chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 days p/vax pt devel temp 103-105 APAP administered;next AM T103, rash-small red dots;noticed shuddering taken to MD;3PM began seizing, stiff, eyes rolled back, foaming @ mouth;limp, stopped breathing, turned blue;limp
Sever abdominal pains and diarrhea. Soon after body aches and fever of 102+ set in for at over 72 hours. Next congestion and chronic coughing and and chest congestion began. I was given Benadryl for swelling and Ibuprofen for the fever and the pain. A cough suppressant and inhaler were taken to assist with breathing. Excessive fluids given to assist with fluid loss from diarrhea.
Patient had just been advised that his cancer had stopped growing and would be able to resume his immunotherapy drug Tagrisso. After receiving his first dose he went downhill very quickly. On the evening of 2/23 he had an unexplained seizure and went to the ER through 2/26. He was discharged to Hospice and passed away on 2/28.
Patient came into pharmacy 6-8-13 with redness and soreness around injection site of ZOSTAVAX. Pt stated had taken 2 BENADRYL.
No additional AE/PQC details provided.; PNUEMOV AX 23 was administered to 2-3 male patients today; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot # T010779, expiration date reported as 30-JAN-2022). No additional adverse event details provided.  According to the reporter, the vaccine that was stored in their refrigerator that broke and reached a temperature of 68 degrees Fahrenheit for 12 hours on 21-SEP-2020 (product storage error), without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports form the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA009474:
Severe Chills; Achy joints; fever; headache; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.  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.   The concomitant medications and treatment details were not provided.
Moderna COVID-19 Vaccine EUA Slight Rash on Right side of stomach that resolved after two days (1/26/21) Rash at injection site has appeared one week later after injection (1/31/21)
fatigued; no appetite; testicular pain; clammy, fatigued, no appetite, testicular pain; This spontaneous case was reported by an other caregiver and describes the occurrence of COLD SWEAT (clammy, fatigued, no appetite, testicular pain), FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 13-Jan-2021, the patient experienced COLD SWEAT (clammy, fatigued, no appetite, testicular pain). On an unknown date, the patient experienced FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain).   At the time of the report, COLD SWEAT (clammy, fatigued, no appetite, testicular pain), FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Pain, redness and swelling in arm. Chills, headache and fatigue. Trouble sleeping.
1-12-2021 Cough, runny nose 1-13-2021 sore throat
Within 24 hours after receiving Anthrax and Hep B injection, member developed a generalized macular-papular rash: started on back and spread over body except for face. Treated with Medrol Dosepack, Atarax, Kenalog lotion with complete resolution of symptoms within 24 hours. Patient did not come in to be seen until 12 days after reaction began.
coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) 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 COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Information has been received from a health professional concerning a 27 year old female who on 12-JUN-2007 was vaccinated intramuscularly with her first dose of Gardasil. On 13-AUG-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil. On 12-DEC-2007 the patient was vaccinated intramuscularly with her third dose of Gardasil (lot # 659439/1267U). Concomitant therapy included albuterol (VENTILAN (albuterol)) as needed and cough, cold, and flu therapies (unspecified). On approximately 12-JAN-2008 the patient experienced a tender "knot" at the injection site. The patient's tender "knot" at the injection site persisted. The patient saw her primary physician and he will be ordering unspecified tests. No other details. Additional information has been requested.
Day after vaccine I developed tinnitus that has persisted to this day. Treated with steroids and antibiotics with no relief.  Also, 2 days after vaccine I developed a very rapid heart rate, greater than 150, and lasting for greater than 10 minutes. Sought treatment at  in  , where heart rate was still elevated upon arrival. EKG and labs were normal with exception of potassium, which was a little low at 3.2. Followed up with a cardiologist. And an electro physiologist cardiologist with no real conclusion of the cause.
Pt got vaccine on 6/8/16 in (R) deltoid noticed this AM that she had some itching and swelling of (R) arm. (+) pain with deep palpitation.
1/21/22 pt to hospital for left foot wound with plans for I&D in next few days; given ABX; amputated 1st metatarsal of left foot; 2/7/22 pt had audible crackles and wheezes; breathing heavily; CXR showed pulmonary edema and pneumonia; 2/8/22 pt had a positive COVID test; increase in O2 need; placed on Vapotherm; family changed pt status to DNR; poor respiratory status; pt became bradycardic and expired in the hospital
This spontaneous report as received from a consumer who refers to himself, a 69 year old male patient with chronic lymphocytic leukaemia, gastroesophageal reflux disease and allergy to contrast dye. On 26-JUL-2015, the patient was vaccinated with ZOSTAVAX dose 1 (Product circular #: USPI-V211-I-FRO-1602R019, lot number and expiration day unknown). Concomitant therapies included LIPITOR, extended release INDERAL and PRILOSEC. The patient reported that after receiving ZOSTAVAX, his glomerular filtration rate (GFR) levels have gone down. Before the ZOSTAVAX his levels were "73.2," however now it is "49.29" (conflicting information as the AE onset date was reported as 10-JUN-2015, which is prior to the start of therapy with ZOSTAVAX. The patient reported having routine blood work done very 6 months. The patient sought medical attention by presenting for an office visit and reported he received no treatment for his decreased GFR levels. The reporter did not assess the causal relationship between the adverse event and the therapy with ZOSTAVAX. The outcome of glomerular filtration rate decreased was reported as not recovered. No further information was provided. Additional information has been requested.
p/vax pt devel soreness & stiffness in arm, shoulder & up into neck but no other sequelae;pt w/working w/hep b carrier child who spits & bites & want to cont that job;
Patient received vaccine and began filling dizzy. She then said her head was hurting behind her eyes. Blood pressure was 161/99. Patient left with ems
dripping bloody nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (dripping bloody nose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced EPISTAXIS (dripping bloody nose). At the time of the report, EPISTAXIS (dripping bloody nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mom called on 10/21 and said that the patient reported diarrhea and nausea following receiving the vaccine.
Patient was given 0.5ml for her fourth dose Moderna booster around 11:30am on Friday 1/28/22. Patient was informed and did not report any side effects or symptoms as of yet. Patient was told to notify her primary care physician and pharmacy informed primary care as well, and patient was counselled on potential side effects similar to first 3 doses. Patient was understanding and seemed unconcerned.
Information has been received from a registered nurse concerning a patient who in approximately 4/05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647724/0946N). Last month, the patient developed a similar reaction to cellulitis. Unspecified medical attention was sought. The patient's outcome was unknown. The nurse requested an investigation into this lot number. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Patient experienced swelling, redness, and soreness in left deltoid following immunization. Patient stated that she took some NSAIDs and put an ice pack on the area, which did not significantly change outcome. Patient is able to move arm.
This spontaneous prospective pregnancy report as received from a physician for GARDASIL a Pregnancy Registry product, concerning a 16 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with lot # (670050/1229AA) dose1, 0.5 ml of GARDASIL IM on 08-JUN-2012. There were no concomitant medications. Subsequently, the patient became pregnant. On 06-JUL-2012, a serum pregnancy test was performed with a positive result. The patient's LMP was on 08-MAY-2012 and an her EDD would be on 12-FEB-2013. Initial exposure to GARDASIL was at 4 weeks. The patient was exposed to GARDASIL during trimester 1. No problems were reported. Additional information has been requested. Follow up information received, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. This case was lost to follow up. The pregnancy outcome was lost to follow up. Additional information is not expected.
Within a few hours I began to hear a ringing in both ears. It became progressively worse. After Tylenol due to headache I developed from the noise,  I was able to sleep a few hours .  However, it is back in full force this morning.   I?ve had no prior issues with hearing, no prior ENT visits, and have never had anything like this.
This spontaneous report as received from a licensed practical nurse refers to a 61 year old patient. On 30-APR-2013, the patient was mistakenly vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not reported) instead of ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to a 6 months years old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1806USA000270: US-009507513-1811USA001371: US-009507513-1811USA001369.
Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but felt face tingling similar to hyperventilating. ER visit identified normal o2 and provided allergic reaction treatment of benadryl pills and prednisone injection right arm.
Periodic tightening of chest (primarily on right side of body) Periodic odd sensations around lymph node area Week-long severe tongue swelling & pain (limited diet to soft foods like applesauce) preceded by inner lip bumps in November 2021 "Breakthrough" COVID case in December 2021 Weird ongoing multi-week gum swelling above upper teeth (right inside quadrant of mouth) from January 2022 into February 2022
fever (to 101.2),  myalgias, local swelling;pain @ vax site over 48hr period following vax; no tx
Left arm swollen and in pain for 3 days after immunization.  Tylenol given 2 days after immunization and swelling and pain subsided on third day.
I received my vaccine and within two days I ran a temperature of 103.2 for six days. I contacted my doctor to see if this reaction is normal and I was told yes. I did not take anything to break the fever as I don't believe in doing that. I did lose my appetite and I did lose weight. I drank water and I did eat. I did test positive for COVID-19 on 11/2022. As of today, I feel better, but I do suffer from shortness of breath.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Guillain Barre syndrome (in 2008) and rheumatoid arthritis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced cold sores, feeling miserable, influenza-like symptoms, headache and fever. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the cold sores, feeling miserable, influenza-like symptoms, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, cold sores, feeling miserable, influenza-like symptoms, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. In the evening after receiving the SHINGRIX injection, the patient experienced soreness at the injection site that lasted for 3 to 4 days. In 2018, less than a year after receiving SHINGRIX, the patient experienced headaches, fever, and flu like symptoms that were still ongoing at the time of reporting, they came and go every few days. In 2018, less than a year after receiving SHINGRIX, these symptoms make her feel miserable. The patient reported that she has not a cold sore for years, however since less than 3 months after receiving SHINGRIX, she had several outbreaks. The patient reported that she had one cold sore that will not resolve. The patient had denied permission to contact their physician. Referred patient to her PCP.
Not feeling well the evening of the vaccine, began running a temp that evening with aches, chills headache.  The following day continued to run a temp of 103.6 F, aches, fatigue, chills, headache,  and tachycardia (120 bpm).  The following day, developed itching w/o rash.  Itching and fatigue lasted for approximately 8 days, the other symptoms subsided after approximately 3 days.
Patient received the Jannsen vaccine on 3/11/21 and then scheduled the Moderna vaccine on 4/9. Pt was adimate that she had received the Moderna for her first vaccine which is what was reflected on her paperwork. Therefore, patient was vaccinated with one Jannsen vaccine and one Moderna vaccine. Pt denied any adverse reactions from either vaccine.
On 12/22/99, the pt received her 1st dose of Havrix. "Right after the injection", she experienced headache, dizziness and was "hyper". Additionally, she lost her appetite and lost 20 pounds, experienced swollen lymph nodes and occasional yellow stools and muscle aches. Her feeling "hyper" subsided, but she still had loss of appetite, continued to lose weight, and had muscle aches. A doctor or ER visit was required. No treatment was given. Multiple tests were performed (NOS) but no dx was arrived at. The most recent information received on 5/10/00, reports the outcome of the event is unknown.
- Headache began upon waking up this morning (7:30 am); subsided some after taking Tylenol (full dose, regular strength) - Headache returned around 11:00 am; has been progressively worse - Fever and chills began around 12:15 pm - Currently 12 weeks, 6 days into my second pregnancy - Husband received the same vaccine (Lot EN6024) and reports no adverse symptoms, other than a mild headache (may or may not be related to the vaccine)
Fainted. Also had sore arm at injection site, low grade fever, head ache.
3 wks p/1991-1992 flu vax pt devel Bell's Palsy;
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I got the 2 COVID shots and still got the COVID Virus; I got the 2 COVID shots and still got the COVID Virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got the 2 COVID shots and still got the COVID Virus". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Pushing multiple shots that were not vaccines against getting the disease at all. She got the 2 COVID shots and still got the COVID Virus and had to take Paxlovid for 5 days. She never had a flu shot and never had the flu of any kind.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Full Fibromyalgia flare up. Extreme Pain over 10 on 1-10  scale. Incapacitated.  I feel this should have be told. Especially for other people with the condition.
Dermatographia lasting still to this day (3/29/22). Severe rashes and hives that spread across entire body. "Itchiness" at a level that made it difficult to focus on anything else. Trouble breathing if I wasn't taking anti histamines on occausion during the first week of symptoms. Any place that I scratched would then break out in hives and itch more for the next 30-60 minutes. I have found comfort from taking allegra and pepsid twice a day, everyday. Any attempt to break away from taking these drugs have led to a reoccurrence of symptoms (although not as severe as when they first began).
Started with diarrhea the night of the vaccination. Then by morning developed hives in several areas. The injection site was warm to touch and erythmatic. She was seen by a physician. She was advised to take Benadryl and rest.
SEVERE INFLAMMATORY FLARE-UP at site of osteoarthritis, both knees (first time in 14 years, left knee; first time in 7 years, right knee) Right knee approximately 80% recovered, left knee approximately 60% recovered and improving.
Onset Seizure. 7 seizures in 6 months .... mostly grand mal. All imaging normal. No past health history or family history.
The night of the night and my left eye was in pain, my left eye. I thought I had an infection so I made an appointment because I though it was a pink eye. They called in some eye drops. 12/31/2021 I had intense pain, even if I closed my left eye or see the light. My dad ended up taking me to the ER and I was referred  with an eye doctor and so I went and saw a doctor and he diagnosed me with uveitis and so they put me on new eye drops and steroids because my eye was attached to my lance or that's what they said. They do believe it was due to the booster. I see my eye doctor again in June/July. I was told that my white blood cells has a marker HLA-B27.