chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient complains of severe itching, on his head and between his fingers and was given Benadryl by mouth and started on a Medral dose pack.
day after her second dose (3/28), pt experienced itching, runny nose and swollen lips.  on 3/30 pt felt lethargic. 4/6 pt experienced burning skin and difficulty swallowing, pain in right breast, rash on right breast, neck, legs and left side of face.
Child cried during vaccinations, then went and sat in waiting room with parent while paperwork was entered and record could be printed, child was standing by our desk, passed out and fell to the floor, unresponsive but breathing, sternal rub, responded, blue around mouth, HR 50-60, resp 6, 911 called, Epi 0.2 administered at 2:40 pm. EMS arrived at 2:50, child was awake, slow to respond, neck was supported, HR 96-100, resp 10, interpreter called and asked mother further questions if this had happened in previous country since they did not have their records, she answered no. EMS left with child to Hospital, mother in ambulance. Hospital called said she was ok, they thought it could have been a vagal response.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: Em9809), in left arm and on 24Feb2021 as dose 2, single (Lot number: En6203) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 012h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure and covid-19 included Paxlovid started on 21Aug2022 and stopped on 26Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect cannot be excluded .The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
24 hours after inoculation the inoculation site became reddened and warm to the touch. Patient took oral allegra.
injection site swelled; very inflamed; hot to touch; very itchy; lymph nodes in armpit area swelled and were sore and icky; lymph nodes in armpit area swelled and were sore and icky; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swelled), VACCINATION SITE INFLAMMATION (very inflamed), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (very itchy) and LYMPHADENOPATHY (lymph nodes in armpit area swelled and were sore and icky) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelled), VACCINATION SITE INFLAMMATION (very inflamed), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (very itchy), LYMPHADENOPATHY (lymph nodes in armpit area swelled and were sore and icky) and AXILLARY PAIN (lymph nodes in armpit area swelled and were sore and icky). At the time of the report, VACCINATION SITE SWELLING (injection site swelled), VACCINATION SITE INFLAMMATION (very inflamed), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (very itchy), LYMPHADENOPATHY (lymph nodes in armpit area swelled and were sore and icky) and AXILLARY PAIN (lymph nodes in armpit area swelled and were sore and icky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided. Upon in internal review on  21 -May 2021, the age was corrected to  unknown  years"   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Upon internal review on 27 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; 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.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Muscle soreness started around 11 pm on 11-12.  On 11-13 I was feeling a bit shaky, but went to work.  I was dehydrated and shivering around 11 am.  Once at home I collapsed, unable to get out of bed, was napping for several hours, feverish.  Had over 99 temp in evening, temperature probably higher earlier.
Shingles on face, around eye and temple; Residual pain; Rash around temple area; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. In October 2022, 2 months after receiving Shingrix, the patient experienced shingles, pain and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27 DEC 2022 Reporter's comment: This case was reported by the pharmacist. The pharmacist reported that received first dose of Shingrix vaccine late August 2022.  Approximately two months later the patient developed shingles on face around left eye and temple area.  The patient was treated with Valtrex, but still had some residual pain and slight rash around left temple. The first dose was administered at a different pharmacy so the reporter did not have the exact date or lot number expiration date information.  At the time of reporting, the second dose has not been administered. Additional supportive information: The case has been linked to US2022AMR194482, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR194482:Same reporter - Shingrix
Fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (Fever of 103). At the time of the report, PYREXIA (Fever of 103) outcome was unknown. Not Provided          No concomitant medications were provided  No treatment details were given.
Severe body aches, joint pain, migraine, nausea, hot flashes, cold sweats, insomnia
Injection site pain/tenderness, fever, headache, chills, muscle pain, nausea, persistent pain in the abdomen,  diarrhea,  swollen lymph nodes
Patient tested positive on 13Jul; Patient tested positive on 13Jul; This is a spontaneous report from a contactable Health Care Professional. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: Unknown), via intramuscular route administered in left arm on 09Apr2021 at 16:00 as dose 2, single; and received first dose of BNT162B2 (Lot Number: EP6955 and Expiry date: Unknown) via intramuscular route administered in left arm on 19Mar2021 at 16:00 as dose 1, single; both (at the age of 25-years-old) for COVID-19 immunization. Patient had no medical history and no known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient has been tested for COVID-19. On 13Jul2021, Patient tested positive for COVID-19. Adverse event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR Nasal Swab): positive on 13Jul2021. Therapeutic measures were taken as a result of event. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Vaccination failure, Covid 19 and the suspect drug bnt162b2. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
I woke up  at 1:00 am and it felt like my legs were on fire, I had the chills and a fever, I took tylenol, later that morning about 5:30 am my whole body hurt. it lasted into the next day.
Immediate feeling of 'ground glass' and light sensitivity when driving home. Moments of slightly blurred vision. It progressed to double vision, eye drooping and inability to see clearly unless one eye was closed. Intermittent. Sensitivity to sunlight. Feelings of fatigue.  Several test performed. Blood, MRI Etc. Prescription: Pyridostigmine 60MG, One every 6 Hours.
A female reported that she received an injection of DTP when she was an infant. Subsequently the vaccination "caused a high fever".
glands or lymph nodes were swollen; pain in the armpit; injection site pain; she experienced "normal" or mild pain in the arm; 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 32 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 32 years 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 PAIN (non-serious) with onset 12Apr2021, outcome "not recovered", described as "injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 12Apr2021, outcome "not recovered", described as "she experienced "normal" or mild pain in the arm"; LYMPHADENOPATHY (non-serious) with onset 13Apr2021, outcome "unknown", described as "glands or lymph nodes were swollen"; AXILLARY PAIN (non-serious) with onset 13Apr2021, outcome "not recovered", described as "pain in the armpit".  Additional information: After having the vaccine, she experienced "normal" or mild pain in the arm. One day later (Tuesday), she experienced pain in the armpit area that wraps on her elbow and goes inside of the arm- the same arm where the vaccine was administered. She has also observed that her glands or lymph nodes were swollen. The pain also doesn't really go away according to her. Now she wanted to know if these are commonly reported side effects of taking the vaccine. Now she wanted to know if  how long will these symptoms appear/last. Now she wanted to know if she can take something for the pain. Caller verified if we have any data specific to "pain in the armpit area that wraps on her elbow and goes inside of the arm- the same arm where the vaccine was administered" specifically- used VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) but qualified also that pain in the injection site is reported AE. Referred to physician/HCP for appropriate diagnosis and further clinical recommendations. Response: Pfizer was unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine; clinical judgment made by her physician/HCP based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FATIGUE; PAIN AT INJECTION SITE; Ache; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and INJECTION SITE PAIN (PAIN AT INJECTION SITE) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 11-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 PAIN (Ache), HEADACHE (HEADACHE) and INJECTION SITE PAIN (PAIN AT INJECTION SITE). On 13-Feb-2021, the patient experienced FATIGUE (FATIGUE). On 12-Feb-2021, PAIN (Ache) and HEADACHE (HEADACHE) had resolved. On 13-Feb-2021, FATIGUE (FATIGUE) and INJECTION SITE PAIN (PAIN AT INJECTION SITE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Tylenol.
Chills; shaking; Nausea; Vomiting/threw up twice; mind was racing; severe headache/dull pain in the back of his head; couldn't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6198) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aorta valve transplant" (unspecified if ongoing), notes: 3 years ago, everything seems to be fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 Received 17Feb2021, lot EN6201), administration date: 17Feb2021, when the patient was 78 years old, for COVID-19 immunisation, reaction(s): "mild flu like symptoms". The following information was reported: CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Chills"; TREMOR (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "shaking"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Nausea"; VOMITING (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Vomiting/threw up twice"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "mind was racing"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (15Mar2021), described as "severe headache/dull pain in the back of his head"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "couldn't sleep".  Additional information:  The caller walks every day, about 1.5 hours which was close to 4 miles. After the second shot at 5:00 pm or so, the caller ate a big supper, then a chill came over him that was so strong he was actually shaking, he put a heating pad on his chest. The caller couldn't sleep, he threw up twice, was nauseous, had a severe headache, this was Thursday evening. Friday the caller woke up and felt fairly good. Then at 2:00 pm the caller had another attack- chills, not as hard as the day before it was milder, he wasn't nauseous, he seemed to come through it. Saturday evening the caller still had this mild headache in the back of his head, he had it until Sunday. The caller feels fine now but maybe if they told him to take it easy after the second shot this wouldn't have happened. The symptoms were more than severe, the caller almost called someone to take him to the Emergency room. The caller still had the dull pain in the back of his head but it went away now. The caller did not know if it was because he was so active after the second shot? Then it hit him like unbelievable. The caller will be 79 in a month and he was not used to having that kind of reaction.   No follow-up attempts are possible. No further information is expected.
Symptoms: Tightness in front of chest.  Signs: elevated heart rate (over 120), respiratory rate was high, O2 levels stayed above 90 Time course: 60 minutes
This spontaneous report as received from a health care worker refers to an unspecified amount of patients (gender and age unknown). The patients' medical histories, concurrent conditions and concomitant medication were not provided. On unspecified dates the patients were administered M-M-R II via intramuscular route for prophylaxis. No adverse events were reported. The outcome of the event was unknown. Additional information has been requested.
Missed the second dose (more than 8 weeks since first dose); This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)). On 26-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: form, Reporter responding to FU attempt 1
My daughter received 1 dose of the GARDASIL vaccine and within 10 days had a fever, bleeding gums, canker sores inside the mouth, fatigue, no appetite. No one else in the family or friends were ill.
11 days after the shot big sores grew on my palate. Throat is sore glands are inflamed and its hard to eat because of the sores. After six days with no change I called the clinic and have an appt next week. never had this in my life
Two weeks after my first covid vaccine, I experienced weak muscles., light headedness, brain fog and general malaise. It was alarming due to being so far after the foretold reaction time. I tested negative for covid twice because the symptoms lasted two weeks right up to my second dose.  My doctor stated that this far of a delayed response was uncommon but hoped it wasn't unusual and to keep hydrated.  On 2/25, one week after my second dose which was administered 2/17, I experienced acute blurred vision followed by memory loss. Events that I participated in had to be told to me with my having no recollection of them. I was told that I spoke of feeling dizzy "like  being on a boat" and feeling brain fog before falling asleep for hours. I wake up with no memory of any of the events. This has happened three times since.  2/25, 2/26 and 2/28 so far.  It is very alarming and concerning and I wonder if it is normal to have these side effects although they are not mentioned on any website I have visited when researching side effects. I have once again contacted my doctor for further advice.
One day after vaccine mother state patient had a seizure lasting ten min.  Mother states prior to that patient had a temp. of 101 to 103 F.  Mother took patient to hospital where septic w/u was done and at this point remains negative11/28/07-Hospital records received ED DX: Fever of unknown origin. Febrile seizure. Temp 103 (r). Mother states she thinks the baby may have had a seizure about 15 minutes prior. PE: WNL.
p/vax pt seen for painless, mucous bloody stools x 3 that day;pt had rice cereal 10 days prior (from exclusive breast feeding);stool cult done-no enteric pathogens found;advised to restrict rice cereal-was better w/o rice;