chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in for her second dose, and reported that she had terrible arm pain after 1st dose. Also stated she had terrible pain over body since vaccination 3 weeks prior. Stated that on a pain scale of 1-10 (10 being the highest), that her pain was over a 10. This had been intermittent over the past 3 weeks. She stated that she would take Tylenol, and after the Tylenol would wear off the pain would come back greater than before. I told her she needed to see her primary care provider before the second dose would be administered due to her pain being higher than a 10 after 3 weeks of 1st dose.
12:35 Immunization given left arm. Put band-aid on. Had complaints of feeling dizzy, breathing shallow, helped to couch, passed out face forward. Clonic movements of upper arms, stiffening of entire body, eyes rolled in back of sockets. about 2-3 seconds. Woke up saying how long was I out. No post itchiness response noted. ? lips, feet movement with 1305 U/S. 13:10 EMS here. 13:20 mom escorted child in private car to ER.
Received MMR, VZV and Prevnar on 11/06/00 and was marked irritability for 10 days, post vax. No fever or treatment required.
arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unknown date, patient experienced arm soreness following both vaccine injections. The outcome of event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Pt. states that after receiving the 1st dose of Phizer 02/21/2021, started experiencing symptoms 02/24/2021 of injection site infection across the arm to the elbow * antibiotics. Primary visit 03/04/2021 treated with Antibiotics.
This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On 17-AUG-2015, 19-AUG-2015, 24-AUG-2015 and 31-AUG-2015, the patients were vaccinated with improperly stored doses of VARIVAX lot # J012328, expiration date 02-OCT-2015 (dose, route of administration and anatomical location were not reported). No adverse experiences were reported. Additional information has been requested.
I began experiencing skin issues in the weeks/months after my booster. Extreme itching, red scaly patches on face, arms, legs. Also eczema type bumps on torso.  Also psoriasis on scalp.  Additionally yeast infection in arm pits that won't resolve with prescriptions ointments.
Stomach discomfort; This case was reported by a pharmacist via call center representative and described the occurrence of stomach discomfort in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was recovered/resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The patient received Boostrix 10 years ago from the reporting date and had stomach discomfort. The vaccine was administrated on another facility and no vaccination date provided.  The lot number and expiration date were not provided. The consent to follow up was not asked.
Approximately 30 minutes after receiving the vaccine, the patient described the onset of an itchy, full-body rash. Later that evening, she had fatigue, headache, myalgia, subjective fever, low appetite, as well as, low energy. She noticed the onset of several erythematous patches consistent with hives on her arms, legs, trunk (including groin), back, neck and face. She was uncomfortable. This persisted until her appointment Monday afternoon with no treatment. She took ibuprofen 200mg on Saturday 5/22.
Tested positive for COVID-19; congestion; runny nose; Muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-SEP-2015, the patient was vaccinated with a dose of improperly stored VAQTA lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperature: 34F (1.111 Celsius degrees) for 120 hours and 33 F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pt received his first COVID-19 vaccine (Moderna) and within 12 hours had full blown COVID symptoms including headache, body aches, low grade fever, sore throat. Within the next 24 hours those symptoms had increased by 50%.
Headache, Fever, swelling of lymph nodes under arm under right breast (lots of swelling, felt hot), muscle pain, joint pain, stomach ache and cramping.  Hurts to move arm, pain radiates down arm. Taking Tylenol and Aspirin every 4 hours.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 4th of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
This spontaneous report has been received from a nurse practitioner referring to a male patient of unknown age with colitis ulcerative. The patient's medical history and drug reactions/allergies were not reported. Concomitant medications included infliximab (REMICADE).  In December 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, lot #, expiration date or anatomical location were not reported) subcutaneously as prevention of shingles. On an unknown date, the patient experienced an increase in "ulcerative colitis" after receiving the vaccine. No additional adverse event information was reported. The outcome of the event and the causal relationship with the suspect therapy were not provided. Upon internal review the colitis ulcerative was considered as a medically significant event. Additional information has been requested.
Patient received initial COVID-19 vaccine on 1/16/2021.  Experienced injection site soreness and a little fever lasting 48 hours.  On 1/19/2021, patient developed severe sore throat/odynophagia.  Went to an urgent care, and strep throat screen and COVID test and both resulted negative.  Odynophagia continued, painful to swallow food/liquids.   Never developed tongue or lip swelling.  Due to ongoing fevers, patient admitted to hospital for ulcerative pharyngitis
Pain in both arms from elbow to just below shoulder, thinks it began in November. Mentioned it to PCP. No treatment at this point. Then went to ER for arm pain where they ran tests for muscle weakness & blood tests. Referred to Cardiologist who tested his heart and found no problems. Referred to rheumatologist, has not had appointment yet. Arm still sore, burning ache and pain varies in intensity.
This spontaneous report as received from a 75 year old female retired nurse (who was also the patient) with MACRODANTIN reaction/allergy, possibly narcotics reaction/allergy, elevated blood pressure, elevated cholesterol, osteoarthritis, might possibly have rheumatoid arthritis, urinary tract infection (began prior to receiving ZOSTAVAX). Her primary physician prescribed BACTRIM but she had not taken if yet and high creatine level (unspecified what her usual level is). The patient's medical history included insulin resistance, shingles and double coronary artery bypass grafting (CABG) in 2005. On 18-NOV-2013, the patient creatine was 1.18 (the lab that ran the test said their "normal range" was 0.5 to 1.10) (ordered by her primary physician). On 19-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported) at an unspecified pharmacy. Concomitant therapies included acetaminophen (manufacturer unknown), TYLENOL Extended Release, aspirin (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LOVAZA, magnesium (manufacturer unknown), metoprolol (manufacturer unknown), NIASPAN, nitroglycerin (manufacturer unknown), omeprazole (manufacturer unknown), potassium chloride (manufacturer unknown) and vitamin D (manufacturer unknown). On 21-NOV-2013, the patient creatinine level increased, her creatinine was 1.7 (the lab that ran the test said their "normal range" was 0.7 to 1.2) (ordered by her rheumatologist). The patient sought for medical attention (phone call). No treatment given for the events. The outcome of creatinine level increased was not reported. Additional information has been requested.
Round and bumpy swelling around injection site for the flu vaccination. Hives growing at the nape of the neck. Right arm had no swelling. Over time swelling in left arm went down. Took 50mg of Benadryl.
pt recv vax 10JUL95 & 12NOV96 pt devel chicken pox following exposure to chickenpox;reporter also stated that pt brother devel chicken pos following vax;
Grandmother stated that infant cried inconsolably for 5 hours. (Pt had IPV/Connaught/T0786/IM/LL/0 previously on 7/16/01).
There was no adverse reaction noted but this patient had already received the Bivalent Booster on 9/22/2022. Patient is aphasic and his spouse requested the vaccine and was not present. The COVID card was not available at the appointment.
Multiple Sclerosis triggered Auto-Immune Arthritis, Chronic Fatigue. Double-Blind study. It took until this past summer for the doctors to make the connection. Doc 213587 states the following: " Because this was done under a double-blind study. I was never given all of the information that you're looking for. I do not know the vaccine lot or manufacturer. I am only now reporting this because it wasn't until this past summer when the connection between the vaccine and triggering the MS was made.
NauseaVomiting chills, pasty look, weak, sweating Narrative:
Hot arm; Knot; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site warmth and injection site induration. On an unknown date, the outcome of the injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the injection site warmth and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had both the doses over 2 month apart in 2022. The injection site was right arm both times. After the 1st dose, the patient had mild reaction like hot arm and knot. No fever or weakness every time. The patient had no reaction to the 2nd shot and asked if it was still good.
Chest thightness; Lightheadedness; He became cyanotic; Nausea; Patient fell over; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014N20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The parent's past medical history included Epilepsy and Allergy.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over). The patient was treated with NORMAL SALINE at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Follow up information was received on 10-Mar-2021Report contains no new information, however listedness added, outcome added which was missed in previous version, seriousness criteria removed as it is not given in the document
Information has been received from a physician concerning a 16 year old patient who was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #658059/0383U).  Subsequently the patient experienced abnormal swelling and abnormal redness at injection site.  The patient's outcome was not reported.  Additional information has been requested.
Day 2 after first dose of Pfizer covid 19 vaccine I had 4 inch hives/rash at injection site. It went away by Day 5. The hives/rash come back bigger 5 inches on Day 7. Used Benadryl creme on it and the rash went away on Day12. On Day 14 I felt extreme fatigue, burning muscle aches, burning skin, joint pain, nerve pain, temperature 98.8 (usually is 97), high pulse rate (80-125 (usually 62-75) high blood pressure 199/90 (usually 125/80), sweating, weakness, numbness in feet and left arm and hand and mouth. Saw primary care doctor for lab work which came back normal, went to Emergency Room on Day 35 with more extreme symptoms.
Patient reported her last UC flare up was 2 years ago, never required hospitalization for UC flare up. Patient followed up with Dr. and has been on Xeljanz 5 mg since 2019.  Patient's denied any recent travel history, or any food poisoning, anybody around her was sick.  Received 2nd dose of Pfizer vaccine on 5/19. She mentioned it second day after she got her COVID vaccine, she noticed she started having non bloody diarrhea, abdominal cramps, nausea vomiting, loss of appetite, she contacted GI office, she was prescribed with p.o. steroids, and asked her to monitor her symptoms. She feels like her symptoms is likely UC flareup like the one she has in the past. Her symptoms subside after 1 week, however 1 week later, her symptoms back again, presented with 10 bloody bowel movements daily, nausea vomiting, unable to have good oral intake, and fever 100.5. Patient went to ED on 6/4, c-diff negative, CT abdomen and pelvis w/ contrast showed severe colitis involving the left colon from splenic flexure to rectum. Patient was recommended she should admit to the hospital for IV steroids but she left AGAINST MEDICAL ADVICE. After leaving hospital 6/4/2021, patient continued to have similar symptoms and had fever of 102 on 6/5. She decided to come back to hospital again. Patient received IV solu-medrol 20mg TID and clear liquid, and slowly advance to low fiber diet and switch to PO.
Musicale aches, fatigue, tingling, crawling and prickling skin, mild headache and low-grade temperature
Low grade fever for 2 days with large area of redness on right thigh. Diagnosed as cellulitis. Treated with antibiotics, Augmentin ES.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (1st COVID on 04 or 11-Mar-2022 tested positive, Paxlovid taken for 5 days felt better shortly.) in March 2022. Previously administered products included for Flu vaccination: Flu vaccine (Flu yearly (around October)) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided.  The Patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 21-Nov-2021 with lot number 034F21A, 2nd booster dose on 08-Apr-2022 with lot number 002M21A.  She states that this was the 2nd time she got the COVID after getting the Moderna COVID-19 vaccine. She says that she thanks Moderna for the vaccine but she was quite disappointed because she had all the doses and yet she ended up getting it twice.  The AE cause patient to seek medical care at office consult only no hospitalization.  The symptoms were still ongoing.  It was reported that prescribed with Mucinex DM by doctor, day 4 of illness at the time of call.   This case was linked to US-MODERNATX, INC.-MOD-2022-672539 (Linked Report). This case was linked to MOD-2022-672560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672539:Husband's case
This spontaneous report as received from a nurse refers to a 10 months 24 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
On 4/25/00, the pt awoke very weak and shaky. She could barely get out of bed. She complained of nausea and denied vomiting. She had sever fatigue. She had weakness in her hands affecting fine motor skills like make-up application, writing, and dressing. A doctor visit was required. No treatment was given.
DEVELOPED HIVE LIKE APPEARANCE ON 04/05-SAW THE DR ON 04/07, RECEIVED STEROID, BY 04/10 IT WAS MUCH WORSE WITH PIERCING PAIN AND BURNING ALONG WITH HEADACHES, AND ON 04/12 SAW THE DR AGAIN, DIAGNOSED WITH SHINGLES
Swelling/pain/redness at the effected site. Muscle pain. Swollen lymph-nodes.
no adverse event reported - we are to log Ped Pfizer vaccine with lot number that got administered October first after the recall came down concerning lot FL2747. told by manufacturer that dose was still viable but to still report.
pt recvd vax & devel temp 103 by 6PM cont fever 102 x 2 days; APAP given; crying high pitch sound w/o tears-2 days; welts over body day 1 p/vax w/swollen lips & difficulty swallowing-fine rash cont day 2&3 could be felt on face, trunk limb;