chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Fever, Rash, Diarrhea, Chills, fatigue Narrative:
Unconsolable high-pitched cry x3 hrs.  Also, 60x70 mm area of warm, red inflammation over right anterior mid thigh surrounding injection site of Pentacel vaccine.
1/5/2021 1st Pfizer Covid vaccine EL0140 11a Left Arm 1/26/2021 2nd Pfizer Covid vaccine EJ1686 11a Left Arm 5/4 ill 5/5 Covid Positive 5/15 Potential to RTW
Client had vaccine fainted fell out of chair.  Abrasion to right cheek , eye and left elbow reported right head pain from the fall. Stated she felt like she hit on her right shoulder.   Diaphoretic b/p 104/72 99%PSO2 pulse 68.  Did not want to go to ER.  2:10 diaphorectic fainted again. b/p 110/68 pso2   98%  pulse 62.  woke quickly taken to ER via wheelchair @2:13
fever; joint pains on his knees, arms, shoulders, and hips/joint pain in ankles, shoulders, hips, and elbows; pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 25Aug2021 (Lot number: FC3183) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Controlled hypertension" (ongoing), notes: Diagnosed with around 1998, 1999 or 2000, caller can't remember.; "Stent" (unspecified if ongoing), notes: heart patient that has 5 stents. The stents were placed in the years 2001, 2002 and 2018.; "anti-cholesterol medicine to keep cholesterol down" (unspecified if ongoing). Concomitant medication(s) included: REPATHA taken for blood cholesterol decreased (ongoing); PLAVIX taken for stent placement (ongoing). Vaccination history included: Bnt162b2 (First dose: 26Jan2021 , lot: EL9263, Route of administration: Right arm), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Second dose: 16Feb2021, lot: EL9267, Route of administration: Left arm), administration date: 16Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain at the injection site"; PYREXIA (non-serious), outcome "recovered" (2021), described as "fever"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "joint pains on his knees, arms, shoulders, and hips/joint pain in ankles, shoulders, hips, and elbows". Additional information: The joint pain came up a couple of weeks ago and its not from physical exercise or anything, has had a lot of joint pain which is abnormal for him.  No follow-up attempts are possible. No further information is expected.
I got like really sick last night; I couldn't sleep; My body was really hot, I think I had a fever; Chills; Leg cramps; Body aches; Arm is really sore; This is a spontaneous report from a contactable consumer.A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.The patient previously received first single dose of bnt162b2 on 28Jan2021 for Covid-19 immunization. The patient stated she just want to report that she got the vaccine yesterday (confirmed as 17Feb2021) and on 17Feb2021 she got like really really sick last night, she couldn't sleep, her body was really, really hot and then she also had chills with it. So, she think she had a fever but she just didn't have the thermometer to check exactly what it was. And she had really bad leg cramps and body aches and she just felt really sick, she couldn't sleep, her arm is really sore and she just wanted to report it because she know as an employee that is our responsibility to report it. She stated she took Tylenol and Advil last night .She took 1 Advil last night and 1 Tylenol this morning. The outcome of the events were recovering.  Information about lot/batch number has been requested.
First dose: 4/10/2018 / Second dose: 3/4/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10h April 2018).   On 4th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up.
I feel lethargic; have diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea). At the time of the report, LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact
Patient called to report redness and pain after receiving the vaccination in his left arm Friday. He stated that the redness had grown to approximately an area of 6x6. He denies swelling below his elbow or up into his neck or face. He denies new or worsening dyspnea. 11/26/18 Primary Care MD note assesses condition, but does not indicate any treatment required.
never sick, but shot put me in bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received a dose of Shingles vaccine and experienced sickness. The patient reported that he/she never got sick but the shot put him/her in bed for 3 days. The patient declined the second dose. The follow up was not possible as no contact details were available.
Initial report received on 24 September 2009 from a consumer. A 60 year old female patient with no reported medical history developed a reaction one day after she received ADACEL (lot number C3098AA) intramuscularly in the right deltoid on 27 June 2009. On 28 June 2009 the patient reported swine flu like symptoms which included cough, low grade fever, extreme difficulty breathing, fluid in her lungs, coughing up large of amounts of mucus which was initially clear then changed to green. Her symptoms progressed into pneumonia. The patient was sick for three months. She was seen by a physician who prescribed Amoxicillin and antivirals which had no effect. During that time, she improved two times and then had relapsed. The patient was reported as recovered. List of Documents held by Sender: none.
Patient reported difficulty swallowing several hours after the vaccination. This did improve the following day. She stated she was walking funny and her was sore for the injection site up over her shoulder into her ear.  She did take an ibuprofen
HIVES OF MULTIPLE SIZES BY DAY 4 AFTER VACCINE ON BACK OF LEGS.  HIVES PROGRESSED BY DAY 12 AND COVERED LEGS, ARMS, CHEEK AND LOWER ABDOMEN.  DSHS FOLLOW UP CALL WITH MOM 11/8/2010...CONDITION IS WORSE 2 MONTHS AFTER VACCINATIONS RECEIVED. MOM STATES PATIENT COVERED HEAD TO TOE WITH HIVES.  MISSED WEEKS OF SCHOOL AND WAS FINALLY REMOVED FROM THE CLASSROOM AND IS NOW HOMESCHOOLING.  LOCAL DOCTORS PRESUME IMMUNE SYSTEM DISORDER OF SOME SORT.  REFERRED FAMILY TO HOSPITAL.  GOING TO 3RD APPOINTMENT THERE TUESDAY 11/9/2010. TWIN SISTER HAD HIVES FOLLOWING A FLU SHOT BUT RESOLVED QUICKLY.
WE WERE MISINFORMED BY THE HEALTH DEPARTMENT REP THAT WE CAN ADMINISTER THE MODERNA VACCINE TO ANYONE YOUNGER THAN 18 YEARS AND WE GAVE THIS 17YR OLD PATIENT THE MODERNA VACCINE.  SHE WILL NEED HER SECOND DOSAGE, BUT WE WANTED TO KNOW WHAT SHOULD BE DONE? THE PATIENT HAS HAD NO REACTION TO THE VACCINE.
N/V/D, redness around area of vaccine  Began Monday night. Status: improvement, gradual. Aggravated by eating. Improvement with Pepto, clear liquids. Associated symptoms include, vomiting, diarrhea, ABD pain, tired Denies: blood in stool or vomit, ENT sx, fever and contacts with same s/s.Pt c/o NVD since Monday. Pushing fluids, urine was a bit concentrated today. She gets occ. pain near the belly button when she eats, up to 8/10, improved w/ heat and pepto, improving. Doesnt radiate. she ? pulled a muscle from vomiting. non-tender, no bulge. No pain w/ movement. Diarrhea improving- x 1 today, watery stool. Has not vomited since last night. Tolerating PO liquids and small amt of toast today. No fevers, felt a bit warm last night. She got her covid vaccine (Pfizer) 1st dose 4/23 and had redness at the injection site which is improving.  Supportive care advised
blood in urine noticed about 24-36 hours after shot, at 48 hours after went to clinic and urine was positive for blood and negative for all other things. urine was coca cola colored to pink
booster; the vaccine may not be working; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller reports history of her and her husband being slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2, first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site.), for Covid-19 immunization, reaction(s): "mild tenderness at the injection site".  The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "the vaccine may not be working".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101706398 same reporter/drug/AE with different patient
Did not respond p/3 doses of Engerix-B; converted since 5th dose;
Muscle pain arm where the vaccine was administered (left), inflated area of the vaccine. Take Panadol.
Unusual Angry attitude at day care, throwing things, saying 'no' to everything, hitting, not listening (2 days).
Muscle aches and pains - about two months after injection; digestive issues got worse at the same time.  ER - Diverticulitis issues. Things have gotten worse with these things after vaccine. Fluids and suggested a reduced diet and to continue on with the Pantoprazole and watch what I eat.
having some weird side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (having some weird side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (having some weird side effects). At the time of the report, VACCINATION COMPLICATION (having some weird side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Swelling of Right arm below the elbow not at the injection site. Soreness and tightness of the right hand. After 72 hours these symptoms resolved however on 12/19/2020 developed burning and itchy hives over abdomen, back and trunk. On 12/21/2020 the hives developed on the scalp.
Extended local reaction with erythema, induration & pain 10 x 4 cm on (L) upper arm down from inj site of DTAP.
tested (nasal swab done) on Sunday; received positive test result; Patient had COVID, did not know she had COVID and got the vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable pharmacist (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EH9899) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had COVID, did not know she had COVID and got the vaccine. Patient received vaccine on Saturday, tested (nasal swab done) on Sunday. Patient received positive test result on 21Dec2020. Outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
5+ days of chest tightness; Low heart rate (47-51 BPM); Fatigue/Exhaustion; Headache; Nausea; Vomiting; Fibromayalgia symptoms; Diarrhea; Cold feet/hands; Muscle shaking; Confusion; Abdomen discomfort; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: EW0161) via an unspecified route of administration, administered in Arm Left on 23Apr2021 19:15 at the age of (26-years-old) as a dose 2, single for covid-19 immunization. Medical history included sjogren's syndrome, Hashimoto's, fibromyalgia, asthma, endometriosis, Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Concomitant medication included hydroxychloroquine taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient did not diagnose with covid-19. Since the vaccination patient was not diagnosed with covid-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: ER8730) via an unspecified route of administration, administered on an unspecified date in mar2021 at 07:00 PM as a single dose for covid-19 immunisation. It was reported that on 24Apr2021 13:00 the patient experienced 5+ days of chest tightness, low heart rate (47-51 BPM), fatigue/exhaustion, headache, nausea, vomiting, Fibromyalgia symptoms, diarrhoea, cold feet/hands, muscle shaking, confusion, abdomen discomfort & joint pain. On 24Apr2021 the patient underwent lab tests and procedures which included heart rate which includes low heart rate (47-51 bpm), on 27Apr2021 Nasal Swab test: negative, PCR test: negative, Rapid Test: Negative Nasal Swab. On 29Apr2021 COVID-19 BY NAAT PCR, TMA: negative. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
patient reports "tremors/seizures" starting  the day following the vaccination. I inquired about fever, but patient was unsure if she was running a fever. Recommended acetaminophen to control fevers below 101. Recommended prompt follow up with ER or PCP.
Fever, upset stomach, diarrhea, muscle tightness, extreme muscle soreness. Three days after, new symptoms of red streaking and swelling, further red skin and warmth to touch four days after. Went to urgent care clinic and was treated for infection caused by vaccine injection.
Information has been received from a licensed practical nurse concerning a patient, who on 18-MAR-2009 was vaccinated with the first dose of PNEUMOVAX (Lot # 662785/1124X), intramuscularly. The nurse reported that on 20-MAR-2009, the patient developed cellulitis. The patient was treated with antibiotics and at the time of the report, the patient was recovering. The patient sought medical attention through an office visit. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 63-year-old female patient who received SHINGRIX (batch number 7447A, expiry date 25th April 2020) for prophylaxis. On 12th April 2019, the patient received SHINGRIX. On 12th April 2019, unknown after receiving SHINGRIX, the patient experienced accidental underdose. In April 2019, the patient experienced pain, injection site pain, malaise and fatigue. On an unknown date, the outcome of the pain, injection site pain, malaise and fatigue were recovered/resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the pain, injection site pain, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient jerked while administering SHINGRIX and fluid leaked out which led to accidental underdose. The patient experienced pain, injection site pain, malaise and fatigue. On 15th April 2019, the reporter followed up with the patient and patient stated that she had aches, pain, malaise, and fatigue and now all resolved.
Information has been received from a health registered nurse, for GARDASIL a Pregnancy Registry product, concerning a 15 year old female patient with no drug reactions/allergies and no pertinent medical history, who on 29-JUN-2012 was vaccinated with the third dose of GARDASIL (dose and route not reported) (lot number 672232/1495AA, Exp: 22-AUG-2014) and also found out on the same day that she was pregnant. Concomitant therapy included loratadine, CELEXA and "PRO AIR". Her second dose of GARDASIL (dose and route not reported) (lot number 668051/0178AA, Exp: 09-MAR-2012) was administered on 30-JUN-2011 and date for the first dose of unspecified. The patient's last menstrual period was 02-MAY-2012 and estimated delivery date would be on 06-FEB-2013. No treatment was given for the AE. Laboratory diagnostic study was performed: pregnancy test. The patient sought medical attention - office visit. Additional information has been requested.
kidney stones; blood in her urine; sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took glipizide for diabetes and experienced bruising and bleeding. About three years ago, the patient took Glipizide ER for about 3 months (dose unknown but she was splitting the tablets and taking small amount) and noted an increased incidence of bruising which was worsening over time and longer bleeding because of it. She had blood work done and results came back within normal limits, including platelets. She discontinued the glipizide ER. The patient currently has kidney stones that can shift around and cause blood in her urine which occurred on an unspecified date in Jan2021, about 3 days after the first Pfizer COVID vaccine. After receiving this first vaccine, she had a sore arm, but no bleeding or bruising. The patient underwent lab tests and procedures which included blood work: within normal limits, including platelets on an unspecified date. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient came back to pharmacy an hour after the vaccine shot, complaining of numbness and tingling on the left side of the face and arm. NP on site was contacted and she took vital signs. 911 was called and they came and took vital signs. The patient was checked out fine by the EMS crew and was not taken to the hospital per patient's wish.
Patient presents with shortness of breath, wheezing, cough, fever and generalized weakness. Found to have Covid-19 infection, diagnosed with Covid-19 pneumonia. Placed on IV abx, solumedrol, vitamin supplements, steroids, eliquis.
Information has been received from a 52 year old licensed visiting nurse who was splashed while she was withdrawing a dose of PNEUMOVAX 23 in approximately September 2008 (fall of 2008). Concomitant therapy included hydrochlorothiazide and WELLBUTRIN. In November 2008, the patient experienced bronchitis, shortness of breath and sinus infections. The patient was tested for Valley fever and had a chest x-ray performed (results not reported). The patient was seen by her physician. The outcome was not recovered. Follow-up information has been received from a licensed visiting nurse with a history of sinusitis concerning her experienced while giving residents immunizations at a skilled nursing facility. On approximately 01-NOV-2008 the nurse was drawing up either the PNEUMOVAX 23 or influenza vaccine (NOVARTIS) and small amount of vaccine escaped from the needle/vial as she withdrew the needle. This surprised her and she gasped at the same moment and inhaled either flu vaccine (NOVARTIS) or PNEUMOVAX 23. The nurse stated she only remembered this a week or so after the fact, when on 02-NOV-2008 she ended up in the ER with shortness of breath, unable to catch her breath shorting after the incident. On an unknown date a chest X ray was done and was clear. Ever since the patient has been wheezing, coughing and with shortness of breath and have not recovered. The nurse considered that the events resulted in persistent or significant disability. Additional information has been requested.