chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 hours after receiving 2nd Moderna vaccine on 1/28/21 at 9a my deltoid began aching.  I took 400mg ibuprofen and went to sleep that evening as usual.  Around 3am I began noting severe pain in my left arm and then got up at 5a per usual.   3cm below the injection site bandaid was an orange-sized erythematous swelling.  It was exquisitely tender to touch (like gout).  Any little movement of my left arm was painful.  I also experienced headache, chills, and fatigue but these symptoms were nothing compared to the arm pain.  I took ibuprofen 400mg every 6 hrs and stayed in bed all day 1/29.  My left arm continued to have severe pain all day and that night, though was better the next day.  Today 1/31/21 my left deltoid swelling has decreased to the size of a small lime and the pain has sIgnificantly improved.
This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 13-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever; headache; couldn't function; This is a spontaneous report from a contactable consumer reported for a patient (Fiance). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, headache and couldn't function on an unspecified date. It was reported that, his symptoms began at 3 pm on Wednesday as well with a fever, headache, couldn't function and felt like he hit a wall. Caller enquired if they should get the second dose of the vaccine. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
On 01/26/2022 at 09:50 I had a Pre-op test where they did a routine COVID where results came back positive. I had no symptoms at all, not even a fever or cough and never developed any. I had an in-home test I did on either the 3rd or 4th of February that was negative. I didn't have any problems at all. I was able to have surgery on 03/28/2022 and they told me that if I had a positive test in the past 60 days that they were not going to re-test me. Why and how, I have no idea.
Patient presented to clinic for 2nd Pfizer covid vaccine. Vaccine administered @ 1520 and patient waited for 15 min with no reaction and discharged @ 1540. Patient called the next day (2/11/21) @ 0927 and reported swelling on left side of face and lips and denied any SOB or difficulty swallowing.  Patient came into office to be assessed by Doctor; Assessment and Plan angioedema-adverese reaction to 2nd Pfizer covid vaccine, mild and should subside spontaneously. Recommend Benadryl OTC for swelling. Regarding future covid vaccines not enough information for specific advice, however would presume she would never take this particular vaccine again, not sure about a different type/brand.
she woke up with a head cold this morning; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she woke up with a head cold this morning". Clinical course: The patient received the 1st Pfizer COVID 19 vaccine and scheduled to get her 2nd dose tomorrow, but she woke up with a head cold this morning. Patient would like to know if she should get the 2nd dose.  No follow-up attempts are possible. No further information is expected.
eye was all swollen; Arm feels like its infected; feels hot to touch; arm has a hard knot; it is all red; Still feeling fatigue; hives on her rear end; skin felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch) and PRURITUS (skin felt itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRAMADOL, DULOXETINE and ALPRAZOLAM for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (hives on her rear end) and PRURITUS (skin felt itchy). On an unknown date, the patient experienced EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot), VACCINATION SITE ERYTHEMA (it is all red) and FATIGUE (Still feeling fatigue). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), PRURITUS (skin felt itchy) and VACCINATION SITE ERYTHEMA (it is all red) outcome was unknown and VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot) and FATIGUE (Still feeling fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
So wired couln't calm down; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (So wired couln't calm down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (So wired couln't calm down). At the time of the report, ANXIETY (So wired couln't calm down) outcome was unknown.        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 medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No new information was reported
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 02-FEB-2018 (also reported as 02-FEB-2020), the patient was vaccinated with properly stored but expired dose ZOSTAVAX, lot # M041085, expiration date 03-JAN-2018 for prophylaxis (dose, route of administration were not reported). The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
pt recv vax 10MAY94 & 16MAY94 exp numbness & soreness of the armpit & chest wall on the side of the inj; armpit also itched & burned & lt breast itched as well; loss of sensation;
PT REPORTS ITCHINESS, HIVES WITHIN 1-2 HRS OF VACCINE; MUSCLE TREMORS ONE WEEK AFTER RECEIVING VACCINE AND REPORTS CONTINUES TO TREMORS.
Vaccine given on oct 15 2021 . Vaccine expired Sept 25 2021
dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205), via an unspecified route of administration and unspecified anatomical site on 17Mar2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included back surgery in Dec2020 (four months ago, from the time of reporting) and since that time the patient had episodes of dizziness, unknown if it is ongoing. In Dec2020, two days after back surgery, he had a syncopal episode and hit his head. The patient was evaluated at hospital emergency department and he reported negative computerised tomogram (CT) of head from the visit and was diagnosed with concussion. Concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on an unspecified date, as a single dose for COVID-19 immunisation, and patient did not experience any event with the first dose of COVID vaccination. On 17Mar2021, during his fifteen minutes waiting period after the second dose of vaccination, the patient began to experience dizziness. The patient denied any other symptoms. The patient received water as a therapeutic measure. The follow up response to treatment was excellent. The patient was stable to go home and advised to follow up with primary care physician (PCP). The clinical outcome of the event dizziness was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient age added, the first dose of BNT162B2 previous was captured as Past Drug Event and updated as Historical Vaccine, CT of head added as lab data instead of medical history, removed duplicate indication of COVID-19 immunisation, Vaccination Facility Country added, narrative updated accordingly. No follow-up attempts are needed. No further information is expected.
she passed out; she couldn't see; sick; stomach started to hurt; had chills; her arms hurt; she was freezing; her arm had swollen like a balloon; her arm had swollen like a balloon and became hard as a rock; hit her head; dizzy; she couldn't walk around her house; Her heart was "loudly" palpating; extremely low blood pressure/Her heart was "loudly" palpating; This spontaneous report as received from a consumer concerning herself a 67  year old patient. Pertinent medical history, drug reactions and allergies, and concomitant medications were reported as none.  Early in June 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).   In June 2017, reported as later that same date after received the vaccine, she started to feel sick. She reported that her stomach started to hurt, had chills, and her arms hurt. As the day progressed, her sickness continually "got worse and worse". She reported that she was freezing despite tons of clothing and layers on. The next day her arm had swollen like a balloon and became hard as a rock. At one point she passed out and hit her head on her dresser. When she woke up, she couldn't see, and eventually her sight came back in blobs/spots (blindness transient). Over the next week, approximately in June 2017, it progressively became worse and she reported being so dizzy that she couldn't walk (blindness transient) around her house without grabbing onto a wall (Gait inability). Her heart was "loudly" palpating (Heart rate decreased) and she had an extremely low blood pressure. One doctor told her that her "heart is just not operating as it should", however a different doctor said her heart was fine. After completing a detox, changing her diet, and taking vitamin supplements she slowly started feeling better (also reported as not recovered by the same reporter). She reported that she "hasn't been the same" since she received that re-vaccination. She still currently experienced dizziness from time to time and was afraid to take the COVlD-19 vaccine due to her adverse experience with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. None laboratory test was performed  The outcome of illness, hypotension, heart rate decreased, gait inability, dizziness, head injury, induration, peripheral swelling, feeling cold, pain in extremity, chills and abdominal pain upper was reported as not recovered. The outcome of loss of consciousness and blindness transient was reported as recovered, on an unspecified date in 2017 (conflicting information also reported as not recovered).        The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was  assessed as related  by reporter.  Upon internal review the events of passed out and she couldn't see (Blindness transient )was considered to be medically significant.
Had injection site reaction such as sore arm; Had injection site reaction such as sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm). At the time of the report, VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm) 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 medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-333515 (Patient Link).
3 hours after vax had "very severe pain in all joints". Went to PMD - given prednisone - blood sugar went up - went off prednisone. Now has "throat infection and swollen glands".
I started noticing a blister type rash/bumps on my hands, wrists, elbows, and bottom of my feet 9 days after receiving the Moderna Covid-19 vaccine. On the 10th day, I noticed it was getting worse and some of the spots were an itchy/burning feeling (it woke me up at night). On the 11th day, I went to the doctor and was prescribed oral prednisone (60 mg x 3 days, 40 mg x 3 days. 20 mg x 3 days, 10 mg x 4 days), hydroxyzine PRN for itching, and triamcinolone ointment. The rash started improving after 2 days on prednisone and I only used the ointment and hydroxyzine for 2 days.
Abnormal high blood pressure (190/100) the morning following the injection. Addition aspirin was taken to thin my blood and this was successful. The addition aspirin is still required to main normal blood pressure.
PAIN; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced pain, fatigue, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, pain and low grade fever was not reported. This report was non-serious.
Patient seen 08/26/2003 and received injections at about noon.  Mom reported at 22:00 that night after sleeping approximately 1 hour in car seat, patient had jerking of all extremities and staring into space for 10-15 seconds.  She then slept all night.  Patient brought to office for evaluation 08/28/2003.
The same day of having the vaccine, 10/29/2021 at around 6:00pm I started to feel achy all over, headache, tired, cold.   Took a hot shower and went to bed.  I sleep til 8:30.  Got up for about half hour & went back to bed.  Still felt achy, still had a headache, still felt cold.  I got up again about 5:00 and stayed up till I went back to bed about 9:00 pm.  I still was achy, headache, cold & tired.  The following morning, Sunday morning, I did feel better when I woke up.  As of today, November 11, 2021, I have not had any further symptoms.
increased heart rate within an hour of injection; Headache; injection site soreness; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included restless leg syndrome. The patient did not have any allergies to food, medications, or other products. Concomitant medications included pramipexole dihydrochloride monohydrate (MIRAPEX), tramadol hydrochloride (ULTRAM), magnesium (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 09:45, the patient experienced headache for five days and injection site soreness for two days. At 10:30 (reported as within an hour of injection), the patient experienced increased heart rate. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, vaccination site pain and heart rate increased. The clinical outcome of the event vaccination site pain was recovered on 24Mar2021; headache was recovered on 27Mar2021 and that of heart rate increased was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
(R) facial nerve palsy Treatment-Doxycycline 100 mg po bid Prednisone 50 mg po dd x 5 dy 7/19/07-records received-7/6/07 seen in ED. 7/12/07 follow-up visit. Right facial nerve pasy. No headaches, no fever no ear pain. Improved mobility, noticing that she is able to open and close her eye a little bit more, able to close eye 90% of way. . Speech better. No associated weakness. No joint swelling
Arm red area size of a large dollar, swollen, warm, sore and moving into neck area.
Fever to 104 for 48 hours after FluMist. Given antipyretics. Onset of fever 12 hours after vaccine given.
itchy red rash; spots on the arm; varicosity; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy red rash), RASH MACULAR (spots on the arm) and VARICOSE VEIN (varicosity) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Stroke, Atrial fibrillation and Varicose veins of lower extremities (leg has varicosity). Concomitant products included APIXABAN (ELIQUIS) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Atrial fibrillation and Stroke.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced RASH PRURITIC (itchy red rash), RASH MACULAR (spots on the arm) and VARICOSE VEIN (varicosity). The patient was treated with TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy red rash), RASH MACULAR (spots on the arm) and VARICOSE VEIN (varicosity) outcome was unknown.        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.      Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Significant follow up appended
Pt recvd vax 5MAR92 & exp nausea, diarrhea, fatigue, vomiting, abdo cramping;
Nausea- Intense (6 hours); Arm pain- Persistent (3 days); pain began at the injection site and eventually moving towards and stopping at the elbow; pain began at the injection site and eventually moving towards and stopping at the elbow; Movement of the arm was significantly reduced; This is a spontaneous report from a contactable consumer (patient). A 30-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 30-years-old intramuscular, administered in Arm Left on 11Aug2021 11:35 (Batch/Lot Number: EW0196; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history was none.   There were no concomitant medications. On Wednesday, 11Aug2021 at approximately 11:35, the first dose of the COVID19 vaccine was received. Within 15 seconds pain began at the injection site (left arm, upper muscle) and eventually moving towards and stopping at the elbow. The pain observed and continued for three complete days was much like that of a tetanus shot arm pain, however a bit more intense. Movement of the arm was significantly reduced with no movement begin obtained until the morning of day 3 of the arm pain (persistent for 3 days). Additionally, on Wednesday, 11Aug2021 at approximately 19:30, intense nausea occurred. This nausea lasted for approximately six hours until the patient was able to fall asleep. Upon waking, the nausea had dissipated. Nausea and arm pain were considered to cause Persistent / Significant disability / Incapacity. No treatment was received for nausea and arm pain. The patient recovered from arm pain and nausea on an unspecified date in Aug2021; the outcome of Movement of the arm was significantly reduced was unknown while the patient did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
PATIENT WAS GIVEN THE VACCIN AT 3:52 PM PATIENT FELT DIZZY AT 4 PM AND HAD A SEIZURE FOR 30 SECONDS.CALLED PARAMEDICS , SHE, WAS FINE MOM REFUSED TO TRANSPORT TO HOSPITAL. BLOOD PRESURE WAS 110/71, PATIENT LAYED DOWN FOR 10-15 MINUTES THEN SAT FOR ANOTHER 10 MINUTES THEN LEFT AFTER SHE FEELS FINE
Vaccine was diluted incorrectly. Diluted with a 0.2ml instead of 2.2 mls. Patient communicated no signs or symptoms by 5pm