chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gout in the left leg triggered.; injection site pain; mildtemperature rise; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7533) via unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included gout and colitis that had been in remission for the last 7 years. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (unspecified) (MANUFACTURER UNKNOWN) and diosmin, herperidin (DIOSMIN COMPLEX) for unknown indication from unknown date. On 01Apr2021 at 22:00, the patient had gout in the left leg which was triggered (gout aggravated) in the evening after the vaccination. He was prescribed with indomethacin and COLCRYS and had mild effects after 14 hours of first symptoms. On the same day, the patient had very little pain at injection site (vaccination site pain) and also experienced a mild temperature rise in the first 24 hours. Therapeutic measures were taken as a result of injection site pain, mild temperature rise and included treatment with indomethacin and COLCRYS. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event gout in the left leg triggered which was resolving, while the injection site pain and mild temperature rise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Observation 9/10/22-9/12/22 SOB, cough, weakness, dizziness, loss of taste and smell, decreased appetite, leg edema, PE, abnormal labs, HTN,
Patient experienced anxiety post vaccination. Chest burning, sweating, nauseated. Waited approximately 35 minutes and said she felt much better. Called patient at 10:42 and she stated all symptoms had completely resolved.
Pt developed menstrual cycle which involved more cramping and heavier flow than is normal for her
strange feeling in tongue, tight in chest, scratchy voice, hoarse voice, itching around moth, abnormal breathing, coughing, injection site produced sunburn mark
I feel like crap/I do not feel right; I can hardly breath; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route, as 2nd dose, single dose on 27Apr2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient stated, patient had a big problem with the vaccine, '20' patient was vaccinated, 2 weeks ago and patient felt like crap. Patient went to the emergency room, doctor said that patient had COVID, they did the testing for the COVID. Patient got the Pfizer COVID 'flu' testing, nothing appears wrong but does not feel right, patient could hardly breath, patient need help. The clinical outcome for the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Seasonal allergy symptoms; Missed 2nd dose on 25 Mar 2021; positive PCR; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive PCR), SEASONAL ALLERGY (Seasonal allergy symptoms) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (positive PCR). On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021). On an unknown date, the patient experienced SEASONAL ALLERGY (Seasonal allergy symptoms). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021) had resolved. On 30-Mar-2021, COVID-19 (positive PCR) had resolved. At the time of the report, SEASONAL ALLERGY (Seasonal allergy symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Polymerase chain reaction: negative (Negative) Negative-not detected (Source of sample-Nasopharyngeal). On 15-Mar-2021, Polymerase chain reaction: positive (Positive) Positive-detected Source of sample-Saliva).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The patient had done with quarantine on 30 Mar 2021. The patient experienced COVID-19 symptoms of chills and fatigue.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received updated patient demographic details, laboratory data, narrative information. On 28-Jul-2021: Follow  up information Received on 28-JUL-2021 contains No New Information.
This case was reported by a healthcare professional (also the subject) and described the occurrence of swelling injection site in a 42-year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and accellular pertussis vaccine, absorbed BOOSTRIX, (GlaxoSmithKline). The subject received her last tetanus diphtheria vaccine four years previously, but had not received BOOSTRIX. There was no relevant medical history, concurrent conditions or allergies. The subject did not use tobacco and her alcohol use was described as social. Concurrent medications included LOESTRIN FE, AMBIEM and LEXAPRO. On an unspecified date the subject received 1st dose of BOOSTRIX (0.5 cc, intramuscular, left deltoid). On 9 April 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling at injection site and injection site soreness. On 21 April 2009, the events were resolved. The healthcare professional considered the events were related to vaccination with BOOSTRIX.
Information has been received from a healthcare worker concerning her 15 year old daughter who on an unspecified date was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # not reported).  Concomitant therapy included an injection of tetracycline.  Subsequently the patient developed hives.  At the time of this report the patient had not recovered from the hives.  Additional information has been requested.
Suspected syncope/pass out soon after administering shot, called 911, paramedics said she had low blood pressure, they thought she was good to go and she left
On 7/28/16 at approximately 2000, LPN reported to this writer that it was discovered that PEDIARIX Lot # 22J73, with an expiration date of 10/09/15 were inadvertently given to patient by LPN on 5/31/16, 4/5/16, and 1/26/16. All 3 were signed out by LPN.
liquid retention on the right leg; aortic valvle replacement. 2nd process, because of a "leaking valvle; difficult breathing. He was admited in ER.; pneumonia; He never get the 2nd dose of Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) in a 75-year-old male 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 Pneumonia, Thoracic cavity drainage on 04-Mar-2021 and Aortic valve replacement (Replacement 2nd process, because of leaking valve) on 29-Mar-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (difficult breathing. He was admited in ER.) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) (seriousness criterion hospitalization). In 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FLUID RETENTION (liquid retention on the right leg) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  On 4 March2021 Doctor performed a thoracic drainage,On 29 march patient went to the hospital for aortic valve replacement 2nd process, because of leaking valve and patient suffered with liquid retention on the right leg.  Company Comment  This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.; Sender's Comments: This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (DILUENT MRK INJ) used to reconstitute the VARIVAX was properly stored. On 08-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N031001 and expiration date 03-NOV-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001756:
At around  09:30 am I was feverish, tired and sick at my stomach and vomited twice.
had pain in both arms from the elbow to the shoulder / pain / comes and goes; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   The patient's past medical history included breast operation and shingles.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2020, the patient received FLUAD (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil), paracetamol (Tylenol), trolamine salicylate (Aspercreme) and biofreeze (nos) (Biofreeze). On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: On 10th October 2020, the patient received Fluad. The beginning of November 2020 she had pain in both arms from the elbow to the shoulder. The patient reported it was not a steady pain but comes and goes. The patient had used Advil, Tylenol, Aspercreme, and Biofreeze to help treat the pain.  The patient did not have lot number or expiration date information to provide. The reporter consented to follow up. It was unknown if the reporter considered the pain in arm to be related to fluad.
Seizure  - trip to emergency room - follow up MRI, Cardiologist and Neurologist appts
Large red rash on left hand left middle finger; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 at 13:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included fish allergy (Salmon allergy). Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ) 50mg daily and ibuprofen (MOTRIN) 500mg morning; both for unknown indication started for an unknown date. The patient previously took PERCOCET, VICODIN, AUGMENTIN, CELEBREX, LEVAQUIN and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 04:00, the patient on the left hand in the left middle finger experienced a large red rash size of a 1/2 dollar coin. It doesn't bot hurt or itch. Just very noticeable. The patient did not receive any treatments for red rash. The clinical outcome of the event red rash was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; Felt a little tired; nauseated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Felt a little tired"; NAUSEA (non-serious), outcome "unknown", described as "nauseated".  Additional information: Patient had sore arm the next day and felt a little tired and nauseated but it was very short lived. Patient also had cancer so was expecting to be little worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tightness in throat, numbness in tongue and tingling in R hand. She went to the ER at 15:30 to get checked out. She reported that they gave her IM BENADRYL. She stated that her symptoms resolved in the next hour after that.
Four minutes after vaccination with 2nd dose of Pfizer Covid vaccine, mom and sister reported patient's eyes rolled back, closed eyes, "shook for a moment", and slid down chair. Family yelled for help and I called 911. Patient's eyes reopened and was feeling dizzy; seemed to understand questions but unable to speak immediately after. Wet paper towel was provided to put on forehead and patient was monitored for anaphylactic, seizure, and other symptoms until emergency personnel arrived. Patient was evaluated and fireman stated that patient likely had "syncopal reaction".
GENERAL FLU; Loose stools; Arm soreness; muscle soreness; FEVER OF 102; This spontaneous report received from a patient concerned a 34 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: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced general flu. On APR-2021, the subject experienced loose stools. On APR-2021, the subject experienced arm soreness. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced fever of 102. Laboratory data included: Body temperature increased (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, muscle soreness, fever of 102, general flu and loose stools was not reported. This report was non-serious.
7/26-28, Slight sore arm, fatigue started in 24 hours then came chills & a dull gas like pain under right rib cage GI trac (No upset stomach), stools start softening. 7/29-9:30am soft stool w/dark patches possibly old blood or clots & ribbons of fresh blood suspended in the water, 1/3-1/2 tsp blood in water 3x that day. 7/30-31 stools soft and mixed w/ dark patches, water tinted pink (not ribbons). 8/1-2, stools slightly firmer, less dark patches, water less pink tine. 8/3-4, stool softer again w/ patches & light tint again. Dull pain under right ribs more intermittent. ( My son had the same pain under right rib w/soft stool but no blood. Same day vac). 8/2-4- contacted Pharmacy they said this is not normal.
trouble breathing; heart rate went up to 150, 160; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) and TACHYCARDIA (heart rate went up to 150, 160) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and TACHYCARDIA (heart rate went up to 150, 160). At the time of the report, DYSPNOEA (trouble breathing) outcome was unknown and TACHYCARDIA (heart rate went up to 150, 160) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported. Treatment information was not provided.
About 3 wks after vaccine, aching & cramping in muscle and joint in upper L/arm at vax site. Dr put him in sling & take 2 days off from work; got a little better but now is getting worse. Can't sleep for the pain; never completely went away
It started in the middle of the night waking me up while laying in bed.  The bed felt like it was spinning.  (No. I had not been drinking alcohol) Dizziness, unstable when walking-needed to stop and hold on to something to stable myself., Dizzy and wobbly feeling upon moving head side to side or walking, bending down and back up.  Mostly dizzy upon movement which lasted for 5 days until Saturday, January 23 afternoon.
pt recv vax & 10min later c/o itching on lt arm w/a 5cm red circle over lt arm;pt reported feeling a little weak but not SOB;pt BP was 130/90, 140/70 over next 15min;pt c/o itching over rt arm;
Case number PHEH2014US018220 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 29 Aug 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Swollen hard red rashy lump about 2" diameter at injection site.  Fever, all over muscle weakness and aches, loss of appetite, nausea, fast heart beat.
pt exp pain @ the inj site;the reporter was uncertain whether the pain began immed p/inj & persisted for 2.5wk, or whether the pain did not begin until 2.5wk p/the inj;
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 43 year old female. 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 not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20210807937.
TIRED; ACHY; SHAKES; COULD NOT  MOVE; CHILLS; ZERO ENERGY; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 13:00 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 20-JUN-2021, the subject experienced achy. On 20-JUN-2021, the subject experienced shakes. On 20-JUN-2021, the subject experienced could not move. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced zero energy. On 21-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy, zero energy, shakes, and could not move, and had not recovered from tired. This report was non-serious.
Vomiting and diarrhea and fever after shots. Vomiting has resolved. Still has diarrhea and intermittent fevers.
Hives; rash; swelling of right side of face by the cheek; This is a spontaneous report from a contactable consumer(patient) reported that. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 17Jun2021 10:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 68 years). The patient past Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, Algae no's, cyanocobalamin, nicotinamide, pantothenic acid, pyridoxine, riboflavin, selenium, thiamine, tyrosine (THYROID COMPLEX) taken for an unspecified indication, vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 18Jun2021 14:00, the patient experienced hives, rash and swelling of right side of face by the cheek. No treatment was received. The event outcome was recovering.  Information on the lot/batch number has been requested.