chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, temperatures to 101.8 F, chills, nausea.  Lasted 30 hours
PATIENT PRESENT WITH LARGE RED AREA THAT WAS PAINFUL AND WARM TO THE TOUCH. SHE WAS ASSESSING IF IT HAD SPREAD OVERNIGHT AND IT DID. I ADVISED HER TO PRESENT TO THE DOCTOR FOR ASSESSMENT AND I AM AWAITING PATIENT'S CONTACT.
pt recv vax & immed p/vax there was a tremendous amount of bleeding @ the inj site;w/in 24hr a 15cm area of redness, warmth, induration, pain & mult purple & red ecchymotic splotches formed;pt was seen by MD who prescribed a steroid cream;
1/8/10 progressive paralysis of extremities X 4. pins and needles in hands, which moved to elbows. and joint pain. then unable to swallow. also had blurry vision, severe fatigue. weakness in legs severe, unable to walk.  unable to hold head up in sitting position.
At 3:00 woke up with headache and slight nausea and sore arm. Felt constipated and went back to sleep. Woke up at 9am felt nausea and was constipated but went to bathroom and small amount of stool. Then within another hour went to bathroom fine but still felt sore arm and stomach felt nausea. Then in 30 min around 10am after getting into bed again I got up and went to bathroom again and had slight diarrhea of soft stool and mash potatoes stool. Also I felt my lymph nodes under my chin and they were a bit swollen more than normal and still felt headachy and a bit of nausea but never felt like throwing up. Then ate breakfast and felt better but dull headache was on and off all day so took acetaminophen every 6 hours and then went to sleep and was good the next day no headache but swollen under the chin lymph nodes 9 days now. No other symptoms. No more sore arm unless I rub it I only feel it slightly n stomach is fine and no nausea after that first day.
830 Flu and shingles, 840 felt a little itchy, 1030 feeling generalized itchiness and flush took Benadryl, 11AM nauseated and throat feeling funny. 1145 felt terrible, wife states he passed out- patient says he was just too sick to speak. 1pm seen in the clinic.
Subsequent to receiving an injection of Acel-Imune, pt developed a fever and an injection site reaction characterized by redness, warmth and swelling which extended to the ankle.  The pt was immediately treated with Cefzil.
Vaccination Failure; Diarrhea; Vomiting; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Y5CZ7, expiry date 28th February 2019) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 9R3ZC, expiry date 14th October 2019) for prophylaxis.   On 13th March 2018, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 29th May 2018, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 11th June 2019, 1 year and 90 days after receiving Rotarix lyophilized formulation and 1 year and 13 days after receiving Rotarix lyophilized formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus and vomiting were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and vomiting to be related to Rotarix lyophilized formulation and Rotarix lyophilized formulation.  Additional details were provided as follows: The patient developed symptoms but was seen in the office for a rectal swab which returned positive for rotavirus. The reporter was okay for follow-up. This case was linked to case US2019117690 reported by same reporter.
TINGLING SENSATION IN LEGS; VARICOSE VEINS; BRUISING; LEG PAIN; TEETH CHATTERING/ CHILLS; HEADACHE; FEELING HOT; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia, and concurrent conditions included acne, amoxicillin allergy, non-smoker, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 14:30 for prophylactic vaccination. Concomitant medications included spironolactone for topical acne. On 01-APR-2021 03:00, the subject experienced feeling hot. On 01-APR-2021 03:00, the subject experienced flu like symptoms. On 01-APR-2021 03:00, the subject experienced teeth chattering/ chills. On 01-APR-2021 03:00, the subject experienced headache. On 05-APR-2021, the subject experienced tingling sensation in legs. On 05-APR-2021, the subject experienced varicose veins. On 05-APR-2021, the subject experienced bruising. On 05-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, flu like symptoms, and teeth chattering/ chills on 02-APR-2021, and was recovering from headache, leg pain, tingling sensation in legs, varicose veins, and bruising. This report was non-serious.
Had a dime size hematoma at injection site.  Arm turned blue immediately after shot.  Patient was given Benadryl and watched appropriately.  Doctor checked him and he was ok.
Confirmed Breakthrough 1st Dose  2/25/2021 - EN6202 2nd Dose 3/18/2021 - EN6207
pt recv vax 19MAR98 & febrile 103 25MAR98-3APR98 full work up done;no bacterial source;no URI;no UTI;no rash etc;poss case of Kawasaki disease;
allerg rxn, palms red, rash lt leg started 6/30/99 Pm;warm compress lt leg PRN;APAP;
About 10 hours after receiving my second dose of moderna, I began experiencing intense chills and joint pain.  My joint and muscle pain was very severe even after taking ibuprofen.  I developed a fever of 102.1.  Symptoms lasted for about 15 hours, then I slowly started to feel better.
double pneumonia and sepsis; double pneumonia and sepsis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history was chronic obstructive pulmonary disease (COPD). The patient previously took prednisone for COPD. She has a history of COPD and prior to getting her first Pfizer vaccine, she was on prednisone and antibiotics and was not feeling well. Concomitant medications were not reported. When she got her first vaccine on 30Jan2021, she started having problems breathing and a high fever and thought it was related to the vaccine. She was admitted to the hospital last Tuesday and was diagnosed with double pneumonia and sepsis. The doctor said it was not related to the vaccine. She got out of the hospital on Saturday. She is still on prednisone and antibiotics and now on oxygen all the time. She is getting mixed messages from her doctors on whether or not to get her second vaccine tomorrow. Some say yes, others no. She has not felt well for the last 5 weeks. The patient underwent lab tests and procedures which included body temperature: high fever on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
I received the second vaccine about 2:10pm on May 1, 2021. Around 8:00 pm, my arm started hurting intensely. I felt very tired and had a headache. I went to bed at 9:30 pm, but was woken up with an intense headache, back ache, and rapid breathing/heart rate. I had no problem with the first vaccine injection; this was the second one. I started running fever between 100 to 101 F, became nauseated and extremely fatigue, and cannot lift my head without pain. I have been sipping water as I don't have much of an appetite. It is now May 2, 2:20 pm and the symptoms are still present. The headache, nausea, and back ache have not changed. 100 fever is consistent. I am extremely fatigued and cannot get out of bed or off the couch. I have not taken any OTC meds yet.
Viral Exanthema - Information has been received from a health professional concerning a 1 year old female who on 19 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  concomitant therapy included one dose of varicella virus vaccine live MSD and hib conjugate vaccine MSD.  On 09-Oct 2000 the patient experienced virus exanthema.  she experienced a rash with macular papular eruptions.  The rash was all over the body except for the palms of the hands and soles of the feet.  The reporter felt that virus exanthema was related to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  (MSD) On follow up, it was noted that no other / further adverse reactions occurred.
Confusion, disorientation, memory loss, nausea, vomiting, brief episode, approximately 2 hours
arm pain; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm pain on an unspecified date with outcome of unknown. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial and follow up information has been received through the Merck pregnancy registry through a health care professional concerning a 21 year old female with nausea and pain, with a history of 1 pregnancy and 0 live births and a history of alcohol abuse, Papanicolaou smear abnormal, who had a colposcopy and a loop electrosurgical excision procedure performed in April 2007.  On 13-Mar-2007 the patient was vaccinated with her first dose of GARDASIL (lot number 655617/1447F) and on 14-May-2007 the patient received the second dose of GARDASIL (lot number 653736/0014U).  Concomitant therapy included NUVARING until May 2007, VITRUM PRENATAL, PHENERGAN and ADVIL.  the patient had on OB panel on 13-Sep-2007 and a Pap on 09-Oct-2007, results reported as "abnormal".  Patient is now pregnant (LMP=20-Jul-2007) estimated delivery date of 26-April-2007.  As of 10-Sep-2007 the patient is taking prenatal vitamins and PHENERGAN.  The patient's obstetric history included 1 previous pregnancy which ended in an elective termination at an unknown number of weeks from LMP.  A prenatal ultrasound was done on 04-DEC-2007 which showed to be normal.  The estimated delivery date was mentioned as 25-APR-2008 (previously reported as 26-APR-2007).  The patient sought medical attention with an office visit.  No adverse experience related to this event.  In follow up information from the doctor's office it was reported that mother had pregnancy induced hypertension and preterm labor (no onset dates reported).  It was also reported that she was positive for group B streptococcus agalactiae (+GBs) (date of onset not reported).  On 25-MAR-2008 she delivered a normal male baby 35 weeks 3 days from her LMP.  The baby weighed 7 lb 1 oz and his length was 19.5".  His Apgar score was 7/8 and head circumference was 12.6".  No complication or abnormalities were reported.  Additional information is not expected.
A pt's mother reported that her son received vaccine on 9/5/00, the vaccine was administered closer to the elbow than the deltoid and may have been SQ. On 9/6/00 the pt developed an injection site reaction characterized by swelling, hardness, redness, tenderness, and a bump.
Patient received vaccine and the next day her arm was sore and red. Five days after the vaccine her arm began to itch profusely and radiated to left hand. She also reported itchiness in right hand but not right arm. At this point, she has not visited a physician but will do so if symptoms get worse
Angina numbness and tingling in fingers, weakness in r hand, dropping items Narrative:  On 1/3/23 (over 1 year since booster recieved) reports experienced chest pain on 11/9/21 within 5 hrs of recieving covid booster. These symptoms were just reported 1/3/23. States visited ED on 11/9/21, normal ekg and labs, including inflammatory markers drawn, findings normal. She was discharged to home. Also reporting since the covid booster tingling and numbness in hands, weakness of grip dropping items with right hand. Is followed by pcp, and a nerve conduction study is pending with her pcp. Offered occupational medicine visit for possible vaccine reaction, employee declines this.
Pt was a non-responder to a complete series of Engerix-B (3 doses); outcome of 2 addt'l doses of vax is unk.
A fever began 36 hours after the vaccination was administered and persisted for four days, severely for two days. Arm swelled up to the point that a lump could be seen through the clothes. Arm is still swollen, though to a much lesser extent, today (8 days later).
Rash (red bumps); extreme itching on both arms, stomach, and both legs; This is a spontaneous case is received from a contactable consumer. A 77-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on 09Feb2021 15:45 as single dose for covid-19 immunisation. Medical history included covid-19. The patient previously took pfizer biontech covid 19 vaccine, phenolphthalein and experienced drug hypersensitivity. On an unspecifie date, the patient received first dose of BNT162B2. The concomitant medication was not reported. On 10Feb2021 at 12:00 AM, the patient experienced Rash (red bumps) and extreme itching on both arms, stomach, and both legs. The outcome of the event was non recovered.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & had local redness; warmth; induration; tenderness; itching area; pt presented w/ 12cm x 8cm pink indurated area, warm to touch;
A report has been received from a health professional, concerning a Male patient of unknown age. No relevant history, concomitant disease or concomitant medications of the patient were reported. The patient had received FLUMIST QUADRIVALENT (intranasal) on 15-Oct-2013. Lot number and expiration date was not reported. It was reported that the patient tested positive for Flu A on 03-Jan-2014. Action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the event of tested positive for influenza A was  unknown. The report was considered to be non-serious by the reporter.
Approx. 36-48 hrs p/recving vax, left upper arm became tender, red & indurated; c/o feeling "achy", especially neck; denies fever; symptoms lasted approx. 48 hrs; site red & indurated 4-5cm when seen in clinic 15OCT91;
Received vaccine at 10am CST 04/09/2021. By 6pm, whole-body chills had set in, as well as whole-body joint pain. Fever was 102. Took 2 Ibuprofen for the aches and 2 aspirin for the fever. Retired 0930pm.  On 04/10/2021, awoke at 0730am, feeling fatigued, but chills were reduced from previous evening. Continued with ibuprofen and aspirin. Went back to bed, as still feeling fatigued and chills. Temp 101. By 0200pm, feeling better but not normal, so continued ibuprofen/aspirin regime.
6 x 6 cm LA upper. 3 x 3 bruise LA lower.
Hypoglycemia with seizure like activity. Blood Sugar 44. Glucose gel was give and was sent to our emergency room.
w/in 5 minutes of inject, pt exp intense itching @ inject site; noted puffiness & redness @ inject site also applied ice; Approx 45 min p/inject, noticed wheals below inject site & extending below elbow; All sx cleared (2.5 hrs p/inject);
PATIENT CALLED AND REPORT REDNESS, SWELLING  AND A LITTLE ITCHY
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medications provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 216 hours, the lowest recorded temperature was 20 F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
covid; covid; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in arm, on 01Jan2021 as dose 2, single (Lot number: EL3246), in arm and on 08Oct2021 as dose 3 (booster), single (Lot number: EW0196), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Former smoker" (unspecified if ongoing); "HIV" (unspecified if ongoing). Concomitant medications included: BIKTARVY; ATORVASTATIN; TAMSULOSIN and others. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: Quidel Antigen Test positive; SARS-CoV-2 test: (26Dec2021) positive, notes: Antigen Test positive nasopharyngeal; (05Jan2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, includes: Bamlanivimab did not help vs omicron from 27Dec2021 to 27Dec2021. The patient received coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 068H21A), in arm for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of suspect cannot be excluded for the reported events.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Face swelling, tingling, hot red face, headache. Treated with Prednisone and Benadryl.
Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via EMS due to confusion and memory loss. Pt's son states that pt was diagnosed with "TIA" and stayed in the hospital x 3 days. Pt states that the physicians at facility was not sure if TIA was related to vaccine but encouraged him to report adverse event. Pt's son states that pt has short term memory loss and has since moved in with him after this event happened.
Headaches, chills, muscle aches, joint aches in my right hand which is the arm I received the vaccine in. dizziness, fogginess, fatigue,   I didn't go to the doctor because it wasn't that bad. It felt like the fog of a bad cold but without to coughing and runny nose stuff.
pt recvd series of Rabies shots on 9APR91, 16APR91 & 30APR91; following 2nd inject pt c/o h/a, stiff neck & vertigo which lasted 1wk; also back & leg pain w/quadrocepatrophy; MD felt vax made pt become more symptomatic lumbar spondylosis;
Expired Vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 003C21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Patient experienced swelling on the left side of her face about 5 hours after the vaccination, went to the ER , was advised to take Tylenol, reported the adverse effect to the pharmacy on 2/18,was still experiencing the swelling of the face and  is scheduled to see her PCP on 2/19.
Pt recv vax on 12/1/98; on same day pt exp Rt arm tender & sore w/ heaviness; chills & shivering; fever (101.4); Rt arm red & swollen w/ itching
Patient presents for Covid-19 vaccine booster. Patient reports having received second dose of original Moderna series on 3/11/21 and vaccine card is reviewed; date of vaccination verified and confirmed. Patient passes CDC prevaccination checklist for covid-19 vaccination. Denies being immunocompromised and reports feeling well today. Denies having allergic reaction to any vaccine in the past. Temp is measured at 97.3. Vaccine is given in left deltoid. Patient tolerated well and is monitored for 15 minutes following vaccination. No signs/symptoms of adverse or allergic reaction. Patient profile is accessed in ImmTrac (immunization registry) in order to document vaccine administration. When reviewed, it is discovered that patient has already received 3 vaccines. The third (Pfizer) dose was documented as administered on 8/18/21. Patient is asked about this and states "We forgot about receiving the third dose in August. We (my wife and I) were going on a trip and our doctor friend told us to get it. Sorry, we forgot about that." Patient is educated that the CDC guidelines require at least 6 months from the time of the second dose to receiving the covid-19 booster vaccine. Patient verbalizes understanding. No obvious signs or symptoms of adverse effects noted at this time.
Temp 103, Fine red bumps on left check, Started @ night on 7/22/01-day of vaccine
Administered FLUZONE HD to 64 1/2 y/o patient at a senior flu clinic. Mistakenly believed he was 65 y/o. No adverse side effects reported or observed.
Nausea Diahrea Chills Body aches Muscular pain Exhaustion (General flu-like symptoms)
Mother reported that student started developing redness around injection site that worsened. Took her to ER 11/01/2017 and was diagnosed with cellulitis and was put on KEFLEX 500mg qid for 10 days.