chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; could not walk; A spontaneous report was received from consumer concerning a 39-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and could not walk.  Medical history was not reported. Concomitant medication was not reported.  On 19-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection and developed fatigue.  On 21-Jan-2021, the patient could not walk and was hospitalized.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the events fatigue and could not walk was not provided.  The outcome of the events fatigue and could not walk 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.
increased blood pressure; profound tinnitus; This is a spontaneous report from a contactable nurse (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (Age at vaccination was 58 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. No known allergies reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: el4236), via intramuscular in right arm on an unspecified date in Jan2021 at 08:00 AM. The patient was not received other vaccine in four weeks and other medications in two weeks. The patient not had Covid prior vaccination and not Covid tested post vaccination. On 11Feb2021 at 12:00 AM, the patient experienced increased blood pressure and profound tinnitus. The report was assessed as non serious. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
0905 tightening in chest, 0907 difficulty breathing-wheezing, grunting.  Epi .3 mg x3 IM.  Benadryl .25 po.  02 via nc at 3 LPM.  EMS on arrival gave Predisone IM and 02 via face mask Pt was taken to the ER for treatment.  Was started on BiPap overnight.  Was discharged home the next day.
vaccine dose number=3, 04Sep2021; COVID 19 Treatment; vaccine dose number=3, 04Sep2021; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 at 04:00 as dose 1, single (Batch/Lot number: unknown), on 22Jan2021 at 02:00 as dose 2, single (Batch/Lot number: unknown) and on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ XR, start date: 03Jul2019; OMEPRAZOLE; AMERGE; HYDROCODONE. Past drug history included: Amoxicillin for Allergy:Amoxicillin; Imitrex for Allergy:imitrex; Demerol for Allergy:Demerol.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccine dose number=3, 04Sep2021; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Hypertension: High BP; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had treatment with anti-viral product, brand paxlovid, treatment start date: 30apr2022, treatment stop date: 04may2022, indication: treatment of covid-19. The patient had very High BP while taking. Recurrence of covid symptoms and positive covid test again 5 days post completion of treatment. The patient had other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash to arms, neck, and back. No blistering or weeping. Pt has appt. with PV. MD
After about 26 hours post injection started with pain in injection site, left axillary pain, left axillary lymphadenopathy, fatigue, chills, arthralgias. I have taken 2 doses of Ibuprofen 600 mg.  At 48 hours I continue with pain in injection site, left axillary pain, left axillary lymphadenopathy.
SILVER DOLLAR SIZE REDNESS AND SWELLING ON BACK SIDE OF LT. ARM WHERE MMR WAS ADMINISTERED.
Exactly 32 hours after injection, both myself and a 41 year old friend who got the vaccine with me experienced the following: vomiting, incredible amounts of mucus coming from lungs, uncontrollable diarrhea, violent sweating and chills, extreme headache, bed-ridden for two days. Both the pharmacy and the health dept. refused to record our reactions, and the health dept. hung up when we tried to report this incident. The pharmacy would not call us back.
Patient with COVID vaccinations who admitted with incidental positive COVID test.  Provider d/c note:  ""73 YO M with hx afib, HTN, CKD, hx SAH, dementia, who was admitted for acute on chronic right sided weakness. He had distant history of stroke with R sided weakness, but was more weak than usual. Admitted for stroke workup. He was also found to have incidental COVID-19 infection.  He was found on MRI to have acute to subacute infarct at the left corona radiata extending to the left basal ganglia.  CT angiogram showed multilevel stenosis without large vessel occlusion.  Neurology was consulted.  He was restarted on Eliquis, aspirin and statin.   His course was complicated by acute on chronic CHF and acute kidney injury.  Cardiology and Nephrology were consulted early in his hospital course for assistance managing those issues with improvement.  He also developed prolonged episode of confusion and agitation thought to be due to delirium in setting of advanced dementia.  Over time and with assistance of Seroquel this also improved significantly.  Discharge was delayed primarily due to agitation and mental status changes.  As these issues resolved he was thought to be a candidate for transition to SNF with therapy.  Discharged in good condition."
DTaP injection given 3-10-06; 3-12-06 notice swelling and redness; 3-16-06 reported swelling and tenderness but no redness - diameter of soft tissue swelling 2". 4-10-06 No redness to skin but palpable nodule, soft, mobile under skin is 1/2 centimeter diameter. Area of overlying skin is occassionally itchy.
Patient reported the day after vaccination that she had arm pain and received Tylenol 650mg on 12/31/20 at 0934 and later Zyrtec for allergies at 1010. Patient also reported two loose stools this day and reported no symptoms on 1/1/21.
Nausea/ Extreme nausea; Vomiting; Extreme Fatigue; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Anxiety and Depression. Concomitant products included THYROID (ARMOUR THYROID), PROBIOTICS NOS, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue). At the time of the report, NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: AE contact information,patient details added
The following day after the vaccine at 5:00 AM he had joint and muscle pain and weakness, not able to move his legs.  He would sit down in a chair and needed help to get back up.  Headache, dizziness.  He had a low grade fever of 100.1.   This got progressively worse and then by evening got better.  His wife called the visiting nurse that they had coming who she believes notified the doctor, and told them it would go away.  By the next morning it was basically gone.  He took Tylenol for the symptoms.
Constant terrible pain for 5 weeks--only relief I could get was while my arm was wrapped in a heating pad--felt like nerve pain--horrible. It tapered off after the initial 5 weeks to intermittently and still to this day. (4/6/22) I still have pain every night while trying to get to sleep and sometimes during the day as well--always know it is there.
13NOV97 mom called to report that pt has had inconsolable crying since vax was given;mom also reports redness & swelling in pt lt thigh;recommend that mom check pt temp-given APAP dosage per infant weight, luke warm bath;
PER HYUSBAND, SHE HAD DEVELOPED A LUMP UNDER SKIN. SHE HAD GENERAL MALAISE FOR A FEW DAYS.
lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepping on her chest; shortness of breath; really bad stomach ache; Inside of cheek felt rough; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration (at the age of 55 years) on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that she was very sensitive to a lot of things, so she opted to stay for half an hour (after vaccination). Once she got in the car, she took her mask off, and realized her lips were swelling. She turned around and went back, and they let her sit for a little while longer. The swelling eventually stopped, but she did have swelling inside her cheek as well. It also felt like someone was stepping on her chest the rest of the day, she experienced shortness of breath, heaviness in chest, a really bad stomach ache, but didn't really eat much so didn't think that it was from food. Inside her cheek felt rough. The lip swelling went away without medication. The outcome of swelling inside her cheek, felt like someone was stepping on her chest, shortness of breath, heaviness in chest, a really bad stomach ache, cheek felt rough was unknown.  No follow-up attempts are possible, information on lot number cannot be obtained.
Patient given Moderna per request; but when billed later patient was 16 (under-approved age).
developed fever and rash approx. 10 to 12 days after mmr was giver on Jan. 1, 1998, after rash was gone they developed cough around Feb 11, 1998. Mother took patient to doctor on Feb 16. Dx w/ pharyngitis and told increase heart rate due to infection. Sent home w/ antibiotic. On Feb 17, patient vomiting, mother called doctor, MD orderde suppository over phone. Mother tried suppository for vomiting, did not work. Patient appeared to be getting worse. By 3:00 am Feb 18 mother took patient to ER. Patient died by 4:ooam. Autopsy ordered.  4/17/09 Autopsy report states COD as acute viral myocarditis & manner of death as natural.  Report also states patient had been seen by PCP for cold symptoms on 2/16/1998, dx w/pharyngitis & tx w/antibiotics.  Later that day, began vomiting, called clinic & tx w/suppositories. Coughing & vomiting continued & developed fever on 2/18.  Presented to ER on 2/18/98 w/very labored respirations & fever.  Shortly after arrival, went into cardiopulmonary arrest, resuscitation unsuccessful.
Information has been received from a woman in a doctor's office concerning a 32 year old male who on 05/14/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). On 05/16/2002 the pt developed an inflamed right deltoid muscle, local redness, local soreness, local swelling and cellulitis. The pt was placed on PO, cephalexin (KEFLEX), 500 mg, and diphenhydramine hydrochloride (BENADRYL) for inflammation. Subsequently, the pt recovered. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #0206USA00883 and 0206USA00884). No additional info has been requested.
Initial soreness in shoulder starting one hour after injection and continued for two days. Right eye pain started about 18 hours after injection. Chills and low grade fever (99.1) recorded 26.5 hours after injection. Body Aches, primarily back, and general weakness occurred 28 hours after injection  400mg of Advil taken 32 hours after injection and prior to bed time.  No symptoms following morning/day.
Case number PHEH2015US019559, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 55-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX was stored at room temperature for 24 hours was administered to the patient. No adverse event was reported following the medication error.
The first reaction was redness and swelling at the injection site.  Subsided within three days and did not occur with the second dose.  The second possible reaction was low kidney function tests during a July 2019 doctors office visit indicating the patient had Stage 4 kidney failure.  Increased hydration has improved these numbers to be almost back to normal .  Further blood tests will show if any additional improvement has occurred.
10/10/11 Woke up & noticed that she had numbness in 3 fingers on her R hand, a spot above her R knee & the ball of her R foot. States that the numbness has been progressing since then and now affects the entire right side of her body. NO weakness or pain.
Pt had minor redness around injection site with soreness. Size of a quarter-half dollar. No other symptoms. Pt received ice pack to injection site which she said helped. She was consulted to call her md, or to seek emergency medical care if she notices any chest pain/tightness/ swelling in face/tongue/throat or any other alarming symptoms.   upon follow up phone call 09142019 921am pt reports that she is fine and that symptoms resolved yesterday.
elevated cardiac enzymes; Heart attack; extreme hypertension; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "TAVR" (unspecified if ongoing), notes: TAVR patient. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant), outcome "unknown", described as "elevated cardiac enzymes"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; HYPERTENSION (non-serious), outcome "unknown", described as "extreme hypertension". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Electrocardiogram: Normal; Myocardial necrosis marker: Elevated. Clinical course: Optional Information: TAVR (Transcatheter aortic valve replacement) patient, heart in great condition, no visible signs of damage of obstruction. EKG normal, CT scan normal, only elevated cardia enzymes and extreme hypertension scan normal, only elevated cardia enzymes and extreme hypertension. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Consent form completed by patient and guardian did no have the correct date of birth  Verified at time of administration and not corrected to actual legal date of birth by either the patient or guardian.  Consent form had age over 16 years - eligible for vaccination no adverse event reported - given to individual under 16 years of age. - denied having any ID to verify DOB
4/26/21 2:36 PM  Office Visit 4/27/2021   Internal Medicine Suspected COVID-19 virus infection +1 more Dx Shortness of Breath  ? Earache  ? Generalized Body Aches ? Nasal Congestion Reason for Visit    Note    Pt called in c/o of COVID sxs- b/l ear pain, SOB, loss of taste & smell, burning sinuses, muscle aches, fatigue. Pt denies N/V, cough, & diarrhea. I offered pt an appointment in the overflow room- 04/27/2021 .    Pt would like to know if she should hold off on getting her 2nd COVID 19 vaccine on 05/01/2021   Clinical Support 4/29/2021  Encounter Notes All notes    COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide     MAB Infusion Treatment Team:
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, nerve injury and product administration error. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site muscle pain and nerve injury were not recovered/not resolved and the outcome of the product administration error was unknown. It was unknown if the reporter considered the injection site muscle pain and nerve injury to be related to SHINGRIX. Additional information were reported as follows: The patient received SHINGRIX and did not experience pain upon administration, but later developed pain at the site that was continued till the time of report. The pain was not terrible, but the patient decided not to get the 2nd dose. The patient consulted with her physician and chiropractor and felt that there might have been an issue with the administration and perhaps a nerve was affected. The pain was localized to the muscle. There was consent to follow up.
According to patient's husband who came in to fill a prescription for an oral antiemetic, patient was having severe HA, nausea, chills, and her "throat began to tighten".
Shingles; This is a spontaneous report from a contactable consumer (consumer).  A female patient of an unspecified age received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it is okay to receive as scheduled on 20Feb2021 her second dose of Pfizer-BioNTech COVID-19 Vaccine if she has shingles. She stated that she went to the hospital because of it and it started 2 and a half weeks ago. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX lot #N021171 expiration date on 01-NOV-2018; VARIVAX lot #N020014, expiration date on 17-JUL-2019, lot #N020015, expiration date on 17-JUL-2019 and lot #N024566, expiration date on 07-SEP-2019; and PROQUAD Albumin status of rHA (recombinant human albumin) for lot #N024563 expiration date on 06-MAR-2019, lot #N025718 expiration date on 17-MAR-2019 and lot #N023965 expiration date on 28-FEB-2019, (strength, doses, routes and anatomical locations were not reported) for prophylaxis; which experienced a temperature excursion between 6 and 14 Fahrenheit degrees (F) (13.1 F) for 2 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effect reported. A product quality complaint was not involved. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No further information was provided.
Numbness from Neck to face to head on the left side.  Lasted a few days. 12-30-2020 to January 3rd, 2021.
Got covid 13Apr2021; Covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received the bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 (Batch/Lot number was not reported) (received at the age of 20-years-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot number was not reported) (received at the age of 20-years-old)  as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines within four weeks prior to receiving the Pfizer vaccine. Medical history included known allergy to tree nuts. She has no other medical history. She had no covid prior to vaccination. She was not pregnant at the time of vaccination and adverse events. There were no concomitant medications. It was reported that patient got covid on 13Apr2021. The patient was tested for covid post vaccination. She had undergone a nasal swab on 13Apr2021 and the result was positive. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the reported  COVID  infection as documented by a positive nasal swab in the context of a vaccine failure is possible.  The case will be assessed further upon receipt of additional information.
RED BLOTCHES ALONG THE ABDOMEN AREA. AND PRESSURE UNDER THE ARMPIT AREA.
missed second dosage; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage) outcome was unknown. Not Provided          No concomitant medications  information was reported.  No Treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Followup received on 15-jun-2021 and 2nd dose updated, no AE