chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported by a health care professional that a 5 year old girl was vaccianted with 7/5/06 at 10am with a dose of TDaP vaccine Covaxis, lot # C2291AC, into the left upper arm. 90 min P.V. she experienced a convulsion with staring, stiffness and unresponsiveness for 1 to 2 minutes. She was hospitalized had recovered the same day. No further information (such as hospital report, results of EEG, neurological exam etc.) was provided. The case is closed.
lump in your armpit after getting the vaccine booster; This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY MASS (lump in your armpit after getting the vaccine booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lump in your armpit after getting the vaccine booster). At the time of the report, AXILLARY MASS (lump in your armpit after getting the vaccine booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a nurse who refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL. The patient received dose of GARDASIL that was stored improperly. No adverse effects reported. The outcome of the patient received dose of GARDASIL that was stored improperly was unknown. Additional information has been requested.
I felt pain in my calf; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 17:45 (Lot number: EP7534) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Corneal abrasion" (unspecified if ongoing), notes: Other medications in two weeks: yes, eye drops for Corneal abrasion. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovering", described as "I felt pain in my calf". The event "i felt pain in my calf" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event: I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant. At 40 hours after second vaccine dose, I went to the ER and was diagnosed with a DVT in my right calf and treated with blood thinners.  No follow-up attempts are possible. No further information is expected.
Body aches and flu-like symptoms following each shot that resolved within the week.   Continuing daily headaches that were not present prior to vaccine shots.
At approximately 3:45 pm 12/15/2020 patient was given the first of a two injection series new employee Hepatitis B vaccination. After receiving the vaccination she was observed for 15 minutes with no reported adverse reaction. At approximately 4:30 pm after returning home 12/15/2020 she stated felt anxious. At approximately 6:30 pm 12/15/2020 she had nausea/vomiting, hot/cold chills, temperature 99.6. She reports at 3:00 pm 12/16/2020 she is still having a low grade fever of 99.6 and nausea/vomiting. No reported pain, swelling or rash at injection site. She will be contacting her physician today for an appointment.
Vasovagal syncope immediately after immunizations given. Patient was assisted to supine position on exam table by nurse. Event lasted 10 -15 seconds. Mother was at bedside. Patient reported feeling nauseous. He was alert and oriented to person, place, and time.  Heart rate was 82 with regular rhythm  normal S1 S2 and without murmur. Lungs were clear to auscultation.  Pupils were PERRL  2+ bilaterally.  Patient admitted to being very anxious about getting the vaccines due to fear of needles. Patient was given apple juice which he drank. Patient was observed for 15 -20 minutes prior to being discharged home in the care of his mother.  Patient was going home to rest for the remainder of the day. Mother was instructed to call clinic with concerns or report to ER if needed.
Gland in throat swollen, sinus difficult breathing, ear pain. Sjogrens Syndrome diagnosed a year later I'll for past year since vaccination
pt recv vax & exp h/a, sore throat, t100.4 & stomach upset;MD office was called & felt there was no connection to vaccine;
Pain in biceps area/Pain in fingers; Can't rising right arm in the morning; Pain in right elbow/Pain in right shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-APR-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, 1 week after receiving Shingrix, the patient experienced pain in extremity (Verbatim: Pain in biceps area/Pain in fingers), mobility decreased (Verbatim: Can't rising right arm in the morning) and arthralgia (Verbatim: Pain in right elbow/Pain in right shoulder). The outcome of the pain in extremity, mobility decreased and arthralgia were not resolved.   It was unknown if the reporter considered the pain in extremity, mobility decreased and arthralgia to be related to Shingrix.     It was unknown if the company considered the pain in extremity, mobility decreased and arthralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter was the patient who stated that a week after second dose the patient started with pain in right shoulder and right elbow, also pain in fingers.  The reporter also complained of inability to rising right arm in the morning and also pain in biceps area.  All the symptoms were persist until the date of reporting. The reporter did not consent to follow-up.
I did very well with all my vaccines without an adverse event. In 01/2023 I went in for a standard physical and they found I have an irregular heartbeat.  I have a had several test and all was within normal range. In 04/2023, I got in to see a cardiologist. At this time, I am being monitored.
2 of the doctors did not convert with antibody test which was performed about 10-18 days after the 2nd Pfizer vaccine dose; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), both via an unspecified route of administration on unspecified dates and at single dose for COVID-19 immunisation. The patient received the product in the hospital. The patient's medical history and concomitant medications were not reported. The physician reported that several doctors have received both vaccines and 2 of the doctors "did not convert with antibody test." HCP stated the test was performed "about 10-18 days after the 2nd Pfizer vaccine dose." The patient underwent lab tests and procedures which included COVID-19 antibody test: did not convert with antibody test on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171614 same drug/reporter/event, different patients
BODYACHE; CHILL; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 59676D58015 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced bodyache. On 24-MAR-2021, the subject experienced chill. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, bodyache, fever and chill was not reported. This report was non-serious.
Severe joint pain (hip, knees, lower back), severe stiffness, muscle pain, extreme weakness, couldn't walk  normally, uncordinated, unbalanced, brain fog, short term memory loss, whole body pain and swelling, not relieved by max dose  ibuprofen and benadryl. Broke out in psoriasis.
Severe itchiness and bumps on hairline within multiple areas of body. Head is the worst. Took Zyrtec, seemingly calming down.
A child received the Moderna vaccine at the age of 16; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16). On 08-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
started experiencing the same pain after being under the sun on the same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (started experiencing the same pain after being under the sun on the same day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (started experiencing the same pain after being under the sun on the same day). At the time of the report, PAIN (started experiencing the same pain after being under the sun on the same day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Red induration 4 1/2 inches x 4 1/2 inches, warm to touch.
I woke up and felt some nausea. I decided I didn't feel well and took a COVID-19 home test. I called the doctor and they prescribed PAXLOVID. I started taking PAXLOIVD that day. I had a pretty mild case. I mostly felt sleepy and nausea with a slight cough. It took three weeks for me to finally recover and get a negative COVID-19 test. I still feel some stomach issues till this day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported chills, fever, malaise. Considered going to ER, chose not to do so. Patient reports feeling back to normal as of this morning (10-1-14). Based on what he described, I estimate his symptoms did not appear for at least 2-3 hours and were greatly improved well within 24 hours.
30 YO man developed erythema, tenderness & warmth below injection site 2 days after immunization.  Ellipsoid area 4X6CM, Injection site itself is clear.  Dx : Cellulitis vs injection site reaction.
Vaccine recipient developed right facial nerve palsy 24 hours after vaccine administered.  Palsy is persistent now 10 days later.  Not progressing at this time.
3/26 - 4/9 vaginal outbreak. tested for herpes & other STDS, came back negative. doctors had no answers. could not walk, sit, urinate, etc without being in excruciating pain. 8/22 - 8/29 mouth outbreak. clogged ear from sinus drainage (first time immune system had been jeopardized since vaccine). dozens of canker sores and mouth sensitivity. could not talk, eat, drink without being in excruciating pain. detrimental to my job and had to call out several days. went to ENT and was prescribed prednisone and amox.  9/5 first day ear unclogs after meds, but it is on and off and still not consistent. 9/12 - current date mouth outbreak. canker sores. dozens.
This spontaneous report was received from a certificated medical assistant concerning a two unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAY-2017, the patients were vaccinated with expired doses of VARIVAX (expiration date of 06-MAY-2017; strength, dose, route, anatomical location and lot number were not provided), for prophylaxis, which were diluted with sterile diluent (manufacturer unknown). No adverse effects were reported.  Additional information is not expected because there was no consent to contact the reporter.
No adverse event; one vaccine was given past 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by date.).    No concomitant medication was reported.  HCP stated that they had a shipment of Moderna Bivalent however it expired a day before reporting and one vaccine was given past 30 day use by date.  No treatment information was provided.
Left temple Migraine; Random temple pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 10Feb2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Jan2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 12Feb2021 at 12:00, 2 days after the vaccination, the patient experienced left temple migraine which lasted for 4 days or so. She also experienced random temple pain on and off for days where she never had a headache like that. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left temple migraine and random temple pain was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Client c/o dizzy and tingling in left arm. Reported having similar reaction when given Flagyl. Client placed in prone position and monitored. VSS O2 99% on RA. After monitoring and evaluation by on-site EMTs, pt reported feeling better, able to ambulate with minimal assistance. Family present in clinic.  Client left with spouse and family at 1505.
Day 1 post receipt she was very fatigued, and they noted severe erythema, edema, pain, induration, pruritis and tenderness at the vaccine site with peripheral involvement from above her knee to her upper thigh, almost groin. They were unsure which vaccine given at that site. She was seen in Urgent Care on day 2 and treated with ZYRTEC, TYLENOL and MOTRIN and cold compresses. The symptoms improved and were mostly resolved in another 2 days.
TEMPORARY BELL'S PALSY; INTESTINAL RESECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 1 administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced temporary bell's palsy, and had to get a portion of her intestines removed which was intestinal resection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary bell's palsy and intestinal resection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220845198-covid-19 vaccine ad26.cov2.s -temporary bell's palsy. This event(s) is labeled per Agency and is therefore considered potentially related.  20220845198-covid-19 vaccine ad26.cov2.s -intestinal resection . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Covid Arm; Chills; Headache; Nausea; Body Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 10:00 (Lot number: ER8730) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "High cholesterlol" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Proplene Glycol allergies" (unspecified if ongoing), notes: Known allergy. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: CHILLS (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Nausea"; PAIN (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Body Aches"; LIMB DISCOMFORT (non-serious) with onset 02Apr2021 16:00, outcome "recovered" (2021), described as "Covid Arm". Therapeutic measures were not taken as a result of chills, headache, nausea, pain, limb discomfort.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. List of any other medications the patient received within 2 weeks of vaccination was vitamins. Does Pfizer have permission to contact the reporter about this event was reported as yes. Does Pfizer have permission to contact your/the patient's healthcare provider about this report was reported as no.Patient received bnt162b2 (BNT162B2), administered in left arm, administration date 28Apr2021 10:00 (Lot number: FWDMI) as dose 2,single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
103 degrees temperature, severe asthma breathing problems, body aches, chills, chronic deep cough 11/19/09 DC summary, ED and hospital records received for DOS 11/16/09-11/18/09. Pt. presented with fever, chills, shortness of breath, cough, wheezing and hypoxia.  He was treated with oxygen, bronchodilators, Tamiflu and cough supression.  Pt. gradually improved.  Discharged stable. DC DX: H1N1 Influenza A, bronchopneumonia with hypoxia, high probability obstructive sleep apnea
Had fever for 1st 2 sets of shots for 48 hrs including his single PREVNAR vaccine #3.  With last set #4 he ran fever for 7 days 102 & greater.  He did not run fever with 3rd set of shot (no PREVNAR).  We were on back order.