chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches and headache; Aches and headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 13:00 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Penicillin allergy" (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing); "Brain aneurysm rupture with coiling" (unspecified if ongoing); "I did have COVID", start date: 02Nov2020 (unspecified if ongoing), notes: symptoms included fatigue, loss of taste and smell, and a headache and pain. There were no concomitant medications. Past drug history included: Erithromycin, reaction(s): "Known allergies: Erithromycin". The following information was reported: PAIN (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Aches and headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache.  Additional information: Patient felt like the virus attacked her weakest parts of  body (for instance). head hurt on her left side, as if she was punched. It lasted two days. That seems to be where her pain was from COVID. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination.no treatment received for the adverse event. patient was diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. patient was Allergies to Penicillin, Erythromycin. Vaccine Facility information was available. Facility where the most recent COVID-19 vaccine was administered was at Hospital. Ethnicity information is available. Race information is available.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021419276 Same patient, different drug, different event (split)
Initial unsolicited report received from a physician on 27-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with Fluzone intradermal (batch number: unknown, expiry date and route of administration: not reported) on September 2016 (unspecified date). Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date, post vaccination, the patient claims that the Fluzone interacted with steroid and caused bumps on face. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
heart is messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "heart is messed up". The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart is messed up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx. 10 minutes after immunization was given, after leaving and getting in the vehicle to go home, he went limp, passed out, and had seizure  like activity.  This lasted approx. 1 1/2 minutes.  He was very pale and weak.  The rest of the evening, he was short of breath, yawning frequently, and complaining of severe stomach pains.  At apprx. 6:30pm he vomitted and began to feel somewhat better for about 1/2 hour.  He then began to complain about his stomach hurting and vomitted again around 8:00 pm.
After receiving MENACTRA and MMR vaccines patient grew faint, demonstrated seizure like activity, and loss of consciousness. EMS called. Patient did regain consciousness and was oriented prior to EMS arrival. Patient taken to emergency room for further evaluation and treatment.
Phone call with patient on 10/06/2020. called in with complaint of sore left arm. She states initial administration of vaccine felt "normal", but noticed soreness in left arm "a few hours later". She states feeling is characterized as stiff, dull pain on "side" of arm approximated with the center of the lateral deltoid muscle. She specifically states that pain is not at the "top" of shoulder, but is localized approximately 2 to 3 inches "down" from peak of shoulder girdle. She states pain is worsened upon movement, particularly when raising arm above head. She states she initially took ibuprofen approximately 09/28/2020, but only took once as she characterizes herself as a "tough it out" person. She states she also sleeps on her left side and regularly lifts and carries a heavy backpack for school, which she believes may be contributing to the continuation of soreness. I recommended rest of afflicted arm, cool/warm therapy, and NSAID therapy if NSAIDs are approved by her primary care doctor.  states she plans to make an appointment with Dr. at Hospital to have left arm evaluated.  During follow-up phone call on 10/06/2020  states that she was previously vaccinated with flu vaccine at primary care doctor's office at  Hospital in January 2020 after returning home from studying abroad. She states that the medical professional who gave the vaccine seemed "unsure" of how to administer vaccine, and states that during and shortly after vaccination in January 2020 her left arm "didn't feel right", but at the time did not have any unusual pain or soreness in arm other than "any other vaccine."
fell ill; has been on medications for breathing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing). At the time of the report, ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Reporter states that reporter friend fell ill just 2 weeks after the exposure to these experimental chemicals and has been on medications for breathing since. Patient received the poke in the fall of 2021.   This case was linked to MOD-2021-434221 (Patient Link).
within 2 months of receiving the second Pfizer dose, I developed a constant head tremor. Otherwise healthy person
Mild tightness in chest and shortness of breath; Mild tightness in chest and shortness of breath; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; This is a spontaneous report from a non-contactable consumer.  A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 20Jan2021 10:00 dose 2 at SINGLE DOSE for covid-19 immunisation. Vaccine location Right arm, Facility type vaccine: Hospital. The patient medical history was not reported. The patient received first dose of vaccine bnt162b2 lot number=EL1284, on 30Dec2020 at 02:45 PM, vaccine location right arm. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient reporter that " on 20Jan2021 the temperature started rising 10 hours after second dose (at 8:00pm). Patient took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had fever 100.0°. Fever continued to get under control and rise again off and on for the first 36 hours. Mild tightness in chest and shortness of breath began 24 hours after the second dose and continues 6 days later." The action taken was not applicable. Chest discomfort and dyspnoea were not recovered other event were recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms from his neck to his feet) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for an unknown indication. The patient's past medical history included Blood pressure, Diabetes and Lupus syndrome. Concurrent medical conditions included Drug allergy (penicillin allergy).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasms from his neck to his feet). At the time of the report, MUSCLE SPASMS (muscle spasms from his neck to his feet) 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.   No concomitant medications were provided Treatment ibuprofen
PFIZER MONOVALENT VACCINE GIVEN AS BOOSTER ON 09/01/2022. RECEIVED EMAIL ORDERING THE DISCONTINUATION OF USING PFIZER MONOVALENT VACCINE ON 09/01/2022 2 3:42 pm. NO PHYSICAL ADVERSE REACTION IN PATIENT.
- 17 weeks pregnant (due date April 22) - Weight 142LBs - 9:20am Moderna booster shot (3rd shot) - Mild symptoms like fatigue, naseau, headache all day - Tylenol taken 10am and 3pm - 8pm fast onslaught of heat starting in the head. Really itchy feet. Itching spreads to whole body. Whole body hives, redness, itching. Followed by chills and shaking. - Chills, shaking, itching lasted about one hour - Itching and chills managed by lots of heat (warm blankets) - Slight itching lasting all night wherever bodyparts aren't incredibly warm - Slight itching continuing into day after booster shot - managed by keeping warm
3:40PM--Patient received vaccination without any adverse symptoms. 3:42PM--Patient report SOB with chest pain and feeling uneasy. He then slumped against the wall and slid to the floor still awake and coherent, just slightly groggy. 3:43PM--Patient was promptly helped to Room 5 and sat into chair. Provider was notified and began to evaluate patient by listening to his heartbeat and observing his breathing pattern. He was immediately placed on an O2 sensor and his BP was checked. Patient looked pale and his vitals were: Pulse: 56, BP: 86/44. 3:53PM--Patient was rechecked for vital signs. His appearance has pinked up and he is acting "normally" per mom. He reports he is feeling normal again. His vitals were: Pulse: 62 and BP: 93/55. We informed patient he would be monitored for 10 more minutes. 4:15PM--Patient was rechecked for vital signs. He is now joking with his sister and playing with the vital machines. His vitals were: Pulse: 66 and BP 104/60. Mom was given the emergency number to call Dr if he had any further symptoms and educated on what to look for if further symptoms occur. Patient was ready to go and appeared to have recovered from his brief symptoms.
day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain and fatigue - very tired end of day 3 - Lymph nodes swollen - under left arm  4th day lymph nodes swollen in neck and under arm  - left side took Tylenol 2 x a day starting day 2 by 7th day, was no Tylenol needed, lymph nodes gradually went down.
5/1/21 - Patient called for Nurse Advice, reported:  "Key Symptom: covid19 vaccine 2 days ago. hives on arms and  legs today. not responding to benadryl" -Patient has chronic persisting urticaria, which all seemed to start after Moderna dose 2,   which has been reported/ known to happen  -Treatment: Patient is getting treatment for the urticaria in allergy dept
Swelling at injection site, size of 50 cent piece with pain, skin hot to touch, tenderness to touch, pain radiating down forearm & tingling in hand.
Extreme Burning leg pain, lost use of leg over 3 months, leg weakness & extreme cramping - sittin, lying down, and walking.  Right face numbness & pain.  Stomach pain & bouts of sudden nausea.  Migraines.  Stomach issues. Dercums disease (painful nodes with sporadic shooting pain), fibromyalgia, asthma, random shooting pain, chronic fatigue
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Vaccine was provided past the beyond use date of 01/02/2022, Incident report has been submitted
Information has been received from a licensed practical nurse concerning a 19 year old female who on 31-AUG-2007 was vaccinated IM a first dose of Gardasil (lot #658554/0928U).  Concomitant therapy included birth control pills.  A few hours after the vaccine was given, the patient experienced dizziness, felt faint, itching on her legs and hives.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007 - Additional informaiton is not expected
Developed swelling in L upper arm with some redness at inj site shoulder to elbow swelling. Saw 48 hrs after injection; worse night of injection.
TDAP given mistakenly for DTAP, dose #4.  Called CDC - advised dose #4 valid, does not need to be repeated - minimal chance of adverse reaction.
Received 1st Hep-A on 6/7/01. Developed fever to 101F and hives around injection site that same day. Hives spread to other parts of body, still present on 6/12/01. Will recover/become asymptomatic.
Father of child stated child developed sweaty palms prior to vaccine administration because he was worked up over getting shots. Hep A given at 1:15pm. HPV given at 1:16pm. Child was tense during vaccine administration. Complained right shot hurt a lot. I gently massaged right deltoid while talking to child about school. Child then wanted to see how tall he was; got up from chair; stood at the length board; measurement completed. Noted child turned pale; requested he sit down in nearby chair and put his head between his legs; gave him a glass of water and 2 crackers. He took a drink, stated he was fine and stood up. He turned pale; started to get weak at the knees. Father of child and I lowered him to the floor. Requested child lay down; elevated lower extremities. 1:20pm: B/P: 100/52; P: 60; R: 16. Child states our voices are muffled. Continued to lay on the floor for another 10 minutes. Color improved; states voices no longer muffled. 1:30pm: child states he feels fine; assisted to sitting position; drank a glass of water and ate 2 crackers. Assisted to nearby chair. B/P: 108/54; P: 60; R: 16. Child continues to state he is fine. Obtained VAERS information from father. Father and child left office at 1:40pm. Will follow up tomorrow.
crying x 25mins-turned red, tremors/shaking of upper/lower extremities; shaking of lower extremities, glassy eyes;
Initial information has been received from the physician's office via medical records concerning a baby girl with a history of neonatal jaundice, mongolian spots and torticollis after maternal exposure to GARDASIL (MSD WAES # 0708USA00006) who on 28-FEB-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 13-MAR-2008 the baby came in for a well child visit at 15 days old.  There were no complaint or concerns at this time.  The baby recovered from neonatal jaundice.  The following lab results for the baby was negative: newborn screen amino acid D/O, Fatty Acis D/O, Organic Acid D/O, Galactosemia, Biotinidase deficiency, Endocrine D/O and Hemoglobinopathy.  A venipuncture was also performed.  Follow-up was scheduled for 2 weeks.  On 31-MAR-2008 the baby came in for a well child visit at one month and 3 days old.  The baby had a rash on her shoulder and back (acne neonatorum).  The baby was also administered DAPTACEL (Lot # C2951BA) IM 0.5 cc in the left thigh, ACTHIB (Lot # UF253AD) 0.5 cc on the right thigh, IPOL (Lot # A0490-2) IM 0.5 cc administered on the left thigh, ROTATEQ (lot # 660291/1829U) 2 mL administered orally and PREVNAR (lot # C45153) 0.5 cc administered on the right thigh.  Follow-up was scheduled for 2 months.  On 16-JUL-2008 the baby came in for a well child visit at 4 months and 18 days.  The baby holds her neck to the right side and still had craddle cap.  The baby was also administered DAPTACEL (C2934AA) IM 0.5 cc in the right thigh, ACTHIB (UF260AB) 0.5 cc on the left thigh, IPOL (Lot # A0492-2) IM 0.5 cc administered on the right thigh, ROTATEQ (Lot # 660600/0281X) 2 mL administered orally and PREVNAR (C65928) 0.5 cc administered on the left thigh.  Follow-up was scheduled for 2 months.  On 31-JUL-2008 the baby was 5 months 3 days and complained of a possible ear infection.  The baby was pulling at the left ear, dry on ear lobe- not sure if it was drainage.  Denies fever.  ENT/respiratory examination revealed throat moist membranes, post nasal drip seen, tonsils erythematous, no exudates, auditory canals normal, no wax, tympanic membranes erythema and fluid, dull appearing, bulging, nasal mucosa boggy nasal mucosa, yellowish rhinorrhea.  Assessment was otitis media, acute and otalgia nos.  The baby was given OMNICEF powder for reconstitution 125mg/ml, drops every four to six hours prn for pain and MOTRIN three to four times daily.  Follow-up was scheduled for 2 weeks.  On 28-AUG-2008 the baby came in for a well child visit at 6 months.  There were no complaints at this time.  The baby was also administered DAPTACEL IM 0.5 cc in the right thigh, ACTHIB 0.5 cc on the left thigh, RECOMBIVAX HB 0.5 cc on the right thigh, IPOL IM 0.5 cc administered on the right thigh, ROTATEQ 2 mL administered orally and PREVNAR 0.5 cc administered on the left thigh.  Follow-up was scheduled for 3 months.  Additional information is not expected.
Suspected vaccination failure; Shingles; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-MAY-2023 The patient experienced Shingles after receiving Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter was consented to follow up.
This spontaneous report as received from an other health professional refers to an unspecified number of patients were not mentioned by the reporter. On an unknown date the patients were vaccinated with VARIVAX (Merck) of lot # L001334, expiry date: 13-JAN-2017 (strength, dose #, route, site of administration and indication were not reported) which had been improperly stored (incorrect product storage). No adverse effects were reported. Product Quality Complaint was not filed. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
LOSS OF TASTE; SUSPECTED ARTHRITIS IN HER KNEES; HIPS ACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 11-MAY-2021, the subject experienced loss of taste.  On 11-MAY-2021, the subject experienced joint pain. On 11-MAY-2021, the subject experienced knees hurt all the time. On 11-MAY-2021, the subject experienced hips ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, and joint pain, and the outcome of knees hurt all the time and hips ache was not reported. This report was non-serious.
01/19/2021 @ 9:00 PM Headache and fatigue for two days. Verbalize feeling well and resolved.
Information has been received from an investigator concerning a 68 year old male with diabetes, benign prostatic hyperplasia and hyperlipidaemia and a history of myocardial infarction (1996) and cataract operation who entered a study, title as stated above. On 18-DEC-2007 the patient was vaccinated with blinded therapy. On 08-MAR-2008 the patient died. The cause of death was unknown. At this time, relationship of death to study therapy is unknown. The records for this patient was unblinded on 01-MAY-2008. The patient was treated with Zostavax (Oka/Merck) 0.65 ml. Additional information has been requested.  5/7/08-record received Cause of Death: Cardiac insufficiency. Diabetes. Hypertension
no adverse affects noted.  patient was given 4th dose of 0.5 moderna.  She is immunocompromised so should have had 3 doses of 0.5 and then booster of 0.25 ml.  She got her doses at various places so may have been unkown.