chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a dose of the Pfizer covid 19 vaccine but ended up in the ER with a small intestine issue; She also mentioned she takes a blood pressure pill.; 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 female patient received BNT162b2 (BNT162B2 NOS), as dose 1, 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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "had a dose of the Pfizer covid 19 vaccine but ended up in the ER with a small intestine issue"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "She also mentioned she takes a blood pressure pill.". The event "had a dose of the pfizer covid 19 vaccine but ended up in the er with a small intestine issue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure abnormal.  Additional Information: The caller shared also that she had a dose of the Pfizer COVID 19 vaccine but ended up in the ER with a small intestine issue. After the first vaccination of the COVID Vaccine she was in the emergency department with small intestine issue. She also mentioned she takes a blood pressure pill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Quarter size area of redness noted at injection site that steadily increased in diameter and appeared to be more tender over the course of 48 hours after the vaccine was administered.
Monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have any adverse events or outcome.
achy; head with headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (achy) and HEADACHE (head with headache) in a 68-year-old patient of an unknown 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 MYALGIA (achy) and HEADACHE (head with headache). At the time of the report, MYALGIA (achy) and HEADACHE (head with headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
feeling abnormal; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 27May2021 at 08:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19. The patient had no allergies to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 06May2021 at 08:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 09:00, the patient stated that magnet sticks to her arm at injection site and there is a strong magnetic pull in other areas of her body/feeling abnormal. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event magnet sticks to her arm at injection site and there is a strong magnetic pull in other areas of her body/feeling abnormal was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Onset of chest pain approximately 30 mins. post Flu vaccine. Pt. described pain to be 6/10 initial BP reading was 130/103. Upon administering 2 doses of ASA 81 pain and BP subsided a little bit. Followed by a brief relief and int. pain.
This spontaneous report was received from a registered nurse refers to the patients of unknown age and sex. On an unspecified date, between August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB lot # J014855 expiry date 16-APR-2015. Concomitant medications were not reported. No symptoms were reported. No PQC were involved and no further information was provided. This is one of the several reports from the same source. Additional information has been requested.
tenderness; axillary swelling; chills; arthralgia; myalgia; headache; nausea; vomiting; fatigue; Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia) and MYALGIA (myalgia) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Penicillin allergy (Penicillin reactions in the past).    On 24-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Sep-2023, the patient experienced TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, TENDERNESS (tenderness), SWELLING (axillary swelling), CHILLS (chills), ARTHRALGIA (arthralgia), MYALGIA (myalgia), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient never experienced any side effects with her last doses. She was staying hydrated and stayed in bed. She started experiencing side effects on the night of 24-Sep-2023 and early in the morning of 25-Sep-2023.  Treatment information was not reported.
tingling in his feet; he was underage; numbness in his feet; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness in his feet), PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced HYPOAESTHESIA (numbness in his feet). On an unknown date, the patient experienced PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage). On 28-Jul-2021, HYPOAESTHESIA (numbness in his feet) had resolved. At the time of the report, PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.   The treatment information was not reported.  It was reported that the patient received 1st Moderna dose with immunizer not aware of age below 18 until preparing for 2nd dose. After interviewing patient prior to second dose he mentioned tingling in his feet after the 1st vaccine.   Resolved before 2nd dose was due.   This case was linked to MOD-2021-339395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received and patient demographics updated. event (numbness in his feet) onset date updated. On 01-Oct-2021: Follow up received, reporter contact details/patient birth year updated, event end date added.
10 episodes of vomiting with pain 1 hour after vaccines given. Non responsive 3 hours later, for about 30 minutes. Spontaneous recovery at ER.
Pt states area was getting red around site, tender at site, redness increased over 2 day spread down arm around under armpit 120 mm length 80 mm width seen 10/6/10 tx with abx.
Was administering VARIVAX pt was crying. Gave MMR pt's hands formed inward & was holding breath, I told mom to pick him up & blow in his mouth mom shook a little bit & pt started crying again went & got Dr. right away.
Pt fell off the chair onto the ground few seconds after receiving Janssen Covid 19 vaccine. 911 was called. Patient regained consciousness right away and was taken to the hospital by paramedics. Per paramedics, pt's  blood pressure was a little bit low.
Patient developed cellulitis on next day after injection over left forearm. Resolved nicely on antibiotics (oral).
Slight tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Slight tiredness). At the time of the report, FATIGUE (Slight tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-101570 (Patient Link).
Shoulder pain, ache + stiffness.  Some sharp pain when lifting.  For the last 2 weeks.
5/30 I woke up feeling badly and unable to sit up. I had a great deal of fatigue, and was unable to do much before needing to take a break; nausea; dizzy; weakness; headache; and my eyes hurt very badly. At home COVID test, negative on 5/30, and again on 5/31. 6/1 tested positive with at home COVID test. Saw doctor on 6/1 who prescribed PAXLOVID. Headache and sensitivity to sound/noise. By 6/10 or 11, I could sit up and eat a little. 6/16 tested positive on at home COVID tests through 6/22. I got Bronchitis and Sinus infections during this week, June 16 to 22nd.
Patient was a new admit to the nursing home. We did a Covid shot clinic on 11/1/2022 to give the new bivalent boosters to those who had not received them yet. Patient was on the list of not having the bivalent booster, so we administered it to him.   Upon further research, the facility learned that he did not have record of even a primary series in his past prior to being admitted .    Patient received bivalent booster without having received a primary series.   There were no adverse reactions associated with this error.
93 Male vaccinated Pfizer 1/06/2021 & 1/28/2021. Symptom onset 4/30/2021 - SOA, fatigue. Taken to ER 5/10/2021 for blurry vision. Diagnosed with COVID 4/30/2021. Started dexamethasone. Patient claims left eye problems secondary to dexamethasone. Discharged and final diagnosis at time of death 5/24/2021 - COVID-19 with PNA
Pt contacted Dr. regarding L arm pain following TdAP shot last week.  She recalled more pain than she usually has with an IM injection right at the time of the shot, then felt fine through the day, then awoke at night that night with marked pain in the L upper arm muscle area.  Over the next several days, her arm has felt sore and heavy, though seems to be getting better.  She's also noted some tingling of the L 3rd, 4th, and 5th fingers though this seems gone today.  Her L arm may be weaker than the R vs just limited by pain.  She does not recall that the shot seemed to be given in an unusual location.  No fever or systemic illness.  Has taken no medications for the symptoms  Pt was advised pt to apply ice to L deltoid tonight; use ibuprofen 600 mg- 800 mg bid w/ meals for next three days, and see md if sxes not entirely resolved in next 1- 1/2 wks. Pt was  offered opportunity to be seen tomorrow but she is not available then.
Patient got 1st dose of Pfizer vaccine on 4/1/21 from Pharmacy. Patient was due for second dose of Pfizer vaccine, but unable to get as Pharmacy was out of vaccine. Patient came to Walmart pharmacy thinking Walmart has Pfizer vaccine. Pharmacy administered patient Moderna vaccine. Patient only speaks Spanish and due to language barrier patient got wrong vaccine.
Patient presented to pharmacy and requested a flu shot, filled out paperwork, was given the VIS and discussed difference in regular vs hi-dose flu shot for this year. After all questions were answered, regular quad flu shot was administered.  Upon documenting was discovered that pt had already gotten a flu shot during her office visit earlier today.
Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and drug allergies who in September 2002, was vaccinated with a "standard" dose of MMR II, SC, at his 15 month checkup and regressed developmentally. There was no concomitant medication. The patient had lack of eye contact, low muscle tone, focused on one thing, wouldn't respond to his name, and did things differently than other children in his age "within a week after vaccination". Lab diagnostic studies included "child development inventory test, ADOS". The son was diagnosed with autism 3 years later, in approximately September 2005. The patient had sought medical attention and visited the office. The outcome was unknown at the time of report. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Arm was achy right away and then just never went away. Went through physical therapy to try and relieve pain and improve range of motion when lifting arm with no real relief. 11 months later they finally ordered at MRI to see what is happening.
Case number PHEH2015US027321, is an initial spontaneous report received from a consumer on 9 Dec 2015. This report refers to a female patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with unapproved batch of FLUVIRIN (batch number: 1514501) on an unknown date. No adverse event was reported following administration of unapproved batch of FLUVIRIN.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up received and added age group.
Dizzy, muscle aches, joint pain, nausea,  flu like symptoms for 3 1/2 days Rather severe Same problems on second shot but less so.
The day after the second COVID-19 vaccine I had moderate body aches and fatigue.  This continued for about a week.  At that time it "settled" in my upper arms, shoulders, and neck.  My upper arms felt heavy and ached for three weeks.  I had difficulty unloading the dishwasher, folding laundry, etc.   The aching was accompanied by stiffness in this area of my body as well as fatigue. After about three weeks I sought medical care from my internist.  He thought I may have PMR (polymyalgia rheumatica)and did blood work. and I began a course of steriods.  The blood work did not support this diagnosis.  Referred to rheumatologist who did further blood work, all of which came back with negative results.  He felt the problem was the result of a possible side effect of the COVID-10 vaccine and not PMR.
Reported due to being transferred to hospital within 3 days of vaccination.  Patient sustained a fall and likely this is not related to COVID vaccine as he had no post vaccination symptoms and has a history of falls.  He returned after being evaluated and hospitalized for 6 days Dx included urinary tract infection and acute kidney injury.   We were instructed to report any hospitalizations within 3 days of vaccine.
Report 20000307171 describes fever in a 26 year old male who received Engerix-B for prophylaxis of hepatitis B. Allergies, medical history, and concomitant medications are unknown. On 09/01/2000, the vaccinee received his first IM left deltoid dose of Engerix-B. Subsequently, he experienced a fever of 103 degrees F which lasted two weeks. No treatment was given. As of 10/05/2000, the outcome of the event is resolved.
now is experiencing "blotches" in the arm where he received the vaccine.; the blotches as not itching but being hot.; speak to someone about this event to make sure it is not an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date Mar2022 (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: RASH MACULAR (non-serious), outcome "unknown", described as "now is experiencing "blotches" in the arm where he received the vaccine."; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "the blotches as not itching but being hot."; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "speak to someone about this event to make sure it is not an allergic reaction".  Additional information: caller behalf of her husband who received the Pfizer COVID-19 Vaccine last Friday and now is experiencing "blotches" in the arm where he received the vaccine. Caller wanted to know if this was normal. She also described the blotches as not itching but being hot. Patient wants to speak to someone about this event to make sure it is not an allergic reaction, or if her husband should go to the doctor.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Left upper arm - redness, swollen, itchy, burning w/in the muscle; hot to touch, rash. Reaction w/in 24 hr. Reaction lessening over 48 hr. Patient to take BENADRYL for histamine release, APAP for pain.
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left.  Tingling around area of right ear and hearing changes on right side.  Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
fever/off food 10 days p/vax; erythematous, maculo papular rash on trunk & face;
Information has been received from a physician concerning a 13 year old patient who on 28-DEC-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported) instead of VARIVAX (Merck) for the treatment of chickenpox. The patient did not seek medical attention. Follow-up information was received via telephone call from a nurse who stated that it was a case of the wrong product was grabbed off the shelf by mistake. She also stated that it was not a case of product confusion. Additional information is not expected.
Seizure, violent shaking; chills. Diarrhea & Vomiting
She took the influenza vaccine on the same day she took her COVID vaccine; Suicidal; Severe mental health issues worsened; Severe mental health issues worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FD8448), via an unspecified route of administration, administered in the left arm on 18Aug2021 around 12:00 or 13:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization; and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, administered in the right arm on 18Aug2021 (lot number was not reported) at unspecified dose for an unspecified indication. The patient mentioned that she usually gets the influenza vaccine every year, but she gets sick after it and she usually doesn't take it because of this. Medical history included stroke, brain bleed, traumatic brain injury (TBI), severe migraines, and mental health issues (runs in her family). Concomitant medications included several daily medications (unspecified). The patient reported that she took the influenza vaccine on the same day (18Aug2021) she took her COVID vaccine. On an unspecified date (after the vaccination), the patient was suicidal and her severe mental health issues worsened. The patient wanted to report some severe mental health changes. The patient was suicidal and may need treatment for that but has not had any treatment since the event. She was thinking there was something severely wrong with her but now she was reading things and it said that this could've happen after the vaccine. This happened a week or 2 after the shot, but she didn't think it had anything to do with the shot. The patient mentioned that she's not going to get the second dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before resolving.  From 0900 to 1600 experienced fatigue and heaviness that prevented me from working that day. From 1600 to 2000 I felt "normal". At 2100 I went to bed with chills and overall malaise, awoke at 0000 1/8/21 with a fever of 101 F. Throughout the night I experienced severe body aches and a headache that made my teeth and jaw ache 7/10 on the pain scale. Tylenol 500mg taken at 0500 1/8 with relief. Fatigue/weakness experienced until 1700 on 1/8/21 after which I felt like myself again. In total, 2 days of work missed as a result of symptoms.