chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; fatigue; muscle pain; It's sort of having COVID again; sore arm - right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - right arm), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 70-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.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Arthritis rheumatoid.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache). On 18-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (muscle pain) and COVID-19 (It's sort of having COVID again). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Mar-2021, HEADACHE (headache), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (muscle pain) and COVID-19 (It's sort of having COVID again) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm - right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used ibuprofen as treatment medication.  No concomitant medications were reported.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced sinus infections, ear infection, pneumococcal titers were low and unspecified illnesses. The patient received a dose on an unspecified date. On an unspecified date, the patient experienced sinus infections, ear infection, pneumococcal titers were low and unspecified illnesses. The reporter commented that the events occurred over the past 2 years, with an unknown number of children of various ages, genders and race. The patient's were treated with antibiotics. It was unknown if subsequent doses of PREVNAR were administered. The outcome of the events was not reported. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
RASH ON SHOULDER; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Shingrix was interrupted. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient was around 55 years old. After receiving dose of Shingrix, the patient experienced rash on shoulder. The patient did not want to take 2nd dose of Shingrix. The reporter consent to follow up.
Mom noticed redness/rash on left thigh one day after vaccines were administered. Treated with Benadryl/ibuprofen.
Mild Hives on left side of torso: 1 A.M. 10/27/02 Mild Hives on right side of torso and inside  upper arm:10:00 A.M. 10/27/02
Allergic reaction to Tdap. On Sept. 15th, & 16th, on back left arm shoulder to almost the elbow. Swelling, itching & burning & a lot of pain. On the 17th, three huge red splotches, shoulder to elbow. Looked like a scalding from boiled water, or a radiation burn. Visit with Dr. on 20th. Given Benadryl & Desoximetasone cream.
feeling achy; feverish; fatigued; headache; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-032321), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of pain (feeling achy), pyrexia (feverish), fatigue (fatigued) and headache in female patient of an unknown age who received apixaban (Eliquis) tablet for cerebrovascular accident prophylaxis. co-suspect products included Covid-19 Vaccine for COVID-19 immunisation. In March 2021, the patient started Eliquis (oral), 5 milligram twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). Further treatment periods at the same dose started on 26-Mar-2021. On 27-Mar-2021, the patient experienced pain (feeling achy), pyrexia (feverish), fatigue (fatigued) and headache. The action taken with Eliquis(oral) was unknown. At the time of the report, pain, pyrexia, fatigue and headache outcome was unknown. For Eliquis(oral), the reporter considered pain, pyrexia, fatigue and headache to be not related.
Approximately 30 minutes after dose, left side of jaw along jaw bone became gradually but increasingly numb, slowly expanded upward from jaw bone for approximately 1/2 to 1 inch followed by itchy left cheek; decreased after approximately 10 to 12 minutes and disappeared none
peripheral neuropathy, could not walk, feet hurt a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and GABAPENTIN ongoing since an unknown date at a dose of 300 mg three times a day. At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient said that she still cannot walk as much as she used to and is still having some troubles. Patient's neurologist recommended for her to increase her Gabapentin 300mg from 2 tablets to 3 tablets.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
pt recv vax & c/o numbness, swelling, stiffness, discoloration of lt lower arm & hand;taken to MD;pulses were present;
This spontaneous report as received from a nurse refers to a patient of unknown age. On 04-AUG-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J000443, expiration date 11-APR-2014, dose, route, frequency and strength were unknown). No adverse effects were reported. The outcome of the events was unknown.  Additional information has been requested.
5/2/15 @ 10:00 PM Severe pain in deep muscle of right arm. Swelling noted at injection site. Could not lift hand due to pain in upper arm at vaccine administation site.  Onset of high fever 102.0 F.  Inablility to concentrate, body weakness and fever continued into 5/3/15.  Unable to sleep through the night.  5/4/15 fever 100.oF.  Less pain in arm.  5/5/15 Fever on and off, body weakness and "woozy" feeling.
This spontaneous report as received from a nurse refers to a 7 months 24 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Received only the diluent CWY of the vaccine; Received only the diluent CWY of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA677A, expiry date 31st March 2024) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: The patient received a partial dose of Menveo as patient received only the diluent CWY of the vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the diluent CWY of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
I experienced the same oculo respiratory syndrome symptoms reported with the 2003 and 2209-2010 influenza vaccine. I received the Fluzone HD (65+) PFS 2019-2020 0.5ml on January 13,2020 at 6:00 pm and by 9:00 pm was experiencing continuous coughing, sore throat, hoarseness, and chest pressure which continued throughout the night. Most of the respiratory symptoms resolved by morning. In addition, my eyes began to itch and tear and throughout the night there was enough mucus discharge to glue my eyes shut. My eyes were also slightly swollen and very red consistent with conjunctivitis. My doctor prescribed antibiotic eye drops to resolve this condition. These symptoms are consistent with the findings in this study: https://clinicaltrials.gov/ct2/show/NCT01247415
This spontaneous report was received from a healthcare worker referring to a 5 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
10/24/09 Itching started on calf area bilateral. 10/25/09 Calves covered in welts/hives in AM. By that evening, entire lower half of body covered in hives. From lower abd/lower back down to calves.
Second Dose Side Effects A fast heartbeat Dizziness and weakness Fatigue/tiredness Headache Muscle & Joint pain Chills Fever Nausea Vomitting Diarrhea Abdominal pain Lost OVER 20 lbs from starvation, inability to eat for 5 weeks, this skyrocketed ALT and AST.
My scalp was itchy and I found 2 bald patches on my scalp which was later diagnosed as Alopecia Areata by my dermatologist, the following week. The patches got larger and I am still losing hair after cortisol injections as a treatment 2 weeks ago.
1JUN93 temp 104 @ 3PM, 9PM treated w/ APAP; vomiting started @ 3AM on 2JUN93 cont w/fever 100-104 until 6JUn still cont w/diarrhea which started 3 hrs p/recvd shots; last vomiting was 7PM 6JUN93;
She could not walk. Both legs were extremely sore and she had to be carried to the bathroom for the rest of the day. The next day there was still some soreness, but she seemed fine by nightfall.
I had my second Pfizer shot on 03 AUG 2021 for COVID-19 prevalence. However, from that time, I keep falling sick with a cold and running nose, and fatigue. I am not fully energetic like before, before the vaccine I used to get flu symptoms hardly once a year, but from the second shot i am infected with a cold almost 7-8 times, this is so annoying and i feel very strange. I suspect this Pfizer vaccine weakens my immunity to other infections. Kindly investigate the issue as soon as possible, even my husband experienced the same after a single Pfizer shot, we both have a clear change in our lives after this covid-19 Pfizer shot, become miserable. Kindly investigate the issue as early as possible,  use my mail ID to contact me further.  Please hide the personal details as per the Compliance & Ethics policy.
One of three pts who exp dizziness, faintness, profuse sweating & was very shaky 1-2 mins following immun; pt recovered spontaneously;
The vaccine refrigerator went out and compromised the MMR vaccines making it invalid at time of administration. No adverse effects were reported. Patient to be revaccinated.
Neck pain, profound fatigue, muscle weakness, dyspnea, altered mental status, confusion, lightheadedness, muscle twitching.  Tx with 5mg cortisol tid for 3d
On 10/01/2021, I woke up with intense abdominal pain that got progressively worse. I went to the ER. They did a CT scan and blood work. They determined that I had an inflammation of my appendix. On 10/02/2021 in the evening, they removed the appendix. On 10/03/2021, I returned home - where I am still recovering.
patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 3 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-369020, MOD-2021-368822, MOD-2021-368863, MOD-2021-368935, MOD-2021-369043, MOD-2021-368886, MOD-2021-369053, MOD-2021-369371, MOD-2021-368831, MOD-2021-369347, MOD-2021-369022, MOD-2021-369249, MOD-2021-369376, MOD-2021-369056, MOD-2021-369020 (Patient Link).
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Caller was asking how long he has to wait to get the booster dose because he tested positive for Covid 10 days ago, 29Dec2021. It was unable to provide contact number, gather address and transfer because the call got disconnected. Created Manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states she did not eat or drink anything in the morning prior to her vaccine. Crackers and water given prior to vaccine. Vaccine administered at 0730. 0748 patient stated she was dizzy, pale, and had blurry vision. She states she felt a whoosh. She was transported to wheelchair and transferred to observation area. BP 81/34 HR 86 100% RA. Patient drank more water and crackers. Remained pale, nauseous. Denies dizziness/blurred vision. 0751 85/40, HR 68 100%RA. 0756 89/53, HR 60, 100% RA. 0801 100/49, 61, 100% RA. 0807 95/64, 57, 100% RA. Patient denies any symptoms. Educated patient and mother on when to call 911. Patient ambulated without difficulty. Discharged home with mom.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF1ZCCFF2528) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Negative, notes: 2 and 4 days later, tested Covid negative; (unspecified date) Positive, notes: 2 days later Covid symptoms reappeared and tested positive again; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Report about Covid treatment reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24May2022, Treatment stop date: 29May2022, Indication: Treatment of COVID-19. If vaccine received reported as Yes. Other medication in 2weeks reported as No. Tested positive 23May2022. Took Paxlovid 5 days. 2 and 4 days later, tested Covid negative. 2 days later Covid symptoms reappeared and tested positive again. Known allergies reported as No. Other medical history reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
STOMACH ACHE; Generalized body pain; Dizziness; FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (STOMACH ACHE), PAIN (Generalized body pain), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE) in an adult female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Kidney stones in 1991, Hives (Iodine allergy manifested by generalized body hives), Asphyxia (Cefazolin allergy manifested by asphyxia), Lithotripsy renal (Lithotripsy in left kidney) in 2017 and Lithotripsy renal (Right kidney lithotripsy) in September 2019. Previously administered products included for Drug use for unknown indication: Iodine and Ancef. Past adverse reactions to the above products included Hives with Iodine; and No adverse event with Ancef. Concurrent medical conditions included Headache, Fibromyalgia since 2020, Fatty liver since 2019, Rheumatoid arthritis, Iodine allergy (Iodine allergy manifested by generalized body hives) and Allergic reaction to antibiotics (Cefazolin allergy manifested by asphyxia). Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Fibromyalgia and Muscle relaxant, ERENUMAB (AIMOVIG [ERENUMAB]) for Headache.   In October 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 06-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (STOMACH ACHE), PAIN (Generalized body pain), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE). At the time of the report, ABDOMINAL PAIN UPPER (STOMACH ACHE), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE) was resolving and PAIN (Generalized body pain) had not resolved.            No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of DIZZINESS, FEVER, HEADACHE, GENERALIZED BODY PAIN and STOMACH ACHE with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. 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.   This case was linked to MOD-2021-623959 (Patient Link).
pt recvd vax; raised nodule areas on hands & elbow that were itchy; 10jan94 biopsy NEG for erythema multiforme;
Dizziness. Water, crackers, juice given. Pt laid on stretcher for 15 more minutes. Stable and released.
Pt received tetanus shot in L deltoid on 9/10/02. Pt states she has had soreness and a tingling sensation (live nerve) in deltoid. Pt states she is unable to abduct her arm or lift anything. Her grasp is equal. Sensation in hands are equal.  Pt states sharp shooting pain from deltoid to wrist.
Patient reported on 2-2-21 that she had a "seizure" during the night following the vaccine.  Patient reports that around 12 hours after the injection (which would have been around 2 am on 1-6-21) that she woke up with her arm sore and with nausea.  Reports that she went to the bathroom because she thought she was going to be sick but husband reports she passed out and had "seizure like" activity.  Husband reports that she "was out" for about 1 minute.  Patient was evaluated by ER staff with labs, CT, urine specimen.  Per the patient everything came back ok except wbc and tsh were slightly elevated.  She is establishing care with primary MD and he is desiring  MRI.  Patient has not had MRI to date due to insurance requirements.  Patients stated that she had COVID in September 2020 and since October 2020 she has been having dizziness and that it has been increasing over the last few months.
No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator and refers to a unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 time dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Caller reports that improperly stored vaccines were administered (Product storage error). The vaccine underwent temperature excursion -40 Fahrenheit (F) for 70 hours 5 minutes. No other adverse events reported.  Lot number #3397T1 is not valid for hepatitis a vaccine, inactivated.