Five additional episodes since.  No history of vertigo prior to COVID vaccing
Information has been received from a physician concerning a 69 year old female with no known allergies or pertinent medical history who "in the first week of October 2007" on approximately 01-OCT-2007 was vaccinated SQ with Zostavax (Oka/Merck). There was no concomitant medication. On 17-NOV-2007 the patient developed blisters on the injection arm that quickly spread to her entire upper body. The patient did not have pain, but reported itching. The patient was diagnosed by a dermatologist on 04-Jan-2008 with lichen planus. There was no product quality complaint involved. Additional information has been requested.
Significant redness & swelling at site of KINRIX injection, 5-6cm (edema & redness). Ice to arm to decrease swelling.
local redness and blotchy skin (L) arm fever *attempted to contact pt to get more info-unable to
BLOOD CLOTS; This solicited report received from a consumer via social media, concerned a female of unspecified age of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2023, the patient experienced blood clots, and was hospitalized. Duration of hospitalization and discharge information were not reported. It was reported as "Just last week I had my sister hospitalized for blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was related.  This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230434716.; Sender's Comments: V0: 20230433876- blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Pt received Hep B vaccine and reported vomiting x1 within 15 minutes. Pt came to pick up.
Mom called stated pt complained of spine pain, headache, nausea, & trouble walking. Mom took child to ER on 10/2/19. Called mom this morning stated the ER informed them pt was having muscle pain due to flu vaccine.
Chills, lethargic, bad headache, diarrhea, shooting muscle pain, unable to sleep due to the discomfort, arm pain at injection. Basically, felt like when I had covid.  This is why I was hesitant to get this shot.  I missed 2 days of work and will be out of commission I?m sure, this weekend.
Febrile seizure, lasted about 10 seconds, no treatment needed, labwork done was normal.
I have had a rash on my lower legs for 1 1/2 weeks ,have not gone to the Dr. .I have tried calamine, rubbing alcohol,. now I am trying Benadryl
Cyst in Uterus; hormonal problems; This spontaneous case was reported by a patient and describes the occurrence of UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027620A) for COVID-19 prophylaxis.     Patient never had myocarditis or pericarditis. Patient was never tested positive for COVID-19.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems). At the time of the report, UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-649984, MOD-2022-649987 (Patient Link).
dose spilled out of needle; dose spilled out of needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle). On 29-Mar-2021, UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Underdose and device connection issue for mRNA-1273, lot #  028A21A  with no associated AEs.
pt recvd vax & exp tremors of arms, legs & head which lasted for several minutes & occurred intermittently throughout the day & through the noc; remained conscious; rt leg red & swollen;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563: US-009507513-1801USA002564.
With the 1st one I had severe chills whre my teeth were chattering the second day, body aches and some fatigue.  Lasted about 3 days.  With this 2nd one, I woke up the first night with a terrible headache and chills.  By morning the chills were gone but I am so tired and my whole body hurts.    I had Covid in November and the symptoms are similar to what I experienced with Covid except I had a 103-104 fever and no chills.  I had to go in the hospital to get an IV with steriods to help my lungs so I could breathe.
Approximately 8 minutes, post vax, pt vomited. Vital signs were stable. She complained of a frontal headache. She was medicated with Children's Tylenol and again complained of nausea but no vomiting. Supine for about 35 minutes. Discharged to home; headache better.
Janssen COVID-19 Vaccine EUA - headache- lasted for 10 hours; comes and goes still. *Taking Tylenol - nausea- lasted for 1-2 hours (no vomiting) -racing heartbeat- lasted 15-20 minutes around 3pm -Numbness, tingling, "feeling of freezing" finger tips and toes- lasted for 1-2 hours - Body chills- still on-going - feeling dehydrated- on-going still. *Drinking Liquid IV and lots of Water - 102 temperature at 9:30pm on 4/7- lasted for 1 hour. *Took Tylenol -Feeling of vertigo/cloudy head- happens occasionally