chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp pains in lower back; Almost falling asleep in the afternoons; Sick feeling in the morning; Muscle pain; Fatigue/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014S21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAMADOL HYDROCHLORIDE (TAMADOL) for Increased intraocular pressure.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Feeling sick, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired) outcome was unknown.            This case was linked to MOD-2021-325386 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low WBC" (unspecified if ongoing), notes: other medical history: Low WBC. Concomitant medication(s) included: OMEPRAZOLE; EZETIMIBE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Negative covid test after 10 days from first test; Positive, notes: COVID Rebound after 15 days; Unknown results, notes: Negative covid test after 10 days from first test COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201001918 Same patient, different product and event;
I did not have an adverse reaction to the vaccine. I have a pre-existing condition called diverticulosis that was diagnosed with a colonoscopy in 2019. I normally did not have complications or pain, but I had a flare up after the vaccine and saw my doctor. My doctor recommended a change in my diet to avoid having a flare up.
Pain in arm where I can't raise the arm. Cold shivers even while under 2 blankets. Exhaustion - slept all afternoon on 12/15/18. Took ibuprofen on 12/14 and 12/1518.
Patient developed hot flashes (body and face getting warm) 60 minutes after receiving vaccination. Patient claimed she was feeling very hot no sign of itching or respiratory depression. Had patient under observation for 30 minutes while she cooled down with ice and water. Patient was also given 2 doses of Benadryl 25mg. Patient cooled down and went back to work after feeling better. However, we checked on patient again after a few hours to make sure she was ok. She was getting another episode of hot flash about 3:30 hours after first episode. Patient was given 1 more dose of Bendaryl. Checked patient BP systolic was slightly elevated (140s/70s)and HR was 101. Patient called husband to pick her up to go to PCP for monitoring. Patient claimed she only had a sore arm during her first COVID vaccine.
He has a confluent area of erythema measuring 11 x 12 centimeters.  Skin is intact and warm to touch.
Immediately - dizziness, heart racing, difficulty breathing, lightheadedness, pain in arm, slight trembling, moderate chest pain.   20 minutes afterward - confusion, delusions, trembling, chills, uncontrolled teeth chattering, tensed muscles, uneven gait, arm pain slowed body mechanics. Persistent day of to 3 days after - low grade fever 101.3F, chills, excessive thirst, stiff joints, loss of range of mobility in finger movements, enduring  arm pain, exhaustion, fatigue, muscle aches, photophobia, headaches, swollen glands, red mark on arm lasted for days. Longer range changes - persistent chills and fatigue. Menstrual cycle disrupted. Menstrual-like bleeding  but 2 weeks early.  Still bleeding.
I woke up to severe pain in my left arm, I felt very ill and very cold. I checked my temperature and it read 100.9. I took my medications which included 1 Lortab 7.5 mg. 1 ibuprofen 800 mg. and 1 OxyContin 20 mg. After a couple of hours my fever started to spike and it went up to 102.9, my fevers continued fluctuating between 102.9 to 100.9 and back up. I took my pain medication as directed along with my ibuprofen but that did not even touch the pain even taking an extra Lortab still it did nothing to alleviate the excruciating pain in my arm. I continued to have fevers and severe excruciating pain in my left arm (where the shots were given), on through until this morning at which time, (so far anyway), I have not yet ran a fever but my arm is still sore  with a blistered type of look, red and swollen. I want to say though that looking at my arm today the redness is worse than in the beginning.
1/21/21 Midnight  102.3 fever, fatigue, body aches, chills, diarrhea   1/22-1/23/21 Intermittent fever 101, body joint aches, headache 1/24 fever 99.9, fatigue, joint/body aches,headache,  1/25 fatigue
Complained of pressure in chest, was anxious prior to vaccination. VS 154/100, HR 138. Asked to remove mask and took slow deep breaths, no improvement. 141/100 HR 103, complained of tongue feeling thick, speech impacted.  Transfer to ED via stretcher
Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient date of birth and exact administration date not available at time of reporting. The patient received dose one of Shingrix approximately 2 months ago and felt bad afterwards. The patient declined the second dose. The specialist attempted to further clarify felt bad, and pharmacist stated it was just the normal injection reaction, nothing unusual. The reporter consent to follow up, but stated she does not want to be on any GlaxoSmithKline mailing lists.
trouble walking; knees are stiff; arthritis "all of a sudden; fingers feel a little stiff; the aches affect the walking; pain in the arm of the injection; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (trouble walking), MUSCULOSKELETAL STIFFNESS (knees are stiff), ARTHRITIS (arthritis "all of a sudden), MUSCULOSKELETAL STIFFNESS (fingers feel a little stiff) and VACCINATION SITE PAIN (pain in the arm of the injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The medical history was not provided by the reporter.     On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection) and NAUSEA (Nausea). On 05-Apr-2021, the patient experienced GAIT DISTURBANCE (trouble walking), MUSCULOSKELETAL STIFFNESS (knees are stiff), ARTHRITIS (arthritis "all of a sudden), MUSCULOSKELETAL STIFFNESS (fingers feel a little stiff) and MYALGIA (the aches affect the walking). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 29-Mar-2021, VACCINATION SITE PAIN (pain in the arm of the injection) and NAUSEA (Nausea) had resolved. At the time of the report, GAIT DISTURBANCE (trouble walking), MUSCULOSKELETAL STIFFNESS (knees are stiff), ARTHRITIS (arthritis "all of a sudden), MUSCULOSKELETAL STIFFNESS (fingers feel a little stiff) and MYALGIA (the aches affect the walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data include an X-RAY and it looks like patient has arthritis Concomitant medications include Blood pressure medications Treatment include ice/heat on the knees.
Vaccine received on 3-8-13. Pt noticed pain and knot in arm on 9th. Fever up to 100.8. Knot increased in size on 10th to size of fist, red, hot to touch. Pt states TYLENOL brought temp down to 100.2. Instructed pt to f/u with PCP or go to ER with any s/sx SOB or trouble breathing.
Patient developed red, raised, warm, tender to touch area on her right inner arm near arm pit area. This is the same arm PNEUMOVAX was given she took 1 tab of BENADRYL on night of Oct 12th.
Information has been received from an office nurse concerning a female patient who on an unknown date was vaccinated with GARDASIL (lot number, route and site not reported). One or two years later after receiving GARDASIL, the patient developed Papilloma viral infection (HPV). The nurse did not specify how many doses of GARDASIL were given. It was unknown if the patient sought medical attention. Additional information has been requested.
moderate pain at injection site rt arm.  lots of body/ joint pain. chills. headache.  no fever . lasting 24 hrs
Pt did not feel well 6/20/19. On 6/21/19 had swelling & Rash on (R) side only of Face, Eye, neck & chest
IgG test came back negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (IgG test came back negative) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (IgG test came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (IgG test came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Antibody test: negative (Negative) IgG test came back negative.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information was received on 16-Jun-2021: contains no new information.
Pt experienced light headedness, jittery, nausea and loss of appetite. Treated with  Zyrtex, Pepcid and Prevacid.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of an unknown age with no pertinent medical history, concurrent conditions, and drug reactions or allergies. As concomitant therapies, the patient was taking CYMBALTA, WELLBUTRIN, and AMBIEN. Approximately in 14-DEC-2016 reported as "on an unspecified date in December 2016", the patient was vaccinated with a dose of ZOSTAVAX dose and frequency reported as "one dose / once", route reported as "injection" (strength, anatomical location, lot number, and expiration date were not provided), to prevent shingles. Subsequently, about a week later on 21-DEC-2016, the patient experienced a rash on her back. It was reported that the patient sought medical attention but it was unspecified, and as a result she was placed on treatment with VALTREX, and consequently, on an unknown date, the rash resolved. It was unknown if laboratory diagnostic studies were performed. The causal relationship between the therapy with ZOSTAVAX and the event of rash was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013227.
01/17/23 presents to ED for "fatigue, hypertension, shortness of breath". PMHx of "HTN/HLP, CKF stage IV, current tobacco use/abuse"
no additional AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 7 pounds.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis.   The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004:
9/29/07 fever of 103, Sunday rash started on nose and cheeks then moved to chest and stomach then 10/1/07 rash moved to legs - acted irritated - crying/fussy and decreased appetite.
Debilitating headache, systemic pain (joints, muscular, esp. neck), lower-back/lower-side pain for three (3) days after receiving vaccine; persisting significant lower-back/lower-side pain remains eight (8) days after receiving vaccine..  Note: Patient did not contract chickenpox until the age of twenty-six (26) years old.  Patient reports that his reaction to the chickenpox infection at that time as having been  "extreme" (inability to move due to pain, trouble breathing, high fever), with symptoms lasting seven days.
exposed by virus (non COVID) after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (exposed by virus (non COVID) after first shot) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (exposed by virus (non COVID) after first shot). At the time of the report, VIRAL INFECTION (exposed by virus (non COVID) after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported No treatment medications was reported No concomitant medications was reported
Developed (R) deltoid/shoulder pain and also neck pain within 1 day of receiving INFLUENZA vaccination.
Cellulitis; arm swollen; Redness in the Injection site; Swelling in the Injection site; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA201A, expiry date 30th October 2020), (batch number AMVA206A, expiry date 13th November 2020) and (batch number AMVA323A, expiry date 31st March 2020) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Menveo. In August 2020, less than a day after receiving Menveo, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema and injection site swelling. On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: It was reported that, several patients had been experiencing redness and swelling in the injection site, whole arm swollen and cellulitis after receiving a dose of Menveo.  The symptoms were started within hours. The reporter was consented to follow up. The reporter did not know how many patients experienced the symptoms but agreed to follow up and look up the information.  The reporter only reported that one patient was 11 years old and other was 16 years old.  She reported 3 different lot numbers and expiration dates for the vaccines administered to different patients.  She had those details in hand because she was worried that the side effects were due to a lot issue. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159654:same reporter US-GLAXOSMITHKLINE-US2020AMR160036:same reporter
Left arm, swelling/reddish and hot/sweating/nauseous. Pneumococcal polysaccharide vaccine.
BP 255/105 / BP 212/84; SHAKING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 105 pounds, and height was not reported. The patient's concurrent conditions included blood pressure disorder, and other pre-existing medical conditions included patient is on medication for bp .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced bp 255/105 / bp 212/84. On 20-MAR-2021, the subject experienced shaking. Laboratory data included: Blood pressure (NR: not provided) 255/105 mmHg, 212/84 mmHg. Husband calls to report wife's BP read 255/105 about 12 hours after receiving the Janssen COVID-19 vaccine. Also reports shaking. Wife reports that she was missed a dose of BP medicine but did take it at 9:30 or 10 pm PST. Had since decreased to 212/84. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bp 255/105 / bp 212/84, and shaking on 20-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340054-COVID-19 VACCINE AD26.COV2.S -BP 255/105, BP 212/84. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning a 22 year old female who on 21-JUN-2007 was vaccinated with Gardasil (lot # not reported) 0.5 ml injection. There was no concomitant medication. On 21-JUN- 2007, the patient experienced severe dizziness, nausea, vomiting which resulted in a migraine. Medical attention was sought. The experience lasted approximately 12 hours. On 22-JUN-2007, the patient recovered. No additional information is expected.
Arm is still swollen; Arm  is still very red; A spontaneous report was received from a non-health professional concerning a consumer of unknown age and gender, who received Moderna's COVID-19 vaccine and developed an arm that was swollen and red.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     On 22 Dec 2020, after receiving the mRNA-1273 vaccination, the patient's arm began to swell and red. The patient reported, on 31 Dec 2020, the arm was still swollen and very red. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, arm that was swollen and red, were considered not recovered.  The reporter's assessment of causality for the events was not provided.; 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. Further information has been requested.
Patients right arm swelled markedly, edema from shoulder down to forearm. It was not red and not painful to the touch but injection site was painful.
Left arm sore/like a muscle contraction; This booster dose was actually his fourth dose/Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm sore/like a muscle contraction) and EXTRA DOSE ADMINISTERED (This booster dose was actually his fourth dose/Extra dose administered) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nauseated, Dizziness and Muscle pain.    On 13-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Jan-2022, the patient experienced EXTRA DOSE ADMINISTERED (This booster dose was actually his fourth dose/Extra dose administered). On 14-Jan-2022, the patient experienced VACCINATION SITE PAIN (Left arm sore/like a muscle contraction). On 13-Jan-2022, EXTRA DOSE ADMINISTERED (This booster dose was actually his fourth dose/Extra dose administered) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm sore/like a muscle contraction) outcome was unknown.            No concomitant medications were provided.  The reporter stated that the vaccination site thought he was receiving his 3rd shot (booster dose) because the vaccination card the he gave to the facility did not show that he had already received a 3rd full dose on 16 August 2021. Therefore, that booster dose was actually his fourth dose.  While receiving the booster dose the reporter reported that when the vaccinator pulled out the syringe, he felt leakage as liquid rolled down his left arm. The reporter asked the vaccinator what the liquid was and he was told it was rubbing alcohol coming out.  The reporter stated at his age, he considers himself immunocompromised although he reported he has not been classified as being immunocompromised by his doctor.  No treatment medications were provided.   This case was linked to MOD-2022-455602, MOD-2022-455587 (Patient Link).   Reporter did not allow further contact