chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adolescent patient who received BEXSERO. On 20th June 2017, the patient received BEXSERO. On 20th June 2017, less than a day after receiving the BEXSERO, the patient experienced injection site pain, joint pain, nausea, injection site erythema and fatigue. On an unknown date, the outcome of the injection site pain, joint pain, nausea, injection site erythema and fatigue were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, joint pain, nausea, injection site erythema and fatigue to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site. The pharmacist reported that her information was limited to a small sticky note. The patient's injection was given at another facility (unknown).
Liver inflammation/ swelling of the abdomen within 24 hours of the 1st vaccine dose.  Fever, body aches, headaches, and neuropathic pain experienced.
A WEEK AFTER HER INJECTION, THE INJECTION SITES TURNED RED AND WARM TO THE TOUCH.  THERE IS A BID RED CIRCLE AROUND THE INJECTION SITE & THERE IS A HARD KNOT UNDERNEATH THE INJECTION SITE.
Fever - body aches - lack of energy - burning and watery eyes - even my skin hurts Symptoms began between 5:00-6:00 p.m. (injection was at noon).  I have been controlling symptoms with Advil.  I had EXACTLY the same reaction to the first shot.
shortness of breath; left side of her body - leg, arm and face - started to get numb; Dizziness; sharp pain in neck; fever; nauseating headache; nauseating headache; body ache; reduced mobility of left arm; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 27Feb2021 at 20:00 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included food allergy (Known allergy: cucumber). Patient was not pregnant. Patient not administered other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), fluoxetine, collagen; all taken for an unspecified indication, start and stop date were not reported. The patient experienced shortness of breath, left side of her body, leg, arm and face started to get numb, dizziness, sharp pain in neck, fever, nauseating headache, body ache and reduced mobility of left arm on 27Feb2021 at 20:15. Patient not had COVID prior vaccination. Patient was tested COVID post vaccination. Patient not administered other vaccine in four weeks. Patient did not receive any treatment as a result of event. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
One week and a day after injection - red itchy circle around injection site about 3 inches in diameter.
Sore arm.; Body aches; Joint pains; Swollen lymph nodes in arm pit; Tired.; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 15:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified birth control medication within two weeks of vaccination.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 15:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation.  On 29Apr2021 at 15:15, the patient experienced sore arm, body ache, joint pains, swollen lymph nodes in armpit, tired and mild headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, body ache, joint pains, swollen lymph nodes in armpit, tired and mild headache were recovered on an unknown date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 days after receiving the Pfizer vaccine, the spot on my right arm where the shot was administered began feeling painful (again). However, this was 10 times worse than that experienced in the 1-2 days after the shot. There was not rash or swelling. However, the pain was so intense that I did could not use my right arm or hand to do much. This pain lasted 3-4 days before subsiding.   I researched this online and also talked to a pharmacist/friend and found that this was probably "vaccine arm". However, there has been little reporting on this.
Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) 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) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
2days p/vax pt cried for 12 hours, screamed inconsolable. sx did resolve
Immunized with 0.5ml Fluzone at approximately 9:30 AM. 12:40 PM, feet itchy and flushed upper left arm with redness of area, followed by flush/dizzy spells and tightness across chest. Seen in ER; blood pressure and heart rate increased. Symptoms lasted about 3 hours then subsided gradually.
HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report received from a consumer concerned a 61 year old female. 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing in ears. On 08-APR-2021, the subject experienced shaking in arm. On 08-APR-2021, the subject experienced pain in both legs. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, headache, shaking in arm, and tired, and the outcome of pain in both legs was not reported. This report was non-serious.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Blacked out, then came to and felt dizzy and vomited, remained on floor conscious until paramedics came-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Pt developed a rash that started with red bumps at injection site and then traveled down arm and then to whole body. Total time of rash, lasted 1 week. No treatment.
pt recvd vax & exp arthus-like rxn (erythema & tenderness, resembling a cellulitis), which extends from shoulder to elbow on the vax arm w/in 24-48 hrs
Large hard lump; Hot; Very sensitive; Red; Lethargic; Tired; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient 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 09Apr2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no known allergies to medications, food or other products. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:30, the patient experienced large hard lump, red, hot and very sensitive, lethargic, tired, muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of large hard lump, red, hot and very sensitive, lethargic, tired, and muscle pain were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Since I got vaccinated with Tdap vaccine on 8/18/2010 the pain in my arm has not gone away.  I can not lift my arm pass my shoulders, it hurt too much.  Nor sleep on my left side either.
(note: I had no reaction to the first dose)  13 hours after receiving my second dose I had been in bed for a couple of hours unable to get comfortable because I felt weird. That?s when my ankles and feet began to itch. I checked for mosquito bites, none were there but I noticed that my ankles and feet were swollen. I applied a lotion recommended eczema  thinking my skin might be dry. Over the next hour the itching got worse and spread up my calves. That?s when I noticed that my tongue felt weird and kinda poofy. I?m used to occasional dry mouth due to my meds, but this was nothing like that. It freaked me out so I got up took Allegra hoping that on top of the Zyrtec I?d taken hours before would help. Since I was restless and desperately needed sleep  I took 1/2 of a 15mg trazadone tablet. That did the trip. No itching and I was able to sleep. Now I?ve been in bed all day with flu-like symptoms, I?m miserable and I?ve missed work. Unless I awake tomorrow morning feeling magically better I?ll miss work again.  The itching and swollen tongue  really freaked me out, hence my report today.
Around 1 week after vaccine was administered, the site of the injection swelled up and was both painful and pruritic. The lymph node in the armpit of the arm that received the vaccination was also swollen, painful, and palpable. I also felt more fatigue than I normally do. Symptoms resolved within 2 days.
Patient reports she continues to have localized pain in left arm at administration site since receiving immunization on 10/3/14.
Had COVID antibody testing and showed no immunity; This is a spontaneous report from a contactable consumer, she was an audiologist, she was a PhD doctor and not a medical.  A 70-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), three weeks apart on unknown dates at single dose for COVID-19 immunization, via unspecified route of administration. The patient was on very high doses of steroids due to Temporomandibular joint syndrome pain. The patient had COVID antibody testing done after receiving both doses and showed no antibodies.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Individual presented at community covid-19 booster event.  Reported having Pfizer vaccine series, 3/1/21 and 3/24/21 and presented covid-19 vaccine card with same information.  Following event this RN entered patient record which reflected Pfizer covid-19 vaccines 3/1/21 and 3/24/21 and Janssen vaccine 6/2/21 prior to 10/30/21 Moderna booster (0.25ml).  Sought guidance from facility Infectious Disease physician who suggested contacting patient and completing VAERS reports.. Called patient who states he is "fine" and has not experienced side effects from vaccine 48 hours prior.  Patient  now states that he is aware he received more covid-19 vaccines than recommended and understands he should not request or receive additional doses.  He says he has 3 separate covid-19 vaccine cards.  He was advised to update his providers of dates of all covid-19 vaccines and to contact PCP with any further questions or concerns or changes to health status. He was also encouraged to seek assistance at time of next  medical appointment to consolidate information on multiple vaccine cards so he has a single, accurate card.
No Adverse event; Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Patient got second COVID vaccine on 4/1/21 Lot ER8737. On 4/2/21 she present to ED with R hip pain and was noted to have left lower extremity edema, ultrasound showed near occlusive DVT of L tibial vein. Time course of symptom onset unclear.  Started on eliquis and continues to be monitored.
weakness, lt hand/finger, paresthesias; onset 7-10 days p/vax resolving but not gone by 10NOV95;
On the day of the vaccine my arm was sore, the action injection site was red my arm was sore for about 2 days or so. Later on that evening I felt tired, probably during the weekend I felt more tired than usual. My injection site stayed a little bit red, warm to the touch and about 2 weeks later when I reported to VSafe it got more red and itchy, warmer and actually even to this day the is a slight redness to the injection site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (lot number FJ524) at the age of 29 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 17Mar2021 as dose 1, single (lot number EP7534), in left arm, on 08Apr2021 as dose 2, single (lot number EW0158), in left arm and on 05Nov2021 as dose 3 (booster), single (lot number FF2520), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was healthy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving covid booster. Patient hospitalized for COPD and essential hypertension.
Hives on face, chest, and back. He is strictly breastfed and my (mother's) diet had not changed so I feel confident that it is one of the vaccines he received at his four month check up.
2021 ICD-10-CM Diagnosis Code H90.41   Sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side.  Onset of right side diminshed hearing the morning of Sunday Jan. 31st, 2021. More pronounced by Wednesday am Feb. 3rd, 2021.  Seen at the University for Medical Sciences in the outpatient clinic. No significant wax in either canal. Bilateral type A tympanograms.  Markedly abnormal audiogram compared to base line obtained by same facility approx. 8 months earlier. 60 DB loss across all hearing ranges right ear only. Left unchanged.
Received 1st Dose of Heplisav-B, Patient Tested Positive for Hepatits B After Vaccination; Initial Report Received on 17-Mar-2023  A physician reported to a company representative that a patient received HEPLISAV-B for Hepatitis B immunization and subsequently tested positive for hepatitis B after having received the first dose of HEPLISAV B.    There were no medications or additional medical history provided.   On an unspecified date, dose 1 of HEPLISAV-B (Lot # and expiration date not reported, NDC 43528-002-01), was administered.    The patient reportedly was screened for hepatitis B after vaccination and the results indicated the patient was positive for hepatitis B.    No additional information was provided.   Company Comment: The company assessed the event as non-serious and non-immunologically confirmed for lack of efficacy since vaccine series was not completed, and no titer or time to titer was reported.; Sender's Comments: The company assessed the event as non-serious and non-immunologically confirmed for lack of efficacy since vaccine series was not completed, and no titer or time to titer was reported.
The night I got my 2nd dose I started experiencing very bad chest pains. Like it was my left lung or heart. It felt like it was being squeezed. I felt like I could barely breathe. My neck was hurting and I kept having to sleep. I've been super lethargic, and I get pain whenever I inhale or have to swallow something. It feels either like my lung is full of fluid or being squeezed.
Fatigue approximately 28 hours post injection, then within a couple hours developed body aches and low grade fever, injection site red, swollen and itchy. Tylenol and bed and when I woke up Sunday morning all resolved except injection site still slightly swollen, warm and itchy, but not as bad as the night before.
Headache, Moderate to severe headache and fatigue that lasted 2 weeks. Narrative:
Shingles on face and neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles on face and neck). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by consumer via interactive digital media. The reporter reported that it was very painful so he or she would never get the Shingles vaccine. The reporter reported that he or she know the patients who received Shingles vaccine and still experienced shingles soon after the receiving vaccination. The reporter also reported that the more than half of patients experienced shingles on the face and neck severely. The reporter reported that the few patients he or she know experienced shingles on their upper body without receiving of Shingles vaccine. The follow-up could not be possible as the as no contact details were available.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 17:30 as dose 4 (booster), single (Lot number: GJ3274) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: 25 plus year history of migraine; "hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LEVOTHYROXINE; RIZATRIPTAN; NURTEC ODT; IBUPROFEN; BOTOX. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering"; MIGRAINE (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering"; MYALGIA (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering", described as "muscular pain at injection site". Therapeutic measures were taken as a result of migraine. Therapeutic measures were not taken as a result of myalgia, fatigue.  Additional information: Patient had not received any vaccines within four weeks. Patient received the treatment with rizatriptan and neurotic for migraine nothing for fatigue or muscle pain. Patient had COVID-19 prior to vaccination. Patient had not been tested for COVID-19 post vaccination. The patient had no known allergies.  Did does not result in physician office visit or emergency room visit.;
fever 2-3 hrs p/vax; inactivity; convuls seizure; 4-5 hrs p/immun;