chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in her left arm; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2021, the patient received the 1st dose of Shingrix. On 20th September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix at her pharmacy on the left arm. The patient reported that the evening of the vaccine, she experienced pain in her left arm, fever and chills which had since resolved.  The patient had disconnected from call before she could be asked the Vaccine adverse events related questions (date of birth, Lot, Expiration, Route, Site of Administration) and therefore was unable to get consent to contact the patient's doctor.
Swelling in the back of then neck at night.  Left shoulder discomfort.  Right hip pain and unable to bear wait.  Right arm stiff and painful.
chills; extreme sleepiness; leg twitching; received 2nd dose 3 months after 1st dose; dull head ache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull head ache), VACCINATION SITE PAIN (arm pain), CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (dull head ache) and VACCINATION SITE PAIN (arm pain). On 09-Apr-2021, the patient experienced CHILLS (chills), SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. On 28-Jan-2021, HEADACHE (dull head ache) had resolved. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose) had resolved. On 11-Apr-2021, CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) had resolved. Not Provided          This case was linked to MOD-2021-114225 (Patient Link).
After vaccination patient reported pain in both arms and "major" headache.  Increased HR; transported to ER.
About 12 days after my vaccine I got a UTI  from serratia marcescens. This particular infection is unusual and usually occurs in people that have a compromised immune system. I was completely healthy and the only unusual thing was the vaccine.
Subdural hem; Tiredness; Loss of appetite; Loss of smell; This is a spontaneous report from two contactable consumers (one of was patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 26Feb2021 16:00 (Lot Number: EN6205) as dose 2, single (at age of 76-year-old) for covid-19 immunisation. Prior Vaccinations was none. Medical history included blood pressure abnormal, chronic obstructive pulmonary disease (COPD), cholesterol abnormal. Concomitant medications included lisinopril taken for blood pressure abnormal from an unspecified date to 22May2021; salbutamol sulfate (PROAIR HFA) via Inhalation route taken for COPD from an unspecified date to 22May2021; pravastatin taken for cholesterol abnormal from 2019 to 21May2021. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9265) Intramuscular administered in Right deltoid on 02Feb2021 08:45 AM for COVID-19 immunisation (at age of 76-year-old) and experienced flu like, sweats, chills, fever, vomiting, extreme tiredness, ill. The patient experienced subdural hem (death, medically significant) on 23May2021, week long tiredness on 2021, loss of appetite on 2021, loss of smell on 2021. The second dose resulted in week long tiredness, loss of appetite, loss of smell. The event subdural hem required visit to Emergency room and had no treatment. The patient died on 24May2021. An autopsy was not performed. Outcome of the event subdural hem was fatal, of the events tiredness, loss of appetite, loss of smell was unknown.     Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Subdural hem
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # L037790 with expiration date 30-DEC-2016 (route of administration and anatomical location were not reported) for prophylaxis. It was reported that sterile diluent (company product) (dose, lot# and expiration date were not reported) used for vaccination was not expired. No adverse effects were reported. The product quality complaint was not involved. Additional information has been requested.
In March of 2022 I began to notice chest pains. There didn't seem to be a pattern. They come and go at random. They aren't excruciating but are uncomfortable. Sometimes I feel out of breath when climbing stairs. I contacted my transplant team who advised that I see a doctor. I went to be checked and they did some tests but advised that I go to the emergency room where more tests were done. I have been following up with my cardiologist and my primary care physician who believe it may be a G.I. issue. They still have not narrowed down a diagnosis but do not believe it is heart related. I have received a round of Evusheld injections in March 2022.
Patient reports itchy red rash began on upper thighs a few days after receiving first dose of Covid vaccine on 3/4, has appeared on arms as well.  States is worse after showering (admits to taking hot showers and rash looking worse with heat) Denies that she has attempted to treat at all.  Denies SOB or airway involvement.
Mild Fever, Fatigue, Body Aches, Headache, Malaise, Nausea all on Tuesday November 16th. Mild Body Aches, Mild Headache on Wednesday November 17th.
five months later patient tested positive.  c\o fever, chills, muscle aches, runny nose, cough, sob, nasal drainage
Fever, cough, fatigue and sore throat. Influenza H1N1 positive, treated with Tamiflu.
Initial medication error report received on 09 December 2013 from reporter. A child whose age, gender, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot number and site of vaccination was not reported) on an unknown date. Patient received only the DTaP/IPV part without the ACTHIB. Patient did not have any adverse events. List of documents held by sender: none.
Extremely severe nasal discharge for 5 days following Flumist.  Bloody nose on and off for 2 days.  Cold progressively worse until 9/12/08.  Body aches, head aches. Dr. office visit - recieved chest x-ray due to severe congestion (negative for pnuemonia). Starting to clear up as of 9/17/08.
Patient is complaining of Tendinitis aggravation resulting from the vaccine. Patient is experiencing symptoms on both elbows.
PT WOKE UP WITH SWOLLEN RT EYE, CHEEK, AND LIP SWELLING, VERY PAINFUL. WENT TO PCP WHO PRESCRIBED A CREAM FOR THE PAIN, HAD FLU SHOT PREVIOUS DAY IN RT ARM. NOW RESOLVED.
The pt calls today with a report of hives after receiving Menactra and Hepatitis B on 8/16/06.
This spontaneous report as received from a registered nurse refers to a 36 year old female patient. The patient's pertinent medical history was not reported. On 16-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K009809, expiration date: 16-MAY-2015 (dose and route of administration were not provided). No information regarding concomitant medications was reported. On 17-MAR-2015, the patient developed a large lump at the injection site that was red and burning. On the same day (on 17-MAR-2015), the patient went to an unspecified urgent care facility for evaluation and she was prescribed an unspecified dose of prednisone. The outcome of the large lump at the injection site that was red and burning was unknown. The relatedness between the event and the vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Fever; Bone pain; still have some pain in head; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Fever), BONE PAIN (Bone pain) and HEADACHE (still have some pain in head) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Fever), BONE PAIN (Bone pain) and HEADACHE (still have some pain in head). At the time of the report, BODY TEMPERATURE INCREASED (Fever) and BONE PAIN (Bone pain) outcome was unknown and HEADACHE (still have some pain in head) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-216289 (Patient Link).   Reporter did not allow further contact
Blurry vision in left eye; This is a spontaneous report from a non-contactable consumer. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) in the right arm on 08Apr2021 at 14:45 (at the age of 40-year-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on 18Mar2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 the patient experienced Blurry vision in left eye. Blurry vision in left eye - opposite side from which the vaccine was given; it was given in the right arm. This had occurred after receiving both vaccines. The blurry vision occurred 4 days after the first vaccine and a little over 24 hours after the second vaccine. No therapeutic measures were taken as a result of the event. The clinical outcome of the event Blurry vision in left eye - opposite side from which the vaccine was given; it was given in the right arm. This had occurred after receiving both vaccines. The blurry vision occurred 4 days after the first vaccine and a little over 24 hours after the second vaccine was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 61-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 VACCINE, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Vaccine brand was noted as Pfizer/BioNTech. Other medication in 2 weeks was noted as unknown. Paxlovid oral started on 07Dec2022 for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
RA site red, swollen, warm to touch, no fever. Enc'd to alternate warm/cold compress to site. Mother concerned that this is more than mild reaction. Enc'd mother to seek further evaluation at PCP office.
Pt recvd 3 doses of Engerix-B & did not convert to antibodies;
Patient became light headed and almost passed out.  She reported feeling nauseous but did not vomit.  She also reported pain in her collar bone region and up into her neck.
I had pimply, scrappy, itchy on my two fingers on my left hand. I was red and raised as well.  I started getting hives on my arms.  These symptom was ongoing.
Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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 (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 18 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Rash started on 11-3-19 on pt's thighs, back and buttocks. on 11-4-19 rash spread to arms, hands and palms. Rash is also very itchy. Pt has not tried anything for the rash, we recommended Benadryl OTC
wrong vaccine given. Was supposed to be given initial Moderna covid vaccine instead of bivalant booster dose.
Arthralgia, new onset arthritis, muscle pain, bone pain, spinal arthritis. Arthritis development on the side of vaccine administration
Neuropathy; tingling in her hands, like neuropathy, up to the forearms; Dizziness/ dizzy 24 hours a day/dizziness makes you feel like you're high or drunk; horrible, extreme migraine; Muscle weakness; Muscle cramps; pain in her legs; headache; couldn't sleep; felt sick; crying; pain; could not even walk up the steps; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 22Mar2021 (Batch/Lot Number: ER8727) (at the age of 69-years-old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 12Apr2021 (Batch/Lot Number: EW0162) (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient explained that 15 days after completing vaccine series (in 27Apr2021), she experienced horrible, extreme migraine, neuropathy, muscle weakness, muscle cramps, dizziness and pain in her legs. She was also having tingling in her hands, like neuropathy, up to the forearms. She confirmed that all of the previously stated side effects occurred at the end of Apr2021. She said the headache is what happened first, and she felt sick and then the other side effects, like the neuropathy and the weakness in her calves and the tingling all slowly crept up on her. She went to the doctor, but they said nothing because they do not know if it is from the COVID vaccine, they just said that she was sick, and they didn't do anything or help. She just came home from seeing a neurologist who was doing tests on her. She stated that the side effects slowly reached a crescendo and it got bad to where she was crying and she couldn't sleep because she was in such pain and then they kind of got a little better but they were all still there. It dropped a level of the pain, she was not at a 9 or a 10 anymore, now she is at a 5. But they are all still there, and she is still very dizzy. She could not even walk up the steps because she felt that sick and dizzy. Patient wanted to know if her side effects have been reported previously. She stated that the pain was life changing, and that she is not dead from COVID, but this is altering her body. She is dizzy 24 hours a day and she is not a drinker, but the dizziness makes you feel like you're high or drunk. The patient stated that all side effects are current, they initially "crescendo" got really bad and have gotten a little bit better. She went to a neurologist on 14Jul2021 to have testing and labs. The outcome of the event migraine was recovered with sequelae, while for the rest of events was unknown.  Follow-up attempts are completed. No further information is expected.
Generalized shaking for > 1 minute, < 5 minute History consistent with simple febrile seizure
Pt has a history of seizures. Last seizure was in January 2010. She is on LAMICTAL, TRILEPTAL. About 16 hours after getting vaccines (KINRIX, MMR, VARIVAX). She had a 3 minute seizure. No fever. She is fine now.
I'm due November 22, I got my vaccine when I hit my 3rd trimester. I got tachycardia that afternoon it lasted 3 days, I got light headed and nauseated, I felt weak. I still been having chest pain on and off. They monitored me for an afternoon about 5 hours in labor and Delivery.
fever, loss of appetite, night sweats, headache, stomach nausea, constipation, eye sensitivity to light, lethargy, weakness, depression fatigue
Big red circle about 2 inches  UNDER injection sight. Circle is sore to touch but not itchy.
First Pfizer Dose was administered to patient via right arm injection at 3:00pm on June 24,2021. Around 7pm same day patient began experiencing abnormal vaginal bleeding. The bleeding was about the same amount as the start of a menstrual cycle. Patient has not had a  menstrual period since 2015 due to the  surgical removal of all her reproductive organs including uterus , ovaries , fallopian tubes. Cervix was surgically stitched shut. Patient had to have her reproductive system removed due to a diagnosis of breast cancer back in 2013 to her left breast which required her to undergo chemo and hysterectomy of her breast and reproductive organs. Post vaccination patient abnormally experienced vaginal bleeding that cannot be explained being that she has no reproductive system. The bleeding lasted till next day.
friend got very sick within two weeks of getting their so called safe and effective profit shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "friend got very sick within two weeks of getting their so called safe and effective profit shots". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt felt ill, his arm was painful and he developed a patchy hive-like eruption grouping of 3-4 smaller lesions. They are reminiscent of shingles, painful to touch. (the total area of eruption was about 4cm on his right arm near the site of varicella injection).
The client began to experience symptoms consistent with COVID-19 on December 5, 2021.  He had a cough, shortness of breath, chills, muscle aches, sore throat, fatigue, diarrhea, and experienced anorexia for four days prior to seeking medical care.  The client was admitted to the Hospital on December 9, 2021, where he was diagnosed with Pneumonia.  He was prescribed Methylprednisolone, Oxygen, and Duoneb treatments.   He appeared to be recovering  from COVID-19 when he suffered a cardiac event on December 13, 2021.  The client did not survive this event.   The client had received three dosages of the Pfizer vaccine.
Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migraine like headaches and nausea. Symptoms are lessened with sunglasses. Onset is within minutes of being in direct or overcast sunlight.  Symptoms have persisted for 8 consecutive days since vaccine.
Initial report received from a health care professional on 09 May 2011. An unidentified patient (sex and birth date not reported) received on an unknown date an injection (route and site not reported) of ADACEL, sanofi pasteur lot number 4247AA (Not a valid lot number). The patient had an onset of headache, body aches, and hand tremors after the ADACEL, approximately 90 minutes after the vaccine. The patient's symptoms resolved. All further information was refused to be provided including to repeat the lot number. The outcome was reported as recovered. Documents held by sender: None.
Developed an egg allergy less than 24 hrs after receiving vaccine, 35 yrs always ate egg without a problem, from that point on my throat swells whenever eating eggs.
Patient experienced severe heat and swelling in shoulder and upper arm extending down to elbow the night of immunization. Swelling has gone down some today, but skin from area is tight and warm from swelling. Instructed patient to follow up with dr if the swelling got worse or did not go down after a few days.
Information has been received from a female consumer in her 30s, who on an unspecified dates was vaccinated with the 3 doses of GARDASIL (Lot #, routes no reported). The consumer reported that after receiving the 3 doses she had been diagnosed with an abnormal pap smears. The patient also had noticed intermittent vaginal bleeding. She had scheduled a colposcopy. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
MODERNA COVID-19 vaccine eua  Hands tingling numbness, especially pinky fingers. Very strong pain. Hands are weak. Pain in left leg& slight numb toes. Legs cramping throughout night.