chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Celiac artery was compressed; feeling sick; did not stop throwing up; nauseated; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of COELIAC ARTERY COMPRESSION SYNDROME (Celiac artery was compressed), MALAISE (feeling sick), VOMITING (did not stop throwing up) and NAUSEA (nauseated) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis. Concomitant products included USTEKINUMAB (STELARA) for Psoriasis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COELIAC ARTERY COMPRESSION SYNDROME (Celiac artery was compressed) (seriousness criterion hospitalization), MALAISE (feeling sick) (seriousness criterion hospitalization), VOMITING (did not stop throwing up) (seriousness criterion hospitalization) and NAUSEA (nauseated) (seriousness criterion hospitalization). At the time of the report, COELIAC ARTERY COMPRESSION SYNDROME (Celiac artery was compressed), MALAISE (feeling sick) and NAUSEA (nauseated) outcome was unknown and VOMITING (did not stop throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She gave her stool sample on 12 Apr 2021 and result will take 1 to 2 weeks, she was still throwing up on and off and she was not 100% better. She took ondansetron to treat her vomiting and nausea. She was concerned if she can she take 2nd dose of Moderna vaccine and what would happen if she miss the time limit.; Sender'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.
Cough; Congestion; Clearing his throat constantly; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   In 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) (unknown route) 1 dosage form. In 2021, the patient experienced COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly). The patient was treated with GUAIFENESIN ongoing since an unknown date for Cough and Congestion nasal, at a dose of 400 mg. At the time of the report, COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly) outcome was unknown.            Treatment medication also includes nasal inhaler.  Patient had past issues with statins that gave him muscle aches.
Fever 99.9; Chills; Hot flashes; Body aches; Headache; Nausea; Weak feeling; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an intramuscular route of administration in the left arm on 26Apr2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. 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 sertraline hydrochloride (SERTRALINE HCL) from an unknown date and unknown if ongoing for an unknown indication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 03:00, the patient experienced fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Apr2021, the patient underwent body temperature test and the result was 99.9 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.9, chills, hot flashes, body aches, headache, nausea and weak feeling were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 25-SEP-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Muscle aches starting at 3pm 1/9/21, progressing into the e night
Two weeks after the first dose I suddenly experienced sudden tinnitus, ear fullness, and vertigo. I sough medical care the next day and was told I had allergies, after two days I went to an ENT and was given audiometry testing and it was discovered I was experiencing sudden hearing loss. I was put on a high dose of prednisone for 12 days, had a intratympanic injection of dexamethasone to try and regain the lost hearing and help with the tinnitus and none of the treatments worked. Now almost two months after the event I am still experiencing tinnitus and was diagnosed with sudden idiopathic sensorineural hearing loss and tinnitus. I did not think to attribute it to the vaccine but saw some other reporting a similar experience and wanted to report just in case this is a side effect that can be researched and even fixed in the future.
Red bumpy itchy hives appeared first on my right collarbone, then left collarbone on Monday morning after the Friday afternoon vaccination.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medications was not reported. On unkonwn dates, the patients were vaccinated subcutaneously with doses of VARIVAX (Merck) (0.5 ml, lot# and expiration date were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Expired Shingrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 74FB9, expiry date 17-MAR-2023) for prophylaxis.   On 21-MAR-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 21-MAR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Shingrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-MAR-2023 The reporter reported a patient was administered an expired (17-Mar-2023) vaccine inadvertently. The reporter consented to follow up.  The patient was administered an expired vaccine inadvertently, which led to expired vaccine used. This case was linked with US2023046086, US2023046091 reported by the same reporter.; Sender's Comments:  US-GSK-US2023046091:Same reporter US-GSK-US2023046086:Same reporter
could not sleep; felt jittery; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep) and FEELING JITTERY (felt jittery) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (could not sleep) and FEELING JITTERY (felt jittery). At the time of the report, INSOMNIA (could not sleep) outcome was unknown and FEELING JITTERY (felt jittery) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Fatigue; Sharp pulsating pains in lower right leg.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 10:00 (Lot number: 301458A) at the age of 54 years for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 01Sep2021. The following information was reported: FATIGUE (non-serious) with onset 29Sep2021, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Sharp pulsating pains in lower right leg.". Therapeutic measures were not taken as a result of fatigue, pain in extremity. No follow-up attempts are possible. No further information is expected.
c/o itchy, runny eyes, swelling in both eyes, runny nose;wheezing & some diff w/breathing;pt given epi & DPH, ice pack applied to rt arm;
pt recv vax;devel croup;5nov devel classic parotis which involved throat swelling;lab eval revealed IgG=4.47,WBC count=13.1;RBC count=4.36;hemoglobin=12;hematocrit=35.8,MCV=82.1;MCH=27.5;MCHC=33.5;RDW=12.4;Platelet count=386;MPV=7.8;Lymph
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jun2023 as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) at the age of 71 years, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing). Other medical history was reported as "healthy." The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Drug Ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I received the vaccine on 12/23. I noticed my back was really itchy that day but didn't think much about it. The next day I had a rash on my arms, back, and chest. My eyes were swollen on 12/25. Rash still has not resolved today, maybe even worse.
SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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 patient experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Headache & Tachycardia Narrative: 1/5 received the vaccine. Woke up in the middle of the night with heart rate to 115-116. Resting heart rate is normally 45. This morning his heart rate was still elevated to 100 range. Has slight headache which developed 1/6 around 9:30. He drank water and it's improved. His heart rate is about 95 BPM at 10:30 on 1/6. He denies all other symptoms. He didn't sleep well because of the fast heart rate so he feels fatigued today.
Increased heart palpitations that have increased starting a few days after injection  fever and sweats for 2 days post injection
Red rash starting from left arm between the shoot and elbow in ~5-6 hrs and spread to both arms, legs, face and neck by ~18hrs. Included swelling of face and lips. No breathing trouble or throat swelling. Treatment giving Benadryl starting ~18 hrs. after shoot. 50 mg Bendaryl every 6 hrs. treatment on going today  (4/25/21) >72 hrs after shoot. Will continue treatment and observation.
8.5 hours after vaccine, experienced convulsive  shaking, teeth chattering, trouble walking/ handling objects.  Severe pain all over body, particularly in spine and hips.. Lasted 1 hour.  Followed by fever that lasted 9 hours.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple dates (08-JAN-2016, 11-JAN-2016, 20-JAN-2016, 26-JAN-2016, 27-JAN-2016, 01-FEB-2016, 02-FEB-2016 and 03-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II albumin status recombinant human albumin (rHA), lot # L020188, expiration date 03-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
dose of PROQUAD administered to patient following a temperature excursion; No additional adverse event; This spontaneous report was received from a vaccine coordinator/healthcare professional concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter, once, lot # T025506, expiry date: 23-JAN-2022, for prophylaxis (route not provided); following a temperature excursion. The vaccine was stored  at 5.68 Fahrenheit (F) degrees for 5 minutes. In a previous temperature excursion, the vaccine was stored at 18 F for 1 hour 30 minutes. The temperature excursions were detected by a data logger. No additional adverse events were reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA000593: US-009507513-2104USA000593:
This spontaneous report as received from a physician via company representative refers to a 57 year old female patient. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX 0.5 ml/one shot dose (route not reported) lot # J011828 and expiration date 26-DEC-2014 in the left arm. There was no pertinent medical history. There were no allergies or drug reactions reported. There was no concomitant medication. On 12-MAY-2014, the patient developed a large open blister at the ZOSTAVAX injection site on their left arm. The patient stated that it was hot all around (the blister). The patient sought medical attention and was given SILVADENE and unspecified antibiotics for treatment. At the time of the report the outcome of the events was reported as not recovered. Additional information is not expected.
Was seen in ED on 9/4/18 for maculopapular rash and decreased temperature. Mother reported sweating through her clothes. She then noted babe was cold and re-dressed her. Babe again sweat through her clothes and as mom was undressing her again, checked her temperature (96.4 rectal) and noted a rash on her abdomen. Temperature was 97.3 degrees in ED. ED stated that this is consistent with viral illness.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of M-M-R II, lot numbers reported as M037096 and M044351, with expiration date of 23-AUG-2018 and 04-NOV-2018 respectively (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger".  No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA010669:
SEVERE ARM /SHOULDER PAIN PERSISTING FOR 3 WEEKS AFTER INJECTION
Pt received anthrax shot #3 on 11/14/02. Pt noticed local reaction in morning of 11/15/02. Swelling measures 5 inches in length.
TC fr mom infant has swollen eyes; Starts to suck from bottle & quits, "acts like he is worn out"; Referred for eval; no fever;
Pt called office with complaint of arm swollen, red, warm and painful to touch. Swollen area bigger than a 50 cent piece. Advised office visit.  Pt seen on 07/13/2010 advised to use Benadryl and cool compresses if worsens or new symptoms needs to be seen. Pt. returned to office with increased swelling on 07/14/2010 seen by Dr pt treated with Prednisone 20mg BID X 5 days told to stop Benadryl and use Atarax 25mg every 6 hours as needed and Keflex 250 mg BID X 10 days.  Told to call or return to clinic if new symptoms or worsens.
He got his vaccine, and had no reaction at that time.  He noticed that he has lost his body hair, his legs are smooth, his arms are smooth and he was hairy before the vaccine.  He has no body facial hair and was extremely embarrassingly hairy prior to this, very thick and curly and now  has nothing  on the legs and arms.  The hair on his chest is darker but not as full as it was.  This has been rather sudden of a change.
pt had diff raising lt arm since day p/inj;c/o pain localized @ inj site & diff w/showering & dressing;pt feels sx are worse now;tx w/Myoflex;did not consult FMD;
Increasing body ache, mild fever, injection site pain, chills, very sensitive skin, left face pain
Client was followed up with about six weeks or so after vaccination d/t billing question. She had notable but not concerning bleeding at the time of vaccination. She stated her arm hurt and continued to hurt afterwards. She reported bruising for about 3-4 weeks. She did not receive any follow-up care nor did she have any complaints at the time of phone call.
Patient reported redness, pain in her wrist,  and swelling  24 hours after receiving vaccine. Patient reported that it was still stiff and sore 2-3 days after
I had severe pain that started in my left shoulder, then into my left neck for 5 days; I had severe pain that started in my left shoulder, then into my left neck for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy, Food allergy (sea food), Asthma and Hypertension.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days). At the time of the report, ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days) had resolved.            No concomitant medication were provided No treatment details were provided