chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/21/2021, Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening.  During the observation period, she experienced an adverse reaction with the following symptoms:  Itchy throat and a " feeling of pressure to her throat". Assessment : Time of assessment 356pm. Alert and oriented and no visual swelling to face or throat. Actions taken:  Vitals sign taken, form obtained and completed by RN. Family member to transport patient home. 330pm- 137/90, P- 61, O2- 100%, 335PM_ bp- 129/81, p- 64, o2- 100%, AT 340- bp- 130/91, p- 56, o2- 100 %, 407PM- bp- 113/97, p- 61, o2- 100%, 450PM- 132/81, p- 60, o2- 100% Medications administered: Benadryl 25 mg 1 po x2 at 330pm and 354pm, famotidine 20 mg 1 po x 1 at 427pm. Disposition: Reports no further symptoms of adverse reaction after observation for 60 , patient is doing virtual visit with PCP while in clinic at 456pm. minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Immunizations Administered, Pfizer COVID-19 Vaccine,4/21/2021  2:49 PM,0.3 mL, 2/25/2020, Intramuscular.
I gave the vaccine IM on her right thigh, advised parents to give patient Tylenol or Motrin as needed, when patient came to clinic 3 days after vaccine was administered her entire right thigh had a red patch going horizontally along the right side to her left side.
One week after vaccination, right armpit began to bother him--stinging, sensitive, but no blisters. Also had some swelling at times in that area. This continued, with some symptoms, including itching spreading to the right upper back. He was eventually seen by his PCP on 10/16/17 with 8 raised pink crust lesions about 1-2 mm size, appear to be resolving with crusting over per PCP. Diagnosed with what appears to be shingles per PCP and was given antiviral med and orders for symptomatic treatment with baking soda or Burow's solution.
DIZZINESS, LIGHTHEADEDNESS, NAUSEA, AND VOMITING AFTER 13 MINUTES OF INJECTION.
Patient passed out/syncopal episode with head injury approximately  16 hours after getting vaccine per patient. Patient states she had a headache, fever, body aches, chills approximately 7 hours the vaccine. Patient sustained a head injury/possible concussion with nausea, head pain, irritability after syncopal episode.
NOTE: Following my second shot of the Covid 19 Moderna vaccine, which was injected in my left shoulder. Within my left shoulder joint/muscle, I have been having extreme shoulder pain and I am not, nor have been able to rest on my left shoulder at all. Note that the pain is "not" related to the shot point of injection at all..!
tingling in lower legs. At minute five afterwards, passed out several times, Paramedics called. Low blood pressure. Low heart rate. Overall weakness. Treated in ambulance, stabilized,  and taken to hospital. Released several hours later after bloodwork and ekg.
Body aches, headache,  fever,  chills,  sore arm, tired 48hrs
Patient received Boostrix vaccine and was waiting at the pharmacy afterwards. He reported feeling dizzy then fainted. Emergency services were contacted and arrived shortly. The patient felt fine after the event and refused services from emergency services.
NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN CHEST; NO SLEEP; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and restless leg syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no sleep. On 10-APR-2021, the subject experienced pressure in chest. On 10-APR-2021, the subject experienced ear ache. On 10-APR-2021, the subject experienced felt cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced joint pain in knees. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced nerve pain in leg and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no sleep on 10-APR-2021, was recovering from nerve pain in leg and arm, and had not recovered from joint pain in knees, ear ache, pressure in chest, felt cold, chills, and headache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pregnancy Hx: initial positive UPT on the weekend of 10/7/23-10/8/23 EDD: tbd  Friday, October 6th, pt., came into the office for a travel consultation for a trip 12/5/23-01/08/24. When reviewing her health history that she filled out online, I mistakenly overlooked that she had noted possible pregnancy and no mention of it was made by pt. at the visit. After reviewing all of her vaccination records that she brought with her, pt. received Hep A dose #2, Polio, Tdap, and Varicella dose #2. She also prepaid and scheduled a cholera vaccine. Additionally, I dispensed an oral typhoid vaccine to her at the visit and eRx'd malarone and azithromycin to her pharmacy. I received a message on Tuesday Oct 11 that she had called to report that she had a positive pregnancy test over the weekend. I called pt. Tuesday morning to instruct her to not start the oral typhoid. She had told me that she wouldn't be taking it over the weekend and once she found out she was pregnant, she did not start it. Additionally, I informed her that the malarone and azithromycin Rxs had been cancelled and she will need to consult with and get Rxs from her OB for malaria and TD as malarone, doxy and azitromycin are CI in pregnancy and Larium is CI for her as well due to her psychiatric hx. Client told me that she does have an OB visit scheduled 4 weeks prior to trip to discuss options. Informed client we will cancel cholera and refund cost. Client informed that all other vaccines are fine in pregnancy with the exception of varicella which is CI due to it being a live vaccine. Reassured client that the risk to the fetus is theoretical and no complications of pregnancy have been reported in any studies. I did emphasize that all vaccines received on Oct 6th, particularly the varicella, need to be disclosed to her OB in case her doctor needs to follow up on anything. Client verbalized understanding. I spoke with pt. again on Wednesday, Oct 12 and asked her to return the oral typhoid to the clinic. I offered a Typhim Vi vaccine, per the suggestion, but pt. declined stating that she might be cancelling her trip due to her limited options for malaria medication. She agreed to return the oral typhoid to the clinic this week during our open hours which are between 9:30-5:30 M-F. She informed me that she spoke with a nurse at her OB's office and the OB is supposed to call her back to discuss options for malaria medications. I reiterated that she needs to inform her OB of the vaccines she received last Friday, especially the varicella since it is CI in pregnancy. Client verbalized understanding.
2.5-3 inch hard spot on her arm (half the size of a tennis ball); Swelling and redness in the injection site; Swelling and redness in the injection site; More painful/soreness at the injection site post first dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)). 01-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 28-Feb-2021 for Injection site reaction, at a dose of 1 dosage form. At the time of the report, INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) had not resolved.            As treatment patient  also applied ice but with no relief   This case was linked to MOD-2021-030659 (Patient Link).
Headache, Myalgia, NauseaVomiting, Fatigue, Sore arm
Extremely painful arm with pain extending into left side of neck and chest, on the first night. Concerning health issues through most of the following, enough to stop me from doing usual activities such as hiking and doing routine chores on house and property. Fatigue, breathlessness, rapid heartbeat on wakeup and audible heartbeat with a rushing noise in my left ear in time with my pulse for maybe a half hour after getting up to sit here and begin my day. One episode of no heartbeat accompanied by euphoria and near fainting, then my heart kicked in again, lack of heartbeat lasted maybe eight seconds. Occasional chest pains that are associated with heart attack usually, but no nausea. I'm a runner, know that extreme exertion will produce many of the same symptoms including nausea but since I had no nausea I thought this was a lesser issue. I did not seek treatment, being more concerned I might catch COVID at the hospital. Was sick three times after being vaccinated and boostered, with symptoms consistent with COVID, but again did not seek treatment. I have declined any further COVID vaccinations.
Patient came to pharmacy on 3-2 showed me her arm and around injection site it was round whelp. She stated the night after shot (2/27) she began itching before bed. She said she did not use ice pack, MOTRIN, TYLENOL, or BENADRYL but I instructed her to before shot and also when she showed be on 3-2.
Left leg redness/heat which grew 2" overnight from borders marked 1 day prior. Saw urgent care and dx with cellulitis of the leg. Was treated with a shot and PO medications.
Received 1 yr vax, present on 5-15 with approximately 18 lesions scattered on tunk, buttocks, abdomen, chest that were erythematous papules and errupted the previous day. Chest/lungs clear.
20 hours after the vaccine,  at 3:00 PM on 16th I had small a fever and chills. Those symptoms lasted until 05:00 PM on 17th.  I had a sharp pains in my chest that would come and go. That lasted for three to four days. Then they just went away. I just kept taking my meds. It wasn't clear if it was a muscle pain or inside my chest - it wasn't bad enough to hinder me or for me to see a doctor.
Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation). At the time of the report, CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: severe (abnormal) Severe.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
The patient received the vaccine in the left deltoid at 07:45 on 1/7/21.  The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds.  Did not re-occur.  Did not seek treatment.   Reported to Dr. and no further issues seen.
Itched 4-5 hours after shot, and upper arm swelled. Are was better next day.
Child started having seizures, lasting approx. 5-7 min. The next day was unable to do anything, other than sleep the majority of the day.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in patients who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The age at vaccination was not reported. The reporter stated that an unknown number of patients have experienced injection site soreness after receiving BEXSERO. As per reporter, no other reactions or necessary medical intervention was needed to the patients. It was reported that, some patients had also received 2nd dose of BEXSERO more than one month after their first dose. The reporter did not have access to information regarding specific patients during time of call.
booster; joint pain; fatigue; felt run down a little; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose=1), for Covid-19 immunization; Bnt162b2 (Dose=2), for Covid-19 immunization; Flu shot (she felt unwell after receiving her flu shot), reaction(s): "felt unwell". The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "joint pain"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "fatigue"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "felt run down a little".  Additional information: 48-year-old female consumer said she and her 48-year-old husband received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine on Tuesday afternoon. She said she personally had mild joint pain, fatigue, and felt run down. Her husband, on the other hand, had more severe symptoms such as pain, fatigue, pain at the injection site, and under his arm. She said his underarms were swollen. She said she is more concerned about the pain and swelling under her husband's arm. Consumer wants to know if they should be concerned about this, if this has been reported before, and if this is a common side effect of the booster dose. She also said that her husband also got a little sick yesterday (just like how she felt unwell after receiving her flu shot), and today he still feels run down. Reason for no lot number: of third dose of the Pfizer covid vaccine: Caller unwilling to complete the report. The report is cross referenced to report ID: The caller was calling regarding her husband; they both got the booster shot Tuesday afternoon. Yesterday both of them had side effects. The caller had milder side effects- joint pain, fatigue, and felt run down a little. The caller clarifies and confirms that she is talking about the third dose of the Pfizer covid vaccine when she says booster dose. They had the listed effects that you could have. The caller and the patient didn't have any side effects outside of the 4-5 common side effects that you have after the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
shoulder pain; lethargy; flu like symptoms; fever; softball-size redness; unable to lift arm; unable to lift arm past 45° without pain; This case was reported by a physician via sales rep and described the occurrence of shoulder pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement. On an unknown date, the outcome of the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement were unknown.   It was unknown if the reporter considered the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Bexsero vaccine, the patient experienced extreme shoulder pain, lethargy, flu like symptoms, 100.9 degree C fever, softball size redness, unable to lift arm past 45° without pain. It was unknown, if the reporter consented for follow up.      Lab Comments: On an unknown date, lab test was performed.
Temperature 102-104 F 15 hours after vaccine. No temperature when going to sleep 3 hours earlier. Chills and severe shaking. Fainting when standing to go to bathroom (fell on bed no injuries). Chills and temperature continued for next 12 hours. Stayed in bed the entire next day (3 March). Temperature subsided and was able to work on 4 March.
Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021477197 Same reporter/ drug/ AE, different patient
10 days post vax exp inc fatigue, dec appetite, n,v & cold sweats; also devel t103, lt sided chest pain & a cough-greenish sputum; dx bronchitis; acute renal failure, poss Goodpasture's synd, or Wegener's granulomatosis; dec urine;
Vaccine administered around 14:00 on Sunday 10/5/2008.  Beginning Wednesday (10/8/2008) morning around 07:00, patient experienced significant GI upset, watery diarrhea, fever to 101 degrees Farenheit, significant body aches rated by patient as 7 out of 10 in severity.  Treated with fluids, bowel rest, acetaminophen, and ketoprofen.  Aches only responsive to ketoprofen.  Symptoms finally lessening and patient is now afebrile (15:00 on Friday 10/10/08).  Resulted in 3 missed days of work.
Soreness at site of injection-outside of left arm. Redness, soreness and swollen inner arm, near lymph glands. Extreme fatigue, flu like symptoms. Headache. Weakness. These symptoms lasted about 36 hours. Redness, soreness and swollen inner arm remained same for 4 days. Soreness continued on inner arm total of 6 days. Headache waxed and waned  for 6 days. Tylenol and Imitrix 50 mg needed to control headache pain.
Pericarditis; Myocarditis; Localized reaction at the site of administration; This spontaneous report was received on 03JUN2019 from a physician. A 24 years old male patient presented with a reaction from ACAM2000. He experienced myocarditis, pericarditis and localized reaction at the site of vaccination following the administration of ACAM2000 (smallpox vaccine).  Ten days ago on an unknown date (??-MAY-2019), the patient was administered ACAM2000 (lot, dose and route unknown) in the right arm.  The patient was transferred from an unknown emergency room to their emergency room for a higher level of care. The patient had a localized reaction at the site of administration, developed myocarditis and pericarditis. On 31MAY2019, an electrocardiogram(EKG) showed pericarditis and patient was hospitalized. MRI result was still pending. He was treated with colchicine and ibuprofen orally with events improving. The patient was still in hospital at the time of the report.  Medical history: None reported.  There was no known allergies.  The event was considered to be serious (life threatening, hospitalization).  Company Medical Assessment:  The Company considered that there was temporal relationship to ACAM2000 vaccination and because myocarditis and pericarditis are known complication phenomenon of ACAM2000. Because there is not enough information, the Company assessed these events as "suspected" or possible related. The vaccination reaction is considered "definitely" related as it is a common mild vaccination and local complication. The Company does not consider that the AEs were "Life threatened" as they do not meet the seriousness criterion of Life threatening.    It appears that this case is the same case as 19000138SP. The company is waiting for more information.
Injection in joint leading to bursitis; Initial information received on 03-Feb-2021 regarding an unsolicited valid non-serious case received from a pharmacist .  This case involves patient (unknown demographics) who experienced injection in joint leading to bursitis (bursitis), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious injection in joint leading to bursitis (bursitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  It is unknown if the patient experienced any additional symptoms/events.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.