chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue, Mild Grade Fever, Muscle Soreness, Severe Headache  Fatigue started at 7am on 2/10/21  Muscle soreness started at 9am on 2/10/21 Fever and headache started at 2pm on 2/10/21 Nausea started at 9pm on 2/10/21  All symptoms except the headache resolved on 2/11/21 at 7am
Sensorineural sudden hearing loss.  Treated with Prednisone for 10 days.  Hearing returned to normal.  Physician will monitor in 3 months.
This spontaneous report was received from a medical assistant referring to a 71-year-old female patient. The patient's pertinent medical history and concomitant therapies were unknown by reporter. Concurrent condition was allergy to codeine sulfate. On 01-MAR-2019 the patient was vaccinated with a dose PNEUMOVAX 23 lot # R007721, expiration date 01-MAR-2020 (strength, dose, route and frequency were not reported), for prophylaxis. After the vaccination the patient experienced "cellulitis in her left deltoid" and went to emergency room for an evaluation but was not admitted to the hospital on the same day. The outcome of "cellulitis in her left deltoid" was unknown. Causality was not provided. Upon internal review, cellulitis in her left deltoid was determined to be medically significant.
Information has been received from the patient's wife, referring to her husband, a 79 years old patient of unknown gender with congestive heart failure. Information about medical history and concomitant therapy was unknown. On 11-DEC-2014, the patient was vaccinated with PNEUMOVAX 23 (1 injection (1 dosage form), route reported as injection; strength, frequency, lot# and expiration date were unknown) for prophylaxis (Product use in unapproved population). On 26-OCT-2017, the patient was vaccinated with PREVNAR 13 for prophylaxis.
4 1/2 hours following immunizations, mom reports increased redness/swelling of (L) thigh (upper). 20 minutes later, pt with short/shallow respirations an apneic periods, per mom lasting 5-6 seconds. Parents took patient to medical center ER for evaluation. 1 hour after symptoms presented symptoms resolved, not requiring medical intervention.
About 2 hours after receiving Hepatitis B vaccine in the right arm, the patient experienced tingling fingers and edema.
right cheek swollen from her nose to the end of the jaw bone; it was tender to the touch; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement in August 2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 4) on 24-May-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 5) on 14-Nov-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 25-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 28-May-2023, the patient experienced SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch). At the time of the report, SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to MOD-2023-726955 (Patient Link).
The patient developed a rash below the injection site several days after administration which continued to get larger.  After 4 days the patient presented to her primary care physician with a 2 inch diameter discoid rash that was warm to the touch.  The patient was subsequently started on a course of Antibiotics (Augmentin 875mg) twice a day for 7  days.
After getting the vaccines on 3/2/2014 12:00 pm, the left arm area of injection varicella site swollen redness, lump and warm to touch difficult to lift arm feels heavy and sore, joints ache, generalized itchiness, stiff neck, exhausted all the time, just wants to sleep. Per provider recipient monitor left arm site and if worsening of symptoms to return to clinic.
Bronco spasm, cough, throat swelling, inability to speak-treated with solumedrol,epinephrine,Benadryl, Pepcid, resp neb(pulmocor and Duoneb),
Patient had a big bruise on her left arm covering about half the length of the upper arm. It looked to be more on the front side of the bicep and with the edge of the bruise being by the injection site. She came in to the pharmacy on 10/5 wanted me to take a look at it.
Pt received Covid #1 at out of office vaccine clinic on 5/27/21. Seen at ER 5/30/21 for behavior change (decreased level of responsiveness, staring off into space, vomiting & nausea, hyperventilation, anxiety Please see enclosed ER note. Spoke with Mom on 6/1/21 is improved History of Present Illness HPI Narrative: 14-year-old boy with history of autism presents with behavior changes, nausea, vomiting.  Patient and his mother provide the history.  He was in his usual state of health last night, had a normal dinner.  Did not answer his door this morning.  Parents found him staring off into space with decreased level of responsiveness.  He was able to drink fluids.  Patient reported having a few episodes of vomiting and abdominal pain earlier.  They were concerned that he could be having a reaction to his COVID-19 vaccine which was given 4 days ago.  Mom gave 25 mg of Benadryl at home.  They were driving to Hospital for evaluation when the patient started looking worse.  He has been hyperventilating but also has now clenching of hands and reports that his feet feel funny.  Mom reports that he is not at his behavioral baseline currently.  No prior abdominal surgeries or additional issues.  Not currently take any medications.  Patient denies taking any Illicit medications/substances.
Itching arm; Swollen down to elbow; Arm sensitive to touch; Red down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow). At the time of the report, PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Myalgia, Arthralgia, Fever, fever, sore throat, fatigue, body aches Narrative:
POSSIBLE REACTION; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (POSSIBLE REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (POSSIBLE REACTION). At the time of the report, ADVERSE EVENT (POSSIBLE REACTION) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Tasted the medication, felt flushed, heart racing, BP 166/118 P 125 PO2 100% Repeat BP 150/106 P90's Rapid response RN here BP 159/89 P 89
Facial rash with swelling, opposite arm of vaccine rash.  worsened for a week, then resolved.  Patient took diphenhydramine and loratadine
Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  It was reported that the two vials were initially stored in the refrigerator on 24-Mar-2022. The vaccine were administered (1 or 2 doses) 02-Apr-2022 and (3 doses of 0.25 mL) on 03-Apr-2022. It was also reported that vial did not undergo any temperature excursions it was kept in freezer up until 24-Mar-2022. Estimated total doses were 5 and all doses administered intramuscularly and were booster doses of 0.25 mL.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up received included. Suspect vaccine information and event onset date were added. Updated narrative.
This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus (second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin) and AMENORRHOEA (Lost of menstruation cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety). On 26-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety) outcome was unknown.            Treatment drugs included steroids for symptoms after second dose. Patient has an appointment scheduled on 04-AUG-2021.   This case was linked to MOD-2021-275318 (Patient Link).
Having memory issues after taking the Pfizer vaccination; Or if the vaccination may have triggered something in his brain to react like Dementia; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 21Jan2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer wanted to confirm, could the Pfizer vaccination cause some memory loss, her husband (patient) was having memory issues after taking the Pfizer vaccination and she was wondering if that was a possible rare side effect that may get better with time or if the vaccination may have triggered something in his brain to react like Dementia. The patient further stated that in early March the patient started having memory problems and was admitted to the hospital and he received both, the different blood test and urine test and brain scan and so far, he was being diagnosed with probable dementia. The patient was a 58 years old male and all this happened in early March after receiving the first two dose of the vaccine in January and February. The patient underwent lab tests and procedures which included blood test, scan brain and urine analysis, all unknown results on an unknown date in Mar2021. The clinical outcome for events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I did not have an adverse reaction to the vaccine. I have a history of atrial fibrillation, but I was having trouble in 10/2022. I was having trouble with shortness of breath and went to the emergency room. I was diagnosed with pneumonia on 10/08/2022. I am scheduled for an atrial ablation on 03/15/2023.
Thursday 4/8: 3:20pm: COVID injection given in right arm  Friday 4/9: ~1:00 am: woke up shaking with chills and severely cold; had slight headache. Had insomnia all night.   6:00 am: woke up with bad headache, slight fever.   7:00 am: got out of bed and had vertigo and was running into walls trying to walk to my living room, along with the worst migraine I?ve ever had. Also had dizziness, nausea,  chills, 100+degree fever, aches, skin sensitive to touch, and severe tinnitus. All of the veins were visibly popping out of my head.   As the day went on, everything got worse. Any time I moved, my head would throb so bad that I thought I was going to have to go to the hospital.   3:45 pm:  the headache started to finally go away. It would only hurt if I moved fast. At this point my fever was only slightly high, about 99 degrees. I was still unstable when I walked and dizzy. I went from being super cold, to being super hot and sweaty. And I was alternating between cold & hot and sweaty for the rest of the night. Was also having some memory issues, repeating things when I was having a conversation with someone over the phone.   I was sweating all night when I was sleeping.   Saturday 4/10: 7:00am: woke up with a slight headache; still out of it and dizzy.   8:00am: after being awake for about an hour or so, I looked in the mirror and my whole face (around the lips, cheeks, and jawline, and under the eyes) was really swollen and puffy. My face was even mis-colored. Under my eyes was purple and yellow, and my cheeks were white.   Some confusion persisted throughout the day as well as dizziness.
Got sick; getting chills; tired; she felt like she had the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4528946.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Worsening menstrual cramps" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "Allergies" (ongoing); "Forgetfulness" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick"; CHILLS (non-serious), outcome "unknown", described as "getting chills"; FATIGUE (non-serious), outcome "unknown", described as "tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she felt like she had the flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
C/o tingling in abd (unilateral area) lightheaded and hernia. Rit to mom head but knees 60--- rash to had P 60 RPR--- resp CTA- unresolved- s1 flushed facial.  recovered in 6  mins.
27JUN95 started w/loose stools; 3JUL95 had a grand mal sz; 4JUL95 vomiting, diarrhea, unconsolable crying; malaise 7KUL95 rash covering body;
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). In 2021, PYREXIA (Fever) had resolved.      It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of Pyrexia was not provided with HUMIRA.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
arm was really sore; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media.  This case involved an adult patient of an unknown age and gender who experienced arm was really sore (Limb discomfort), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported Just got the flu shot ist day may arm was really sore, but that was the only symptom (Limb discomfort).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Shingrix (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 29th June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema, injection site pain, neck pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, neck pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, neck pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The healthcare professional stated that the patient received their 1st dose of Shingrix 2 months ago, presented on the day of reporting for dose 2. The patient developed an injection site reaction quickly after the dose of Shingrix. The patient was unsure how long after exactly he experienced events. The healthcare professional stated that the patient reported the injection site soreness spread to the patients neck and lasted for about 2 weeks.
Awoke with flu-like feeling, body aches, headache, few scattered small round hives on the elbow/wrist and around waist.