chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
I received both a flu vaccination and a pneumonia vaccination on Friday afternoon. On Saturday evening my neck became sore and I began to develop a headache in what felt like the back of my head. By midnight I was in a lot of pain, very stiff neck and severe headache. Thought I'd try to sleep it off and went to bed. My body starting shivering to the point my teeth were clattering. Eventually fell asleep but was awakened multiple times from the neck pain and headache. By 8:00 AM when I awoke for the day, the stiffness and headache had subsided, but I was left exhausted. I felt mostly recovered by early Sunday evening and fully recovered by Monday morning.
Fever up to 101 degrees fahrenheit; Muscle aches; headache; fatigue; lymph node swollen to size of golf ball under shot arm; sore arm; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route, administered in Left Arm on 29Apr2021 at 13:15 (45-year-old vaccination) as Dose 2, Single for Covid-19 immunization. The patient was non-pregnant. The patient's medical history included current subacute thyroiditis, endometriosis. The patient's concomitant medication(s) included ascorbic acid (VITAMIN C), VITAMIN D3, loratadine and ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; folic acid; nicotinic acid; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride; tocopheryl acetate (MULTIVITAMIN). The patient previously took avelox, prednisone, singulair and experienced allergies for all past drugs. The patient had not received any other vaccine within 4 weeks prior vaccination. The patient was neither tested for Covid prior vaccination nor post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729) via an unspecified route, administered in Left Arm on 08Apr2021 at 16:30 (45-year-old vaccination) as Dose 1, Single for Covid-19 immunization. On 30Apr2021 at 02:00 AM, the patient had experienced fever up to 101 degrees Fahrenheit, muscle aches, headache, fatigue (after 18-36 hours of vaccination) and (after 36-96 hours) lymph node swollen to size of golf ball under shot arm, sore arm. No treatment received for resulted events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
It was reported that a 19 year old male received a Menomune A/C/y/W-135 vaccination on 1/25/00. Reportedly, on 1/27/00, the pt developed a headache and a fever. The pt took Tylenol and was effective. The pt was not evaluated by a physician. From additional correspondence, it was reported that the pt was evaluated by a nurse practitioner. "No other symptoms consistent with 'flu', i.e.: 'aches', sore throat, cough, etc."
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Mar2021 as dose 2, single (Lot number: EX10175), in right arm, in Oct2021 as dose 3 (booster), single (Lot number: ER8730), in right arm and in Jul2022 as dose 4 (booster), single (Lot number: EN6198), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patent had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 05Oct2023 to 09Oct2023. Clinical course: Vaccine administration time was 10:00 AM for all suspect doses.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331711 same reporter/patient, different drug/AE;
The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 26Oct2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and other HCP (registered medical assistant) via a sales representative. This other HCP reported similar events for two patients. This is 1st of two reports. The reporter was calling on behalf of both of the physicians who administered PREVNAR 13 to the 2 patients. A 75-year-old female patient received PREVNAR 13 (Lot Number N16560, Expiry date Sep2017, NDC number 0005197101) intramuscular at 0.5 ml, single in the left deltoid on 29Sep2016 01:45 for immunisation. Medical history included ongoing hypertension (taking NORVASC and COZAAR for it), ongoing atrial fibrillation (taking LOPRESSOR for it), ongoing blood pressure measurement, ongoing diabetes mellitus. Concomitant medication included LOPRESSOR orally 25 mg tablet, twice a day ongoing for atrial fibrillation, NORVASC orally 5 mg tablet, once a day ongoing for hypertension, COZAAR orally 50 mg tablet, twice a day ongoing for hypertension. The patient previously took prednisone and experienced blood glucose abnormal. The patient experienced greater than 10 cm redness on 01Oct2016 with outcome of recovered, swelling on an unspecified date with outcome of unknown, malaise on 01Oct2016 with outcome of recovered, headache on 01Oct2016 with outcome of recovered, depression spot in the middle where with the needle had been injected on an unspecified date with outcome of unknown, slight dark area where the swelling had been on an unspecified date with outcome of unknown. Treatment received for redness and swelling included some Prednisone but the patient discontinued it after few days because the patient was a diabetic and it (Prednisone) was messing with her (patient) sugar so the patient discontinued Prednisone on her own. Sender's Comments: Linked Report(s): US-PFIZER INC-2016504326 Same reporter/drug, different patients, similar event.
Pt appears to have received the IM injection near the shoulder joint capsule.  Noted redness to area, pt reports extreme pain to left shoulder and that she is unable to move her arm,  also left neck pain.  Provider noted left lymph node enlargement on clavicle and left neck junction, pt reported pain on palpation.  Severe limitation of motion to left arm with flexion and rotation
Patient was admitted due to complicated UTI and renal failure. During this admission, the patient was given an expired dose of the Moderna COVID vaccine after not being scanned in the EMAR prior to administration. The patient remained inpatient and then passed on 8/4/2021 during the same admission following worsening kidney failure
"Purpura" type rash on baby's back and back on arms noted by mom 24 hrs following vaccine. No other symptoms noted. Lab work done-CBC with diff and pt well normal. No fever, no appetite change.
aprox 9  hrs post booster (pfizer) pt developed urticarial rash, generally unwell feeling and subjective fever and chills.  Non toxic in appearance. Treated symptomatically with H1/H2 blk, presnisode. Stable for D/C home.
Did a clinic and business wouldn't disclose employee's information due to confidentiality. I was only able to find out her arm was swollen and she went to the ER to be treated. Pts received flu shot with/without Pneumo / Tdap.
diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DIARRHOEA (diarrhea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (headache). On 12-Feb-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and DIARRHOEA (diarrhea) 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.
Light headed, fatigued, persisted until night of 3-20-21. Tenderness on injection site for same duration.
Patient woke up 2/11/06 AM with 2 small areas (about 1.5" diameter), outlined with redness, centers had blotchy redness. No raised areas; no itching. Each area occurred about 1" above injection site on each arm. Rashes identical no both arms. No fever. Resolving as of 2/13/06.
Seriousness criteria other medically significant (OMIC). Initial report received on 10/25/06 from a health care professional. A three year old female pt had received a right thigh injection of Ipol, lot number W1582-2, on 11/9/05. Fourteen days post vaccination, the pt developed paralysis of the left lower leg calf area with progressive atrophy of the left leg and contracture of the Achilles tendon. No additional information was provided. At the time of this report, the pt had not recovered.
pt recv vax 4JUN97 & devel a rash 16JUN97 & was dx as having a meeasles rxn by NP;the rash was behind pt ears & on upper body, DPH & APAP were prescribed;
Onset of pain to the outer aspect of my left ankle that is worse with walking or extension of the foot.
Hyplemic, raised lesion developed on site of injection which was left deltoid. About 1cm diameter.
Malaise, Chills, Hot-Flashes, Dizziness, Profound Weakness and Fatigue X 5 days.      No fevers, No dyspnea
I have chest. Pain and hand joint and muscle pain on my right hand, and sometimes it feels like the palm of my hand is under fire.
10 minutes after injection patient reported feeling nauseated, itchy all over, and was found to have redness and hives near injection site. Patient was seen by doctor on call who recommended administration of epi 0.3 mg. Patient began to improve. EMS was called per protocol for patient to be transported and monitored.
The pt presented dizziness, high fever of >103 deg. F. and lethargic.
Parent called states pt has developed warts on her hand. has had (2) Gardasil vaccines 6-14-07 and 9/28/07. Mom states she has no history of warts-concerned that it maybe related to vaccine
I had severe fatigue and headache that lasted for about 5 days. On Jan 10th, I tested positive for COVID-19.
Vaccination Error. Patient was scheduled for covid 3rd booster dose. However, at registration window, BOOSTER dose was mistaken to FLU SHOT and somehow patient's insurance went through. Patient was administered FLU SHOT. However, after the shot, patient reported she already got flu shot 2 weeks ago and she actually wanted booster dose. After monitoring patient for 30 minutes, since patient still wanted booster dose, 3rd covid pfizer vaccine was administered. Additional monitoring time of 15 minutes was allowed. Patient did not have any reaction. Patient tried to be reached today (10/22) but unable to reach.
Approximately 6-7 hours after influenza shot, patient described sensation of warmth all over body, rash on arms, legs, abdomen, and back, itchiness, and slight tightening in the throat. Patient was given BENADRYL 50mg po x1 on 9/3/08 PM. Symptoms had completely resolved by the following morning (9/24/08). Follow up 09/23/2008: Influenza vaccine given. Patient has received the influenza vaccine 0.5 ml IM at this encounter, from a multi-dose vial. The patient was also provided a copy of the CDC influenza immunization information sheet, dated 07/24/08. Patient denies any previous adverse reaction to influenza vaccine. Denies allergy to eggs or fever. Potential side effects of site tenderness, fever, chills, and muscle aches for first 48 hours explained. Special precautions of rare fatal reactions, hypersensitivity and Guillan-Barre Syndrome explained. Patient instructed to call with any problems.
4:58 pm -Patient in monitoring area, in vehicle,  spoke to monitoring nurse, stated was doing fine. 5:03 pm patient honked horn, stated wasnt feeling well, felt like he was going to pass out. Patient was pale, cool and clammy to touch. While attempting to recline patient, he  passed out. Reclined patient in seat of his car. Blood pressure not detectable. Lung sounds clear to auscultation. RR 10. Sternal rub, client came around, still not feeling well, cool moist cloth applied, client stated he had never had that happen before after getting shots.  5:07- B/P 110/72, P41, pulse ox- 97% on Room air. Less than 5 minutes later, client began feeling like he was going to pass out again, 911 called. Client oriented X3. Monitored client continuously. Paramedic from another section of clinic came to location to help with patient. Called client's wife to inform. 5:19 -Ambulance arrived. Care handed of to EMS.
Symptoms of illness started 11/4/21: fever, body aches, fatigue, HA, nausea, congested. Two others in household recently tested positive for COVID. All fully vaccinated
Dose administered to patient after improper storage and handling; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy since 11-Apr-2019. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) from 28-May-2021 to an unknown date for Epilepsy, OLANZAPINE (ZYPREXA) from 09-Aug-2021 to an unknown date, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 10-Aug-2021 to an unknown date and MIRTAZAPINE from 23-Aug-2021 to an unknown date for Mental state abnormal.   On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient race information was given as black  It was reported that patient was given vaccine that was thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information received and contains new information. Reporter details, Patient details , vaccine details, Concomitant medications were updated.
Fever 11-28 until 11 12-1 highest was 11-29 evening 103.1 rectal.  Medicated with ibuprofen and Tylenol. 12-3 developed rash on chest and abdomen.  Child having sleep disturbances since vaccine given. Decreased appetite.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-SEP-2013 the patient was vaccinated with an expired dose of MMR II (lot number reported as 1405AA, expiration date 06-SEP-2013), dose, route and anatomical location unspecified. Concomitant medications were not reported. No symptoms were reported. Additional information has been requested.
Pt recv vax on 3/9/99; 3 hr post vax pt exp hot/cold sweats, lethargy, light headed
Friday - slight fever, aches, easily agitated, irritable. Saturday - irritable, stomach pain, afternoon temp increase. Sunday - diarrhea, feeling of nausea, hip pain. Monday stomach pain, hip and thigh pain, tired.
Symptoms of weakness started about 6 weeks after influenza vaccine. Admitted to the hospital for altered mental status and weakness. Was diagnosed with axonal variant of Guillain-Barré syndrome (acute motor and sensory axonal neuropathy), completed 5 days of therapeutic plasma exchange with improvement of motor function. Per the neurologist, it  is possible for patients to develop Guillain Barre syndrome 4 - 6 weeks after the influenza vaccine, but the true incidence is unknown and is difficult to prove it was the vaccine that triggered this syndrome. However, given the severity of his symptoms, the patient wanted us to report to VAERs just in case as he is a retired doctor.  Of note, the patient was hospitalized for other issues in addition to this (purpura with hematoma, heparin induced bleeding, systemic inflammatory syndrome) , so the hospitalization itself was not entirely due to the Guillain-Barre syndrome. Also, the patient had received the influenza vaccine many times in the past (gets it almost every year) and did not have this reaction.
The patient got her flu shot on 11/8/18. On 11/25/18 she was shopping at another Pharmacy and reported that her arm was still sore. The other store called me so I could report the incident and she was instructed to follow up with her doctor.
Extremely sore arm; Body aches; Headache; Tiredness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 29Apr2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no 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. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 02:00, the patient experienced extremely sore arm, body aches, headache, tiredness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely sore arm, body aches, headache, tiredness and fatigue were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2013US017479 is an initial spontaneous report received from the health care professional on 15 Aug 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A12123) intramuscularly and hepatitis A vaccine (unknown manufacturer, batch number: not reported) on 15 Aug 2013. On the same day, couple of minutes after vaccination, he fainted. The event outcome, seriousness and causality were not reported. No additional information was available.
MY BLOOD SUGAR WAS OT OF CONTROL FOR 4 DAYS..FIRST 2 DAYS COLD NOT GET  BELOW 300..even WITHOUT  eating and giving insulin injections every 2 1/2 hours?.THE THIRD AND FOURTH DAY COLD NOT GET A BLOOD SUGAR READING BELOW 200.  The adverse reaction subsided on day 5!! I SPOKE TO. Y DIABETES SPECIALIST ON THE PHONE AND MY PRIMARY PHYSICIAN AND WAS GIVEN THIS SITE TO REPORT THIS EVENT..
Patient who received the COVID-19 vaccine on March 15, 2021 is presenting pain and redness at the site of the vaccine 1 day ago.
pt felt weak w/fever, aching pain all over body & muscle stiffness;pt went to MD on 9MAR99;MD told pt this was serum sickness from vaccine;pt was feeling better 10MAR99;no pain, etc;
Patient fainted 10 minutes after getting the vaccine in the store.  she was feeling little dizzy after. Other than that  She was doing fine and she was offered call emergency call but patents refused it.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
-intensely itchy rash on left arm on injection site, and on right forearm as well  -denies throat closing or difficulty breathing  -went away after a week, but still remains with a dark rash on arms  Patient with localized allergic reaction after first dose of Moderna a month ago. He brings pictures of the rash when it was at its worst, on his phone--and appears to be true allergic reaction with hives scattered on forearm, and hives/very large erythema on injection site. He now has hyperpigmentation over the site of where the rash was, and I believe this to be a post-inflammatory hyperpigmentation from the allergic reaction.