chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of shingles vaccine and experienced sore arm for a day, no issues at all. The follow-up would not possible, as no contact, details were available.
Patient complained of "lightheadedness and feeling hot". Patient denied dizziness. Patient alert and oriented. Patient denies chest pain, SOB, rash, and itchiness. Patient provided with ice pack. Blood pressure 128/88, respiratory rate 16, and temperature 97.4F.  Symptoms subsided at 1530 with ice pack, rest, and relaxing measures.
My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; This is a spontaneous report from a contactable Consumer. This 66-years-old female Consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/exp. date unknown), via an unspecified route of administration on 23Jan2021 11:45 AM at single dose on left arm for covid-19 immunisation at a Clinic/ Administration facility.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  Patient had no known allergies. Patient did not have any other vaccine in four weeks. Concomitant medication included metformin, thiamine hydrochloride (VITAMIN B-1), cyanocobalamin (VITAMIN B-12).  After the 1st dose, her muscle and nerve on both side of her face (especial jawline area) are uncomfortable. The nerve of both of front elbows was uncomfortable "stronger" on an unspecified date with outcome of not recovered.  Patient has not tested post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 07-MAR-2019, the patient was administered PROQUAD (subcutaneous, lot: R011215, expiration date was 15-OCT-2019; strength and dose were not reported) for prophylaxis and VARIVAX (subcutaneous, lot: R012531, expiration date was 01-MAY-2020; strength and dose were not reported) for prophylaxis concomitantly (Overdose). No adverse effects was reported.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history and drug reactions/allergies were not reported. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not reported). Then, on an unspecified date in 2015 (reported as the weekend), the patient went to a pharmacy requesting a dose of ZOSTAVAX, which was administered. On 30-NOV-2015, the patient called to the pharmacist to report that she was already vaccinated in 2008. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
pt recvd vax; 2 days later, inject site very red, red bump size of silver $; no v/d; no fever;
Within 24 hours of receiving the vaccine, my left shoulder completely froze, and I had limited mobility and suffered severe pain and weakness. It took almost a full year to regain full range of motion, strength, and use of my left arm. My practitioner thought the pharmacist may have hit a nerve. My daughter, a Nurse Practitioner, said she believed the vaccination caused adhesive capsulitis. She suggested treating it with ibuprofen and physical therapy exercises she gave me, and overtime, my shoulder began to heal. There are still times when I wake up in the middle of the night with sharp pains in that shoulder.,
severe hip pain and low back; severe hip pain and low back; This is a spontaneous report from a contactable pharmacist.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 24Dec2020 15:30 to at a single dose, for COVID-19 immunization. Medical history included arthritis in the lumbar region, a slight herniated disc. The patient's concomitant medications were not reported. Two (2) days after vaccination, in the morning of 26Dec2020, he had 'severe hip pain and low back'. It was stated that he did not do anything to flare that up. Also, never had pain in his hips before, and the pain in his back is higher. He has been off work this week due to the pain. Visited ER doctor who provided recommendations including application of heat. It is not getting better. Although with heat it feels better. The outcome of events was recovering.   Follow-up attempts are completed. The following information on the batch number has been requested.
Info has been received from an RN concerning a 31 year old white female with no known drug allergies and no illness at the time of vaccination, who at 11:15 on 7/11/05 was vaccinated, IM, in the left deltoid with a dose of MMRII (lot 649746/0778P). Concomitant therapy included hormonal contraceptives (unspecified) "until this past month". The nurse reported that the pt winced as the vaccine was administered so it was probably slightly painful. No other reaction was noted. It was reported that a recent titer showed no immunity to rubeola, but the pt stated she had received the vaccination as a child. Unspecified medical attention had been sought. On 7/13/05, at 09:00, ;the pt was vaccinated, IM, in the left deltoid with a 2nd dose of Hep-B (Engerix-B) (lot AHBV074AA). No additional info is expected.
patient described vomiting and diarrhea the morning after injection followed by body aches and chills that lasted until the next morning.
administered a dose of proquad intramuscularly instead of subcutaneously; No adverse effect; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 14-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), of one dosage form (lot S012531 exp.date : 31-OCT-2020) via intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis. No adverse events were reported. No product quality compliant was reported. The outcome of incorrect route of product administration and no adverse event was unknown.
PATIENT DESCRIBED ADVERSE EVENTS / SYMPTOMS TO BE RASH, ITCHY, PAINFUL, HOT AND INFECTED
Rash on forehead and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on forehead and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on forehead and neck). At the time of the report, RASH (Rash on forehead and neck) outcome was unknown.            Reporter did not allow further contact
REPORTS ON 7/25/2022 NOTICED WHEN WOKE UP FINE BUMPS, ITCHY RASH THAT STARTED ON LT EAR AND NECK BY 7/27/2022 HAD SPREAD TO LT ARM, LT UPPER BACK AND LT UPPER CHEST WITH SOME SCATTERED BUMPS ON RT SIDE ARM AND NECK.  ON 8/4/2022 WENT TO PCP, WHO PRESCRIBED A TOPICAL CREAM TO APPLY TO AFFECTED AREA. PT BOUGHT SOME OTC ALLERGY RELIEF CERTRIZINE TO TAKE.FOR COMPLAINT OF SEVERE ITCHING
Information was received from a pediatrician regarding a 4-month-old patient who experienced diarrhea. The patient received a dose on an unspecified date. The patient experienced diarrhea. No additional information was available at the time of this report. See related cases: US-WYE-H07073908 (adverse event, non-expedited); US-WYE-H07074008 (adverse event, non-expedited); and US-WYE-H07074108 (adverse event non-expedited).
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (Patient recieved dose 1 of Pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval) and NO ADVERSE EVENT (No adverse event.) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis. Patient had no allergies to medications, food and other products. Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (first dose) on 06-Aug-2022. Past adverse reactions to the above products included No adverse event with Pfizer. On 22-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)) and INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine). 22-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event.). At the time of the report, COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval) 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 assessments were provided for COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval).  It was reported that patient received the vaccine in right leg and was not aware of any symptoms experienced by the patient after the vaccine was administered. HCP did not know if patient was under any treatment for any symptom, of if patient was under any concomitant or regular medication.
patient is a 65 y.o. female patient of  MD with history of Coronary artery disease, hypertension, hyperlipidemia, and asthma, now presented to a local Hospital with pneumonia.   COVID 19 pneumonia   Acute hypoxemic respiratory failure d/t above  Sepsis, POA, d/t above and below  Lactic acid within normal limits, no need for IVF resuscitation WBC 29K CTPA: negative PE.  MF pneumonia noted. Bronchial wall thickening present as well  Blood and urine cultures NGTD.  Strep & legionella negative Continue remdesivir, and decadron.  Will increase decadron to 10mg daily.  Discontinue levaquin given negative procal and imaging suggestive of viral pna  Suspect leukocytosis d/t steroid administration  MRSA swab negative. PCT negative, discontinue abx.   CRP markedly elevated and improving.  Resume home lasix  Stable on 4-5L NC with ambulation.   Ready for discharge home to complete steroid therapy  RX for ativan PRN for anxiety sent to pharmacy    hypertension  Initially low normal, now elevated.  Resume home lisinopril and coreg.   prescribed 40mg BID of lisinopril which is inappropriate.  Change to daily   Resume home lasix  Continue nifedipine daily on discharge.    hyperlipidemia Continue home pravastatin.   Cigarette dependence without complication Counseled on cessation for 3-10 minutes.   Will write for tobacco replacement patch.   Solitary pulmonary nodule Incidental finding in the right upper lobe on admission CT chest. Outpatient surveillance imaging at discretion of family physician after resolution of acute presenting issues.
4-6 hours after shot developed red swollen eyelids and periocular areas. No airway symptoms. Treated with antihistamines and today given Prednisone (10/13/16). Vaccine given 10/11/16.
Diarrhea; Nausea; Migraine for two days; Stomach pain; his is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 24Apr2021 at 14:15(at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm left on 03Apr2021 at 15:00(at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 00:00, the patient experienced diarrhea, nausea, migraine for two days and stomach pain. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine was resolved on 27Apr2021, while the clinical outcome of the events diarrhea, nausea and stomach pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had rapid heart rate.  It felt like there was fluid in my lungs.  I had hard time breathing.  I was congestive and had a running nose.  My breathing was wheezing, pressure, and uncomfortable at times. I was very fatigue.  I went to ER.  The did a x-ray and blood work.
I experience extreme insomnia and felt my heart was racing last night around 1-3am. Was difficult to sleep. Right now I am sitting watching tv with my son around 8pm and felt like slowly I difficultly breathing and heart racing.
had fever on date p/shot; given APAP; cont w/fever until 24SEp; took to hosp was admitted w/pneumonia;
Son who is 16 received the Moderna vaccine by mistake; A spontaneous report was received from a HCP concerning his 16-year old, son who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, my son who is 16 received the Moderna vaccine by mistake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the 16-year old received the mRNA-1273 vaccine. No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 16-year old received vaccine was considered Resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
vaginal bleeding. menses not due until 2 wks. I don't suffer from irregular bleeding
Felling chill and joint pain after 2nd dose  But ringing in right ear started after 1st does. Now after 2nd it is strong ringing in both ears. I have never had this issues before. It?s maddening!
Left thigh swollen, hard to touch, painful and red on the day after vaccine given. Seen in ER and was given Keflex po.
RED SWOLLEN PATCH AT INJECTION SITE, SWELLING OF UPPER ARM.  THE RED SWOLLEN PATCH CONTINUED TO SPREAD ON 9/20 TO A PATCH ABOUT 2.5 IN X 4 IN.  IT IS VERY TENDER AND ITCHY.
Pt reported that evening that Fluzone HD was received, 10/30/21, he had pain and deep purple bruising from the injection site down to his wrist. He is currently on Eliquis. Went to hospital to be evaluated where the provider told him to alternate hot/cold compresses until resolved. Pt presented to pharmacy on 11/15/21 and spoke to the pharmacist, showing her the bruising which is still present (purple and yellow in color) and mentioned it is still very painful, with difficulties sleeping at night on the left arm. Pharmacist mentioned that he may want to reach out to PCP to have it looked at again. Pt stated that his son is a physician and agreed that hot/cold compresses were the best treatment option at this time.
tiredness; headache; just did not feel her self; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via unknown route of administration on 10Mar2021 at single dose for COVID-19 immunisation. Medical history included immunocompromised condition and severe allergies but not to vaccines. Concomitant medications were not reported. Patient had first dose of the pfizer covid 19 vaccine was on 10Mar2021. patient reported tiredness, headache and just did not feel herself in Mar2021. Caller wanted to know if she should get the second shot. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient felt runny nose and sore throat coming on. By 3:30pm, patient was vomiting, had chills, 101 degree temperature, achy arms and hurt everywhere.
Information has been received from a physician concerning an 18 month old female who on 22-MAY-2008 was vaccinated with VARIVAX (Merck). The physician reported that the patient developed rash at the injection site on the leg for 3 days following vaccination with VARIVAX (Merck). It was not clear if this was the first vaccination with VARIVAX (Merck). On approximately 25-MAY-2008 the patient recovered from rash at the injection site on the leg. Additional information has been requested.
Patient presented to ED with complaints of cough and shortness of breath. CT did not show signs of PE, however had bilateral ground glass opacities and small pleural effusions. Patient was fully vaccinated with Pfizer vaccine on 2/5/21 and 2/26/21. Admitted to hospital with COVID-19 on 1/6/22.
after 15 minute loss of focus feeling lightheaded ; sent to medical pod help;BP   170/80/oxygenalevel okay; sat for a few minutes; BP checked again and asked if I had ever been told I had an irregular heartbeat; answer was no ; okay after this able to stand up and get back in passenger seat of car.  10 days later "covid arm"  sore, itchy, large red blotch elbow  to shoulder; flushed cheeks; resolved after a few day but still faintly noted took Tylenol and used ice pack; not really a lot of help
Approx. 4 hours after vaccination patient was driving and became extremely itchy over his entire body. He states that he pulled over and  developed "welts" over his body. Patient hyperventilated and had a syncopal event. EMS was called. Patient took 2 BENADRYL and is doing well today.
Patient was in waiting room after receiving the vaccine and informed me that she fainted. This was approximately 10 minutes after receiving the vaccine. The patient was awake and alert. She did not fall after fainting, she was sitting down so she just slumped down in her chair.
Patient was given adult dose of Covid-19 Vaccine.  It was diluted as if it was a Pediatric Vial.  Pharmacy reported she got 10% of the vaccine.
Patient came in today and said that after she received flu-HD and AREXVY (on 8/24/2023), the left arm area  where AREXVY was injected was swollen and redness at the injected site and it spreads through her left  shoulder, the entire upper  LEFT arm  area was  painful and hard due to swelling, was very  sore, and she also had a big headache. Patient said after she took tylenol 500mg   it helped a little bit with the pain and headache and then she took ibuprofen and she feels better. Today, she said she is about 70-80% better, but she still has soreness and redness around the injected area where AREXVY was injected.
Vaccine administered was HPV.  Moments afterward, the patient fainted and collapsed, injuring her tailbone on the floor and her head on the wall.  She was helped onto the patient examining table and did not regain full consciousness for more than an hour.  What's particularly upsetting is that usually when any shots are given, patients are asked if they have an aversion to needles or a history of fainting.  In this case, the patient (my daughter) does, so we would have said "Yes."  At that point, the administering nurse should have informed us that a common side-affect of HPV vaccine's is fainting.  She did not.  If we would have known this, we would certainly have elected not to have her subjected to this vaccine, particularly since it is new and quite controversial.