chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very tired; Slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and HYPERSOMNIA (Slept all day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Drug allergy (codeine) and Contrast media allergy.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (very tired) and HYPERSOMNIA (Slept all day). At the time of the report, FATIGUE (very tired) and HYPERSOMNIA (Slept all day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.  Treatment information not provided.
This spontaneous report was received from a male patient of unknown age, who was reporting on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in October 2015 (reported as "6 months ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided). On an unknown date in October 2015 (reported as "6 months ago"), on the next day following vaccination, the patient developed sores on his feet. The outcome of the event was not recovered. The sores did not improve and have not healed at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.
A serious spontaneous report of narcolepsy and non-serious event of weight gain has been received from a physician concerning a four-year-old female, subsequent to FLUMIST. The patient's medical history was not reported. The patient had no concomitant medications. The patient received FLUMIST on 01-Oct-2010. The first symptoms to start were tiredness, hyporeflexic and ataxia to a point of inability to walk. The child was normal and was not on concomitant medications prior to onset of symptoms. The child became symptomatic in Nov-2010 and was hospitalized in Dec-2010 for several days. MRI and CSF tests were normal. Weight gain was also reported. The child was symptomatic at the time of reporting and prescribed modafinil as diagnosed with narcolepsy and cataplexia. The outcome of all the events was not recovered.
Lesion measuring 1.2 cm in elevation and 1.5 cm in diameter. Firm to touch with no associated fluctuance. No drainage. Erythematous. No associated hot. Ultrasound: A region of increased echogenicity, which is moderately demarcated from adjacent subcutaneous fat, is demonstrated anteriorly in the right thigh, corresponding to the palpable abnormality. It measures 7.8 x 6.8 x 4.5 mm. A portion of the center is slightly more hypoechoic, but no significant fluid is identified within the region. A small linear collection of fluid may be present deep to this region. Findings are most consistent with a region of induration/reactive change. A drainable abscess is not identified. This apparently corresponds with a region of a vaccination.
golf ball sized hard lump on her deltoid, discomfort, redness of the injection site, hot to the touch
Intensely itchy red rash which appeared 9 days following vaccination, in the area of the vaccination site, about 4 ?x 5?. It appeared suddenly on 1/31 and has subsided slightly now.  I had surgery at Hospital today to remove a port and the medical personnel advised me to report this rash.  I attempted to do so,   but was advised by Urgent Care to go to the Emergency Room, which seemed totally unnecessary. I have an appointment for the second shot on 2/22 and wanted to get advice before that.
Shivering; Getting very cold; Very very tired like I'm coming down with something; Hands are cold and numb; Hands are numb; This case was reported by a consumer via sales rep and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019 04:00, the patient received the 2nd dose of Shingrix. In October 2019, 21 hrs 30 min after receiving Shingrix, the patient experienced shivering, cold, tiredness, cold hands and numbness in hand. On an unknown date, the outcome of the shivering, cold, tiredness, cold hands and numbness in hand were unknown.   It was unknown if the reporter considered the shivering, cold, tiredness, cold hands and numbness in hand to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started getting very cold shivering very very tired like coming down with something, and hands were cold and numb after vaccination. The patient was watching 6 1/2 month old grandchild and hoping that this is not causing him to be in any kind of danger. The patient did not think to ask that since it was immunization and did not think it would cause a baby any harm.
Fever of 101.1, chills, sweats, chest heaviness, horrible headache, nausea, fatigue, muscle soreness, sore left arm, decreased appetite.  Fever started early Wednesday and was gone by Thursday (11/11/21). Muscle soreness was better by 11/12/21.  11/13/21 still fatigued, chills, sweats and horrible headache.
3/26: first dose Pfizer  4/6: insane nausea, chills, migraine, body aches, vivid dreams, insomnia  4/7: severe lower abdominal pain, cough, rash on injection arm
Bruised immediately, swelled up. On the way home patient vomited, and had an anaphylactic reaction. Co-worker took patient to the ER. Patient recieved 3 Benadryl injections, IV fluids, given Rx for Benadryl and phenegran for vomiting. Doing well now.
C/O Right ear pain for about 5 months, intermittently.  Does have swollen pre-auricular lymp node.  Ear pain and swelling occur since COVID 19 vaccine in January.  lasts up to one week at a time, then subsides for about 1 week or more.  Pain located in right jaw, right ear canal and up into the right scalp.  Pain is aching, not sharp pain. Sometimes throbbing pain.  Sometimes right sided headache.  Denies photophobia or phonophobia.  No history of ear pain or headaches.  no swimming. no ear drainage.  Denies fevers, chills or night sweats. No weight loss.  Feeling of fullness, no hearling loss.  Took amoxacillin 1000 mg BID x 2 weeks when symtpoms began several months ago.  Then doxycycline 100 mg BID x 2 weeks.  No improvemen tin symptoms.  Pain not effected by opening or closing mouth.   Cleaned ear 1 week prior to MD appointment with a Q tip and there was brownish green liquid on the q tip.
bad headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority.  A male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "bad headaches". Therapeutic measures were not taken as a result of headache.  Additional information: A contactable consumer reported for a male patient (husband) to report some adverse events experienced by her husband. The reporter mentioned that after her husband's 2nd shot of the vaccine (10Mar2021), he started experiencing bad headaches and wants to know if it's okay to take pain relievers. She also clarified that her husband didn't take any pain relievers yet. the reporter was not a Healthcare Professional (HCP). It was unknown whether the reporter's contact information available to you or a sub-contracted party or If the reporter is not the prescribing HCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHE; VOMITING; DIARRHEA; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, vomiting, diarrhea, chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, nausea, vomiting and diarrhea was not reported. This report was non-serious.
My arm was sore for 3 days but worth it.; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient demographics were not reported,age group captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and experienced pain in arm for 3 days. The case is linked with Mother's case (US2021AMR104391).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104391:same reporter (mother´s case)
p/vax pt collapsed @ school w/dizziness & T39.6C & also exp tenderness @ local spine;pt was hosp in the ICU overnoc;
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feel tired) and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced FATIGUE (Feel tired) and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still). At the time of the report, FATIGUE (Feel tired) outcome was unknown and LYMPHADENOPATHY (Developed swelling of his lymph nodes next to his left ear and towards the jaw and the bottom of his chin which hurt, He says the pain is bad still) had not resolved. No concomitant medications was reported. No treatment was reported. This case was linked to MOD-2022-543615, MOD-2022-543563, MOD-2022-543627 (Patient Link).
Information has been received from a certificated medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates after 29-OCT-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L021215, expiration date 10-JUN-2017, dose and route were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the two reports from the same reporter. Additional information has been requested.
About 12 hours after the injection I experienced explosive diarrhea that continued off and on for  about 5 hours until my stool ran clear. Also gut cramping.
Patient stated that after vaccine was administered she was very sore "all over" & had a low grade fever over the next 3-4 days. Also complained of a possible sinusitis a couple of days following.
Patient received improperly stored PROQUAD; No additional adverse effect reported; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions y concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S021732 and expiration date 10-JAN-2021 (strength, dose, frequency and route of administration were not reported). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  vaccine was diluted with a properly stored sterile diluent No additional adverse effect reported.   The temperature excursion was from -9°C to 8°C - 8.56C, during a time frame of 1 hour. No previous temperature excursion was reported.   It was reported that the call was made because a digital data logger.
7.5cm x 6cm area of erythema/warmth in right deltoid area. Ice, Motrin.
pt recv vax 30-apr-96&devel pain&swelling;tx w/compress&APAP;2MAY96 noted to have 2+ erythema of the rt arm w/tenderness extending around the rt upper arm,the elbow,& down the proximal third of the forearm;cellulitis
The patient reported that she felt tired the day following the vaccination (4/2/11). She took a nap in the afternoon and when she awoke, she had pain in both of her legs. She went back to sleep and when she woke up (around 9:30pm), she continued to have leg pain and also felt "out of it", and had fever symptoms. She went to the ED at hospital at 11pm. She had a temp of 102 degrees and also complaints of stomach ache, cough, and shortness of breath. She reported that she was discharged on Sunday (4/3/11) from the ED, stayed home from work on Monday (4/4/11) and returned to work on Tuesday, April 5th. She related that the doctor at the hospital was "not sure if it was related to the rabies shot".
Pt developed a generalized papular eruption pattern, especially dense on trunk, neck, both lower extremities and also on face.
Woke up at 3:16 a.m. very warm and with EXTREME dizziness - comparable to bed spin. Also, some weakness and nausea. Had a difficult time standing and walking to the bathroom. Sat up on the bed and rested my head against the wall hoping for dizziness to subside. Tilted my head back and focused on the ceiling to be able to walk and steadied myself by leaning on the bed. Took 4 ibuprofen and 1 meclazine and went back to bed. Injection site very sore, but no visible redness. Took 2 more ibuprofen when I got up at 7:00. Dizziness almost gone. Felt almost normal around 9:00a.m. Still a little ?residual dizziness? but not bad.
Pt recv vax on 3/1/99; on 3/2/99 pt exp LA pain at vax site, headache, nausea; tx=Esoteric, ice
Dermatological effects: rash, itching on the left arm from the elbow to the wrist
She presented with symptoms of palpitations and was diagnosed with myocarditis.  She was hospitalized 5/27-5/28/21 and discharged in stable condition.
Case number PHEH2014US021541 is an initial spontaneous report received from a nurse on 24 OCT 2014. This report refers to a 15 months old female infant. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411601) via intramuscular route on 09 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Presented on 26June06 with c/o pustules to L shoulder, L neck, L side of chin, and L thigh following smallpox vaccination on 15June06. Reports feeling feverish previous week with pustule formations beginning at that time. C/O tenderness to smallpox vaccination site. Seen at ER on 25June06. Area of erythema and swelling to vaccination site measured 6 inches by 6 inches.
Severe muscle aches, severe nausea, dizzy, unable to lift the arm injection was received in.  Continued past 24 hrs after injection.
The patient came in to receive an updated Bivalent Pfizer booster but was accidentally given the original Pfizer vaccine
Severe fatigue, Headache, and intermittent "warmth" for the past 6 days.
TACHYCARDIA; PAIN IN ARM; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a 41 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not provided and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced tachycardia, pain in arm, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tachycardia, headache, nausea and pain in arm was not reported. This report was non-serious.
Patient felt dizzy then collapsed and became unresponsive 10 minutes after vaccine shots. Peripheral pulse not palpable HR very low. She was given Epipen 0.3 mg and she responded to this right away. HR, BP, mental status all improved. Transferred to the ER.
Onset w/ h/a, fever, cough ATB taken x 7 days; cough continues w/call MD again due to painful cough; 10DEC recovered w/o further MD intervention;
Under arm pain on arm of injection. Swelling of under arm as well. Lasting 6 days. Did require me to take over the counter pain relief.
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Pain near armpit; potentially be caused by a clot; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (at the age of 55 years); tofacitinib citrate (XELJANZ), oral from an unspecified date (Batch/Lot Number: DY4552) to an unspecified date, at 10 mg, twice a day for an unspecified indication. Medical history included Ulcerative colitis, unspecified with unspecified complications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received her covid vaccine on 19May21. Approximately 2 weeks later, she started experiencing pain near her armpit between breast and arm. She wanted to know if her xeljanz could cause this. I advised that it is not a common side effect but could potentially be caused by a clot. Patient stated it does not get worse when she takes a deep breath. The outcome of the event was unknown. The action taken in response to the events, for tofacitinib citrate was unknown.
I developed 3rd degree heart block or Atrioventricular block after my vaccine shot of the 2nd dose covid19 vaccine.  I went to the Emergency room and was admitted for Emergency surgery on my heart.  After my surgery I had developed chest pains that lingered for 1 month until the symptoms improved.  My surgery was on March 16th, 2021
Cut end of left thumb with circular saw and came to HD for Td on 04/15/03.  Developed large hard sore area at site of injection.  This gradually improved and now has small pea-sized knot. About 2 weeks after injection noticed throbbing pain and weakness on exertion of forearm - pain when arm rotated.  This is still present as well as numbness of thumb at the tip where injury occurred.  Has had to take pain med several times.
Experience chills on the next day after administration of 2nd dose; This is a spontaneous report from a contactable non-healthcare professional. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 13:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. It was unknown if the patient had any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), mefenamic acid (ADVIL), multivitamin and probiotic (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 23Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 10:00, the patient experienced chills on the next day after administration of 2nd dose. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills was not recovered at time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax;3-4 days later reported myalgia in lower limb,thighs & buttocks;pain & tenderness in neck muscles;fever 102.5 w/ shaking chills;myalgia present regardless of motion;exp mild conjunctivitis;studies done by rheumatologist
This spontaneous report as received from a registered pharmacist refers to a 66 year old male patient. On 12-SEP-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided). Concomitant therapies included LUNESTA, XANAX, CELEBREX, ANDROGEL, VIAGRA. Approximately in September 2013, reported as "since the administration of ZOSTAVAX", the patient had lost weight. The patient contacted pharmacist. The outcome of the event was unknown. Additional information has been requested.