chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flashes in her back; body pain; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Jan2022 (Batch/Lot number: unknown) 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: HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes in her back"; PAIN (non-serious), outcome "unknown", described as "body pain"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  Additional information included: For the last 3 days patient had been experiencing hot flashes in her back and body pain. She was asking what other possible side effect is she to expect with the Pfizer COVID-19 vaccine besides the hot flashes and body pain and what kind of treatment medicine she could take.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (01Feb2022): 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 completed. No further information is expected.
nightmares; foggy head; headaches; chills on and off; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off). On 15-Feb-2021, NIGHTMARE (nightmares) and FEELING ABNORMAL (foggy head) had resolved. At the time of the report, HEADACHE (headaches) and CHILLS (chills on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
PATIENT EXPERIENCED SWELLING/REDNESS ON 22OCT2019 AFTER RECEIVING AFLURIA INFLUENZA VACCINE ON 21OCT2019. PATIENT HAD NO DIFFICULTY BREATHING OR SWELLING IN ANY OTHER AREAS. PT PRESENTED TODAY. 23OCT2019, WITH STIFFNESS, REDNESS, AND SWELLING AT INJECTION SITE, AND INJECTIONS SITE "FEELS HOT". PATIENT STATES SYMPTOMS AT AREA AFFECTED HAS GOTTEN WORSE SINCE DATE SYMPTOMS FIRST APPEARED, BUT NO NEW SYMPTOMS HAVE PRESENTED.
5 hours after receiving vaccine, patient developed throat swelling. Treated with PO Tylenol and Benadryl. Swelling resolved by 1/11/2021.
This spontaneous report was received from a medical assistant referring to a 1 year old male patient, without siblings, or any allergy, birth defects, medical conditions or concomitant medications. On 07-AUG-2015 at 11:57 a.m. the patient was vaccinated with the second dose of VARIVAX (Merck) (dose was not reported) (lot # K018959, expiration date 15-OCT-2016) subcutaneous in the right leg, that had been improperly stored. The patient was not ill at the time of the vaccination and did not present any adverse event prior or after the vaccination. This is one of the two cases from the same source. Additional information is not expected as all correspondence was received.
Patient had immunization at 1:30 pm within 20 minutes patient had left and begin to feel warm, then hot, felt like he was  burning up and became diaphoretic. Pt reached hosptial had blood pressure taken 168/100, told he was pale. Pt returned to occupational health clinic, felt nauseated and warm.  Mildly diaphoretic, able to communicate begin to feel less nauseated,less warm.  Pt told provider he was scared.  Pt examined and vital taken, found within normal limits no need for transfer to level of higher care.  Pt reassured, told to lie down and rest.  Vitals taken every 15-20 minutes for an hour.  Pt given Benadryl 25 mg po x once.  Pt with no other problems monitored for 1 hour sent back to work.
Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 17 year old daughter with no medical history and no drug allergies reported, who on 09-JUL-2007 was vaccinated with the first dose of GARDASIL and on 21-SEP-2007 was vaccinated with the second dose of GARDASIL while she was pregnant.  The patient did not know at the time of vaccination that she was pregnant.  The patient gave birth two months early on 14-DEC-2007.  The patient was hospitalized twice during the pregnancy due to unspecified complications.  The patient received the third dose of GARDASIL after giving birth but it was unknown if the vaccine was given late.  There was no concomitant medication.  The patient's LMP was unknown.  Additional information has been requested.
Patient started vomiting several times a day after last dose. He also did not want to take as much food/ breast milk as normal. It was also reported that he had a change in his bowel movement patterns.
Rash involving buttocks and legs 1 day after vaccine administration. Erythema multiforme minor.
Developed a itchy, mildly painful rash around the injection site a full week after the vaccination.  The area was also swollen and warm to the touch.   At the recommendation of my doctor responded by applying ice to the area twice a day, applying cortisone cream 3 or 4 times a day and taking Benadryl at bedtime.   It is 90% better at the time of this report approximately 4 days after the first symptoms.
Received vac. on 2/10/2021 and on 2/15/2021 had a stroke with no warning. Hospital and Rehab ever since.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/13/2021, 02/03/2021, 10/06/2021, and 04/19/2022. They tested positive for COVID-19 on 08/13/2022 at the nursing home at which they were a resident. I see no indication they were hospitalized around this time. They died on 08/22/2022.
stomach is queasy; 100.4 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is queasy), PYREXIA (100.4 fever) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is queasy), PYREXIA (100.4 fever) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (stomach is queasy), PYREXIA (100.4 fever) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Day 2 after receiving vaccine, began having mild stomach upset and noted that the injection site was itchy and getting "hard". Redness began spreading into left lateral upper arm, axilla, and left chest area. Physician has low suspicion for cellulitis, dx with severe local reaction to vaccine. Because the patient has a history including skin grafts to the area, he covered the patient with antibiotics. He was also prescribed diphenhydramine 50mg q6h, prednisone 20mg bid, Pepcid bid, and cephalexin 500mg tid x 7 days. Discharged home in stable/improved condition.
Pink bump on right shoulder.  Noted a weeping lesion on base of neck on 3/19/2013 at 11:00 AM and third non-weeping lesion noted at 7:00 PM.
Body aches, pain at injection site, swelling at injection site, low grade fever, malaise. Pt took APAP. BENADRYL, NSAIDS/APAP and ice pack to area was recommended by PA.
After 2 hours post injection to Left arm, parents noticed swelling, redness, and painful area on the Left deltoid area.
Appx. 2 days after injection, swelling on left collarbone. Saw Doctor on 5/26/21. Still palpable as of 7/16/21. Will be checked in a few months.
Aching arm < 30 minutes after shot. Swelling in neck (left side) 2-3 hrs after shot. Body aches within 6 hours. Fever, chills, and ringing in head within 10 hrs after shot. Fever up to 102.5F.  Shot given 2/16 at 8:30 am. 2/18 at 1pm numbness to left side of face. Went to ED. Swelling in neck  visible with movable gland. Discharged home. 2/19 numbness gone and swelling decreasing. 3/5 arm aches, swelling mild in neck, movable gland persists, ringing in head continues.
positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 05May2021 as dose 2, single (Lot number: EW0179), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "born with 1 kidney" (unspecified if ongoing), notes: born with 1 kidney; "Acid stomach" (unspecified if ongoing), notes: Acid stomach; "outdoor allergies" (unspecified if ongoing), notes: outdoor allergies. Concomitant medication(s) included: OMEPRAZOLE; IBUPROFEN; MELOXICAM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after testing negative a couple of days earlier; (05Jul2022) Positive, notes: positive for COVID (after testing negative a couple of days earlier). Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patent age group was Adult (18-64 Years). The patient was received Covid-19 treatment with Paxlovid from 26Jun2022 to 30Jun2022 (Lot number GA3594). The patient received other medications within 2 weeks to the Covid-19 vaccine. The patient had no known allergies. Adverse event Four days after completing treatment, began to feel congested in nose/ears. Experienced a sinus headache. Took a home test five days after completing treatment and it came back positive for COVID (after testing negative a couple of days earlier). The patient not received treatment and the outcome of the event was not recovered.
No additional AE; HCP called to report that they administered GARDASIL 9 to their patient as follows: first dose at age 13, second dose at age 14, and a third dose today on 06/08/2023. No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to a 20-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.     In approximately 2016, when she was 13-year-old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), then in approximately 2017 when she was 14-year-old, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). Finally, on 08-JUN-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) once for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Swollen axillary lymph nodes within 48 hours, emergence of rash and hives beginning approximately a week after vaccination throughout entire body.  Presence of hives exacerbated with heat and friction.  Use of antihistamines needed to decrease itching and swelling.  Hives have attenuated in intensity over time, but still continue.
MENACTRA & FLUZONE vaccines given 10/22/2012 symptoms reported 11/13/2012. C/O fatigue, vertigo, headaches, cognitive and sensory deficits, photophobia.
PATIENT SATES MUSCLE ACHES AND PAIN KNOT UNDER MUSCLE FOR MORE THAN 1 MONTH, kNOT IS UNDER MUSCLE NOT NEAR INJECION SITE.
Guillain-Barre syndrome; change in mental status; This spontaneous report as received from a consumer refers to an unspecified female patient of unknown age.  the patient's concurrent conditions, medical history and concomitant therapies were unknown.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, lot and dosage information were unknown) for prophylaxis.  On an unknown date the patient developed Guillain-Barre síndrome  and change in mental status.   The outcome of Guillain--Barre syndrome and mental status changes was unknown.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was also unknown.  The reporter stated that there should be more research performed in the population for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    Upon internal review Guillain--Barre syndrome was considered to be a medically significant event.   This is one of three cases from the same reporter (2007USA000339 and 2007USA000244). The patient's sisters experienced the same adverse events after vaccination.; Sender's Comments:  US-009507513-2007USA000339: US-009507513-2007USA000244:
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes.  The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same report.; Sender's Comments: US-009507513-1711USA002012:
Janssen Covid 19 Vaccine EAU -  3/14/21 -Headache, Fever (99.2) , joint aches, Took Ibuprofen X 400mg at 9AM. Had headache and felt tired and achy all day. At about 6:30PM took Ibuprofen 400mg,  Awoke morning 3/15 with slight headache but nothing requiring medication. Feel that reaction is 99% resolved
patient that got their first dose from the expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Pt came for Pfizer covid booster. With in 5 mins of injection patient became nauseated and vomited twice. Had patient lie on cot. Patient states this happened after other 2 covid vaccines and only last a few minutes. Pt declined going to ER. Pt left with her mother at 10: 50am stating she felt better and wanted to leave.  Vitals - BP - 110/74, P - 76, O2 - 9
Patient reported worse headache of life ("worse than pain of childbirth"), nausea, chills, bloating, body aches, and loss of appetite. Symptoms started morning following vaccine administration and lasted 4 days (Friday, Saturday, Sunday, Monday). Patient discussed event with PCP however did not go in to seek medical care at hospital, pcp, or ugent care.
CDC Reports:2 yo child recvd DTP/OPV/MMR 16Jan90.  22Jan90 had pain in hands & experienced seizure.  On 3Feb90 had 2 seizures, taken to ER & was started on Phenobarbital,
Acute Myocarditis with chest pain and elevated troponin (peak level 27) occurring 3 days after 2nd Pfizer covid shot. Treatment with Ketorolac and morphine, clinically improving at the time of report.  Echo reassuring with good function and no effusion, ECG initially with RBBB repeat ECG with early depolarization, no arrhythmias
Had Pfizer for first and second dose. 7 months later took Moderna booster.  My symptoms for Pfizer #1 was sore arm only. My symptoms for Pfizer #2 was sore arm and fatigue for one day. My Moderna booster symptoms were considerably worse. I had everything ranging from very sore arm (pain with any movement), headache, body aches, fever (100.7F), chills and sweats. Sore arm started about 2 hours after shot, fatigue about 12 hours, and the rest (fever, aches, chills) occurred about 18 hours afterward (at 4pm) and lasted all evening thru bedtime.
11/16 at 6pm - sore arm (Left) and chills. 11/17 Woke with nausea, chills, headache, feeling weak, PO temp - 100.2F. Arm is still sore & with redness & swelling. 11/18/10 seen by PMD. Temp is 100.8 degrees F. Arm sore with redness & swelling. MD gave her Cephalexin 500mg 1 PO qid x 10 days.
Right arm swollen and feels hot >50% of circumference and length on 9/4/03.
Pt on the phone with sister when she suddenly could not speak, she had similar episode is the past when she had a grand mal seizure.  Pt did not take her dose of keppra on 12/24./21, was diagnosed with covid19 on 12/16/21
Felt faint. Rested. Juice and crackers. BP normal. Returned to class.
Breakthrough case admission after 4 vaccines Moderna 12/30/20 Lot#025J20A Moderna 1/27/21 Lot# 25J20A;  Moderna 11/3/21 Lot# 076C21A Moderna 4/14/22 Lot# 033K21-2A
I experienced a breakthrough case of COVID-19 with coughing, fever, loss of taste/smell, joint aches, diarrhea, congestion and loss of appetite.
Patient's age is under 12.  Patient and patient's father lied his age. He wrote patient's DOB , but his actual DOB reported. He already got his 1st dose at Pharmacy on 6/16/21, and he got his 2nd dose at out location today (7/08/21). No symptoms have been reported so far.
headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache in Jan2021. Caller asked if she could take OTC medication after receiving her vaccine first dose on Friday 08Jan2021 at 3:00 pm. She was c/o "a headache". The outcome of event was unknown.  Information on Lot/Batch number has been requested.
really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced really bad rash on her chest and upper neck/her chest has become, and her neck was raised red bumps and very itchy. Verbatim and Event Description: (Name) the patient's daughter called on behalf of the patient regarding an adverse reaction the patient experienced after taking the Pfizer-BioNTech COVID-19 Vaccine During the call caller stated. Reporter mother got the COVID shot from Pfizer in January, end of January she developed a really, really bad rash on her chest and upper neck, have you had any complaints about that. She got it in the end of January and her chest has become, and her neck is raised red bumps and very itchy. Outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on Oct2017 at a single dose for pneumococcal shot/pneumonia. The patient's medical history and concomitant medications were not reported. The patient reported she got a pneumococcal shot the previous week or so and on an unspecified date was having itching, lips were swollen, had fatigue, and sweats. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
LEFT ARM, UNDERNEATH THE ARMPIT FELT LUMP; ACHE/BODY ACHES; CHILLS; PRESSURE ON THE FOREHEAD (TIGHT FEELING); TIRED; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sleep apnea, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: not reported) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021 22:00, the subject experienced ache/body aches. On 11-MAR-2021 22:00, the subject experienced chills. On 11-MAR-2021 22:00, the subject experienced pressure on the forehead (tight feeling). On 12-MAR-2021, the subject experienced left arm, underneath the armpit felt lump. On 12-MAR-2021 14:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pressure on the forehead (tight feeling), and tired on 12-MAR-2021, was recovering from ache/body aches, and the outcome of left arm, underneath the armpit felt lump was not reported. This report was non-serious.
pt recv vax 24OCT95 & that evening devel a fever (100.2),chills & myalgia;
Initial report was received from a health care professional on 18 January 2008. A 3-year-old child with no past medical history, had received an intramuscular, left deltoid injection of FLUZONE SV (lot number invalid). On an unspecified date and approximately two days later, the child developed a fever of 103.5 degrees Fahrenheit and their left arm became very reddened and swollen from the shoulder and axillary areas down to their mid arm and hard at the injection site. The needle size utilized had been 25 gauge, 5/8 inch length. Corrective treatments included TYLENOL, BENADRYL, and an antibiotic. The patient had no known allergies and had not received any other vaccines during the four weeks prior to receipt of FLUZONE SV. At the time of the report, the patient had not recovered from the event.