chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hunches over when she walks; migraine, a horrible headache; feels like a weight on her stomach; did not sleep all night because of how bad she feels; urinating but not a lot; feels so nauseous that she cannot eat anything; tired/exhausted; feverish (101°F fever); worse chills ever; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels) and URINE OUTPUT DECREASED (urinating but not a lot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101°F. On 18-Feb-2021, Urine output: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13 JUL 2021 in which Contact information is updated. On 04-Aug-2021: Follow up received included laboratory data was added.
pt recvd vax 5PM 30MAR93 & 10PM had large emesis & became "as white as a ghost" & shook like had been dipped in a tub of ice water; lips were white as was entire body; no temp; not noticeable sz; no limpness; color returned;
This patient presented to the ED on 10/7/2021 which chest pain. She was found on CTA to have a pericardial effusion and subsequent TTE reported "There is small pericardial effusion which is circumferential, more so anterior than posterior. There is organized material along the anterior visceral pericardium." She did not have EKG changes suggestive of pericarditis other than possible PR depression in one lead. Troponins were negative x 4. In retrospect, she said she began to feel chest discomfort about 2 days after vaccination, but she was taking scheduled naproxen at the time for side effects from the vaccine, then her chest discomfort became more noticeable when she stopped taking naproxen, which was the days she came to the ED. Our cardiologists felt that pericarditis was the most likely diagnosis. Given the temporal association with her 3rd dose of the pfizer vaccine, they felt it was possible that this was the trigger. We did not identify evidence for other causes of pericarditis. She was treated with colchicine and ibuprofen with good response.
Pt had received her first vaccine and was in the observation area. She was seen to have slumped in her chair, preceding a syncopal episode. The patient remained in her chair during the episode. Pt informed us after the syncopal episode that she had felt as if she fell asleep. She has no medical history of seizures or syncope in the past. She did have limb movement during the period of syncope. The episode seemed to last no more than 15 seconds. The patient quickly woke and began speaking to us. She was clammy and sweaty, vitals were completely normal as taken by the RNs. She was observed in the private area for > 15 minutes, given drink and crackers, tolerated well. She ambulated well and had her fiancé pick her up.  She will follow up with her PCP this week.   vitals:   BP: 120/80, P 72, O2 98%
She broke out in a rash; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: Unknown), via an unspecified route of administration, on an unknown date, as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced a broke out rash. Caller does not know if the rash is due to covid vaccine. The patient enquired if she could take an antibody test. And also enquired if she should take a second dose after her reaction. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Patient was given 0.3ml of undiluted vaccine.  Patient reported some vomitting but stated that this is normal for him post dialysis.  No other adverse events reported.
Pt presented to Emergency Dept with (L) upper arm posterior swelling, redness, and firmness at the injection site consistent with a cellulitis versus a delayed hypersensitivity reaction. Amoxicillin and prednisone prescribed by ED and pt followed up with PCP.
Breakthrough headaches of hemicrania continua despite successful suppression of headaches with indomethicin.  Hemicrania continua began with headaches after the second dose (2/9/21) at two week intervals.  Starting 4/30/21, headaches remained 24/7, with no interruptions.  Initially diagnosed with chronic migraine but changed to hemicrania continua on 9/1/2021.  Worsening of hemicrania continua from 9:30 pm to 12:00 am on day of booster shot.  Mild headache remains 18 hours after injection.
My period was always regular for the past 10+years, 30 days term with 6 days length. After the first injection, I immediately felt the difference, period gap changed from 30 to 25 days with cramping. And it lasted for the past several months
Elevated temperature (99.5 degrees for 24 hours), chills, sore muscles, 5-inch rash and swelling on upper arm around injection site,
The day after receiving second shot of Moderna  vaccine I  felt very  weak,  had chills and felt generally malaise.  On the next day I felt much better with some very less side effects.  I only had a slightly sore arm sore arm, which  didn't bother me.  The first shot  gave me no side effects.
SHE STARTED FEELING HOT.  THEN SHE BEGAN ACHING ALL OVER AND RUNNING A TEMPERATURE OF 102.  THIS LASTED 2 DAYS THEN SUBSIDED.  APPROXIMATELY, 2 WEEKS LATER ON 09/22/2010 SHE NOTICED A PROBLEM WITH HER HEARING.  ON 09/25/2010, WHEN SHE WOKE UP SHE COULD NOT HEAR AT ALL IN HER LEFT EAR.  SHE WENT TO THE EMERGENCY ROOM AND THE DOCTOR WHO SAW HER THERE COULD NOT FIND ANYTHING SO HE REFERRED HER TO AN OTOLOGIST.
The patient received her first booster following an initial double dose without complaint nine months before.  She developed extreme abdominal pain in the days immediately following the booster injection.  This was diagnosed the next month as occult source malignant lymphoma with accompanying lower abdominal tumors, some or all of which presumably were already present before the booster injection.  Chemotherapy was begun but failed to arrest the spread and growth of tumors and resultant kidney failure.  Leukocyte count remained unproblematic.  The patient passed away 3 months after the booster injection.  Other than proximity in time, the relationship, if any, of her adverse event with the booster or the earlier injections is unclear.
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  On 21-Sep-2021 vaccine was placed for refrigeration. There was no temperature excursion and the patient did not experience any adverse event.
Rash, pustular (3-5 noted at injection site), 3 days after. No pain in arm, By 1/1/05 opened and drained, drained again Saturday 01/08/05. Cleaned with alcohol, soap and H20, denies arm feeling bad, seen by MD, 1/10/05, no treatment, released.
Systemic musculoskeletal pain in muscles and joints with mild headache and moderate fatigue.
Upper arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper arm was sore). On 23-Feb-2021, PAIN IN EXTREMITY (Upper arm was sore) had resolved.            No concomitant medicine reported. Treatment medication was not reported.
TINITUS Buzzing in both ears low but constant 24/7 since noticed 2 days after sencond shot
3" x 3" raised, red, whelp.  Site reaction where it was painful and swollen. Her physician examed the patient and determined it was not allergic in nature, but was an irritation due to the drug being deposited in that area, or a possible antibody reaction.
29OCT91 c/o pain in upper rt arm lt arm chest, neck & top of head 1 day p/recvd vax; also c/o unable to sleep due to pain w/no relief w/OTC meds; no appetite x 3-4 days;
soreness & swelling @ inject site @ 10PM on 13MAY93; 14MAY93 8PM inc swelling, pain, stiffness of lt elbow noted; 15MAY93 redness 11cm by 7cm below inject site & hot to touch;
Patient was diagnosed bronchitis and given antibiotics by her primary and pulmonologist as an outpatient. She was tested positive for COVID on 7/23/21, and she received Regeneron on 7/29/21. She came to ED with worsening shortness of breath with low grade fever on 7/31/21 and was hospitalized for further management.  8/10/2021: patient transferred to another hospital 8/12/2021: patient still admitted at the time of this report submission Note: patient completed Pfizer vaccines (02/13/21 and 03/06/21).
CHILLS Narrative:  THIS IS A 65 YEAR OLD WITH SLIGHT CHILLS AFTER RECEIVING HIS FIRST COVID 19 PFIZER VACCINE ON 1/29/2021. REACTION WAS SELF-LIMITING.
Fever, chills, nausea, fatigue, blinding headache, body aches. Took 2 ibuprophin because the headache was unbearable.
Patient filled out a Pfizer consent form and I pulled and gave a Pfizer vaccine to the patient and then realized that his first dose was Moderna and he should have gotten Moderna the second time as well. My manager came in and spoke with the patient letting him know what had happened and the patient sat with us for 15 mins without complications and then left.
Numbness and tingling on the left side of my body from my left arm to my left foot on both injections. On the second injection palpitations.
Pt. received PNEUMOVAX on 12-28. On 12-29 had temp of 100, sore arm and achy all over. 12-30 saw provider. Large area redness at inj. site and temp of 103 on 12-29.
I got my 1st Moderna Covid Vaccine shot on 3/6/21. I started to notice my tinnitus more than usual. I got my 2nd Moderna Vaccine shot on 4/5/21. Then on April 9th around 4AM it's like someone turned my tinnitus up. It got significantly louder out of the blue. Was harder to sleep. I still hear it now while I am awake which I usually don't notice it. I also feel slightly dizzy as I walk around the house.
Lightheadedness, tingling of lips, tongue, dry mouth, felt like throat was swollen.
cannot eat; tired; nausea; severe headache; total body aches; shortness of breath; severe pain in lower abdomen; severe chills; sweating; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 18May2021 at 14:30 (at the age of 63 years old) as single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had been tested for COVID-19. On 08Apr2021, the patient underwent SARS COV2 by PCR (nasal swab) test and the result was negative. On the same day, the patient underwent SARS-COV-2 by RAPID ANTIGEN (nasal swab) test and the result was negative. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 27Apr2021 at 14:30 (at the age of 62 years old) as single dose for COVID-19 immunisation. On 18May2021 at 14:45, within 20 minutes of vaccination, the patient experienced severe pain in lower abdomen. On the same day, in the night, the patient experienced severe chills and sweating. On 19May2021, the patient was tired, had nausea, severe headache, total body aches and shortness of breath. The patient stated she almost went to emergency room (ER) and patient had to sit upright all night. On 20 May2021, the patient finally got out of bed, but cannot eat and only drank ice water. The events were present event at the time of report and the patient missed work for 4 days and was sure even the next day of report she will not be able to work. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe pain in lower abdomen, severe chills, sweating, tired, nausea, severe headache, total body aches, shortness of breath and cannot eat were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patient. The physician on the line reporting the patient received SHINGRIX two weeks ago was still complaining of diffuse myalgia and pain. While reporting on patient the reporter heard of this for 24 to 48 hours but not two weeks. The reporter declined to provide further details regarding other patients. This case has been linked with the case US2019037720, reported by the same reporter. The age group was not reported, but was selected adult as per vaccine indication' in additional narrative.
local expanding erythema migrating dependently from injection site.  no fever dyspnea or generalized rash.
24 hours, post vax, pt had firm and red area noted. 48 hours, post vax, pt had swollen, red upper thigh with nodule noted.
No additional AE reported; Pharmacist reports administration of MMR II on 01FEB2023 via the intramuscular route instead of the subcutaneous route; This spontaneous report has been received from a pharmacist, concerning a male patient of unknown age.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 01-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, dose frequency: 1, administered via the intramuscular route instead of the subcutaneous route as prophylaxis (exact dose, lot number, and expiration date were not provided) (Incorrect route of product administration).  No additional information provided. No additional adverse event (AE) was reported.
This case was reported by a physician and described the occurrence of blood in stools in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ROTARIX (unknown). On 31 July 2011, 4 days after vaccination with ROTARIX, the subject experienced blood in stools. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Patient received her first Pfizer Covid vaccine on 10/28. A few hours after the vaccine, she had a sharp pain in her abdomen to chest. She reports that everyday since the vaccine, she had intermittent CP, SOB and DOE. On 11/8 CP became more frequent and intense. Patient took ibuprofen for pain management. On 11/8, she consulted PCP, CRNP and was referred to cardiology. On 11/11 she was evaluated by Cardiologist. Abnormal EKG results: Sinus Tachycardia, RSR(V1), Right atrial enlargement, Nonspecific ST depression. CRP, ESR and Troponin were wnl. ECHO done on 11/12 with abnormal results showing: Evidence of pericardial thickening and trivial circumferential pericardial effusion. She was started on colchicine and prn ibuprofen, cardiac MRI pending (11/15) r/o chronic pericarditis. She has pmh of pericarditis and was advised
Hot arm; Itchy arm; Arm swelling, huge like grapefruit; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included COPD. Concomitant products included BUDESONIDE and IBUPROFEN for an unknown indication.   On 04-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 April 2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm) had not resolved.
Information has been received from a nurse practitioner (N.P.) concerning a male who on an unspecified date was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). The N.P. reported that the patient developed shingles after he had been given ZOSTAVAX (Merck). The outcome was unknown. Unspecified medical attention was sought. Follow-up information was received from the nurse practitioner (N.P.) concerning the 79 year old male with hypertension, benign prostatic hyperplasia and aortic stenosis who on 29-NOV-2007 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 658839/1411U). Concomitant therapy included NORVASC, AVALIDE and NIASPAN. On 13-APR-2009 the patient developed vesicular rash at T5 right dermatome with 2 lesions on back and 1 lesion under right breast. The rash was resolving but the patient was experiencing post herpetic neuralgia which was rated 3/4/10. The patient was treated with gabapentin. Additional information has been requested.
Broke out in hives on arms and neck about 18 hours after vaccine.  Hives were resolved within 24 hours
mild hives, nightmarish hives over my entire body, They were painful and itchy; I had soreness at the injection site; muscle aches in both arms; redness; stiffness in my neck; pain in my neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy) and INJECTION SITE PAIN (I had soreness at the injection site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms). On 16-Apr-2021, the patient experienced URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy). At the time of the report, ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided Treatment medications Benadryl
HA; Chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "HA"; CHILLS (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "muscle aches". Therapeutic measures were taken as a result of headache.  Additional information: The reporter in good health experienced mild adverse effects after receiving Covid booster shot 2. Adverse effects started several hours after immunization and resolved late morning the next day. The reporter did not receive chronic medications. The reporter took ibuprofen for HA with good effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.