chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense headaches; This is a spontaneous report from a contactable other health care professional (nurse). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient 's medical history and concomitant medications were not reported. It was reported that some of her coworkers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days. She mentioned that one person, until now has headaches and takes tylenol for it. The outcome of event was not recovered.  No follow -up attempt are possible ; information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning himself who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Two days later the patient developed "weak muscles, sweating and dizziness." The consumer stated he felt tired and his legs were also sweating. The consumer stated he went to the emergency room but was not admitted. He reported he still felt "burning on his face, neck, arms and back" and believed this may be from the vaccine. He stated that he had never had shingles in the past but had read about shingles and stated that his symptoms resemble "what it feels like before and after someone has shingles". The consumer stated he was given the vaccine at a military base but was seeing a different physician at the time. At the time of reporting the patient was not recovered. Additional information has been requested.
Began with shortness of breath.  Then came extreme rapid heartbeat which lasted approximately one hour followed by a brief 15 period of fever.  The next 24 hours were a period of extreme tiredness.
Tested positive for covid after the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid after the first dose of the vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Chemical exposure in September 2011. Concurrent medical conditions included Paraplegic. Concomitant products included GABAPENTINE, CELECOXIB (CELEBREX), PANTOPRAZOLE, METFORMIN, MONTELUKAST, TIZANIDINE, TRAZODONE and ALBUTEROL;IPRATROPIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 (Tested positive for covid after the first dose of the vaccine). At the time of the report, COVID-19 (Tested positive for covid after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant medication included Stool Softener. Treatment information was not provided.
This spontaneous report was received from a healthcare worker regarding a 21 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2008 (reported as about 10 years ago), the patient received the first dose in the human papilloma virus (HPV) vaccination series with GARDASIL or GARDASIL 9 (unidentified Merck HPV vaccine) (dose, route, lot#, and expiration date unknown) for prophylaxis. On 26-APR-2018 (reported as today), the patient was at the pharmacy to receive the second dose in the HPV vaccination series with GARDASIL 9 (dose, route, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported.
Diagnosed with COVID 8/31/21 with onset 8/29/21.  Intubated
Headache beginning several hours after injection and lasting for one day.  Day after injection I get a stomach ache that continues into the third day which is when Im writing this.  Some nausia and hot flashes.  Tired and feel sick on the 8th.  Shot was on the sixth
5 days after receiving the second dose of the vaccine I developed a rash on my toes similar to "covid toes".; Several red bumps on my toes around the nail beds; On tips of the toes that get very itchy on both feet; This is a spontaneous report from a contactable other HCP. This 32-year-old (Non-pregnant) female received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 25Jan2021 15:30 (at age of 32-years) as single dose for COVID-19 Immunization. Patient medical history was not reported. There are no known allergies. Patient concomitant medications include ethinylestradiol, norethisterone acetate(MICROGESTIN), Olly flawless complexion supplements used for unspecified indication from unknown date and unknown ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 04Jan2021 15:30 as single dose for COVID-19 Immunization. On 30Jan2021, (5days after vaccination) patient developed a rash on toes like covid toes. She had several red bumps on her toes around the nail beds and on tips of the toes that got very itchy on both feet. Treating with antifungal products did not improve symptoms. Patient did not receive any treatment for adverse event. The outcome of event was not recovered.   Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
COVID-19; Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   In February 2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. In February 2022, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) and COVID-19 (COVID-19) had not resolved.     The action taken with mRNA-1273(Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; pt recvd Engerix-B on 30SEP91 & on 15JAN92 HBSAB was pos & hence resolved;
Vaccine was administered to patients which has been greater than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a pediatrician concerning a 13 month old healthy female infant. The infant was last seen by pediatrician on 12/19/01 for constipation and vomiting X 1 day; no fever. It was also reported that her left leg was bent on 1/18/01, but it was massaged and it returned to normal. The pediatrician indicated that she had a normal exam documented in the infant's chart for 12/19/01. On 1/11/02, the infant was vaccinated with a 1st dose of MMRII (lot 638925/0379L). On 1/18/02, the infant developed fever, tonic-clonic seizures and hypoxia. She was taken to the ER, intubated and then transported to another hospital and admitted to the ICU with encephalopathy. She was discharged from the hospital on 1/25/02. She was seen in the office on 1/28/02 and was still having truncal ataxia and non-purposeful movements of her arms and legs. The infant's twin brother (WAES0202USA00757) had a similar experience following exposure to MMRII. Additional information has been requested.
Case number PHEH2014US020355, is a spontaneous report initially received from a radiologist (also patient) on 07 Oct 2014. This report refers to a 33-year-old female patient (age at the time of report). Her concurrent condition included allergy to latex. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date after vaccination, her whole arm and lymph nodes on that entire side swelled up and was very painful. One year it was minor and rashy and each year it got increasingly worse. It was reported that it has been a long time since she got a flu vaccine due to these events. She was pregnant at the time of this report. Outcome of lymphadenopathy, lymph node pain, extensive swelling of vaccinated limb and pain in arm were assessed as non-serious. Seriousness criteria of rash were not reported. Causality of the events was not reported. Follow-up information received from radiologist (also patient) on 02 Nov 2015: New events (lymph node pain and pain in arm), patient's demographics, outcome, seriousness criteria and other clinically relevant information updated in the narrative.
About 3 min p/inject, c/o nausea, hot head, perspiring profusely; rx bedrest, cold applications, sips H20, P60, BP 120/70;
fully vaccinated (moderna, 2/8/21, 3/8/21); onset of symptoms 8/1/21
Pt developed an injection site lump subsequent to receiving a hepatitis a virus vaccine. Additional information has been requested.
Was fine at the time and shortly after the injection. Woke up the next morning to a 103 degree fever, chills, sweating, disorientation, headache, vertigo. several days later developed a "shingles-like" rash around the injection site which is now radiating down the arm and back of shoulder. Rash is only in that area and no where else on the body. no previous history with vertigo or shingles rashes
She experienced fatigue and a low grade fever which resolved in approximately 24 hours. She then experienced a headache for approximately 24 hours
DR. FROZEN SHOULDER, STEROID SHOT IN THE SHOULDER ON 10/24/2018. MASSAGE THERAPY,  I'M TRYING TO GET PT AND HAVE NOT GOTTEN A DOCTORS ORDER. VERY VERY PAINFUL. THIS HAS BEEN GOING ON WAY TO LONG AND I'M HURTING. PLEASE PUT A WARNING IN REACTIONS. I DECLINED THE 2ND SHOT DUE TO THIS FROZEN SHOULDER. PAINFUL PAINFUL IF YOU NEED MORE INFORMATION CONTACT ME. I WOULD NOT HAVE GOTTEN THE SHOT IF I WAS GIVEN THE RISK TO A FROZEN SHOULDER. AND YES, I HAVE HAD THE SHINGLES LAST YEAR. I WOULD HAVE SHINGLES AGAIN BEFORE GOING THROUGH THIS EVER AGAIN. SHOULDER PAIN THAT CAN BE SEVERE AND LONGER LSTING IS NOT WHAT I'M HAVING. SORE SHOULDER AND A FROZEN SHOULDER IS A BIG DIFFERENCE.
Patient immediately felt dizzy after vaccinated. She proceeded to vomit and feel hot and flushed. Stated eyes were itchy but no other signs of anaphylaxis. Progressed within minuets of vaccination.  Gave appropriate dose of benadryl and patient was fine.
Swollen left lymph node in armpit area; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 19Mar2021 at 16:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, the patient experienced swollen left lymph node in armpit area. Therapeutic measures were taken as a result of the event and included treatment with ADVIL and ice. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen left lymph node in armpit area was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable nurse via a Pfizer Sales representative. A patient of unknown age and gender received PREVNAR 13) at single dose for immunization via unspecified route on unknown date. Medical history and concomitant medication were not reported. The patient experienced itching at the injection site.  No follow-up attempts are possible. No further information is expected.
Patient reported redness and swelling of right arm from elbow to shoulder. Patient reported that it made her feel sick all day. This resolved after 1 day to only minor swelling and resolved completely after 2 more days.
Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Patient admitted to hospital on 1/20/2023 and diagnosed with a cerebellar hemorrhage requiring posterior fossa decompression.
Red area on arm 1/2 inch by 1.5 inches. Red and swollen, painful.
This spontaneous report as received from a consumer refers to her family members. No demographics were provided for the patients. The reporter stated that her family had a history of unspecified allergic reaction to M-M-R II (dose, frequency, lot #, route of administration and indication were not specified). No product quality complaint (PQC) was involved. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to M-M-R II. Additional information is not expected, as no contact details were provided.
Chills; Muscle soreness; Joint pain; soreness around the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness around the vaccine site), CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), DIAZEPAM (VALIUM) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness around the vaccine site). On 11-Jan-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain). On 11-Jan-2021, VACCINATION SITE PAIN (soreness around the vaccine site) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Employee reported today (9/3/21) of redness, swelling to the left arm (injection site). Area was tender and warm to touch. Redness lasted for one month. HCW also reported to have a new onset of palpitation that started within the same week of vaccination and she went to urgent care. EKG was performed and findings were within normal limits per employee. No medications was prescribed to her. States she applied Ice/cold pack was placed to the affected arm. Currently, no redness, swelling, tenderness to the affected arm. Employee states that everything was resolved except for the palpitation that she is still experiencing off and on. She states she will keep following up with PCP.
Fever 102F and per grandparent's report; pt shaking and unresponsive X 40 seconds; afterwards was alert and interactive. To ER for evaluation. Missing vaccine information is unknown.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, (strength, lot number, expiry date and dose were not reported) orally, which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started with an red patchy rash on her face, neck and upper chest about 5-10 minutes after vaccines were administered. Rash was not itchy. She denied any shortness of breath or tongue swelling or difficulty swallowing.
No adverse effects; administered first dose on 3/28/2019 and second dose little early on 5/17/2019; This spontaneous report was received from a consumer refers to a 25-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On 28-MAR-2019, the patient administered her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot and expiration unknown). On 17-MAY-2019, little early the patient administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot and expiration unknown) (inappropriate schedule of product administration). The consumer reported her physician authorized the second dose early because she was going to travel. No adverse effects reported.
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing  extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
I have a little red mark on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2023, outcome "not recovered", described as "I have a little red mark on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient was tested for COVID and the result came back positive. However the lab made a mistake as it was not the patient's result. She was given the PAXLOVID medication, but the patient didn't take it or open the box as her HCP told her not to take it because of the lab error. The patient had the Pfizer COVID-19 vaccine formula 2023-2024 three weeks ago. (Oct2023). She had a little red mark on the injection site. It had been about little less than three weeks maybe 2 and half weeks, the small red dot was still there. The patient thought it's a size of a dime.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received
She got her vaccine, at 10:30 she got the Bivalent booster.  She did not have any pain in her arm or anything.  Around 8:00 PM she started having severe chills, headache and fever to 102.  She took Tylenol and went to bed.  She woke up with sore throat and chest congestion, but no fever.   It is now 9/22/22 and she is still coughing and congested.  Her taste is diminished.  She is taking OTC medication.  She saw the doctor and has been using her inhaler that she uses prn every 6 hours.  Her doctor felt that because she has had the vaccine that it would not do any good to do testing as it was more than 5 days, and stated that she had all the symptoms of COVID but did not have any symptoms before the vaccine.
Upon checking on resident to obtain vital signs, resident reported "not feeling great." When asked what resident was feeling, resident stated "my body hurts all over, my arm hurts, I have a headache and I feel like my breathing is weird." Asked resident if he was experiencing SOB and resident stated yes and "it is hard for me to breath." Vital signs included BP 107/76, HR fluctuating between 122-145, O2 ranging from 95-96%, temperature 98.4, RR 19.  Took resident to  Emergency Department.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. Nurse reported that four doses of GARDASIL which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 31-JUL-2015. No adverse experience has been reported. Additional information has been requested.
Patient developed a fever of 103.9 on 4/10/2013 and had a febrile seizure in the morning of 4/11/13 and subsequently developed a vesicular rash.  Pt. went to emergency department and is currently admitted to the hospital.